chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pulmonary pain, Vomiting
Clinical narrative: could not taste or smell; could not taste or smell; nasal congestion; Achyall over; Vomited; Migraine; lungs started burning; persistent dry cough; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 21Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced achy all over, vomited, migraine, lungs started burning, and persistent dry cough on 21Dec2020 and could not taste or smell and nasal congestion on 22Dec2020 at 15:00. The clinical course was reported as: The patient felt a little achy, then vomited. She had a migraine for 2 hours, lungs started burning, and had a persistent dry cough. The patient was achy all over. At about 3:00 PM the next day, the patient could not taste or smell and had nasal congestion. The patient stated that this could be typical for positive COVID-19 infection. The patient was later getting better and feeling better. The clinical outcome of achy all over, vomited, lungs started burning, persistent dry cough, could not taste or smell, and nasal congestion was recovering and of migraine was recovered in Dec2020.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: developing a left facial droop; Bell's palsy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable physician reported that a female patient of an unspecified age received the first dose of bnt162b2 (COVID-19 Vaccine) via an unspecified route of administration on an unspecified date in Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that the patient received the COVID-19 vaccine roughly two weeks ago (Dec2020) and is developing a left facial droop, they are concerned if that is a sign of facial Bell's palsy. It's left side and it's a facial droop. The physician was concerned if patient is developing Bell's palsy and they are wondering if she should get the second dose or not. The physician further stated that her patient got the vaccine like about 2 weeks ago and developed Bell's palsy three days after the administration of the vaccine (Dec2020) and of course she won't be able to get to see because we are all booked up until yesterday and that is like about a week ago, after the onset of Bell's palsy. Outcome of the event was unknown.   Information about lot and batch has been requested.; Sender's Comments: The event is considered possibly related to the suspect product based on the assumed positive temporal association. The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular the following relevant information is not available: patient's medical history and concomitant medications, exact vaccination date, event outcome. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test, Upper respiratory tract congestion
Clinical narrative: Cold/ cold like symptoms; Sore throat; Congested/ sore throat; Sore arm; I was hurting for a day; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscular on left arm at single dose for COVID-19 immunization on 23Dec2020 at 61-year-old. No medical history or concomitant medication. Yesterday (30Dec2020), the patient woke up with a sore throat, it was like getting cold with a sore throat, congested, the patient had cold like symptoms, seemed like the patient was getting a cold. The patient just took decongestant medication. After waking up this morning (31Dec2020) the patient did not have taken anything. The patient got tested for COVID (for antigen not a PCR) yesterday (30Dec2020) and was negative. The patient did not have got any fever, just sore arm a week ago (Dec2020). She was hurting for a day and then she was good, everything good. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Chills, Feeling cold, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: lost his sense of smell/cannot smell anything; Sore throat; sweating a lot; Fever; chills; body felt cold; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899  and Expiration Date: 31Mar2021) via an unspecified route of administration on 21Dec2020 14:30 at single dose in left arm  for Precaution (covid-19 immunization). NDC number of Pfizer COVID Vaccine: 59267-1000-2. The patient's medical history and concomitant medications was reported as none. The patient works in a hospital and got the first shot.  Before he got the vaccine, he did not have any symptoms and felt great. They told him he may feel some symptoms for a couple of days. Now, he was getting symptoms of COVID 2 nights ago (around 20:00 28Dec2020) such as fever, chills, body felt cold, fever. Last night (30Dec2020) when he slept, he sweated a lot. Maybe it is one of the reasons.  He did not have a fever, but he sweated a lot.  He felt like his shirt was wet in the morning. He also had sore throat and lost his sense of smell on 06:00 31Dec2020. It is weird. He never had that before.  He doesn't know what the do. If it was normal or it was symptoms of COVID. Second one will be on 12Jan2020. Should he get tested for COVID. Wanted to know if he should get the second dose. The outcome of events, fever, chill, felt cold, sweating a lot was recovering. The outcome of sore throat and cannot smell anything was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lost his sense of smell/cannot smell anything; Sore throat; sweating a lot; Fever; chills; body felt cold; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old male patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899  and Expiration Date: 31Mar2021) via an unspecified route of administration on 21Dec2020 14:30 at single dose in left arm  for Precaution (covid-19 immunization). NDC number of Pfizer COVID Vaccine: 59267-1000-2. The patient's medical history and concomitant medications was reported as none. The patient works in a hospital and got the first shot.  Before he got the vaccine, he did not have any symptoms and felt great. They told him he may feel some symptoms for a couple of days. Now, he was getting symptoms of COVID 2 nights ago (around 20:00 28Dec2020) such as fever, chills, body felt cold, fever. Last night (30Dec2020) when he slept, he sweated a lot. Maybe it is one of the reasons.  He did not have a fever, but he sweated a lot.  He felt like his shirt was wet in the morning. He also had sore throat and lost his sense of smell on 06:00 31Dec2020. It is weird. He never had that before.  He doesn't know what the do. If it was normal or it was symptoms of COVID. Second one will be on 12Jan2020. Should he get tested for COVID. Wanted to know if he should get the second dose. The outcome of events, fever, chill, felt cold, sweating a lot was recovering. The outcome of sore throat and cannot smell anything was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Chills
Clinical narrative: nurse got Covid after getting the vaccine; nurse got Covid after getting the vaccine; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that a nurse got Covid after getting the vaccine. The reporter wanted to know if the chills were common. She wanted to know if it is okay to feel chills every now and then. She wanted to know how people would know if they are positive when getting the vaccine. The outcome of the event was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Based on the limited information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Flushing, Immediate post-injection reaction, Palpitations
Clinical narrative: a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This is a spontaneous report from a contactable Nurse(patient). This Nurse reported for similar events for 6 patients. This is 1st of 6 reports. A 49-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at the 49 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The registered nurse and 5 other registered nurses she worked with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after she was injected with the COVID-19 Vaccine. She had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes.  The patient said she had no other symptoms after receiving the COVID-19 Vaccine. The reporter said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. The reporter said stated the registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter stated she did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. The patient works at a hospital but didn't received any medical treatment. The patient just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. Case will be reevaluated based on follow-up information ,Linked Report(s) : US-PFIZER INC-2021001363 same reporter/drug/event, different patient.;US-PFIZER INC-2021001364 same reporter/drug/event, different patient.;US-PFIZER INC-2021001195 same reporter/drug/event, different patient.;US-PFIZER INC-2021001204 same reporter/drug/event, different patient.;US-PFIZER INC-2021001329 same reporter/drug/event, different patient.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: a strong, whole body heat, and flushing; a strong, whole body heat; tachycardic; Palpitations; This is a spontaneous report from a contactable Nurse(patient). This Nurse reported for similar events for 6 patients. This is 1st of 6 reports. A 49-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at the 49 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The registered nurse and 5 other registered nurses she worked with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after she was injected with the COVID-19 Vaccine. She had a strong, whole body heat, and flushing. She said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes.  The patient said she had no other symptoms after receiving the COVID-19 Vaccine. The reporter said there were 5 other registered nurses that received the COVID-19 Vaccine at the same time and had the same exact symptoms she experienced. The reporter said stated the registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine. The reporter stated she did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. The patient works at a hospital but didn't received any medical treatment. The patient just waited her symptoms out, and within 5 minutes her symptoms had gone away. The outcome of the events was recovered on 28Dec2020.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association. Case will be reevaluated based on follow-up information ,Linked Report(s) : US-PFIZER INC-2021001363 same reporter/drug/event, different patient.;US-PFIZER INC-2021001364 same reporter/drug/event, different patient.;US-PFIZER INC-2021001195 same reporter/drug/event, different patient.;US-PFIZER INC-2021001204 same reporter/drug/event, different patient.;US-PFIZER INC-2021001329 same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Oropharyngeal pain, Pain
Clinical narrative: headache; body ache; chills; runny nose; sore throat; diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself; occupation/specialty: hospital worker) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 at 18:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient mentioned that the paper works she had stated that the side effects would start within an hour, but in her case, she experienced side effects over 24 hours that's Friday on 01Jan2021, such as headache, body ache, chills, runny nose, sore throat, and diarrhea. She wanted to know if she was infected with Covid, because of her job or she was having side effects because of the vaccine. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: headache; body ache; chills; runny nose; sore throat; diarrhea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself; occupation/specialty: hospital worker) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 at 18:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient mentioned that the paper works she had stated that the side effects would start within an hour, but in her case, she experienced side effects over 24 hours that's Friday on 01Jan2021, such as headache, body ache, chills, runny nose, sore throat, and diarrhea. She wanted to know if she was infected with Covid, because of her job or she was having side effects because of the vaccine. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea
Clinical narrative: got symptoms of mild cold; running nose; cough; This is a spontaneous report from a contactable physician (patient). A 81-years-old male patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, unspecified route to administration on 23Dec2020 (at the age of 81-years-old) as a single dose for COVID-19 immunization.  Medical history included hypertension and mild diabetes Concomitant medication included nebivolol hydrochloride (BYSTOLIC), clonidine, hydralazine, losartan, nifedipine. The physician got symptoms of mild cold, running nose and cough in Dec2020. "It just came a last two days and it's been cough and runny nose. I don't have a fever." Outcome of the events mild cold, running nose and cough was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Fatigue, Headache
Clinical narrative: headache; feeling like having a temperature; was not high and it was 95; felt like tired; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, expiry date were unknown) via an unspecified route of administration on 31Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Jan2021 almost like 11 o'clock, the patient started with headache and was feeling like having a temperature but when checked, temperature was not high and it was 95, the patient felt like tired. The patient stated "I remember they said after you put in this, this is may be what happen. So, is it still in there is it still, so my question is can I take a some medicine or I need to wait till later with no medicine." The outcome of the events headache, body temperature decreased, fatigue was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Sore arm at injection site; Fever; Chills; body aches; This is a spontaneous report from a contactable physician (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on left arm on 21Dec2020 13:30 at single dose for COVID-19 immunization. Medical history included COVID-19 from Apr2020 to an unknown date and dust allergy. Concomitant medication included ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient experienced sore arm at injection site, fever, chills, body ache (mini COVID as compared to when he had COVID in early April) on 22Dec2020 03:00 (reported as 12-13 hours later). Symptoms controlled with Tylenol for about 15-20 hours. The patient underwent lab tests and procedures which included nasal swab on 09Dec2020, 14Dec2020, and 16Dec2020, results are all negative. The outcome of the events was recovered.  Information about Lot/Batch number is requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Feeling of swelling in throat within 30 minutes of vaccine; This is a spontaneous report from a contactable physician (patient himself). A 56-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer, lot EK9231, expiry date not reported), intramuscularly in the left arm on 02Jan2021 12:00 at single dose, for Covid-19 immunisation. Medical history included seasonal allergy and mild allergic rhinitis. There were no concomitant medications. The patient experienced feeling of swelling in throat within 30 minutes of vaccine, lasted 5+ hours, mostly by 9 hours on 02Jan2021. He took Singulair, Pepcid, Albuterol, Intranasal steroids and Phenylephrine as treatment. The outcome of event was recovering.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Pyrexia
Clinical narrative: extreme fever; chills; shortness of breath; This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included hospitalization due to COVID-19 (severe case several months prior but less than 90 days). The patient's concomitant medications were not reported. The patient experienced extreme fever, chills, and shortness of breath on an unspecified date. The clinical outcome of extreme fever, chills, and shortness of breath was recovered on an unspecified date.   The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: extreme fever; chills; shortness of breath; This is a spontaneous report from a contactable physician (patient). A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included hospitalization due to COVID-19 (severe case several months prior but less than 90 days). The patient's concomitant medications were not reported. The patient experienced extreme fever, chills, and shortness of breath on an unspecified date. The clinical outcome of extreme fever, chills, and shortness of breath was recovered on an unspecified date.   The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Sex: M
Vaccine: FLUX
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: green bret syndrome and he died from it; Initial information was received on 05-Jan-2021 regarding an unsolicited valid serious social media case from a consumer.  This case is linked to case 2021SA003660 (same reporter).  This case involves male patient (of an unknown age) who had green bret syndrome and he died from it (Guillain-Barre Syndrome) after receiving NFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious green bret syndrome and he died from it (Guillain-Barre Syndrome) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the outcome was reported as fatal for the event Guillain-Barre syndrome.  It is unknown if an autopsy was done. The cause of death was reported as Guillain-Barre syndrome.  Information on the lot number was requested.; Sender's Comments: This was a poorly documented social media case involves male patient (of an unknown age) who had Guillain-Barre Syndrome and died from it, after receiving INFLUENZA VACCINE. Time to onset is unknown. Additional information regarding patient's relevant medical history, health condition at the time of vaccination, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: green bret syndrome
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: vaccination in a pregnant woman with no adverse event; Initial information received on 04-Dec-2020 regarding an unsolicited valid non-serious case received from a healthcare professional (patient).  This case involved an unknown age female patient who received INFLUENZA VACCINE while she was pregnant with no adverse event (Exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. She was exposed to INFLUENZA VACCINE at an unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatments, vaccinations, concomitant medications and family history, were not provided.  Information regarding current pregnancy history was not reported.  Information regarding previous pregnancy was not reported.  Information regarding maternal drug exposure was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via unknown route at an unknown administration site as prophylactic vaccination.  Information regarding pregnancy complication was not reported.  It was not reported if infertility treatment was given or not.  Information regarding family history of congenital abnormality was not reported.  Information regarding prenatal testing was not reported.  At time of reporting, the pregnancy was still ongoing.  Information on the batch number was requested.
Sex: M
Vaccine: DTAPIPV, HIBV, PNC
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient under required age limit being administered with Quadracel instead of Daptacel; Initial information regarding an unsolicited valid non-serious case received from a health care professional on 15-Dec-2020.  This case involves a 15 months old male patient who was under required age limit being administered with quadracel instead of daptacel (product administered to patient of inappropriate age), while he received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar); HepB vaccine and hib vaccine conj (tet tox) (Acthib).  On 23-Oct-2020, the patient received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE at a dose of 0.5 mL daily via intramuscular route right thigh (lot number: C5772BA; Expiration date: 07-Oct-2022) for prophylactic vaccination.  On an unknown date, it was reported that the was under required age limit being administered with quadracel instead of daptacel (product administered to patient of inappropriate age) (non-serious event) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  No laboratory tests were reported.  It was not reported if the patient received a corrective treatment. At the time of report, the outcome was not applicable for the event.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave Quadracel to a male patient who is 3 years old; with no AE; Initial information received on 18-Dec-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 3 years old male patient who received diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] (product administered to patient of inappropriate age).   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad).  On 18-Sep-2020, the patient of 3 years old received a dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccineat a dose of 0.5 ml once (lot C5688AA, with unknown strength, formulation and expiration date) via unknown route in unknown administration site (product administered to patient of inappropriate age).   It is an actual medication error case due to inappropriate age at vaccine administration.   At the time of report, no adverse event was reported.   There will be no information available on the batch number for this case.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect route of product administration, Product preparation issue
Clinical narrative: patient was administered with liquid portion, with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Global Medical Information (Reference number- 00401074) and transmitted to Sanofi on 21-Dec-2020.  This case involves a 7 months old male patient who received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number UJ342AAA, expiration date 22-Jun-2021, second dose, strength-standard) via intramuscular route in the right thigh for prophylactic vaccination on 17-Dec-2020 (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) and INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for prophylactic vaccination.  It was a case of actual medication error due to Inappropriate reconstitution technique (latency-same day).  At the time of report, no adverse event was reported.  Reporter stated that while training new medical assistant (MA), got box of Pentacel. New MA gave only vial containing liquid portion (IPOL and Daptacel) and reporter did not check Pentacel box for any other components and just injected patient. Reporter discovered this error while documenting the dose when noticed that ActHB component was in the box. Reporter asked if the dose was valid and if patient need to revaccinate and when.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: "Moderna COVID-19 Vaccine EUA"  Vaccine administered to wrong age patient. No known allergies or medical conditions. Nurse who administered vaccine did not know vaccine not approved for anyone under the age of 18.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysphagia
Clinical narrative: About 30 minutes after shot - mouth dryness then slight difficulty swallowing.  Took Benedryl and cleared up within the hour
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: Diarrhea Chills Fever
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, aches, headache, Tylenol and rest. Recovered after 1 day
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Neck pain
Clinical narrative: My right neck shoulder region started hurting approximately 7 hours after the vaccination and progressively increase in pain. I took Tylenol 1300mg on Tuesday evening. I woke up Wednesday morning with some discomfort and decided to take another dose of Tylenol 1300mg approximately 10:00 am. The pain increased and I took another dose of Tylenol 1300 mg approximately 1500. Tylenol was not relieving my discomfort and approximately at 1800 I took Celebrex 200 mg . I went to bed at 2200. Lying down was difficult. I could not turn my head from side to side without excruciating pain. I finally went to sleep. I woke up Thursday morning pain free.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Onset of fever, chills, muscle aches/joint pain, headache 11 hours after injection. Fever, chills, and severe muscle aches/joint pain lasted for about 24 hours. Milder muscle aches and headache lasted for about 36-48 hours.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Myalgia, Pain
Clinical narrative: Onset of fever, chills, muscle aches/joint pain, headache 11 hours after injection. Fever, chills, and severe muscle aches/joint pain lasted for about 24 hours. Milder muscle aches and headache lasted for about 36-48 hours.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Onset of fever, chills, muscle aches/joint pain, headache 11 hours after injection. Fever, chills, and severe muscle aches/joint pain lasted for about 24 hours. Milder muscle aches and headache lasted for about 36-48 hours.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Myalgia
Clinical narrative: Dizziness muscle aches, chills, fatigue
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Hot flush, Nausea, Pruritus
Clinical narrative: 40 minutes post shot - became extremely flush and hot; face and neck redness that lasted about an hr..  8 hrs. post injection had extreme itching in upper body (stomach, arms, back and head).  Also experiencing nausea and headache since onset of itching.  Taking Benadryl, Pepcid and Zyrtec.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site scab, Injection site swelling, Injection site warmth
Clinical narrative: Day 7 after vaccine, noted itching and swelling to left deltoid. Day 8 after vaccine, noted increased swelling, redness, itching and heat.  Entire left deltoid area affected Day 9 after vaccine, redness extended past margins, itching and heat continued.  Swelling subsided somewhat.  Seen at Urgent Care.  No medications received.  Instructed to monitor and call for antibiotics next day if s/s continue or worsen Day 10 after vaccine, swelling subsiding, redness turning pink, continued with warmth and itching  Day 11 after vaccine through today Day 14, itching continues, scab at site of injection noted.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fear of injection, Hyperhidrosis, Nausea, Tinnitus
Clinical narrative: Patient c/o dizziness, nausea, diaphoresis, tinitus. Patient states this occurs after every vaccination due to her fear of vaccinations/needles. Patient moved to a cot via wheelchair and placed in trendelenberg for approximately 30 minutes. Offered water, crackers. Symptoms resolved and she exited clinic without difficulty, accompanied by a friend.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Cellulitis, Erythema, Injection site pain, Skin warm, Swelling
Clinical narrative: 12/24 received moderna vaccination had soreness x 48hours which resolved, did not experience redness or swelling   12/31 started to experience pain at injection site again 1/1 noted redness and the development of swelling extending from the axillary region to the elbow   Denies fever chills Reports she feels well otherwise12/24 received moderna vaccination had soreness x 48hours which resolved, did not experience redness or swelling   12/31 started to experience pain at injection site again 1/1 noted redness and the development of swelling extending from the axillary region to the elbow   Denies fever chills Reports she feels well otherwise Skin:    General: Skin is warm and dry.     Findings: Erythema present.     Comments: Left deltoid region-edema medially extending near axillary to elbow Deltoid region warm to touch Tender to palpation At baseline she has redness of both deltoid regions but the left is significantly more erythematous Infectious Disease    Cellulitis of left upper extremity - Primary      Given degree of edema tenderness and erythema suggestive of a cellulitis Cephalexin 500 mg 4 times daily x7 days given Tylenol for comfort      Relevant Medications   cephALEXin (KEFLEX) 500 mg capsule
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Tenderness
Clinical narrative: 12/24 received moderna vaccination had soreness x 48hours which resolved, did not experience redness or swelling   12/31 started to experience pain at injection site again 1/1 noted redness and the development of swelling extending from the axillary region to the elbow   Denies fever chills Reports she feels well otherwise12/24 received moderna vaccination had soreness x 48hours which resolved, did not experience redness or swelling   12/31 started to experience pain at injection site again 1/1 noted redness and the development of swelling extending from the axillary region to the elbow   Denies fever chills Reports she feels well otherwise Skin:    General: Skin is warm and dry.     Findings: Erythema present.     Comments: Left deltoid region-edema medially extending near axillary to elbow Deltoid region warm to touch Tender to palpation At baseline she has redness of both deltoid regions but the left is significantly more erythematous Infectious Disease    Cellulitis of left upper extremity - Primary      Given degree of edema tenderness and erythema suggestive of a cellulitis Cephalexin 500 mg 4 times daily x7 days given Tylenol for comfort      Relevant Medications   cephALEXin (KEFLEX) 500 mg capsule
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Erythema, Feeling hot, Headache
Clinical narrative: diarrhea, headache,chills,sweats,nausea welt the size of a small orange that is red and hot with a rash
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Rash, Urticaria
Clinical narrative: diarrhea, headache,chills,sweats,nausea welt the size of a small orange that is red and hot with a rash
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Throat tightness
Clinical narrative: On my way home, about 30 minutes after the vaccine, my throat became tight and my lips and tongue were tingly. At 4 pm I took a Benadryl. At 7pm I took a second one and went to bed at 7:30. In the morning these symptoms were gone
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Headache, Pain in extremity, Pruritus
Clinical narrative: Two hours after receiving the vaccine, I had extreme headache, this lasted for over 24 hours, after that the next 2 days was a lighter headache and some light brain fog feeling.  The day after the vaccine had some mild chest pain, 5 minutes worth and than went away. Left arm hurt but just the usual with a shot. 6 days after vaccine, I had a rash and bump over my right ear, itchy arms and hands and neck area.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Two hours after receiving the vaccine, I had extreme headache, this lasted for over 24 hours, after that the next 2 days was a lighter headache and some light brain fog feeling.  The day after the vaccine had some mild chest pain, 5 minutes worth and than went away. Left arm hurt but just the usual with a shot. 6 days after vaccine, I had a rash and bump over my right ear, itchy arms and hands and neck area.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: Fever 104, chills, nauseas, swollen lymph's armpits, severe headaches
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, severe chills for around 4 hours
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: Patient felt dizzy 30 minutes post injection, required extra observation and rest time to dissipate. She was slightly hypertensive 145/88 mm/Hg and 147/91 mm/Hg. Heart rate was consistently in the 80 BPM range.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Patient developed metallic taste in mouth post vaccination, gingerale helped to alleviate it.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Neck mass, Urticaria
Clinical narrative: A week after receiving the vaccine I woke up with hives like symptoms at the injection site (right arm) and on my chest. There is also a lump that developed on my right collarbone within the past two days.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: injection site is swelling and hot to the touch
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth at injection site 8 days after injection, began 01/07/21 and still currently present
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Joint swelling, Muscular weakness, Myalgia
Clinical narrative: Generalized fatigue, right knee pain and swelling. Muscle pain and weakness around right lower extremity.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Began with very painful and swollen injection site the first night. Tuesday during the day I took Tylenol and it helped. Tuesday evening I was hit with extreme chills and body aches. Injection site was very hot, painful, red and swollen. Stayed wrapped in a blanket for hours. Lasted into my sleep. Had a low temp in the morning on Wednesday (99.7) Seemed to have the" sweats " most of the day. Injection site was still hot, red and swollen. Today feeling better but injection site is still painful and has a mounded lump.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Began with very painful and swollen injection site the first night. Tuesday during the day I took Tylenol and it helped. Tuesday evening I was hit with extreme chills and body aches. Injection site was very hot, painful, red and swollen. Stayed wrapped in a blanket for hours. Lasted into my sleep. Had a low temp in the morning on Wednesday (99.7) Seemed to have the" sweats " most of the day. Injection site was still hot, red and swollen. Today feeling better but injection site is still painful and has a mounded lump.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo - started 2 hours after injection and lasted 24 hours
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Muscle twitching
Clinical narrative: After the standard soreness after injection lasting approx 3 days, symptoms dissipated. At around 7 days post injection, acute onset of profound redness, swelling and pain was noted to the injection site.   Now at 10 days, redness and swelling still present, however symptoms have decreased in severity. Now I have muscle twitching at the injection site as well.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Feeling hot, Headache, Nervousness
Clinical narrative: Was nervous about getting the shot. Felt clammy and hot.  Felt weak and had a headache.  A Code was called and he was transported to the emergency room for monitoring.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Rash erythematous
Clinical narrative: 7 days after, sore arm, red rash approximately size of palm of hand, warm to touch,
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Nausea, Pain
Clinical narrative: woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F. Fever did not respond to 600 mg ibuprofen. Later that day developed headache and body aches. Pain at injection site present as well.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F. Fever did not respond to 600 mg ibuprofen. Later that day developed headache and body aches. Pain at injection site present as well.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Rapid onset chills 103 temp injection site tenderness
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chlamydia test, Culture urine, Epididymitis, Gonorrhoea, Testicular pain
Clinical narrative: Right testicular pain, diagnosed R epididymititis, treated with levaquin 500 gm qd x10d
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Right testicular pain, diagnosed R epididymititis, treated with levaquin 500 gm qd x10d
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: RASH IN THE  LEFT ARM WHERE THE  THE VACCINE WAS ADMINISTER. THE EMPLOYEE TAKE ZYRTEC FOR TWO DAYS
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills and body aches for 24 hours
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium, Blood pressure increased, Electrocardiogram, Full blood count, Heart rate increased
Clinical narrative: 5 mins after injection heart rate increased ton170 and blood pressure increased to 180/00 showed no signs of anxiety.  Symptoms subsided within 2 hours
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction
Clinical narrative: 5 mins after injection heart rate increased ton170 and blood pressure increased to 180/00 showed no signs of anxiety.  Symptoms subsided within 2 hours
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site scab, Injection site swelling, Skin exfoliation
Clinical narrative: on 7th day post vaccination, I had left upper arm swelling, rash, and pain where there had previously been none. Freckles on that upper arm scabbed over and peeled. This event lasted less than 2 hours. No medications taken, no medical care received. No further reaction since then.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: fever, chills, headache, muscle and joint pain, duration 24 hours