chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: He almost passed out a couple times; Fever; weak; Awful shakes; Sweating; Chills; Stomach like on fire; Diarrhea; He lost about 4 pounds; has autoimmune disease, lupus; has autoimmune disease, lupus; he thinks he was almost dehydrated; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration at right arm, on 22Jan2021 14:30, at SINGLE DOSE for COVID-19 immunization.  Medical history included autoimmune disease, systemic lupus erythematosus diagnosed in 2018 (over 3 years ago). Concomitant medication included baricitinib taken in a clinical trial, a study, unknown if 2 or 4mg plus placebo for lupus. On 25Jan2021, at 14:30 in the afternoon, the patient was sweating and it was awful shakes and chills, and it lasted over three hours, and on 26Jan2021 he was weak. The patient lost about 4 pounds on 25Jan2021, with all the water running out of of him. The sweating and shakes happened so suddenly and stomach felt like it was on fire on 25Jan2021. The stomach feeling like it is on fire has gone away, he almost passed out a couple times on an unspecified date, he had diarrhea on 25Jan2021, it was unbelievable. The sweats with awful shakes has gone away on 25Jan2021, but it was horrible, he has recovered with a lasting effect, he is a little weak, but he can move he had to take his dog to the beautician. Diarrhea: the is not eating (had no breakfast this morning) however it was also reported that the patient had a little slice of roast beef and blackberries not many, and he has been drinking, he thinks he was almost dehydrated in Jan2021, he drank about a quart of water so far today. On an unspecified date, the patient had fever. His doctor called the day before and said it was alright; his rheumatologist said it was ok. Outcome of the events he almost passed out a couple times, fever, chills, weak, Diarrhea, He lost about 4 pounds, he thinks he was almost dehydrated was unknown; the events sweating, awful shakes recovered on 25Jan2021 with sequalae, while Stomach like on fire recovered in 2021.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Hyperhidrosis, Loss of consciousness, Pyrexia, Tremor
Clinical narrative: He almost passed out a couple times; Fever; weak; Awful shakes; Sweating; Chills; Stomach like on fire; Diarrhea; He lost about 4 pounds; has autoimmune disease, lupus; has autoimmune disease, lupus; he thinks he was almost dehydrated; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration at right arm, on 22Jan2021 14:30, at SINGLE DOSE for COVID-19 immunization.  Medical history included autoimmune disease, systemic lupus erythematosus diagnosed in 2018 (over 3 years ago). Concomitant medication included baricitinib taken in a clinical trial, a study, unknown if 2 or 4mg plus placebo for lupus. On 25Jan2021, at 14:30 in the afternoon, the patient was sweating and it was awful shakes and chills, and it lasted over three hours, and on 26Jan2021 he was weak. The patient lost about 4 pounds on 25Jan2021, with all the water running out of of him. The sweating and shakes happened so suddenly and stomach felt like it was on fire on 25Jan2021. The stomach feeling like it is on fire has gone away, he almost passed out a couple times on an unspecified date, he had diarrhea on 25Jan2021, it was unbelievable. The sweats with awful shakes has gone away on 25Jan2021, but it was horrible, he has recovered with a lasting effect, he is a little weak, but he can move he had to take his dog to the beautician. Diarrhea: the is not eating (had no breakfast this morning) however it was also reported that the patient had a little slice of roast beef and blackberries not many, and he has been drinking, he thinks he was almost dehydrated in Jan2021, he drank about a quart of water so far today. On an unspecified date, the patient had fever. His doctor called the day before and said it was alright; his rheumatologist said it was ok. Outcome of the events he almost passed out a couple times, fever, chills, weak, Diarrhea, He lost about 4 pounds, he thinks he was almost dehydrated was unknown; the events sweating, awful shakes recovered on 25Jan2021 with sequalae, while Stomach like on fire recovered in 2021.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: He almost passed out a couple times; Fever; weak; Awful shakes; Sweating; Chills; Stomach like on fire; Diarrhea; He lost about 4 pounds; has autoimmune disease, lupus; has autoimmune disease, lupus; he thinks he was almost dehydrated; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration at right arm, on 22Jan2021 14:30, at SINGLE DOSE for COVID-19 immunization.  Medical history included autoimmune disease, systemic lupus erythematosus diagnosed in 2018 (over 3 years ago). Concomitant medication included baricitinib taken in a clinical trial, a study, unknown if 2 or 4mg plus placebo for lupus. On 25Jan2021, at 14:30 in the afternoon, the patient was sweating and it was awful shakes and chills, and it lasted over three hours, and on 26Jan2021 he was weak. The patient lost about 4 pounds on 25Jan2021, with all the water running out of of him. The sweating and shakes happened so suddenly and stomach felt like it was on fire on 25Jan2021. The stomach feeling like it is on fire has gone away, he almost passed out a couple times on an unspecified date, he had diarrhea on 25Jan2021, it was unbelievable. The sweats with awful shakes has gone away on 25Jan2021, but it was horrible, he has recovered with a lasting effect, he is a little weak, but he can move he had to take his dog to the beautician. Diarrhea: the is not eating (had no breakfast this morning) however it was also reported that the patient had a little slice of roast beef and blackberries not many, and he has been drinking, he thinks he was almost dehydrated in Jan2021, he drank about a quart of water so far today. On an unspecified date, the patient had fever. His doctor called the day before and said it was alright; his rheumatologist said it was ok. Outcome of the events he almost passed out a couple times, fever, chills, weak, Diarrhea, He lost about 4 pounds, he thinks he was almost dehydrated was unknown; the events sweating, awful shakes recovered on 25Jan2021 with sequalae, while Stomach like on fire recovered in 2021.  Information on the lot/batch number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Flank pain, Pleurisy
Clinical narrative: Atrial fibrillation; pleurisy (flank pain, diagnosed as pleurisy at the ER); pleurisy (flank pain, diagnosed as pleurisy at the ER); This is a spontaneous report from a contactable consumer. An 86-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: E13248, expiry date: unknown), via an unspecified route of administration on 23Jan2021 07:00 at single dose (Left arm) for COVID-19 immunization. Medical history included well managed hyperlipidemia and hypertension, arthritis, meningioma benign, Bell's palsy (onset was 2010) resolved with sequelae. Known allergies include Sulfa, Codeine, and Macrobid. The patient is not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), losartan, hydrochlorothiazide (HTZ), desmopressin, fenofibrate. Facility type vaccine was reported as Doctor's office/urgent care. The patient experienced atrial fibrillation, pleurisy (flank pain, diagnosed as pleurisy at the ER) on 24Jan2021 20:00. Events resulted in Emergency room/department or urgent care. Treatment of IV pain medication (unk) was given. Patient had no covid prior vaccination, covid was not tested post vaccination. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events.
Sex: F
Vaccine: COVID19
Symptoms: Mononucleosis heterophile test negative, Odynophagia, Pharyngitis, Respiratory viral panel, SARS-CoV-2 test negative
Clinical narrative: Started showing symtpoms of odynophagia (pain in swallowing) on 19Jan2021; Had ulcerative pharyngitis; clean based yellow ulcers on tonsillar beds bilaterally; This is a spontaneous report from a non-contactable consumer. A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient started showing symptoms of odynophagia (pain in swallowing) on 19Jan2021. The patient also experienced ulcerative pharyngitis, clean based yellow ulcers on tonsillar beds bilaterally. No purulent discharge, no lymphadenopathy, no angioedema, mon screen negative, COVID screen negative, strep throat negative, viral panel negative on an unspecified date. The patient was hospitalized for 2 days due to the events. The patient received treatment for the events. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test negative, Tonsillar ulcer, Viral test negative
Clinical narrative: Started showing symtpoms of odynophagia (pain in swallowing) on 19Jan2021; Had ulcerative pharyngitis; clean based yellow ulcers on tonsillar beds bilaterally; This is a spontaneous report from a non-contactable consumer. A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient started showing symptoms of odynophagia (pain in swallowing) on 19Jan2021. The patient also experienced ulcerative pharyngitis, clean based yellow ulcers on tonsillar beds bilaterally. No purulent discharge, no lymphadenopathy, no angioedema, mon screen negative, COVID screen negative, strep throat negative, viral panel negative on an unspecified date. The patient was hospitalized for 2 days due to the events. The patient received treatment for the events. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Neurological symptom, Pain
Clinical narrative: All my stroke symptoms returned immediately; numbness on left side of face, left hand, left foot, left chin; Weakness; pain; all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin. Weakness and pain; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: PF EL3249), via an unspecified route of administration in arm left, on 16Jan2021 12:00 PM at single dose for COVID-19 immunisation. Medical history included massive stroke in Jul2018, left side effected; numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago; asthma. Patient was allergic to shrimp, lobster. Patient is not pregnant. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Concomitant medications included Losartan, Amlodipine, acetylsalicylic acid (ASPIRIN), Atorvastatin, Montelukast. Patient was previously allergic to codine, tetracycline. On an unspecified in Jan2021 (reported as 15Jan2021, pending clarification), all her stroke symptoms returned immediately. Numbness on left side of face, left hand, left foot, left chin, weakness and pain from stroke 2 years ago returned immediately and had not subsided 2 weeks later. Patient received treatment, physical therapy continued for stroke symptoms. AE resulted in doctor or other healthcare professional office/clinic visit, the reported seriousness criterion is disability. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Unevaluable event
Clinical narrative: She has COPD and other health conditions and went to the hospital for a few days after getting the vaccine; This is a spontaneous report from a contactable consumer (reported for her mother-in-law). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID-19 vaccine on 07Jan2021. It was reported that on Jan2021, she has chronic obstructive pulmonary disease (COPD) and other health conditions and went to the hospital for a few days after getting the vaccine. The reporter was where she can get the second dose now, she thinks the date she was supposed to get it has passed. She needed to find out where the second dose can be attained and asked for the number to the local health department for their area. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Haemorrhage, Limb injury
Clinical narrative: he was bleeding profusely; fell; hurt his hand; This is a spontaneous report from a Pfizer-sponsored program. A male patient (caller's husband) of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at single dose on 24Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient got his Covid vaccine on 24Jan2021 and today (26Jan2021) he fell and hurt his hand and he was bleeding profusely. They want to give him a tetanus shot, but caller was not sure if he can get it or not. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Pyrexia
Clinical narrative: appendicitis/abdominal pain/fever; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a fever on 26Jan2021. She was having abdominal pain. She went to the emergency room and found out she had appendicitis. On 29Jan2021 (reported as six days after getting vaccine), she had to have emergency surgery and have an appendectomy due to have appendicitis. She mentioned she is following up finding out statistics with CML and appendicitis. She did not regret getting the vaccine, but she wanted to make sure events were reported. Like anything leaded to a hospitalization needed to be noted regardless if it was concluded to be related to the vaccine or excluded from being related. She mentioned she wanted to find out the most accurate up to date information on how many cases of Adverse Event reactions have occurred, related to appendicitis. She wonders if there is a website where she found this information. She did not want to look on internet and find inaccurate information. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The reported appendicitis with symptoms of abdominal pain and fever is considered related to the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association.    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 RA, IEC, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Hepatic cirrhosis, Platelet count decreased
Clinical narrative: cirrhosis of the liver; Low platelets; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced low platelets and cirrhosis of the liver on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, SARS-CoV-2 antibody test negative
Clinical narrative: negative for both in spite of two doses of vaccine; This is a spontaneous report from a contactable Physician (patient). A 70-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration, the second dose on 11Jan2021 (lot number: EL1284) in right arm and the first dose on 21Dec2020 (lot number: EK5730) in left arm, both at single dose for covid-19 immunisation. Medical history included osteoarthritis, diagnosed 10 years prior to the report. Concomitant medications included metformin at 500mg tablet by mouth once daily for longevity (off label); paracetamol (TYLENOL) at two one time and on occasional acetylsalicylic acid (ASPIRIN) at one 325mg tablet on as needed basis. Patient was calling about the COVID vaccine, and he received two doses, and the problem was, he had an IgM and IgG test on 25Jan2021 and he was negative for both in spite of two doses of the vaccine. The outcome of the event was not recovered. Serious criteria for the event was reported as medical significant. The reporter considered the event was unrelated to COVID vaccine, stated it was the exact opposite, it didn't cause anything, which was unfortunate.; Sender's Comments: Event represents an intercurrent medical condition and unrelated to bnt162b2.  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.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female
Clinical narrative: breast cancer; This is a spontaneous report from a contactable consumer reporting for self. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient said she was recently diagnosed with breast cancer and has been newly prescribed the hormone, Aromasin 25mg. She was scheduled to have her second COVID-19 Vaccine dose on 03Feb2021. She said she has not started the Aromasin 25mg. She said she wanted to check to see if she should hold off on starting the Aromasin 25mg until after she receives her second COVID-19 Vaccine dose, and when would be an appropriate time to start the Aromasin 25mg. Outcome of event was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram abnormal, Palpitations, Tachycardia
Clinical narrative: Atrial fibrillation; palpitations; tachycardia/heart rate 141; This is a spontaneous report from a contactable healthcare professional (HCP). This HCP reported similar events for 2 patients. This is 1st of two reports.  This 58-year-old female HCP (patient) reported for herself that received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) on 10Jan2021 at 0.3 mL single by intramuscular injection left arm for COVID-19 vaccination.  Medical history included ongoing hypertension and diabetes type 2, both diagnosed about 10 years ago (2011). Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot number: EH9899) on 21Dec2020 at single dose for COVID-19 immunisation. The patient reported that a few days after receiving the 2nd dose (on 14Jan2021), she went into atrial fibrillation and had been having palpitations ever since. She had a cardiology appointment in a few weeks and they started her on apixaban (ELIQUIS). Lab data on 14Jan2021 included EKG: normal sinus and Kardiamobile (a medical grade ECG): it showed tachycardia and at least one other time showed atrial fibrillation, heart rate 141. The outcome of palpitations was not recovered, outcome of other events was unknown. Reporter seriousness for atrial fibrillation and palpitations was medically significant.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of  atrial fibrillation cannot be fully excluded.   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.  ,Linked Report(s) : US-PFIZER INC-2021111803 same reporter/drug, similar events, different patient
Sex: F
Vaccine: FLUX
Symptoms: COVID-19, Influenza
Clinical narrative: flu; covid; Initial information received on 24-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a female patient of an unknown age who experienced flu (influenza)  and Coronavirus disease (COVID -19), while she received vaccine INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant  medications and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and Coronavirus disease (COVID -19) (Unknown latency) following the administration of INFLUENZA VACCINE.  Reported Adverse Event Information: Product name was not provided. Since this is a public post on the Sanofi flu shot campaign. The Race to 200M we are assuming the consumer is referring to the Sanofi flu vaccine. It was reported that mother got a flu shot and now has the flu and COVID. Please refer source document for complete information. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Not provided.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  The outcome of events was reported as unknown.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain, Rash morbilliform
Clinical narrative: looked like the old red measles all over my body; Initial information received on 11-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional.  This case involves an adult patient (exact age and gender unknown) who experienced red measles all over his/her body (Morbilliform rash), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included Influenza vaccine for prophylactic vaccination and no adverse event reported (patient had taken the regular flu shot for years with no problems). The patient's concomitant therapy, medical treatment(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.  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.  Vaccination details and reason for taking the vaccine: Dose: unknown; Frequency: unknown.  On an unknown date, the patient developed serious red measles all over my body which hurt so bad (Morbilliform rash) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was reported that patient would never take the flu shot ever again. It was unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns an adult patient (exact age and gender unknown) who experienced Morbilliform rash after vaccination with INFLUENZA VACCINE. The time to onset was unknown. Further information regarding concurrent condition during vaccination and laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 31-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves adult patient who got the flu (influenza), while he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication 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 not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received any corrective treatment.  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm still hurt; Initial information received on 30-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a patient of unknown age whose arm still hurt (vaccination site pain), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient whose arm still hurt (vaccination site pain), (latency: unknown) following the administration of suspect vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 31-Jan-2021 regarding an unsolicited valid non-serious social media case received from a consumer via social media.  This case involves a 65 years old patient gender unknown who experienced flu (influenza), while he/she received INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.   It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date once about 30 years ago, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer batch number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date 30 years ago, the patient developed a non-serious flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Reported Adverse Event Information: Since this is a public comment on an influencer post for the campaign. The 65 years old patient have only gotten the flu shot once about 30 years ago. Got the flu 30 years ago. Have not gotten the shot or the flu since.   It is unknown if the patient experienced any additional symptoms/ events.   Medication Details and reason for taking the medicine: Not provided.  It is unknown if there were lab data/ results available.  It was not reported if the patient received any corrective treatment.  The outcome of event was unknown, at the time of reporting.  There will be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient can't take the flu shot. They caused the patient flu; patient got sick every time; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a patient of unknown age who can't take the flu shot. they caused the patient flu (influenza) and got sick every time (illness), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MALUS SPP. VINEGAR EXTRACT (APPLE CIDER VINEGAR) and AMYLMETACRESOL; DICHLOROBENZYL ALCOHOL (ROBITUSSIN).  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient who can't take the flu shot. they caused the patient flu (influenza) and got sick every time (illness) (latency: unknown) following the administration of suspect vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: TD, TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: The patient was given a dose of Adacel or Tenivac via subcutaneous route, no Ae; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case from pharmacist.  This case involves patient of (unknown demographics) who was administered DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], (lot numbers and expiration date were not reported) via subcutaneous route (incorrect route of product administration) in an unknown administration site for prophylactic vaccination on an unknown date.  Medical history, past medical treatment(s), medical treatment(s), concomitant medications, vaccination(s) and family history were not reported.  This was an actual medication error due to incorrect route of product administration (latency was same day).  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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.  There will be no information on the batch number for this case.
Age: 11.0
Sex: M
Vaccine: DTAP, DTAPIPVHIB, FLU3, IPV, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: A temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a 11 years old male patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on Dec-2021.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination].  Details of laboratory data not reported.  It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines.   It was not reported if the patient received a corrective treatment.  At the time of report, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was inadvertently administered an expired dose of Menactra, no AE; Initial information received on 26-Jan-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 18 years old female patient who was inadvertently administered an expired booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6486AC and expiration date :10-Jan-2021) via intramuscular route in the left deltoid for prophylactic vaccination on 25-Jan-2021.  Patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL).  It was a case of actual medication error due to expired vaccine used (expired product administered, latency on same day). And they wants to find out if the medication needs to be re-administered   No adverse event were reported at the time of reporting.   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: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site bruising, Urticaria
Clinical narrative: patient had a black and blue mark on the injection site; bright red face and breasts like cherry red; big welt on the arm; Initial information received on 01-Feb-2021 regarding an unsolicited valid non-serious case from non-healthcare professional.  This case involves a 65 years elderly female patient who had black and blue mark on the injection site (injection site discolouration), bright red face and breasts like cherry red (erythema) and big welt on the arm (urticaria), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included Prevnar 13 given in SEP-2020 for prophylactic vaccination and had delayed anaphylactic reaction.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date in November 2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiry date not reported] via unknown route in the left arm for prophylactic vaccination.  On an unknown date in November 2020, the patient developed a non-serious black and blue mark on the injection site (injection site discolouration), bright red face and breasts like cherry red (erythema) and big welt on the arm (urticaria) on the next morning, following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The patient recovered from all the events as it is reported that it took 3-4 weeks for urticaria and erythema to go away and injection site discolouration to fade away too.  There will be no information on the batch number to be requested for this case.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Throat irritation
Clinical narrative: About 20-25 minutes into wait time, felt slightly short of breath, scratchy throat. Note had felt shortness of breath 10d after 1st vaccine day after received it. Denies throat tightness, can swallow ok. BP 150/90. HX sulfa allergy. Continued being monitored; BP down to 120/80 and pulse 70s. Scratchy throat the same; able to take deep breath; same sob; NO feeling of throat tightness.  Stable; agreeable to leave for work in hospital setting; to follow up with MD re: symptoms.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Headache
Clinical narrative: I was fine for the first twelve hours and then I had extreme arm pain, all the way down my entire arm, and expanded through my whole body. I had extreme body aches, and headaches. Joint pain was very bad. Took Tylenol, but that didn't help, and I iced my arm but that also did not help. I was not able to to sleep all night. Fevers, chills, and fatigued. Right arm is still pretty red and hot to the touch.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Skin warm, Sleep disorder
Clinical narrative: I was fine for the first twelve hours and then I had extreme arm pain, all the way down my entire arm, and expanded through my whole body. I had extreme body aches, and headaches. Joint pain was very bad. Took Tylenol, but that didn't help, and I iced my arm but that also did not help. I was not able to to sleep all night. Fevers, chills, and fatigued. Right arm is still pretty red and hot to the touch.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Feeling hot
Clinical narrative: 11:42 Patient complained of lightheadedness and being hot. BP 97/62, HR 63, O2 sat 98% 11:45 Diphenhydramine given 12.5mg/5ml PO elixir/solution 11:52 BP 103/67, HR 65, O2 sat 97% 12:00 BP 112/74, HR 63, O2 sat 99% 12:10 BP 111/70, HR 64, O2 sat 98%
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Oedema peripheral
Clinical narrative: right arm edema, right arm extensive bruising poss DVT
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Injection site warmth, Pyrexia
Clinical narrative: pts daughter stated ear lobes were red, he had low grade fever and left arm was warm to touch about 3" below injection site the day after the vaccine.  Next day after the arm was increasingly turning more red.  On 1/12/2021 the pt went to the ER clinic and was diagnosed w/ cellulitis on left arm.  Pt is now recovered from this after being treated w/ antibiotics.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Pain, Pyrexia
Clinical narrative: Chills Fever migraine headache, acheyness
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oesophagogastroduodenoscopy, Vomiting
Clinical narrative: Nausea and vomiting
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vomiting
Clinical narrative: started to dizzy about 4 hours after given the shot.  Next morning woke up, throwing up that only lasted  1 hour. The next couple of days, still feeling dizzy, very tired, feeling like y head had a balloon in it.  Nothing serious, did not need medications, just stayed home, put my head down when needed.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Fatigue, Headache
Clinical narrative: Chills, body ache, inj site sore approx  12 hrs, followed by clammy, headache, fatigue, inj site sore for approx 12 hrs, then headache, fatigue, inj site sore for approx 12 hrs.     OK for 36 hrs then overnight chills followed by headache, lightheaded, slight sore throat to present
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Oropharyngeal pain, Pain, SARS-CoV-2 test negative
Clinical narrative: Chills, body ache, inj site sore approx  12 hrs, followed by clammy, headache, fatigue, inj site sore for approx 12 hrs, then headache, fatigue, inj site sore for approx 12 hrs.     OK for 36 hrs then overnight chills followed by headache, lightheaded, slight sore throat to present
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Flushing
Clinical narrative: Systemic: Other- flushing, increased blood pressure, and weakness- Mild
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Condition aggravated, Headache
Clinical narrative: After dose #1 on 1/5/21, patient developed nausea, headache, "stabbing bone pain". Dull pain continued in knees, hips, shoulders, thoracic back pain. Continued bone pain.  Second dose on 2/3/21 with subsequent vomiting, fever, and increased bone pain.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Nausea, Pyrexia, Vomiting
Clinical narrative: After dose #1 on 1/5/21, patient developed nausea, headache, "stabbing bone pain". Dull pain continued in knees, hips, shoulders, thoracic back pain. Continued bone pain.  Second dose on 2/3/21 with subsequent vomiting, fever, and increased bone pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: A rash started spreading on patients chest that she noticed the night of 2/8/21 after taking a shower. As of right now, 2/9/21 patient still has rash. Additional symptoms are sore arm and mild fever
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperglycaemia, Pain, Vascular stent thrombosis
Clinical narrative: 5DASY AFTER RECEIVING 1ST DOSE OF COVID 19 VACCINE, PATIENT DEVELOPED GENERALIZED BODYACHE, ACUTE SOB, HYPERGLYCEMIA(BG RUNS 500-600'S), AND LOWER EXTREMETIE PAINS FOUND TO HAVE STENT THROMBOSIS.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Starting around 8:00 PM on day of vaccination; Fever of 102.8 F for 6+ hours that was refractory to ibuprofen. Projectile vomiting, chills, and body aches.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received first dose on 1/22/21.  Earliest date patient could receive 2nd dose was 2/19/21.  Patient presented to vaccination clinic site on 2/9/21 in error.   Patients 2nd dose was administered on 2/9/19.  Patient denied any adverse reactions after vaccine administered.  Will continue to follow up with patient to monitor symptoms.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site nodule, Injection site pain, Malaise
Clinical narrative: Soreness at injection site initially which progressed to mediate pain, like a knot in the arm that was painful.   Also, around 4 hours after the injection, extreme fatigue set in  and it felt like I was getting sick, like I normally do with a cold or flu.  After 12 hours of sleep from the tiredness, I felt normal the next day, but site where shot was in the left arm was very sore and painful.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain, Pruritus
Clinical narrative: Left shoulder (Upper Arm) reddish, feverish, firm, slight itch, slight pain.  This has been going on since the 2nd day after injection and this is 5th day after injection.  Applied cortisone cream (OTC)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Arthralgia, Blood glucose increased, Coating in mouth, Delirium
Clinical narrative: I found her unresponsive in her room, she had some white stuff on her mouth. I called 911. while waiting I placed ice on the back of her neck and she began to respond, as she began to become more responsive she defecate all over herself. I checked her blood sugar it was 159.  The ambulance arrived, they checked her vitals said they were ok, they gave me the option of monitoring her at home or going to the ER. I chose to monitor her at home. Monday all day she still had a fever complaining of headache, joint pain and pain in the arm she received the vaccine, at times she became very delirious, nothing she said made sense. . Her doctor said she had a seizure and offer to place her on seizure medication. I gave her two  500mg Tylenol   she has an appointment on March 7th for the second dose but I am afraid to give her the second dose.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Pain in extremity, Pyrexia, Seizure
Clinical narrative: I found her unresponsive in her room, she had some white stuff on her mouth. I called 911. while waiting I placed ice on the back of her neck and she began to respond, as she began to become more responsive she defecate all over herself. I checked her blood sugar it was 159.  The ambulance arrived, they checked her vitals said they were ok, they gave me the option of monitoring her at home or going to the ER. I chose to monitor her at home. Monday all day she still had a fever complaining of headache, joint pain and pain in the arm she received the vaccine, at times she became very delirious, nothing she said made sense. . Her doctor said she had a seizure and offer to place her on seizure medication. I gave her two  500mg Tylenol   she has an appointment on March 7th for the second dose but I am afraid to give her the second dose.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Pruritus
Clinical narrative: At about 10 minutes after receiving his second vaccination, patient stated his had started itching. About a half hour later, patient states he felt he was having some difficulty swallowing. He was given 50 mg. of Benadryl and felt better.