chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: my husband, an hour after, got a really bad headache; This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an 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 the patient (husband) got a really bad headache an hour after, got a really bad headache and still cannot get rid of the headache The outcome the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Pain
Clinical narrative: chills; body aches; fever; flu like symptoms; headache; was drenched in sweat; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the second dose of BNT162b2 (lot: EL1283), via an unspecified route of administration in left deltoid on 09Jan2021 15:30 at single dose for covid-19 immunization. Medical history included asthma from Dec2019 and ongoing, insomnia, hypertension. Concomitant medication included ongoing hydrochlorothiazide, metoprolol tartrate (LOPRESSOR HCT) for Hypertension. The patient previously took lopressor and experienced edema. The patient previously received the first dose of BNT162b2 (Lot number: EK5730), intramuscularly in right deltoid at single dose on 19Dec2020 for covid-19 immunization. The patient experienced fever, chills, flu like symptoms, headache all day long on 10Jan2021. The above events were reported as serious as medical significant. No nausea or diarrhea. She had chills and was drenched in sweat on 10Jan2021. She woke up at 10:30 am with chills, body aches on 10Jan2021. Last night at 10 pm she finally fell asleep. She woke up this morning (11Jan2021) and felt fine. The outcome of the event sweating was unknown, other events was recovered on 11Jan2021.; Sender's Comments: Based on a close temporal relationship there is a reasonable possibility of an association between the events and the product. 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; body aches; fever; flu like symptoms; headache; was drenched in sweat; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the second dose of BNT162b2 (lot: EL1283), via an unspecified route of administration in left deltoid on 09Jan2021 15:30 at single dose for covid-19 immunization. Medical history included asthma from Dec2019 and ongoing, insomnia, hypertension. Concomitant medication included ongoing hydrochlorothiazide, metoprolol tartrate (LOPRESSOR HCT) for Hypertension. The patient previously took lopressor and experienced edema. The patient previously received the first dose of BNT162b2 (Lot number: EK5730), intramuscularly in right deltoid at single dose on 19Dec2020 for covid-19 immunization. The patient experienced fever, chills, flu like symptoms, headache all day long on 10Jan2021. The above events were reported as serious as medical significant. No nausea or diarrhea. She had chills and was drenched in sweat on 10Jan2021. She woke up at 10:30 am with chills, body aches on 10Jan2021. Last night at 10 pm she finally fell asleep. She woke up this morning (11Jan2021) and felt fine. The outcome of the event sweating was unknown, other events was recovered on 11Jan2021.; Sender's Comments: Based on a close temporal relationship there is a reasonable possibility of an association between the events and the product. 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: she had a stiff neck; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), via an unspecified route of administration on 18Dec2020 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. Patient received the first dose of vaccine on 18Dec2020 and reported that she had a stiff neck for two days. The outcome of the event was recovered on 20Dec2020.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site pain
Clinical narrative: Localized pain at injection site; pain in her arm pit to the touch and when she moves it; This is a spontaneous report from a contactable consumer. A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK9231, Expiry: Apr2021); via unspecified route of administration on an unspecified date at single dose at left arm for covid-19 immunisation. There was no medical history and concomitant medications reported. The patient previously had BNT162B2 for COVID-19 immunization and experienced localized pain at injection site. Stated that the patient got the 2nd dose of the Covid-19 vaccine on an unspecified date (reported as Friday). She didn't have a fever or chills, but she did have localized pain at injection site which she also had with the first dose. She is calling because she still has pain in her armpit, to the touch and when she moves it reported on 08Jan2021, but there is no swelling, lumps or bumps. The patient stated that the pain has decreased; it's not as bad as it was when she first noticed it. The patient got the 2nd dose at 5:30pm, and had pain at around 8pm or 9pm that night. The following day was the height of the pain for the second dose, and it has been decreasing since then. The outcome of the event localized pain at injection site was unknown, while recovering for the event pain in her arm pit to the touch and when she moves it.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: felt a little stuffy; sick; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. This Nurse reported information regarding a coworker. The patient felt a little stuffy and mentioned that no one was sick like her; no one else missed work; they all went around the same dates to get the vaccine because they work in home health kind of roles; so they did not all get them at the same time like if they were in a facility. The outcome of the events was unknown.  Information about Lot/Batch number is requested.
Sex: U
Vaccine: COVID19
Symptoms: Platelet count, Platelet count increased
Clinical narrative: High platelets; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for two patients. This is second of two reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician (through the healthcare professional) would like to know if the company had any reports of thrombocytosis post vaccination. The physician had seen two patients who had high platelets after the vaccine on an unspecified date. There is no reported platelet value for this patient. The healthcare professional has no information on the patient since the physician only asked her to call. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021017585 Same reporter, product, and event; different patient
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from the Pfizer Sponsored Program received by a contactable consumer (patient husband).  A female patient (age not provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 10Jan2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. In Jan2021, after vaccination, the patient developed headache. The reported asked if she could take acetaminophen. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a bit of a headache for the second dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization and experienced slight swelling. The patient had taken both doses of the Pfizer COVID vaccine and did not experience any side effects like the everybody else. She stated that she is concerned since everyone she had talked to who received the vaccine experienced some kind of side effects (fever, chills, body ache) and was wondering if the vaccine might not be working. She only experienced a bit of a headache for the second dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Urticaria, Vaccination site pain
Clinical narrative: Hives; Left arm 0.3mL/ sore ness on the arm Left; This is a spontaneous report from a contactable consumer (patient). A 42-year-old (also reported as "41") female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248, Expiry Date: 30Apr2021, 3 mcg/ml), via an unspecified route of administration on 08Jan2021 08:40 at 0.3 mL, single dose at left arm ("Dosage text: Left arm 0.3mL") for COVID-19 immunization. Medical history included asthma. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA, reported as "BREO") for asthma. The patient was given 0.3mL, 30mcg of the COVID vaccine. The patient experienced sore ness on the arm left on 08Jan2021 and hives on 09Jan2021. She is calling about the Covid Vaccine, she got it on Friday 08Jan2021 at 8:40AM and she went home got soreness in arm (began the same day), it was a couple hours after at 10 or 11 and it stopped on Sunday 10Jan2021. She took pain killers. She woke up Saturday morning, and her whole body has broken out in hives, she has been taking Benadryl around the clock. She broke out in hives on 09Jan2021, it is still ongoing, its in between, she is still scratching and taking the Benadryl. Therapeutic measures were taken as a result of the events which included pain killers and Benadryl. The outcome of the event sore ness on the arm left was recovered on 10Jan2021, of hives was not recovered. She has never had a positive test for COVID prior to the vaccine. She has had an Antibody test 4 times and each time it was negative, she had her last antibody test in Nov2020. She has had no issues with vaccines in the past.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: muscle aches; fever; nausea; Vomiting; This is a spontaneous report from a contactable other healthcare professional (patient).  A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, intramuscular right arm from 08Jan2021 to 08Jan2021 as single dose for COVID-19 immunisation. Historical vaccine includes first dose of BNT162B2 via intramuscular from 18Dec2020 to 18Dec2020 with lot number: EJ1685 on right arm. Medical history included allergies to sulfa drugs. Concomitant medication included metronidazole. The patient previously took Ciprofloxacin and Codeine and experienced allergies. On Saturday, 09Jan2021 at 07:00 AM, the patient developed fever, muscle aches, nausea, and vomiting. The outcome of the events was recovered on  Jan2021.  No treatment was given for the events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Mild headache (Day 2); Injection site soreness (Day 1 and Day 2); This is a spontaneous report from a contactable other healthcare professional (patient herself). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK5730, expiration date was unknown), intramuscularly on the left arm on 18Dec2020 at 13:15 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. The patient had no known allergies; she had no allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Dec2020 at 16:00, the patient experienced injection site soreness (day 1 and day 2) and mild headache (day 2) on 19Dec2020. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events (AE). The patient recovered from both the events on an unspecified date.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: red blotches on my arms and upper chest; This is a spontaneous report from a non-contactable other health care professional. A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose at arm left for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 08Jan2021, the patient experiencing red blotches on my arms and upper chest. The patient did not receive treatment for the adverse event. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Musculoskeletal stiffness, Nausea, Vaccination site reaction
Clinical narrative: Nausea; shortness of breath; tiredness; stiffness at the injection site; stiffness at the injection site; This is a spontaneous report from a contactable consumer. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot numbers and expiry dates were unknown) via an unspecified route of administration on 08Dec2020 for the first dose and on 08Jan2021 for the second dose, both administered in the right arm at a single dose for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Jan2021, the patient experienced nausea, shortness of breath, tiredness, and stiffness at the injection site. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovered. The report was considered as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Suprascapular lymphadenopathy noted 3 days after vaccination, unilaterally on the same side as the administration; This is a spontaneous report from a contactable nurse (patient himself). A 24-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), intramuscular in the left arm on 21Dec2020 18:45 at single dose, and then second dose (lot number: EL0142, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported.  The patient experienced suprascapular lymphadenopathy noted 3 days after vaccination, unilaterally on the same side as the administration on 24Dec2020 09:00. No treatment was received for the adverse event. Clinical outcome of the event was not recovered.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: I was never sick until the year I got the flu shot then I was sick the entire season; Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown age patient who was never sick until the year, patient got the flu shot then patient was sick the entire season (illness), while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications 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 unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that the patient was never sick until the year, patient got the flu shot then patient was sick the entire season (illness) (Unknown latency) following the administration of Influenza Vaccine. Every season every year for the next several years. It was at least 10 years or longer before I got the shot again. patient would not have gotten it then, but his/her employer required it. And once again he/she became sick for the entire season. Went a few years without it and was not sick at all but then her/his employer insisted he/she get it and was sick the entire season afterwards. had not it the past 3 years and have not been sick any. So it may not affect some but it sure makes he/she sick so would not get them again.  Final diagnosis was the patient was never sick until the year, patient got the flu shot then patient was sick the entire season.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  No further information was reported.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This spontaneous case was received on 05-Jan-2021 from other non-health professional (consumer) via Agency (reference number: NUS2020US193921) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with influenza virus vaccine monovalent (brand not specified; indication, dose, route of administration and anatomical location: not reported). The batch number was not reported.  On an unknown date, an unknown amount of time after receiving influenza virus vaccine monovalent, the patient experienced allergic reaction.  On an unknown date, the patient was hospitalized due to the event for seven days.  The outcome of the event of allergic reaction was not reported.  The reporter did not provide a causality assessment.  The event of allergic reaction was considered to be serious due hospitalization.  Company comment: A female patient experienced hypersensitivity an unknown amount of time after administration of influenza virus vaccine monovalent. The patient's medical history and concomitant medications were not reported. Causality is unassessable due to lack of reported information.; Sender's Comments: A female patient experienced hypersensitivity an unknown amount of time after administration of influenza virus vaccine monovalent. The patient's medical history and concomitant medications were not reported. Causality is unassessable due to lack of reported information.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: appeared on my back / small itchy sp[ots on the left side of my back; This case was reported by a consumer and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2020, the patient received the 1st dose of Shingrix. On 17th September 2020, less than a day after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. Within the day or two, very itchy was appeared on back, directly across on the left side from where the shot was given. The patient still getting small itchy spots on the left side of my back. The patient asked should get the 2nd shot.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: erythema 3" by 3" raised and red hot.; erythema 3" by 3" raised and red hot.; erythema 3" by 3" raised; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema, feeling hot and swelling. On an unknown date, the outcome of the erythema, feeling hot and swelling were unknown.   It was unknown if the reporter considered the erythema, feeling hot and swelling to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix immunization caused a raised area of erythema which was quite hot and measured about 3" by 3". The patient inquired that  could he get the 2nd dose of Shingrix after 2 months or it was considered as an allergic reaction or normal reaction. The information regarding consent to follow up was not reported. No further information was available.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on his forehead; This case was reported by a consumer via call center representative and described the occurrence of rash in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced rash spread on his face to his cheeks. The rash was unresolved. This case has been linked with case US2020AMR249090, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249090:same patient
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain in her left arm / never resolved / still ongoing; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd May 2018, the patient received the 2nd dose of Shingrix. On 2nd May 2018, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient she developed arm pain in her left arm, that has never resolved and was still ongoing. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248587:same reporter US-GLAXOSMITHKLINE-US2020248574:Same reporter US-GLAXOSMITHKLINE-US2020248580:Same reporter US-GLAXOSMITHKLINE-US2020248583:Same reporter
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: makes me sick so no i dont get it; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a patient of unknown demographics who makes him sick so no the patient dont get it (Illness), while the patient received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.   On an unknown date, the patient received influenza vaccine (Strength, formulation, dose, frequency, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date (unknown latency), after started therapy with suspect vaccine, makes the patient sick so the patient did not got it (Illness).  Action taken with the suspect drug was not applicable.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: pediatric patient was given Pentacel with only diluent with no adverse event; Initial information regarding an unsolicited valid non-serious case received from the other healthcare professional via phone at a call center as a Medication Inquiry on 11-Jan-2021.  This case involved a 9-month old female patient who was given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL) with only diluent with no adverse event (Product preparation issue).  It was an actual medication error due to inappropriate reconstitution technique.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine for prophylactic vaccination.  On 28-Dec-2020, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE 0.5 mL (lot number: U6842DA, expiry date: 05-Jul-2021) via intramuscular route in the right thigh for prophylactic vaccination.  On 28-Dec-2020, it was reported that pediatric patient was given Pentacel with only diluent with no adverse event (Product preparation issue).  At the time of reporting, the patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Pt developed a bilateral rashes on the arms 10 min s/p COVID vaccine administration.  No other symptoms were experienced.  Pt received 20 mg of Famotidine and 25 mg of Diphenhydramine.  Rash improved.  Pt was monitored for 30 minutes, and was able to return home with no issues
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Electrocardiogram, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Woke up with sore left arm and headache. As day progressed headache continued and had several episodes of feeling hot, sweaty, and nauseous. At approximately 8 pm I had another episode of feeling unwell. I sat down on couch and had a seizure. Arms went straight out from body, legs got tense, loud noise  from mouth, then was slumped over on couch. Husband got me to the pickup and drove me to the emergency room.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Muscle tightness, Nausea, Pain in extremity
Clinical narrative: Woke up with sore left arm and headache. As day progressed headache continued and had several episodes of feeling hot, sweaty, and nauseous. At approximately 8 pm I had another episode of feeling unwell. I sat down on couch and had a seizure. Arms went straight out from body, legs got tense, loud noise  from mouth, then was slumped over on couch. Husband got me to the pickup and drove me to the emergency room.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Partial seizures, Posture abnormal, Screaming
Clinical narrative: Woke up with sore left arm and headache. As day progressed headache continued and had several episodes of feeling hot, sweaty, and nauseous. At approximately 8 pm I had another episode of feeling unwell. I sat down on couch and had a seizure. Arms went straight out from body, legs got tense, loud noise  from mouth, then was slumped over on couch. Husband got me to the pickup and drove me to the emergency room.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Nasal oedema
Clinical narrative: Very minor swelling of my nose along with some redness.  No pain or shortness of breath.  Symptoms dissipated with 24 hours.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Headache, Nausea
Clinical narrative: severe nausea, vomiting, diarrhea, headache, fevers, dizziness, arm pain and abdominal pain.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: severe nausea, vomiting, diarrhea, headache, fevers, dizziness, arm pain and abdominal pain.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Migraine, Nausea, Pain
Clinical narrative: Severe nausea, with vomiting, which started approximately 9 hours after the injection. This also included body aches, chills, mild fever, and dizziness. Vomiting lasted for approximately 2 hours, but nausea persisted for approximately 2 days. A significant migraine occurred approximately 6 hours after the injection, and lasted approximately 6 hours.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Severe nausea, with vomiting, which started approximately 9 hours after the injection. This also included body aches, chills, mild fever, and dizziness. Vomiting lasted for approximately 2 hours, but nausea persisted for approximately 2 days. A significant migraine occurred approximately 6 hours after the injection, and lasted approximately 6 hours.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Impaired work ability
Clinical narrative: Debilitating lower back pain beginning mid-morning on the day following the vaccine administration. It came on quite suddenly.  I left work early due to the pain. It feels like a deep twisting pain that seems to decrease strength in the back area.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash about 3 inches in size. Noticed after it started itching. Itches occasionally, then goes away. Started a week after first dose of vaccine. Currently on day 2 of the rash. Tried Zyrtec, Benadryl, and Hydrocortisone ointment with some itching relief, but rash hasn?t decreased in size or has gone away yet.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure systolic increased, Chills, Cough, Disturbance in attention, Dysphagia
Clinical narrative: 12/20: 10 mins after the injection my arm started hurting so I was moving it around and suddenly a felt a tickle in my throat, swallowed and felt like I swallowed the wrong way and was coughing to the point of feeling like I was going to vomit. Per everyone around I was bright red and I looked weird. The ER nurse said my heart rate was 125 and my systolic BP was elevated at 130s (normally in the 110s). After sitting for 45 mins heart rate was back to 60s. Still felt like I was in a fog but felt ok. Once I walked to my car I felt alot of nausea again and was on and off the rest of the day.  In the middle of the night I woke up short of breath laying on my back had to lay on my side.  12/21. I was moving pavers and got short of breath. Checked my heart rate and it was 100. O2 sat was 99%. If I sat and didn't move I was fine as soon as I started moving it started again. Also felt nauseating all day. I was having a hard time concentrating and my husband was getting frustrated that I wasn't understanding what he was saying. My left arm hurt really bad all day  12/22 By the afternoon felt more normal except my arm still hurting really bad.  12/26 was shoveling dirty and suddenly my arm where I got the injection started hurts and I got very nauseated again.  On 12/29 the cdc called me because I did the vsafe program. They were wondering if I was actually going to get the second vaccination because they said my reaction is a severe reaction.  12/30 my arm started itching had chills and temp right after  1/1 rapid test was negative for covid  1/2 pcr was negative
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Feeling abnormal, Heart rate increased, Injection site pain
Clinical narrative: 12/20: 10 mins after the injection my arm started hurting so I was moving it around and suddenly a felt a tickle in my throat, swallowed and felt like I swallowed the wrong way and was coughing to the point of feeling like I was going to vomit. Per everyone around I was bright red and I looked weird. The ER nurse said my heart rate was 125 and my systolic BP was elevated at 130s (normally in the 110s). After sitting for 45 mins heart rate was back to 60s. Still felt like I was in a fog but felt ok. Once I walked to my car I felt alot of nausea again and was on and off the rest of the day.  In the middle of the night I woke up short of breath laying on my back had to lay on my side.  12/21. I was moving pavers and got short of breath. Checked my heart rate and it was 100. O2 sat was 99%. If I sat and didn't move I was fine as soon as I started moving it started again. Also felt nauseating all day. I was having a hard time concentrating and my husband was getting frustrated that I wasn't understanding what he was saying. My left arm hurt really bad all day  12/22 By the afternoon felt more normal except my arm still hurting really bad.  12/26 was shoveling dirty and suddenly my arm where I got the injection started hurts and I got very nauseated again.  On 12/29 the cdc called me because I did the vsafe program. They were wondering if I was actually going to get the second vaccination because they said my reaction is a severe reaction.  12/30 my arm started itching had chills and temp right after  1/1 rapid test was negative for covid  1/2 pcr was negative
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pruritus, SARS-CoV-2 test negative, Throat irritation
Clinical narrative: 12/20: 10 mins after the injection my arm started hurting so I was moving it around and suddenly a felt a tickle in my throat, swallowed and felt like I swallowed the wrong way and was coughing to the point of feeling like I was going to vomit. Per everyone around I was bright red and I looked weird. The ER nurse said my heart rate was 125 and my systolic BP was elevated at 130s (normally in the 110s). After sitting for 45 mins heart rate was back to 60s. Still felt like I was in a fog but felt ok. Once I walked to my car I felt alot of nausea again and was on and off the rest of the day.  In the middle of the night I woke up short of breath laying on my back had to lay on my side.  12/21. I was moving pavers and got short of breath. Checked my heart rate and it was 100. O2 sat was 99%. If I sat and didn't move I was fine as soon as I started moving it started again. Also felt nauseating all day. I was having a hard time concentrating and my husband was getting frustrated that I wasn't understanding what he was saying. My left arm hurt really bad all day  12/22 By the afternoon felt more normal except my arm still hurting really bad.  12/26 was shoveling dirty and suddenly my arm where I got the injection started hurts and I got very nauseated again.  On 12/29 the cdc called me because I did the vsafe program. They were wondering if I was actually going to get the second vaccination because they said my reaction is a severe reaction.  12/30 my arm started itching had chills and temp right after  1/1 rapid test was negative for covid  1/2 pcr was negative
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Pruritus, Urticaria
Clinical narrative: Headache day of vaccine, itchy skin and hives developed on arms and legs day after vaccine, lasting 2 days. Swollen, painful  lymph node in armpit started the day after vaccine and continues to present, nearly a week post-injection.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Dyshidrotic eczema, SARS-CoV-2 test negative, Urticaria
Clinical narrative: Onset of severe pompholyx and uriticaria on hands and feet. Prescribed famotidine, prednisone and hydroxyzine.   Pompholyx on hands developed into blisters 4 days after onset of symptoms
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Im having sime pretty aggressive chills and nausea
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Erythema, Inappropriate schedule of product administration, Pain
Clinical narrative: Vaccines received in series on 12/11/20 and 1/11/21. Three days before due date for second COVID vaccine, started severely itching and experiencing hive-like rash all over body, especially to hands and head; mostly relieved by benadryl but wore off every 6 hours. Contacted PCP (listed in form) who suggested taking zyrtec and using a moisturizing lotion. This helped for the day of receiving the vaccine. Thinking it was something unrelated due to the time elapsed from the vaccine, despite no changes in consumption or products/environment encountered, I went ahead and got the second vaccine. Day 1 after vaccine, I experienced the usually reported side effects, including slightly elevated temp, chills, and body aches. Itching and hives continued but not as noticeable due to other side effects. The next morning, hives and itching were significantly worse; any time I scratched (or something touched my skin more than lightly), large, red welps would nearly immediately develop, and often had raised bumps within the irritations. To date, this is continued, slightly relieved by allergy medications, but not entirely and must be taken around the clock or severe symptoms will begin again.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash papular, Urticaria
Clinical narrative: Vaccines received in series on 12/11/20 and 1/11/21. Three days before due date for second COVID vaccine, started severely itching and experiencing hive-like rash all over body, especially to hands and head; mostly relieved by benadryl but wore off every 6 hours. Contacted PCP (listed in form) who suggested taking zyrtec and using a moisturizing lotion. This helped for the day of receiving the vaccine. Thinking it was something unrelated due to the time elapsed from the vaccine, despite no changes in consumption or products/environment encountered, I went ahead and got the second vaccine. Day 1 after vaccine, I experienced the usually reported side effects, including slightly elevated temp, chills, and body aches. Itching and hives continued but not as noticeable due to other side effects. The next morning, hives and itching were significantly worse; any time I scratched (or something touched my skin more than lightly), large, red welps would nearly immediately develop, and often had raised bumps within the irritations. To date, this is continued, slightly relieved by allergy medications, but not entirely and must be taken around the clock or severe symptoms will begin again.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Pain, Pyrexia, Sleep disorder
Clinical narrative: Staff had 2nd vaccine yesterday 01/13/2021 at 11:20.  At night 3 am woke up with bodyache, lower back pain, fever 103, could not sleep.  Took Tylenol.  Today at 12 noon staff feels chill, fever 102.  Now ok.  W
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling hot, Pain
Clinical narrative: Vaccine at 8:30am in the morning.  Around 4 pm started feel warm, weakness.  Took Tylenol 1000 mg.  Helped a little bit.  Today still having bodyache and chills.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Guillain-Barre syndrome
Clinical narrative: 2nd vaccine on Saturday.  Sunday, burning feet, leg, thigh.  Went to ER to check if it was cause by diabetes, was told its probably not Gulliam Barre. Still having the symptoms.  Worsen when laying down, better with movement.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Pain, Somnolence
Clinical narrative: In the evening 01/12/2021 started having bodyache, fatigue, chill 99.8.  Took sick day yesterday and slept most of the time.  Feeling fine today.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 01/11/2021: Same day at 8 pm started to have body ache, headache, a little fever 100.1 and very tired. Took Tylenol.  Got up next day at 12:30 a lot better.  Today ok but not 100%.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Lymphadenopathy, Pruritus, Swelling
Clinical narrative: Disclosure: I do not have a severe side effect- I want to report this do it can help science. Hope it helps.    Minor adverse event - 1. Bull's eye Rash on the vaccine site. I have taken a photo if ever needed. 2. Swollen lymph nodes.  I wanted to emphasize on the bull's eye rash which started after 5 days after vaccination. it's itchy and swollen. No pain or other discomfort.  I never noticed lymph nodes  before the peculiar rash.  I am overall health and has no other contra indications.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, Urticaria
Clinical narrative: *Rash ,whelps  and swelling on bilateral arms from the shoulder area to hands.  *Rash ,whelps  and swelling on bilateral legs from upper thighs down to feet *Severe Itching  Received the vaccination on Wednesday, January 6, 2021. Symptoms started on Saturday, January 9, 2021 around 1pm.  Symptoms intensified as the days went by. Went to Urgent Care on Monday, January 11, 2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Lymphadenopathy under left clavicle 2 days post injection.  Also had minor headache 1 day post vaccination which resolved by day 2. No medical treatment needed at this time.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue pruritus
Clinical narrative: covid: vaccination clinic S: At 1557 patient c/o tongue swelling and itchiness. Given 25mg PO benadryl at 1557   O: Patient alert and oriented, airway patent.   BP 129/88 HR 74 O2 98%   1617 Repeat O2 sat 98% HR 59. Patient c/o persistent tongue swelling.    A/P: 28 F with history of nut allergy with tongue swelling after Pfizer vaccine. EMS notified 1620. Patient evaluated by EMS and declined further treatment by EMS and stated that she would walk over to ED for further evaluation.    Further return to ED precautions discussed with patient.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Palpitations, Pruritus
Clinical narrative: Patient reports pain at the injection site lasting from 01/12/21 at time of administration until the morning of 01/14/21. Patient reports heart palpitations during the evening of 01/13/21 and hives/rash that developed on 01/13/21 starting on the upper back and has now spread to abdomen and both armpits. Patient took Benadryl on 01/14/21 around 8pm and itching/sensitivity is lessened. Patient reports fatigue on 01/13/21. Patient reports headache on 01/12/21 which subsided with the use of acetaminophen. Patient states headache returned on 01/13/21 to a lesser degree and resolved on its own. Patient denies continued heart palpitations.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Patient reports pain at the injection site lasting from 01/12/21 at time of administration until the morning of 01/14/21. Patient reports heart palpitations during the evening of 01/13/21 and hives/rash that developed on 01/13/21 starting on the upper back and has now spread to abdomen and both armpits. Patient took Benadryl on 01/14/21 around 8pm and itching/sensitivity is lessened. Patient reports fatigue on 01/13/21. Patient reports headache on 01/12/21 which subsided with the use of acetaminophen. Patient states headache returned on 01/13/21 to a lesser degree and resolved on its own. Patient denies continued heart palpitations.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Electrocardiogram normal, Full blood count normal, Hypertension
Clinical narrative: As per Emergency Dept note of 23 Dec 2020:  "Syncope, related to getting the vaccine. Normal ECG, no evidence of arrhythmia, normal H/H, no evidence of ACS, CHF clinically. Normal nonfocal exam. Symptoms resolved. Home with reassurance."  As per follow-up note of 04 Jan 2021: "62yo female s/p first dose of Pfizer-BioNTech vaccine on 12/23/2020 who experienced syncope, hypertension (200/100) within minutes after receiving the vaccine. She was then transported to the ED where she was given IV fluids, anti-emetic and discharged a few hours later. She reports the onset of fever, chills, anorexia, malaise, and emesis 4 hours after receiving the vaccine. The malaise, chills and anorexia persisted for 4 days at which point she started feeling better. COVID test was reportedly negative. She wants to decline 2nd dose of vaccine."