chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Heart rate increased, Hypertension, Nausea, Pruritus
Clinical narrative: Hello,     I am currently a high school counselor.  I am also 26 weeks pregnant with my first child.   On February 6th at approximately 12:30 pm I was given the Pfizer vaccine at the Vaccine Site for my first round of the vaccine.  Within minutes I began to have extreme rapid heartbeat, shortness of breath, high blood pressure, 101 fever, itchiness, red spots, nausea and diarrhea.  I would also experience waves of feeling as though I would pass out for hours after receiving the vaccine.  I was hooked up to the EKG machine in the paramedic facility on site and offered to go to ER, which after consulting with my OBGYN she wanted me to go to ER incase we needed to monitor our baby further.  I was admitted to the ER once I got there.  I also took two Benadryl pills to help with the symptoms. At the ER I was checked out my blood pressure and body temperature had come down, they also performed an ultra sound on my baby ( I believe this was all OK). My symptoms/reaction did not subside for a full 10 hours from the time of the vaccine ( I had a reaction within two minutes of getting it).    The following day I continued to be exhausted, nauseated, diarrhea, headache, and chills.  Currently, it is four days later and I feel back to normal, however I would say for at least two full days afterwards I did not.  I will refuse the second vaccine and do not intend to ever get it until after I deliver my child.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash macular
Clinical narrative: Hello,     I am currently a high school counselor.  I am also 26 weeks pregnant with my first child.   On February 6th at approximately 12:30 pm I was given the Pfizer vaccine at the Vaccine Site for my first round of the vaccine.  Within minutes I began to have extreme rapid heartbeat, shortness of breath, high blood pressure, 101 fever, itchiness, red spots, nausea and diarrhea.  I would also experience waves of feeling as though I would pass out for hours after receiving the vaccine.  I was hooked up to the EKG machine in the paramedic facility on site and offered to go to ER, which after consulting with my OBGYN she wanted me to go to ER incase we needed to monitor our baby further.  I was admitted to the ER once I got there.  I also took two Benadryl pills to help with the symptoms. At the ER I was checked out my blood pressure and body temperature had come down, they also performed an ultra sound on my baby ( I believe this was all OK). My symptoms/reaction did not subside for a full 10 hours from the time of the vaccine ( I had a reaction within two minutes of getting it).    The following day I continued to be exhausted, nauseated, diarrhea, headache, and chills.  Currently, it is four days later and I feel back to normal, however I would say for at least two full days afterwards I did not.  I will refuse the second vaccine and do not intend to ever get it until after I deliver my child.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Electrocardiogram, Heart rate irregular, Hypertension, Oxygen saturation decreased
Clinical narrative: She states that after 10 minutes of getting her vaccine she started to have SOB, she was asked to sit for observation and then her BP rose to 150/110. She was then rushed to the ER at Hospital. Pt informs that an EKG and chest xray was taken an they were Neg, she was also given an IV of Benadryl, Pepcid, 2 bags of saline and prednisone.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest X-ray normal, Dyspnoea, Electrocardiogram normal
Clinical narrative: She states that after 10 minutes of getting her vaccine she started to have SOB, she was asked to sit for observation and then her BP rose to 150/110. She was then rushed to the ER at Hospital. Pt informs that an EKG and chest xray was taken an they were Neg, she was also given an IV of Benadryl, Pepcid, 2 bags of saline and prednisone.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe Left shoulder and arm  pain   Can?t lift arm    It started approximately 2 hours after vaccine I believe it was given incorrectly ....too high
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Severe Left shoulder and arm  pain   Can?t lift arm    It started approximately 2 hours after vaccine I believe it was given incorrectly ....too high
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Full blood count normal, Hypoaesthesia, Neck pain, Pruritus
Clinical narrative: Elevated heart rate, anxiety, subjective "scratchy" throat and tongue swelling per patient within 20 minutes of vaccination. Patient seen in ED - offered treatment with benadryl and solumedrol, patient declined treatment as symptoms had resolved. Lab work obtained
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Full blood count, Heart rate increased, Metabolic function test, Swollen tongue
Clinical narrative: Elevated heart rate, anxiety, subjective "scratchy" throat and tongue swelling per patient within 20 minutes of vaccination. Patient seen in ED - offered treatment with benadryl and solumedrol, patient declined treatment as symptoms had resolved. Lab work obtained
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Elevated heart rate, anxiety, subjective "scratchy" throat and tongue swelling per patient within 20 minutes of vaccination. Patient seen in ED - offered treatment with benadryl and solumedrol, patient declined treatment as symptoms had resolved. Lab work obtained
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: Within a few minutes had hives, itching, some swelling in lips and eyes. For 48 hours afterwards had low grade temp (100.1), diarrhea, chills, body aches, exhaustion.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Lip swelling, Pain
Clinical narrative: Within a few minutes had hives, itching, some swelling in lips and eyes. For 48 hours afterwards had low grade temp (100.1), diarrhea, chills, body aches, exhaustion.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Pyrexia, Swelling of eyelid, Urticaria
Clinical narrative: Within a few minutes had hives, itching, some swelling in lips and eyes. For 48 hours afterwards had low grade temp (100.1), diarrhea, chills, body aches, exhaustion.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Cardiac arrest, Cough, Death, Dyspnoea
Clinical narrative: was not feeling well at 10 pm that night (approximately 15 hours after the shot)  called the ambulance and died at the Hospital
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Intraosseous access placement, Laryngeal mask airway insertion, Oxygen saturation decreased, Pulse absent
Clinical narrative: was not feeling well at 10 pm that night (approximately 15 hours after the shot)  called the ambulance and died at the Hospital
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulseless electrical activity, Pyrexia, Respiratory arrest, Resuscitation, Unresponsive to stimuli
Clinical narrative: was not feeling well at 10 pm that night (approximately 15 hours after the shot)  called the ambulance and died at the Hospital
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ventricular fibrillation
Clinical narrative: was not feeling well at 10 pm that night (approximately 15 hours after the shot)  called the ambulance and died at the Hospital
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Malaise
Clinical narrative: was not feeling well at 10 pm that night (approximately 15 hours after the shot)  called the ambulance and died at the Hospital
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Epinephrine, Injection site pruritus
Clinical narrative: Progressive itchy arm with progressive shortness of breath started 20 minutes after injection. Took 50mg of Benadryl. Very short of breath and feeling of dread over next 10 minutes followed by .3 epi pen injection, transported by ambulance to ER, given Iv fliuds, solumedrol, pepcid and back to normal by noon. Sent home with methylprednisone 4 mg dose pack, benadryl and pepcid.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Malaise, Pruritus
Clinical narrative: Progressive itchy arm with progressive shortness of breath started 20 minutes after injection. Took 50mg of Benadryl. Very short of breath and feeling of dread over next 10 minutes followed by .3 epi pen injection, transported by ambulance to ER, given Iv fliuds, solumedrol, pepcid and back to normal by noon. Sent home with methylprednisone 4 mg dose pack, benadryl and pepcid.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Had the vaccine at approximately 2:45 pm.  At  about 10 pm that night I got hives on my  face and my left eye was itchy.  The next day I called my doctor and I took Benadryl.  As of today 2/10/21 it is clearing up
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Urticaria
Clinical narrative: Had the vaccine at approximately 2:45 pm.  At  about 10 pm that night I got hives on my  face and my left eye was itchy.  The next day I called my doctor and I took Benadryl.  As of today 2/10/21 it is clearing up
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Hypertension
Clinical narrative: Patient has a history of hypertension, asthma (borderline), obesity and lymph node issues. She complained of complained of not feeling well on 2/7/2021. She had difficulty sleeping, tiredness and lightheadedness.  Her symptoms worsened to include nausea.  On 2/8/2021, the decedent was found on the floor after a probable syncopal episode.  Once in bed, her breathing became labored. She is pronounced dead at home by EMS.    She had her first vaccine with Pfizer on 2/4/2021.   Her only complaint at the time was a sore arm.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dizziness, Dyspnoea, Fatigue, Insomnia
Clinical narrative: Patient has a history of hypertension, asthma (borderline), obesity and lymph node issues. She complained of complained of not feeling well on 2/7/2021. She had difficulty sleeping, tiredness and lightheadedness.  Her symptoms worsened to include nausea.  On 2/8/2021, the decedent was found on the floor after a probable syncopal episode.  Once in bed, her breathing became labored. She is pronounced dead at home by EMS.    She had her first vaccine with Pfizer on 2/4/2021.   Her only complaint at the time was a sore arm.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Nausea, Pain in extremity, Syncope
Clinical narrative: Patient has a history of hypertension, asthma (borderline), obesity and lymph node issues. She complained of complained of not feeling well on 2/7/2021. She had difficulty sleeping, tiredness and lightheadedness.  Her symptoms worsened to include nausea.  On 2/8/2021, the decedent was found on the floor after a probable syncopal episode.  Once in bed, her breathing became labored. She is pronounced dead at home by EMS.    She had her first vaccine with Pfizer on 2/4/2021.   Her only complaint at the time was a sore arm.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Insomnia, Nausea
Clinical narrative: Patient has a history of hypertension, asthma (borderline), obesity and lymph node issues. She complained of complained of not feeling well on 2/7/2021. She had difficulty sleeping, tiredness and lightheadedness.  Her symptoms worsened to include nausea.  On 2/8/2021, the decedent was found on the floor after a probable syncopal episode.  Once in bed, her breathing became labored. She is pronounced dead at home by EMS.    She had her first vaccine with Pfizer on 2/4/2021.   Her only complaint at the time was a sore arm.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Nausea, Panic reaction, Speech disorder
Clinical narrative: within 3minutes of vaccine administration patient became diaphoretic, flushed and reported chest and neck tightness. She was placed in the Clinic Observation Room.  VSS were taken immediately. Unable to obtain a BP, HR 130's T97.7F temporal 02Sat 100% Allergist on call paged admin Zyrtec 10mg po x1, patient continued to gasp, oxygen via nonrebreather applied, patient put hands around throat and was thrashing, Epi pin admin x1 in the right thigh. Simultaneously, the Rapid Response Code Team had been paged.  They arrived promptly and took over care of the patient.  The patient was transferred to the Emergency Room at MGH
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Tryptase
Clinical narrative: within 3minutes of vaccine administration patient became diaphoretic, flushed and reported chest and neck tightness. She was placed in the Clinic Observation Room.  VSS were taken immediately. Unable to obtain a BP, HR 130's T97.7F temporal 02Sat 100% Allergist on call paged admin Zyrtec 10mg po x1, patient continued to gasp, oxygen via nonrebreather applied, patient put hands around throat and was thrashing, Epi pin admin x1 in the right thigh. Simultaneously, the Rapid Response Code Team had been paged.  They arrived promptly and took over care of the patient.  The patient was transferred to the Emergency Room at MGH
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Flushing, Hyperhidrosis, Muscle tightness
Clinical narrative: within 3minutes of vaccine administration patient became diaphoretic, flushed and reported chest and neck tightness. She was placed in the Clinic Observation Room.  VSS were taken immediately. Unable to obtain a BP, HR 130's T97.7F temporal 02Sat 100% Allergist on call paged admin Zyrtec 10mg po x1, patient continued to gasp, oxygen via nonrebreather applied, patient put hands around throat and was thrashing, Epi pin admin x1 in the right thigh. Simultaneously, the Rapid Response Code Team had been paged.  They arrived promptly and took over care of the patient.  The patient was transferred to the Emergency Room at MGH
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal discomfort, Seizure
Clinical narrative: within 3minutes of vaccine administration patient became diaphoretic, flushed and reported chest and neck tightness. She was placed in the Clinic Observation Room.  VSS were taken immediately. Unable to obtain a BP, HR 130's T97.7F temporal 02Sat 100% Allergist on call paged admin Zyrtec 10mg po x1, patient continued to gasp, oxygen via nonrebreather applied, patient put hands around throat and was thrashing, Epi pin admin x1 in the right thigh. Simultaneously, the Rapid Response Code Team had been paged.  They arrived promptly and took over care of the patient.  The patient was transferred to the Emergency Room at MGH
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Swollen tongue, Tachycardia
Clinical narrative: 1417 assoc c/o left arm tingling. observed by vaccination team 1425 assoc c/o left arm, left chest, and lips tingling 1430 vitals- pulse 91 b/p 120/80 O2 100%. tongue visibly swollen. 1435 given oral benadryl dose unknown 1439 pulse 102 b/p 130/90 O2100% room air. assoc advised the team she was just finishing 21 hr shift 1442 noted swelling in tongue decreased. team delivered O2 2L NC. assoc developed rigors, rapid response team called. assoc c/o chest pressure. team administered Epiniphren 0.3 IM to left thigh. 1448 vitals hr 11 O2 100% 2L NC b/p 140/95 1450 ems arrived 1455 stretcher arrived separately and assoc transported to ED. in ED assoc given solu medrol, zyrtec, and prednisone
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Electrocardiogram, Electrocardiogram normal, Paraesthesia
Clinical narrative: 1417 assoc c/o left arm tingling. observed by vaccination team 1425 assoc c/o left arm, left chest, and lips tingling 1430 vitals- pulse 91 b/p 120/80 O2 100%. tongue visibly swollen. 1435 given oral benadryl dose unknown 1439 pulse 102 b/p 130/90 O2100% room air. assoc advised the team she was just finishing 21 hr shift 1442 noted swelling in tongue decreased. team delivered O2 2L NC. assoc developed rigors, rapid response team called. assoc c/o chest pressure. team administered Epiniphren 0.3 IM to left thigh. 1448 vitals hr 11 O2 100% 2L NC b/p 140/95 1450 ems arrived 1455 stretcher arrived separately and assoc transported to ED. in ED assoc given solu medrol, zyrtec, and prednisone
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Tachycardia
Clinical narrative: 1417 assoc c/o left arm tingling. observed by vaccination team 1425 assoc c/o left arm, left chest, and lips tingling 1430 vitals- pulse 91 b/p 120/80 O2 100%. tongue visibly swollen. 1435 given oral benadryl dose unknown 1439 pulse 102 b/p 130/90 O2100% room air. assoc advised the team she was just finishing 21 hr shift 1442 noted swelling in tongue decreased. team delivered O2 2L NC. assoc developed rigors, rapid response team called. assoc c/o chest pressure. team administered Epiniphren 0.3 IM to left thigh. 1448 vitals hr 11 O2 100% 2L NC b/p 140/95 1450 ems arrived 1455 stretcher arrived separately and assoc transported to ED. in ED assoc given solu medrol, zyrtec, and prednisone
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Thirst
Clinical narrative: Thirst; dehydration; This is a spontaneous report from a non-contactable consumer. This report was received via a sales representative. An adult male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previous received the first dose of bnt162b2 in Dec2020 for covid-19 immunization. The patient experienced thirst and dehydration on Jan2021. The outcome of the events was recovered in Jan2021 at the time of last observation. No treatment received for the events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: Lymphadenitis; This is a spontaneous report from a non-contactable consumer. An adult male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. The patient experienced lymphadenitis on Jan2021. It was unknown if the patient received treatment for this. Outcome of the event was recovered on Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine was administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) 1 injection, (lot # T004378, expiration date reported as 31-OCT-2022, but upon internal validation stablished as 01-NOV-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of vaccine was stored in the temperature of above 9 degrees Celsius (13.4 degrees Celsius) for 2 hours and 9 minutes. There were no previous temperature excursions reported. The improper storage was recorded by digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2101USA013389: US-009507513-2101USA013543: US-009507513-2101USA013730: US-009507513-2102USA000172: US-009507513-2102USA000195: US-009507513-2102USA000219:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs no PQCs; Temperature: -13.7C; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 01-FEB-2021, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # T025222, expiration date: 19-JAN-2022 (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at - 13.7 Celsius degrees (C) for 42 minutes. There was no previous temperature excursion reported. The call was not due to digital data logger. No additional adverse event was reported.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Product storage error
Clinical narrative: product storage error; This spontaneous report was received from a licensed practical nurse regarding a 1 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 13-DEC-2019, the patient received improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S037501, expiration date of 12-NOV-2021, subcutaneous in the right thigh , varicella virus vaccine live (oka/merck)(VARIVAX) lot # T017686 with expiration date of 21-MAY-2022, subcutaneous in the left thigh, hepatitis a virus vaccine inactivated(HAVRIX) lot # N592C with expiration date of 12-JUN-2022, intramuscular in the right vastus lateralis and pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) lot # D57723 with expiration date of 30-SEP-2022 intramuscular in the left vastus lateralis, all for prophylaxis The vaccines experienced temperature excursions with a total of 29.5h.   This is one of several reports from the same reporter(US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; This spontaneous report was received from a licensed practical nurse regarding a 4 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 14-DEC-2020, the patient received improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S037501, expiration date of 20-NOV-2021, subcutaneous in left arm and  varicella virus vaccine live (oka/merck)(VARIVAX) lot # T017686 with expiration date of 21-MAY-2022, subcutaneous in the left arm for prophylaxis.  The vaccines experienced temperature excursions with a total of 29.5h.  This is one of several reports from the same reporter(US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:
Sex: M
Vaccine: RV5
Symptoms: Rash
Clinical narrative: rash on his head; This spontaneous report was received from an unspecified reporter and refers to a 4 month old male patient. . No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis.  On an unknown date the patient experienced presented with a rash on his head but it did go away.      Causality was not provided.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details are available; AE for ROTATEQ which was administered after improper storage; This spontaneous report was received from a medical assistant and refers to a 6-month-old patient.   The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.   On 01-FEB-2021, the patient was vaccinated with an improperly stored dose  of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 milliliters, orally, lot number 1742461, and expiration date on 17-NOV-2021 (formulation, strength,  frequency, and anatomical location were not reported) for prophylaxis.  No additional adverse event details were available.     The administered dose of vaccine experienced the temperature excursion of 9.9 degrees Celsius for 35 minutes. The previous temperature excursion was not reported. Data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: varicella rash; This spontaneous report was received from a physician and refers to a patient of unknown age and gender with heart disease congenital. Te patient's medical history and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dose, frequency, lot # and expiration date were not provided) for prophylaxis.  On an unknown date, the patient experienced a new varicela rash(rash vesicular). The outcome of rash vesicular was unknown.     The reporter considered rash vesicular to be related to varicella virus vaccine live (Oka/Merck)(VARIVAX).
Age: 82.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injury
Clinical narrative: other zoster related injuries; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was 82 years old. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On or about 21-OCT-2013, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a physician at a family care facility for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events of shingles and other zoster related injuries to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: fever; Sore arm; Swollen arm; . This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced fever, pain in arm and swelling arm. On an unknown date, the outcome of the fever, pain in arm and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, pain in arm and swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient received the 2nd dose of Shingrix and experinced fever, sore arm and arm swelling. Patient asked regarding how long the side effects such as fever generally last.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dizziness, Headache, Incomplete course of vaccination, Nausea
Clinical narrative: severe shivering, was so bad that she could not dial a phone; severe headache; nausea; dizziness; had her first dose in April or May of 2019.; This case was reported by a consumer and described the occurrence of shivering in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, 30 min after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shivering, headache, nausea, dizziness and incomplete course of vaccination. On an unknown date, the outcome of the shivering, headache, nausea and dizziness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shivering, headache, nausea and dizziness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for the 2nd dose. The patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. In April or May 2019, the patient received 1st dose of Shingrix and experinced severe shivering so bad that she could not dial a phone, severe headache, nausea and dizziness. The symptoms lasted approximately an hour before reducing in severity but had not resolved until 6 to 8 hours later. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site rash, Syncope
Clinical narrative: Headache; Collapsed on the floor; Left arm injection site red; Rash; A spontaneous report was received from a consumer, who was also a 80-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced syncope, injection site redness, rash, and headache.  The patient's medical history, as provided by the reporter, included high blood pressure. Concomitant product use reported included atenolol and atorvastatin.  On 11 Jan 2021, one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient noticed her left arm was getting redder and redder at the injection site. When she turned to look at the clock, the patient collapsed on the floor. She went to the medical center and was prescribed prednisone and diphenhydramine.  On 21 Jan 2021, the patient reported she now had a headache that began on an unspecified date, and that her injection site redness and rash were still present, but getting better.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event, syncope, was unknown. The events, injection site redness and rash, were considered resolving. The event, headache, was considered not resolved.; Reporter's Comments: This spontaneous report concerns an 80-year-old, female patient with medical history of high blood pressure who experienced serious event of syncope and non-serious events of injection site redness, rash and headache. The events of syncope rash and injection site redness occurred 1 day after administration of mRNA-1273 (Batch number: 039K20A, expiration date-unknown). On an unspecified date on the event of headache began.  Treatment provided for the events included prednisone and diphenhydramine and the outcome is not resolved. injection site redness, rash and headache are consistent with the known safety profile of the mRNA-1273 Vaccine and hence, based on the temporal association between the events and the vaccine administration, a causal association cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: she got the first dose of the covid vaccine on 04Jan, scheduled to get the second dose of the covid vaccine on 24Jan; experiencing runny nose; colds; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age was scheduled to get the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 11:28 at single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease, ongoing torn rotator cuffs. The patient also believed she was immunocompromised. The patient confirmed that the shoulder pain that she was getting the Cortisone shot for was prior to the COVID shot and she had been getting them for some time. The patient previously took prednisone regularly and took BNT162b2 (Batch/lot number: EL0142, Expiry Date: 20Mar2021) via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunization and had swelling and pain on the arm that was injected on an unspecified date in Jan2021. Also, she had a fever and felt lethargic that night but the next day she felt fine. The caller clarified that the next day she actually could hardly get out of bed and felt fatigued and tired. Her temperature reached 100.7. This happened on 05Jan2021. The patient's concomitant medication was not reported. Caller asking if she can have the second dose of the covid vaccine if she was scheduled for a cortisone injection to both of her shoulders. Caller reported that she got the first dose of the covid vaccine on 04Jan, she was now scheduled to have cortisone injections to both of her shoulders for torn rotator cuffs on 13Jan and then scheduled to get the second dose of the covid vaccine on 24Jan. The patient got the second dose of the vaccine on 25Jan2021 11:28 and is experiencing runny nose and colds. The outcome of the events was unknown.   Follow-up (25Jan2021): New information received from a contactable consumer includes: additional events (runny nose, and colds).   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dysaesthesia, Hyperaesthesia, Neuralgia, Pain
Clinical narrative: post injection experienced tingling, burning pain over left clavicle and into L neck; post injection experienced tingling, burning pain over left clavicle and into L neck; post injection experienced tingling, burning pain over left clavicle and into L neck; nerve pain (hyperaesthesia, tingling, zinging); nerve pain (hyperaesthesia, tingling, zinging); nerve pain (hyperaesthesia, tingling, zinging); This is a spontaneous report from a contactable physician. An adult non-pregnant female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) intramuscularly on 22Dec2020 at 19:45 as a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies and known allergies: sensitivity to toluene and strong fragrances, from unspecified dates and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (reported as other medications in two weeks) included clarithromycin (CLARITIN) taken for an unspecified indication from an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Dec2020 at 19:45 the patient experienced "post injection experienced tingling, burning pain over left clavicle and into L neck" and "nerve pain (hyperaesthesia, tingling, zinging)". The clinical course was reported as follows: "Injection was painless, starting 5-10 minutes post injection the patient experienced tingling, burning pain over left clavicle and into L (left) neck. No associated rash, redness, color or temperature change. No swallowing or breathing difficulty. Nerve pain (hyperaesthesia, tingling, zinging) persisted 3 weeks later at lower intensity over medial clavicle and supraclavicular fossa aggravated by clothing, Valsalva, certain L arm movements." The adverse events resulted in a doctor or healthcare professional office/clinic visit. Treatment was given in response to the events and included gabapentin. The clinical outcomes of the events "post injection experienced tingling, burning pain over left clavicle and into L neck" and "nerve pain (hyperaesthesia, tingling, zinging)" were recovered/resolved with sequel (with lasting effects). It was also reported that the patient was tested for COVID-19 post vaccination on 04Jan2021, with a nasal swab, which was negative.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: post injection experienced tingling, burning pain over left clavicle and into L neck; post injection experienced tingling, burning pain over left clavicle and into L neck; post injection experienced tingling, burning pain over left clavicle and into L neck; nerve pain (hyperaesthesia, tingling, zinging); nerve pain (hyperaesthesia, tingling, zinging); nerve pain (hyperaesthesia, tingling, zinging); This is a spontaneous report from a contactable physician. An adult non-pregnant female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) intramuscularly on 22Dec2020 at 19:45 as a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies and known allergies: sensitivity to toluene and strong fragrances, from unspecified dates and unspecified if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (reported as other medications in two weeks) included clarithromycin (CLARITIN) taken for an unspecified indication from an unspecified date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Dec2020 at 19:45 the patient experienced "post injection experienced tingling, burning pain over left clavicle and into L neck" and "nerve pain (hyperaesthesia, tingling, zinging)". The clinical course was reported as follows: "Injection was painless, starting 5-10 minutes post injection the patient experienced tingling, burning pain over left clavicle and into L (left) neck. No associated rash, redness, color or temperature change. No swallowing or breathing difficulty. Nerve pain (hyperaesthesia, tingling, zinging) persisted 3 weeks later at lower intensity over medial clavicle and supraclavicular fossa aggravated by clothing, Valsalva, certain L arm movements." The adverse events resulted in a doctor or healthcare professional office/clinic visit. Treatment was given in response to the events and included gabapentin. The clinical outcomes of the events "post injection experienced tingling, burning pain over left clavicle and into L neck" and "nerve pain (hyperaesthesia, tingling, zinging)" were recovered/resolved with sequel (with lasting effects). It was also reported that the patient was tested for COVID-19 post vaccination on 04Jan2021, with a nasal swab, which was negative.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Influenza like illness, Malaise
Clinical narrative: my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; felt like my heart pounding and racing/ fast heart rate; feeling too sick; started to feel flu like; muscle pain; fatigue; The initial report was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration in the left arm on 15Jan2021 09:15 AM at a single dose to prevent COVID-19. Medical history included known allergies: latex. Concomitant medications in two weeks included ergocalciferol (VIT D) and cyanocobalamin (VIT B12). The patient did not have any other vaccine in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular route of administration in the left arm on 26Dec2020 10:30 AM. She also previously took NYQUIL and experienced known allergies. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. The patient stated "I started to feel flu like around 7pm on January 15th. I had extreme muscle pain and fatigue. I woke up at 2am with what felt like my heart pounding and racing. The fast heart rate lasted about an hour. For the next +5 days, I had extreme fatigue, taking 3 hour naps at a time and still suffering from muscle pain. I attempted to go to work a couple of those days but went home half way through my shift because I was feeling too sick. Friday morning, 22Jan, I woke up feeling like I had leg weakness but I was still able to do activity normally. Saturday morning, 23Jan, I woke up with tingling to my hands and feet. I even had trouble typing at work. I made it through my shift this day with waves of muscle pain, fatigue and constant tingling to my hands and feet. Today Sunday, 24Jan I still have hand & feet tingling and my feet feel so cold like ice. I still feel 'off' overall. I plan do see my PCP this week to discuss these new symptoms in my hands and feet." The patient did not receive treatment for the events. She was not tested for COVID post vaccination. The outcome of 'heart pounding and racing/ fast heart rate' was recovered, and of remaining events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Paraesthesia, Peripheral coldness
Clinical narrative: my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; felt like my heart pounding and racing/ fast heart rate; feeling too sick; started to feel flu like; muscle pain; fatigue; The initial report was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration in the left arm on 15Jan2021 09:15 AM at a single dose to prevent COVID-19. Medical history included known allergies: latex. Concomitant medications in two weeks included ergocalciferol (VIT D) and cyanocobalamin (VIT B12). The patient did not have any other vaccine in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular route of administration in the left arm on 26Dec2020 10:30 AM. She also previously took NYQUIL and experienced known allergies. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. The patient stated "I started to feel flu like around 7pm on January 15th. I had extreme muscle pain and fatigue. I woke up at 2am with what felt like my heart pounding and racing. The fast heart rate lasted about an hour. For the next +5 days, I had extreme fatigue, taking 3 hour naps at a time and still suffering from muscle pain. I attempted to go to work a couple of those days but went home half way through my shift because I was feeling too sick. Friday morning, 22Jan, I woke up feeling like I had leg weakness but I was still able to do activity normally. Saturday morning, 23Jan, I woke up with tingling to my hands and feet. I even had trouble typing at work. I made it through my shift this day with waves of muscle pain, fatigue and constant tingling to my hands and feet. Today Sunday, 24Jan I still have hand & feet tingling and my feet feel so cold like ice. I still feel 'off' overall. I plan do see my PCP this week to discuss these new symptoms in my hands and feet." The patient did not receive treatment for the events. She was not tested for COVID post vaccination. The outcome of 'heart pounding and racing/ fast heart rate' was recovered, and of remaining events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: hives in her upper thigh, toes, eyelid; Throat closed; This is a spontaneous report from a contactable consumer (patient). A female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunisation. The patient's medical history included allergic to Penicillin. The concomitant medications were not reported. With the COVID-19 vaccine, patient had a reaction of hives in her upper thigh, toes, eyelid; went to sleep, when woke up it was pretty much gone with Benadryl. Patient have throat closed. For second dose, patient wanted to know if it be needed the EpiPen or tell ambulance just in case. Her second injection was on Sunday. As per the verbatim the patient had not administered the second dose yet. The outcome of hives in her upper thigh, toes, eyelid was recovering. The outcome of throat closed was unknown.  Information on the batch/Lot number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Tachycardia
Clinical narrative: Tachycardia; dizziness; flushed feeling; sweating to hands and back of neck; This is a spontaneous report from a contactable nurse reporting for herself. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:Ek4176), via an unspecified route of administration on the left arm on 12Jan2021 17:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, melanoma in situ, diverticulosis, allergies to sulfa, betadine and reacted to depo-medrol injection. Concomitant medication included lisinopril (LISINOPRIL), estradiol (ESTRADIOL), ibuprofen (MOTRIN) and cyanocobalamin (B12). The patient experienced tachycardia, dizziness, flushed feeling and sweating to hands and back of neck on 12Jan2021 17:30. Therapeutic measures (Benadryl 25mg) were taken as a result of the events. The outcome of the events was recovered on an unspecified date in Jan2021.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: Fever; Chills; body aches/muscle soreness; body aches/muscle soreness; This is a spontaneous report received from non-contactable consumer (patient) via Pfizer Sales Representative. A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration in the left arm on 14Jan2021 15:00 at single dose for COVID-19 immunization in a hospital. Patient medical history and concomitant medications were reported as none. The patient had no other vaccines in four weeks and no other medications in two weeks. Patient previously received the first dose of BNT162B2 at the age of 47-years on 24Dec2020 at 03:00PM in the left arm, for Covid-19 immunization in a hospital. On 14Jan2021 23:00 patient experienced fever, chills, body aches/muscle soreness. No treatment was received. Patient was not tested for Covid post vaccination. Outcome of events was recovered on an unspecified date in Jan2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.