chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 yo M with anaphylactic reaction on 12 Jun following  immunizations including JEV, anthrax, typhoid, and yellow fever.  Patient presented approximately 20 min after receiving immunizations with urticaria, conjunctival injection, and difficulty breathing.  Epinephrine administered with relief of symptoms, and patient transported to Hospital Emergency Department by ambulance for additional treatment/observation.
Pt experienced fever 100.4, chills, nausea, vomiting x 2. Recovered enoug to go back to school 5/1/08 (Pt's father and grandmother are allergic to Tetanus)
Patient received a Pfizer COVID-19 booster vaccine on 1/22/22.  Patient stated  on questionare that he became dizzy after vaccinations several years ago.  He was fine after his first 2 Pfizer vaccines received at this location.  Approximately 10 minutes after receiving the vaccination the patient began feeling dizzy.  I assisted him to the floor where he laid down for approximately 15 minutes. I gave him an ice pack to place on his head because he felt "a little clammy".  I stayed by the patient until he could get back into the chair.  He sat there for an additional 10 minutes.  He felt better and stood up with someone else and myself by his side. His dizziness resolved and he left.
Arm soreness by 6 PM, headache by 12 AM during sleep, next morning by 6:30 AM fatigue, stomach cramps, continued headache, arm pain when moving arm, body aches. Second and third days some symptoms slightly better but still lingering. Fourth day nausea, vomited once, shivers, unable to sleep due to aches and restlessness.
sharp shooting tooth pain; temperature; aching arm; chills; This is a spontaneous report from Pfizer sponsored Program. A contactable consumer (patient) is the reporter.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 (Lot number: FA7485) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose #1 on 01Feb2021 about 14.00 in the left arm. Caller does not have NDC or dose to provide. States the CDC cards says lot S318, expiry May2021), administration date: 01Feb2021, when the patient was 73 years old, for COVID-19 IMMUNISATION; Bnt162b2 (dose #2 on 22Feb2021 about 11-12 in the left arm. Caller does not have NDC or dose to provide. States the card says lot S318, expiry May2021), administration date: 22Feb2021, when the patient was 73 years old, for COVID-19 IMMUNISATION, reaction(s): "temperature", "aching arm", "chills". The following information was reported: TOOTHACHE (non-serious) with onset 2021, outcome "recovering", described as "sharp shooting tooth pain"; BODY TEMPERATURE INCREASED (non-serious) with onset 2021, outcome "recovered" (2021), described as "temperature"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "aching arm"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of toothache, body temperature increased, pain in extremity, chills.  Additional information: Patient did not had Emergency Room visit or Physician Office visit. Patient did not had Prior Vaccinations within 4 weeks. Patient did not had any AE(s) following prior vaccinations. Patients Medical History and relevant tests were none.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. The vaccine was administered to 4 patients today and it has been greater than 30 days in the refrigerator.Three out of the four patients received the vaccine today as their first dose. Caller states that they have not followed up with any of the patients because they want to hear from Moderna first; and none of the patients have called to report any adverse event.
Initial and follow up information has been received from a nurse concerning a 22 year old female with no previous medical history and no known drug allergies, who on 27-SEP-2007 was vaccinated with a first dose of GARDASIL (Lot # 659435/1263U). On 21-NOV-2007 she was vaccinated with a second dose of GARDASIL (Lot# 659435/1263U. On 11-APR-2008 she was vaccinated IM in the left deltoid with the third 0.5 ml dose of GARDASIL (Lot # 659182/1757U). There was no concomitant medication. On 12-APR-2008 the patient experienced redness, swelling, and hardness at the injection site following the last injection of vaccine. The patient called an office for medical attention. On 16-APR-2008 the patient stated the redness and swelling had resolved. The patient was not treated. The redness and swelling had improved. Unspecified medical attention was sought. Patient outcome was recovering. No product quality complaint was involved. Additional information has been requested.
Redness, swelling, warmth, hardness, itching, tender. No treatment.  Lasted for about 2 days.
Aches in his joints; A headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Aches in his joints), HEADACHE (A headache) and CHILLS (Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.  On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ARTHRALGIA (Aches in his joints), HEADACHE (A headache) and CHILLS (Chills). At the time of the report, ARTHRALGIA (Aches in his joints), HEADACHE (A headache) and CHILLS (Chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The patient felt like he was experiencing COVID-19 again.  No relevant concomitant medications were reported.  No treatment information was provided.
pt w/very little crying-5 min p/vax; pt was diaphoretic BP 80 systolic;
Ringing and buzzing in left ear.  Consulted ENT received steroid nasal spray on 3/15/2021. Has not improved
Site: Pain at Injection Site-Medium, Additional Details: PATIENT WIFE CAME IN PHARMACY 11/5/22  JUST  TO LET US KNOW HER HUSBAND HAD PAIN IN ARM AFTER VACCINE. AND HE WENT TO ORTHO. MD GAVE HIM  IBU AND MOVEMENTS TO TRY TO HELP. WIFE STATED HUSBAND WAS DOING FINE AND GETTING BETTER
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 64 years old male patient who experienced shivering pain, fever at 102 and pain at the injection site, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a standard dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI980AB via unknown route in the left arm. On an unknown date, the patient developed a non-serious shivering pain (chills), fever at 102 (pyrexia) and pain at the injection site (vaccination site pain) Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that the symptoms were started about 0300 and lasted through the night for about 24 hours. (Other relevant tests included No lab data.) Final diagnosis was pain at the injection site, fever at 102 and shivering pain. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovered for shivering pain, pain at the injection site and fever at 102. List of documents held by sender: none.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M009764, expiration date 23-FEB-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.3 degrees Fahrenheit for 25 hours. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dose administered from a vial that was more than 30 days on the fridge; vial that spent more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge) and PRODUCT STORAGE ERROR (vial that spent more than 30 days on the fridge) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (vial that spent more than 30 days on the fridge). On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge) had resolved. At the time of the report, PRODUCT STORAGE ERROR (vial that spent more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-326421, MOD-2021-326307, MOD-2021-326468, MOD-2021-326218, MOD-2021-326383, MOD-2021-326432, MOD-2021-326432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant Follow up received. Patient initials was updated . Race and ethnicity was added. Dose 2 vaccine administration date, batch number, anatomical location  was added.
Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported.  Since 28-NOV-2016, the patients had been administered improperly stored doses of VAQTA lot # M015290, expiration date 20-SEP-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse experiences had been reported. The doses of VAQTA were exposed to a temperature >46°F but <77°F and were out of range for 21 hours. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA003203: US-009507513-1701USA003709: US-009507513-1701USA003710: US-009507513-1701USA003712:
This spontaneous report as received from a nurse refers to a patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB dose 1, .05 ml, intramuscular (lot number was not reported) at 2 months of age. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB dose 2, 0.5 ml, intramuscular (lot number was not reported) at 4 months of age. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB dose 3 (booster), 0.5 ml, intramuscular (lot number was not reported) at 8 months of age. Concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a mother refers to her 11 years old son with no drug allergy. The patient's medical history included attention deficit disorder (ADD). In about 2 months ago, approximately June 2012, the patient was vaccinated with GARDASIL (lot # not reported) intramuscular on his left arm. No other co-suspects were reported. Concomitant medications included: STRATTERA, In about 2 months ago, approximately June 2012, the patient experienced extremely bad nose bleeds on average of 3-4 times per day daily. The nose bleeds were randomly even waking him up and night and soaking through towels and pillows. The patient had sought unspecified medical attention and no laboratory performed. The outcome was unknown. Additional information has been requested.
Patient presented with a macular rash on bilateral upper abdomen, right AC, right upper and lower back; no itching or systemic symptoms
Patient is here today for COVID-19 immunization per federal guidelines/written order. See immunization activity for details. Patient was observed post-immunization for a minimum of 30 minutes due to previous history of immediate allergic reaction to a vaccine or injectable therapy and/or history of anaphylaxiswithout evidence of intolerance. Patient instructions added for patient to review in her account. At 15 minutes, patient began to feel lightheaded.  Nurse escorted to Room where vitals were taken: 1140: BP 126/56 P 74, Pulse Ox 97% Patient states she ate breakfast and was given a glass of water during observation. 1150:  BP 117/58 P72 1200: attempted to stand with persistent lightheadedness. 1208:  BP 133/63 P 81 1210:  Patient discharged, ambulatory, without complaint.  No intervention required during 30 minutes of observation.   COVID-19 post-vaccination Patient Instructions added to After Visit Summary for patient to review in her account.
Bilateral knee pain/ pain while not moving; Difficulty walking, going up and downstairs; Inability to totally straighten or bend the knee; This is a spontaneous report from a contactable other health care professional, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9266), via an unspecified route of administration in the left arm on 18Feb2021 at 16:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and prenatal vitamins (MANUFACTURER UNKNOWN); both from unknown dates for unspecified indications. The patient previously received naproxen (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 21Feb2021, the patient experienced bilateral knee pain; lasting for five weeks, difficulty walking, going up and downstairs, pain while not moving, and inability to totally straighten or bend the knee. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with celecoxib. The clinical outcome of the events knee pain, difficulty in walking and movement reduced was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Runny nose/Congestion,  Shortness of breath or difficulty breathing, Hospitalized 08/14/2021 to 08/18/2021.
10 Jun 2021,  approximately 1400 hrs Shoulder where shot was given in right arm swelled up, was hot, and hurt within15 minutes. Additionally,  i was sick for  3-4 days with flu like symptoms,  cold, hot, sneezing,  coughing, and entire body hurting.  I told the army doctor and that my left shoulder still hurt 30 Jun 2021. He said to use the right arm for 2nd shot. Additionally,  i still haven't had a menstrual cycle since the shots. As of 8 Sep 2021 my left shoulder still hurts where the shot was given.
Stroke; This is a spontaneous report from a contactable consumer. A 94-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 16Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing hypertension (took medication). Patient did not have COVID-19 prior to vaccination. Concomitant included unspecified medication for hypertension. The patient experienced stroke on 31Jan2021. The patient was brought to the emergency room and hospitalized  due to the event on 31Jan2021. No therapeutic measures were taken as a result of the event. The patient underwent lab tests and procedures which included COVID-19 virus test: negative in Feb2021 (a week before report); investigation: brain bleed and discovered she had a stroke (on unknown date in 2021). The patient died on 03Feb2021 due to stroke and old age. An autopsy was not performed. Patient's family did not attribute her death to the vaccine at all.  The information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: stroke; Old age
I developed shingles just a couple of days after receiving the two vaccines (diagnosed by my primary care doctor 2 days after rash started). My shingles covers my entire left arm (the arm I received the Covid booster in).  While I know it is not likely that the vaccine caused the shingles, it seems like maybe both vaccines at once (along with being a new parent and being sleep deprived) was just too much for my immune system to keep shingles from occurring. I was started on VALACYCLOVIR HCL 1 GRAM  3x per day for 7 days. My doctor expects a routine course of shingles with full recovery in a few weeks.
chills, sweating, tachycardia , leg cramps, headache,back and neck ache evaluated in ED, EKG, IV fluids, dehydration, elevated ketones 01/5/2021 03:30am 01/07/2021  Reported  Feeling better, discomfort in lymph nodes under arm , Temp 99.. sweating, HR +80
I developed serious hives all over my body, my throat closed up and my tongue swelled up. We called in 911 and the paramedics gave me benadryl and prednisone.
deathly sick from the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent (patient's mother).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "deathly sick from the booster".  Additional information: Reporter was the mother of the patient. Reporter was stated that her daughter was deathly sick from the booster and she was on the Pfizer vaccine and reporter was asked for patient information, lots, expiry dates, NDC numbers and dates of her daughter's Pfizer Covid vaccines and declined and states she has none of that information to provide.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
January 25th: very painful shot, arm sore immediately afterwards took Ibuprofen. 26th: sore arm all day. 27th: sore arm all day, dusky red, 3 inches by 4 inches (Grade 3 local reaction), took Ibuprofen. 28th: sore arm, applying alternating hot and cold compress. 29th: mottled local reaction with some bruising, arm still sore and itchy. 30th  Feb 2nd: arm slightly sore and itchy.
Pt has no findings at injection site there is a 4 cm round area centered 8cm distal to the injection site exhibiting erythema, warmth and mild tenderness with poorly defined borders. Assessment plan: local reaction to Hep B vaccination plan, no further Hep B inj, titer to be drawn in 6 weeks.
Received Expired Vaccine of Moderna COVID-19 Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine of Moderna COVID-19 Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine of Moderna COVID-19 Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine of Moderna COVID-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
TDAP site red, erythematous, warm, painful local site reaction, r/o infection Rx: CEFTIN 500mg BID x 7 days, warm compress.
Narrative: COVID infection following COVID vaccine series 07/29, Pfizer dose #1 08/19, Pfizer, dose #2 01/03 COVID swab, result: detected 12/27 pt cc: headache, fever, body aches, cough, and chest pain exposure: unknown 12/28 pt admit ED cc: headache, fever, body aches, cough, and chest pain dx: COVID+ LOS: 1 day 12/28 CXR impression: No acute thoracic abnormalities.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for four patients. This is the 1st of four reports. A patient of an unspecified age, gender, race and ethnicity received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced body ache and chills. Clinical outcome of the events was unknown at time of this report. The information on the lot number has been requested. Sender's Comments: Linked Report(s) : US-PFIZERINC-2018186944 same reporter/drug/event, different patient; US-PFIZERINC-2018186945 same reporter/drug/event, different patient; US-PFIZERINC-2018186901 same reporter/drug/event, different patient.
Information has been received from a physician concerning a male, who on 03-JUL-2007 was vaccinated with a "single dose" of Zostavax (Oka/Merck).  The day after the vaccination, on 04-JUL-2007, the patient experienced a "papular nodular rash with a small vesicle" on his chest.  Unspecified medical treatment was sought.  No outcome was reported.  No product quality complaint was involved.  Additional information has been requested.