chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist via sales representative regarding a 54 year old male patient. There was no pertinent medical history, drug reactions or allergies. On 19-OCT-2013, the patient was vaccinated with a subcutaneous dose of ZOSTAVAX, (dose and lot number were not provided). Concomitantly on the same day, the patient received FLUVIRIN (unspecified dose/frequency and manufacturer) in the opposite arm. On 19-OCT-2013, immediately after administration with ZOSTAVAX, the patient complained of burning at the injection site, and his arm was red and swollen from the deltoid region down to the elbow. The representative stated "the swelling of the arm looked like it was retaining fluid." The patient was treated with BENADRYL (unspecified dose, frequency and  manufacturer) and patient was advised to apply ice to the swelling. The patient sought medical attention, telephone call to the pharmacist on 21-OCT-2013. Laboratory test was not performed. At the time of the report, the patient had not recovered from the adverse events. Additional information has been requested.
Headache, nausea, ringing in left ear & slight fever ( .6 of a degree)
MA accidentally administered two doses of Kinrix due to Twin B was present for the same vaccines. The provider spoke to mom and reassured her they should not be any concerns with additional KINRIX dose. Mom expressed understanding.
Bruising at site of injection and multiple areas covering body (limbs, back, abdomen) that was noticed beginning 12/24/20 and has continued over several days
Pt received 1st dose dose of Moderna vaccine.  10 - 12 minutes post receiving vaccine, pt started vomiting, then became unconsciousness.  Used Ambu Bag, and pt was transported to ED.  O2 Sat: 98% room air and HR:86 at time of transfer
6/14/2021 (4:30 - 4:45 am):  Awakened from sleep with fever, chills, nausea, upset stomach, joint pain 6/14/2021 (4:45 - 5:00 am):  In the bathroom with fever, nausea, vomiting, joint pain Felt too sick to go to work.  Called in sick for the day and went back to bed. 6/14/2021 (5:00 am - 2:00 pm):  Still having nausea, upset stomach, joint pain.  Resting at home.
Hypotensive after vaccination. 3 minutes 75/32 P-49; 20 minutes 88/51 P-54; 30 minutes 110/74 P-72
Patient was in medical observation fell on floor and passed out. Moved back to cc part of building where we kept for 30 plus minutes. Asked patient if he hit his head he stated no- no neck problems just right knee was hit when he fell. BP 115/72 mmHg, pulse 72 bpm, pulse ox 99%, RR 16 brpm. Patient was monitored for 30 minutes and then discharged home.
sz & t103 45 mins p/vax; mom states that pt had 3 sz prior to care; no observed sz activity by medical staff; mom has hx of sz;
Red rash about the size of 4 quarters, itchy, swollen, looks small raised bump where shot was injected, area warm to touch.
Have had shingles/first shot it didn't work; Itching; Pain are so bad; Is very debilitating; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (The patient had shingles for 42 years, started on feet, the arches of left foot, then moved to spine). Previously administered products included Valtrex. Concurrent medical conditions included scar (patient had scarring from years ago).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles, pruritus, pain and debility. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles, pruritus, pain and debility were unknown.   It was unknown if the reporter considered the shingles, pruritus, pain and debility to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR139421   Additional Information: GSK Receipt Date: 26-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had 1st shingles shot and experinced shingles.  The patient stated that shot did not worked.  The doctor finally prescribed acyclovir and the patient took it 2 times a day, if the patient missed taking it, the patient might run out the shingles come back.  The patient was very debilitating and had the itching and pain were so bad, the patient had been scarred from years ago. Additional supportive information: The follow-up would not possible, as no contact details were available. This case has been linked with the case US2022AMR139421 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR139421:
This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 03-APR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose, frequency and route were not reported) (lot # N034005, expiry date: 31-JAN-2020) for prophylaxis. No adverse effect reported. No product quality complaint involved. The LIQUID PEDVAXHIB was stored in temperature of 32 degree Fahrenheit (F) to 35 F (32 F) for 8 minutes. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.
mild hoarseness--wheezing for about 2 hrs when lying down, paleness in hands, slight weakness (difficulty holding my 1 year old son of 30lbs and completing my physical fitness exam for work), heartbeat of 88 bpm (not sure if this is fast or not)
Patient was administered pediatric dose instead of booster dose. No issues post vaccine.  Parent was notified at clinic.
p/vax pt devel inj site rxn characterized by a 30cm by 50cm area of pain, redness & swelling @ site of pnu imune 23;
tested positive on  22Apr2021; a mild case with a stuffy nose; This is a spontaneous report from a contactable consumer (Patient) and received from a Pfizer sponsored program. A 52-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported tested positive on 22apr2021 and a mild case with a stuffy nose on Apr2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event tested positive on 22apr2021 was not recovered while for another event it was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 lot # L019297, 18-AUG-2017, L043214 30-AUG-2017, M003659 20-SEP-2017, M005717 03-OCT-2017. No adverse effects were reported. Temperature excursion 9 C for 9 hours, 0.3 C for 837 hours and 30 F for 542 hours. There were no prior excursions. Additional information has been requested.
When I woke up I noticed a big hot lump in my arm, about 5 inches long, very sore and then it started itching. It lasted about 5 days. Just used some ice. Also had a headache (mild, nagging headache, took some Advil and it subsided).
20 minutes after receiving the injection I started to get a sharp pain in my upper left chest right on my peck muscle. I would describe the pain as 3/10 where 10 is excruciating pain. It would hurt for about 2 minutes and then go away for about 10 minutes and then come back. This happened on and off for about 5 hours. While I was experiencing the pain, breathing very deeply increased the pain to 5/10. Physically applying pressure on the area also increased the pain to 5/10. After about 5 hours the pain did not come back and I have not experienced it since. I did not have any difficulty breathing or any other symptoms.
Headache, Myalgia, Tachycardia, chills, fatigue. Narrative:
12 hours after receiving the shot, I began to experience: chills, fever, hallucination, headache, and bodily pain. The symptoms lasted for about 30 hours. For an additional two days after that, I continued experiencing headache, bodily pain, and fever.
Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB adult formation 10/1.0 microgram/ml (dose, lot # and route unspecified). Information regarding medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Patient became lightheaded.  Patient laid on table and no LOC.  Given ginger ale & lollipops.  BP 130/80 after vaccine & HR 70.  AAO x3.  Pt observed x15-20 mins alert full recovery and discharged to home.
35 Y female no signif PMH but with OCP (TriSprintec) since at least 2018, family hx of strokes in family members' 40s, daily marijuana use, and recently (10 days ago) seen in clinic for shortness of breath who per chart review was in her usual state of health until 10:30 am today shen she developed R sided headache, slurred speech, and L arm weakness while she was working out at the gym. At the time she was doing light cardio exercise including jumping jacks and lunges.    On arrival stroke scale - 3 for facial palsy, left arm drift, and mild dysarthria. CT H  demonstrated hyperdense R MCA which corresponded with a filling defect in the R MCA (M2/M3 segment) c/w thrombosis; her CTa neck was normal and there were no e/o hemorrhage. Furthermore, this same CTa showed extensive bilateral PE. An extended stroke alert was called and she was given IV tenecteplase at 1250pm and underwent thrombectomy.   2 weeks ago (6/2) she was seen in clinic for sudden onset shortness of breath, thought at that time by that clinician to be most likely exercise-induced asthma vs less likely ACS. She was advised to use her already written albuterol and had follow up in 2 days (6/4). At that time it was noted she had more SOB with exercises and increased chest tightness that were both relieved with inhaler use.   She has a family history of strokes: Maternal uncle and maternal aunt strokes in their 40s Recent surgeries/immobility/travel: No surgeries, no more than a 2 hour car ride Smoking history: Dialy cannabis smoking but no tobacco smoking Age appropriate cancer screen: Yes  Family history of cancer: breast cancer in grandmother   Baseline functional status Full IADL's and A&O x4.   At time of ICU consult, temp 98, BP 140/89, HR 88, RR 18.  Patient received: intraop NS, Versed, fentanyl, tenecteplase for thrombectomy Labs notable for All labs wnl  35 y.o female with no significant PMH on OCP presented with shortness of breath and slurred speech and LUE weakness found to have acute right M1 occlusion. She underwent thrombolysis with successful recanalization. Deficits resolved. She was also found bilateral PE and non occlusive DVT. Repeat imaging stable. TTE with evidence of small PFO. Today, she is feeling well, denies shortness of breath or new neurological complaints/deficits.    1. R MCA infarct s/p TNK and thrombectomy 6/14 with no residual deficits - secondary to paradoxical embolism. Appreciate neurology recommendations. Small PFO found on TTE, appreciate cardiology evaluation for closure.  2. Bilateral PE/non occlusive DVT - mildly elevated homocysteine level. Rest of hypercoagulable workup pending. Continue heparin gtt, transition to Pradaxa with Lovenox bridging.
17OCT94 pt recvd vax & exp difficulty sleeping 23OCT; more irritable, loss of appetite, fever to 104 (? by ear thermometer); seen in office 26OCT; exam neg except faint pap rash (scattered);
FELT SHAKY; SLEEPY; FELT CHILLED; FEVER; FELT TIRED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-AUG-2021, the patient experienced felt shaky. On 31-AUG-2021, the patient experienced sleepy. On 31-AUG-2021, the patient experienced felt chilled. On 31-AUG-2021, the patient experienced fever. On 31-AUG-2021, the patient experienced felt tired. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine was not applicable. The outcome of the felt chilled, fever, felt tired, felt shaky and sleepy was not reported. This report was non-serious.
Mrs L. M. received rubella vaccine on 1/14/1999 and on 1/31/2000 the lab came back negative for any rubella titer or evidence of antibodies. Also, she is pregnant at this time.
Pt admit to hospital 5/29-6/1 with COVID PNA (tested positive for COVID 5/29/22). Pt received 3 COVID19 vaccines prior to admit (3/10/21 - moderna, 4/7/21 - moderna, and 12/19/21 - Pfizer)
headache; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 03Feb2021 (at the age of 75 years old) (Lot Number: EL9264) as dose 2, single for COVID-19 immunisation. Medical history included chronic lymphocytic leukemia from an unknown date and unknown if ongoing (CLL, or chronic lymphocytic leukemia, which he is at stage zero, so requires no active treatment at all) and headache from an unknown date and unknown if ongoing (which started before he got the vaccine doses). Concomitant medications included acetaminophen taken for headache, start and stop date were not reported; ibuprofen (ADVIL [IBUPROFEN]) taken for headache, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 13Jan2021 for COVID-19 immunisation. On an unspecified date, the patient experienced headache. It was reported that the headaches probably started in April or May last year, it bothers him for a few weeks then went away then returned about a month ago after his second dose of the Pfizer COVID-19 vaccine, about 8 weeks ago. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: negative on 03Mar2021 has had two antibody tests which came back negative and SARS-CoV-2 antibody test negative: negative on 22Mar2021 (SARS-CoV-2 antibody test negative). The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 20-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included no previous pregnancies.  The subject was not using contraception prior to becoming pregnant.  On 22 September 2011 the subject received a dose of Boostrix (.5 unknown units, intramuscular, unknown site), and experienced vaccine exposure during the second trimester of her pregnancy.  The subject was approximately 26 weeks gestation at the time of vaccination.  The conception was reported to be normal.  Date of last menstrual period was 19 March 2011 and estimated date of delivery was 24 December 2011.  Prenatal testing including ultrasound on 16 August 2011 had revealed no evidence of a defect.  Maternal serum alpha-fetoprotein had been declined.   Upon internal review done on 18th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 16 August 2011 had revealed no evidence of a defect.
Extreme fatigue; malaise / Unwell feeling; congestion; cough; headaches; nausea; diarrhea; chest rash; thumb and side of hand became red and itched; thumb and side of hand became red and itched; hand spasm; 99.2 fever once; This is a spontaneous report from a contactable other HCP (patient). A 71-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN5318) via an unspecified route of administration in right arm on 03Feb2021 at 11:00 AM as 1st dose, single dose for COVID-19 immunization. Medical history included hypothyroidism, allergic to Penicillin, Sulfa drugs, dust, hay fever. Concomitant medications were not reported. Patient was not pregnant. Patient did not receive any other vaccine in four weeks. Patient took other medication in two weeks. Patient was not diagnosed COVID prior vaccination. On 04Feb2021 at 10:00 AM, patient experienced Extreme fatigue, malaise, unwell feeling, congestion, cough, headaches, nausea, diarrhea, chest rash, thumb and side of hand became red and itched, hand spasm, 99.2 fever once. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. Patient had not been COVID tested post vaccination. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
Vaccine not approved to be given under the age of 18, patient is only 17 years old and was given this vaccine
Pt was visiting dr for routine checkup. Pt began to experience difficulty breathing, 911 called. I showed up to pt apneic, pulseless. CPR initiated. Return of spontaneous circulation in ambulance (without Rx). Pt intubated, ventilations continued throughout contact. Pt  still had spontaneous pulse upon delivery ti ED, placed on vent in our presence. Pt later transported to Level 1 hospital on vent.
1st dose- 06Jan2021/ her 2nd dose received on 20Jan2021; wiped out/ tired; headache; had no energy; Rigors; fever of 102.6; This is a spontaneous report from a contactable nurse (patient). This 55-year-old female patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 at 8:45AM via an unknown route at right arm for Covid-19 immunization. No vaccines administered on same date with the Pfizer vaccine considered as suspect. Medica history and concomitant drug were reported as "none". Patient previously had 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 in right arm (Lot/NDC/Expiry unknown). No other vaccinations within four weeks prior to the first administration date of the suspect vaccine; no adverse events following prior vaccinations. No family medical history relevant to adverse event. The patient reported some side effects from her 2nd dose received on 20Jan2021 at 8:45AM. She had a fever of 102.6 which started at 8pm on 20Jan2021 and broke this morning at 6am. The patient stated that the fever was gone, but she wouldn't say she has recovered completely because she still feels wiped out; had headache and was tired; also stated that she was not able to eat, and had no energy while she had the fever. The rigors started at 9pm on Wednesday, 20Jan2021. She stated that she couldn't do anything for the few hours it lasted. No other relevant diagnostic and confirmatory test results for events. No investigation assessment performed. The event did not require a visit to Emergency room or Physician office. The reported considered seriousness for fever was medically significant, for rigors was disabling.  Outcome of fever was resolving. Outcome of rigors was resolved on 21Jan2021. Outcome of the other events was unknown.    Information on the Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia and chills cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
fatigue; headache.; This is a spontaneous report received from contactable Pfizer Vaccine representative. A 30-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date, patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) for covid-19 immunization. After receiving second dose he was experiencing fatigue and headache. The event assessed as non-serious with outcome of unknown.   Information on the lot/batch number has been requested.
Profuse diarrhea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Profuse diarrhea) and CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart failure. Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for Heart failure.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced DIARRHOEA (Profuse diarrhea) and CHILLS (Chills). At the time of the report, DIARRHOEA (Profuse diarrhea) and CHILLS (Chills) outcome was unknown.            No treatment information was provided.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 03-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Adverse events included Injection Site Pain, Fatigue, Headache, Achy Joints (mostly knees), Chills, Nausea, and Swollen lymph nodes in armpit nearest injection site.  Only treatments were rest and acetaminophen.  Symptoms started approximately 12 hours after vaccine administration and lasted approximately 24 hours.