chrisvoncsefalvay/vaers-outcomes huggingface dataset:
getting a headache and got worse and worse; took everything she had not to throw up; arm was very sore; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Mar2021 15:00 (Batch/Lot number was not reported) at the age of 45 years old as 1st dose, single dose for COVID-19 vaccine. Medical history included had two kids naturally; known allergies with sulfa; hydrocephalus (found in 30's), no shunt. The patient rarely gets headaches. The patient was not pregnant. No other vaccines in four weeks. Concomitant medication included citalopram hydrobromide (CELEXA) taken for an unspecified indication, start and stop date were not reported; and unspecified multivitamin. The patient got her shot on 09Mar2021 15:00 (Tuesday afternoon). The patient's arm was very sore on 09Mar2021 (unknown time, Tuesday and Wednesday; also reported as on 11Mar2021 17:00), but she didn't take anything for the pain. Then on 10Mar2021 (Wednesday; also reported as (12Mar2021), she started getting a headache and got worse and worse throughout the day. It got so bad around 5PM that she thought she was going to have to go to the ER and it took everything she had not to throw up. She ate, drank and took a paracetamol (TYLENOL) and felt a little better. She does not get many headaches and has a very high tolerance for pain (had two kids naturally, no epidural or pain meds). This was the worst headache of her life and was considering not getting 2nd shot. 5 days later and she still has a minor headache. Also, she has never had a reaction to any vaccines in the past. The patient has no COVID prior vaccination and was not tested for COVID tested post vaccination. Outcome of event " took everything she had not to throw up" was unknown, while other events were recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
When the patient was given the Pfizer Covid vaccine she felt dizziness at first. Immediately afterwards she fainted and urinated within a few seconds apart. The patient sat in the chair for the remaining 15 minutes and was given water to drink. She had not eaten anything since the night before and this was her first vaccine. After 15 minutes, her head was clear and she was not dizzy anymore and her father came to pick her up.
Initial report received from a health care provider on 26/Jun/2006.  A 42-year old female patient had received an injection of Adacel, lot number not reported, on 20/Jun/2006.  Approximately nine hours later, she experienced diffuse joint pain and took TYLENOL 1000 mg.  The following morning, she had developed a rash over her arms and legs and was experiencing intense diffuse joint pain.  She discontinued taking TYLENOL and began taking Ibuprofen and BENADRYL.  The next morning, the rash had resolved, but the joint aches continued.  She continued taking ADVIL.  On the next morning, she was examined by her physician for joint aches and a lymph node that was tender.  She was treated with a Kenalog injection and advised to continue the Ibuprofen for three additional days.  Recovery status was not provided by the reporter related to joint pain or lymph node tenderness.  Follow up report received on 27/Jul/2006 from a health care professional.  The patient's age was corrected to 32 years (previously reported as 42 years).  The lot number for the Adacel vaccine was reported as C2456AA and it was administered intramuscularly in the left deltoid.  The patient's past medical history included migraines and chronic pain.  Following the events on 20/Jun/2006, the patient was seen by a physician on 23/Jun/2006.  She was treated with Kenalog 60 mg.  Her symptoms resolved on 26/Jun/2006.  Further information is not expected.
Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 16-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
One month later, I developed shingles. I relate this to the vaccine being 38 and healthy nothing should have triggered a shingles outbreak at this age. It was a very mild case, and was treated early.
345pm parent left message: daughter's eyes swollen/draining (teary), throat itches, rash on neck/back. Took several tries to get hold of parent - instructed to go to local emergency room now. Tx'ed at hosp. with prednisone/BENADRYL.
She had a bump about 2 inches below elbow.. Her doctor said he has seen this numerous times with vaccine injection.
Not wanting to eat or drink anything, dry heaves, paleness, severe vomiting from 9:00 pm through 3:00 am.
Still have edema in extremities; Where it is hard to walk; Legs are swollen; Period is super heavy; Period is super heavy and always late; Break out in hives at random times now; Dizziness constantly; Headaches; This is a spontaneous report from a non-contactable nurse, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration on 27May2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on 06May2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Sep2021, 4 months later the patient still had edema in extremities to where it was hard to walk because legs were swollen and period was super heavy and always late. The patient broke out in hives at random times now and had dizziness constantly as well as headaches. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. The patient underwent COVID-19 via nasal swab test on 03Jun2021, 10Jun2021, 17Jun2021, 24Jun2021, 01Jul2021, 08Jul2021, 15Jul2021, 26Aug2021, 02Sep2021, 09Sep2021 and 16Sep2021 and the result found to be negative. Therapeutic measures were taken as a result of the reported events included on an unknown date in 2021, blood tests run was conducted and also MRI (magnetic resonance imaging) performed results were unknown. The clinical outcome of the events still had edema in extremities, where it was hard to walk, legs were swollen, period was super heavy, period was super heavy and always late, break out in hives at random times now, dizziness constantly and headaches was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 08-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018   was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709:
Tired. Scratchy throat. Burning lungs. Swelling throat, mouth, eyes. Mucus in eyes and throat. Difficulty breathing. Severe chills.
This spontaneous report as received from a office manager refers to a 6 month old female patient. Medical history and concurrent conditions were not reported. On an unknown date, the patient completed the first and two doses in series of ROTATEQ oral (dose, lot number and expiry date were not provided). There was no concomitant medication reported. On 15-DEC-2014, the patient sought medical attention, was admitted to an unknown hospital and diagnosed with intussusception. Patient was discharged (in December 2014) and followed up with physician on 29-DEC-2014. The patient received unspecified treatment. The outcome of diagnosed with intussusception was reported as recovering. Relatedness between the therapy with ROTATEQ and the event: diagnosed with intussusception was not reported. Additional information has been requested.
Fever, headaches, tiredness, muscle pain, pain in general, lower back pain and urine of like pink color. Symptoms started with tiredness in general followed by fever. The treatment has been resting, hydrating myself and acetaminophen 1000 mg every 6 hours. I then lowered it to 500 mg every 4 hours. Fever has diminished but the symptom that worries me the most is the color pink on my urine.
Immediately s/p MMR SQ injection, pt fainted; unresponsive, eyes rolled and extremities stiffened during approx. 2 minute time lapse. Pt awoke oriented x 3, pulse regular at 56 beats, per minute. Pt supine for 25 minutes, semi-fowlers 10 minute. Pt dc'd approx. one s/p ADR - LPN.
Urticarial-like rash with low-grade fever. R/o HSP/SBI.
No additional AE detail; the vaccine was administered to patient during the excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were unknown.  On 05-JAN-2020, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (0.5 mL, strength and route were not reported, lot # S032036 has been verified as valid, expiration date 05-JAN-2021) for prophylaxis.  The vaccine administered experienced a temperature excursion of 16.0 degrees Fahrenheit, for a time frame of 25 minutes. There were no previous temperature excursions. The digital data logger was involved. The outcome of the event was unknown.
Tightness in chest; Cough; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jan2022 at 11:00 (Lot number: unknown) at the age of 44 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillins. Concomitant medications included: C; D3; B6; ZINC; FOLIC ACID; MACROBID; IBUPROFEN and B12. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 14Jan2022 at 00:00, outcome "unknown", described as "Tightness in chest"; COUGH (non-serious) with onset 14Jan2022 at 00:00, outcome "unknown", described as "Cough". Therapeutic measures were taken as a result of chest discomfort and cough.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the reported events included Levalbuterol. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Exhausted all the time just simple everyday things makes me short of breath and tired. Started the day after getting the vaccine.  My period has been messed up. I was 7 days late I spotted for half a day and now it?s the heaviest it?s ever been.
I got the shingles. It was undiagnosed for a while. It lasted for about 3 months. It effected the retina on my left eye and I needed eye surgery. It wasn't until after I had eye surgery that it was confirmed I had shingles which no doctor previously could diagnose me.
crying > 4 hrs p/inject mod erythema, induration & tenderness to rt thigh;  17FEB93 f/u family reports nl behavior, no fever, sl induration to thigh; small abrasion w/bruise over site was reported due to post inject fall in home;
Blistering of fingers; Peeling of fingers; This is a spontaneous report from a contactable physician. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via intramuscular route of administration on 16Feb2021(at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient medical history included diabetes and hypertension from an unknown date. The patient was allergic to penicillin. The patient previously received celecoxib (CELEBREX), gabapentin (MANUFACTURER UNKNOWN) and experienced drug allergy. It was unknown if patient had received any other medication within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via intramuscular route of administration on 26Jan2021(at the age of 65-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 the patient experienced blistering and peeling of fingers that started approximately 5 weeks after vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with topical triamcinolone. The clinical outcome of the event blistering and peeling of fingers were recovering at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Breakthrough case admission after 4 vaccines Moderna 2/8/21 LOt# 010M20A;  3/5/21 Moderna Lot# 011M20A;  Moderna 11/12/21 Lot# 051F21A; 10/20/22 Moderna NO LOT#
Sleeplessness, headache, eye pain, severe sore throat, throat dryness
COVID 19 (Vaccination failure); COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 62 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 08Apr2021 as dose 2, single (Lot number: ER8737), in left arm, on 31Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9393), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to wasp venom" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "COVID 19 (Vaccination failure)"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID), from 07Oct2023 to 11Oct2023.
prick sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (prick sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALCIUM for Supplementation therapy, LEVOTHYROXINE, VITAMIN B COMPLEX (B-COMPLEX [VITAMIN B COMPLEX]), COLLAGEN, CYANOCOBALAMIN (VITAMIN B-12) and CELECOXIB (CRIL) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (prick sore). The patient was treated with NAPROXEN SODIUM (ALEVE) for Knee pain, at a dose of 1 dosage form twice a day. At the time of the report, PAIN (prick sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included organic collagen and B-shot.  The patient was not immunocompromised.   This case was linked to MOD-2021-354658, MOD-2021-354443 (Patient Link).
This reporter inadvertently administered pediatric Pfizer bivalent covid vaccine instead of pediatric Pfizer monovalent covid vaccine as the first dose in the series.  Discrepancy was noted during charting after vaccine was given.  facility  were contacted; they advised that the dose administered was valid and did not need to be repeated.
Patient receive the Pfizer COVID Vaccine earlier in the day.  She called the Clinic line at 1500 and spoke with a nurse.  She said she went to sleep and awoke with numbness in her right hand with pain. She complained of pain radiating from her biceps to her elbow. She states she has a headache along with lower back pain. She states she has nausea, vomiting, and that she feels really bad. She is able to move her right hand but states " it hurts".   Reported to physician and patient instructed to call Emergency Services.
patients were accidentally given the Daptacel and Ipol liquid portions only and not given the ActHIB powder portions of the Pentacel injection/No AE; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA172656 same reporter.  This case involves 4 years male patient who received only liquid portions of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ082AA, expiry date-13-Oct-2020 via intramuscular route in the left deltoid on 30-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and AESCULUS HIPPOCASTANUM (VARIVAX [AESCULUS HIPPOCASTANUM]) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique. Nurse reported that patients were accidentally given the Daptacel and Ipol liquid portions only and not given the ActHIB powder portions of the Pentacel injection.  No AE reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Arm felt broken 2 hours after vaccine  Woke at 3 am with chills and body aches, diarrhea and extremely nauseous.  By 7 every muscle and joint hurt.  Tongue felt tingly  Sore throat   stiff neck  By 11 am fever of 102.7 Slept off and on most of day with Tylenol every 8 hours.  Fever back By 7 pm 102.3 Could not move arm most of day  2nd day still extremely tired  Body aches slight headache  Still nauseous and have diarrhea
Malaise, hot flashes, bruising Narrative:  Patient received her 2nd dose of COVID vaccine on 02/18/2021 and noticed bruises on site of injection, chest, and right thigh, and experienced other symptoms like dizziness, body aches, bloating, diarrhea, malaise, and hot flashes, all of which have been improving when follow-up call was made 02/27. No reactions were noted when patient received her 1st dose of COVID vaccine. Patient also mentioned that her period started 02/20 which may have contributed to the symptoms she experienced. Per notes form primary care, patient took Aleve and applied her lidocaine patch for her body aches. Of note, naproxen was not on record so this may have been bought from an outside pharmacy.
Between 30-60 minutes after vaccination, inner burning, itching of skin.  Red, raised, itchy lesions by 1.5 hours on legs (knees up), stomach, back).  Next morning woke up with increased number of lesions (ankles up).  Patient seen in civilian ER and diagnosed hives.  ER physician commented on fluid-filled lesions (based on indentation after pressing on lesion).  Treated with oral steroids, antihistamines.  Lesions have improved significantly 3 days later.
Severe pain in the left shoulder along with fevers up to 102 x 1-2 days. Noticed lump on her neck 2 days later. Also c/o tiredness tiredness and fevers lasted for 3 days. Given LEVAQUIN 500 mg for possible infection.
Patient presented to ED on 3/24/21, and also had another ED visit on 3/28/21 where she was subsequently admitted. These visits were within 6 weeks of receiving COVID vaccination.
Missed the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product usage were not provided. Treatment details were not provided.   Reporter did not allow further contact