chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sharp "Nerve pain" on injection, but it went away. Fever rising to 101F, intense muscle aches, weakness, dizziness, nausea.  800mg Ibuprofen taken at 5:00 PM did not help.  Fever went down by next day, but triggered migraine for the next week.  Did not develop muscle pain at injection site until two weeks after, now it is tender. Never EVER have reacted to vaccinations before in my life.
1st dose about a year and a half ago, has not received 2nd dose because of COVID; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about a year and a half ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The patient did not receive the 2nd dose of the Shingrix vaccine yet because of covid, which led to social problem. The reporter was requesting information regarding the recommendation for patients who did not receive the second dose within two to six months after the first dose. The reporter did not consent to follow up.
Presented with SOB/hypoxia; CXR "patchy infiltrates bilaterally"; Labs: D-dimer 0.79, CRP 12.95, Ferritin 844.90; Tx: Rocephin, Decadron, Remdesivir, Zithromax, Lovenox, Minimal O2 supplementation @ 3 LPM; back to room air at d/c
Wheezing; SOB; Diarrhea; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), WHEEZING (Wheezing) and DYSPNOEA (SOB) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse drug reaction (medical history was not provided.). Concomitant products included METOPROLOL TARTRATE (METOPROLOL ACTAVIS [METOPROLOL TARTRATE]), LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 21-Jan-2021, the patient experienced WHEEZING (Wheezing) and DYSPNOEA (SOB). The patient was treated with ALBUTEROL SULFATE (ALBUTEROL SULFATE inhalation) ongoing since an unknown date at an unspecified dose and frequency and CAMPHOR, ESSENTIAL OILS NOS (AEROSOL SPITZNER) ongoing since an unknown date at a dose of 90 microgram every six hours. On 16-Jan-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, WHEEZING (Wheezing) and DYSPNOEA (SOB) had not resolved.        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.   patient stated that she has an appointment schedule with Cardiologist and will make an appointment with pulmonologist after seeing Cardiologist. Caller has provided PCP and Cardiologist information.   treatment includes Albuterol Sulfate Inhalation Aerosol 90 MCG: 1-2 puffs by mouth every 4-6 hours
Prolonged diarrhea, eosinophilia. Diarrhea lasted 2-3 weeks
Pregnant patient was ordered routine TDaP vaccine during pregnancy.  new RN, orienting with existing clinical coordinator inadvertently administered Gardasil-9 vaccine.  MD made patient aware.  No immediate concerns at this time.
Woke up with hive on her back; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). This patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced woke up with hive on her back on an unspecified date with outcome of unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Fever; chills; nausea; vomiting; diarrhea; sore arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 15Jan2021 16:00 at single dose for COVID-19 immunization. Medical history included COVID prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever, chills, nausea, vomiting, diarrhea, and sore arm on 16Jan2021. No treatment was received for the events. The patient was not tested for COVID post vaccination. The patient was recovering from the events.
Rash; red, itchy, mostly upper body.  Injection site hot to the touch.
fatigue, diarrhea, body aches, chills, sore throat, runny nose, headache, abdominal pain lasting for 2 weeks and not improving
Vomiting x 1, diarrhea/loose stools x 2-4 then acute inappropriate lethargy and encephalopathy until 8/23. Hospitalized with presumed meningitis but CSF was negative for pleocytosis and HSV, WNV,Lyme ultimately negative. Enterovirus Ab pending.
Patient received prime dose 5/18/2021  Walked into clinic too early for booster dose on 6/4/21 and received booster dose in error.
pt recv vax 28MAY96 & 7JUN97 pt devel a fever then devel lesions on chest, back, legs, neck, arms, mouth & poss on throat;
Intussusception- pt had to have surgery to remove 3 inches of colon 10 days after she received the rotavirus vaccine.  5/6/08 Reviewed hospital medical records of 3/24-3/26/2008. FINAL DX: Intussusception w/ischemic bowel, ileal cecectomy w/primary anastomosis. Records reveal patient experienced abdominal pain, vomiting, lethargy & bloody mucoid stools x 1 day.  Seen in outlying ER where abdominal x-ray suspicious for IS & transferred to higher level of care.  Taken to OR for exp lap which was difficult to reduce.  Ileal cecectomy w/primary anastamosis done.  Recovered well post operatively & d/c to home
Swelling of right arm and hand, swelling of axilliary lymph nodes in right arm pit, red appearance of right arm and hand; treatment given consisted of Amoxicillin for 10 days; swelling of axilliary lymph node in right armpit subsided, however, swelling of right arm and hand continues.
Red, swollen, bruised area noted on lt upper arm, midway between elbow & shoulder; Has become progressively larger & more tender since day p/vax;
Narrative:  90yo pt died in a relatives driveway on 8/6/2021. Pt had received covid vaccines on 1/12/21 & 2/9/21. Pt was being treated with antibiotics for UTI with blood in foley drainage bag and foul smelling urine on 7/27/2021 per notes. Given 6months prior to death pt received last covid vaccine, likely death is not related to covid vaccines. Also given pt's advanced age.
bad headache (felt like nerve pain); bad headache (felt like nerve pain); achy body; body felt heavy; stomach ache; mild fever; chills/shivering all night; feels weak; sleepiness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.An adult (non-pregnant) female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single dose for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for COVID-19 immunization and experienced body felt heavy. On an unspecified date in Jun2021, the patient experienced bad headache (felt like nerve pain), achy body, body felt heavy, stomach ache, mild fever, chills/shivering all night, feels weak, sleepiness. It was unknown if therapeutic measures were taken as a result of the events. Outcome of the events was recovered on an unspecified date.The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
very sore arm at injection site for 2 days; moderately sore on 3rd day
This spontaneous report was received from a healthcare worker and refers to a male patient of unknown age, reporter's son. There was no information regarding the patient's medical history, concurrent conditions or concomitant medications reported. On an unspecified date in 2015 (also reported as "a few weeks ago"), the patient was vaccinated with reconstituted VARIVAX (Merck) (dose, route of administration, lot # and expiry date were not specified) that was stored in the refrigerator in a syringe for 18 hours prior to administration. No adverse symptoms were reported. Additional information has been requested.
Developed shingles; pain, itching, and blisters under breast and on back about 4 days after receiving the vaccine shot. Rx Famvir 500mg, Tylenol and Codeine.
Information has been received from a registered nurse concerning a 57 year old male with no past medical history or allergies who in 1991 was vaccinated with a full series of RECOMBIVAX HB (Lot # 655810/1022F) IM. In 1992, the patient had a documented, positive hepatitis b antibody titer. After blood exposure, at the end of 2006, blood work indicated a negative hepatitis b titer. On 29-DEC-2006, the patient was re-immunized with RECOMBIVAX HB. A follow-up titer was negative. No adverse experience was related to this event.  Unspecified medical attention was sought. Additional information has been received from the registered nurse who stated that the patient had a full dose series of RECOMBIVAX HB in 1991. The titer was done in 1992 and was noted as reactive. In December 2006, the patient was involved in a BBP exposure and was retested. The testing came back negative and at that time patient was given a booster dose of RECOMBIVAX HB. No further information is expected.
bad headache; body aches; chills; she experience arm sore after the vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She receive 1st dose of covid19 vaccine last Saturday and she experience arm sore after the vaccine and today 25Jan2021 she also had symptoms bad headache, body aches and chills. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a pharmacy technician refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 30-JAN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA001558:
Racing heart-tachycardia in the mornings only; Myocarditis; Panic attack; Anxiety; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), PANIC ATTACK (Panic attack), ANXIETY (Anxiety) and CHEST PAIN (Chest pain). On 22-Jun-2021, the patient experienced TACHYCARDIA (Racing heart-tachycardia in the mornings only). The patient was treated with ALPRAZOLAM (XANAX) (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis), PANIC ATTACK (Panic attack), ANXIETY (Anxiety), CHEST PAIN (Chest pain) and TACHYCARDIA (Racing heart-tachycardia in the mornings only) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.    Caller received the Moderna vaccine series and experienced adverse events including myocarditis, panic attack, anxiety and chest pain and consulted emergency room and primary care physician. Patient had EKG.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-231677 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Racing heart, anxious. BPs 114/57 (pulse 69), 145/64 (pulse 67).
75 people got vaccinated from vials that were expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (75 people got vaccinated from vials that were expired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004021A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (75 people got vaccinated from vials that were expired). On 27-May-2021, EXPIRED PRODUCT ADMINISTERED (75 people got vaccinated from vials that were expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information received on 01-JUN-2021contains non-significant information.
Patient complained of dizziness appoximately a couple minutes after recieving first pfizer dose. Pt was offered a seat. Pt blood pressure monitored. First blood pressure 98/53. Reassessed patient, patient stated she did not feel better. Rapid response team called. Blood pressure progressively decreased down to 72/41. Pt stated she felt worse. RRT transferred patient to Emergecy Room.
Hives & swelling hip to knee (R) thigh P.O. BENADRYL swelling. Resolved 12 22 11.
- SORENESS AT INJECTION SITE FOR THE FIRST 2 DAYS AFTER VACCINATION - 7 DAYS AFTER VACCINATION, INJECTION SITE IS SWELLING, ITCHING, SORENESS AND WARM TO TOUCH. SELF ADMINISTERED 2 IBUPROFEN AND 1 DIPHENHYDRAMINE ON 01/14/21. - 01/15/2021 NO ITCHING. DELTOID MUSCLE STILL SWOLLEN AND PAINFUL
LATE EVENING OF 12/30/20 DEVELOPED FEVER, CHILLS, VOMITING, BODY ACHES, AND FATIGUE. LASTED 3 DAYS. IS NOW RESOLVED.
transient numbness is right leg presenting 20 minutes after vaccine, patient rested in chair and numbness was alleviated within 10 minutes
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Lot number: EP7533) as dose 2, single and administration date 08Mar2021 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "positive COVID-19 test with symptoms". Only symptoms are congestion and runny nose. Tested positive on either 18Nov or 19Nov. The patient underwent the following laboratory tests and procedures: covid-19: (Nov2021) positive, notes: Tested positive on either 18Nov or 19Nov.  Follow-up attempts are completed. No further information is expected.
My arm was quite sore for a few days but wasn?t red or hot. On the 10th day, I developed a red rash with a darker ring at the injection site. It is itchy ( how I noticed it) and some pain returned. It is still there.
Patient reported "trigger finger" in right ring finger that started Friday 2/12/21. She said she never had trigger finger before. Patient was referred to her doctor since she has not contacted him yet.
Within 24 hours noticed right lower facial twitching.  The frequency varies between a few in an hour to several in 5 minutes.
She experienced redness, swelling, itching, and pain around the injection site. The redness and itching extended further down the arm.
Pt felt nauseas and then fainted and fell, came to a minute later, pt was monitored by myself (RPh) while paramedics were called and arrived. Pt felt better once came too and paramedics cleared him to leave.
Patient had no known adverse effects after injection. Patient was underage but authorization from legal guardian was granted.
R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction
Limp & unresponsive; improved 24 hrs later; Hospitalized 29DEC89 F/U; convuls x 1;
My body odor changed significantly (I smell like sauerkraut now!) within 3 hours after my first shot. This abated slightly after a couple weeks, but once I received my second shot (8/3/2021 at 8:30 am, same location), the powerful body odor returned. It seems this is my permanent scent now, and not only is it disgusting, it?s unnerving. My chemistry has changed, I?m upset.
About 24 hours later I started having chills, then body and head aches with a swollen lymp node, low grade fever
approx 410PM pt collapsed & seized x 1min;it consisted of eyes rolling back, leg stiffening & RUE tremors, inc salivation, circumoral cyanosis;post-ictally, pt was paretic & sluggish to respond w/slurred speech;
This spontaneous case was initially received on 17-Nov-2015. The case report was received from a Health Professional and concerns a female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received Influenza vaccine on 21-Oct-2015 - unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: Site: Right arm. On 21-Oct-2015, the patient received the second dose of PNEUMOVAX 23, on the left arm. The first dose was administered on an unspecified date in 2015. On 21-Oct-2015, after starting treatment with Flu shot the patient experienced Feeling tired, Feeling sick, Feeling achy. The patient also developed a welt on her left arm. For relevant test results see appropriate report section. Reporter's assessment: n/a.
rash all over upper torso and arms noticed within first couple hours after administration, pt called md and was counseled to take benadryl and watch for further symptoms.  Pt states she's fine and no further problems beside the rash.
Patient states she has a rash and hives on palms and fingers. Patient refered to Urgent Care doctor as she does not have a primary care doctor.
Positive for COVID-19; Positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 01Feb2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]. Patient had no past drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Apr2021, outcome "unknown" and all described as "Positive for COVID-19". Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2021) Positive, notes: Blood test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300132926 Same product, patient and different event;US-PFIZER INC-202300133156 Same product, patient and different event;
Patient came into the office for an  18 month check up. Patient received a Pfizer Bivalent COVID vaccine for 6 month - 4 years of age as dose #1. Patient should have received Pfizer monovalent COVID 6 month - 4 years of age vaccine since this was the first dose in the series for this patient.
patient received her first dose of IMOVAX RABIES, was due for her second dose on 15nov2020, but missed it, no AE; Initial information received on 18-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist via phone via call center in the.  This case involves a 26 years old female patient who received her first dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (batch number and expiration date not reported) via unknown route in unknown administration site for pre-exposure prophylactic vaccination on 06-Nov-2020 and she was due for her second dose on 15-Nov-2020, but she missed it (product dose omission issue).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It was a case of actual medication error due to missed dose.  At the time of report no adverse event was reported.  Reporter asked does patient need to restart the dosing. Patient is employed with animal control and therefore needs the pre-exposure prophylaxis.  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.  There will be no information on the batch number for this case.