chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines given 7/11/07. Grand mal seizure 8/6/07 evaluated at hospital ER. Seizure occurred while showering lasting 2-3 min. Lab work CT normal, Abnormal EEG. Given dose of Benadryl night prn. Brother developed seizure with abnormal EEG 6/07 Patient on Keppra.
Severe Vertigo about a day after the shot; This is a spontaneous case received from two contactable consumers. An adult male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 28Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced severe vertigo about a day after the shot on 29Mar2021. It was unknown if the treatment received for the adverse event or not. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was unknown.  No follow up attempts are needed. information about lot/batch number can not be obtained.
Violent chills; Temp up to 102.6; Body and joint aches; Joint aches; Slept x 24 hours due to headache; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL 3246, unknown expiration), via an unspecified route of administration in left arm on 12Jan2021 at 12:30 PM at a single dose for COVID-19 in a public health clinic/facility.  The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK 5730, unknown expiration) via an unspecified route of administration in left arm on 22Dec2020 at 12:30 PM for COVID-19. Medical history reported as none.  The patient's concomitant medications were not reported.  The patient previously took thimerosal and experienced allergies. By midnight of 12Jan2021, the patient experienced violent chills, temp up to 102.6, body and joint aches, and she slept x 24 hours due to headache. She started to feel better on 13Jan2021 at 8:00 PM, and 100% better on 14Jan2021 at 07:15 AM.  The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient recovered from the events on 14Jan2021 at 07:15 AM. The events were assessed as non-serious.
Patient was administered DTAP-IPV component of PENTACEL without being reconstituted with the lyophilizes ACTHIB component,with no reported adverse event; Initial information was received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 1 years old female patient who stated patient was administered dtap-ipv component of pentacel without being reconstituted with the lyophilizes acthib component,with no reported adverse event after receiving diphtheria/tetanus/5 hybrid ac pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine.  On 10-Feb-2023, the patient received a 0.5ml, total dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(vero)/HIB(PRP/T) vaccine Suspension for injection (lot: UJ682AAA, expiration date:16-Sep-2023) via intramuscular route in the left vastus lateralis for Immunization.  On 10-Feb-2023 the patient developed a non-serious event patient was administered dtap-ipv component of pentacel without being reconstituted with the lyophilizes acthib component,with no reported adverse event (single component of a two-component product administered) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/IPV(vero)/HIB(PRP/T) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
Sore arm; Dizziness; Tiredness; nausea; fever of 102°F; severe headache; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date unknown) intramuscular at the left arm on 18Dec2020 at a single dose for COVID-19 immunization in the hospital. Medical history included allergy to Sulfa from an unknown date. Concomitant medications included escitalopram and clonazepam. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient experienced sore arm after first 8 hours; dizziness, tiredness, nausea, fever of 102 F and severe headache all on an unspecified date in Dec2020 (reported as 12Dec2020 at 01:15 AM). The patient was tested for COVID post vaccination and had a nasal swab with negative results. The patient recovered from sore arm, dizziness, tiredness, nausea, fever of 102 F and severe headache all on an unspecified date in Dec2020.
Patient received vaccine Friday afternoon and noticed she had a sore arm Sunday morning. Has a red, swollen and tender to touch area on back of left arm. Area is about 2 1/2 inches in size and also hard to the touch. Today (Monday) she feels it is the same but will monitor it.
Initial information received on 28-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age patient who experienced due to temp excursion product was not acceptable for use, while he/she received vaccine MENACTRA. 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  dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine lot number not reported. It was a case of medication error due to product storage error. 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.
Woke up to my son having a seizure in the middle of the night 4 days after he had some vaccines. I believe it was a reaction to the MMR shot. I called 911 because I didn't know what was wrong with him at the time. He was just limp and unresponsive. He was taken to Hospital, then transferred to another Hospital. While there, he had another seizure due to his high fever. His pediatrician then transferred him to a third hospital. His fever was so high, even the hospitals couldn't get it to always break. While in the third hospital, they ran several tests while constantly alternating giving him childrens Tylenol and ibuprofen every 2 hours. They never found a "cause" for his fever so said it was probably a virus. When his fever finally broke 5 days after the seizures began, he broke out with a rash all over his body, mainly his back, stomach and areas on his neck. After doing research and having a nurse look at the rash, we believe it looked like the measles.
I started to have contractions, which I thought were Braxton Hicks and they became stronger. On 6/17/2015 I went into Doctor's office for an unscheduled visit and was already .5 cm dilated and 25% effaced. My due date was 7/19/2015 and I gave birth to my son who was preterm at 35 weeks, 6 days on 6/20/2015. I had no prior complications and my pregnancy was easy and low risk. Yet I gave birth 8 days after getting the TDAP vaccination.
Swollen at injection. Respiratory problems. Tightness in chest & coughing. Fatigue.
Hair loss / it has gotten worse; This spontaneous case was received on 05-Oct-2023 from other non-healthcare professional (consumer) via Regulatory Communications (reference number: SEQW23-03063) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On 28-Sep-2023, at 05:01 pm, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for flu vaccination. The batch number reported was 370647 and the expiry date was 24-May-2024.  On an unspecified date in Oct-2023, reported as three to four days after receiving Flucelvax Quadrivalent, the patient was experiencing hair loss. As reported, the vaccine was the only thing that went into the patient's body, and she had not changed any of her eating habits or medications.   On 05-Oct-2023, the hair loss had gotten worse and was noticed. The patient did not receive any treatment for the event of hair loss.  At the time of initial reporting on 05-Oct-2023, the patient had not recovered from the event of hair loss. As reported, the event was unresolved and ongoing.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked with case 202304656 (the same reporter).  Company comment: A patient of unreported age was vaccinated with the suspect product Flucelvax Quadrivalent. The patient developed alopecia three to four days after vaccination, by report. Based on biological implausibility, causal role of the suspect vaccine is assessed as not related.; Sender's Comments: A patient of unreported age was vaccinated with the suspect product Flucelvax Quadrivalent. The patient developed alopecia three to four days after vaccination, by report. Based on biological implausibility, causal role of the suspect vaccine is assessed as not related.
vial was initially stored in the refrigerator on 18-Oct-2022, before use date was 17-Nov-2022,  the administration of vaccine was on 18-Nov-2022.; No adverse event; bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 18-Oct-2022, before use date was 17-Nov-2022,  the administration of vaccine was on 18-Nov-2022.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 18-Oct-2022, before use date was 17-Nov-2022,  the administration of vaccine was on 18-Nov-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 18-Oct-2022, before use date was 17-Nov-2022,  the administration of vaccine was on 18-Nov-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 18-Oct-2022, before use date was 17-Nov-2022,  the administration of vaccine was on 18-Nov-2022.).    No concomitant drug was reported. The vial size was reported as 2.5 ml. The vial was initially stored in the refrigerator on 18-Oct-2022, before use date was 17-Nov-2022,  the administration of vaccine was on 18-Nov-2022. It was reported that the vial did not undergo any temperature excursions.  No treatment drug was reported. This case contains information for the 7th of 14 adult patients described by the reporter.
a 39-year-old patient received expired booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a 39-year-old patient received expired booster dose of Moderna COVID-19 vaccine) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (a 39-year-old patient received expired booster dose of Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a 39-year-old patient received expired booster dose of Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Did the vial undergo any temperature excursions was given No Expiration date :31-DEC-1969 Date the vial was initially stored in the refrigerator: 13-JAN-2022  No concomitant drug information was provided.
No adverse events; the patient was supposed to be administered a dose of PEDVAX HIB but was instead administered a dose a RECOMBIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 14-MAY-2019, the patient was supposed to be administered a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), but was instead administered a dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R012001, expiration date 06-NOV-2020, intramuscular, in error (strength, dose and anatomical location were not provided). No adverse effects were reported.
A non-serious spontaneous report of not feeling well, stomach complaints, nasal and throat congestion, and a runny nose has been received from the patient's parent concerning an 11-year-old female patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. On 14-Oct-2009, patient received FLUMIST. On 17-Oct-2009, the patient experienced not feeling well and developed stomach complaints, nasal and throat congestion, and a runny nose. The outcomes for the reported adverse events were not reported.
Patient stated receiving J&J vaccine on 03/19/21. Patient came to ER with acute DVT in left lower extremity on 04/21/2021.
Patient fainted approximately 5 minutes after he received the vaccine.  He stumbled to pharmacy counter saying he was not feeling right.  Then he began to faint.  He was grabbed and guided to the floor slowly, paramedics were called.  Patient did not go to the hospital and did not experience any other adverse effects. EMS checked vitals and they were WNL
Nausea; Elevated Heart Rate (24+Hours After); Tingling; Numbness of the arm (24+ Hours); Pain in the armpit (started approx 36 hours after the injection; Fever; Pain in hips and entire back; Pain in hips and entire back; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Lot number: EJ1686), via an unspecified route of administration in left arm on 19Jan2021 15:45 at single dose for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previous received first dose of bnt162b2 (Brand: Pfizer, Lot number: EK9231), via an unspecified route of administration in left arm on 29Dec2020 07:00 AM for covid-19 immunization. The patient experienced nausea, elevated heart rate (24+hours after), tingling, numbness of the arm (24+ hours), pain in the armpit (started approx 36 hours after the injection), fever, pain in hips and entire back, headache (24+ hours) all on 19Jan2021 19:30. The patient underwent lab tests and procedures which included heart rate: elevated on 19Jan2021. The outcome of events was not resolved. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment received. No other vaccine in four weeks. Other medications in two weeks: Birth control. No COVID prior vaccination. No COVID tested post vaccination. Not known allergies.  No follow up attempts are possible. No further information is expected.
pt recv vax 11OCt96 & 21OCT96 pt devel chickenpox primarily on torso, neck, arms & legs;pt returned to MD office on 24OCT96 & determined that the pt did not have a rxn to varicella vax but had viral synd;
This spontaneous report as received from a physician via a company representative refers to a 11 year old female patient. On unknown dates the patient was vaccinated with three doses of (Oka/Merck) VARIVAX (lot #, dose, route not reported). Confirmed extra dose administration. Concomitant therapy was not  reported. On an unknown date the patient developed the varicella like rash. The physician stated that the patient's varicella like rash was distinct in an unspecified way. The patient had sought medical attention. Outcome of the event was unknown. This is one of several reports received from the same reporter (other MARRS#1406USA009945). Additional information is not expected.
Lightheadedness, orthostatic hypotension, presyncope, somnolence
On 03/20/2022 I started developing sx, I started with sore throat. On the 03/21/2022, I developed a fever. I had chills and was achy for a couple days and then it was like a cold. The sx lasted about 7-8 days or so. Spoke to a doctor on telehealth, I was prescribed Paxlovid, but I ended up not taking it. I took Aspirin vitamin D, supplement on top of the multivitamin I already take.
This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (005570). A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history included COVID-19 (unspecified if ongoing). The patient's concomitant medications not reported. The patient experienced chills (non-serious), with outcome of unknown. Additional information: A contactable consumer (patient's wife) reported for a patient (her husband). Reporter got it from her husband. The side effects of the aftermath lingers on. It seems to affect other things in the body. Follow-up attempts completed. No further information expected.
Patient developed hives to face, trunk, & extremities also swelling to hands and feet. Was given CLARITIN and CALADRYL was applied. Rash was on off and went away on 3-25-13.
Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.