chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 14 year old patient of unknown gender. On 02-MAY-2014 the patient was vaccinated with PROQUAD (Merck), subcutaneous injection (dosing regimen unspecified). Patient's concomitant medication was not reported. On 02-MAY-2014, medication error reported that a 14 year old patient was inadvertently administered PROQUAD (Merck). No adverse effects reported. There was no product quality complaint (PQC) involved. The outcome of medication error that 14 year old patient was inadvertently administered PROQUAD (Merck) was unknown. Additional information has been requested.
a few minutes after receiving vaccine patient felt flushed/warm feeling and tingling, felt like she could not swallow. BP 138/98.  resolved after several minutes and was able to go home at 10:11
After dinner the fourth  day after vaccination I had an uncomfortable feeling of fullness that would not go away with a headache and upset stomach  five days later I feel better without headache and upset stomach.
Subject presented to the ER with one month history of diarrhea, weakness, fatigue, and abdominal pain. Subject was found to be positive for C. Diff, and positive for E. Coli Pyelonephritis. Patient was assessed and was found to be severely malnourished with weight loss (BMI 18.8kg/m2) and has an acute kidney injury. Patient has chronic anemia in the setting of renal disease and malnutrition. Subject was scheduled to receive IP, but it was never administered.
Systemic: see below-Mild, Additional Details: daughter called and reported mom was having issues with arm vaccine was given in.  Daughter stated her mom had vaccine administered in arm that she should not have due to lymph issues.  Daughter did not state specifically what was wrong with arm other than she was having issues with it and believed it was due to covid vaccine received in 2021.  At this time I have no other information.
Within an hour developed a headache that got worse every hour. Within 24 hours from vaccination, felt extreme myalgia that I have not been able to find relief for. 48 hours after still feeling myalgia. Headache has gotten better but still have one.
This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (Very itchy rash under her mask), RASH (Spread to her neck, shoulders, back and upper chest) and RASH (Rash on her legs extremely itchy only on the nights) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ALENDRONATE SODIUM (FOSAMAX), NORTRIPTYLINE and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RASH PRURITIC (Very itchy rash under her mask) and RASH (Spread to her neck, shoulders, back and upper chest). On 07-Mar-2021, the patient experienced RASH (Rash on her legs extremely itchy only on the nights). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Very itchy rash under her mask), RASH (Spread to her neck, shoulders, back and upper chest) and RASH (Rash on her legs extremely itchy only on the nights) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow Up information received on 24-MAY-2021 contains no new information. On 15-Jul-2021: Follow up received and Event outcome was updated.
the patient experienced COVID; the patient experienced COVID; MODERNA COVID-19 VACCINE (ELASOMERAN) and PFIZER BIONTECH COVID-19 VACCINE; MODERNA COVID-19 VACCINE (ELASOMERAN) and PFIZER BIONTECH COVID-19 VACCINE; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3950656-00.  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the patient experienced COVID"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "MODERNA COVID-19 VACCINE (ELASOMERAN) and PFIZER BIONTECH COVID-19 VACCINE".  The reporter's assessment of the causal relationship of "the patient experienced covid" and "moderna covid-19 vaccine (elasomeran) and pfizer biontech covid-19 vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Headache, Myalgia, Fever, NauseaVomiting, fatigue, left arm pain to left wrist Narrative:
2nd Covid Pfizer vaccine give 20 days from 1st vaccine (vaccine was given at 20 days instead of 21 days)
3-4 hrs of cont crying secondary to vax; excessive fussiness persisted x 48 hrs; t max 102 24 hrs later; no other sx; pt was back to nl 72 hrs later;
(No facial or lip fillers) Face swelling, burning,  tingling , and numbness of lips, numbness of face and fingers. Itching over whole body first night. Perception of throat and nasal swelling. Symptoms have recurred during the two weeks since I received the first vaccination.
Patient received Afluria IM 10/12/2023.  As per system patient got Fluzone HD 09/21/2023 .  Error Wrong patient
Child was given Hep-A and Hep-B injections. She fainted after 2 other children with her had received their shots. Mom took child to doctor, after leaving health dept. Mom said child had adverse reaction to IZ. The doctor said that mom didn't want child to have anymore IZ, so he wrote an order not to give any more Hep-A or Hep-B.
Felt fatigue early on, went to bed at 9:00.  Woke up at 11:30 pm with uncontrollable nausea, headache and chills.  Started vomiting at midnight, kept going until 4:30 am coupled with GI distress.  Fever ranged from 101- 103, headache, brainfog and all over body ached lasted throughout the following day and night.  Fever broke at 11PM the next night (29th).  Then took some tylenol for body aches (was scared to take earlier due to nausea) and slept through the night.  Woke up this morning and noticed the injection site is still red and very swollen (looks like i was hit by a baseball) and I have a rash all over the tops of my feet and shins?  Looks like a series of tiny red dots.
2:00 p.m. - Head felt disconnected/ lightheaded, chills 5:00 p.m. - stomach ache, extremely sore arm 6:00 p.m. - Low grade fever chills, headache, lightheaded 8:00 p.m. - Took 3  ibuprofen 9:00 p.m. - Fever of 101.7, severe chills, headache, chest pains 10:00 p.m. - Elevated resting heart rate (117bpm), pounding heart, chest pains, fever 102, severe chills, headache, lightheaded 10:45 - Took Tylenol 1:00 a.m. - Elevated resting heart rate (woke up and still 108-117bpm), pounding heart, fever down to 100.7, headache, chest pains  Finally fell asleep after this for the night, woke up around 7:30 a.m. and felt mostly back to normal, slight headache & more tired than usual.  I made sure to drink 2x as much water the day before the vaccine and the day of so dehydration was not a factor. I have had anxiety and panic attacks in the past and this did not feel like that whatsoever.
I had a sore arm for a day or so. Had pneumonia  in Nov2021 and saw the doctor.  Covid  - 12Jan2022 - cold like and congestion. runny nose, cough and total loss smell. Maybe a mild headache. Saw the doctor on14Jan2022
Throat tightening and patient started to tremble 30 minutes after vaccination. Also became tachycardic. Patient was treated with methylprednisolone 80 mg IV x 1, famotidine 20 mg IV x 1, and diphenhydramine 50 mg IV x 1.
Child sat in dad's lap, was visibly scared and crying, cleaned his arm, gave him the shot... as the needle came out of his arm he closed his eyes, his head tilted back and he trembled- almost seizure like- for not more than 5 seconds, opened his eyes and was fine- got off of his dad's lap and had urinated on his dad's pants- parents said he had never had any reaction with any vaccination he had ever had in the past including flu shot- called dad later and said child was fine and though he possibly was holding his breath because he was so scared and that may have caused the reaction... also said his son asked him if he had 'fallen asleep' when he got his shot... suggested they follow up with his pediatrician on Monday.
have gotten worse since then; Dry heaves; not being hungry; dizziness; Lots of Phlegm; Chills, no fever, feels like has a fever but temperature is normal; arm sore that night, could hardly lift it; feeling sick; nauseous; headaches; joint aches; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 03Apr2021 around 1:00 p.m at the age of 56-years-old as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes mellitus from unspecified date. Concomitant medication included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. History of all previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. The reporter stated that he received first shot on Saturday 03Apr2021 around 1:00 p.m. It was reported that on 04Apr2021, he was still experiencing over a week now, arm sore that night, could hardly lift it. Then started feeling sick, nauseous, headaches, joint aches, and have gotten worse since then. His headache, nausea, not being hungry, dizziness, Lots of phlegm, chills, no fever, feels like has a fever but temperature is normal, and later mentioned joint pain all started on 04Apr2021 and dry heaves on 12Apr2021. States when he lays down to rest it is fine, but then gets up and its worse. These symptoms have been persisting. The reporter stated that he was not taking second dose, he was not going through this again. The patient underwent lab tests and procedures which included temperature (body temperature): normal (no fever, feels like has a fever but temperature is normal) on 04Apr2021. The outcome of events, Condition worsened and Dry heaves was unknown while other events were not recovered.  No follow-up attempts are possible. No further information is expected.
12 hours after my shot I had the normal symptoms that were expected: headaches, sore throat, chills, swollen right lymph node, sinus pressure, body aches, dizziness and  nausea. What I did not expect was my menstrual cycle to be thrown off and start early. This happened with the 2nd modern shot as well. I have PCOS, so my periods are abnormal, but it is too early for my cycle. Could it possibly be connected to hormones? Could it affect those who have difficult conceiving?
18 days after vaccine administered, pt. presented to office w/ c/o <24 hour history of (R) cheek pain and swelling, no fever. Physical exam consistent w/ parotitis, treated w/ observation, resolved.
Patient noticed soreness on upper arm (left). Patient still has soreness and lifting arm is painful. He spoke to his PCP I advise him to recheck and schedule appt with his MD to check if this could be related to immunization.
Pt noticed next day at injection site was sore and hard. On 1/3/12 pt noticed that site was hard, red, and itching. Patient's spouse called physician's office on 1/5/12. Dr. was notified by RN, and prescribed rest of extremity, ibuprofen as needed for arm discomfort, and compress for site. Wife verbalized understanding of plan of care.
Pfizer / BioNTech/ COVID 19 Treatment 22/May/2022; Pfizer / BioNTech/ COVID 19 Treatment 22/May/2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose number unknown, single (Batch/Lot number: unknown), on 25Mar2021 as dose number unknown, single (Batch/Lot number: unknown) and on 19Oct2021 at 15:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ELAVIL [ALLOPURINOL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "not recovered" and all described as "Pfizer / BioNTech/ COVID 19 Treatment 22/May/2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (03Jun2022) positive, notes: keep testing positive on day 13. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other medication in 2 weeks. Patient had Chest congested and keep testing positive on day 13 (adverse event start date: 31May2022). Patient received treatment for Covid-19 with Paxlovid from 22May2022 to 26May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling, soreness, bruising at injection site on 5/17/06. On 5/18/06, temp. 99.8, diaphoresis also s/s at injection site. 5/19/06, afebrile. Local s/s improved.
This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-OCT-2017, the patient was vaccinated with one dose of expired ROTATEQ lot # M014318 and expiration date 30-SEP-2017. No adverse effects were reported. No causality assessment was provided by the reporter.
Lose consciousness and faint as well as began to have a seizure; Lose consciousness and faint as well as began to have a seizure; Lose consciousness and faint as well as began to have a seizure; Vitals were not great, faint pulse, dilated pupils; Vitals were not great, faint pulse, dilated pupils; Vitals were not great, faint pulse, dilated pupils; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 12May2021 09:45 (Batch/Lot Number: EW0182) (at the age of 25 years old) as 1st dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included COVID-19. Concomitant medication included lithium taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and had allergies. Facility where the most recent COVID-19 vaccine was administered was in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12May2021 10:00, the patient experienced lose consciousness and faint as well as began to have a seizure, vitals were not great, faint pulse and dilated pupils. After vaccine administration, patient began to lose consciousness and faint as well as began to have a seizure. EMT's were called vitals were not great, faint pulse and dilated pupils. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event included ambulance ride, EMT's (as reported). The patient was recovering with lasting effects. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequelae on unspecified date.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 20-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7534) intramuscular, on 21Apr2021 as dose 2, single (Lot number: EP7534) and on 20Dec2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 20 years intramuscular 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 10May2022, outcome "recovering" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: If covid prior vaccination: Yes; (10May2022) Positive, notes: Nasal Swab, QuickVue At-Home OTC COVID-19 Test (Lot F40656); (12May2022) Positive, notes: Nasal Swab, QuickVue At-Home OTC COVID-19 Test (Lot F40656). Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts were possible. No further information was expected.
Parent states patient had fever last night. Temperature was 97.6 at 2 PM on 02/24/05. Right thigh was warm, red, swollen superior to injection site. Parent advised to ice area. Alternate Tylenol with ibuprofen. Return to clinic if fever continues.
Very sore arm but by midnight my whole left side was sore from the hip to the ankle, both muscles and joints. The next morning my right hip was hurting as well. Felt less muscle soreness by the end of the 2nd day but my knees and ankles were still somewhat sore for about a week. A week after the shot the injection site became hardened (like a small gum ball) and itchy. It went away after two days.
vaccine expired 7/13/2022 used in clinic 7/15/2022 no adverse reactions reported as of 7/27/2022
Missed period. Second vaccine on April 15.  Missed cycle on April 19  Feeling PMS symptoms
lower lip swelling and mild redness slight tingling in throat  pt did have lip fillers in Sept 2020
Headache; fever; chills; fatigue; vomiting; ear infection; Achy; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8734) via an unspecified route of administration in the arm left on an unknown date in Apr2021(at the age of 49-year-old) at 09:15 as a single dose for COVID-19 immunisation. Medical history included migraine, arthritis and COVID-19. Concomitant medications included mometasone furoate (FLONASE), topiramate (TOPAMAX), azelastine (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN)all from an unknown date for unknown indication. The patient previously took Ceftin and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021 at 2.30 patient experienced Covid Arm + 5 days, Headache 2 days (48 hours after), Achy, fever, chills, fatigue, vomiting and ear infection post vaccine 3 days. Therapeutic measures were taken as a result of ear infection which included treatment with ear drop for Otitis media/externa. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events Covid Arm, Headache 2 days, Achy, fever, chills, fatigue, vomiting and ear infection were resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Woke up with chills, shaking, nausea, one episode of vomiting and diarrhea 2-3 hours after the immunization.
Patient got Dtap in L leg Tues 9/27/05 on Wednesday had fist sized red, warm area on that leg and by Thurs, 9/29/05 it was swollen, red, warm down to her left knee. Mother called Dr's office, recommendation was to given child Benadryl and Tylenol which mother did and area resolved. PHN advised to talk to MD at Kindergarten entrance and suggest DT.
Patient DX with shingles from ER. Given VALTREX 1000mg TID. Patient says whole left leg involved. Patient has shingles rash.
Yesterday (7 days after shot) I noticed the injection site was very firm. Today there is now a red ring surrounding the injection site and it is warm to the touch.
Information has been received from a doctor of pharmacy reporting that a physician reported to a patient that he had seen an increase trend of patients that were diagnosed with shingles after they had received ZOSTAVAX (Merck) (Lot number not reported). It was reported that shingles was diagnosed "more than two times a week" in a physician's practice. At the time of the report, the patient's outcomes were unknown. Attempts are being made to verify the existence of an identifiable patient. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
redness, hot and hurting (R) UA from Varivax immunization, 1/2 dollar size on 8/29/07 at 3.25. On 8/30/07 size 3 1/4" long red-warm to touch and oozing clear fluid