chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was feeling lightheaded approximately 3 minutes post vaccination (1st dose of Pfizer). Pt then had syncopal episode while remaining in chair. EMS on site and was immediately alerted. EMS put pt on stretched and brought to ambulance for further assessment. Pt observed by EMS for 15 minutes and then went home with Dad. Per Dad pt has history of syncopal episodes post vaccination.
Itching at injection site; swelling at injection site; headache; upset stomach; malaise; fever; at injection site / which radiated to the elbow and the shoulder; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received on an unknown date, refer case US2021AMR016528).   In December 2019, the patient received the 2nd dose of Shingrix. In December 2019, 2 hrs after receiving Shingrix, the patient experienced injection site itching, injection site swelling, headache, upset stomach, malaise, fever and erythema of extremities. On an unknown date, the outcome of the injection site itching, injection site swelling, headache, upset stomach, malaise, fever and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling, headache, upset stomach, malaise, fever and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient experienced swelling at injection site, redness at injection site which radiated to the elbow and the shoulder, itching at injection site, fever, malaise, upset stomach, and headache. The patient stated that the events occurred just over a year ago and had since resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR016528:1st dose, same reporter
This case was reported by a nurse and described the occurrence of expired vaccine used in a child male patient who received INFANRIX (batch number AC14B157CA, expiry date 13th September 2014). In September 2014, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to INFANRIX. Additional information received on 29 September 2014: An expired dose of INFANRIX was inadvertently administered.
Generalized erythema, edema of left upper arm from slhoulder to elbow which is painless and has full range of motion.
arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Migraine headache; intense body aches; This case was reported by a consumer via call center representative and described the occurrence of migraine headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2020, the patient received the 1st dose of Shingrix. On 28th October 2020, 1 days after receiving Shingrix, the patient experienced migraine headache and general body pain. On an unknown date, the outcome of the migraine headache and general body pain were unknown.   It was unknown if the reporter considered the migraine headache and general body pain to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Patient reported that she received 1st dose of shingrix vaccine on 27th October,2020 and after that patient experienced migraine headache and intense body aches.  The reporter did not consent to follow up.
Patient was unknowingly given Dose #3 of an expired vaccine.  Once this was realized the patient was notified by his provider
Moderna COVID-19 Vaccine EUA 10cm x 5cm area surrounding injection site - red, itching, hard welts Benadryl 25mg x1, event is ongoing Pregnancy history: three full term live births - 1977, 1982, 1986
6:40PM pt started to complain of "tingly" on LEFT hand up to her wrist, said her throat was a little itchy", benadryl PO was given  6:45PM pt stated her LEFT hand was " waking up" and but still felt like it was tingly  6:50PM pt stated her throat was less itchy and her LEFT hand she only felt her finger tips were "tingly".  6:55PM pt started to feel more calm and asked about what to do incase she starts to feel worse. pt was instructed to call 911 if there are any sudden changes and to follow up with a provider before getting her 2nd dose.  6:55PM pt was hesitant about staying longer because she was accompanied by her brother and she wanted to go home. Pt was re-educated to call 911 if there were sudden changed or felt like she needed medical attention, and given information on hand when to call 911
This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, improperly stored doses of VARIVAX (Merck) lot # L016126 exp. 06-MAY-2017 (route of administration, dose were not reported) were administered to unspecified patients. There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 15-NOV-2011, the patient was administered with a dose of VARIVAX (merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Patient felt her throat was closing. She experienced nausea and itchiness. EMS responded and administered diphenhydramine 25mg injection. Patient was taken to hospital via ambulance.
Medication Error Report: On 08/16/2021 Patient received Covid Janssen, Lot: 202A21A, 0.5ml, right deltoid. Patient returned on 09/20/2021 requesting Second dose Covid 19 vaccination. Patient was screened and accidently given: Covid Pfizer, Lot: FE3592, 0.3ml in right deltoid. Patient was ok.
Left side of my face I had slight tingling that started 45 mins after vaccine was given.  Vaccine appointment was at 10:00 am. I left facility after 15 min wait (wait time over at 10:30 am) I drove home and started feeling the tingling around 10:45 am.   Now at 11:35, I have a mild headache starting.
Patient went to emergency room complaining of headache and swelling of face and eyes. Patient was treated and released same day.
Nausea, headache, muscular pain at injection, chills, upset stomach, total muscular pain throughout the body, exhaustion.
SORE; VIRTUALLY IN BED; SPIKED A 103 FEVER FOR 2 DAYS/ FEVERISH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the patient experienced sore, virtually in bed, and spiked a 103 fever for 2 days/ feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spiked a 103 fever for 2 days/ feverish, sore and virtually in bed was not reported. This report was non-serious.
itching; rash chest, both arms and face; A spontaneous report was received from a consumer who was 69 years old male patient who received Moderna's COVID-19 vaccine and experienced itching, rash chest, both arms and face. Patients medical history  showed that he had allergy to raw peanuts, fresh berries and seasonal allergies. His concomitant medications were  not provided.   On 6th January 2021, the patient received1 dose of   mRNA-1273 vaccine intramuscularly.   On 07-JAN-2021, the patient felt itching ,rash chest, both arms and face.  On 12-JAN-2021 ,the patient spoke to the physician and he was treated with Claritin, Hydrocortisone 2.5%, Soap and Aloe Vera lotion.  Action taken with  mRNA-1273 was not reported.  The outcome of the events, itching, rash chest, both arms and face was considered as unknown.
Vomiting, Headache, Generalized weakness, fever swelling @ site of injection.
Initial and follow-up information has been received from a physician concerning a 67 year old female patient with osteoporosis and seasonal allergy who a "few months ago" was vaccinated intramuscularly into the right arm in the deltoid region with the first dose of PNEUMOVAX 23 (lot # 655766/0038U). After vaccination the patient had pain, swelling and fever. The patient went to Hospital Emergency Room and was found to be febrile and tachycardic with a systolic blood pressure around 89. The right deltoid region showed evidence of erythema, induration, tenderness and swelling. The white count was elevated at 22,000. Her potassium was 3.0. Creatinine was 1.4, BUN 28. Liver function tests were within normal range. The patient was assessed to have cellulitis and was admitted to the hospital. She was put on vancomycin and UNASYN. With antibiotics, her fever decreased. her white count improved from 22,000 to 18,000 at the time of discharge. Her swelling, induration and tenderness significantly decreased in the right deltoid region, although the patient still had erythema, which surprisingly increased a little bit. A computed tomography scan of the right upper extremity was obtained, which showed no evidence of different abscess formation. The patient had been discharged on 30-NOV-2008 on seven more days of clindamycin and montelukast sodium (MSD) and had been instructed to follow-up with the regular doctor. In addition, the patient also had episodes of nonbloody, noncramping watery diarrhea after antibiotics were initiated. The patient reported having similar symptoms in the past following the use of antibiotics. The patient had been advised to use anti-diarrheal agents on an as-needed basis, but to withhold anti-diarrheals and report to her regular doctor should she had fever or had abdominal cramps. The patient was recovered on 30-NOV-2008. Additional information is not expected. All medical records are available upon request.
NauseaVomiting BACKACHE, SOB Narrative:  Other Relevant History:
8 hours post shot extremely cold, chills, severe body aches, severe headache, hives, skin felt on fire
Pruritus  I don't recall exactly when symptoms began, but I'm guessing about 2 days after the injection. The itching sensation is limited to my face, including nostrils and eyelids  I do my best not to scratch, and have been using saline spray in my nostrils and Visine Dry Eye Relief a few times a day on the affected areas (i.e., nose and eyes).
Chills, temp 100.2. Took aspirin. Cleared up by evening.
I tested positive with a PCR test on 29May2022; I tested positive with a PCR test on 29May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immune disorder" (unspecified if ongoing); "known allergies: nuts all nuts" (unspecified if ongoing), notes: known allergies: nuts all nuts. Concomitant medication(s) included: DAPSON, start date: Jan2021.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29May2022, outcome "unknown", COVID-19 (medically significant) with onset 29May2022, outcome "not recovered" and all described as "I tested positive with a PCR test on 29May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (29May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Anti-viral Product for COVID-19 Treatment, Brand: Paxlovid, treatment start date 29May2022, treatment stop date 26May2022. the patient took other medications/products within 2 weeks of starting COVID-19 treatment. The patient tested positive with a PCR test on 29May2022, took Paxlovid then tested positive again and was much sicker than she was the first time she tested positive. Second time had a sinus infection as well and started a Zpac, she was now 4 days positive, her parents also experienced COVID rebound, and they were all exposed at the same wedding.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
hearing loss; multiple outbreaks of herpes zoster; postherpetic neuralgia; cardiovascular event; This initial spontaneous report was received on 11-DEC-2020 from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 28-FEB-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a provider for: multiple outbreaks of herpes zoster, post herpetic neuralgia, cardiovascular event, and hearing loss. The outcome of the events were not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss (deafness) was considered to be medically significant.
All Side effects listed in the package insert; 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 VACCINATION COMPLICATION (All Side effects listed in the package insert) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION COMPLICATION (All Side effects listed in the package insert). At the time of the report, VACCINATION COMPLICATION (All Side effects listed in the package insert) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided  This case involves 5 unidentified patients.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient gender , initials, physical address, email updated
DVT; PULMONARY EMBOLISM; KIDNEY BLEEDING; This spontaneous report was received from a physician, and concerned an adult male patient (greater than 50 years old).  Initial report was processed along with additional information received on 12-APR-2021. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine AD26.Cov2.S (suspension for injection, intramuscular, batch number was not reported) dose and site of vaccination were not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced deep vein thrombosis (DVT), pulmonary embolism (PE), and kidney bleeding. The patient was admitted to the hospital and was treated with heparin as well as an inferior vena cava (IVC) filter (put in after he experienced bleeding from his kidney). Laboratory data included: a negative COVID-19 virus test, and throughout hospitalization his platelet count (NR: not provided) was normal: 191,000 and 264,000 (units not provided). The patient's test came back positive for one copy of the Factor V Leiden mutation which predisposed him to blood clots. On 12-APR-2021, the patient was to start a trial to Lovenox (enoxaparin sodium); they will assure there is no bleeding, prior to discharge. At the time of this report, the patient was still hospitalized but doing well.  Action taken with Covid-19 vaccine AD26.Cov2.S was not applicable. The patient was recovering from DVT, pulmonary embolism, and kidney bleeding. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: v0 An adult (greater than 50 years old) male patient with a past medical history remarkable for the Factor V Leiden mutation experienced deep vein thrombosis, pulmonary embolism, and kidney bleeding on an unspecified date after receiving Janssen COVID-19 Vaccine Ad26.COV2.S.  The patient was admitted to the hospital and was treated with heparin as well as an inferior vena cava (IVC) filter (put in after he experienced bleeding from his kidney). The patient had a negative COVID-19 virus test, and throughout hospitalization his platelet count was normal: 191,000 and 264,000 (units not provided). The Factor V Leiden mutation is known to predispose patients to venous thrombosis, therefore the causality for deep vein thrombosis, pulmonary embolism as well a consequent kidney bleeding most likely due to heparin treatment is assessed not related to the vaccination.
Numbness, tingling in R arm distal to injection site. Swelling at injection site. Restricted movement due to pain.
Local reaction redness 21 x 1 cm on right arm. Firm mass, tenderness
Headache, Myalgia, inj site pain and discomfort, headache, chills, body aches, fatigue, chest pain Narrative: Day 1 - pain and discomfort to inj site, headache; Day 2 -pain and discomfort to inj site, headache, chills, body aches, fatigue, chest pain
The patient was administered an expired Pfizer vaccine. The vaccine expired on 12/16/22 and was given to the patient three days later on 12/19/22.
Patient received shot on 12/1/17 and reported to us 2 months later on 2/1/18 that his arm is still sore. He describes it as a dull, aching pain.
Grandmother reports 3-4 hrs after receiving immunizations on 3-25-08. Child had "staring like day dreaming". Reports 3-4 episodes which last approximately 3-4 minutes each time. Denies fevers higher than 100.2 - 100.4. Denies jerking. Describes child as "cranky" denies nonstop crying.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Jan2022 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ) (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19".  Causality for Rinvoq (Upadacitinib) The reporter's causality for the event(s) of contracted Covid with Rinvoq (Upadacitinib) was no reasonable possibility.   Causality PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) for event COVID-19 (COVID-19) Causality as per reporter (Drug/Vaccine): Probable De challenge: N/A  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: cine BNT162B2 cannot be ruled out.  Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However,  case will be reevaluated should additional information become available.
sore arm, chills throughout the day, fatigue, headache, and vomiting at 3:20a.m. on 02/04/2021
A physician reported that his 2-month-old son received his 1st dose of Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine on 05-JUN-2003. Concomitant vaccines included Haemophilus b conjugate vaccine (manufacturer unknown) and DPT (diptheria and tetanus toxoids and pertussis vaccine) vaccine (manufacturer unknown). One day post-immunization, the child developed a fever.
Pt c/o pain and limited ROM since about 2 days post injection. Denies swelling or redness at injection site. Pt did see her PA for this.
Large blotchy hives showed up on feet, hands, and wrists showed up around 12 hours later that burned and itched. Took Claritin and put cortisone cream on it but it did not help.  Went to urgent care (virtual), took Benedryl
Pain at the injection site; Pain under the arm (armpit); Shooting pain when the left arm is extended over the head or straight ahead (similar to muscle pain); This is a spontaneous report from a contactable healthcare professional, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 07Mar2021 at 13:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021 at 07:00, post-vaccination, the patient experienced pain at the injection site, in addition to that, pain under the arm (armpit) and shooting pain when the left arm was extended over the head or straight ahead (similar to muscle pain). The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 10Mar2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the events pain at the injection site, pain under the arm (armpit), shooting pain when the left arm was extended (similar to muscle pain)  were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.