chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On an unknown date in 2013 (also reported as at least a year ago) the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date in 2013 (also reported as about a month after receiving ZOSTAVAX) the patient experienced shingles. The pharmacist also reported that the dose of ZOSTAVAX that the patient received, may have been exposed to room temperature for 1 to 2 hours prior to administration of the vaccine. It was also reported that the dose of ZOSTAVAX was dispensed or given at the pharmacy, but was administered at an unspecified physician's office. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. It was reported that the pharmacist had conferenced with the generalist and asked whether the patient get chicken pox from ZOSTAVAX and can a patient who has never had chicken pox receive ZOSTAVAX. The pharmacist also asked should a patient be revaccinated if they received a dose of ZOSTAVAX that was exposed to room temperature for 1-2 hours. Additional information has been requested.
Case number PHEH2011US07093 is an initial spontaneous report received from a nurse on 13 Oct 2011 with a follow-up received from a health care professional on 02 Nov 2011: This report refers to 20-year-old male patient. His vaccination history included administration of MMR vaccine (other manufacturer) on an undetermined date. He was given only the CYW-135 liquid component of MENVEO (batch number: M10062) intramuscularly on 12 Oct 2011. No other adverse event was reported. Follow-up received from a health care professional on 02 Nov 2011: Updated vaccination history and batch number of MENVEO.
Severe hemolytic anemia, drop in hemoglobin and red blood cells.  Needed two units blood transfusion at  Hospital  2/16-22/18 2021. Released under prednisone prescription
I felt light headed, weak, shortness of breath and chest pain. Discomfort in my chest area.
Patient developed ALS shortly after his vaccine. He passed away within 4 months. It is unclear whether or not there is any relation to his development of ALS and his taking the vaccine - other than the association of timing.  His wife felt strongly that this should be reported.
I had a sore throat, pressure in my left ear, head congestion, coughing, and a fever of 101.2 degrees. I had a telehealth visit with the doctor. I was prescribed PAXLOVID. I still have head congestion. I had a side effect of bitterness in my mouth after taking the PAXLOVID.
injection arm hurts really bad; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 24Dec2021 (Lot number: 331308A) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, lot number ER8729), administration date: 21Apr2021, for Covid-19 immunization, reaction(s): "Covid"; Bnt162b2 (Dose 1, lot number ER8733), administration date: 24Mar2021, for Covid-19 immunization, reaction(s): "Covid".  The following information was reported: IMMUNISATION (non-serious) with onset 24Dec2021, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection arm hurts really bad".
heart rate would randomly go up to 120+ while just sitting, at work, at home, doing nothing. My resting HR is normally around 60.
Had fever, chills (temp 99.9 degrees F) 5 hours after getting vaccine. Had a splitting headache, sore throat. 3 days later, has symptoms of a cold (congestion, running nose). Other symptoms reduced significantly.
Pruritic urticaria of face, chest, arms and shoulders. No respiratory or cardiac issues. IM Epinephrine and po Benadryl given. Transported to Emergency Room via ambulance for further observation and treatment.
Student came to health office the next morning. Reporting a low grade fever the night before and feeling dizzy currently. He was sent to Urgent Care because he did not have a PCP. Urgent care determined he currently had no fever although the student often feels dizzy if he gets a fever or has seasonal allergies. So urgent care released him to home thinking the dizziness may have been from either allergies or possibly the low fever he had the night before.
PATIENT REPORTS SENSATION OF BUGS CRAWLING ON SKIN AND LIGHT SENSITIVITY STARTING THE DAY AFTER VACCINATION AND CONTINUING FOR 2 DAYS.
getting pre-exposure vaccines / second / on 11/13/2020 / for COVID / cannot get her third dose until 12/07/2020; second dose on 11/13/2020.; This case was reported by a pharmacist via licensee and described the occurrence of social problem in a 21-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis, rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis, Rabies NVS (RabAvert) for prophylaxis, rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Rabavert (1st dose received on 30th October 2020).   On an unknown date, the patient received the 3rd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 13th November 2020, the patient received the 2nd dose of RabAvert. On an unknown date, the patient started Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 13th November 2020, not applicable after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device and unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the social problem and drug dose administration interval too long were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The patient was in quarantine for COVID and she could not get the 3rd dose until 7th December 2020, which led social problem. The patient was a vet student. The reporter consented to follow up.
This spontaneous report as received from a physician via company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown dates, the patient received four doses of pneumococcal vaccine, at least one dose was PNEUMOVAX 23 (dose, route and lot# was not reported). On an unspecified dates after vaccination, the patient had two cases of pneumonia. In approximately 2015, the patient developed a third case of pneumonia, for which the patient was hospitalized at the time of reporting. The patient received an unspecified treatment for the event. On an unknown date, the patient was tested for pneumococcal pathogen serotypes (units were not provided): serotype 1: less than 0.1, serotype 3: 0.3, serotype 4: 0.4, serotype 5: less than 0.1, serotype 8: 2.2, serotype 9N: 0.6, serotype 12: less than 0.1, serotype 14: 2.3, serotype 19: 2.3, serotype 23: 1.0, serotype 26: 0.2, serotype 51: less than 0.1, serotype 56: 1.3, serotype 68: less than 0.1. At the time of reporting, the patient had not recovered from a third case of pneumonia. The outcome of the previous episodes of pneumonia was not reported. The relatedness between all three episodes of pneumonia and PNEUMOVAX 23 was not provided. Additional information has been requested.
patient came into the pharmacy on 10/14 to show me her arms. Both arms had a large red patch on the lower portion of her upper arms. Patient stated that she thought the vaccines were administered too low on each arm. She thinks it was about 2 inches off to where it should have been given. By 10/19, she stated that the red marks were improving and did not think they were infected. Offer was made to revaccinate with the influenza vaccine, if she believed it was administered subcutaneously. Patient has not yet come back in for revaccination.
Rash/Hives starting 2 days after injection.  Appeared on face, neck, arm, knees, hands.  Saw doctor and she said it was an allergic reaction.  Also had "COVID-Arm" after the 2nd shot.  No reaction after the first shot.
Got vaccine on 12/29/20. On 1/8/21 - developed raised, red 2inch x 2inch rash with smaller rash below it.
Doubled heart rate for over 2.5 months, fever, chest pain, shortness of breath, acid reflux, insomnia, weight loss, extreme fatigue, left arm weakness, faint
Muscle spasms in right jaw; Fatigue; Shortness in breath; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 03Jan2023 at 12:00 as dose 1, single (Lot number: FR2587) at the age of 31 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Spastic bowel syndrome" (unspecified if ongoing); "Gluten allergy" (unspecified if ongoing); "Yeast allergy" (unspecified if ongoing). Concomitant medication included: INFLUENZA VACCINE, on 29Dec2022 as dose 1, single. The following information was reported: FATIGUE (medically significant) with onset 04Jan2023 at 13:30, outcome "recovered with sequelae"; MUSCLE SPASMS (medically significant) with onset 04Jan2023 at 13:30, outcome "recovered with sequelae", described as "Muscle spasms in right jaw"; DYSPNOEA (medically significant) with onset 04Jan2023 at 13:30, outcome "recovered with sequelae", described as "Shortness in breath". The events "muscle spasms in right jaw", "fatigue" and "shortness in breath" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2023) Negative. Therapeutic measures were taken as a result of muscle spasms, fatigue, dyspnoea reported as "volume shot". Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19.
2 hrs p/shot uncontrollable, high pitched screaming, vomiting, shaking/shivering uncontrollable, difficulty breathing, t102; @ hosp sx cont & fever went to 104;
Started having cough and nasal congestion / runny nose approximately 6 days after my last day of the 5 day treatment course of paxlovid. Coughing a fair bit, every few minutes or so, and rhinorrhea.; Started having cough and nasal congestion / runny nose approximately 6 days after my last day of the 5 day treatment course of paxlovid. Coughing a fair bit, every few minutes or so, and rhinorrhea.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 at 19:00 as dose 1, single (Batch/Lot number: unknown), on 21Feb2021 at 16:00 as dose 2, single (Batch/Lot number: unknown) and on 26Sep2021 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 06Jun2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Kidney Disease" (unspecified if ongoing); "ESRD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE MOFETIL, start date: 08Nov2019; NULOJIX, start date: 08Nov2019; PREDNISONE, start date: 08Nov2019; NATURE'S BOUNTY IRON; WELLBUTRIN, start date: 12May2021. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Started having cough and nasal congestion / runny nose approximately 6 days after my last day of the 5 day treatment course of paxlovid. Coughing a fair bit, every few minutes or so, and rhinorrhea.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19.  Additional information: Anti-viral details: Product: COVID 19 Treatment, Brand- Paxlovid by Pfizer, Treatment start date: 10May2022,Treatment stop date: 15May2022, Treatment Indication: Treatment of COVID-19. Adverse event: Started having cough and nasal congestion / runny nose approximately 6 days after my last day of the 5 day treatment course of paxlovid. Coughing a fair bit, every few minutes or so, and rhinorrhea.  The information on the batch/lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was given.
Rash to arm.  Started left elbow.  To chest, right elbow and legs.  Started slowly.  By March was itching.  Still present on arms and chest
Rash Vesicular Information has been received from a health professional concerning a 14 year old female, with no medical history and no allergies, who on 14-APR-1998 was vaccinated with a dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot #625043/1567E). There was no illness at the time of vaccination. It was reported that over the weekend of 17-DEC-2005 the patient's mother called the office to complain that her daughter had a rash, like chickenpox, spread over her entire body. Subsequently the patient recovered. Medical attention was not sought. Additional information is not expected. The patient's sister experienced chickenpox following vaccination with varicella virus vaccine line (Oka/Merck) (WAES0601USA004021).
Patient (08/22/1991) received the [1st] COVID vaccine (Pfizer lot #EW0179 and expiration date 04/24/2021) at 5:40pm. Client reported to EMT.  EMT alerted RN. EMT and another EMT provided client with recliner chair and transported client into semi-fowler position. Client reported to RN "I am feeling sweaty and dizzy". VS at 12:03pm HR 50, BP 116/80, Spo2 98%RA, RR 24. Client denies shortness of breath, itchiness, chest pain, itchiness, swelling in throat or tongue, or pain. Client reports similar incidents in the past at the sight of needles or when his blood is drawn. Client states symptoms resolved within 2 minutes of onset and states he no longer feels dizzy. Client denies medical history or taking medications. No allergies reported. Client is alert and oriented to time, date, place, and event. Client provided with water. VS at 12:12pm HR 61, BP 120/78, Spo2 987%RA, RR 16. Client placed in sitting position and monitored. VS at 12:31 pm HR 77, BP 128/82, Spo2 97%RA, RR 16. Client provided with education on signs and symptoms of mild to sever allergic reactions. ER precautions given. RN provided instructiosn to f/u with PCP for discussion of reaction. Client verbalized understanding. Symptoms resolved at 12:05pm. Client reported his fiance would be driving client home. RN escorted client to fiancé's car. Client walking with a steady gait.
Febrile seizure after shots fever 103.2 given ibuprofen fever wouldn't come down seizure started. Also (R) thigh redness, swelling noted 10/19/12 in 24 x 12 cm.
Swelling/ redness on right thigh; 99.1 temperature; fussiness.
PT RECIEVED ADULT PFIZER VACCINE INSTEAD OF PEDIATRIC PFIZER
INASVERTENTLY VACCINATED BEFORE 12 YRS OF AGE. WRONG DATA ENTRY. UNABLE TO CONTACT.
I had some muscle soreness and headache. Not to long after that I started to lose my hair. I'm over the soreness and headaches, but I'm still having hair loss.
Burning sensation in her armpit like a sunburn or swim burn (left); Tiredness; Cramps in her legs, in her calf area; Booster; She feels like if she was beat up with rocks, that it is hurting bad; Pain in her left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 14:00 (Lot number: SE3594) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Lot number of ER8732), administration date: 01Apr2021, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "Stated that she did not experience side effects with first two"; Covid-19 vaccine (Dose: 2, Lot number of EW0164), administration date: 30Apr2021, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "Stated that she did not experience side effects with first two"; None (Patient History: No). The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 14:00, outcome "unknown", described as "Booster"; BURNING SENSATION (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Burning sensation in her armpit like a sunburn or swim burn (left)"; PAIN (non-serious) with onset 20Dec2021, outcome "not recovered", described as "She feels like if she was beat up with rocks, that it is hurting bad"; FATIGUE (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Tiredness"; MUSCLE SPASMS (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Cramps in her legs, in her calf area"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Pain in her left arm". Therapeutic measures were taken as a result of burning sensation, pain, fatigue, muscle spasms.  Additional information: The patient did not experience side effects with first two. She got the shot in her left arm and under her arm pit is like a burning sensation like a sunburn or swim burn. The patient wanted to make sure if this is normal. She did great with the first two. She experienced body feels like it has been beat up with rocks after she laid down a few hours later after coming from the site. It got more intense when she woke up around 5am this morning and her armpit a sensation of burning. She got the shot yesterday at 2pm. She was tired after she woke up this tired. The leg cramps comes and goes and started this morning. Stated that the leg cramps were in her calf area. She took Tylenol for body feels like it has been beat up with rocks. Stated that she put a cold rag underneath her armpit. Stated that she has been lying down drinking fluids for tired. Stated that she rubbed her legs with alcohol.  No follow-up attempts are required. No further information is expected.
gave a Menactra vaccine to a patient, and after they saw it was expired,/NO AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 11 years old female patient who received 0.5 mL expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6002AA, expiry date-11-Sep-2019 via intramuscular route in the left deltoid On 27-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines administered.  It was a case of actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 at 13:15 as dose 1, single (Batch/Lot number: unknown), in right arm, on 27Mar2021 at 13:15 as dose 2, single (Batch/Lot number: unknown), in right arm, on 09Oct2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 15Jul2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM, start date: Apr2022, stop date: Sep2022; LISINOPRIL, start date: Apr2022, stop date: Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "After finishing treatment for Covid about a week later tested positive for Covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: After finishing my treatment for Covid about a week later tested positive for Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: The patient was treated for covid-19 with Paxlovid from 23Aug2022 to 28Aug2022. After finishing treatment for Covid about a week later tested positive for Covid again. She had a runny nose, cough, and sore throat with a slight fever. She had no allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a registered pharmacist concerning a "teenager" female who in February 2008, was vaccinated with the First dose of GARDASIL (Lot not reported). Subsequently the patient experienced "muscle problems". The pharmacist noted that the patient went to see her physician. At the time of reporting the outcome of the patient was unknown. Additional information has been requested.
Patient was admitted with impression of COPD exacerbation and hypoxia. She was treated with antibiotic and bronchodilators. Her symptoms gradually improved and she was discharged. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.