chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. On 06 Dec 2021,placed Lot 012H21B vials in our refrigerator.   This case was linked to MOD-2022-449524 (Patient Link).
Only got one Shingrix shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received four years before the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The patient was positive that they only got one Shingrix shot four years ago. The reporter asked if in this situation GlaxoSmithKline restart the series or give the second dose as soon as possible. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. Attempted callback today (day of reporting) to HCP (Health Care Professional) to gathered more information but had to leave voicemail for callback.
MGUS (MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE); MUSCLE TWITCHING; WHEELCHAIR BOUND, WHEELCHAIR ALMOST PERMANENTLY DUE TO SIDE EFFECTS; INABILITY TO WALK; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a physician concerned a 45 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: some mild arthritis of the spine. The patient was previously treated with ergocalciferol for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the patient experienced muscle pain, and weakness. On an unspecified date, the patient experienced mgus (monoclonal gammopathy of undetermined significance), muscle twitching, wheelchair bound, wheelchair almost permanently due to side effects, and inability to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, weakness, wheelchair bound, wheelchair almost permanently due to side effects, muscle twitching, and inability to walk, and the outcome of mgus (monoclonal gammopathy of undetermined significance) was not reported. This report was non-serious.
Dizzy then described "feeling funny", itchy arms, then itch spread to back, red spots visible on arms, face had blotches of red.  No respiratory symptoms.  Sent to ER for treatment.
This spontaneous report has been received from a pharmacist and referred to a patient of an unknown age and gender.  The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 "PFU" (dose, frequency, and route of administration were not reported; lot number M041182 with expiration date 04-JAN-2018) for prophylaxis, that was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number M012717 with an expiration date 19-SEP-2018). The temperature data logger measured a vaccine dose stored temperature range of 6°F to 14°F for a period of 1 hour. There were no previous temperature excursions. There were no side effects reported.  Additional information has been requested.
The next day, arm was red, "killing me",  and was swollen.  Left breast was swollen and sore. Left side of neck was painful to move. The following day left side of neck was swollen. A week later swelling has decreased, but still present. Had to take Tylenol for discomfort.
pregnancy after being fully vaccinated; This is a spontaneous report from a contactable consumer. This is a maternal report. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced pregnancy after being fully vaccinated (non-serious) on 07May2021. The outcome of the event was unknown. The mother reported she became pregnant while taking bnt162b2.   Information about lot number has been requested.
Reported 7.5 hours after receiving MMR, "broke out in hives, tongue swelled and became bumpy with blisters."  Trouble swallowing and talking.
Patient received booster dose on 11/23/2021, started with shoulder pain shortly after receiving the vaccine. the pain migrated down her harm to her hand since that time. her thumb, index finger, and middle finger have been throbbing "like a toothache" and on 12/4/2021 it became severe and debilitating  and she presented to the Emergency department around 2AM. the dorsum of hand is reddened, pain with grip, grip is weakened, pain is severe. Patient was admitted to hospital for observation and pain control with "right hand pain - severe requiring narcotic analgesics - radiculopathy versus neuropathy from immune reaction/complex pain syndrome. The following morning the physician's exam suggested some radiculopathy around C5-C6 with inflammation starting in the shoulder - provided intra-articular injection to right shoulder of Kenalog and Marcaine - this provided symptom improvement and was discharged home 12/4/2021 around 1130AM.
pt recv vax 8OCT97 & pr reported severe sx of chickenpox described as a rash from head to toe, fever, upper resp sx & pox on face, trunk, back & mouth;
Information has been received from a physician concerning a 5 year old female pt who in approximately January 2003, was vaccinated with a dose of varicella virus vaccine live. One year later on approximately 06Jan2004, the pt developed a viral rash with a few vesicular lesions. Unspecified medical attention was sought. At the time of the report, the experience has not abated. A product quality complaint was not involved. Additional information is not expected.
I have constant ringing/buzzing in my right ear that has started last night (5/9/2021) at approximately 9 pm and has not stopped
Fainting spell, lightheadedness. (5 mins). Note!! Pt alert and responsive throughout episode.
Within 5 minutes of receiving the shot, my entire body went hot from head to toe and then I broke out into a sweat. Sweat was running off my entire body. I went completely pale. I felt like I was going to throw up or pass out or both. The PA overseeing the waiting area attended to me along with either another PA or a nurse. They took my blood pressure and it was a little low for me. They retested my blood pressure about 30 minutes later and it was back to normal. My arms from my elbows down went numb and tingly. I had what felt like a lump in my throat. They had me lay down completely in my driver seat and apply ice to my neck. They also gave me some crackers and Gatorade. I later broke out into goosebumps all over my body and then began shivering and my teeth clattering which I was unable to control. My 20 minute wait turned into almost an hour and a half before I felt well again.
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever, pain, feeling down, chills, nausea and influenza-like symptoms. On an unknown date, the outcome of the fever, pain, feeling down, chills, nausea and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, pain, feeling down, chills, nausea and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The consumer reported the following via online chat the patient had side effects after 1st shingle shot fever, ache, down several days. The reporter asked should they expect them with the second dosage. Yes, it was and the patient had flu like symptoms including fever chills and nausea. It was confirmed that the patient received SHINGRIX. The reporter did not consent to follow up.  The reporting consumer declined to provide more information.
spontaneous nose bleed for over a week; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (spontaneous nose bleed for over a week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Nasal operation (vessel that was bleeding was so far up in the nose that couldn't be cauterized).   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced EPISTAXIS (spontaneous nose bleed for over a week). At the time of the report, EPISTAXIS (spontaneous nose bleed for over a week) outcome was unknown.            No concomitant medication was reported No treatment medication was reported.
Patient reported symptoms of arm pain and difficulty using her arm to accomplish tasks starting at the time of administration and continuing for 13 days.
hot at injection site; red spot at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (got the other vaccine for shingles years ago). Concomitant products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)).   On 18-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). In SEP-2023, an unknown time after receiving Shingrix, the patient experienced injection site warmth (Verbatim: hot at injection site) and injection site erythema (Verbatim: red spot at the injection site).  The outcome of the injection site warmth and injection site erythema were unknown.   It was unknown if the reporter considered the injection site warmth to be related to Shingrix. The reporter considered the injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site warmth to be related to Shingrix. The company considered the injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-SEP-2023 The patient reported she got the Flu vaccine the same day when she administered Shingrix vaccine but on the right arm. The brand name of the flu vaccine was unknown.   The patient stated she had a big red spot at the injection site from the Shingrix thank you so much for this life a life line really she did not had to bug the doctor to see if everything was normal or ok. The size of spot that occurred was half a dollar, but bigger than a quarter. The patient stated that spot was hot, it was warm on the reporting day but yesterday (19th September 2023) it was hotter. Lot and expiration date of either vaccines were unknown.  No additional information was provided. The reporter did not provide consent to follow up with healthcare professional.
pt recvd vax; arm pain & feeling very tired; arm also had tingling & numbness;
Approximately 24 hrs after dose administered: lethargy, body aches/pains, dizziness, night sweats. Pain at injection site radiating to shoulder, neck and opposite shoulder. Most s/s lasted approximately 48 hrs.
Approximately 12 hours after receiving the vaccination, I started feeling clammy and achey. Within a few hours after that I had a fever of 101, extreme body aches and pain, chills and discomfort. Symptoms were worse than any flu or cold k have ever had. Symptoms lasted approximately 24 hours then I just felt tired and lethargic.
Headache, Myalgia & Fever Narrative: dose 2- day 1-3 sore arm; day 1-4- chills; fever; ha; bodyache;
Orange size, red, hard knot, warm to touch localized reaction in right arm where DTaP #5 was administered on 07/05/02.
This spontaneous report was received from a back office lead and refers to a 37 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in left deltoid, lot # reported as 042946, expiration date 15-SEP-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
severe vomiting for 5 hours and high fever, headache, fatigue for 18 hours
Approximately one to 1.5 hours post vax pt complained of itching on lower back. Step father noted a hive-like rash on lower back which spread to upper back and front torso within 20 minutes. No difficulty swallowing or breathing. Physician treated child with Claritin with relief.  Follow up 12/22/2000: "Impossible to provide time of events."
Fever; chills; Disoriented; He got so weak; Really sick for 3 days/the third dose did havoc to his body; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills), DISORIENTATION (Disoriented), ASTHENIA (He got so weak) and ILLNESS (Really sick for 3 days/the third dose did havoc to his body) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 012M20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis (40 years ago, ongoing and stable), Idiopathic pulmonary fibrosis (Stable) since 2021, Cholesterol and Thyroid disorder. Concomitant products included GUSELKUMAB (TREMFYA) for Psoriatic arthritis.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Aug-2021, the patient experienced PYREXIA (Fever), CHILLS (chills), DISORIENTATION (Disoriented), ASTHENIA (He got so weak) and ILLNESS (Really sick for 3 days/the third dose did havoc to his body). On 18-Aug-2021, ILLNESS (Really sick for 3 days/the third dose did havoc to his body) had resolved. On 20-Aug-2021, PYREXIA (Fever), CHILLS (chills), DISORIENTATION (Disoriented) and ASTHENIA (He got so weak) had resolved.            It was reported that patient was really sick for 3 days, and symptoms lasted for a total of 5 days, after which patient started getting better.  It was also reported that patient took antacid and some medication for Cholesterol and Thyroid. Patient did not have any allergies from medications, food and other products  No treatment details were provided   This case was linked to MOD-2022-539507 (Patient Link).
pt recv vax 24NOV98 & that evening pt devel a low grade fever & severe diarrhea w/cramping;stool specimens were negative for C difficile toxin & ova & parasites & positive for rotavirus antigens;
Systemic: Facial Flushing (Resolved after 20 mins); symptoms lasted 0 days
received an expired dose of FLUZONE HD QIV with no adverse event; Initial information received on 21-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and gender patient who received an expired dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Nov-2022, the patient received an unknown dose of expired suspect influenza quadrival A-B high dose hv vaccine (lot: UJ764AA; expiry date: 30-Jun-2022) (strength, form unknown) via unknown route in unknown administration site for prophylactic vaccination with no adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event received an expired dose of fluzone hd qiv with no adverse 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.
After 1st shot I developed strong  unvolunteer spasms in both my legs down the knees. After 10 hours  getting 2nd shot there was 101 F fever, strong headache, sleep disorder, nausea, tingling ( needles) in my both legs down knees, dizziness,  vertigo, tinnitus.  Fever and strong headache were gone in a few days but all the other symptoms are still here and I am suffering so much.
On 12/02/2022, patient given initial dose of Pfizer 12+ monovalent COVID vaccine from refrigerator. Upon documenting administration, manufacturing date on vial found to be 12/2021, so called CDC, Pfizer, and LPN to clarify expiration date. MD informed; per provider, MD called and informed patient father. Vaccine administered at 0945 AM.  RN called CDC on 12/02/2022, who advised to contact Pfizer, as they did not have any data on the stability of the vaccine; CDC website states that dose should be repeated. Called Pfizer medical information, who advised that they did not have any data on the stability of the vaccine after expiration, but did confirm that the expiration date was 11/30/2022, so vaccine was given two days out of date. contact confirmed the same on 12/05/2022.  Enquiry form completed by RN and submitted to Pfizer for further information. Patient in no apparent distress upon leaving Facility.
c/o mild sob and chest pressure middle area of chest States she thinks it's from drinking coffee this morning, which is unusual for her and does not drink it in the morning and states that it might be the GERD. Pt was advised to take  off 1 mask due to double masking.  Pt states she feels better.  Monitored for 15 min, pt "feels better" denies sob and only mild pressure.  VS: 120/70 68HR 96%
Mother stated that on afternoon of 09/17/2009 a rash appeared on proximal right leg, which consisted of "water blisters", that also appeared on toes of child. On 09/18/2009 the same rash and "water blisters" appeared on left leg and toes also. This reaction lasted for approx. one week. Mother did not seek medical attention during this week and did not treat areas.
Super sick after each dose Ie febrile, aches, pain.  Now nearly 11 months out of the first dose I am still having significant heavy menstrual cycles and significant pain in my lower abdomen as well as heavy cramping.
hot to the touch; Tired; Arm redness; Felt Pain /achy; Soreness at injection site /achiness returned and the area 10 inches below the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th January 2020, less than a day after receiving Shingrix, the patient experienced pain, injection site pain, tiredness and erythema of extremities. On 23rd January 2020, the patient experienced skin warm. On an unknown date, the outcome of the pain, injection site pain, skin warm and erythema of extremities were not recovered/not resolved and the outcome of the tiredness was recovering/resolving.   It was unknown if the reporter considered the pain, injection site pain, skin warm, tiredness and erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The patient received a dose of Shingrix in an unknown arm. The patient felt pain, soreness and redness at the injection site. She stated that she also felt achy and tired. One day after the injection, the patient said that the symptoms began to resolve.  On 23rd January 2020, the achiness returned and the area 10 inches below the injection site was red and hot to touch.
Swelling and redness with heat and tenderness started 6-9-16, continued to worsen - 20 cm x 12 cm. Antibiotics given if cellulitis, BENADRYL for today. Swelling and cool compresses.
fever of 101.5; chills; nausea; body aches; burning behind the eyes; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 12Jan2021 17:15 (05:15 PM) at a single dose for Covid vaccine. Medical history included known allergies to penicillin and Covid prior to vaccination. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). It was reported that within 16 hours the patient had fever of 101.5, chills, nausea, body aches, and burning behind the eyes, all on 13Jan2021 08:00 AM. Treatment was not received for the events. She did not have Covid tested post vaccination. The outcome of the events was recovered on Jan2021.  Information on lot/batch number has been requested.