chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 2/10/02, pt called me and said she had been unable to sleep the night before because of soreness in her arm where Td was given (Right deltoid). Stated that she had a fever of 100.5 degrees F. Said her arm was red and swollen at the time of her call-5 pm. Told pt to use cool compresses and  take Tylenol and see MD if it got worse. By 2/11/02, improving and today pt states it's better right deltoid has 50 mm area of redness-heat.
Patient has had dozens of flu shots, but none have hurt as much as this one did when it was administered or for such a long time afterward - more than three weeks later! Arm is so sore patient can barely move it and has lost sleep. Apparently the pharmacist/technician hit a nerve in the deltoid area. Whatever the case, it was not administered correctly. Patient has applied heat and taken NSAIDS, but should not have to do this almost a month after receiving a shot. Next year, patient is going to a real nurse and getting the shot in the hip.
Bivalent COVID booster was given to patient that was beyond the use date of reconstitution (BUD was 3/15/23 @21:51 and patient received the booster on 3/16/23 @11:19). Informed patient we would not re-vaccinate and would call with further information. Patient did not have any adverse reaction and after further discussion with our drug information team, another dose will not be given to the patient.
Vaccine was initially stored in refrigerator on 10-Jul-2023 and vaccine was administered on 10-Aug-2023.; No adverse event; 2 pediatric patients received expired Moderna Bivalent COVID-19 vaccine on 10-AUG-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 pediatric patients received expired Moderna Bivalent COVID-19 vaccine on 10-AUG-2023), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jul-2023 and vaccine was administered on 10-Aug-2023.) and NO ADVERSE EVENT (No adverse event) in an infant female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Aug-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 pediatric patients received expired Moderna Bivalent COVID-19 vaccine on 10-AUG-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jul-2023 and vaccine was administered on 10-Aug-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 pediatric patients received expired Moderna Bivalent COVID-19 vaccine on 10-AUG-2023), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jul-2023 and vaccine was administered on 10-Aug-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (2 pediatric patients received expired Moderna Bivalent COVID-19 vaccine on 10-AUG-2023) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jul-2023 and vaccine was administered on 10-Aug-2023.).    Reporter was pharmacy tech.  Concomitant product use was not provided by the reporter.  Suspect vaccine manufacturer expiry date was reported as 14-Oct-2023. In the box vial size was 2.5 ml. Dose was administered 30 days beyond use by date. Vial did not undergone any temperature excursions. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 1st out of 2 infant patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-737509 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737509:
received first dose /in March of 2020 and had not yet received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included bexsero (1st dose received in March 2020 on unknown date).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by patient's mother. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Bexsero, which led to incomplete course of vaccination. The reporter did not want to provide any demographics for the patient. The reporter did not consent to follow up.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 24-SEP-2015, the patient was vaccinated with an improperly stored doses of ROTATEQ lot # L008053 with expiration date 30-NOV-2016, oral, (dose was not provided) and RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). The vaccines were exposed to temperature excursion of 34 degrees F during that month. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023; No adverse event; expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated) and PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023).    No relevant concomitant medications were reported.  It was also reported that there was potentially a second lot number that was expired on 28Feb2023 and was administered to patients on 3Mar2023, but HCP did not have any details on this event at this time.  Vial size was reported as 10 dose vials. The vial hadn't undergone any temperature excursions.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Total number of vials were reported as 102 doses for LOT 026C21A The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was reported as unknown. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received contains non-significant information.
Woke @3:00 AM with severe pain from waist down to leg joints and from hip to hip. Currently I have S/I joint pain but not like this pain. Severity lasted throughout day and night despite mega doses of Tylenol. Pain was 1/2 as much on 03-06-2021 and gone on 03/07/2021.
Heart feels like it?s fluttering at random times of the day and night, hard to breathe during those episodes.
Patient reports she was lost weight and her weight was somewhere between 125 lbs. and 130 lbs; sinus headache around her eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Lot number: EW0182) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (ongoing), notes: Verbatim: seasonal allergies. Concomitant medication(s) included: BENADRYL taken for hypersensitivity (ongoing); ALLEGRA-D [FEXOFENADINE; PSEUDOEPHEDRINE HYDROCHLORIDE] taken for hypersensitivity (ongoing). The following information was reported: SINUS HEADACHE (non-serious) with onset 07May2021, outcome "unknown", described as "sinus headache around her eyes"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Patient reports she was lost weight and her weight was somewhere between 125 lbs. and 130 lbs". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She is calling to ask if she can take her seasonal allergy medication. She usually takes Benadryl or Allegra D. She has taken these medications for quite some time. She has seasonal allergies. She is asking if taking her Benadryl or Allegra-D will affect the Covid 19 vaccine she received. she is lost weight, and her weight is somewhere between 125 lbs. and 130 lbs. She reports her family all got the Covid 19 vaccine. She reports she was hesitant about getting the Covid 19 vaccine, but she started listening to reports about the vaccine and none of her family members had side effects after receiving their Covid 19 vaccines. She has not taken any of her allergy medication today. She also did not take her allergy medication yesterday, 06May2021, prior to receiving her Covid 19 vaccine. She is starting to get a sinus headache around her eyes right now. She usually gets a sinus headache with her seasonal allergies.  are her worst seasons because of the flower budding.  No follow-up attempts are possible. No further information is expected.
at about 20 hours post vaccination I had onset of fatigue, generalized body aches, joint aches, headache, and felt febrile. I took my temperature twice in the absence of antipyretics and did not have a fever (98.7 and 98.2) but my skin felt hot and painful as it does when I have had a fever in the past. By about 5:00 or around 24 hours post vaccination, all symptoms resolved aside from fatigue and headache, but the headache was less than it was before. I experienced those symptoms for the rest of the evening and woke up this morning feeling completely normal.
Heart started beating irregular. Have episodes of hard beats and getting very lightheaded and dizzy. Feeling faint. Left side of chest feels under pressure. Tightness of chest. Hard to get a full breath.  Feel fatigued.
I felt nauseous with chills about 3 hours after 2nd dose.. when I got out of bed next day around 1;30 I was having pain in hip the same side as shot making it difficult and causing pain to walk
07/29/2005 (48 hrs after vaccine Adm) patient became limp, pale, and lethargic. Went to pediatrician, then to hospital, in hospital x 24 hrs. Discharged 07/30/2005. Ok now.
administration of ROTATEQ after temperature excursion; This spontaneous report was received from a reporter referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.    On 18-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742457, expiration date reported as 16-FEB-2022 but upon internal validation established as 06-JAN-2022, at a dose of 2 milliliter, orally for prophylaxis.  The vaccine was stored in a temperature of 1.3 degree Celsius  for 19 minutes as recorded by a data logger. There was no previous temperature excursion reported.
This spontaneous report as received from a healthcare worker refers to 5 unspecified patients of an unknown age. The patients' relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, 5 unspecified patients were vaccinated with improperly stored dose of VARIVAX (Merck) lot # K005427 (expiry date: 15-APR-2016) (start date and dosage not reported). No adverse effect reported. The nurse reported a temperature excursion for the VARIVAX (Merck). No further details provided. This case is linked to case# 1603USA005931 and 1603USA003817 via same reporter link, Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patent of unknown age and gender. On 31-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F ) was 120, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
I had a sore throat; I called my doctor for a strep test. I had to have a COVID-19 test before I could come in. I took a home test and it was positive. He prescribed me Paxlovid, and then that was on a Friday, so three days later I got a Strep test and I also had Strep. During this time, it was just sore throat. If my child didn't have Strep, I would have never called the doctor, I didn't think I had COVID-19. I took the medicine and then on day 5 my chest was bright red. I was also taking the Amoxicillin for Strep. The doctor said not to take the last dose of Paxlovid. I only had four and half days of Paxlovid. It was horrible, I had this taste that was the most disgusting ever. I feel better now. I do feel lethargic and with Brain fog as of today.
Some lesions on trunk, groin area, buttocks. Mom thought insect bites. Severe itching.
Pt said she had bruising at site of injection. The bruise spread down her arm to elbow. She said she's had the high dose last year but did not have the same reaction. The pt reported this today on 10/30/12.
screamed-high pitched started 4hrs p/shots-cried all noc sl leg swelling
Around midnight, Friday 30 April 2021, woke to severe, crushing left-side chest pain, dizziness, shortness of breath, and nausea. Took 324mg aspirin after about 30 minutes, pain subsided an hour later. Pain returned the following morning, requiring a second dose of aspirin and again, a third dose of aspirin in the evening. Left with severe fatigue, disorientation the following week and mild recurring chest pain. Did not call doctor. Did not go to hospital.
have had "moving pains" throughout my body starting 4 days after the first dose and continuing until now (approx. 6 weeks past my first dose and almost 3 weeks past my second dose.); They have literally traveled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines; They have literally traveled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines; They have literally traveled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines; They have literally traveled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines; I've also had swelling and inflammation in my pointer finger; I've noticed the swelling is worse at the same time the pains are moving around my body; I've also had swelling and inflammation in my pointer finger; This is a spontaneous report from a contactable consumer (patient himself). A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration in left arm on 18Apr2021 at 17:00 as dose 1, single (at the age of 39-years-old) for COVID-19 immunization. The patient did not receive any other vaccine in four weeks and other medications in two weeks of vaccination. The patient's known allergies were none. The patient medical history was not reported. There were no concomitant medications. The patient experienced that he had moving pains throughout his body starting 4 days after the first dose and continued until now (approx. 6 weeks past his first dose and almost 3 weeks past his second dose), they have literally travelled all along my right ribs, my sides, my back, my kidneys, my stomach and my intestines, he also had swelling and inflammation in his pointer finger and he had noticed the swelling was worse at the same time the pains were moving around my body on an unspecified date. It was reported that the moving pains literally move all across his body over the course of a few days. Leaving one area of his body and then manifesting somewhere else. He had never experienced anything like that before and it was so strange. The only thing he could attribute it to that is different was obtaining that vaccine. They were not debilitating pains nor did they impede his activity in anyway, but were definitely present and they were travelling throughout his body. It was reported that he was assuming it was a form of inflammation brought on by the vaccine. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; 6 June evening had arm pain which radiate across muscles in upper back/shoulders; This is a spontaneous report from a consumer (patient's mother). A 14-year-old female (not pregnant) patient received the second dose of BNT162B2 via an unspecified rout of administration on the left arm on 05Jun2021 at 09:00 (Lot number: ew0178) at 14-year-old as single dose for COVID-19 immunization. Medical history was none. Prior to the COVID vaccine, the patient didn't received any other vaccines within 4 weeks. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Known allergies was none. Concomitant medication included ascorbic acid (VIT C), ibuprofen and cetirizine hydrochloride (ZYRTEC ALLERGY) within 2 weeks of vaccination.The patient previously took the first dose of BNT162B2 via an unspecified route of administration on the left arm on 13May2021 (Lot number: ew0169) at 14-year-old as single dose for COVID-19 immunization. On 06Jun2021 at 17:00, the patient experienced arm pain which radiate across muscles in upper back/shoulders. The reporter was aware the evening of 06Jun2021 and reported 07Jun2021 morning. The patient received ibuprofen as treatment. The outcome of events were recovering.  No follow-up attempts are possible; no further information is expected.
Client received vaccination at approximately 11:55 am.  Client was escorted to observation area at 11:57 am.  She sat down and began reviewing V-Safe material. At 12:01 pm she asked "Am I supposed to be feeling lightheaded?"  Observer assisted client to lying on the floor position and elevated her legs.  Observer radioed for assistance.    12:03 pm B/P 146/98, pulse 66; color good. Client talking coherently;  12:05 pm Pulse Oximeter 97%, pulse 77;  color good, apple juice offered.  12:10 pm B/P  122/80; Pulse 81; 12:15 pm B/P 122/66, pulse 84, oximeter 97%; Assisted client to sitting position ;  12:27 pm Client assisted to standing position.  Stated she is feeling fine.  B/P 124/66 pulse 78, oximeter 97% 12:30 pm Client escorted to first floor and she left the facility.