chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme muscular pain at injection site with inability to lift left arm or move it. No localized edema or erythema. No subcutaneous fluid collection or abscess formation.  No constitutional symptoms.
On the 8th and 9th day after vaccinations, high fevers ranging 102-103 degrees. Same exact symptoms as fraternal twin brother-2 weeks apart.
Patient was ordered Bivalent 5-11 and received Bivalent 12  and up.
distal bicep/forearm pain I have had the same pain in my arm for the past 6 months  Starting physical therapy
Severe continuing diarrhea. Nausea, body aches, fatigue, loss of appetite, bad taste in mouth, ceaseation of urine
Fatigue, muscle soreness, fever 103-started Malarone and Vivotif day prior-fevers for 20 days accompanied by rash, joint aches, still occassional fevers.
Flu shot. Guillian Barre Syndrome, onset diagnosis 11/22/2001. Now in hospital on treatment. Per 1 year follow up: It is unknown if pt has recovered. Last seen 01/08/2002. Residual symptoms presented at 01/08/2002. Hyporeflexia and mild distal sensation.  Follow up 12/13/2001: Phone # of comany who gave on original report."
Vaccine administered 3:30 pm, 11:30-12 mn began to have seizure, lasting 2-3 min. Afebrile in ER. No treatment, labs, ct head normal.
Shortly p/inject, arm felt hot & hurt, tingly from head to toe; felt faint, nauseous, incontinent-voided; fell out of chair onto face-light abrasions; pt taken to ER by ambulance, refused x-ray or rx MD released;
Excruciating stomach pain/Horrific pain; Excruciating stomach pain/Horrific pain; She can barely speak; Crying; This is a spontaneous report from a contactable consumer. A 19-year-old female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. Stated that, the reporter called about 19-year-old daughter and stated that, she's there with the reporter in the bedroom. The reporter's daughter was the one who got the shot (Unspecified Vaccine). Stated that, the reporter's daughter had her second Pfizer shot yesterday afternoon on an unspecified date and she was in excruciating stomach pain. Stated that, the reporter don't even know what to say about that, it's just, she was right there, the reporter mean she can barely speak, she's crying, she was in horrific pain. Stated that, the reporter don't know what to do with her. The reporter means that, she's an adult she turned to get her shot to get back on college campus and the reporter was not sure how to handle this. Stated that, the reporter mean need to take her to the emergency room, what did the reporter did. The reporter was informed about the role of Pfizer Drug Safety and was also informed about Pfizer Medical Information and offered the number. Stated that, the reporter don't know because the reporter have half an hour probably, the reporter mean to take her to emergency room, so the reporter mean will write it down. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Got the flu shot around noon on saturday.  woke up the next morning on sunday and was itching a little bit in different places but only looked like bug bites.  Later that day on sunday started to really itch and started spreading.  Monday continued to itch and spread more
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown demographics. No current condition was reported. No historical medication was reported. On an unknown date unspecified number of patients were vaccinated with improperly stored PEDVAXHIB (dose strength and route was unknown). No adverse effects were reported. No concomitant medication was reported. The outcome of improperly stored PEDVAXHIB administered to unspecified number of patients was unknown. No PQC was involved. This is one of the several reports related via same reporter. Additional information has been requested.
Mother reported child developed red, raised area on distal aspect of Left upper arm 2 days after receiving vaccines.  This nurse saw client 3 days after receiving vaccines, and site is approx 4 inches x 4 inches round, indurated, red. Redness is not at the site of any vaccine administration site. I is just below Left deltoid area.
got a third dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (got a third dose) 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.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (got a third dose). At the time of the report, EXTRA DOSE ADMINISTERED (got a third dose) outcome was unknown.            No concomitant medications were reported. Treatment medications were not provided by reporter.
The patient received 0.5ml for 3rd doses instead of .025ml  Patient had headache,  nausea, fatigue for two days.    Patient is  complaining of ongoing sinus issues and or possible allergies for the past 10 weeks and fatigue.
Shingles lesions on her face; blister/ lesions are red and have a blister in the middle.; gland on the right side of her neck that is sore; Hurts  to swallow; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had a history of Shingles and she had it several times).   On 22nd May 2020, the patient received the 1st dose of Shingrix (intramuscular). In May 2020, less than a week after receiving Shingrix, the patient experienced lymph node pain and swallowing painful. On 23rd May 2020, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles, blister, lymph node pain and swallowing painful were recovering/resolving.   It was unknown if the reporter considered the shingles, blister, lymph node pain and swallowing painful to be related to Shingrix.  Additional details were reported as follows: The patient stated that on the following day of vaccination with shingrix, she developed Shingles lesions on her face. She told that the lesions were red and had a blister in the middle. Less than a week after receiving shingrix vaccine, she also had a gland on the right side of her neck that was sore and it hurts when she swallows. The reporter did not have lot information. The reporter consented to follow up.
she doesn't want to live/she was feeling suicidal last night; depressed; continuously crying; no appetite; she feels like she doesn't want to live, it feels like her head is going to fall of; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 immunization. The patient was suffering, she was experiencing depression, she was continuously crying, she has no appetite. She was just very depressed and cannot stop crying. She just wanted to know of these were normal side effects. She has only been a caregiver to her husband before because he had Alzheimer's. She feels like she doesn't want to live, it feels like her head was going to fall off. It takes a strong person to feel like how she was feeling, she asked herself why should she be feeling this way. She was formally asked, that she mentioned she feels like she doesn't want to live, does she feel suicidal at the moment. She stated that she was feeling suicidal last night, it went through her mind when she couldn't sleep but she was not suicidal right now at this moment. It was just a depressed feeling of crying, all the bad stuff that ever happened comes up in the mind. The outcome was not recovered for the event crying; and unknown for the rest of the events.   Information on lot/batch has been requested.
Dental pain on and off; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Dental pain on and off) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain (Dental Pain on and off for months).    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (Dental pain on and off). The patient was treated with IBUPROFEN for Toothache, at a dose of ibuprofen 200mg 4 times daily for dental pain. At the time of the report, TOOTHACHE (Dental pain on and off) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Case completed primary Covid vaccine series in March 20212, then was hospitalized for and died of Covid in September 2021.   Case was admitted to hospital with severe respiratory conditions, in the presence of recently deteriorating health and advanced dementia. Comfort care was provided, and patient died soon after admit.
The lot number for the first dose of vaccine taken on 06/17/2021 is: EW0177. And the lot number for the second dose of vaccine taken on 07/15/2021 is: EW0178.  Within 24 hrs of the first shoe i had a sharp pain underneath rip cage under breast and after second shot after just a couple of days  on the same spot there is a like a bump or inflamed area that is very large and is is lightly painful and very uncomfortable when sleeping or exercising and any pressure touches the inflamed bump area.
Patient came in to get PFIZER's COVID-19 shot and received Tdap shot.
Patient stated had pacemaker placed on February 21, 2020; flu-like symptoms; feeling achy; tiredness; This case was reported by a consumer via call center representative and described the occurrence of arrhythmia in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included artificial cardiac pacemaker user.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced arrhythmia (serious criteria GSK medically significant), influenza-like symptoms, pain and tiredness. On an unknown date, the outcome of the arrhythmia was unknown and the outcome of the influenza-like symptoms, pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the arrhythmia, influenza-like symptoms, pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of Shingrix in late January or early February 2020 in left arm. The patient reported tiredness, feeling achy, and flu-like symptoms occurred the day after receiving the first dose of Shingrix and these resolved after one day.  The patient stated had pacemaker placed on 21st February 2020. The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2020164413.; Sender's Comments:  US-GSKCCFUS-Case-00787580_AE-45991: US-GLAXOSMITHKLINE-US2020164413:same reporter
asymptomatic found pt blue & cold in bed in early AM day following immun; called 911; pt apparently had been dead for several hrs;
Rash that was red, flat, blanching, itchy, covered about half my body.  I took Zyrtec and the intensity of rash/itchiness seemed to decrease.  The rash/itchiness migrated over several days, some days on legs, some days on trunk, less on arms.  It resolved after 3-4 days.
about 10 mins p/vax had profuse diaphoresis & felt like was going to faint;
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, dose#, lot# and route unknown). On an unspecified time after receiving ZOSTAVAX, the patient became nauseous and developed a "mosquito-like bite" and redness at the injection site. The outcome of the events was unknown. Additional information has been requested.
Fever, Rash & Diarrhea Narrative:  low grade fever, diarrhea, muscle weakness, nodule and rash at the injection site. States does not have any grip in right hand but states feels like it' s trying to come back
1/10: Began to experience chest pain w/ exertion (running on treadmill). Chest pain would stop w/o exertion. Intermittent chest pain over the next course of 2 weeks. 1/26: Left sided chest pain, constant, radiating to L shoulder blade and down arm.
Within 24 hours: papular rash at injection sites and hives over whole body. Within 48 hours: papular rash extending about 10cm from each injection site. Hives resolved with Benadryl.
Client had a breakthrough infection.  He was vaccinated on 4/1/21. Health Department case management team unfortunately we have not been able to connect with the client regarding his symptoms.
Product Complaint; when the plunger slipped out of the pre-filled syringe and the vaccine spilled out on both of her palms; vaccine spilled out on both of her palms; the plunger slipped out; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 25-year-old female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis. This case was associated with a product complaint.   On 15-AUG-2023, the patient received Bexsero. On 15-AUG-2023, an unknown time after receiving Bexsero, the patient experienced occupational exposure while preparing product for administration (Verbatim: when the plunger slipped out of the pre-filled syringe and the vaccine spilled out on both of her palms), exposure via skin contact (Verbatim: vaccine spilled out on both of her palms) and syringe issue (Verbatim: the plunger slipped out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint).     The outcome of the occupational exposure while preparing product for administration, exposure via skin contact, syringe issue and pharmaceutical product complaint 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: GSK Receipt Date: 16-AUG-2023 The reporter reported that when one of the nurses in her facility was preparing a Bexsero vaccine yesterday (day before reporting), the nurse was about to prime the pre-filled syringe, and the plunger slipped out on both of her palms, which led to  The reporter stated that the nurse did immediately wash her hands and had not noticed any reaction and had no complaints today. The reporter stated the plunger stopper was loose.  The reporter did review the product information for use step by step. The reporter stated that the defect was discovered during preparation. Unknown where in the multi pack the syringe was located. They roll the syringe between their fingers until it reconstitutes. The syringe was not used for administration. The healthcare professional was new user. The syringe plunger was the component impacted. The defect was related to the plunger stopper. The plunger fell out completely during preparation. The detachment happened during use. The HCP did have the suspect syringe and would return it to GSK. Consent to follow up with healthcare professional was not asked.
HAS PETECHIAE IN RIGHT RIB ARE AND BREAST AREA VERY PAINFUL
adverse reaction; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient received one dose of Shingrix and had adverse reactions, and she was inquiring about the efficacy of just one dose of Shingrix. The pharmacist stated that the patient called previously and reported the adverse reaction information and provided case number. Upon research, the case was not found. Follow up email would be sent. No additional information regarding specific adverse reactions was available as call was completed before filing report.
ONSET OF SX 12/28/21, REFUSED MAB THEN.  WORSENING.  RECEIVED REGEN ON 1/6/21.  WORSENED REQUIRING INTUBATION ON 1/16/22.  SUFFERED AKI.  DIED 1/19/22
Swollen/enlarged breasts. Sore/tender nipples x approximately 2 weeks.
Pain in left arm; Generalized pain that she experienced most when lifting her arm; Feels like muscle pain; This spontaneous case was received on 31-Aug-2020 from Agency (reference number: SEQW20-01066), reported by pharmacist and concerned a 72-year-old, female patient.  The patient's concurrent condition included hypertension.  The patient's concomitant medications were not reported.  On 21-Aug-2020, the patient was vaccinated with Fluad Quadrivalent [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, anatomical location: left deltoid, route of administration and indication: not reported].   The batch number reported was 279791, expiration date reported was 28-May-2021.  On 22-Aug-2020, one day after receiving Fluad Quadrivalent, the patient experienced pain in left arm. The patient stated that the pain was not just limited at the injection site, but generalised pain most experienced when lifting her arm, and that felt like a muscle pain. The patient was advised to visit doctor.   At the time of initial reporting on 31-Aug-2020, the patient had not recovered from the events.  The reporter assessed the case as non-serious.  The reporter did not provide a causality assessment.  Company comment: A 72-year-old, female patient was administered Fluad Quadrivalent vaccine. On 22-Aug-2020, one day after receiving Fluad Quadrivalent, the patient reported pain in extremity, pain upon movement and myalgia. Causality is assessed as possibly related for all events, due to plausible chronology.; Sender's Comments: A 72-year-old, female patient was administered Fluad Quadrivalent vaccine. On 22-Aug-2020, one day after receiving Fluad Quadrivalent, the patient reported pain in extremity, pain upon movement and myalgia. Causality is assessed as possibly related for all events, due to plausible chronology.
This spontaneous report was received from the Vaccine Coordinator referring to a 26 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 21-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
pt recv vax & 1hr post vax pt exp n/v, vertigo & tingling in legs & face;pt was observed in the office;these sx resolved w/o tx in 2hr;
I?m due 03/12, and so far I have had a normal pregnancy. I got both rounds of my Moderna before I was pregnant (with little/no symptoms)  and just got my booster on Tuesday. (12/21) all was fine for a while but by that evening my arm had swollen up to the size of a baseball and was as hard as a rock. It was red, and hot to the touch. I had a raging fever and felt someone hit me with a truck. I became extremely nauseous and couldn?t keep anything down and had a series of Braxton hick contractions. More than normal. It?s been 48 hours since my shot, and my symptoms have remained the same and the swelling/pain in my arm is unchanged.
Large red, warm, swollen area on right thigh within 24 hours of DTaP injection.
8-31-09 mother phoned, client ok evening of 8/27, woke up 8/28 feeling "poorly", high fever. Friday evening with quarter size round  reddened areas location of VZV @ L. LTR (left tricep) -"very ill" until 8-30-09 AM. No thermometer available, MOTRIN given, client's pediatrician referred back to us.
18NOV98 pt woke w/stiffness in lt arm husband stated that 4AM pt could not raise arm past shoulder level, but w/extended use, it loosened up but could not raise elbow from relaxed state to raise to 90 degree;exp numbness;inc pain w/mobility
Patient received his 3rd Moderna COVID booster shot on Monday 12/20/21 and began to have fever, chills, fatigue and bodyaches that evening and the next day. Those symptoms resolved by Wednesday but Thursday morning 12/23/21 he began to have some intermittent chest pain. His chest pain worsened and persisted on 12/24/21 and he was subsequently seen in the ER where he was diagnosed with myocarditis with an elevated troponin up to 3.8 but with no EKG changes or abnormalities on left heart catheterization. He was discharged home with instructions to take it easy and use ibuprofen as needed. He took ibuprofen a couple of times for a couple of days and has not needed it since. He feels back to his normal self at this time (1/6/21) and he has no further symptoms. He has been cleared to return to activity as tolerated.
Injection site is red, swollen and warm.  Advised cool compresses and Benadryl.