chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 60 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 05-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot number and dose were not reported), subcutaneous into the outer aspect of the elbow. Concomitant medications were not reported. Registered nurse reported that on 05-SEP-2013, the site of administration was red and swollen and had been treating it with ice. The outcome of site of administration was red and swollen was reported as not recovered/not resolved. No lab diagnostic studies were performed. Patient visited the physician. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Employee stated that two hours after receiving vaccine she felt tightness in her chest and felt that her throat was constricting. Employee stated that this feeling never subsided until she fell asleep that night, approximately 12 hours after receiving vaccine. No treatment was given. Employee did state she is very sensitive to any medication.
1. muscle cramps/spasms in legs and feet. Do not remember exact timing. Usually at night. In the past, prior to my Covid vaccine I've had this however it was linked to a medication (Metformin) which I had stopped taking several weeks prior to the vaccine and have not restarted.  2. unexplained bruise - I didn't pay attention to this at first however it continued after my 2nd vaccine (will report again)
This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (felt arm was a little sore in the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011ZLOA and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Atrium fibrilation (Atrium fibrilation) and Cholesterol. Concomitant products included METOPROLOL and APIXABAN (ELIQUIS) for Atrial fibrillation, SIMVASTATIN for Cholesterol, MINERALS NOS, VITAMINS NOS (ICAPS [MINERALS NOS;VITAMINS NOS]) for Eye disorder NOS, LUBIPROSTONE (AMITIZA), VITAMIN D [VITAMIN D NOS] and CALCIUM for an unknown indication. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (felt arm was a little sore in the injection site). On 11-Jan-2021, VACCINATION SITE PAIN (felt arm was a little sore in the injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not reported. This case was linked to MOD-2021-015964. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Followup received on 26-Apr-2021 content no new information
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   Treatment information was not provided.    This case was linked to MOD-2021-046539 (E2B Linked Report).; Sender's Comments:  MOD-2021-046539:second dose case
Started with stomach upset, headache and now have weakness, body aches, over all heaviness.   No treatment at this time other than rest and fluids.
Received shots 8-16-10. On 8-17-10 began with sore throat, hoarse voice, pale, weakness. Mother took to ER. 8-17-10 in pm.
pt recv vax 21OCT97 & 22OCT97 pt exp progressive arm soreness from the inj site in deltoid area of rt arm to the rt axilla;pt could not sleep on that side;23OCT97 pt exp tenderness @ the inj site;lymph nodes under arm became red & swollen;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 06Apr2021 as dose 2, single (Lot number: EW0150), in right arm, on 20Oct2021 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: No other medication was received in 2 weeks. The patient had an antiviral Paxlovid treatment for COVID 19 from 12Jul2022 to 17Jul2022. The patient had Runny nose, cough, chest congestion, and fever on 22Jul2022 from Paxlovid treatment.  No follow-up attempts are possible. No further information is expected.
I received the Hep A shot, flu shot and covid booster on 10/9/21 around 0900. I worked 12 hours with a headache/lightheadedness/chills, took tylenol as needed and finished work around 1930 when I started developing worsening symptoms. While driving home, I developed shakiness, numbness and tingling that started from my midsection and outwards my extremities including my head, face, neck, mouth, tongue and throat. I then became aware that either my blood glucose is low (did not have lunch that day) or I was having an immune reaction to the vaccines. I came home and tried to eat crackers but was unable to swallow because of the numbness. At this time, I was afraid my airway is being compromised and my wife called emergency services. I was feeling a great sense of impending doom and was convinced I was going to die. EMS arrived and I was unable to stand on my own due to extreme weakness. In the ER. I was given IV plasmalyte, IV zofran, PO ativan and PO potassium. 6 hours later, I was discharged with a diagnosis of "panic attacks, near syncope and nausea without vomiting."
First sign - tingling in upper lip, similar to that of the beginning of a cold sore After 1 hour - lip begins to swell Went to Express Care clinic 6:30pm, nearly 8 hours after shot. Prescribed prednisone to reduce swelling. 7pm - took first dose of prednisone. Lip continued to swell Upper lip continues to swell to a severe level throughout evening and night Overnight, swelling expanded to cheeks . Cheek swelling moderate, lip swelling still severe 7am - took half of 2nd dose of prednisone and applied cool compact Throughout 3/4/2021, lip swelling reducing, cheeks still swollen similar to mumps
Urticaria several hours after receiving Td, MMR, and Hepatitis vaccines. Itchiness in mid upper back, urticaria on left shoulder. Present when seen about 20 hours later. No other symptoms. No local reactions. Rx: Benadryl 50mg PO every 6 hours for itch.
Milk products now taste different. Almost like extra salt and spice (cinnamon?) just weird.  Sour cream, ice cream, coffee creamer, cottage cheese, milk. It is Sunday and I had the shot on Tuesday. It is getting better, I think. It was suggested I get a Covid test, but the urgent care that gave me the shot told me to report this and wait and see if y?all recommended that I get a Covid test.
The day following the second dose, I had strong heart palpitations and heart muscle pain, it subsided within a few hours but periodically reappears. Now I am feeling restless and having difficulty sleeping, heart pain reocurring.
This spontaneous case report was received from nurse (PVX2017-3193) on 13-Oct-2017. The report describes a 54-year-old male consumer who "ate chips 30 minutes after taking VAXCHORA". The consumer was receiving oral VAXCHORA for an unknown indication. It was reported that the consumer ate chips 30 minutes after taking VAXCHORA. The action taken with VAXCHORA with respect to the event "ate chips 30 minutes after taking VAXCHORA" was not applicable. The clinical outcome of the event "ate chips 30 minutes after taking VAXCHORA" was unknown. Sender's Comments: Company's comment: The causality of the event "ate chips 30 minutes after taking VAXCHORA" was considered as not applicable.
Received COVID 19 Treatment; Received COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 3 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Received COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had a rash, soreness, warmth, and swelling on her arm which she received the flu shot
R shoulder & neck pain started in early morning about 12 hours after vaccination with nausea & vomiting (3 times to date). Denies any fever, chills, SOB, CP, other body aches, headache, rash or diarrhea. She did eat some left-over food last night. She did not take anything except fluids for therapy. After she called to report AE this morning she was asked to go to an ED or urgent care for evaluation.
Arrhythmia lasting about 5 - 7 minutes. Unpleasant and got light-headed. Resolved itself instantaneously.
after administering both shots, the patient started complaining of dizziness. A few seconds after she seized for  less then 10  seconds and then passed out for about 10 seconds.  When she came through, she began to complain of her inability to feel her hands and legs. I noticed that her fingers became a little stiff. She was also hyperventilating all through the process.  Her vitals remained steady through the whole ordeal.  She began to feel a little better when the EMTs came in.  She was fully aware and able to communicate her feelings after the seizure and fainting and seemed to be recovering
Information has been received from a physician concerning an adult male who on approximately 08-JAN-2007 was vaccinated SC with a 0.5 ml dose of Zostavax. There was no concomitant medication. Three days after his vaccination, on approximately 11-JAN-2007, the patient was swimming in an area with jellyfish and developed a red rash on both legs shortly after leaving the water. Unspecified medical attention was sought and the patient was treated with Zyrtec for itching. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/13/2007. Additional information has been received from the physician who reported that on 14-Jan-2007, the patient noticed the onset of hives on the lower extremities in an area below his shorts after canoeing in brackish water containing a lot of dead jellyfish. It was unknwon if the patient recovered but he did self-refer to dermatology. No further information is epected.
Patient received vaccination and sat down. then got up again to get a drink and fainted at the register. was completely fine afterward. and mentioned that he had worked all day and hadn't eaten all day
I'm pregnant, due in the middle of November. I got my second covid19 vaccine and about 9 hours later I started having symptoms. I had a sore arm right away but over night I had headaches, body aches, chills, slight fever, and vomiting. I couldn't stop shaking and I couldn't keep anything down. I am a little over 24 hours out from the shot and still have the symptoms, except vomiting has decrease and might have stopped.
Expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA581A, expiry date 31st August 2022) for prophylaxis.   On 14th September 2022, the patient received Menveo. On 14th September 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's comment: The vaccine coordinator reported that a patient received an expired dose of Menveo. The vaccine was expired on 31st August 2022. The reporter consented to follow-up via email. Additional Supportive Information: The patient received a dose of Menveo which was already expired, which led to expired vaccine used.
This is a case is a part of 2 cluster cases and is linked to case 2013-07001 (reported by same reporter, events after ADACEL batch number- C4344AB). Initial report received from a healthcare professional on 18 June 2013. This case is invalid as individual patient identifiers were missing. A cluster of three patients of unspecified demographics had received an intramuscular dose of ADACEL (batch number- C4344AB, expiry date-06/04/2015, anatomical site of vaccination was not reported) on an unspecified date. Patients had no illness at the time of vaccination. Medical history and concomitant medications were not reported. On unspecified date after vaccination, 3 patients presented redness, warm to touch and lump at the vaccination site. No laboratory investigations were done. As corrective treatment, the patients received BENADRYL, TYLENOL and Ice packs on unspecified dates. On unspecified date, the patients had recovered from events. Documents held by sender: none.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In November 2015 (during the time frame of 05-NOV-2015 through 15-NOV-2015), the patient were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # J006681, expiry date 05-DEC-2015; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 12FEB97 & 23FEB97 pt devel erythematous, flat, non-pruritic rash on face, ears, & chest;
sore arm chills, headache, body aches Narrative:  Other Relevant History:
Returned day after vaccine given with swelling and tender in left upper arm. 3 x 4cm area of swelling.
painful at site of injection, arm stiff, muscle pain, headache, fatigue, stomach pain, nausea, cold/shivering, dizziness, increased asthma symptoms, beginning 30 minutes after the shot. Effects lasted three days.
On 7/25 pt had an episode of loss of conciousness, reported seizure activity (by 8 yo witness). Pt did have a very prolonged recovery phase- consistent with a post ictal period. Pt evaluated in the ER 7/25, admitted to the hospital for observation.  10/18/2007 MR received for DOS 7/25-26/2007 for D/C DX of Confusion.  Hx L frontal lobe spontaneous intracerebral hemorrhage 6/2005.  Hx HTN.  Hx hyperlipidemia.  Hx of tobacco abuse. Pt was found by husband lying on the floor.  Eyes were open however pt was not responding in verbally meaningful way. Pt was confused but was reovering upon arrival to ER. Pt has no recollection of event. Admitted for eval of mental status change.
Pain in her back along her rib cage. It started to move to the front.  Dizziness. She started having the burning and she went to her dr and was having all the symptoms of Shingles except the rash. She was prescribed Valtrex.
3ays after shot massive depressive episode, suicidal.  4 days after, exhaustion, muscle weakness (I normally walk 2 - 4 miles daily)- this continued for almost two weeks.  Along with weakness, extraordinary "brain fog", vertigo, loud tinnitus (buzzing). 2 1/2 weeks in I found an elliptical itching rash at the vaccine site.   almost a month later I'm still suffering from dizziness, brain fog, and exhaustion.  2nd dose due 26th March and I'm scared to proceed.
Idiopathic Transverse Myelitis. Also received the influenza vaccine from unknown formulation around October 28, 2022
This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 79-year-old male patient who received Herpes zoster (shingrix) for prophylaxis. Concurrent medical conditions included chronic fatigue syndrome. On 1st January 2022, the patient received the 1st dose of shingrix. In January 2022, less than a week after receiving shingrix, the patient experienced unexpected therapeutic effect and pain in arm. On an unknown date, the outcome of the unexpected therapeutic effect was unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the unexpected therapeutic effect and pain in arm to be related to shingrix. Additional details were provided as follows: The case was reported by the patient. The reporter stated that he had chronic fatigue syndrome. The reporter stated that he was feeling much better than normal and this was the best he felt in a long time after taking the first dose.  The reporter also experienced a sore arm for a day which had since resolved. The reporter did not consent to follow-up. The case has been linked to US2022001254,US2022AMR001808,US2022001255, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022001254:Same reporter; US-GLAXOSMITHKLINE-US2022AMR001808:Same reporter; US-GLAXOSMITHKLINE-US2022001255:Same reporter.
PT PRESENTED TO PHARMACY FOR 2ND DOSE AT 2 WEEKS INSTEAD OF THE RECOMMENDED 4 TO 6 WEEKS. FIRST DOSE GIVEN 6/19/2021. SECOND 7/3/21. PT EXPERIENCED MILD SYMPTOMS AFTER SECOND DOSE (LOW GRADE TEMP, FATIGUE FOR APPROXIMATELY 24 HOURS). NO FOLLOW-UP CARE NECESSARY.
Spot swelling, redness on same arm but opposite to site of injection. No temp. By Sun. signs of sx had disappeared.
Had a injection to prevent Shingles. Three days later developed a rash on my back which later spread to my stomach. Returned to my MD 8 days after receiving the injection for diagnosis. Diagnosis was Shingles. Prescribed Valacyclovir, 1GM 2 x daily for 7 days. No sign of Shingles prior to getting vaccinated.
Wart starting to come back around August or September, but then started to dissipate again 2 weeks ago after receiving the booster dose of the vaccine. Currently the wart is a 1.5 out of 10 and is pretty close to gone after receiving that booster; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Wart starting to come back around August or September, but then started to dissipate again 2 weeks ago after receiving the booster dose of the vaccine. Currently the wart is a 1.5 out of 10 and is pretty close to gone after receiving that booster) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 012M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (surgery to address the wart). Concurrent medical conditions included Wart (on her nose for 10 years).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Wart starting to come back around August or September, but then started to dissipate again 2 weeks ago after receiving the booster dose of the vaccine. Currently the wart is a 1.5 out of 10 and is pretty close to gone after receiving that booster). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Wart starting to come back around August or September, but then started to dissipate again 2 weeks ago after receiving the booster dose of the vaccine. Currently the wart is a 1.5 out of 10 and is pretty close to gone after receiving that booster) was resolving.            Patient took anti wart medication.  Treatment information was not provided.   This case was linked to MOD-2021-379605 (Patient Link).
PT IS NOT FEELING WELL AND HAD 1' BIG ROUND RED SPOT ON LEFT ARM.
While sitting in observation patient became dizzy, felt nauseated and became pale.  EMS was called to her side. Her BP was elevated and she remained pale & dizzy.  She was taken to ED. No medications were administered.
At 3 am, felt very nauseous (threw. up), extreme chills, extreme body aches.  Feels like my back is broken.  Still feeling very tired and unwell.
BODY ACHES; FELT BLAH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and felt blah. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and felt blah. This report was non-serious. This case, from the same reporter is linked to 20210740692.
9:40am injection. 10:30am migraine started. 10:40am strong ringing in my left ear, and feel dizzy. 11am spine, back, and joints hurt. Ringing in both ears, but I have lost partial hearing in my left ear. 10:22pm, still ringing in left ear, partial hearing, small headache, deep aches.
Headaches, body aches, and chills through out the day starting at around 0930 and last through bed that evening. Fever began around 0930 and ranged from 99.9 to 103.1 and was treated with tylenol with minimal results. Finally, systolic Blood pressure was elevated well above normal starting morning after (saturday) dose was given and continuing. Verified with BP cuff on sunday after dose was given. Systolic measured at 151 and 159 at around 815 in the evening with no heavy work or actions throughout the day. Normal Systolic is controlled at 130-135. Dyastolic maintained normal at 85 or so on average.
10 minutes after receiving 2nd dose patient complained of being dizzy. Onsite EMS was called vitals BP 108/64 HR 65 100% O2.  He was given Graham Crackers. Monitored for 30 additional minutes. He hadn't eaten since 10 pm last night. He was encouraged to get some food before he gets home. Released to go home.
SWELLING, REDNESS, AND TENDERNESS AT INJECTION SITE DAYS 1-4 AFTER INJECTION  Narrative: