chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Horrible hives again/hives on his legs and side/ribcage, on his back and the tops of thighs/the hives have been constant but are worse at night when he was not as distracted; Up all night; This spontaneous case was received on 05-Oct-2022 from other non-healthcare professional (consumer) via Novartis (reference number: NUS2022US152520_NC) and concerned a 65-year-old, male patient.  The patient's past medical history included hives. The patient's concomitant medications were not reported.  On 23-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On 26-Sep-2022, three days after receiving Fluad Quadrivalent, the patient experienced horrible hives again. The patient was up all night with hives on his legs and side, ribcage area. The hives had been constant but worse at night when the patient was not as distracted. Later, the patient experienced hives on his back and the tops of his thighs.  The outcome of both events was not reported.  The reporter assessed the events of 'hives' and 'sleep disturbed' as related to Fluad Quadrivalent. As reported, the patient was fairly sure that the Fluad thing did something to kick up his immune system.  Company comment: A 65-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. Three days after vaccination the patient developed hives. As reported patients could not sleep all night due to the event. Based on plausible time relationship, causality for the event urticaria is assessed as possibly related. Based on provided information causality for the event sleep disorder is assessed as not related to suspect product.; Reporter's Comments: As reported, the patient was fairly sure that the Fluad thing did something to kick up his immune system.; Sender's Comments: A 65-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. Three days after vaccination the patient developed hives. As reported patients could not sleep all night due to the event. Based on plausible time relationship, causality for the event urticaria is assessed as possibly related. Based on provided information causality for the event sleep disorder is assessed as not related to suspect product.
Approx a month after receiving the vaccine, I developed shingles on my left side. Could be be coincidental, but wanted to report. Received an antiviral from a clinic and was treated in time before shingles got worse.
Fever 100-104.8 started evening 4/23/03. At 4:20 temp 103 degrees. 04/25 no fever after evening yesterday 4/24.
Signed        Hide copied text  Hover for details 1327 pt began to c/o tingling in her lips, c/o sob, no vomiting, no rash noted, Davinia Yarde, NP at chair side to evaluated. Medical first respose called as pt did not answer questions, remained alert and oriented. pt remained alert and oriented during transport
After 1 hour of recieving H1N1 vaccine member developed pruritic raised erythematous rash on chest, back, neck, and face, legs bilat. No local reaction to site of injection. No swelling of throat, no breathing problems, no cramps. Rash peaked approx 12-18 hours after injection and since then has subsided and 48 hours has slt residual.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a doses of MMR II injection (strength, dose, route of administration, indication, lot# and expiry date unspecified), that were improperly stored on unknown dates. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
The first shot on March 6, 2021, I  only felt muscle pain in my left arm unable to move it on the next day due to the injection. Nothing else.  The second shot  on March 27, 2021 I started with fever, chills, night sweats, stomach cramps, headache, sore throat, nausea, tiredness, shortness of breath, muscle pain, weakness, unable to concentrate or do my job.
Day1 (9/3/2021)within a few hours major malaise, muscle pain, body ache, arm red and swollen began.  Couldn?t sleep all night due to pain.  I was unable to get out of bed for Tylenol. Day2-same as day 1. After 24 hours I treated myself with ibuprofen. Day3- Woke up to racing heart.  Later in the day I went up the stairs and got short of breath, dizzy and lightheaded, and had severe crushing chest pain. My Apple Watch showed A fib. Twice. However, it looked like more of a junctional rhythm ( dr confirmed this) my pulse was between 70-80 .  The rest of my rhythms showed continual ventricular trigenomy.  I decided to rest.  After about an hour the dizziness,  being lightheaded resolved.  But still was having minor chest pain and shortness of breath.  Day 4-  up not feeling myself, having palpitations, minor chest pain and shortness of breath.  But I was anxious about the day before so I let it go. Day5- same as day 4 Day6- same as day 4.  Decided to make an appointment with my PCP.  After running and. eKG I was constantly in ventricular trigenomy and given my symptoms my Dr sent me to the ER.  After waiting 6 hours to be seen and being told it would be another 8 hours I left the ED. Day7- Woke up feeling the same.  Had important things to take care of spoke to Dr over the phone and they sent me back to the ER to rule out PE.  PE ruled out.  Sent home from ED to follow up with cardiologist. Day8-Got in to see my PCP in am.  Dr reconfirmed constant ventricular trigenomy concerned due to receiving Covid shot prior to symptoms and sent to immediately to a cardiologist within 2 hours.  Echo performed.  Was normal.  Was put on a 5 day heart monitor.  Day8-13 symptoms persisted chest pain, palpitations, shortness of breath. Day 13- Heart monitor returned to cardiologist office Day14- Started to feel better, symptoms subsiding Day15-Still having palpitations. waiting on heart monitor results
Moderna 1/2 dose - is what I received. I had a fever and a lot of achiness and joint pain. That lasted about 24 hours. And then Sunday and Monday, I didn't feel totally back to myself. I hadn't had any exposures to anyone who was sick. On Tuesday, I had swollen glands under my neck (bilateral) and a sore throat. I called the Department of Health COVID-19 medical line. I talked to a nurse, and she said it wasn't as common to have it bilaterally under the neck. Urgent Care - they gave me a Z-pack in case I had a bacterial thing to be on the safe side. I have been taking since Tuesday. I don't typically get swollen glands. My glands are much less swollen now and I still have a little bit of sore throat. (Flu shot - had it early September - maybe 7th of September).
Information has been received from a pharmacist concerning a patient of unknown age and gender. There were no concurrent condition, medical history and concomitant therapy reported. On an unknown date, one dose of improperly stored (Oka-Merck) PROQUAD (lot # L023111, Expiration Date 24-DEC-2016) (strength, dose and route not provided) was administered. The vaccine was exposed to 27 F for 1 hour to 15 F for 1 hours and 35 minutes. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
I have had a fast heartbeat since my first vaccine but I didn't think it was the vaccine until I got the booster and then damaged my heart. I also had COVID between 2-3 dose.
DEVELOPED TRANSIENT EAR/JAW (THROAT?) PAIN APPROX 7 DAYS POST VACCINE.  DEVELOPED  RIGHT SIDE FACIAL WEAKNESS/PARALYSIS ON 1/29/21. SYMPTOMS INCLUDED DIFFICULTY CHEWING FOOD, ASSYMETRIC SMILE (NO MOEVEMENT OF RIGHT SIDE OF MOUTH), SPILLING OF LIQUID FROM RIGHT SIDE OF MOUTH WHEN DRINKING AND ALSO TEARING, WEAKNESSOF RIGHT EYE. SAW MY DOCTOR ON 2/7/21 HIS IMPRESSION WAS OF POSSIBLE BELL'S PALSY (FACIAL PARALYSIS) . STARTED ME ON VALACYCLOVIR  1 GR TID ON 2/8/21 . REFERRED TO NEUROLOGIST WHO I SAW ON 2/9/21 PERFORMED NEURO EXAM AND REFFERED ME FOR MRI OF HEAD TO RULE OUT STROKE, mY SYMPTOMS IMPROVED SOMEWHAT ON 2/10/21 AND CONTINUED TO GET BETTER COMPLETELY BY 2/14/21.  MRI DONE ON 2/12/21 INDICATED NO SIGN OF STROKE.
28nov89 pt vax hepta B. pt ex pain at inject site 28dec89 pt vax 2nd hepta B. pt ex prolonged pain and tenderness at inject site which continued for 2days to 1 week. pt recovered.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2weeks was unknown. The patient received treatment brand=Paxlovid, treatment start date=20Jul2022, treatment stop date=25Jul2022. It's actually a GOOD event. I've had a bump on my tongue that was to be removed in a couple weeks. Within a day of finishing the Paxlovid, the bump is completely gone. It was the size of a skin tag and it's gone. It's possible that it was HPV and that the antiviral cured it. Just thought you should know.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I went to my doctors office yesterday morning and received the Shingrix vaccine.  1st dose.  By evening, my left arm hurt and I had body aches.  I wasn't able to sleep well, as my whole body hurt and my head (my front sinuses) felt like it was under so much pressure.  The next morning, I my arm has a slight red rash and is still very sore.  Also, my body aches are continuing.  I took 2 aspirin, so far.  I'll get through it, but I have flu like symptoms.  I have body aches, red arm at injection site, throbbing headache and lethargic.
Nurse reports an improperly stored PROQUAD that was administered; No other AE reported; This spontaneous report was received from a nurse referring to patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella virus vaccine live (PROQUAD) for prophylaxis (lot # S023651 has been verified to be a valid lot number measles, mumps, rubella and varicella virus vaccine live, expiration date reported and establish as 26-JAN-2021) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were from -14° Celsius (C) to -10°C for 45 minutes, and from -9°C to 8°C for 30 minutes respectively.  A digital data logger was involved but there was no previous temperature excursion.   No adverse effect was reported.
12 hours after vaccine, woke up with severe vomiting, no diarrhea (+) headache, no fever lasted 3 hours.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 19th July 2018, the patient received the 2nd dose of SHINGRIX. On 19th July 2018, not applicable after receiving SHINGRIX and unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the patient experienced chills, headache and pain in arm. On an unknown date, the outcome of the chills and headache were recovered/resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the chills, headache and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination for 1st dose could be 61 or 62 years and for 2nd dose was 62 years. On an unspecified date, months before the administration of 2nd dose, the patient received 1st dose of SHINGRIX in the arm. Less than a day after receiving SHINGRIX, the patient experienced chills and headache later that night. Less than a year after receiving SHINGRIX, the patient experienced, the patient had a sore arm that lasted for about 2 weeks and was resolving. The patient received a second dose of SHINGRIX in the left arm. The pharmacist did not use the liquid suspension to mix with the powder that came with the total dose of SHINGRIX. The pharmacist used an unknown liquid diluent, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered. The patient was instructed after the error was found to return for another dose. This case has been linked with case US2018134658, reported by same reporter.
doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date) outcome was unknown. Not provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 160. No concomitant medications were reported. Total number doses were 27 , vial was initially stored in the refrigerator and thawed same day of administration. Vial  did not undergo any temperature excursions. No treatment medications were reported
pt exp rxn w/DT given on 11MAR93; febrile illness w/documented t102 & brief febrile seizure on 2APR; exam revealed otitis treated w/Amoxicillin;
Reports no allergies and had no symptoms until the day after receiving when the area of right upper arm became red. Day 2 of receiving this vaccine, the area of upper arm was very red and warm to touch; no induration but redness was approx. 65mmx85mm. She reports no fever, pain or itchiness. She reports never having a reaction to vaccine in past.
Information has been received from a pharmacist regarding a 64 year old male patient. Patient's medical history was not provided. There was no drug reactions or allergies. On 26-APR-2013, the patient was vaccinated with 0.5 mL dose of ZOSTAVAX, subcutaneous (Lot number reported as J000427, expiration date 10-APR-2014). On an unknown date, the patient who is a dentist, received a dose of ZOSTAVAX and developed an injection site reaction. The affected area was red and rashy. Treatment was not received for the adverse event. Laboratory test was not performed. The patient sought medical attention, he visited pharmacist on 30-APR-2013. At the time of the report, the patient had not recovered. Additional information is not expected.
This case was reported by a healthcare professional and described the occurrence of injection site hives in a female subject (a nurse) aged between 40 and 49 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 5 October 2010 at 09:00 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 5 October 2010, less than one day after vaccination with FLULAVAL, the subject experienced injection site hives and injection site pruritus. At the time of reporting the events were improved. The healthcare professional considered the events were possibly related to vaccination with FLULAVAL. Follow-up information was received on 18 November 2010 via healthcare professional. The reporting healthcare professional associated the events with concurrent illness of an abscessed tooth which was being treated with antibiotics at the time of the FLULAVAL injection. On 08 October 2010, the injection site hives and pruritus resolved.
Information has been received from a physician via field representative referring to a 26 year old female patient. There was no concurrent condition or medical history reported. In 2014 (two years ago) the patient was vaccinated with second dose of GARDASIL (dosage, strength, lot# and route unknown) by a different doctor. There was no concomitant medication reported. After she got her second dose of GARDASIL, she experienced a dermatological reaction to the vaccination. The patient did fully recover from the event within2 weeks of the patient getting her second GARDASIL shot. The patient also thought that she might have developed pederosis and rosacea. The patient went to see her primary care physician. On 18-APR-2016 (today) the patient was scheduled to get her third dose of GARDASIL. The outcome of pederosis and rosacea was unknown. The reporter considered dermatological reaction to be related to GARDASIL. Additional information has been requested.
67 y.o. male with BOOP s/p BOLT 7/2/12 (CMV D-/R+, EBV D+/R+, toxo positive) who is here with worsening respiratory failure.    PMH: CLAD, OSA on CPAP, obesity    He was diagnosed with COVID on 11/13/21 and received monoclonal antibody on 11/17/21. Since then he continues to have worsening productive cough of green sputum. He could not lay flat or on his side due to cough. Denies sinus pain, rhinorrhea, sore throat. He feels that his cough seems to come from his throat. His breathing is also more labored. He could not keep food down due to N/V and abdominal discomfort. 11/24 he has watery diarrhea. He denies fever, chest pain, or swelling in his legs.    He had received COVID booster.    In ER, he was placed on 3 LPM O2. CXR with multifocal infiltrates. Elevated inflammatory marker.     # Pneumonia with acute hypoxic respiratory failure  - COVID-19 vs secondary bacterial infection: Overall getting better  - Ceftazidime 11/23 - 11/26 / doxy 11/23 --11/30 - Preliminary respiratory culture with OPF -- > can switch antibiotic to just doxycycline to complete a 7-day course through 11/30 - D/C vancomycin 11/24 - Negative urine streptococcal/ legionella antigen  - Discussed with ID, start remdesivir 11/24 -- > can discontinue today to go home  - Dexamethasone for 5 days  - O2 to keep SpO2 > 90% - Supportive treatment for cough: Bronchodilator, cough suppressant  - Pending BDG - Negative serum GG 11/23
Heart flutter starting day after vaccination at 11am and ending 3 days after vaccination. Flutter was intermittent and would begin early in the day, usually morning. I did not seek medical attention.
Jolted out of sleep at 02:00, extremely severe lower jaw pain. Fell back  to sleep in about one hour. Awoke at 09:00 with no pain.  No residual or recurrent pain since event.
Employee complained of lip numbness a couple hours after getting the flu vaccine. This lasted for 5 days. Employees own PCP was notified on Friday afternoon.
Breakthrough case admission after 6 vaccines Moderna 3/23/21 Lot# 030A21A;  MOderna 7/27/21 Lot# 043B21A; mOderna 4/11/22 Lot# 022J21A;  MOderna 8/9/22 Lot# 058A22-2A;  MOderna 11/10/22 Lot# 052D22A; Moderna 2/13/23 LOt# 044H22A
Left arm: Pt has swelling and redness under arm neat armpits. Redness is about 4 inches.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. On an unknown date in June 2013, the patient was vaccinated with first dose of PROQUAD (lot number, expiry date and route was not reported). On 16-SEP-2013, the patient was vaccinated with M-M-R II (lot number, expiry date and route was not reported). No adverse symptoms were reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored LIQUID PEDVAXHIB lot # L042835/expiration date 19-AUG-2018. No adverse event. Excursion temperature was 51.22 F and timeframe was 42 hours. There was no previous temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
(previous question confusing. i am reporting it, i am her PCP. the facility that admin it is a medical center) 1.5 weeks after the first dose, pt developed a rash on her abdomen in one spot. per photo, it appears urticarial.  then 2 days after the second dose she developed a generalized urticarial reaction on her trunk. not sure is it affected the limbs also.
2nd vaccination date: 4/27/2021: she started having loss of taste 2 days after 2nd dose which is still persisting. On 01May2021, she began having pain in lower back and below with throbbing pain in both her thighs. Pain is moderate to severe in nature and continues. She hasn't taken any medication yet for pain.
Bad red rash and  very bad itching in a circular area approximately 4-5" diameter around injection site - appeared 4-5 days after injection.  Area was swollen, and 'hard', very red, raised bumps (like hives).   The itching got worse in subsequent day, and I visited a dermatologist on the 3rd day, who prescribed Mometasone Furoate 0.1% twice a day.  The rash gradually went away over 4-5 days.
Could feel but could not move legs and arms.  Whole body.  Felt like was paralyzed.
The patient was given an adult dose of Hep A vaccine. As of now patient has had no reactions. If patient does have a reaction is would be local and just cause redness where the shot was given.