chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; tiredness; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 38-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in right arm on 24Mar2021 at 14:15 (at the age of 38 years) as 2nd dose, single for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Patient had no allergies to medications, food, or other products. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in right arm on 03Mar2021 at 10:00 (at the age of 38 years) as 1stdose, single for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not tested for COVID-19. On 25Mar2021 at 12:00, the patient experienced headache and tiredness. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
No reaction from first two doses. 9-10 days after this most recent booster vaccine I developed itchy hives on my neck. From there it spread down my back and to my scalp. Hives have popped up on my arms, wrists, hands, legs, and stomach. The most severe is neck, wrist, back, and face. I could not sleep the first few nights due to the widespread itchiness. I get a burning sensation and I can tell an itchy spot is about to appear. When I scratched, the bumps would spread and swell. My entire thigh would be covered with swollen red streaks. Every morning when I put makeup on, my eyes would turn red and swell and I would get red splotches all over my face. I would wait about 20 min before leaving so my face would look normal. First I received a Benadryl shot and took Claritin and Pepcid daily. It did nothing. Then I was prescribed prednisone for 5 days which almost cleared it up but they came back after the 5 days. It is not severe as when it started because I have learned not to scratch as much. Currently I take Claritin and Pepcid daily and I have itchiness daily but am able to deal with it. My face doesn?t swell as bad and it it not as frequent as when it began. I am no where near back to normal though.
About 10 minutes after receiving the shot, I felt a warm tingling sensation in my throat. I alerted the nurse and about another 3-5 minutes afterwards felt like a rising sensation up toward my ears. It almost felt like I was being filled with something but could still breathe. I start to have a fast heartbeat and felt like I was sweating. I received Benadryl (IM) and felt relief about 1-2 minutes. After about 7-10 minutes I felt like it was coming back and the feeling rising back to my ears. I received another dose of Benadryl. I went home and made sure I continued the Benadryl  for 24 hours. My throat appeared swollen from the outside of my neck when I woke up from a nap about 3-4 hours after receiving the vaccine shot. My chest did have a little redness like hives but not full blown. Just red and irritated. The next morning my voice was very hoarse for a day and a half.
got it and he has since passed away; had the shingles vaccine and got /suspected vaccination failure; got it and he has since passed away; This case was reported by a consumer via media and described the occurrence of death nos in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced death nos (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the death nos was fatal and the outcome of the vaccination failure and shingles were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death nos, vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that the patient had the shingles vaccine and got shingles a few years ago from the date of reporting and he had since passed away. The patient's shingles was much worse and the were told that it would be much worse if they had not had vaccine. The reporter stated that anayone should not think that her or she was 100 percent safe. The reporter further stated that she still agreed to get vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR175880, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175880:same reporter; Reported Cause(s) of Death: Unknown cause of death
Swelling/redness/warmth to vaccine site and papular rash to face and arms. TX w/ NSAID and antihistamine.
Severe sinus headache Saturday night. This went away by next morning. 90-120 bpm heart rate as per my pulse oximeter that lasted from evening until the next morning Wheezing a little which necessitated taking my asthma inhaler and the Azelastine HCL Nasal spray for the sinus headache (only needed to take 1x) Stomach and intestinal pain cramps that felt like I was going to throw up or have diarrhea (sick feeling went away by morning) Slight bloody nose in left nostril only through today (Monday) - have been using Ayr Saline Nasal Gel to keep both nostrils hydrated Have a little dry cough as of 12:45 today.  Arm pain was same as Part 1 Dr said to notify him if my dry cough stays around. It could be something else that happened at the same time as the vaccine.
PATIENT REPORTS 3 DAYS AFTER FIRST DOSE- WHOLE BODY NUMBNESS.  THE NUMBNESS IS NOW 2-4 TIMES DAILY, LASTING 3-5 MINUTES THEN A HOT/COLD SENSATION.
knot under skin; feeling rotten; This case was reported by a consumer via patient assistance programs and described the occurrence of local swelling in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  On 30th April 2019, the patient received Shingrix .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced local swelling and feeling bad. On an unknown date, the outcome of the local swelling and feeling bad were unknown.   It was unknown if the reporter considered the local swelling and feeling bad to be related to Shingrix.  Additional details were provided as follows: This case was received from the healthcare provider via the vaccine patient assistance program. The patient reported having a knot under her skin and feeling rotten after receiving the Shingrix vaccine (single dose vial). This case did not include product complaint. Lot or expiry date was unknown.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. In June 2009, the patient was vaccinated with the first dose of GARDASIL (lot #, dose and route not reported) and in July 2010, the patient received the second dose of GARDASIL (lot #, dose and route not reported). No adverse effects were reported. Additional information is not expected.
Pt. fully vaccinated with Pfizer vaccine: dose 1 on 12/22/20 and dose 2 on 1/12/21. Pt. reports COVID symptoms of Muscle aches, sore throat, fever, headache, loss of taste, loss of smell, diarrhea, shortness of breath, congestion  starting on 8/30/21. Pt. had 2 high risk community exposures to 2 non-vaccinated household members (children) prior to symptom onset.  Pt. was not able to separate from the COVID+ household members. Pt. tested COVID positive on 9/2/21
Hives, no respiratory distress w/in 5 mins after vaccine was given; BENADRYL 1 tsp PO x 2 dose then Q 6 hours sent to the ER, spreading to front and (L) leg thigh pains-where he got his shot.
Wheezing, severe lung pain with difficulty breathing, swelling inside mouth. Have been able to treat at home with Benadryl, rescue asthma inhaler, and steroids?hydrocortisone that I take for adrenal insufficiency
This spontaneous report as received from a pharmacist refers to a 51 year old female patient with no pertinent medical history and no drug reactions/allergies. On 01-MAY-2013 the patient was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (lot # J000446, expiry date 11-APR-20140. Concomitant therapies included tizanidine hydrochloride, LIPITOR (Generic), FLEXERIL (Generic), acetaminophen, NORCO (Generic), LYRICA, tramadol hydrochloride, AMBIEN, AMITIZA, DEPAKOTE and PRILOSEC. The patient reported to pharmacist that after receiving ZOSTAVAX the injection site became "red at first then on 01-MAY-2013, later that day, the redness extended down her entire left arm, was itching, burning and painful". The pharmacist recommended that the patient visit her unspecified healthcare provider. Before the patient saw her unspecified healthcare provider, she self medicated with BENADRYL. The unspecified healthcare provider stated the patient "had an allergic reaction and should take BENADRYL". There were no laboratory diagnostic studies performed. The patient came in to see the pharmacist "today", 08-May-2013, and the injection site was "just a little red, still itchy but no burning or pain". Additional information has been requested.
On 03/07/2021, a little after midnight, high fever, and intense pain throughout my body. The symptoms lasted for 4 days. About a week after the vaccine, I was suddenly unable to digest garlic it made me break down in hives and have diarrhea. I can no longer have garlic.  Then I had problems with my menstrual cycle. It went out of whack. This lasted for a long time. The problems resolved and appeared again when I received my booster shot. I consulted my physician at the time for all 3 adverse events. She attributed to likely being the vaccine, but there was nothing to really treat the adverse event. I am still not able to digest garlic.
I was a 30 year old man then, I had recurring HPV outbreaks for a few years and my dermatologist suggested that I try the Gardasil Vaccine series because she said that she had patients see the outbreaks either reduce in frequency or stop all together after receiving the vaccine series.  So I got the first shot and a week later, I had severe eye redness, had sensitivity to light, and pain.  I went to the ophthalmologist, where they incorrectly diagnosed me with conjunctivitis.  The eye drops that they prescribed had an antibiotic and steroid mixture, so my eye symptoms improved.  When I got off of the eye drops, again my eye symptoms recurred and I saw a different ophthalmologist who diagnosed me with uveitis.  A course of steroid drops alleviated the symptoms again.  I did continue with the full three shot series of the vaccine because my dermatologist did not believe that it was the cause of my eye issues.  Plus, the first two shots happened before I was properly diagnosed with uveitis, so I was already two shots in and really wanted to get rid of the persistent HPV outbreaks.  The uveitis has recurred every 2-3 months since I received the first shot of Gardasil.  My eye has also presented cases of scleritis, treated with NSAIDs, most effectively Indomethacin.  I had no eye issues prior to the first dose of the vaccine and did not wear glasses or contacts.  I saw a rheumatologist to have blood tests performed to check for the typical autoimmune disorders that have symptoms such as iritis and scleritis.  All the blood tests came back negative.  I have seen five ophthalmologists, each diagnosing me with either iritis or scleritis.  My latest eye doctor has gotten it under control with a low dose of steroid drops and NSAIDs.  This has kept it mostly symptom free with a brief episode a few weeks ago that was quickly controlled with NSAIDs.
Redness, warmth, swelling at injection site - treatment is warm compresses and dicloxacillin 250 mg qid x 7 days.
Swelling / swelling worsening; Pain with movement / pain worsening; This case was reported by a physician via call center representative and described the occurrence of swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   On 2nd June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd June 2019, immediately after receiving Shingrix, the patient experienced swelling and pain upon movement. On an unknown date, the outcome of the swelling and pain upon movement were not recovered/not resolved.   It was unknown if the reporter considered the swelling and pain upon movement to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient received their first dose two months ago and still had pain with movement and swelling. The symptoms started immediately and felt like they were worsening. The reporter gave permission to follow up
I was mainly fatigued, headache and some chills. I took some Aleve due my headache and bodyaches. I never got a fever. I went to the doctor and I was put on a Z-pack, Prednisone and a inhaler due to my cough. I do feel better but I am still coughing.
Pt and mother walked out of office without incident, he became dizzy and fainted in the parking lot.  Mom helped him up and escorted him back inside the clinic where he was assessed.  He was monitored for 15 minutes and recovered without incident.  He was discharged home with his mother.
First shot was given on 04/17/2021 in the left arm around 1pm-ish.  About 30-60min later tingling sensation in the face (left side) which continues until 04/19/2021 (fully recovered on 04/20/2021). No facial paresis - only tingling sensation. Additionally, mild fever started on the evening of 04/17/2021 and continued until 04/18/2021 (one dose of ibuprofen 400mg was taken on 04/18/2021 afternoon). No fever on 04/19/2021 and afterwards.
Patient was vaccinated on 4/12 and we caught the second appointment for his second dose today.
This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable bowel like symptoms that resembled something similar to a stomach bug), DIARRHOEA (Diarrhea where she was going to the bathroom repeatedly but it wasn't runny), ABDOMINAL PAIN UPPER (Few stomach pains) and HEADACHE (slight dull headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 041620A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel like symptoms that resembled something similar to a stomach bug), DIARRHOEA (Diarrhea where she was going to the bathroom repeatedly but it wasn't runny), ABDOMINAL PAIN UPPER (Few stomach pains) and HEADACHE (slight dull headache). The patient was treated with IBUPROFEN for Headache dull, at an unspecified dose and frequency. At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable bowel like symptoms that resembled something similar to a stomach bug), DIARRHOEA (Diarrhea where she was going to the bathroom repeatedly but it wasn't runny), ABDOMINAL PAIN UPPER (Few stomach pains) and HEADACHE (slight dull headache) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The concomitant medication information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Second dose details of Moderna vaccine were updated.
This spontaneous report was received from a pharmacist and refers to a multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patient were vaccinated with an improperly stored dose of ZOSTAVAX, lot numbers M030140 with expiration date 18-AUG-2017and  M041510 with expiration date 27-JUL-2017 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were previously exposed to temperature excursion of 15 Fahrenheit (F) to 46 Fahrenheit (F) during 6 hours in November 16 (year unspecified) additionally, the vaccine was exposed to temperature excursion (unspecified dates) of 15 Fahrenheit (F) to 46 Fahrenheit (F) during 12 hours; however, no patient was vaccinated with the last temperature excursion reported. The call was because "data logger". No adverse effects were noted. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA005912.
On Monday 10/8/2018 HA and didn't feel well called into work. Tuesday I thought my bra was poking me because the right side kinda hurt. Wed. I thought that maybe I had a heat rash by Thursday I knew I had shingles. Saw a provider and was Dx.
Information has been received from a consumer concerning a 10 month old male with no known allergies and a history of prematurity (one month) who in approximately September 2000 at 2-3 months of age, was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent and was vaccinated with a second dose on 5/31/01 at age 10 months. Concomitant therapy included Motrin. On 5/31/01 the pt "was running a high fever" and was taken to the ER that night. While in the ER, the child received the second dose of pneumococcal vaccine 23 polyvalent. The outcome of the child's experience was not reported. No further details were provided. Additional info has been requested.
Information has been received from a pharmacist concerning a 60 year old patient who on 16-SEP-2013 was vaccinated with a 0.5 ml dose of PNEUMOVAX23 lot # 672074/1502AA, Exp date 19-MAY-2013, intramuscular. No adverse effects reported. This is one of several reports received from the same source. Cases linked: 1309USA009508 and 1310USA008720. Additional information has been requested.
Dizziness; Loss of taste and smell; Loss of taste and smell; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ANOSMIA (Loss of taste and smell), HEADACHE (Headache) and PYREXIA (Fever) 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 No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness), ANOSMIA (Loss of taste and smell), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, DIZZINESS (Dizziness), ANOSMIA (Loss of taste and smell), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt came for Pfizer covid booster. Had an adverse reaction. States the first two shots she had a reaction as well. Pt stayed in the office for about 50 minutes. The vaccinator and the on call provider, M.D. were monitoring her. Pt had chills, jitters, and a bit of hyperventilation. States this happened last time as well. Pt states her body just needed time to adjust to it. After 50 minutes she was feeling much better. Checked her BP twice per M.D. request. It was lower the second time. No other concerns.
I got my shot on 4/1/2021. I woke up on 4/2/2021 at 6 AM. I didn't feel right. I felt kind of dizzy and lightheaded. I got up and had a few sips of water, but my stomach did not really feel right. I lay back down and fell right to sleep. I woke up again around 11:30 AM. I had a severe headache and sensitivity to light, and I felt really sick to my stomach. I had a cup of chicken rice soup and went back to bed. And then I slept until 8:30 AM on 4/3/2021. I still didn't feel well, so I called the on-call doctor and told him my symptoms. I got there at about 12:00 PM on 4/3/2021, and they took me in. They did blood work and checked my vitals, plus a urinalysis. They gave me an IV, because they thought I might be dehydrated. After all the test results came back, the doctor felt my illness was not caused by the COVID vaccine. I was having a migraine. I've had them previously, but it felt different from prior migraines. The doctor gave me Botox injections. I got home at about 7:00 PM on 4/3/2021.
pt recv vax in 1993; lab eval in 1994 revealed anti-HBS neg; the nurse also noted 1yr p/3rd dose pt went hunting & had some bad mayonnaise; devel elevated liver enzymes;
fluzone hd stored at around 80F and appeared to be warm to touch and was administered to the patient with no ae; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patient's son).  This case involves an unknown age female patient who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number, exp date not reported) via unknown route and site of administration on unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  This an actual medication error due to Incorrect product storage. It was reported that fluzone hd stored at around 80F and appeared to be warm to the touch with no ae.   At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Batch number was requested.
Third day - Worse joint pain; ankle pain; knees trouble walking; second day - Joint pain; headache,; tired; First day  - Confused feeling; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension It was unknown whether the patient had allergies to medications, food, or other products. Concomitant medications included losartan (MANUFACTURER UNKNOWN)   25 mg for unknown indication, from unknown time. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021, first day the patient experienced confused feeling. On 09Apr2021, second day the patient experienced joint pain, headache, tired. On 10Apr2021, third day the patient experienced worse joint pain, ankle pain and knees trouble walking. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events confused feeling, joint pain, headache, tired, worse joint pain, ankle pain and knees trouble walking were not recovered, at this time of report.  No follow-up attempts are needed. No further information is expected.