chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 February 2021 12:10-15pm Received first dose of Modern Vaccine Rested 30 minutes without any symptoms 3pm injection site, left upper arm one inch below shoulder began to become soar. Felt tingling first and then soreness and pain of 2 between 1 to 10, with 10 being the worst 5pm pain and soreness increased to a 4 8:30pm pain continues at 4 and temperature is at 99.8 deg F. Some dizziness.  9:26pm pain continues at 4 and temperature is still at 99.8 deg F.   6 February 2021 2:57am Pain continues at 4 and temperature is still at 99.7 deg F. Trouble lifting arm over head. 10:57am Pain continues at 4 and temperature now at 103 deg F.  Trouble lifting arm over head. 12:17pm Pain is less at 3 and temperature continues to rise to 104 deg F. Trouble lifting arm over head. 5:28pm Pain is less at 2 and temperature is now normal at 97.8 deg F, 99.4F, 99.4F or average of 98.86F. Trouble lifting arm over head. 8:23pm pain is less at 2 and temperature is 98.3 deg F, 98.7 deg F, 98.8 deg F.    7 February 2021  7:38am Pain is a lot less at 1 and temperature is 96.1 deg F. 8:37am developed a slight headache with pain at 2 in left sinus.  6:29pm Pain in arm is almost gone. No more headache. Temperature at 98.3 deg F.   8 February 2021  9:35am Pain is at a minimum at injection site. No other issues now Temperature at 98.2 deg F.   9 February 2021  Slight tightness at injection site and experienced indigestion and GERD  10 February 2021  All reactogenicity disappeared.
face turned blood red; felt like on fire/internally she felt very hot; worst case of sunburn; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (face turned blood red), FEELING HOT (felt like on fire/internally she felt very hot) and SUNBURN (worst case of sunburn) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa). Concomitant products included METRONIDAZOLE, CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE TOPICAL SOLUTION USP), OXYMETAZOLINE HYDROCHLORIDE (RHOFADE), AZELAIC ACID and VITAMIN D3 for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ERYTHEMA (face turned blood red), FEELING HOT (felt like on fire/internally she felt very hot) and SUNBURN (worst case of sunburn). At the time of the report, ERYTHEMA (face turned blood red), FEELING HOT (felt like on fire/internally she felt very hot) and SUNBURN (worst case of sunburn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Drank Milk
Information has been received from a physician concerning a newborn baby (DOB 20-Mar-2008) who was a sibling of a patient vaccinated with VARIVAX (Oka/Merck), developed varicella on 15-APR-2008 and was admitted to the hospital. The physician was not interested in VZVID. Subsequently, the patient  recovered from varicella months ago. It was not reported whether the patient sought medical attention. This was one of two reports from the same source. The other patient was a sibling (WAES # 0810USA01850). On 10-OCT-2008, the physician's MVX stated that the patient's sibling was vaccinated with VARIVAX (Oka/Merck) at the health department. The patient's sibling had just a handful of lesions that were crusting over when this baby was born and his sibling was the presumed contact. Additional information was received from the patient's HCP physician who reported that the 10 days old patient was a sibling of a 19 month old otherwise healthy child who received VARIVAX (Oka/Merck) and subsequently developed a "bunch" of lesions. The newborn patient developed varicella and was hospitalized, treated with ACYCLOVIR. There was no evidence of meningitis. The baby had recovered; he was now approximately 5 months old an otherwise health (no history of immunocompromise). Additional information has been requested.
Tenderness, redness, soreness at site of injection and below site of injection; pt reported muscle twitch at time of injection.
7 days post vax, the pt developed a fever, cheeks were flushed and then became cold and clammy. Behavior was more difficult to control from 7-14 days post vax. 10 days post vax, noticed 1 inch diameter red, hard, knot at the injection site. Small red spot on chest at 2 weeks.
Presents with vesicular rash on erythemous base few in scalp, face, upper and lower extremities. No fever. Mild case. Isolation at home and Benadryl for pruritis. Will return 1 week.
nausea, lightheadedness, lt arm & leg tingling w/decreased sensation in lt arm, lt leg, lt abd, lt facial; some chest tightness;
This medically confirmed spontaneous report (initial receipt 09-Nov-2015) concerns a female patient who had received the flu shot for the past 7 years and had never had a reaction. She did not know if she had received Afluria in the past. On 06-Nov-2015 at 11am, the patient received Afluria vaccine (Influenza virus vaccine polyvalent, batch number 10849211A) 0.5 mL via the intramuscular route for the prevention of influenza. On 06-Nov-2015 at 8pm, the patient began shaking uncontrollably and her mouth felt sore and swollen. She also had garbled speech, the temperature was above 103 degrees Fahrenheit, tongue swelling, very irritable, and was not feeling well. The shaking was severe. The patient had strange dreams, which was out of the ordinary for her. The patient was scared and described the experience as frightening. She thought she was having a stroke. She had visited the emergency room and had an IV (intravenous) in her.  When she was asked about her diet, she reported that she had not tried anything new. The hospital did an EKG (electrocardiogram) and reported that she had an unspecified fever, dehydration and an upper respiratory infection. She may had a viral infection. Yesterday was the first time she felt 100% better. About 2 days ago, she started feeling nausea but she attributed this to not eating because she was feeling exhausted. She will follow-up with her primary care doctor on 13-Nov-2015. The outcome was recovering. Reporter's Comments: Reporter comments: The hospital would not say if the reaction was due to the Afluria. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus vaccine and the Afluria PI, upper respiratory tract infection and all other events are unlisted. Fever, malaise and nausea are listed. Causality: Possible. Time to onset is same day of vaccination. Event onset on same day is suggestive of combination of systemic events (fever, malaise), autonomic reaction (shaking) and or hypersensitivity (tongue swelling, sore swollen mouth). Dehydration may have resulted from inadequate intake due to other symptoms; collectively all events are causally attributable to vaccination due to temporal association. Neurological event (stroke) is considered to be suspected and not confirmed diagnosis, hence causality unassessable.
Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. At follow up on Jan 4, patient reported having shortness of breath and fast heart rate (has pacemaker). Will see provider this week. Not yet scheduled to receive COVID 19 vaccine
Tuesday in the early am, I woke up and I took my temperature - it was 101.2 (I had taken Ibuprofen 5 hrs prior). I got something to eat and then I took 800 mg of Ibuprofen. I bundled up - h ad chills and fever. Left arm was killing me. I went back to bed. I could hardly move my left arm. I oculdn't lay on it - the ibuprofen didn't work. I had to call out of work. I cancelled Tuesday. I was in bed. I drank a lot of water before the vaccine and after the vaccine. I had soup broth, tea, juice, cider. I slept 3-4 hour nap in afternoon. Diarrhea and cramps late tuesday night - bathroom and bed all of Tuesday. Had a fever again on Wednesday night - 101 (oral). Tired. Left arm was killing me. I continued 800 mg ibuprofen every 6 hours on Tuesday. I started VIT DE again. I was mostly exhausted and my arm still hurt badly. on Wednesday and Thursday. Thursday didn't take any ibuprofen - pushed through the day. On the 5th of February, for the first time in my life - left flank pain; sharp left lateral pain. I couldn't pee for three hours. I was drinking three quarts of water. For the most part, it didn't hurt a lot to move my left arm but it hurt. Bladder was not full even though I couldn't pee. I went to URGENT CARE  - Doctor on Duty - (Friday, the 12th)  UA - no nitrates; large amount of blood but everything was normal. No growth after 48 hours. Flomax - dialator and started to urinate. I didn't have any sense that I had to pee. Friday, the 5th, I took the Flomax once a day - 0.4 micrograms - I took it Friday and Saturday. I did abdomen warm compresses in my abdomen and back. I did it on Sunday twice, two. I started back up on Ibuprofen on Friday, Saturday. Monday - I got my PCM -  Monday the 15th - He did a UA and I had no blood. I stopped  Ibuprofen on Monday. He is going to do a renal ultrasound. I had never had a kidney stone but he has put in a referral to get that done.  Tuesday (after President's day) - UA results - negative and no blood and he wasn't going to send it for culture. I still have minor left flank pain here and there.
After approximately 2 minutes of receiving the injection, patient started having a metallic taste and her lips were tingling. She then had trouble getting her breath. Benadry 50mg given IM and then Solu Cortef 125mg given IM. Administered O2 per mask at 8L/min.  Began to have less distress and improved breathing after about 10 min.  Also developed hives later in evening.
On 01/24/2023 the clinic staff discovered that the ProQuad vaccine had been stored in the vaccine fridge instead of the vaccine freezer.  This patient was identified as one of the patients that received the vaccine that was stored improperly.  Patient will be notified to come back to clinic to be revaccinated.  No other adverse reactions were reported after received the initial dose.
Redness around injection site, gotten redder since shot. Pain when touched, itchy, and hardened area around shot site.
Initial information received on 03 November 2014 from a healthcare provider. An unidentified adult female patient was vaccinated on 29 October 2014 with ACTHIB, batch UI098AA and MENOMUNE, batch UH325AA for a splenectomy. The routes and sites of administration were not reported. At an unspecified date later, the patient experienced a local reaction of redness and swelling and was hospitalized. The patient is being treated with IV antibiotics. The patient's concomitant medications and laboratory tests were not reported. The reporter refused to provide any further information. No further details were available at the time of this report. The patient outcome is unknown. Follow-up information received on 05 November 2014 from a healthcare professional via a company representative. The reporter described the adverse event as "red hot myositis" which occurred in the left deltoid area at the site of PNEUMOVAX 23 and MENOMUNE injections. Details of the PNEUMOVAX 23 vaccine, manufacturer, batch and route were not reported. ACTHIB was given in the right deltoid. The MENOMUNE lot number was confirmed as UH325AA. No further details were available at the time of the report. Documents held by sender: none.
Patient received a 3rd dose of Moderna. 1st dose on 1/22/21, 2nd dose on 2/19/21, 3rd dose on 5/12/21.
I developed flushing on  my chest almost like a sunburn.  Later that evening I got severe joint pain in my hip and jaw, a fever of 100.6 and my injection site became red, hot, hard and itchy with a rash on my arm.
QUADRACEL as their 2nd dose in the series at their previous Doctors Office, instead of PENTACEL, with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 2 Infant patient under age 4 years who were administered quadracel as their 2nd dose in the series at their previous doctors office, instead of pentacel, with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date,  the patients developed a non-serious event of quadracel as their 2nd dose in the series at their previous doctors office, instead of pentacel, with no reported adverse event (wrong product administered) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event .  Outcome: unknown   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 the guidelines. 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.
had negative titers for M-M-R II; one month ago the patient received a dose of mmr II; This spontaneous report as received from a pharmacy student refers to a 50-year-old female patient. The patient's medical history, current condition, concomitant medication and drug reactions/allergies were not reported.      Approximately on an unknown date in December 2019 (reported as one month ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot# expiry date, strength, dosage information, route of administration and anatomical locations were unknown) negative titers for MMR (prophylaxis) (product administered to patient of inappropriate age). The patient had also received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) as a child. On an unknown date, the patient had negative titers for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (antibody test negative).   The outcome of antibody test negative and product administered to patient of inappropriate age was unknown. Causality was not reported
Metal taste in mouth; slight swelling of eyes; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231, expiration date not reported) via an unspecified route of administration on the left arm on 11Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on 21Dec2020 for COVID-19 immunization. On 11Jan2021 02:30 PM, the patient experienced Metal taste in mouth, slight swelling of eyes. No treatment was received. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered in Jan2021.
Pt reporting "avocado size" welt at injection site, significant soreness, itchiness, swelling from shoulder to elbow
Pt. rec'd vacc. 10/28 within 2 hours after vacc. pt experienced chest pain L posterior chest wall. Comes into the clinic 10/30 EKG done, Chest x-ray done.
Pfizer COVID-19 vaccine (5-11yrs) manufacturer expiration date is 8/31/2022. However, vaccine expiration date after being transferred from freezer to refrigerator is 5/17/22. Vaccine was administered on 5/24/22.
Mild erythema with complaints of itching at injection site 7 days after injection. Physician treated with Triamcinolone Acetonide 0.025%, Cream, Topical APPLY TO AFFECTED AREAS TOPICALLY TWICE A DAY FOR 2 DAYS
Full anaphylaxis,  Vertigo, Blood Pressure spike to 200 and it lingered there.  Sent immediately to Hospital.  Was administered IV Benadryl and Prednisone.  Slept for three hours.  BP dropped to 165 and was released with Benadryl and Prednisone to take for the next four days. Next several days of nausea, diarrhea, fever, weakness, shakes.  No energy.  Not feeling well until March 14th.
One and a half hours after vaccine was administered my face started to feel numb and tingly and my lips began to swell. Benadryl 50mg was administered with good results. About an hour after the Benadryl was administered my face and extremities began to feel numb and tingly and my tongue felt thick (I couldn't talk clearly) and my face began to swell. I was then taken to the medical office across the street for additional treatment. My vitals were taken and my blood pressure was elevated, I was taken to a room and Benadryl and a steroid was administered SubQ and I was prescribed an oral steroid  as well.  I continued to have swelling and numbness for five days and I had to take Benadryl every four hours for those five days.
Employee states she began feeling hot and took her temperature it was 101.4, she took 400mg of Ibuprofen and placed ice packs on her head and neck. Rechecked again at 7:00am 99.3. No further events of elevated temp since then.
The same day that I got the vaccine I began to get a headache about 4.5 hours later. I couldnt get the headache to go away even after taking ibuprofen and Tylenol. Later that night I began to run a fever over 100.5 and had chills and body aches. The entire next day my body felt so weak that I could not lift my head off the pillow. I also had nausea. These symptoms lasted until Thursday night around 8pm.
Patient stated that her arm was extremely tender (moreso the skin surrounding the injection than the muscle itself). She was worried that the medication did not get administered into the muscle.
Extreme swelling/warmth- injection occurred on 10/12/16 swelling and redness has moved away from inj. Site and is traveling down her arm.
After being given a DEXAMETHASONE shot for his asthma he became tired and began to complain of feeling not quite right. So he went to bed the next morning he was able to breathe better but as he said the night before he felt not right and now his legs had begun to hurt and became weak - so weak and painful he could not walk. Took him to ER. They did neuro exam and blood work. Sent him home. Then I contacted the study coordinator both he and his brother are in and the Dr. put him in hospital. They only did blood work again and basic neuro exam.  Checked on his asthma and had a physical therapist help him with his legs. Today he still has pain to the touch, he can not bare to stand on them because of the pain - So he is in a wheel chair. We do not know what is wrong with him! Like his brother.
Stomach upset 6 hours after COVID-19 vaccination, followed by severe diarrhea (watery). More than 6 bowel movements a day for 2 days, causing hemorrhoidal bleeding. Completely resolved on October 5, 2023. No sequelae.
Had my period for 16 days out of 30.   Typically it is 4 days out of 30.
Patient received vaccine on 9/28/2023 . Patient developed a rash on his legs and had a rash on his arm as well. Patient went to local emergency department on 10/2/2023 and was prescribed diphenhydramine 25 mg with the directions 1 capsule three times a day as needed for itching.
Patient received Hep B vac. on 7/30/14 - Did not notify provider she had allergy to wheat. On 7/31/14 she developed a rash with n/v that progressed requiring treatment at urgent care. It was not until after I contacted her again today to f/u with her that she remembered she was allergic to wheat.
sick at least 3 months after taking influenza vaccine; Initial information received regarding an unsolicited valid non-serious case received from a consumer via Social media and Transmitted to Sanofi on 31-Oct-2020.  This case involves approximately 80 or 81 years old female patient who experienced sick at least 3 months after taking INFLUENZA VACCINE (Illness).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via unknown route in unknown administration site for prophylactic vaccination.    On an unknown date, Reporter mother was sick at least 3 months after taking INFLUENZA VACCINE (Illness) for the first time in her life because her alcoholic doctor talked her into it. Reporter said that patient ever had been sick much in her 80 or 81 years and after receiving INFLUENZA VACCINE from hell was so low and patient was sick of flu for so long.  Final diagnosis was Illness.   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome is reported as Unknown for Illness.  Lot number was not available for this case.
This initial spontaneous case was received from Other Health Professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 13th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional information was received as follows: This case was reported by a physician assistant via click to chat. The age at vaccination was not reported. The reporter asked that, if the patient got localized tenderness and redness at the injection site after the 1st dose of SHINGRIX, would they expect an even bigger reaction after the second dose of SHINGRIX. Unable to obtained any additional information, including product and patient identifiers.
pt recv vax 25NOV96 & 3DEC96 pt devel large, red, raised rash;6DEC96 & 20DEC95 pt had two additional episodes of rashes;
Initially a mild wave of dizziness, followed by progressive throat over the course of 10 minutes closing.  Throat did not close completely, felt swollen and as though there was mucus to be cleared but there was not mucus present.  Was treated with 2 Benadryl tablets by the pharmacist.
Noted blurriness/change in vision starting 3/29/21, became so prevalent could not read print by 4/5/21.  Saw Retinal Specialist on 4/6/21, diagnosed with posterior uveitis in both eyes.  Ran full blood and x-ray panel to rule out immuno compromise.  All tests normal/unremarkable.  Follow up visit on 4/15/21 showed clearing in right eye, doctor inserted corticosteroid injection in posterior of left eye.