chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 2 month old pt who on 9/8/06 was vaccinated PO with a 2.0 ml dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) (lot number not provided). The physician reported that on  9/8/06, the pt gagged when rotavirus vaccine was administered causing the child to hold their breath for a brief period of time. Unspecified medical attention was sought. On that same day, the pt recovered from their events. Additional information has been requested.
This is a spontaneous report from a contactable physician. This physician reported to a Pfizer Sales Representative on behalf of a patient who began on PREVNAR 13 unknown dose for an unknown indication on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. On an unknown date after vaccination, the patient had a fever. Relevant lab data was unknown. At the time of the report the clinical outcome of the event was unknown. Follow-up (08JUL2011): Follow-up attempts completed. No further information expected.
dizziness; arm pain; This is a spontaneous report from a contactable consumer (wife) or other non-health care professional. A 87-year-old male patient received First dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/Lot Number: FL9261) via an unspecified route of administration on 26Jan2021 at the age of 87-year-old as dose 1, single for covid-19 immunization. Medical history included has a pacemaker, Takes heart pills, Takes three pills a day, sick, and Flu. Concomitant therapy mentioned as yes. Family history was none, No relevant tests. No Prior vaccinations within 4 weeks. Last year when they both got home, they were really sick. Both caller and her husband, had to go to the Emergency room. Were sick for 3-4 weeks. Believes they had the COVID virus. Can't say for sure if it was COVID, but was told they both had the Flu. Caller mentioned this to the doctor and some say she and her husband might have had the COVID virus. Confirmed this was a year ago, prior to receiving the COVID vaccines. On an unspecified date the patient experienced dizziness, arm pain. Outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
At the injection site I had itching, redness, swelling and pain for 2-3 days -- starting at day 9 after the injection
Site: Pain at Injection Site-Medium, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Disorientation-Severe, Additional Details: Patient experienced loss of cognitave ability, severe chills, disorientation. Went to hospital where he was ruled out for sepsis, congestive heart failure. ER doctors decided it was an allergic reaction to Shingrix.
Report A0377268A describes the occurrence of "feeling crummy" in a 59 year old male who received hep A vaccine. This report was received from a nurse. The vaccinee's relevant concurrent condition included hypertension. The vaccinee's concomitant medications include Avapro. On 8/7/02, the vaccinee received the second injection of Havrix. Later that same day, the vaccinee developed a fever of 101.5 deg. and he reportedly "feels crummy." Reporter stated that the vaccinee apparently was already starting to feel bad before his Havrix injection, but didn't tell anyone. Therefore, the reporter is not sure if the vaccinee had a reaction to the vaccine or was just getting sick. No adverse event was reported following the first Havrix injection, therefore, she noted the events could possibly be related to Havrix. The most recent info received on 8/8/02 reports the events to be unresolved; it is unknown if the Havrix immunization series will continue.
Patient was administered the flu vaccine and within 15 minutes began feeling itching in both of her arms. She stated her arms also looked "red", although not observable by the nurse. She was taken to our ED for evaluation and was given po Benadryl. She will be following up with an ENT dr for possible allergic reaction
She got her vaccine, and did not have any reaction immediately.  Her reaction was a bruise on her arm and realized that it could have been her medication that she was taking, but after getting closer to October she started to see a bruise on her arm, but did not think nothing of it until she started to take the medication.  She was taking Bactrim at that time, which is not a reaction to that medicine, and found out she was allergic to it.  Was told that the mark on her had nothing to do with the reaction of Bactrim.  The reaction was right where the shot was given.  The bruise on it was small but red at first, but it never turned black until she started rubbing on it trying to figure out what it was.  She immediatey called and asked if they thought it was due to the Bactrim.  They informed her that it was due to a specific reaction to something in that arm, which was the vaccine.  She knew that it had to be a reaction from the shot she got in the arm.  The area then turned to be a big bruise, got swollen and after that it wasn't too much of a problem.  You can still see a blackish spot on the area of the vaccine.  The area does hurt every now and then on the inside of the arm she can feel a little pain though, but not all the time.    She has not done anything about the vaccine itself.   She did get COVID vaccines while pregnant with her daughter, and after getting the original two vaccines and they both got COVID.  She was born, and they both had COVID about 3 weeks after that.   Her symptoms of COVID lasted for a week or 2 and her daughter also caught it and child services took her from her due to the COVID and she is seeing therapist at this time, and that the decision has been appealed to see if she can get her child back.
I felt a slight pain in my arm a few minutes after the injection. 5-10 minutes after I felt a slight headache. From about 15 minutes after the injection until 50 minutes after I felt tingling in my lower lip and tongue. 5 hours after I was extremely fatigued, and went to bed. Felt fine the next day.
On 2/20/00, the pt developed ataxia, with no rash or fever. She sought unspecified medical attention. The condition resolved the next day. No further information is available.
Patient is experiencing redness, itching, and heat at injection site . Patient was instructed to use cortizone cream , ice and benadryl . If no relief to go to an urgent/ walk-in clinic for further treatment.
2hr ECG documented atrial flutter; day 7 profound weakness & increasing dyspnea followed by marked gluteal and flank pain. Dyspnea improved over several weeks. There was one recurrent arrhythmia .
Employee reports that she experienced redness, swelling and warmth at the injection site within 30 minutes. Instructed her to take a Benadryl and apply ice. She experienced continued symptoms that required her to continue to take Benadryl. On 9/20 a rash and itching developed on her RUE/ injection site. 9/24 symptoms into her shoulders and LUE. 9/28 She reported that she woke up and felt that her lip was swollen. She was seen at her physician's office and treated with steroids and Keflex PO.
Patient is a 51 y.o. female presents to Hospital complaining of 2 to 3 days progressing malaise, DOE, pleuritic chest pain.  Patient is known COVID(+) by outpatient testing on 10/27/2021, symptoms started approximately 10/24/2021 with dry cough and loss of smell.  Home pulse oximeter has read as low as 87% on room air.  Patient also endorses subjective fever and chills.  No nausea, vomiting, diarrhea, headache.   In the ED patient is noted to be hypotensive and very orthostatic with symptomatic presyncope upon standing for vitals.  Very minimal exertion and also drop patient's oxygen to 87% on room air.
Post nasal drip sore throat, aches, chills in PM only. Next day same thing. By Sunday I had extreme sore throat, fatigue, aches, and chills but no fever. Monday aches all day worsening at evening to the point that 400mg ibuprofen does not alleviate chills or aches anymore. Still now fever. No stuffiness no runny nose.
Tested NAAT positive for COVID 10/19/21 after being fully vaccinated.
Within 5 days of receiving my seconds shot I started loosing hair. I?ve never lost this much hair.
Local rxn to MMR w/wheal immediately; No other sx; DPH 25mg PO given APAP 1/2 tsp PO
On March 29, 2021, after having an odd drumming sensation in my ears/head the day prior, I experienced intense pulsatile tinnitus upon getting out of bed. While battling the tinnitus in the ensuing weeks, I experienced panic attacks, hyperacusis, anxiety, intrusive thoughts, rumination, and fasciculations. My condition was at its worst when severe hypnic jerks began in mid-May 2021. These spasms would prevent me from going to sleep. They continued for a period of two or more weeks when I had to check into an ER given my mental state. I was prescribed a benzodiazepine (Ativan) as a bridge drug until I could get psychiatric care. Once in psychiatric care, I was prescribed a host of medications that were more than necessary. After undergoing the grueling experience of weening off those medications, I was finally prescribed sertraline (Zoloft), which calmed by brain activity and allowed me a night of peaceful sleep. I was on the Zoloft from December until November 2022. I have been basically medication free since but can still tell there are residual problems with brain activity (e.g, tinnitus, rumination, depressive episodes). I still have some tinnitus during the day (I think this is my sensing of abnormal brain activity). My libido has also been significantly affected.  I take Trazodone as needed in case I cannot sleep due to my condition.
Wife is pregnant and due with no exact date provided; not moving around that much/the baby was not moving well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transplacental (Batch/Lot number: unknown) as dose 1, single and transplacental, administration date 13Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The mother of the patient was 38 year-old. The mother had no relevant medical history. The mother had no concomitant medications. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Wife is pregnant and due with no exact date provided"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "not moving around that much/the baby was not moving well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: they went and checked on baby in the hospital and they kept the mother overnight. The baby was not moving around that much, but baby was okay. They did an 8 point test to make sure. They told them at the hospital to try and get a hold of PAXLOVID.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101871640 Mother / baby case
Patient reports she had numbness in her face, heaviness on her chest, sweating, and feels like she wants to sleep. LPNs and RN checked patient and called for Ambulance. Patient transported to Hospital to get checked out.
rash; redness; swelling; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness), VACCINATION SITE RASH (rash), INJECTION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness). On 20-Jan-2021, the patient experienced VACCINATION SITE RASH (rash), INJECTION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling). On 15-Jan-2021, VACCINATION SITE PAIN (soreness) had resolved. At the time of the report, VACCINATION SITE RASH (rash), INJECTION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: No specific follow-up information recorded.
Patient received 2nd vaccine. About 10 mins after administration she reported nausea, light headed, itching, rash, numbness. Patient requested to only have 25mg of Benadryl administered. Per Dr. ok to administer that amount. Benadryl 25mg IM in the left deltoid at 11:30 AM by RN
Dizziness; Sore arm; Nauseous; This is a spontaneous report received from a contactable consumer. A 56-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP- 7534) via an unspecified route of administration on the left arm on 16Mar2021 at 16:45 (at the age of 56-year-old), as single dose for COVID-19 immunisation. Medical history included inflammatory arthritis, bronchitis and high blood pressure. Concomitant medications included PLAQUENIL, benzonatate (MANUFACTURER UNKNOWN), lizinopril (MANUFACTURER UNKNOWN) and azathioprine (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on the left arm on 16Feb2021 at 16:45 (at the age of 56-year-old), as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced sore arm, dizziness and nauseous on 17Mar2021 at 11:00. The patient did not receive treatment for the reported events. The clinical outcome of painful arm, dizziness and nauseous were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
On 3/26/03 PT had 4 yrs old WCC (white cell count). On 3/28/03, presented with swelling and redness in right arm. Had temp of 100 oral and c/o pain right arm. Given Rx for augmentin ES pusp, 600 mg, and ESP PO BID x 10 days.
Patient come to pharmacy with distinct circular bruise (dark color with yellow pigmentation around the bruise) located on the left deltoid. Patient stated that she had swelling above her right bicep while there was also having pain in forearm. Patient had difficulty moving arm  in full 360 degree motion. Patient has remained to have these symptoms for almost up to three weeks.
Heart started racing about 7:00 pm the night of the vaccine until today (I haven't noticed it today for the first time since the vaccine). The next morning after - so nauseous; and aching all over; so tired I could hardly move as I had joint pain, too. Couldn't throw up but nausea was there constantly - even when I went back to work on Monday I as still nauseated and still in pain. When I came home from work on Monday the body aches were gone and my leg felt numb. So it lasted a good four days for me.  No treatment except drank lots of liquids and stayed still as I could so nausea wouldn't worsen. I still ache but that might be because of my ruptured disc.
PATIENT SAYS THE VACCINATION GAVE HIM SHINGLES. IT LOOKED LIKE A SCAB A WEEK AFTER THE SHOT. HE SAYS IT WAS NOT ITCHY OR PAINFUL. IT WAS ON THE PATIENT'S FOREARM.
While at vaccine pod patient developed hives on left deltoid and neck/chest region.  Patient given Benadryl and brought back to first aid tent.  Patient developed sore, scratchy throat and headache.  No further symptoms before resolve.  Give ibprofen.
heart pounding rapidly and heartbeat of 101; slightly light headed; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart pounding rapidly and heartbeat of 101) and DIZZINESS (slightly light headed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced HEART RATE INCREASED (heart pounding rapidly and heartbeat of 101) and DIZZINESS (slightly light headed). At the time of the report, HEART RATE INCREASED (heart pounding rapidly and heartbeat of 101) and DIZZINESS (slightly light headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
BODY ACHE; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 11-APR-2021 15:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-APR-2021, the patient experienced body ache, fever, and headache. Laboratory data included: Body temperature (NR: not provided) 102.7 C. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of body ache and headache was not reported. This report was non-serious. This report was associated with product quality complaint: 90000224527. This case, involving the same patient is linked to 20210431635.
received the adjuvant without the active antigen; received the adjuvant without the active antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-Jul-2022 Reporter's Comments: The reporter was a pharmacist.  She was regarding the administration of 3 different patients who received the Shingrix adjuvant without the active antigen component.  The reporter had limited information.  Lot numbers unknown. Additional Supportive Information:  The patient only received shingrix adjuvant without active antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR106414:Same case/same reporter US-GLAXOSMITHKLINE-US2022106113:Same case/same reporter US-GLAXOSMITHKLINE-US2022106113:Same case/same reporter
Body aches fever dizziness foggy tired Red blotch at injection site that grew over 10 days and was itchy
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 20-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 47 F (8.333333333 Celsius) for 40 hours (highest recorded temperature). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized w/ COPD exacerbation. Vaccination took place 10/31/2007. According to physician relationship is 'none'.
Within a few hours I experienced some tingling in my right leg.  By the next day I had bad sciatic pain which continues.  I have not had any pain like this in several years.
I began with chills on Weds. morning around 10am that only got worse not matter what I did. My arm continued to hurt but I thought it was just the injection pain. I then began to exhibit a temperature (100.3) and to feel fatigued and had a bad headache by late Weds. afternoon and evening.(These symptoms were similar to those I suffered when I had Covid back at the beginning of August, minus the throat pain and breathing issues I suffered.  By that night my arm was throbbing and I had fevers that ran as high as 102.7 and suffered multiple night sweats. My wife noticed swelling in my upper left arm and on Thurs. I contacted my Dr. who directed me to take tylenol and apply ice to the swelling. Which I did all day Thursday. The fatigue, fever and headache persisted all day Thursday and my arm began hurting more. I began to notice discomfort in my underarm (left) and my wife (a nurse) noticed it was swollen (softball size), warm to the touch and extending into my left pectoral muscle. I began applying ice to this area also but it had no impact. Contacting my Dr. on Friday about the new swelling, she examined me on Fri. afternoon and prescribed me Cephalexin, Medrol Dose Pack steroid, and over-the-counter Clariton allergy medicine, which I began Friday night. My fever began to subside and by Sat. morning my arm pain began to lessen and some of the swelling went down. Now Sunday morning, the fatigue, fevers and headache have gone, and most of my arm pain in gone (still tender to the touch), I still have some swelling in both upper left arm and Underarm pit. Dr. feels this was and allergic reaction and recommends I do not get the second injection.
Sore tongue; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Mar2021(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included melon allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) for unspecified indication from an unknown date. On an unknown date in 2021, the patient experienced sore tongue. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore tongue was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained; No further information is expected.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: CALLED EMS TO ATTEND TO PATIENT