chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 19 March 2014 from a non health care professional. A five-month old male patient with an unknown past medical history had received on 06 March 2014 the following vaccines: an intramuscular right thigh injection of PENTACEL, lot number C4637AA; Rotavirus (manufacturer, lot number, route and site of administration not reported), and PREVNAR (manufacturer, lot number, route and site of administration not reported). The patient had previously received a dose of PENTACEL. Unspecified amount of time later the night of the vaccine also reported as 07 March 2014, the patient had a seizure and was hospitalized. Treatments were not reported. No further information was provided at the time of the report. The patient's outcome was not recovered. Documents held by sender: none
Period was 10 days late the next month and 5 days late the next. It was also heavier and longer then normal. Just now has normaled back out.
Swelling and redness at the site and covering upper arm X 3 days, post vax. Then developed a fever to 102.3F and cough, runny nose and bilateral otitis media. Dx'd on 2/23/01 with questionable immunization reaction.
Date received shot 1/22/21 @ 10;55.  Symptoms started on 1/26/20 @ 6:00 AM.  Headache behind eyes pain level of 7 on 1-10 scale with slight light sensitivity.  Tired as in muscles are weak - not achy.  Upset stomach, taking dramamine every 4 hours.  No puking, but eating liquid diet with rice and crackers.
10CM X 5cm Red area, burning, itching, warm and painful to touch for eight to ten hours. Benadryl given by mother for relief.
Fever, Discoloration below the injection site, patient was immobilized-could not move arms and legs, could not dress herself or stand up or sit down without assistance. Patient reported overall body pain at a level of 7-8 on a pain scale. Pain and tenderness to the touch in shoulder blades, clavicles, and sternum. These symptoms persisted for 15 days.
I stared to cough, and my chest felt tight. I took an at home COVID-19 test that came back negative. A couple days later my respiratory issues had gotten worse, so I went to the emergency room. I was tested for COVID-19 and it came back negative. They gave me benzoate and I was sent home. About 8 days later I was still experiencing respiratory distress, so I went back into the emergency room. At that time, I tested positive for COVID-19.  I was prescribed Paxlovid. I still have a cough with phlegm. I am seeing a pulmonologist for the continuing respiratory issues. I am taking amoxicillin.
Patient presented for second dose of Pfizer Covid Vaccine.  Has history of anaphylaxis to red bee venom and experienced throat discomfort with first dose Covid Vaccination and received Diphenhydramine susp 25mg by mouth with improvement in her throat discomfort within 5 minutes of administration. Water proved. Patient physically examined by physician. Pulse Ox 99% at discharge home with husband who was driving.  Patient was advised on appropriateness of repeat dosage of 25mg Diphenhydramine if need later in the evening.
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 07-JUL-2014 the patient was vaccinated with second dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J014584, expiry date: 16-JAN-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
Initial unsolicited report received from a consumer (patient's daughter) on 09 June 2016. This case involves a 73-year-old female patient who was vaccinated with a first dose of Fluzone QIV (Batch number: UI422AB, expiration date: 30 June 2016, dose, route and site of administration were not reported) on 18 December 2015. Patient's illness at time of vaccination was not reported. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Alzheimer's Dementia. Concomitant medications were not reported. Other vaccinations within 4 weeks of vaccinations were reported as none. On 18 December 2015 at night, same day post vaccination, the patient felt ill, experienced head cold that progressed to a chest cold, swollen nose, sore throat, chest pressure pain palpitations a feeling like she would die of a heart attack. On an unspecified date, post vaccination, patient was lethargic, developed rash across her back and her hand turned blue, patients Alzheimer's has become progressively worse, patient was prone to outburst and destroying things and cannot hold a conversation, numbness in her hands and feet and pain in her mid-abdomen to her ovaries area. It was reported that the patient had a residual from Guillain Barre syndrome. It was also reported that the patient received her flu shot before traveling and the symptoms have returned. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. The patient was not recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical events Guillain Barre syndrome, lethargic, chest pain, heart palpitation, numbness in feet, numbness in hands, feeling abnormal, worsening of Alzheimer's dementia, outburst of anger and chest cold. List of documents held by sender: none. Sender's Comments: The reported events Guillain Barre syndrome is listed and worsening of Alzheimer's dementia is unlisted with INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is not compatible with the role of the vaccine. Further information for e.g investigative details. This case is not sufficiently documented. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
52 year old female who upon receiving her first dose of Pfizer vaccine, had a severe adverse reaction.    Before receiving the vaccination, all screening questions were reviewed with the client, when asked about any allergies, per client she mentioned that she did have some allergies to several medications (Percocet) and certain foods, which she avoided. When asked about severity, she said that she had itchiness, hives, and some swelling, but never required the use of an epinephrine pen. The client stated that she was anxious but otherwise in good health and that the only medications she was currently taking were steroids.    The client received the vaccine at 7:10 PM, because of her history of allergic reactions, she was asked to wait 30 minutes in the observation area. As the client was about to leave, she began to feel unwell, and ?felt dizzy? with ?the worse headache of her life?. She was moved from the observation area to a chair in the lobby. A set of vitals were taken by RN.    7:50 PM VS HR 70s, oxygen sat 99%, BP 180/119   At this time the client is AO and complaining of numbness in her lips and that her throat felt a little itchy. Upon exam, her lips appeared swollen. Throat and lungs were clear. 25 mg of Benadryl (lot# ADF032) was administered by RN and EMS was called. Client stated that it was difficult for her to swallow and that her headache was worsening. Client asked if she was on any medications for her blood pressure, which she stated she was on Amlodipine but that she was using it as recommended.    8:20 PM Client was complaining of worsening swelling, upon examination, swelling appeared to increase in the lips and throat. Stridor was noted upon auscultation, oxygen sat noted to be in the 80s. Client is lethargic and states that her ?legs feel weak.? Epinephrine pen (Lot # G210504X) 0.3 mg administered into the left thigh of the client. Fire Department arrived, client placed on oxygen via non-rebreather. EMS arrive shortly after and patient is moved to stretcher and per EMS is taken to the closest hospital (local) for further monitoring. Repeat VS at this time: HR 80, oxygen sat 100%, BP 225/109
Flu-like symptoms; joint pain; This is a spontaneous report from a contactable other-HCP. A 64-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on an unspecified date, lot number unknown, at single dose for COVID-19 immunisation. The patient medical history included breast cancer. The patient concomitant mediations included palbociclib (IBRANCE, strength: 125mg) by mouth at 125mg once daily at cycle: 21 days on, 7 days off from 2019 and ongoing for breast cancer. The patient previously received the first dose of bnt162b2 on an unspecified date, lot number unknown, at single dose for COVID-19 immunisation. The patient experienced flu like symptoms and joint pain after the injection but had now resolved (on unknown date). It was unknown if MD is aware but the patient was advised to notify MD of any symptoms.   Information about lot/batch number has been requested.
Reported nausea, tremors, "pressure" and "burning" in upper spine area.  Spasms in back.  Treated with Benadryl 50 mg IM, ibuprofen 800 mg PO, Valium 5 mg PO, and Benadryl 50 mg PO.  Reported to have hives that night also.
started having more like a period, but she was going through menopause before had been spotting only.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 12Jun2021 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization (to prevent the COVID; at least if patient gets it, she won't get it so hard). The patient medical history was not reported. The patient concomitant medication included vitamins nos (patient takes no prescribed medications, only vitamins) taken for an unspecified indication, start and stop date were not reported. The patient received other vaccine within 4 weeks prior vaccinations. The patient previously took shingles vaccine (both doses, administered in left arm). The patient experienced started having more like a period, but she was going through menopause before had been spotting only on 27Jun2021. Adverse event did not result in emergency room, physician office visit. Patient is a 60-year-old female patient who received her first dose of the Pfizer BioNTech COVID-19 vaccine two weeks ago. Then, four days ago she started having more like a period, but she was going through menopause before had been spotting only. She would like to know if the Pfizer BioNTech COVID-19 vaccine messes with her menstrual period. Patient stated she just turned 60 in February and was just spotting and was told that's part of menopause. Patient has been taking some menopause hormone menstrual support. Patient had her first dose of the vaccine two weeks ago and then maybe 3-4 days ago, she started having more like a period. Patient was talking with a friend who heard on the news two months ago that some Covid vaccines were messing with women's periods. Patient stated her second dose is due on 03Jul2021 and is 21 days after her first dose. Clarified with patient that her first dose was 12Jun2021. Investigations: patient said not yet to any tests, because this is her first experience patient has had. Patient stated she is taking it like it's a period. Patient stated she had the Shingles vaccine three weeks prior to the Covid vaccine. She was told she would have to wait two weeks. By the time she had gotten the Covid vaccine, it had been three weeks. This was her second dose of the Shingles vaccine, the first dose was almost six months before that. Patient stated she was achy and had an achy arm from the Shingles vaccine. The patient received treatment for the event. Outcome of the event was not recovered.  Information about lot/batch number has been requested. Additional information has been requested.
Redness, swelling, left upper arm. No tenderness. No fever. Full ROM. Ice 20 minutes out of every hour for evening (5/4/15). Ice 5/5/15 as often as possible.
second dose given 3 years apart form first / May 16th 2018/ May 28th 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th May 2018).   On 28th May 2021, the patient received the 2nd dose of Shingrix. On 28th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The pharmacist was looking for more data about a Shingrix second dose given 3 years apart from 1st dose to the patient, which led to lengthening of vaccinations schedule. The reporter consented to follow up.
infection; patient's armpit near site of injection is "incredibly painful" and "blue"; patient's armpit near site of injection is "incredibly painful" and "blue"; Fatigue; pain; This spontaneous case was reported by an other health care professional and describes the occurrence of INFECTION (infection), PAIN (pain), CONTUSION (patient's armpit near site of injection is "incredibly painful" and "blue"), AXILLARY PAIN (patient's armpit near site of injection is "incredibly painful" and "blue") and FATIGUE (Fatigue) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Jan-2021, the patient experienced PAIN (pain) and FATIGUE (Fatigue). On 15-Jan-2021, the patient experienced CONTUSION (patient's armpit near site of injection is "incredibly painful" and "blue") and AXILLARY PAIN (patient's armpit near site of injection is "incredibly painful" and "blue"). On an unknown date, the patient experienced INFECTION (infection). At the time of the report, INFECTION (infection), PAIN (pain), CONTUSION (patient's armpit near site of injection is "incredibly painful" and "blue"), AXILLARY PAIN (patient's armpit near site of injection is "incredibly painful" and "blue") and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The treatment reported was Bactrim for infection.
This spontaneous report received from a registered medical assistant refers to 52 year old male patient with no drug reactions or allergies who on 26-JAN-2015 was vaccinated with a dose of PNEUMOVAX 23 (lot # K008409, expiration date 04-MAR-2016), 0.5 ml, subcutaneous. On 28-JAN-2015 the patient experienced injection site pain, so the patient sought medical attention by office visit and was treated with unspecified antibiotic and unspecified pain medication. No laboratories diagnostic tests were performed. At the time of the report, the patient was recovering from injection site pain (reported as patient present status "doing well"). Additional information has been requested.
I was diagnosed w tinnitus/I started getting a buzzing in my right ear; the audiologist noted some damage most likely due to my booster .; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "I was diagnosed w tinnitus/I started getting a buzzing in my right ear"; EAR INJURY (non-serious), outcome "unknown", described as "the audiologist noted some damage most likely due to my booster .". The events "i was diagnosed w tinnitus/i started getting a buzzing in my right ear" and "the audiologist noted some damage most likely due to my booster ." were evaluated at the physician office visit.  Additional information: The patient had booster in November in approx. a week and a half and started getting a buzzing in the right ear that was relentless and the patient was struggling with it. The patient was diagnosed with tinnitus and the audiologist noted some damage most likely due to the booster. The patient hoping the vaccine would dissipate so that maybe this horrible buzzing subsided.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 58 years, in left arm 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's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; NATURE MADE CALCIUM + D + K. Vaccination history included: Flu vaccine (Known allergies: I am allergic to flu vaccine), reaction(s): "Known allergies: flu vaccine"; Flu vaccine (Other medical history: had guillian barre syndrome after flu shot), reaction(s): "had guillian barre syndrome after flu shot".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Previously healthy 18 year old developed severe headaches and photophobia with severe fatigue, body pain especially left and right upper abdomen associated with thrombocytopenia (plt. 61K) and abdominal rash over several weeks.  Patient was hospitalized with extensive work-up by infectious disease and neurological specialists.  No source found but she gradually improved but continues with progressive muscle pain, fatigue and daily headaches 6 month later.
Jaw is hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Jaw is hurting) 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 (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (Jaw is hurting). At the time of the report, PAIN IN JAW (Jaw is hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a registered nurse concerning a 21 year old female patient who on 16-OCT-2009 was vaccinated with the first dose of GARDASIL (lot # not reported). It was reported that on 16-OCT-2009 the patient was vaccinated and experienced two seizures about 5 seconds each and approximately two minutes apart. The nurse stated that the patient had not eaten all day. The nurse indicated that the doctor came into the patient's room and held her legs up while she had the seizures. The nurse stated that the patient had some vitamin water before she left the doctor's office. Lab diagnostics studies were not performed. On 16-OCT-2009, the patient recovered. The patient walked out of the office. Seizures were considered to be an other important medical event by the registered nurse. Additional information has been requested.
ears rang so loud it was painful; ears rang so loud it was painful; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 14Apr2021 (Lot number: ER0731) at the age of 46 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: METOPROLOL. Vaccination history included: Bnt162b2 (DOSE 1; Lot number: ER8727; Anatomical location: Arm left), administration date: 24Mar2021, for COVID-19 Immunisation, reaction: "ears rang loudly for 5 days". The following information was reported: TINNITUS (non-serious), EAR PAIN (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "ears rang so loud it was painful". Therapeutic measures were not taken as a result of tinnitus, ear pain. Additional Information: Patient had no other vaccine within four weeks. Patient stated that her ear is still ringing loudly. Patient had no COVID prior to vaccination and had not tested for COVID since the vaccination. Patient has no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021425336 same patient/drug, different dose/event