chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse via field representative refers to a 18 year old male patient. The concurrent condition included no allergy. The patient had never passed out during sports. No family history of sudden cardiac death. There was no weight changes and no current vision abnormalities. The patient's medical history included headaches. On 12-FEB-2016, the patient was vaccinated with GARDASIL 9 (lot # L014415, dose 1, intramuscular in the left arm, dose not provided). No concomitant therapy was reported. After dose 1 was administered, the patient was discharged to waiting area. Approximately after 60 seconds in waiting area, patient suffered sudden loss of consciousness. Ammonia salts were applied but the patient remained unresponsive. There was onset of hand clenching and tightening but no clonic movements were noted. Oxygen mask was applied at 2L but the patient remained unresponsive. Oxygen was increased to 3L and the patient became responsive but very sluggish, pale, nauseated, lightheaded. Oxygen saturation was 99-100%, heart rate was 55, blood pressure was 108/62. Later emergency medical service arrived and blood pressure improved to 112/69 and pulse improved to 85. The patient was taken to the emergency department. The patient denied any chest pain or palpitation before losing consciousness. There was no loss of urine or tongue bite. All diagnostic tests for systems were normal. The patient was finally discharged with instructions to come back if he passes again especially if he don't get dizzy beforehand or if he has chest pain or palpitations. The outcome of the event was unknown. The causality assessment was not reported. No product quality issue was involved. The case was considered serious due to life threatening event. Additional information has been requested.
Hives developed on legs and trunk and back. 25 mg Benadryl given and observed for 30 minutes.
I had a sore arm for about a day after receiving the vaccine. On 12/16/2022, my eyesight was missing. When I looked straight at the dial on the washer and dryer, I could not make out all the letters/numbers. I went to the emergency room for observation. The doctor determined that I had trouble with my left center vision. I had temporary vision disturbance left eye. I had a follow up ophthalmologist. I am taking low dose aspirin until I get back home to see my doctor.
Patient recommended to restart Pfizer series by MD after receiving two Pfizer primary doses in another country, due to incorrect dose date recorded.
Initial and follow up information has been received from a nurse concerning a "70 - 80 year old" female who is a patient in a rehabilitation hospital, who on 11-JUN-2008 was vaccinated intramuscularly with PNEUMOVAX 23 (Lot # 657145/1226U; site not reported). It was unknown whether this was the patient's first vaccination with PNEUMOVAX 23. On 11-JUN-2008 the patient developed a "localized" injection site reaction. The reaction was a red, raised area of 3 - 6 cm at the injection site. The patient sought medical treatment by seeing the nurse and the injection site reaction was being treated with ice to the area. AT the time of reporting, the patient was recovering. No additional information was provided. This is one of three reports from the same reporter. No additional information is available.
This initial spontaneous case, was received on 26-Oct-2017, from a nurse, concerning a 53-year-old adult female patient. The patient's current conditions included type II diabetes, hypothyroidism, hyperlipidaemia, esophageal reflux and was reported as a smoker. The concomitant medications included, SYNTHROID, Aspirin, Metformin, OS-CAL, pantoprazole sodium, slow magnesium, Vitamin C, Vitamin B12, glucosamine/chondroitin, TRESIBA, NOVOLOG insulin, tramadol HCL 50, NAPROSYN. On 17-Oct-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 1721201, expiry date: Jun-2018). It was reported that, within 24 hours of vaccine administration, the patient developed headache, dizziness, decreased blood sugar (as reported). Even though, the insulin dose was reduced to half, the symptoms persisted. There was no pain, inflammation or redness at the injection site or discomfort. The patient felt unwell. The patient took ADVIL was taken for headache and got resolved. At the time of the report, the patient had not recovered from the events other than headache. The reporter assessed the events as non-serious.
Narrative: 11:31 Patient arrived in observation area for 30 minutes observation  status post first Moderna vaccination. At 1155 patients began complaining of feeling of mouth dryness, fullness in back of her throat and numbness in her lips. Patient was assess for symptoms of severe allergic reaction. She reported no difficulty breathing, or swallowing, dizziness, weakness or rash noted. 11:57 Vital signs stable 97.9. 18, 78, 143/95, 100% r/a. monitored until medics arrived. Patient decline use of EPI.
Headache started in about 5 minutes.  I got the Covid vaccine in my right arm.  A few days later, my arm was in a lot of pain.  At the same time, my hip and down to my knee, the pain was horrible.  For 3 weeks, I had to hold on to almost everything when trying to walk . . . the wall, furniture, kitchen cabinets, etc.  I also had a very hard time getting to my vehicle, almost fell every time.  And, when going into the grocery store (which is the only place I went while in the pain for 3 weeks) I had a hard time walking from the parking lot into the store, then holding on to the cart obviously helped me do shopping.  After the 2nd shot, I was still in pain in my hip for about 2 more weeks.
Nausea, vomiting & chills, photophobia, dry heaves, severe infraorbital h/a, light-headed, little glabellar pain; Poss rxn to Hep B vax;...SEE WORM;
Presented via EMS w/ tremors, onset 2 hrs prior. Incidently, Covid+ but asymptomatic. Did get Remdesivir on day 3.
Presented with worsening visual/auditory hallucinations and weakness; Dx: recurrent UTI and +covid infection;  Recieved antibiotics for UTI and low dose decadron for covid; on room air at discharge;
Patient presented to the ED on 4/16/2021 and 4/23/2021. Patient presented to the ED on 4/24/2021 and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, reported as multiple unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, anatomical location, lot# and expiration date were not reported). Administrated doses of GARDASIL 9 experienced temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes, on an unknown date. Temperature was logged with a data logger, and there were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Exhausted; sore; headache; This is a spontaneous report from a contactable consumer.  A 49-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced Exhausted, sore, headache on 18Jan2021. Outcome of events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 20-25 minutes after administration, pinky and ring fingers became tingly on both hands. Resolved on its own within 15-20 minutes.
Started with body aches about 14 hours after injection progress to severe joint and bone aches especially in hands and feet . Stabbing random headaches , fever 101, chills, sweating these symptoms lasted about 24 hours . Then about about 36 hours I woke up in the morning with swollen lymph nodes under left arm very painful. All other symptoms have gone but swollen lymph nodes are persisting current time since dose is about 48hrs.
The day after I got the shot (which was Sunday 1/10/21) I had very bad stiffness in my body. I felt like I was 100 years old, but on Monday 1/11/21 I was fine. This only lasted 1 day. ALSO, one week later, the injection site got swollen, red and itchy. (this was Saturday 1/16/21). This seems to be better now (meaning today 1/20/21). Other than that, I am fine. I did not need to see a doctor for these side effects.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 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 included: "Asymptomatic CAD" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "carpal tunnel" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01May2018; VITAMIN D3, start date: 10Jan2018; MAGNESIUM; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Erythromycin, reaction(s): "Known allergies:Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Nov2022) Negative; (13Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2weeks. The patient stated that they started Paxlovid on 04Nov2022. After completing paxlovid on wed 08Nov, she felt well and tested negative -2 days later. (Thursday 10Nov) On Sunday, 13Nov she started to have a mild sore throat and some nasal congestion and tested positive. She have continued with worsening symptoms positive. She have continued with worsening symptoms of nasal congestion ,cough , chills, body aches and low-grade fever.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Rash on chest with itchiness, 25mg IM Benadryl given on site. Observed in medical tent for 30-60 minutes, vitals stable rash resolved and patient felt much better without progression of symptoms.
positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable physician via a Pfizer-Sponsored Program. This physician reported the same events for two patients. This is the first of two reports. A patient of unspecified gender in their 20s received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. A physician reported that he had a patient who received their first dose of the Pfizer COVID vaccine and then in the interim the patient became ill. The patient was diagnosed COVID positive at some point after the first dose. He stated that the patient got sick with COVID. He wanted to know what the recommendations were for this patient. Should the patient get their second dose or wait? The clinical outcome of the event positive COVID-19 test was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021163951 same reporter/event/drug, different patient
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 30Oct2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid from 19Jun2022 to 23Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt came to clinic 4/10/2000 with complaint of redness and swelling at injection site. Upper left thigh with marked redness. Pt and mother called MD the eve of 4/9/2000 to state she was having redness at the site.
Myalgia pain sided pain down arm/leg. Leg cramp down the right side, spasms down the leg, hurt when she walked, while bathing, was unable to put any pressure on that leg. Similar pain down the right arm. Took Ibuprofen OTC. Today side effects are resolving.
9 days after the first dose patient developed rash on same arm vaccine was administered in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (9 days after the first dose patient developed rash on same arm vaccine was administered in) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (9 days after the first dose patient developed rash on same arm vaccine was administered in). At the time of the report, VACCINATION SITE RASH (9 days after the first dose patient developed rash on same arm vaccine was administered in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  No treatment information was reported.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose number unknown (booster), single (Lot number: GH9694) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "occasional flare up of diverticulitis" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (29Oct2022) Positive, notes: I tested positive for COVID on 10/29/22 (first known time contracting COVID); (08Nov2022) Positive, notes: On 11/8/22, I became symptomatic again with cold like symptoms and testing positive for COVID. It appears to be a rebound of symptoms for me. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient tested positive for COVID on 29Oct2022 (first known time contracting COVID). Provider prescribed Paxlovid on 29Oct2022. Patient began first dose evening of 20Oct22 and completed last dose morning of 04Nov22. She was symptomatic with COVID through 06Nov2022.  She was asymptomatic on 07Nov2022. On 08Nov22, she became symptomatic again with cold like symptoms and testing positive for COVID. It appears to be a rebound of symptoms for her.
pt recvd vax & had chest pain; stomach cramps & mild diarrhea;
Myalgia, Arthralgia, Fever, fatigue, chills, injection site red, swollen, warm and  itching Narrative:  lasted for 4 days
First shot: January 7, Second shot Feb 6, Got shingles on March 12th, it was a mild case and responded well to standard antiviral treatment, resolved within 2 weeks with no open sores
Information has been received from a registered nurse concerning a 12 month old female who on 18-MAY-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot # 0481X, which was valid for MMR). Concomitant therapy included a dose of PREVNAR given on the same day. On 18-MAY-2009, after receiving the vaccines, the patient developed three small hives on her left thigh. On 27-MAY-2009 the patient came into the office and was diagnosed with cellulitis on her left thigh. The patient was being treated with AUGMENTIN and BACTROBAN cream. At the time of this report, the outcome was unknown. The patients' parents were told to follow up with the office in 7 days. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a consumer of 77 year old female with a history of high blood pressure and drug reaction to niacin and stent put in 6-7 years ago, in approximately 2002, who on 20-FEB-2009 was vaccinated with ZOSTAVAX (Oka/Merck).  Concomitant therapy included SIMVASTATIN (MSD), vitamins (unspecified), aspirin and METOPROLOL.  When the patient woke up on 21-FEB-2009, at the injection site, which was on the back on her right arm there was red mark the size of a half dollar, then later on in the day there was swelling, itching and pain below the injection site.  The patient also reported that on the red mark were little bumps and it was also warm.  The patient stated that she called her physician on 22-FEB-2009 who came to look at the injection site and he thought it was some type of allergic reaction and gave her a prescription of HYDROCORTIZONE (Manufacturer unspecified) and she had been using it, since the then her reaction has been gradually getting better.  Additional information is not expected.
Administered MMR 3/1/2006, Headache 3/10, Encephalitis 3/14/06. Per 60 day follow up: Patient is still dealing with some memory loss.
AT 1052, patient waited 27 minutes due to elevated heart rate and anxiety. Afterwards, patient stated he felt ok and heart rate was 70. Instructed to go to the emergency room if symptoms resume and persisted greater than 30-60 minutes.
50 days after (4/12/21) 2nd Covid shot, broke out in Shingles visited UTC 4/16/21 got prescription for Valtrex 1000mg 3x daily
Ten days following this patient's Hep B # 2, the patient had petit mal seizure. The mother reports patient's head jerked back, and their was LOC for approximately 20 minutes. No signs and symptoms of tonic clonic movement. No residual effects seen by the MD. This patient was given extreme testing to determine cause of seizure. He was seen by a Pediatric rheumatologist. In the doctors opinion the rapid drop in Ana titer would indicate a reaction to the Hep B rather than an autoimmune problem.
one week after receiving the vaccine the injection site (left arm) swelled up, very itchy and sore, red (hive-like) about four by four inch square, itching, swollen, redness, pain has so far lasted two days - also including fatigue and nausea
according to ER doctor, I had a moderate localized allergic reaction to the injection site. Told me to monitor it for secondary infection. Also, very powerful, long lasting symptoms.
While being trained, someone grabbed the wrong vaccine to prepare for a patient. I noticed they grabbed the wrong thing because I work in immunizations frequently and know where everything is by placement. The trainee, didn't realize they grabbed the wrong thing and still didn't notice after I informed them. I brought the box in closer to them to show them the fine print of where one says Varicella and the other does not. I never thought it was an issue until they made me realize how easily the two can be confused, even through they are on different shelves.
Severe pain - upper (shoulder) - movement became limited. Received shot Sept. 29, waited approx. two weeks before seeing family Dr. Had X-ray and saw orthopedic, who diagnosed bursitis caused by shot. Have been doing therapy for this since I saw orthopedic.
Fever for 27 hrs, nausea, chills, body aches, headache, tiredness.  Fine by 48 hrs. post injection.
This spontaneous report was received from a consumer, referring to herself, a 66-year-old female patient. The patient's drug allergies included allergy to hydromorphone hydrochloride (DILAUDID) pain medication and scopolamine. On an unspecified date in November 2017, the patient was vaccinated with an unspecified pneumococcal vaccine; the patient said she believed this unspecified pneumococcal vaccination may have been with PREVNAR 13 but she said she was not certain, and PNEUMOVAX 23 could not be ruled out. Additionally, the patient was hospitalized because of a hip replacement that was scheduled prior to receiving the unspecified pneumococcal vaccine. Then, on unknown dates, the patient experienced hardening at the injection site, redness and pain that lasted about a week. Subsequently, the patient received an unspecified treatment for the events and  recovered from them on an unspecified date. On 26-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 in left arm (route, lot # and expiration date were not provided). Patient reported no injection site reaction at all after recent vaccination. At the time of this report, the causality assessment between the aforementioned events and PNEUMOVAX 23 was not reported.
Patient received second COVID vaccine on 6/4.  Chest pain developed on 6/6.  He presented to hospital where EKG showed ST segment changes and troponin was elevated.  he was transferred to our facility.  In our emergency department his EKG was abnormal.  His troponin was elevated, along with CRP, AST, and ALT.  An echocardiogram on 6/7 showed moderately depressed LV systolic function (EF = 34%).  He was admitted to the pediatric cardiology service.  His picture was felt to be consistent with myopericarditis.  During admission, he was treated with NSAIDs and lisinopril was initiated.  Repeated echo on 6/9 showed normal LV systolic function.  he was discharged home on 6/9 on ibuprofen and lisinopril with plan for pediatric cardiology follow up in 4-6 weeks.  Given proximity of patient's onset of symptoms to the second Pfizer vaccine, and given similar cases reported in the literature, the chief concern is whether this patient's symptoms were related to the second Pfizer COVID vaccine.  Please note, I did not care for this patient, but am reporting this case on behalf of the attending physician who cared for this patient while he was hospitalized.