chrisvoncsefalvay/vaers-outcomes huggingface dataset:
35yr old patient with unknown PMH presented on 4/6/21 at DPC office for J&J COVID 19 vaccine.  CMA administered JANSSEN COVID19 VACC (LOT # 043A21A, exp 6/21/21) IM in patient's right deltoid at 1330.  After receiving vaccine, patient complained of dizziness, flushing, and nausea.  No other symptoms endorsed.  At 1340, BP 72/34, HR 66.  Patient reclined and given water.  At 1347, BP improved to 93/57, HR 76.  Symptoms resolved with no other interventions.  Patient monitored.  Provider assessed patient and identified as vasovagal reaction to immunization.  Patient discharged home in stable condition.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 11 April 2007 from a physician. A 17-month-old male patient, with no concurrent illness, and who had a recent history of viral upper respiratory infection on 04 April 2007, had received on 09 April 2007, a third, deltoid, intramuscular injection of Acthib, lot number UE533AA (manufacturer lot number Y0271/2); and a fourth, deltoid, intramuscular injection of Tripedia, lot number U1369CA (The Acthib and Tripedia vaccines were administered as one product Trihibit); and a second, deltoid, intramuscular injection of Vaqta, lot number 1009F. The site (left or right) of administration for all three vaccines was not reported. The following day, at around 13:00 P.M., the patient complained of sore arm (site not reported) and had a fever of 101.0 degrees Fahrenheit. At around 17:00 P.M. that evening he began to have vomiting and diarrhea and around midnight, he developed a temperature of 103.0 degrees Fahrenheit an had a "febrile seizure". He was taken to the emergency room where he was diagnosed with "left otitis" and was subsequently treated and released. Treatments received and diagnostic test performed were not provided. The patient recovered.
Very large, red, itchy spot on the insertion spot; Very large, red, itchy spot on the insertion spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Very large, red, itchy spot on the insertion spot) and VACCINATION SITE ERYTHEMA (Very large, red, itchy spot on the insertion spot) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Very large, red, itchy spot on the insertion spot) and VACCINATION SITE ERYTHEMA (Very large, red, itchy spot on the insertion spot). At the time of the report, VACCINATION SITE PRURITUS (Very large, red, itchy spot on the insertion spot) and VACCINATION SITE ERYTHEMA (Very large, red, itchy spot on the insertion spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
When I woke up, I could tell my tongue was swollen. I took some BENADRYL to stop the swelling. By 2PM in the afternoon it had gotten quite big, and I could not talk. I went into the clinic, and they referred me to the emergency room. They indicated the I had swelling in my neck, throat, and tongue and they would admit me because it would shut off my air passage. They did give me medication and admitted me for observation, and I was released. I was taken off lisinopril also. I had been taking this medication for about 8 years. When I had a dose of Moderna in February of 2021, I had a similar reaction, but we were able to get it under control with BENADRYL. I was given a prednisone dose back. The medication that was given helped to resolve all of my symptoms.
Received Moderna on 5/9/23 and was put in the fridge.  Was used after the beyond use date of 6/8/23
NOSE CLOGGED; CHEST PAIN (DULL) LIKE THE FEELING YOU GET AFTER  YOU STUB YOUR TOE; DIARRHEA; FEELING  VERY TIRED; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: abstains from alcohol, and smoker, and other pre-existing medical conditions included: Patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, administered on 07-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 08-JAN-2022, the patient experienced nose clogged. On 08-JAN-2022, the patient experienced chest pain (dull) like the feeling you get after you stub your toe. On 08-JAN-2022, the patient experienced diarrhea. On 08-JAN-2022, the patient experienced feeling very tired. Treatment medications included: chlorphenamine maleate/paracetamol/phenylephrine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 08-JAN-2022, and had not recovered from nose clogged, feeling very tired, and chest pain (dull) like the feeling you get after you stub your toe. This report was non-serious.
Systemic: Flushed / Sweating-Severe, Additional Details: sweating, felt so hot immediately after the vaccine, and almost faint
Hip, thighs and buttocks pain  3 days after first vaccine, that then worsened dramatically after vaccine two.  Prednsione started 5/28 for likely Polymyalgia Rheumatica diagnosis, with improvement (not resolution) of symptoms within 2 days.
Patient reported with half-dollar sized bruise on and around injection site as well as a hard knot under the site of the injection without pain.
Approximately 12 hours after 2nd dose chills/sweating, fever, headache, fatigue, body/joint aches & loss of appetite.  All symptoms remained over 24 hours then began lessening approximately 36 hours after dose received.
Very sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of no adverse event (received several years ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The patient received the 1st part of this new vaccine (Shingrix) with just a very sore arm. For tolerance of 2nd dose of Shingrix, refer case US2021AMR000333.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR000333:Same reporter
temperature dropped from normal of 98.2°-98.5° to a sudden 97.2° woke up freezing cold even though house was same temperature as normal with normal blankets/covers
Employee reported to Health Services that she tested Positive for Covid on 6/4/2021, after having 2 doses of Covid Vaccine. 12/23/2020 & 1/13/2021
rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): (Novartis).  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown". Additional information: They therefore forwarded the information below relating to our product which was obtained by one of their employees during the normal course of business.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient admitted on 4/9/21 (unsure where they received J&J COVID vaccine on 3/6/21)   Per clinical pharmacist internal event report: Pt received Johnson and Johnson Covid vaccine on 3/6/21. Has chronic sub dural hematomas FYI (seen on scans in Feb).  Patient is a 80 y.o. female patient who presented with complaints of dyspnea and BLE edema and was admitted with a principal diagnosis of Acute on chronic congestive heart failure with left ventricular diastolic dysfunction (HCC). Cardiology consulted. Initially diuresed however became hypotensive. Patient had episode of slurred speech and disorientation on 4/11. Code stroke called.  CTH with stable SDH. CTA of head had no acute cerebral occlusion.    Incidentally was found to have bilateral PEs on CTA h/n. Full CTA chest ordered for further evaluation, noted extensive bilateral pulmonary emboli, associated with Rt heart strain. She was started on heparin drip, Dr. cleared with neurosurgery prior to starting on 4/11 given subacute SDH which has been stable on imaging. Heparin transitioned to eliquis.   Additional chart information:  ht: 5'4" weight: 108.3 kg CrCl: 50.3 mL/min platelets since admission: 160 - 173  Admission Diagnosis: Acute on chronic congestive heart failure, unspecified heart failure type (HCC) [I50.9] Expected discharge: 4/14/21  Active Problems:   Hypertension associated with diabetes (HCC)   Gastroesophageal reflux disease without esophagitis   Non-insulin dependent type 2 diabetes mellitus (HCC)   Seizure disorder (HCC)   Dyslipidemia associated with type 2 diabetes mellitus (HCC)   OSA on CPAP   Pulmonary hypertension due to left ventricular diastolic dysfunction (HCC)   Subdural hematoma (HCC)   Class 2 obesity due to excess calories in adult   Dizziness   Acute on chronic diastolic CHF (congestive heart failure) (HCC)  Hospital course: Patient is a 80 y.o. female patient who presented with complaints of dyspnea and BLE edema and was admitted with a principal diagnosis of Acute on chronic congestive heart failure with left ventricular diastolic dysfunction (HCC). Cardiology consulted. Initially diuresed however became hypotensive. Patient had episode of slurred speech and disorientation on 4/11. Code stroke called.  CTH with stable SDH. CTA no acute occlusion. Suspecting breakthrough seizure. Neuro consulting, EEG normal. Titrating up zonegran - patient will discharge on 100mg in AM and 200mg in PM.   Incidentally was found to have bilateral PEs on CTA h/n. Full CTA chest ordered for further evaluation, noted extensive bilateral pulmonary emboli, associated with Rt heart strain. She was started on heparin drip, Dr. cleared with neurosurgery prior to starting on 4/11 given subacute SDH which has been stable on imaging. Heparin transitioned to eliquis. Will need to follow up with PCP.   Valsartan was held on admission for hypotension. Blood pressure has remained well controlled off of all antihypertensives. She will need to follow up with PCP for further management of BP, may need valsartan resumed in near future. Patient is medically stable for discharge to home.
Large 4-5 inch rash w/ bump (very large), itchy, hot, fever; lasted approximately 1 wk. Pt used BENADRYL.
I had a long period which was similar to the period I had after my last chemotherapy treatment. I missed my period for two months. I lost hair on my right eyebrow, legs, armpits and pubic area and it will not grow back. I had rapid heart rate and extreme fatigue. All of these symptoms began after the second dose vaccine. It seems like the vaccine stirred up a reaction similar to chemotherapy symptoms.
off for a few days (2nd dose); head malaise (2nd dose); This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (off for a few days (2nd dose)) and MALAISE (head malaise (2nd dose)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 004M20A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included LEVOTHYROXINE, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE, TOLTERODINE L-TARTRATE (DETROL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (off for a few days (2nd dose)) and MALAISE (head malaise (2nd dose)). At the time of the report, MALAISE (off for a few days (2nd dose)) and MALAISE (head malaise (2nd dose)) outcome was unknown.            No concomitant medication information was provided.  No treatment medication information was provided.   This case was linked to MOD-2021-329388 (Patient Link).
I had chills, sore throat cough, I just didn't feel good, my eyes were blood shot red. I went to the doctor where they ran a COVID-19 test, influenza test. Both tests came back negative, I was diagnosed with an upper respiratory infection and pink eye. I was medicated eye drops for the pick eye and advised to continue with taking the Mucinex and Allegra-D for the upper respiratory issues.
Subj stated today was day 21 in her Pfizer treatment from 1st dose. After the injection was given it was discovered today was day 14 from 1st dose. Subj stated no adverse effects from the shot, and stated she was feeling fine.  I contacted health services who stated to complete this report and advise subj to seek further medical assistance if any issues occur. Subj left clinic with no issues. Vaccine was given at 11:06 today.
This only applies to the second dose received 3/23/2021. (No significant reaction to first dose). 11-12 hours after getting dose #2, fever and shivers; 102.9 F, and significantly elevated heart rate during sleep (4:00AM) @129 bpm! Similar thing occurred the following afternoon about 4 PM, and again between 4:00 AM and 5:00 AM up to 142 bpm
Horrible pain; Itching; Patient had 2 shingrix vaccines and contracted shingles a month ago tomorrow/ Suspected vaccination failure; Shingles on scalp and left side ear; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JUN-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Patient had 2 shingrix vaccines and contracted shingles a month ago tomorrow/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on scalp and left side ear). On an unknown date, the patient experienced pain (Verbatim: Horrible pain) and pruritus (Verbatim: Itching). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, pain and pruritus to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two doses of Shingrix vaccine 2.5 years ago and he or she contracted shingles a month ago tomorrow. The patient stated that he or she had shingles on his or her scalp and left side behind the ear. The patient had horrible pain and itching. The patient stated that hope the vaccine would protect him or her. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Suffered from chills,nausea,fatigue,fever,headache,body ache.
Patient returned to stoer approx 3 hrs after shot stating felt like something was stuck in her chest or throat and she had been coughing since getting shot. No other symptoms reported. Advised if continue seek medical attention and referred to on-site minute clinic for further asessment if patient wished.
Far sided vision was normal prior to the vaccine.  Since having the vaccine, my far sided vision has dramatically decreased.  And now requires 2.00 cheater glasses,
rapid heart rate; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 9-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (orange cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "rapid heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was presented as a consumer but already had a file here which registered her as an HCP Caller is asking if Pfizer BioNtech Covid-19 orange cap monovalent has been associated with rapid heart rate in children. case is non-serious. Caller was asking if Pfizer BioNtech Covid-19 orange cap monovalent has been associated with rapid heart rate in children.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sore left side of left breast; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Feb2021 at 12:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN), multivitamin (MANUFACTURER UNKNOWN) and vitamin B complex (VITAMIN B) supplement, all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021, the patient experienced sore left side of left breast. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore left side of left breast was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
4/6/03 pt here today to receive his 3rd anthrax vaccination. He has had some questions regarding possible reaction from the anthrax vaccine. He informed me that since he had his 1st anthrax vaccine on 2/7/03 he has been having recurrent headaches. He states that he never had headaches before receiving the anthrax vaccine. He states that his headache began approximately 2 days after having received his first anthrax vaccine. He describes the headaches occurring 2-4 times per week, located on the top of his head. he graded them as a dull headache, as a #2 on a scale of 0-5 scale. He could take a couple of ASA and the headache would go away. He also noted some bruising that occurred on 2 locations. One small bruise on his L anterior forearm measured approx 2cm in diameter.his second bruise was located on his L side between his lower thoroc and his L illiac crest. Both bruises lasted approx. 2-3 weeks and then dissipated. He has had a total of 3 anthrax vaccines. His headaches have become less frequent and less intense as time has gone. He denies having any headaches following his 3rd vaccine.
Patient was given Men B (BEXSERO) when he was supposed to receive Hep B. Patient was notified. No adverse effects.
Received the vaccine @15:20pm, c/o feeling tingling, slightly swelling to tongue and throat @15:55pm.  Symptoms resolving @16:15pm
Information has been received from the patient's mother, concerning a 6 year old male patient. The patient's concurrent condition and concomitant medications were not provided and there was reported that the patient did not experienced chickenpox, herpes zoster or herpes zoster ophthalmic as a medical history. The patient had recent exposure to chickenpox from another patient case (MARRS #1712USA014554). On 29-NOV-2012, the patient was vaccinated with two separates doses of VARIVAX (dose, frequency, route of administration, lot number and expiration date were not provided) for prevent chicken pox.  Furthermore, the patient was also vaccinated on 17-NOV-2016 with PROQUAD (dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. On 28-NOV-2017 (also reported as 29-NOV-2017), the patient developed a rash on one side of his body, left upper torso wrapping to under arm 5-6 varicose clostridium and 2 individuals spots on right side after diagnosis. On 29-NOV-2017, the patient was taken to a doctor and was diagnosed with shingles. A sample was collected on 05-DEC-2017 and showed skin vesicle lesion, papule, rubbed skin cells from rash area. The outcome of shingles was reported as still has rash (not recovered). The causal relationship between the adverse events and the therapies was not assessed. This is one of two report received from the same reporter. ; Sender's Comments: US-009507513-1712USA014554:
Immediate feeling of rush from head to toe with tingling and numbers of her extremities, nervy, and felt not right.  Also had dizziness, tachycardia,   Later blood pressure was taken but it was normal.  Since then she is not feeling normal.
Face and eye swelling and blotchy rash to face.  Localized reaction with redness, warmth, and swelling to left thigh.  No wheezing or distressed breathing, no vomiting, no lip or tongue swelling.  Vitals remained stable.  Treated with oral Benadryl, oral Decadron, and oral Tylenol.