chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 24 hours after received PNEUMOVAX 23 patient started developing redness and swelling around the injection site. Patient was also experiencing fevers, body aches and vomiting. Of note patient also received the flu vaccine (unable to identify Mfr) in the left arm at the same time but no topical reaction developed from that.
little bit rash; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program  Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 12Apr2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her 1st dose on last Monday 12Apr2021. In Apr2021, after her 1st dose she experienced a little bit rash. The patient was scheduled to have her mammogram and pap smear on 21Apr2021. She asked if it's safe to get these procedures after her 1st dose. Outcome of the events was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Poor sleep, constant crying, vomited 11/16/04 PM and 11/17/04 PM, severe L small red spots on face, abdomen, irritable, difficult to console, would not let dad hold. Normally very agreeable/well child. Mother reported to MD 11/19/04.
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No medical history and concurrent conditions were reported. On 30-JUL-2015, the patient was inadvertently vaccinated with expired dose of VARIVAX (Merck) injection (lot # J003705 and expiry date: 27-MAR-2015) (dose and site of administration not reported). No concomitant medications were reported. No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
Shorter time between periods and very heavy including a lot of clots. Drops iron levels to very low levels which cause adverse effects on my body
pt recv vax 29FEB96 & 10APR96 pt found to have elevated liver function tests, specifically; SGOT & SGPT;pt other liver function tests were nl;pt has no sx;
Hot and clammy, some SOB, red blotchy flat rash over chest/trunk with pink face.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 17:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Apr2022 at 17:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300077638 Same patient, different product and event;
Pt mom reported that son's developed arm blister, redness. Local reaction 11 April 2009. Dr. made aware and advised pt to apply cold ice pack, and it keep dry and clean. Follow up if there's any other signs and symptoms.
Cried for 45 minute and seemed to have decrease balance. Child totally normal ? when seen in office. No fever.
Received 0.3 ml vaccine for first shot; A spontaneous report, was received from a consumer (patient), a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and resulted in patient received 0.3 ml vaccine for first shot (underdose).  The medical history of patient was not provided. Concomitant medication was not provided.  On 16 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown), intramuscularly for the prophylaxis of COVID-19 infection.   The patient confirmed that she received her first shot of Moderna COVID-19 Vaccine on 16 Feb 2021, and got a call from the pharmacist that she got a lesser dose of 0.3 ml instead of 0.5 ml. But there was no problem if the patient received more than 0.25 ml, or more and the patient will still receive her second shot. The patient was worried and would like to know if the pharmacist said was true and if the dose given to her was effective or not and needs to be repeated. No treatment mediation information was provided.  Action taken with second dose of mRNA-1273 in response to the event was unknown.  The event, received 0.3 ml vaccine for first shot, was considered recovered/resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of underdose for mRNA-1273, with no associated AEs.
Inflammation . hair loss, gut issues, chronic fatigue mother has autoimmune disease suggested i go see a endocrinologist and was diagnosed with hashimotos within a year after vaccine.
Besides lots of pain and fever, I am more concerned about the neurological symptoms which include tremors and strange symptoms on face as if walking into spider webs
Initial unsolicited report received from a nurse on 17-APR-2017. This case involves a 37-year-old male patient who was vaccinated with a dose of YF-VAX batch number: UI607AA, expiration date: 07-NOV-2018 (dose, dose in series and site of administration not reported), subcutaneously, on 12-APR-2017. Patient's has no Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medications were not reported. On 12-APR-2017, same day following the vaccination, the patient had body aches, fatigue, fever and chills. Lab data and corrective treatment were not reported. On an unspecified date, the patient recovered from the events. List of documents held by sender: none.
Pt reported sharp pain from injection site down left arm.  Reported 3 mins after vaccine and lasted less than 6 seconds.  No SOB, No CP or tightness.  Vitals:  BP 128/88,  HR 66, 97.8, 97%.  Patient stated she was feeling fine.  No further symptoms.  Total observation of 30 minutes completed.
It started as what I thought was a yeast infection with irritation but no drainage. Then I developed the bumps in the perennial area front to back. They were very sore, the soreness turned into nerve pain. It was so uncomfortable that when I went to urinate I would scream. I went to a doctor and he thought it was herpes. He did a blood test and a swab and it came back negative, he gave me antiviral and antibiotics. He referred me to the dermatologist and he thought it was herpes, but he had the negative result. He made the diagnosis of herpetic. It almost went away after 2-3 weeks and then flared up again. I saw him a couple of times over a 3 month period. He checked for fungus and bacteria and the tested came back negative. When the nerve pain went away it continued with inflammation in the area. He then diagnosed me with Lichen sclerosis. I have had 8 rounds of antibiotics and three rounds of acyclovir. Even though the worst episode of this has passed I still get flares up, most frequently when I have high stress. I have been treating it daily with AQUAPHOR. It has caused constipation and bladder issues.
Initial report received on 28 September 2009 from an investigator in the above mentioned trial. A 67 year old male subject developed high grade fever on 22 September 2009 few hours after receiving an injection of FLUZONE SV 2009-2010 on 22 September 2009. The subject had a medical history of diabetes since 1999 and was on unspecified medication. On 22 September 2009, the subject returned to the site with fever of 101.9 degree Fahrenheit. The investigator referred the subject to the nearest emergency room. The subject received corrective treatment with Magnesium Oxide 400mg orally. The event high grade fever resolved the next day on 23 September 2009. According to the investigator, the event was related to the study vaccine. The serious adverse event did not lead to the termination of the subject from the study. No documents were held by the sender.
Pt scheduled appointment for and received correct J&J Covid Vaccine that was requested.  There were no issues with processing nor provision. PT advised RPH that he had a problem with needles and experienced low blood pressure every time he was vaccinated or had blood drawn in the past but had done better the last time and did not want to miss out on getting the vaccine.  RPH was prepared and patient was cared for properly.  Pt arrived at 1244 hrs and was provided vaccine at 1247 hours. Patient was fine for about 1 minute and then reported he was having trouble.  Pt remained seated in booth in chair with room to get to floor if needed.  RPH remained with patient, brought his significant other into the booth to help calm the patient as he was alert and orientated and continued to improve while removed mask and fanned with papers (pt stated the fanning was helping).  Pt was improving slowly and moving/trying different positions as he felt he was improving.  At approx 1325 hrs pt knew he needed to lie down and moved himself to floor with the assistance of his significant other and associate (did not fall nor did head impact the floor at any time).  Code White was called.  PT remained alert and orientated and was talking and stated that this was really helping.  Code Team arrived and pt was continuously monitored until he gradually returned to his feet and was able to leave under his own power.  Pt refused medical attention and refused Ambulance - never lost consciousness so no EMT was called.  Pt's significant other was able to drive them home.  Event concluded at approximate 1345hrs.
Tiredness; Sleepy; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 04Mar2021 at 13:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had received concomitant medication within two weeks of vaccination which was not specified. 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 vaccination. On 04Mar2021 the patient experienced tiredness and sleepy. Since the vaccination, the patient had been tested for COVID-19. On 04Mar2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the events tiredness and sleepy were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Broke out in Blisters over his whole body including his mouth. His whole body swollen.
Diarrhea; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Diabetes and Acid reflux (oesophageal). Concomitant products included GABAPENTIN and AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient take Pepto Bismol for Treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: NNI
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years 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: "CAD (Coronary artery disease)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Paxlovid was taken as a result of therapeutic measures of drug ineffective, covid-19 from 20Sep2023 to 24Sep2023. Clinical course: Patient denied for any known allergies.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300318143 Same patient, different drug;
This spontaneous report as received from a physician refers to a 12 month old patient. On 16-AUG-2017, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 16-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013250: US-009507513-1708USA013251: US-009507513-1708USA013252: US-009507513-1708USA013253: US-009507513-1708USA013254: US-009507513-1708USA013248: US-009507513-1708USA013243: US-009507513-1708USA013244: US-009507513-1708USA013245: US-009507513-1708USA013246: US-009507513-1708USA013247: US-009507513-1708USA013249: US-009507513-1708USA013255: US-009507513-1708USA013242.
Student had gotten a flu vaccine on 10/07/20.  She came to the campus flu clinic on 1/26/21 and received another flu vaccine, her first dose being unbeknownst to the flu clinic staff.
Induration and erythema 9.5cm x 7.5cm deltoid area, no itching, no fever.
Child given vaccine at public clinic.  No history of previous flu shot.  Was sitting in waiting area at the time vaccine was given.  Approx 10 minutes later mother reported child had flushed cheeks.  15-20 minutes later blotchy areas observed in back and shoulders.  Sent to ER where Dr. gave benadryl.  Child recovered.
her tongue kind of burnt; right side of the face being "nummy; eye was watering; This spontaneous case was reported by a nurse and describes the occurrence of TONGUE DISCOMFORT (her tongue kind of burnt), HYPOAESTHESIA (right side of the face being "nummy) and LACRIMATION INCREASED (eye was watering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TONGUE DISCOMFORT (her tongue kind of burnt), HYPOAESTHESIA (right side of the face being "nummy) and LACRIMATION INCREASED (eye was watering). At the time of the report, TONGUE DISCOMFORT (her tongue kind of burnt), HYPOAESTHESIA (right side of the face being "nummy) and LACRIMATION INCREASED (eye was watering) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-033980 (Patient Link).
Information has been received from a physician concerning a 19 month old female patient who on 12-JAN-2010 was vaccinated with the second dose of VAQTA (663683/1715X). On 13-JAN-2010, one day after vaccination the patient experienced diarrhea. The patient experienced diarrhea 4-5 times per day. The patient was examined in the office on 18-JAN-2010 and was found to have a lost 1 and 1/2 pounds in weight. Testing revealed an elevated white blood cell count. A stool sample was negative for rotavirus and c. difficile. A stool culture and sensitivity was negative. The patient developed a fever of 101F on 19-JAN-2010. She was admitted to an medical center on that date. The patient was treated with intravenous hydration and OMNICEF. The patient was discharged on 21-JAN-2010, continuing cefdinir therapy as an outpatient. The patient was seen in the office on 26-JAN-2010 and was found to have recovered. Additional information has been requested. The patient was admitted to medical center.
REDNESS, SWELLING, PAIN, HOT TO THE TOUCH DX: CELLULITIS BEING TREATED WITH KEFLEX
Patient reports a daily headache since vaccination. No history of headaches prior to vaccination . Ongoing  as of 10/28/21
Acute appendicitis; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Acute appendicitis) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D211A, 011A21A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid disorder.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced APPENDICITIS (Acute appendicitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 11-Nov-2021 to 12-Nov-2021 due to APPENDICITIS. The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and Surgery (Appendectomy on 11-NOV-2021) for Appendicitis. At the time of the report, APPENDICITIS (Acute appendicitis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, Blood pressure measurement: elevated (High) Elevated. On 11-Nov-2021, Blood test: abnormal (abnormal) abnormal. On 11-Nov-2021, Computerised tomogram: abnormal (abnormal) Appendix was inflamed.. On 11-Nov-2021, White blood cell count: high (High) 30,000. On an unknown date, Blood test: normal (normal) normal.         Company comment: This is a spontaneous case concerning a 71-year-old female patient with no reported medical history, who experienced the serious unexpected event acute appendicitis that lead to hospitalization and surgery: appendicectomy. The event occurred approximately 17 days after the third dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.  Concomitant medication include thyroid replacement medication for her mal function thyroid. Symptoms: started on 09Nov2021. She had gastrointestinal pain on the abdominal area, nauseated, could not keep anything down, was throwing up, sick, tired and weak. 10Nov2021 pain worsened and she called her doctor. She was informed to monitor for a while. On 11Nov2021 she was admitted to the emergency department. Her test for white cells were 30 000 (normal upper limit:10 000). Blood pressure was elevated. When the doctor saw her blood, they suspected heart failure. Blood values were abnormal. CT Scan showed that the appendix was inflamed. On the same day at 11Nov2021, patient had surgery in the afternoon. She spend one night in the hospital and was discharged on the 12Nov2021.; Sender's Comments: Company comment: This is a spontaneous case concerning a 71-year-old female patient with no reported medical history, who experienced the serious unexpected event acute appendicitis that lead to hospitalization and surgery: appendicectomy. The event occurred approximately 17 days after the third dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient experienced mild alllergic reaction starting at 4:19pm. The ER staff came to tend to the patient. The patient reported dizziness and weakness. Her vitals are as follows: BP 142/80, O2-99% on room air, Pulse-98, Resp Rate-18, Temp-97.3F. The patient was taken to the ER and received Benadryl 50mg IV and an Epipen. The patient's pain was 0/10. The patient was reported stable at 4:27pm.
Information has been received from an investigator regarding a 3 month old female who received her first dose of Prevnar as part of a post-marketing safety surveillance trial. At 39 days, post vax, the infant died due to Sudden Infant Death Syndrome. Both the medical monitor and the investigator agree that this event was not related to the vaccine.  A follow up report received 4/13/2001 adds: Upon further review, this case is being forwarded to as a 15 day alert report per agreement with the FDA. MANUFACTURER'S NOTE: Upon case review on 04/11/2001, this report was found to be a duplication of report with case ID #HQ7326116FEB2001. Therefore, this case has been canceled and informational contents merged with HQ7326116FEB2001.
Pt arrived with confusion and fever. Pt was admitted with acute metabolic encephalopathy superimposed on baseline advanced dementia. Pt also had hypertensive urgency. She was found to be COVID-19 positive with fever, but no acute respiratory issues.
Patient outside of 42 days to receive 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient outside of 42 days to receive 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient outside of 42 days to receive 2nd dose). On 29-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient outside of 42 days to receive 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. Treatment information not provided.  "As per client, MO error in DOB capture".
8/23- 6 days after getting these vaccines, I experienced a red, cobbly rash with burning, stinging, & itching sensations in the left armpit. 8/24-Telehealth visit, provider diagnosed breakthrough shingles. Rx-Valtrex