chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Nausea; Chills; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHEST PAIN (Chest pain). On an unknown date, the patient experienced PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, CHEST PAIN (Chest pain), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Hi,  I took the Moderna vaccination on last Friday, March 19, 2021 between 12:40-1:00pm and I have been experiencing some side effects from it. So far:  Friday, March 19, 2021 - spot where I received shot very tender and sore  -took Tylenol because my head started to hurt this evening  -body started aching later tonight -woke up extremely hot and sweaty  Saturday, March 20, 2021 -head hurts...I took Tylenol  -woke up to wet clothes, had fever while sleeping overnight, I guess -feeling weak; real tired and sleeping a lot  -not hungry  -body aching bad; hurt to get out of bed and even walk -whole arm aches; not just in the spot I received the shot   Sunday, March 21, 2021 -head hurts so I took Tylenol  -still sleeping a lot -woke up to wet clothes again ; don?t know if I had fever while sleeping overnight or not but I was hot  -still feeling weak, tired and sleeping a lot  -only ate a little...didn?t want the rest of my food -woke, this evening, with fever blisters all inside and on top of the sides of my nose. I used Carmex on it.  -body still aching all over...sides, arms, shoulders, lower back, legs, butt, etc -spot where I received shot is hard, still aching and itching -really sore under my arm (armpits) and on the upper side of my right breast -hurt to get out of bed and even walk  Monday, March 22, 2021 -missed work because I?m still sore -woke with the fever blisters that are inside and around the outside of my nose and on my lower lip hurting real bad; small blisters on my face and on the outside of my nose are larger. They are tightening. I?m continuing to use Carmex.  -blisters on the left side of my face next to my nose  -arm and under my arm is still really sore and the upper side of my right breast  -spot where I received shot is still sore, hard and  itching more. Hurts when I raise my arm still.  -lower back still aching and my legs too
Days after the vaccine, inflammation and pain in the area of the puncture. It went away after 3-4 days. However, a week after the administration of the vaccine I woke up with significant inflammation with pain in the same area.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: PATIENT CAME IN TO GET 2ND COVID VACCINE AT 12 PM. AFTER VACCINE PATIENT SAT IN OBSERVATION AREA. AFTER ABOUT 6 MINS, PATIENT STATES BLURRED VISION, HE TRIED TO GET UP BUT THEN FELL TO THE GROUND. PATIENT WAS HELPED UP AND GIVEN WATER. AMBULANCE WAS CALLED IMMEDIATELY. PATIENT STATED HE DID NOT EAT ANYTHING WHICH COULD BE THE CAUSE OF THIS. EMT ARRIVED CHECKED PULSE AND BP. PATIENT WAS NORMAL. PATIENT REFUSED TO GO TO ER. PATIENTS DAD ARRIVED 20 MINS LATER TO DRIVE PATIENT HOME.
on 13Feb test was postive/she came down with Covid; on 13Feb test was postive/she came down with Covid; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 22Jan2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was supposed to be due for her 2nd dose on the week of 09Feb2021 but then she came down with Covid on 13Feb2021. She was starting to feel better but she still has some symptoms which was generally a bad cough. The patient tested negative on 09Feb2021 and second test 12Feb2021 negative and they sent it out and on 13Feb test was positive. She had a chest X-ray and that came back negative, but she was still coughing. She was tested again yesterday and awaiting the results. She was asking how long she needs to wait to get the second. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Started menstrual spotting roughly 24-36 hours after injection, despite not having had any menstrual bleeding since the insertion of the IUD. Some menstrual cramps, but nothing too painful.
A physician reported that a 6 month old infant received Rota Shield, DTAP, HIB and Hep-B vaccine on 6/17/99. On 6/20/99, the infant developed a fever up to 102F. The infant was seen by the physician, who prescribed Tylenol. Follow-up information received from the physician on 9/14/99, indicated that the pt received Rota Shield, Acel-Imune, Hib-Titer and Comvax (Merck) vaccines on 6/17/99. On 6/20/99, the infant developed a fever of 102F. White blood cell count was 5,500 k/UL, urinalysis was "normal" and blood culture was negative. The infant recovered within 48 hours.
She got very sick from it; her immune system was depleted; got COVID around 10-Jan-2023; 3-week bout of bronchitis; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (She got very sick from it), IMMUNE SYSTEM DISORDER (her immune system was depleted), BRONCHITIS (3-week bout of bronchitis) and COVID-19 (got COVID around 10-Jan-2023) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (ampicillin).    On 23-Sep-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced COVID-19 (got COVID around 10-Jan-2023). On an unknown date, the patient experienced ILLNESS (She got very sick from it), IMMUNE SYSTEM DISORDER (her immune system was depleted) and BRONCHITIS (3-week bout of bronchitis). At the time of the report, ILLNESS (She got very sick from it) and IMMUNE SYSTEM DISORDER (her immune system was depleted) outcome was unknown and BRONCHITIS (3-week bout of bronchitis) and COVID-19 (got COVID around 10-Jan-2023) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient reported allergies and no other medical history.  No concomitant drug was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient received Moderna first dose on 1-FEB-2021, lot number: 037K20A, second Moderna dose on 03-Mar-2021, lot number: 043L20A, on 25-Oct-2021, patient received first Moderna booster, lot number : 026D21A, on 01-Mar-2022, patient received second Moderna booster (unknown lot number), on 5-Apr-2022, received third booster (lot number : 002M21A).  Patient wondering if she should be getting another booster because she would be traveling at the end of the month. She got COVID around 10-Jan2023, even after all those boosters. She got very sick from that. Patient had a 3-week bout of bronchitis right before that. The patient was told that her immune system was depleted, so she got COVID. That kicked her.   Patient was put on the drug that people get with COVID (drug name was unknown). It was an awful drug to take, but patient had to take that because she was really sick.   This case was linked to US-MODERNATX, INC.-MOD-2023-714077 (Patient Link).
This case was reported by a consumer via out of hour services and described the occurrence of fever in a 54-year-old female patient who received SHINGRIX. On 9th May 2018 12:05, the patient received the 1st dose of SHINGRIX. On 10th May 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. The reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: At 12:05, the patient received SHINGRIX. A day after receiving the SHINGRIX vaccine, the patient experienced fever (body temperature: 101.8 degrees F). The reporter gave permission to contact their healthcare provider.
vaccine was administered in error as a subcutaneous vaccine rather than the recommended intramuscular vaccine, pt did not report any adverse effects
Pt c/o headache, very strong headache while at work at the clinic, BP was 191/93, was given Captopril 25 mg, rested for about 20 min and then became nausous.  Ambulance was called and transported her to  Hospital. On arrival to hospital, BP 200/101, Tx w/Benedryl and antinasuea medication. CT Scan of head was done, which showed normal CT of brain without contrast.  Headache resolved the next day. ER doctor advised that she not get the 2nd Covid vaccine dose,  CMO at Health Clinic also agrees.
Bump at the sight of the vaccination.; Extremely itchy.; Also little red bruise; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: EL9264) via unknown route of administration on 28Jan2021 06.00 PM in left arm as dose 1, single for COVID-19 immunization at Hospital. Medical history and Concomitant medications received within 2 weeks of vaccination were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. It was reported that patient had bump at the sight of the vaccination. extremely itchy. also, little red bruise on 04Feb2021 06:00 PM. Don't have any pain. No treatment received for the adverse events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient became dizzy, c/o feeling hot and weak immediatly after receiving Influenza vaccine. Vital signs 140/70 BP and pulse 80, random blood sugar 66. Patient continued to c/o weakness, syncope and feeling hot apprximately 20 to 25 minutes and was transfered to the E.R. by ambulance. Pt was discharged in stable condition the same day from the E.R. with the Diagnosis of adverse reaction to Influenza vaccine.
This spontaneous report as received from a consumer refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, expiration date, dose and route of administration were not reported). On an unknown date, the patient developed shingles. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
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 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Oct2021 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE SODIUM. 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, notes: Treatment of 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.
Received 2nd dose of the vaccine that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Approximately one week after the vaccine was administered, I noticed my arm was sore again and it began itching a lot. There was a large, red, itchy and painful area on my arm for over a week. Two days after this started, I had a day of not feeling well. I did not notice a fever but had a bad headache, was nauseous and tired. The next day I felt okay. I do not have any lingering effects now.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients received improperly stored PEDVAXHIB (lot # M001811, expiration date 04-NOV-2018; route and dose were unknown). No adverse effects was reported. This is one of two reports received from the same reporter. Additional information has been requested.
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took Booster dose flu-like symptoms was reported by some patients.  Date the vial was initially stored in the refrigerator 01-DEC-2021 The vial did not undergo any temperature excursions.  No concomitant medication details was provided. No treatment medication details was provided.
Upon administration of vaccine the patient complained of slight dizziness, at the customer request we gave her a candy bar. Vitals were taken. Pulse and blood pressure were within normal limits. The patient remained in the pharmacy for 30 minutes we called the clinical pharmacist, and reported the event and sought guidance. After 30 minutes the patient left the pharmacy with no apparent problems. The patient was followed-up on 8/12/11 and the patient stated she was doing fine. The patient will be followed up on 8/13/11 for further evaluation.
PFIZER-BIONTECH ADMINISTRATION ERROR:  1ST DOSE WAS MODERNA.  PFIZER GIVEN FOR 2ND DOSE OF PRIMARY SERIES. NO EXCEPTIONAL CIRCUMSTANCES NOTED BUT IS NURSING HOME STAFF WITH VACCINATION MANDATE.
Headache (HA); Slight fever; This is a spontaneous report from a contactable consumer (father-in-law). This consumer reported similar events for two patients. This is the first of two reports.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date), via an unspecified route of administration, on an unspecified date at an unspecified dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache (HA) and slight fever on an unspecified date. The outcome of the event was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021031244 Same reporter, drug, and event, different patient
Information has been received from a Registered Nurse (R.N) concerning an "about 20-25 years" old male patient who in approximately 1999, "about 10-12 years", was either vaccinated with a dose of RECOMBIVAX HB or a dose of ENGERIX B (Lot #, dose and route not reported). The registered nurse reported that on an unspecified date, the patient developed 2-3 hives on the leg. On an unspecified date, the patient spoke to a physician. It was unspecified if there was given any treatment for the event. On an unspecified date, the patient was recovered. Additional information has been requested.
9/8/09 left upper arm tingling, radiating up left side of neck to jaw, started 10 minutes after vaccine in left arm. Lasted several hours, faded out. Headache started around same time and continued to 14:00 9/8/09.
Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report as received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
pt recvd vax;w/in 12-24 hrs, devel inflam at inject site & a knot below inj site;
On 12/29/13 - pt called of local reaction - redness, itchy rash in the area of Hep B administration.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-JAN-2015 the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II single 0.5ml dose  (HSA, lot #J006136, expiration date 22-OCT-2016, dose and route were unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 456 hours with the highest recorded temperature of 6 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Rapid heartbeat, extreme thirst 3 hours later. Typical side effects started 18 hours later and some still ongoing now for 10 days. Day 9- extreme dry mouth/throat started
pt devel abscess approx 6wk later which drained & spread to lymph nodes;approx 2-3 1/2 months later pt devel a second abscess DEC95/JAN96 4cm toward the underarm which opened & drained;
On 11/3/98 pt exp worsened diarrhea, on 11/9/98 pt exp runny nose, congestion w/ cont diarrhea, on 11/10/98 pt hosp due to diarrhea & dehydration, testing led to dx of severe combined immunodeficiency syndrome.
patinet had tingling sensation 3 days after the vaccine was given, which subsided over time but still has symptoms. discussed with primary doctor and will monitor the symptoms
Pain in arm, for 8 days. Fever 101F, for 4 days. Chills, for 4 days.  Muscle pain and weakness in legs and bladder muscles, for 5 days.  Muscle weakness in legs continued for 4 more days (9 total).  Mild nonspecific chest pain for 3 days, shortness of breath for 8 days.  Took ibuprofen for fever and muscle pain.
Developed acute onset neck and shoulder pain on 4/10/13. 4/13/13-treated in ER for robust take of SPV site. 5/13/13 - saw a neurologist, dx'd as neuralgic amyotrophy.
Insomnia, overheating with sub normal temp 98.1 at 2am. Followed by headache that lasted 12 hours
Metallic taste in mouth 14mins after injection. Minor tongue swelling, increased saliva production. Resolved within 3hours. No treatment or other medical intervention required.
Patient received first dose with Heplisav-B, and second dose with Engerix; Initial Report Received on 11-OCT-2022  This is a spontaneous report, received from a pharmacist regarding a male patient, aged 42 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 25-AUG-2022, dose 1 of HEPLISAV B (Lot #937781, expiration date 20-SEP-2023, NDC #43528-003-05), route not specified, was administered in the left deltoid for hepatitis B immunisation.  No concomitant medications at the time of vaccination were reported.    On 28-SEP-2022, 35 days after having been vaccinated with HEPLISAV B, the patient was vaccinated with Engerix-B. The patient has not   The outcome of the adverse event was not reported.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
swelling at site, very sore, actual injection site is swollen up more than surrounding swollen area of about 2 inch round
Patient was to receive monovalent Covid Pfizer vaccine for 1st dose in series.  Pt inadvertently was given the bivalent booster instead of 1st dose monovalent.  No adverse outcome, however we will give him his 2nd monovalent dose as per regular course, and continue regular course moving forward.