chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT REPORTED LIGHT-HEADEDNESS AND DIFFICULTY BREATHING (BUT NOT SWELLING IN THE FACE, MOUTH, OR THROAT) STARTING ABOUT 5 MINUTES AFTER VACCINE ADMINISTRATION. NO VISIBLE RASH OR HIVES BUT PATIENT REPORTED FEELING WARM AND THAT HER HANDS AND LATER LIPS WERE TINGLY. 911 WAS CALLED, FIRST RESPONDERS MONITORED BLOOD PRESSURE, PULSE RATE, AND O2 SATURATION. ADMINISTERED IV DIPHENHYDRAMINE. PATIENT REPORTED FEELING BETTER SHORTLY THEREAFTER. PATIENT WAS MONITORED ABOUT 30 MINUTES AND THEN RETURNED TO WORK.
Minutes after Pt received her Pfizer Booster she said that she was experiencing a super tight chest, shortness of breath, trouble swallowing and a very dry mouth. After about 5 minutes she started to experience itching in her throat and some shaking. Her blood pressure and heartrate were both elevated but her O2 levels were steady around 98-99 percent.
Injection given Friday Sept 10 around 10:30-11:30 am Sat around 10:30 metallic taste in mouth, Sat weak, dizzy, very nauseous heart beating really fast, Sunday sweating, wheezing unable to catch breath last a short time 5 min. It's been 5 days now still not  feeling good heart rate fast headache.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 10-JAN-2017, the patient was inadvertently vaccinated with an expired dose of PROQUAD injection, subcutaneously, lot # L024122 with expiry date 30-DEC-2016 (exact dose was not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Additional Details: Patient was very anxious about this particular vaccine and hated needles - 5 minutes after she was pale, sweating, and throwing up. She waited here for 30 minutes and then said she felt back to normal and left.
Approximately 7 hours after injection pt experience painful movement of arm used cold compress, pain greatly reduced next morning. By day 3 pt was not experiencing pain.  She asked Pharmacy to file and incident report.
I actually had COVID-19 back in November and my reaction to the Moderna first shot was twice as bad as the initial COVID-19. I was very weak, lethargic, unable to move quickly and basically felt like crap. It is now two days later and I still feel badly. It makes me truly wonder if I should take the second shot. I?ve heard that it?s the worst one and I can?t imagine feeling worse than I did the day after the initial shot. I?ve heard that they?ve had a problem with people coming in for the second shot and now I totally understand why. I would appreciate some sort of response to this.
Approximately 2 weeks after the vaccine, I had an outbreak of shingles. I am perfectly health, no flu symptoms. Nothing else out of ordinary except receiving the flu vaccine.
2 days after inj. - had localized cellulitis- red-warm to touch 6 cm x 6 cm.
I awoke with a slight headache and a stuffed nose. When I blew my nose and cleared my throat there was a dark brown, grainy substance in the nasal and throat mucus. this persisted for about 20 minutes and then cleared. I've not had any repetition of this since.
Can't move other than to go to the bathroom after 2nd dose; Muscle twitches after 2nd dose; Pressure in head after 2nd dose; Extremely fatigued after 2nd dose; chills after 2nd dose; body aches after 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Can't move other than to go to the bathroom after 2nd dose), MUSCLE TWITCHING (Muscle twitches after 2nd dose), HEAD DISCOMFORT (Pressure in head after 2nd dose), FATIGUE (Extremely fatigued after 2nd dose) and CHILLS (chills after 2nd dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (Can't move other than to go to the bathroom after 2nd dose), MUSCLE TWITCHING (Muscle twitches after 2nd dose), HEAD DISCOMFORT (Pressure in head after 2nd dose), FATIGUE (Extremely fatigued after 2nd dose), CHILLS (chills after 2nd dose) and MYALGIA (body aches after 2nd dose). At the time of the report, MOBILITY DECREASED (Can't move other than to go to the bathroom after 2nd dose), MUSCLE TWITCHING (Muscle twitches after 2nd dose) and HEAD DISCOMFORT (Pressure in head after 2nd dose) outcome was unknown, FATIGUE (Extremely fatigued after 2nd dose) had not resolved and CHILLS (chills after 2nd dose) and MYALGIA (body aches after 2nd dose) had resolved.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.
Tingling; Headache; This is a spontaneous report from a contactable consumer reporting for husband (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL9265), intramuscularly in left arm on 07Feb2021 (at the age of 66-years-old) as single dose for covid-19 immunization. Patients medical history included prostate cancer treated with unspecified medication on an unknown date (diagnosed about a year ago in Jan or Feb) and is cancer free now. Concomitant medications were not reported. On an unknown date in Feb2021, the patient experienced tingling and headache. The reporter stated that her husband was specific where his tingling was but did say that he had tingling after the shot. The reporter stated that she does not know when her husband started experiencing the tingling after his vaccination and said that she does not know if he was still experiencing the tingling. She said that he may have noticed the tingling the next day or the day after. The patient was treated with Ibuprofen for the event headache. The outcome of the events was unknown.
CHILLS; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; Moderna: Dose number=3 / Pfizer/BioNTech: Dose number: 2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Mar2021 at 11:00 as dose 1, single (Lot number: Ep7533), in left arm and on 18Apr2021 at 12:00 as dose 2, single (Lot number: EE0169), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Apr2022 at 14:00 as dose 4 (booster), single (Lot number: o49L21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2008, stop date: 23Jan2023; LEVOTHYROXINE, start date: 01Jan2008, stop date: 05Feb2023; TRAZODONE, start date: 01Jun2022, stop date: 21Jan2023. Not known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Nov2021 at 13:00, outcome "unknown", described as "Moderna: Dose number=3 / Pfizer/BioNTech: Dose number: 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jan2023) Positive, notes: first ever positive test; (03Feb2023) negative; (05Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
blood filled right eye/My eye was diagnosed with hemorrhaging; sore arm; mild headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199), via an unspecified route of administration at left arm on 08Mar2021 at 15:15 at single dose for COVID-19 immunization. Medical history included acid reflux. The patient has no known allergies and has no COVID prior to vaccination. Concomitant medications included omeprazole, naproxen, and calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS). The patient has no other vaccine in 4 weeks. The side effects started the day after the shot, on 09Mar2021 at 05:00, the patient reported that his arm was sore, and he was having mild headache that lasted throughout the day. Two days later (as reported), he woke up with headache and blood-filled right eye. After being seen in the ER, at the advice of his primary doctor, they sent him to a retinal and macular surgeon. His eye was diagnosed with hemorrhaging and he was prescribed a medication. The patient has follow-up visits scheduled to check on the progress of his eye. He was not tested for COVID post vaccination. Therapeutic measure was taken as a result of the events and included treatment with prednisone. The outcome of the events was recovering.
Passed out; A spontaneous report was received from a consumer concerning a 77-year old female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient passed out.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273. Batch number not provided on an unknown date.   On 09 Feb 2021,  prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273: LOT 041L20A. intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 10 Feb 2021, She got up this morning and passed out while standing at the kitchen island for 2-3 minutes. She wants to know if she should be checked out.   Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pink blotch at injection site.  1/12/21  was 6cm by 3 cm. 1/13/21 has diminished in size by half. warm to the touch.
Local reaction - redness, swelling, warmth of entire left upper arm. No systemic symptoms.
This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included tennis elbow. On 22nd January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved. It was unknown if the reporter considered the injection site muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on right arm. The patient had intense pain at the injection site for a while but that had resolved and she noted she couldn't sleep on her arm for 2 to 3 nights. The patient now had a nagging muscle pain still at the injection site. The patient also noted she was supposed to get a cortisone shot in the same arm for tennis elbow in a few weeks. The patient noted she had made her physician aware. The reporter consented to follow up.
Chicken pox rash, we took her to the doctor and they said it was an allergic reaction, it was a chicken pox rash. She had the rash for 2 weeks and then her immune system crashed. Constant fevers, throwing up for 2 more weeks. New allergies to things we could not yet identify. Really irritable. For the next 2 years she was sick every 2-3 weeks with some major health problem, we had to take her back into the doctor every time she got sick with anything because her symptoms were more severe than a normal baby's symptoms would be.
DEATH; HEART PROBLEMS; This spontaneous report received from a consumer via a company representative concerned a male of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was perfectly healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 01 total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after vaccination the patient experienced heart problems in two weeks.  On an unspecified date, the patient died from an unknown cause of death. It was unknown if an autopsy was performed or not. The reporter states "My friend had the shot, went from perfectly health to having a serious heart problems in two weeks. He just passed and his death certificate lists contributing factors as unknown". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of heart problems was not reported. This report was serious (Death). This case, from the same reporter is linked to 20221209280.; Sender's Comments: V0-20221211945-Death . Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
pain at injection site; started approximately 6 - 7 hours after shot ( I am right handed so my left arm is not as active as might right); This is a spontaneous report from a contactable consumer (patient). A 71-years-old non-pregnant female patient received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date was not reported), via an unspecified route of administration administered on left arm on 06Mar2021 at 08:30 hours(age at vaccination: 71 years) at single dose for covid-19 immunisation. Patient had no medical history except cholesterol from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took atorvastatin (Lipitor) and experienced allergies (dosage had been reduced several times in past). The Patient had not received other vaccine in four weeks. Concomitant medication in two weeks included atorvastatin (LIPITOR) taken for an unspecified indication, start and stop date were not reported. On 06Mar2021 at 15:30 hours, patient experienced pain at injection site, started approximately 6-7 hours after shot. Patient stated that she was right handed so her left arm was not as active as might right. Patient received no treatment for the event. Patient was not COVID-19 tested post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Three hours after flu vaccine, runny nose, itchy throat, cough, eyes red. Next day lips swollen, face swollen.
I'm having discomfort on my fingertips on both hands when touching certain types of surfaces. It feels like I have cuts or burns on my fingertips.  The severity of the pain comes and goes throughout the day.  Not all surfaces were causing pain after the 1st dose. The surfaces that would cause the pain include the keyboard, mouse, and cell phone.  The only fingers that were experiencing this discomfort were the thumb, index finger, and middle finger on both hands after the first dose. All my fingers started experiencing this discomfort after the 2nd dose. I have also become sensitive to hot and cold water when the pain is more severe. I have never had this discomfort before the vaccine.
vaccines given 12/9/2008.  High fever 12/10/08 with myalgia.  Fever again 12/16-12/18.  Body rash 12/20/08. Went to PCP and ER.
Pt. fully vaccinated with Pfizer vaccine - dose 1 1/26/21 and dose 2 2/16/21. Pt. reported COVID symptoms of Nausea, vomiting, and headache starting 9/7/21. Pt. tested PCR positive for COVID on 9/7/21. Pt. did not require medical care as of 9/10/21
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 23-OCT-2012 06:08, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker (medical assistant) refers to a 5 year old female patient. Th patient had none pertinent medical history and none drug reactions and allergies. On 16-JUL-2014, the patient received expired dose of M-M-R II, 0.5 ml, subcutaneous (lot # H011907, expiration date: 03-JUL-2014). The healthcare worker reported that the patient received three shots all together including the M-M-R II at the same office visit. Two of the shots were unspecified (it was also reported that there was no concomitant medication). She stated that the patient was screaming and crying while receiving M-M-R II and the two other unspecified shots on 16-JUL-2014. There was no treatment given for adverse events and no lab diagnostics studies performed. The medical assistant reported that the patient stopped screaming and crying after she left the doctor's office at an unspecified time on 16-JUL-2014. The relatedness between screaming and crying and the vaccination with M-M-R I was unknown. The patient did not seek medical attention. Additional information has been requested.
Patient was administered vaccine on 10/28/21. Vaccine was moved from Ultra Low Freezer to refrigerator on 9/24/21 and therefore was expired on 10/28/21 at time of administration.  No known adverse reactions have been reported by patient
Information has been received from a medical assistant concerning a 22 year old female who on 06-OCT-2008 was vaccinated with GARDASIL (lot # 660612/0229X).  Concomitant therapy included YAZ.  It was reported that the patient experienced numerous adverse reactions following vaccination with GARDASIL.  The patient experienced pain at injection site immediately following vaccination, but it was described as "not that bad".  The next day (07-OCT-2008) the patient felt very tired and by Wednesday (08-OCT-2008) the patient felt tired, had a fever of 100.1, experienced nausea with a "fill feeling", taste disturbance.  The rest of the week the tiredness and fever continued with no mention of nausea.  The patient would get a fever around 3 or 4 in the afternoon.  ALEVE was taken for the fever.  On Sunday (12-OCT-2008) the patient felt better, but Monday (13-OCT-2008) the patient called complaining again of tiredness and fever, but no nausea.  The tiredness on Monday (13-OCT-2008) was described as not as bad.  The patient sought medical attention.  At the time of this report, the patient was recovering.  Follow-up information has been received from a health professional concerning a 22 year old female with no known drug allergies who on 06-OCT-2008, at 14:00, was vaccinated IM with the first dose of GARDASIL (lot # 660612/0229X) in the left arm.  On 08-OCT-2008, at 8:00, the patient started feeling bad, feeling tired, fever of 100.1, nausea, not able to taste food, pain at injection site, and was not able to eat.  Additional information has been requested.
Initial and follow up information has been received from a pharmacist concerning a 68 yr old white male with shellfish allergy who on 03Oct05 was vaccinated at 5:30PM IM into the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650331/0749P) and at the same time vaccinated IM into the right deltoid with a dose of influenza virus split virion 3v vaccine inactivated (Fluzone). Concomitant therapy included clopidogrel bisulfate (Plavix), ramipril (Altace) and rosuvastatin calcium (Crestor). There was no illness at the time of vaccination. At 7:00PM on 03Oct05 the pt complained of itching on the back of the neck and woke up at night with swollen, red left arm from the elbow to the shoulder. The pt was seen at the doctor's office and treated with ibuprofen, 800mg 3x/day and ice. At the time of the report the pt's present status was unk. No product quality complaint was involved. Pharmacists is requesting a lot check.  The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information is not expected.
No additional AE reported; A 17-Year-Old patient received Proquad; Patinet was inadverently administered Proquad instead of the inteded MMR II; This spontaneous report was received from nurse referring to a 17 years old male patient. The information about patient's concurrent conditions, medical history, concomitant medications was not reported.  On 09-NOV-2021, the 17-year-old patient was inadvertently administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) (PROQUAD) subcutaneously for prophylaxis (strength, dose, vaccination scheme, and anatomical location were not reported; lot number T034825 has been verified to be a valid lot number, expiration date was 11-APR-2022) instead of the intended measles, mumps, and rubella virus vaccine live (M-M-R II) (product use issue and wrong product administered). The lab diagnostics/studies performed were unknown by reporter. At the time of the report, the patient had not been administered with measles, mumps, and rubella virus vaccine live (M-M-R II). No additional adverse event, product quality complaints (PQC) or further information was reported.