chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy rash on the right side of her body/It was underneath arm and side middle body of arm she had shot.; This is a spontaneous report from a contactable consumer or other non hcp.   A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EN6199, Expiry date: unknown) via an unspecified route of administration, administered in right arm on 08Mar2021 at 11:15, as DOSE 1, SINGLE for COVID-19 immunization. Medical history included localized infection from an unknown date and unknown if ongoing. Concomitant medication included sulfamethoxazole, trimethoprim (SMX/TMP) taken for localised infection from 06Mar2021 to an unspecified stop date. On an unspecified date in Mar2021, the patient experienced itchy rash on the right side of her body/it was underneath arm and side middle body of arm she had shot. The rash was better, but it was not around the shot area. It was reported that sometime around the 1st shot, patient developed itchy rash on the right side of her body for 12 days - On that night she went to ER care unit due to infected finger on the same arm where she had the 1st shot. Patient clarified that she first went into the ER and 2 days after that had the Pfizer COVID vaccine shot. She cannot say for sure if it was an allergic reaction to the vaccine. The rash was bad for 15 days and the last 2 days has been better. She provided name of the antibiotic as generic and stated it was shown on the bottle as SMX/TMP 800mg-160mg and she was taking one tablet twice daily. It is in a pharmacy vial with no lot or expiration. Patient wanted to know if her rashes were brought by the vaccine or antibiotic and get advice about getting second shot. She did not remember if the rash started out 08Mar2021 or 09Mar2021, or somewhere around there. She thought it was an insect bite and then it spread. Then she thought it was a heat rash. Her second dose was on due this Monday. Patient did not think her other medications were relevant. The patient had not received any other vaccine within 4 weeks neither on the same day of vaccination. Patient received no treatment for the event. The outcome of event was resolving.  Follow-up attempts are completed. No further information is expected.
Redness to the upper arm, that surrounds the arm ,skin warm to touch started day of vaccine and worsened. Cellulitis
Vomiting within 18 hrs; Unable to move arm within 12 hrs; Severe headache within 6hrs; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to food and penicillin. 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. The patient received unspecified medications within two weeks of vaccination. The patient previously took sulfur (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 01Apr2021 at 12:45 (at the age of 50-year-old), as a single dose for COVID-19 immunisation. On 22Apr2021 at 18:00, the patient experienced severe headache within 6 hours. On 23Apr2021 at 01:00, within 12 hours, the patient was unable to move arm and same day at 07:00, within 18 hours, patient experienced vomiting. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, unable to move arm and vomiting was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Syncope approximately 10 seconds after last immunization given. Fell and hit nose on table next to chair she was sitting in. Lost consciousness for 2 - 3 seconds. Gently lowered patient to floor supporting head and neck. Legs elevated. Monitored vital signs. All remained stable. Ice pack to nose. Small fine rash approximately 3 inches long noted near right axilla. About 10 minutes later developed fine rash and hives on left neck and shoulder area. Mom declined Benadryl as she herself allergic to Benadryl. Hives remained stable and were resolving when EMS arrived. Transported to ER by EMS for further evaluation and treatment as indicated.
Fever of 103, chills, body aches.  Still undergoing, fever down to 100, she is sleeping and I am monitoring her temperature. It has been 12 hours of fever and body aches.  Fever went from 103 to 100 and is maintaining 100 so far. This is approx. 17-18 hours from the time of the vaccination.
feel like what I have is spreading from my sinuses to my chest (respiratory infection); nausea; loose stools; headache; chills; nasal drainage; sore throat; sinus congestion; hiccups lasting 2+days and still continuing; tiredness; minor soreness at the injection site; This is a spontaneous report from a contactable consumer report for self. A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration in left arm on 12Feb2021 12:15 at single dose for covid-19 immunisation. Medical history included Coronary artery disease requiring stenting, under the care of an Allergist for past 46 years. No Covid prior vaccination. No other vaccine in four weeks. Concomitant medications in two weeks include Atorvastatin Calcium, acetylsalicylic acid (ASPRIN), fexofenadine hydrochloride (ALLEGRA), Clopidogrel. An unspecified date in Feb2021 11:00 PM, patient experienced nausea, loose stools, headache, chills, nasal drainage, sore throat, sinus congestion, hiccups lasting 2+ days and still continuing, tiredness, minor soreness at the injection site but just for the first couple of days which was expected, feel like what have is spreading from sinuses to chest (respiratory infection) which concerns. The outcome of events was not recovered. Treatment not received. Covid Nasal Swab tested post vaccination on 19Feb2021, test result pending.
Left deltoid warm, swollen, tender, itches, indurated. no pustule, no blisters.
heart burn; chest pain; Gaseousness; This case was reported by a consumer via call center representative and described the occurrence of heartburn in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chest pain (1st dose received in November 2018 and experienced heartburn, gaseousness, refer case US2019GSK083554).   On 17th April 2019, the patient received the 2nd dose of Shingrix. On 18th April 2019, 1 days after receiving Shingrix, the patient experienced heartburn, chest pain and gaseousness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the heartburn, chest pain and gaseousness were not recovered/not resolved.   It was unknown if the reporter considered the heartburn, chest pain and gaseousness to be related to Shingrix.  Additional details were provided as follows: On the date of reporting the patient said experienced the same symptoms(pain, heartburn, chest pain and gaseousness) as experienced after receiving 1st dose of Shingrix. The reporter did not consent to follow up.
Fever on and off for 48 hours, chills, headache, nausea, body aches, sensitivity to touch  Symptoms still ongoing after 2 days
3/4/21 out of breath , peaked 3/08/21. 3/09 pain in right lower leg Hospitalized 4 days - 5 hour procedure for Acute DVT and Acute Saddle pulmonary Embolus
FULL BODY CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced full body 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 full body chills and fever was not reported. This report was non-serious.
This is a spontaneous report from a contactable physician communicated to field force sales representative. A 5 month old infant received PREVNAR 13 1 DF intramuscular on an unknown date for immunization. The patient received a total of 7 vaccines. On an unknown date the patient developed a temperature of 38.2C and "inflammation in the fontella". Follow-up (11JUL2012) Follow-up attempts completed. No further information expected.
On Saturday, April 10, 2021, I had started having pain and swelling in my right calf that lasted for several days on and Tuesday, April 13th, I started having pain on the left side of my chest.  On Thursday, April 15th, I went to the ER due to pain and selling in my leg and it was discovered that I had 2 clots in my leg (on at my calf and a second one on the right side of my knee).  Not realizing my chest pain was related, I discussed with my primary care at a follow up visit on Monday, April 19th, and a CT scan was performed confirming I have  an pulmonary embolism (extensive pulmonary emboli in both lungs).  I was immediately put on Xarelto blood thinner and sent home.
5/3/06 AM Reports fever last night (temp not taken) upper left lateral arm red, warm, swollen with raised center. Ice and Ibuprofen suggested. 5/5/06 AM Arms much improved. Reports no other s/s 5/8/06 AM Reports with s/s beginning with fever last night (temp not taken) red, raised, itching, fluid filled lesions on abd and neck. Employee tells us he is using Benadryl cream for itching, we advisehim to continue Ibuprofen for fever. 5/10/06 AM New fluid filled lesions on back and groin appeared last night. All areas drying/crusty except groin. 5/11/06 AM No new lesions, no fever, all sites dry and crusty. 5/12/06 AM Returns to work.
This spontaneous report as received from a registered pharmacist refers to a 60 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) on 12-APR-2012. On approximately 19-APR-2012 (reported as the week after vaccination) the patient experienced full blown case of shingles. The outcome of full blown case of shingles was reported as recovered. The patient sought medical attention by contacting physician. Additional information has been requested.
At 15:30 a flat erythematous patch just inferior to MMR injection site was noted. Within 3 minutes a raised clear area was noticed in the center of the reddened area. Pt also developed flat red blotches at 1.5 cm mid back and 2 linear blotches on left apella. Oral Benadryl 5mL given at 15:25, pt observed until 15:55. Erythematous rash and blotches gradually faded to light pink and left arm became flat and pink. Vital Signs: P: 132, R: 44, no respiratory distress.
Child received vaccines on 8/24/10. On 8/25/10 MOC called and reported client developed hives on legs/stomach. Referral to MD.
I was victim of a medical error by a pharmacist, in a drug store. Instead of giving me a Flu shot and the COVID Moderna Bivalent, she later confessed she gave me 2 COVID vaccines. I was so scared, I asked her what was going to happen to me, and she said she didn't know, the she said  I was going to be ok. I was so anxious to talk to a Pharmacist, but after 25min. I already had gotten a hold of my doctors nurse and she researched, finding no precedent, so she said the drug store had to report to the CDC, do a report of Vaccine Administration Error. The drug store employees handled all very poorly, nobody helped me and the person who gave the vaccine hided. I had the most horrible 36 HRS. Headache that would not go away, chilis, joint pain, backache, and vomit. I am still pretty shook up, as I suffer Fromm Ulcerative Colitis and take Entyvio with a nurse.
First dose on 31-MAR-2021 and second dose on 21-APR-2021(less than 25 days); This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 31-MAR-2021 and second dose on 21-APR-2021(less than 25 days)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression and Allergy NOS. Concomitant products included LAMOTRIGINE, SERTRALINE and TRAZODONE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 31-MAR-2021 and second dose on 21-APR-2021(less than 25 days)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 31-MAR-2021 and second dose on 21-APR-2021(less than 25 days)) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-573518 (Patient Link).
Mother contacted office 5/31 to report pt had been experiencing a headaches since 5/25 (day after injection received).  Mom had been treating with ibuprofen which was slightly effective. Worsen with screen time and reading, headache reported at top of head and brow line. Family saw ophthalmology and diagnosed as ocular migraine per moms report.  As of 6/13 per moms report was sill having sporadic headaches, worsened after piano lessons. As of 6/13 DR (physician at agency) suspected headaches would resolve over the next two weeks. Mom did not have pt evaled at our practice
Within a few hours of receiving Fluzone HD, patient experienced achy joints/fingers/ankles, heavy chest, tachycardia, and her "skin hurt." She reported the reaction to pharmacy (PharmD) on 10/21/19 while visiting the pharmacy (vaccine was administered at the doctor's office, not associated with pharmacy). Patient reported these side effects to be so severe that was unable to sleep the night of receiving the vaccine. Symptoms resolved within about 18 hours.
This is a spontaneous report from a non-contactable consumer who reported for herself via Pfizer-sponsored program. A female patient of an unspecified age received pneumococcal 13-val conj vac  (dipht crm197 protein), on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient received pneumonia shot and on an unspecified date "her arm swelled up, really really hot and in a lot of pain". Reporter explained she had the shot (unspecified) before and "never had this before". As reported: Patient woke up in quite a bit of pain in the middle of the night and through the night still swollen and it was very painful. Final outcome of the events was unknown. No follow-up attempts are possible. No further information expected. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vaccine in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vaccine has submitted the same report to the regulatory authorities.
Immediately after receiving the 5th shot, patient's body slouched over while in sitting position.  When attempting to lay her down on her back, her arms and legs began a jerking movement, head turned to the right and pupils dilated.  Episode lasted 3-5 seconds.  Patient didn't remember the episode when asked.  Physician was called into room and patient was assessed by doctor.  Patient was observed for 30 minutes, and had full recovery by the time she left the clinic.
Headache, unable to sleep at night, back pains, pains in arm, body pain , pain in right breast, wake up with pain on side of face, swollen lymph node in breast
Cherry color pin point papules. VS Q4 x 24, O2 sats.
Pt given Hep B#1 on 8/13/02. Seen in urgent care 8/17/02 c/o rash fine, red, itchy all over body which started the day after injection. Dx: fine reticular rash, arms, back, chest, abdomen, neck, immunization reaction.
little bit of raspiness in his throat; bad cold; severe congestion/some mild congestion; sore throat; could only sleep for about an hour/only able to sleep for 1 hour at a time; cough up phlegm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (little bit of raspiness in his throat), NASOPHARYNGITIS (bad cold), NASAL CONGESTION (severe congestion/some mild congestion), OROPHARYNGEAL PAIN (sore throat) and INSOMNIA (could only sleep for about an hour/only able to sleep for 1 hour at a time) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 004C21A and 020A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced OROPHARYNGEAL DISCOMFORT (little bit of raspiness in his throat), NASOPHARYNGITIS (bad cold), NASAL CONGESTION (severe congestion/some mild congestion), OROPHARYNGEAL PAIN (sore throat), INSOMNIA (could only sleep for about an hour/only able to sleep for 1 hour at a time) and COUGH (cough up phlegm). The patient was treated with TRAZODONE for Difficulty sleeping, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Difficulty sleeping, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (little bit of raspiness in his throat) had not resolved and NASOPHARYNGITIS (bad cold), NASAL CONGESTION (severe congestion/some mild congestion), OROPHARYNGEAL PAIN (sore throat), INSOMNIA (could only sleep for about an hour/only able to sleep for 1 hour at a time) and COUGH (cough up phlegm) was resolving.            Concomitant medication taken by the patient included two different blood pressure medications and cholesterol medication. Current medical condition included blood pressure and cholesterol. Patient started taking Nyquil for his sleep, which allowed him to sleep longer.  Patient had events 24-36 hours after receiving the booster dose of the vaccine. Patient was only able to sleep for 1 hour at a time at first as he would have to wake up, cough up phlegm, then fall back asleep. Patient had an upcoming appointment on 3 Jan 2022.
ABOUT 2 HOURS AFTER VACCINE ADMINSTRATION PATIENT DEVELOPED A SUBJECTIVE FEVER ("WAS BURNING UP") AND VOMITING.  VOMITING DECREASED, FEVER STILL PRESENT.  MOM USING TYLENOL EVERY 4 HOURS.
Following administration of vaccine patient c/o pain on right side of abdomen. Pain 2 on 1/10 scale.
Inflammation in my spine/Myelitis; impingement between C6 & C 7; Numbness in my arm and hand; Stabbing pain in my chest and back; Stabbing pain in my chest and back; Muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 03Jun2021 08:30 (Batch/Lot Number: FA6780) as dose 1, single for COVID-19 immunization at physician's office. Medical history included known allergies: some nuts from an unknown date. Concomitant medications included fish oil; cyanocobalamin (B12); and colecalciferol (D3) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Jun2021 18:00, it was reported that the patient experienced numbness in my arm and hand within 24 hours of my vaccinations, stabbing pain in my chest and back with muscle spasms throughout my arms and chest. The patient went to the emergency room and was diagnosed with inflammation in my spine/myelitis causing an impingement between C6 & C7. I have had to get an injection so I can work and get some of the feeling back in my arm. The patient had to get PT, Spinal injection, Acupuncture, and Chiro and had multiple doctors appointments to try and get back to functionality. The events resulted in hospitalization for 1 day and required emergency room and physician's office visit and was considered by the reporter as having caused disability or permanent damage. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown results on an unspecified date. The outcome of the events was not recovered.
Baby was up screaming at 10:00 PM after going to bed at 7:00 PM, and it was discovered she had a fever of 102.6. Treated with Infant Tylenol, which would reduce the fever slightly for about 3 hours, after which it went up again. Our child was also extremely fussy and irritable. Fever persisted until the afternoon of 05/14/2011, so about 16 hours. She was fussy for about 24 hours after onset of the fever.
Bleeding gums, leg numbness, finger swelling and loss of movement, abdominal swelling, and fever since injection.
ASTHMA WAS UNDER CONTROL PRIOR TO THE VACCINE.  AFTERWARDS, MORE DIFFICULT BREATHING WHEN EXERCISE OR BUSY.  INCREASED MUCUS.  ADDED MUCINEX TO MEDICATIONS.  AS OF 2/1, MY ASTHMA IS STILL WORSE THAN IT WAS BEFORE.  hOWEVER THE FIRST 2 DAYS OF THE REACTION  WERE MORE SIGNIFICANT THAN NOW.
Fever; chills; bodyaches; This is a spontaneous report from a contactable consumer. An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration were not reported), via an unspecified route of administration on 30Mar2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. Patient received other unspecified medications within 2 weeks of vaccination. It was not known whether the patient was pregnant at time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination it was not known if patient has been tested for COVID-19.  The patient experienced fever, chills and body aches on an unspecified date for 48hours. The events were considered non serious. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.