chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gout inflammation; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout inflammation) and VACCINATION SITE PAIN (Pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Gout (Patient reported , even before the vaccination, he noticed(was feeling) that he would have a gout attack.).    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 01-Feb-2021, the patient experienced GOUT (gout inflammation). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 01-Feb-2021 for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, GOUT (gout inflammation) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
husband has acid reflux; He has lost 103lbs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 62-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Dec2022 as dose 3 (booster), single (Lot number: CSJ6738) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes", start date: 1999 (ongoing), notes: Type 2 diabetes diagnosed about 24 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "not recovered", described as "husband has acid reflux"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "He has lost 103lbs". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastrooesophageal reflux disease.  Additional information: Wife's patient reported "acid reflux after all previous Covid shots" and "He had no other problems with the vaccine". His acid reflux has been off and on. Exact start date unknown. He usually took tums, but is on medication now. Acid reflux is consistent at the time of the report, but he watched what he eats.
Pt received vaccine 9/11/2020. Called on 9/25/20 stated night of vaccine arm muscle very sore, then seemed to get better. By late next day very sore with decreased range of motion. This is still ongoing after 2 weeks she is going to call her doctor.
It was reported in a published article, that a male child was born in May 1996 to a mother who was vaccinated on an unspecified date, while she was hospitalized, with a dose of rubella virus vaccine live II. The child was breast fed for 13 months. Subsequently the child experienced severe reactions to most foods, and needed a rotation diet. The child did not receive the "MMR vaccine" because of fear of a reaction. It was reported that the child was developmentally normal and had no signs of autism. The author stated that "In spite of its limitation, this study suggests that an autism/vaccine connection may exist." The author also stated that "Revaccination of women in adulthood should be thoroughly reviewed: It has significant risks for the benefits it provides and often fails to produce immunity." Upon internal review, severe reactions to most foods was determined to be an other important medical event (OMIC). No further info is available.
Thumping in ears; swelling in face; straight mouth unable to move; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. The patient has no medical history. Concomitant medication included acetylsalicylic acid (ASPIRIN BAYER) and vitamin D [vitamin D nos]. The patient experienced thumping in ears while in observation room and had swelling in face with a straight mouth unable to move on 30Jan2021 23:30. Outcome of events was unknown. The adverse events resulted in emergency room/department or urgent care. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
dosage interval reduced; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dosage interval reduced) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dosage interval reduced). On 02-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dosage interval reduced) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drugs were reported.
Joint achiness. Felt hot. Face and abdomen were flushed. Had a headache. Arm hurt for 2 weeks. Felt okay by next morning.
high pitched screaming cry 4PM-9PM on 7JUN95, fever 100 ax, entire lt thigh red & swollen, not hungry
Fully vaccinated, have a shingles outbreak/Suspected vaccination failure; Have a shingles outbreak; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had been fully vaccinated with Shingrix vaccine but had shingles outbreak. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report was received from a registered nurse refers to a 8 weeks old female patient with no pertinent medical history and drug reactions/allergies. On 20-DEC-2012 the patient was vaccinated with 2 millilitre (ml) ROTATEQ, oral (lot H010322, expiration date November 2013) orally. No concomitant medications were reported. On 21-DEC-2012 patient developed diarrhea. The patient did not require medical attention and the diarrhea resolved on an unknown date in January 2013 (reported as after two and one half weeks). No laboratory diagnostic tests were performed. Medical attention was sought via office visit. Additional information has been requested.
In less than a week, patient began taking large exaggerated steps and began to have a bend in his legs.  He had been walking fine before the vaccine. By August he could no longer walk, stand or bear any weight on his legs and his legs became severely contracted.
The reporter received a telephone call from a medical examiner who indicated that on 4/9/00, the pt died of a presumed SIDS. History that the medical examiner obtained from the mother indicated that she and the baby had gone to bed about 3:00am which was not unusual for the baby. The mother slept in the bed with the baby until about 2:00pm when mom awoke. She found the baby dead. The baby was sleeping on his tummy, which has been her practice, as she indicated to the medical examiner that the baby seemed to sleep better and longer and fussed less when he slept on his tummy. In addition, the medical examiner notes that this was a soft bed with a depression in the middle with quite a bit of bed clothes etc, including an electric blanket. He indicates that the entire family were heavy smokers. Medical examiner did not see any evidence of foul play. He is signing this out as a SIDS.
Patient was infected with COVID-19.  He received Regeneron (mAb) on 9/3/21. Per guidelines/EUA, there should be a 90 day period between administration of a monoclonal antibody and COVID-19 vaccination. Unfortunately, this patient received his 1st dose of Moderna on 10/7/21, which was about 2 months too early.  No adverse events were reported because of this early administration
sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 031M20A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included Surgery in February 2006. Concurrent medical conditions included Breast cancer (Breast cancer diagnosed in late 2005) and Emphysema. Concomitant products included LANSOPRAZOLE, THEOPHYLLINE, PRAVASTATIN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) had resolved.            Patient information: Height 5.3. No treatment medications were reported.   This case was linked to MOD-2022-528604, MOD-2022-528616, MOD-2022-528626 (Patient Link).
Typical Moderna 2nd shot reaction... low grade chills & fever, nausea, ringing in ears and a sore arm.  Should NOT have gone swimming yesterday immediately after my 2nd shot  I?m such a doofus! ??????? Resting today.
Patient REPORTED to Employee Health Dept 24 Hours After injection, LEFT upper ARM HAS large area swollen, RED, & HOT to toucH. Reported Burning & pain to SITE of injection.
ADMINISTER PFIZER VACCINE LOT EW0179 0.3 ML LEFT ARM ON 05/04/2021 INADVERTENDLY
2nd Moderna vaccine - Rash, heat, and swelling at injection site a week after injection.
I had sore muscles almost like immediate flu like symptoms for 48 hours after the vaccine. Approximately on 10/24/2021 I started to feel with flu like symptoms, I had body aches, excess of tiredness, sore throat, cough, runny nose, allergy type symptoms, and that made me think I had COVID-19 again. I had no fever, but I did not take my temperature. We went to the doctor on 10/28/2021 and they diagnosed us with a virus, and they gave us an antibiotic. I did the antibiotic for 10 days. Approximately on 11/18/2021 I started getting sick again with allergy and sinus issues and cough, I felt miserable pretty much. I have not been to the doctor for this yet. My employer made me take an at home COVID-19 test on 11/21/2021 and took 2 of them and both were negative.
This spontaneous report as received from a healthcare worker refers to a patient of an unknown age and gender. No information of their medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot # and expiration date unknown). One month after the first dose, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, lot # and expiration date unknown) (coded as inappropriate schedule of drug administration). No adverse effects were noted. Additional information is not expected because the reporter did not provide their contact details.
06/08/21 2nd dose of Pfzier.Vaccination administered @ 10:44. According to client arm fasciculation ? started one minute after vaccine. Nausea 2 minutes after. Complaints of dizziness. Respirations 24 at 10:59. Respirations 28 and irregular at 11:04. Tightness in throat @11:10. Tongue not swollen. Breath sounds unobstructed(report given via school nurse), RN, PHN 06/09/2021 Mom reports child had fever and lump in throat the evening of event. The next morning child vommited x1. RN, PHN 06/11/2021 Mom reports no new side effects since the morning of 06/09/21 and the child is feeling fine. RN, PHN
2 days after vaccination client noticed lesions on right buttock. Diagnosed with Shingles 1/7/21. Rx Acyclovir by Internal Medicine MD.
Fever; Body aches; headache; injection site pain and swelling; injection site pain and swelling; Swollen lymph nodes just felt crappy.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 24Mar2021 at 11:15 (at the age of 56-years old) as a single dose for COVID-19 immunisation. Medical history included diabetics. The patient had a history of allergy to antibiotics. The patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. On 24Mar2021 at 23:00, the patient had experienced fever, body aches, headache, injection site pain and swelling and swollen lymph nodes just felt crappy. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, body aches, headache, injection site pain and swelling and swollen lymph nodes just felt crappy was resolved on an unknown date in Mar2021.  Information about lot/batch number cannot be obtained. No further information is expected.
Within approximately five minutes of injection, felt hot, became flushed, heart racing, short of breath, dizzy, ears ringing, seeing spots. Occurred over approximately ten minutes (best guess). Removed mask, fanned, lay down, closed eyes, was given water. As symptoms subsided, returned to a seated position. Remained at store approximately 45 minutes after injection to confirm able to drive home.
Pregnancy occurred within the 8 days following the vaccine. Pregnancy confirmed with positive urine pregnancy test on 03/01/2021. Some vaginal bleeding began 03/12/2021 but resolved quickly. Abdominal cramping and bleeding on 03/15/2021 and 03/16/2021. Blood work completed on 03/15/2021 and 03/17/2021 showed a decrease in pregnancy hormone and pregnancy was considered miscarried.
nasal congestion, puffy eyes, cough, chest pain, hives, angioedema < 1 hr.  08/13/2007 MR received for ER visit 7/23/2007 for c/o itching, swelling, and rash.  Pt received Varivax, immediately felt ill, vomited, and developed chest pain.  He developed a rash on the face. Txd with epi and benadryl at PCP office.  PE WNL by arrival at ED. DX: Allergic reaction.
running a low grade temperature; This case was reported by a nurse via call center representative and described the occurrence of low grade fever in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On 2nd March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever was not recovered/not resolved.   It was unknown if the reporter considered the low grade fever to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the concerned patient. The age at vaccination was not reported, however the patient could be 73 or 74 years old. The patient received Shingrix in the afternoon. The patient was enquiring that how long she should expect the fever if it was from Shingrix. The reporter stated if it was influenza then she needs to take quick action since she had asthma. The reporter consented to follow up.
On 02.24.21 in the evening I began experiencing body aches.  The following day I had a fever of 100.8 and saw an Urgent Care provider who referred me to the hospital.  Upon arrival my fever spiked to 102.3, bloodwork showed elevated lactate at 2.4 and pulse rate was over 119.  I  was admitted with sepsis symptomatology.
Redness -"Kiwi size"- approx. 3-4 in diameter. Swelling - 1/4 in -raised, painful Afebrile.
Swelling of L leg 2d prior to vaccines. Some painful but had a little limp. Scratching of the area.
Information has been received from a clinical medical assistant referring to a 29 day old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 22-JUL-2015 the patient was accidentally vaccinated with a dose of PEDVAXHIB (dose and lot# were not reported) instead of an unspecified Hepatitis B vaccine (wrong drug administered). No adverse effect was reported. Additional information has been requested.
Patient stated immediate itching, redness and soreness at injection site.  She wasn't concerned with that but then the next day she started developing a rash around the injection site which lasted over a week.  She read it was nothing to be concerned with as it is clearing up now.
within 12 to 18 hours developed a large swollen tender area distal to injection site -- not seen by provider, but consistent with large local reaction acutely by hx.   4 months later still has a large palpable "mass" not otherwise specified at the site of the large local reaction
Patient came by the pharmacy and stated she noticed a red sore (round & big) on her arm where vaccine was injected. She came in on 4/26 but on 4/28 she states the redness went away.
Red, somewhat indurated lesion approx. 5 cm in diameter. Minimally-to-moderately tender. There is no fluctuance noted.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-JAN-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2014, the patient was treated by a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
On 4/1/03 L upper arm-site of DTaP (3/31/03) has 15cm x 11cm area of erythema-not hot, not tender. Slightly swollen, pt not "ill" very active.
Janssen COVID-19 Vaccine EAU Fever of 99.0 degrees for 2 days. Weakness and tired. Sore arm and joints.
Patient had MENACTRA vaccine. Within 5 min at admin had reaction of dilated pupils, slurred speech, decrease heart rate and oxygen,  increased blood pressure. EMS was called and was cleared. Blood sugar and EKG done in office.
Injection site soreness (lasted 2 days),  Significant Weakness with onset about six hours after receiving vaccine lasting for 24 hours, Mild Nausea with onset 26 hours after receiving vaccine and lasting for 12 hours, mild headache with onset about six hours after receiving vaccine and lasting for 15 hours.  Took Ibuprophen for 24 hours after first onset of headache and bed rest.  Now 48 hours after receiving vaccine and all side effects have ended except minor soreness at injection site.
Pt became dizzy and nauseated after IM injection. Assisted to floor to lay down with BLEs elevated. VS as follows: BP 98/68 laying down, HR 99, sats 98% on RA, no LOC. Pt given water and snack bar, recovered within 10 mins and ambulated out of clinic in NAD
Patient called after 3pm on friday 05/12/2023; patient states he has been consistently running a low grade fever, sweaty, having a headache, dizzy (especially when driving), and general acheyness. Patient states he is concerned because his symptoms have lasted longer than 7 days.   I called patient this morning at 8am (5/15/2023) to check on patient. Patient did not answer - left voicemail for patient to call me back.
Patient developed a rash the day after vaccination on the right leg and right side of his abdomen.
On 20NOV90 pt exp rash, joint pain & swelling; Later recovered; No further details were provided;