chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diabetic ketoacidosis: new onset type 1 diabetes mellitus diagnosed this date approximately 1 month after receiving H1N1 vaccination: nausea/vomiting, abdominal pain. Emergency room visit and hospitalization x7 days: treatment is multiple insulin injections daily, multiple finger blood glucose testing daily, routine lab work, diet changes, counting carbohydrates in all foods.
Took 2 weeks to get over it; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-Dec-2020.  This case involves a patient of unknown demographics who took 2 weeks to get over it (Unevaluable event), while the patient received Influenza Vaccine. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient took 2 weeks to get over it (Unevaluable event), unknown latency after the patient got the shot.  It was not reported if the patient received a corrective treatment. Outcome of the event was unknown, at the time of reporting. There will be no information available on the batch number for this case.
Spoke to daughter on 1/26/2021.   On 1/23/2021,  client  began itching on the back of her neck then 1/24/2021 redness on upper right arm - almost her whole upper arm swollen.  Not hurting at all.  Right side of face is red. Denies lips swelling, SOB, or feeling bad.  Daughter is concerned that the redness and swelling worsening.  Daughter asked if she needed to take her to the doctor.  Instructed that if she feels that it is worsening that I would recommend that she take her to her PCP.  States will take to doctor or urgent care today.
The patient received her first dose of the COVID-19 vaccine (Comirnaty).  Standard dose was administered with at first no adverse reaction.  While patient was still  in a seated position, she developed a vasovagal response.  She was alert after a few seconds, but did experience a syncope episode.  After proper patient management, she was alert and conscious.
Pt received 12 month vaccinations on 4/18/09.  She had zero reaction at first, but 1 week after shots pt. began having a fever.  This lasted 4 days off & on.  Her appetite decreased, she was fussy.  On 4/20/09 pt.  had a dime-sized red lump on R thigh, did not seem painful, but was bothersome.  Pt was told to use tylenol prn for fever, & to call back if worsening Sxs.
Left deltoid skin redness and lt. arm pain/cough/cold sx. MOTRIN PRN, KEFLEX x 7 days.
Sore at site - arm became red - warm to touch - edematous - shoulder, wrist and back ache. On 2nd day - arm itching and red from shoulder to wrist - lower arm became deep red progressing to purple for next 3 days - lasted 1 week.
Initial report was received 15 August 2012 from a consumer via the manufacturer's company sponsored website. A patient (gender, age and date of birth not reported) had received FLUZONE, lot number UT433AA on 20 October 2011. The day after vaccination, the patient began to experience increasing pain in the left shoulder and was unable to move their arm by that evening. They presented to the emergency room due to the pain and had an x-ray was performed (results not reported). The patient was prescribed unspecified pain killers and was advised to see Orthopedics. The patient had an orthopedic visit "a couple of days" after their orthopedic visit. A MRI was ordered and showed "adhesive capsulitis etc.". The patient performed intense exercise for a couple of weeks with little relief, and could not sleep many nights due to intense pain. After many months of home therapy, the patient continued to have pain on certain movements and during the night. Outcome was not recovered. Documents held by sender: None.
Patient received Varicella vaccine 06/30/1998. Patient developed "low grade temperature and a bug bite on 03/02/2005 evening" By 03/03/2005, Pt had chicken pox over entire body, pt given Clarinex, Benadryl, and topical steroid per physician. By 03/07/2005 no more chicken pox.
vaccine given at 12:30pm on 4/12/21, around 6:30pm adverse reactions started including headache, fever (temp not actually taken), chills, achy all over. Reported to us today 4/13/21, has taken Tylenol to help relieve symptoms which has help some til it wears off.
A non-serious spontaneous report of headache has been received from a consumer, the patient's wife, concerning an 33-year-old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received FLUMIST on 27-Oct-2009. He received a total of one dose of FLUMIST before the onset of the event. After FLUMIST administration on 27-Oct-2009, the patient experienced a headache. The event resolved within one day on 27-Oct-2009.
Red skin with a slight rash and a bothersome itch became present at the injection site. it is about one and a half inches in diameter.
Associate came for treatment of burn on 07/01/02. Tetanus vaccine was given in left deltoid. Associate returned 07/12/02 r/t continued pain, swelling, and redness at vaccine administration site. Her left deltoid area had an induration measuring 50mmx45mm and erythema measuring 10mmx20mm. Tx-Keflex 500mg po bid x 7 days, Tylenol, cool compresses. Improving, anticipated recovery.
ER x2 6/22/09, Redness, fever, nausea, vomiting, swelling, pain. AUGMENTIN; BACTRIM DS, VICODIN, IBUPROFEN. 16 x14 cm erythematous warm macular lesion surrounding site left deltoid, then 20x16 cm site of erythema moved distal to original site. Still has pain at site. Requiring VICODIN . Out of work since 6/21/09.
fully vaccinated to Cominarty but contracted COVID; fully vaccinated to Cominarty but contracted COVID; This is a spontaneous report from a non-contactable consumer. A patient of an unspecified age and gender received BNT162B2 (COMIRNATY; lot number and expiration date were not reported), on an unspecified date, dose 1, single and on an unspecified date, dose 2, single; both via an unspecified route of administration for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient was fully vaccinated to Comirnaty but contracted COVID and was hospitalized and has had a long recovery period. The outcome of the events was recovered.  No follow-up attempts are possible, No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 18-year-old male patient who received BEXSERO. Concurrent medical conditions included ulcerative colitis. Concomitant products included APRISO, REMICADE and VSL Probiotic Sachets. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced influenza-like symptoms, influenza and sickness. On an unknown date, the outcome of the influenza-like symptoms, influenza and sickness were recovered/resolved. The reporter considered the influenza-like symptoms, influenza and sickness to be related to BEXSERO. Additional details were provided as follows: The reporter was the mother of the patient. The patient immune suppressed. In 2018, the patient received the 1st dose of BEXSERO. In 2018,  the patient started getting sicker with flu like symptoms and tested positive for the flu. This case has been linked to the case US2018051277 and US2018GSK056258 for another patient (twin brother) and linked to US2018GSK057910, reported for the same patient.
8 patients were given the Moderna COVID 19 vaccine 16.5 hours post puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients were given the Moderna COVID 19 vaccine 16.5 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients were given the Moderna COVID 19 vaccine 16.5 hours post puncture). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (8 patients were given the Moderna COVID 19 vaccine 16.5 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter.  The vial was initially stored in the refrigerator on 1 NOV 2021. Date and time vial was first punctured on 1 NOV 2021 at 5pm. Date of administration of vaccine was 2 NOV 2021 between 9am and 9:30am.  Total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F)which was probably like 10 to 15 minutes.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received as no adverse event reported from patient.
Patient received VZV vaccine on 6-20-08.  The mother called back a few days later stating he had a rash on his arm where the VZV was given.  The mother was instructed to carry patient to MD.  Mother called back 7-1-08 & stated the rash is from shoulder to elbow and "oozing".
Information has been received from a physician concerning a 19 week old female who on 11-JAN-2008 was vaccinated with a second dose of ROTATEQ (lot # 657986/1205U) On the evening of 11-JAN-2008 the patient developed loose frequent stools, that persisted for two weeks. There was no report of fever or vomiting. The patient was seen "in the office". Diagnostic testing included "rotavirus and c.diff labs", both of which the results were negative. The patient recovered on approximately 25 JAN 2008. It was noted that on an unspecified date the third dose of ROTATEQ was administered. There was no product quality complaint. Additional information has been requested.
Information has been received from a physician via Pfizer (manufacturer report number# 2016433837), referring to a currently 75 year old female patient. No relevant medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, dose number, lot# and expiration date were not reported). On an unknown date, the patient experienced allergies to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) with symptoms including swelling, dermatitis and fever. The outcome of the event was not reported. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (the suspect therapy was reported as allergen). This is one of two reports received from the same reporter. Additional information has been requested.
On Monday, 11/07/22, patient reported swollen lymph nodes in the neck area, fever and pounding headache. She took acetaminophen (Tylenol) to get relief. She is also going to see her doctor for further evaluation.
Pt seen in office on 1/22/10. Pt received H1N1 at school on 1/20/10. Sxd included dizziness, heart racing, panic attack/hyperventilated. Itchy all over with some redness.
Patient had dizziness, BP 102/60 HR71 RR18, later improved to 111/75, HR78, RR18, left in stable condition
he started feeling sick day after vaccine with flu like symptoms, seen in ED 5 days after vaccination, diagnosed with COVID19,  About 1 week after that, he was found dead at home on his couch.
Gave INFLUENZA A H1N1 vaccine nasal mist. Child was very calm. Nosebleed began within 30-60 sec after spray adm. Nosebleed stopped within 10 mins.
By noon the next day her arm was on fire, bad headache and body aches, joints began to hurt and painful, had chills  muscle pains, nausea, and diarrhea
VACCINE ADMINISTERED AROUND 11 AM.  NURSE DISCOVERED A LARGE HOT RED 2 INCH  PATCH ON HIS LEFT CHEEK (98.2 DEGREES).  THERE WAS A OVER A DEGREE DIFFERENCE IN TEMPERATURE FROM RIGHT CHEEK TO LEFT CHEEK (97. - ISH DEGREES) THERE WAS ALSO A SMALL AREA ON THE LEFT SIDE OF FOREHEAD THAT WAS 100.2 DEGREES.  THE REMAINDER OF THE FACE WAS UNCHANGED AND 97 ISH DEGREES.   UPON INSPECTION THERE WAS NO RASH ON TORSO.  WE DID NOT CHECK HIS LEGS.
rash/hives-woke up around 7AM on 17NOV95 w/rash & hives-treated w/DPH;18NOV95 cont w/hives/itching--hands/feet swelling;19NOV95 cont hives/itching--hands/feet swells
I got my first Pfizer covid shot around 3:30 PM on March 16, 2021.  Around 10:00 PM, my arm started to get some soreness.  I also noticed that I started feeling really sluggish with some muscle pains.   Approximately 11:30 PM, I attempted to go to sleep and noticed that I started having a minor respiratory distress where I could hear myself wheezing.  The wheezing only lasted about one hour.   All the symptoms disappeared after 36 hours without any treatments or medications.  At this point, I'm not sure If I should get my second vaccine shot.
Headaches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 05Mar2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included alopecia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received miconazole nitrate (MONISTAT 1) and experienced drug allergy. On 05Mar2021 at 18:30, the patient experienced headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not 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 headaches and nausea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Swelling extreme sharp pain - right arm limited range of motion, tightness pain upper right arm.
I gave the patient her first COVID vaccination today at approximately 10:30am. After about 30 minutes, she reported tingling lips and a puffy tongue but no trouble breathing. After consulting with our clinical pharmacists, I gave her 50mg IM Benadryl and observed her for another hour. Her vitals were stable. She felt like the Benadryl helped (tingling gone, tongue felt achy), and no other symptoms appeared. She went home with instructions to call the ED with concerns if she developed signs of anaphylaxis, and to take more Benadryl if any tingling/itching occurred. I spoke with her at 7pm this evening and she reports her symptoms have mostly resolved (still a bit of an achy tongue).
Nausea, Vomiting, SOB, Palpitations, Fatigue, Headache
Flu like symptoms; This spontaneous case was received on 27-Aug-2021 via Med Communications (reference number: SEQW21-01771) from pharmacist and concerned a 19-year-old, female patient.   The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine), after which the patient developed flu like symptoms, reported as, this also happened (case 202102928).   On an unknown date in 2019, reported as two years ago, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; route of administration: intramuscular, dose: 0.5 ml and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported.  On an unknown date in 2019, unknown amount of time after receiving Afluria Quadrivalent, the patient experienced flu like symptoms for a week.   On an unknown date in 2019, a week later, the patient recovered from the event.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  The case is linked to case 202102928 due to the same reporter and patient.  Company comment: The event of flu like symptoms was assessed as related to Afluria Quad.; Sender's Comments: The event of flu like symptoms was assessed as related to Afluria Quad.
High fever; Body aches; Muscles spasms all over body; Muscles spasms all over my body all night that made sleeping difficult.; Severe headache; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, anxiety and allergy to shellfish. Prior to 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 did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 18:00, the patient experienced high fever, body aches, muscles spasms all over the body all night that made sleeping difficult and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not 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 high fever, body aches, muscles spasms all over body, sleeping difficult and severe headache was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to ED for COVID symptoms. Positive for COVID. Received Regeneron monoclonal antibodies.
1st shot was similar, it felt like something popped and my sinuses got crazy, my eyes got watery and swollen, my throat was like a stiff neck, my head hurt so bad i was taking tylenol every 4 hours, at night i got a fever and my husband said i was crying for a blanket, I think I might have gone back to when i was at the hospital, I don't know, we both couldn't walk or move everything hurt so bad. The second shot was worse than the first.
This case was reported by a physician and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced shingles, general body pain and tingling feet/hands. On an unknown date, the outcome of the shingles, general body pain and tingling feet/hands were unknown. It was unknown if the reporter considered the shingles, general body pain and tingling feet/hands to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient developed shingles a day after 1st dose of SHINGRIX, followed by months of persistent body aches and tingling of hands and feet. Has this been reported by others, The reporter was asking whether a reactive arthritis or autoimmune reaction to the vaccine.
Information has been received from a pharmacist concerning a female with no pertinent medical history who on 01-DEC-2007 was vaccinated intramuscularly into the deltoid with a 0.5 mL first dose of pneumococcal 23v polysaccharide vaccine (Lot #659148/1382U). Concomitant vaccination on the same day included influenza virus vaccine (unspecified) into the other arm. On 03-DEC-2007, the patient called to report that the arm that she received the pneumococcal 23v polysaccharide vaccine was painful with a red line going down the under side of the arm from the armpit. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Additional information has been requested.
Got the itches today; Got the runs; Maybe from the runs that's making me tired; Got the runs; Maybe from the runs that's making me tired; This is a spontaneous report from a contactable consumer, the patient.  A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: KN5730), via an unspecified route of administration on 17Dec2020 (at the age of 61-years-old) as a single dose for COVID-19 immunization.  The patient had no known medical history.  There were no concomitant medications.  On 18Dec2020, the patient had the itches and runs, and was tired. The clinical outcomes of the itches, runs, and tired were unknown.
around 9 she said she started to feel bad; low grade fever; chills; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (around 9 she said she started to feel bad), PYREXIA (low grade fever) and CHILLS (chills) in a female patient of an unknown age 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 28-Nov-2021, the patient experienced FEELING ABNORMAL (around 9 she said she started to feel bad), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, FEELING ABNORMAL (around 9 she said she started to feel bad), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, Heart rate: 105 (High) heart rate progressively went up to 105 then 130 then she woke up and it was150 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact