chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Body aches; Strong fast heart beats per minute (109-112); This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP and Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Oct2021 11:00 (Lot number: ff2593) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "mild heart murmur" (unspecified if ongoing), notes: many years ago, mild heart murmur on a scale of 1 to 10, a 1.; "known allergies: sulfa" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU, start date: 30Sep2021. Past drug history included: Aspirin, reaction(s): "Allergy: aspirin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO164, Location of injection: Arm Right, Vaccine Administration Time: 10:30 AM), administration date: 14Apr2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER26B, Location of injection: Arm Right, Vaccine Administration Time: 10:30 AM), administration date: 24Mar2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 18Oct2021 23:30, outcome "recovered" (19Oct2021), described as "Fever"; PAIN (non-serious) with onset 18Oct2021 23:30, outcome "recovered" (19Oct2021), described as "Body aches"; HEART RATE INCREASED (non-serious) with onset 18Oct2021 23:30, outcome "recovered" (19Oct2021), described as "Strong fast heart beats per minute (109-112)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested with the Covid-19 Since the vaccination. Patient didn't receive other medications within 2 weeks of vaccination. Patient had received flu vaccination within 4 weeks of vaccination. Patient had concomitant therapy. Patient was not pregnant at vaccination.  No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after 2 vaccines  Moderna 5/16/21 Lot# 041L20A;  Moderna 6/13/21 Lot# 037K20A
Husband stated that the patient had had a rash on chest and arms, felt woozy, progressively hurt, arm swollen from Shoulder all the way down to elbow and turned beet red, hot to the touch. Took Aleve. Patient did go to urgent care and they gave her Benadryl. The rash around arms, chest, red from side to side has gone. Patient is feeling doing much better now.
Continued, chronic sharp full body puritis. Significant to the point of disability. No improvement after >3 months. Significant joint, muscle pain, fatigue x3 days after injection that resolved. However puritis has not. Puritis is accompanied with flushing, erythema.
Vial put into refrigerator 11/01/2021. Used beyond 31 days.
pt recv vax & a couple of days post vax pt devel pus filled pockets all over body & skin was peeling;JUL97 pt hosp for 3wk;d/c in AUG97;pt condition persisted @ the time of the report;
Injection site swelled, reddened "cellulitis" and broke out in vesicles (R) arm.
soon after shot, pain in muscle area  ...around 11 hrs later,very bad chills, body aches started.. then as time went on nausea, weakness and running low grade fevers..symptoms getting better and worse over a period of time thru late Sunday morning when started to feel like myself..by the end of the day, felt  better..
Headache, Myalgia, Fever, Diaphoresis, swollen glands L>R Narrative:
This spontaneous report was received from a pharmacy technician referring to a female patient of unknown age. There was no information about patient's pertinent medical history, concomitant medications and drug reactions. On an unknown date (reported as years ago), the patient was vaccinated with M-M-R II (dose, strength, route, vaccination site, lot# and expiry date unknown) for prophylaxis. On an unknown date, the patient had unspecified titers drawn and the results were positive for Measles and Mumps, but the result for Rubella was negative (Rubella antibody negative). The outcome of the event Rubella antibody negative was unknown. Causality assessment was not provided.
Got the side affect; Covid positive on 3 day of the vaccine; 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 ADVERSE EVENT (Got the side affect) and COVID-19 (Covid positive on 3 day of the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Got the side affect) and COVID-19 (Covid positive on 3 day of the vaccine). At the time of the report, ADVERSE EVENT (Got the side affect) and COVID-19 (Covid positive on 3 day of the vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) COVID Test Positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
He becme pale, light headed, dizzy, with warm skin, feels faint. Had patient lie flat with feet elevated, check his blood pressure. It was 110/69. He felt faint, then call EMS, then his mother said that he has always have such a reaction to any vaccine, his father and brother have the same problem. The EMS checked his bp, it was 112/70, monitored him for 15 minutes, then said he was ok, and should not be any problem. I kept him for one more hour. He was fine. I called the next day talked to his mother. He was fine. I faxed the info to his doctor.
Pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and HEADACHE (Headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced PAIN (Pain) and HEADACHE (Headache). At the time of the report, PAIN (Pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Formulation of Humira was reported as Solution for injection in pre-filled pen.   No concomitant medication was reported.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
left optic neuritis; multiple sclerosis; This spontaneous report was received from an unspecified reporter (reported as researchers) via an online article referring to a 14 year old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date, the patient was vaccinated with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot#, expiration date, dose, route, site of administration and frequency unknown) for prophylaxis. Two weeks after that (date unknown), the patient experienced left retro-orbital pain and blurred vision in the left eye. He was diagnosed with left optic neuritis and reported a second occurrence 2 months after his initial symptoms. The reporter consider the patients experienced multiple sclerosis symptoms. The outcome of the events was unknown. The causality assessment was not provided.  Upon internal review, left optic neuritis and  multiple sclerosis were determined to be medically significant.  This is one of several reports received from the same source.; Sender's Comments:  AU-MERCK-0908USA04367: US-009507513-1803USA006322: US-009507513-1803USA005270:
Vaccine was drawn up in syringe on Friday 8/6, but administered Monday 8/9.  No adverse outcomes at this time.  Awaiting manufacturer's guidance on if need to repeat dose.
This spontaneous report as received from a consumer via Clinic refers to a currently 19 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-JUN-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M020073, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
Awoke in 12/1/99 a.m. following vaccine on 11/30/99 with numbness in both legs, burning and tingling of both feet, felt cold, weakness in L/leg, unsteady gait. Saw neurologist, MRI to follow.
Mother called states patient developed a "knot" right side at immunization site. States that there are "black speckles" around the knot at this time. Patient has complained of occasional dizziness and has vomited a few times. Denies any problems breathing or shortness of breath. Her family doctors out of town for 2 weeks. Recommended Mother take patient to ER for evaluation. Verbalized understanding.
When documenting  I realized that I had administered vaccines that were not due for this patient.   Attempts have been made to notify parents but have not been able to reach parents.  Clinic provider has been notified.   CDC was contacted and recommendation to repeat vaccines at recommended ages was advised.  Will continue to attempt to reach parents to provide that information.
Itched and felt hard and was the size of a quarter to a half dollar at injection site.
During vaccination,  the need to syringe connection came apart and the vaccine spilled out.  The patient was subsequently vaccinated with a full dose.
Redness, swelling, and pain posterior right upper arm. Mild blistering to the area.
Fever; malaise; fatigue; body ache; This is a spontaneous report from a contactable Physician. This 68-Year-old female Physician reported for herself in response to the HCP letter sent in cross reference case which included that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249) via intramuscular route of administration on 12Jan2021 at 08:30 (at 68-year-old) on left arm, as dose 2, single for COVID-19 immunization. The medical history of the patient included Hypertension (01Jan2021), Obesity (01Jan1985). The historical vaccine of the patient included Shingrix taken for shingles and experienced low-grade fever and aches. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EJ1685) via intramuscular route of administration on 23Dec2020 at 09:30 (at 68-year-old) on left arm as dose 1, single for COVID-19 immunization. On 13Jan2021 at 12: 00 hours the patient had Fever 101.5, bodyache, malaise and fatigue. The patient required a televisit. Reaction worsened than illness but vaccine probably helped the get over COVID. Over 30 hours after vaccination the patient received oral ibuprofen. On 17Jan2021 the patient recovered. On 01Apr2021 CT scan showed pufiltrate Consistent with covid pneumonia.  No follow-up attempts were possible. No further information was expected.
Patient came into clinic today for 2nd dose of Moderna, first shot given 4/5/21. Call placed to Dr. to receive TVO to administer 2nd dose of Moderna Vaccine. Order also received per email. Discussed with parent and patient age requirements, they verbalized understanding and parent/patient requested vaccine.
On 21MAY92 had elevated temp; 22MAY92 to ER t105.8 had severe ears & throat infect; 7JUN92 noticed fixed staring, could not get pt to respond; to ER had 2nd sz;
fatigue.; Fever; aches; dizzy; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on 22Mar2021, at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient experienced fatigue, fever, aches, dizzy on 23Mar2021 02:00. The outcome of the events was recovering.    Follow-up (26Mar2021): New information received from same contactable consumer includes: The event awareness date confirmed as 23Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11/18/2001-at 1600, three hours post-vaccination, the patient's eyes and lips began to swell. She took 50 mg of Benadryl p.o. at home and then  fell asleep. She awoke at 2000 with chest and throat tightness. At 2100, she went to the ER c/o wheezing and throat tightness. She received 2 doses of epinephrine, thirty minutes apart and 50 mg Benadryl IV
hard to open eyes; fatigue/extremely tired; extreme pressure in her head; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (extreme pressure in her head), EYE MOVEMENT DISORDER (hard to open eyes) and FATIGUE (fatigue/extremely tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM and DENOSUMAB (PROLIA) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEAD DISCOMFORT (extreme pressure in her head). On 17-Mar-2021, the patient experienced EYE MOVEMENT DISORDER (hard to open eyes) and FATIGUE (fatigue/extremely tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (extreme pressure in her head), EYE MOVEMENT DISORDER (hard to open eyes) and FATIGUE (fatigue/extremely tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-062621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062621:Case for second dose
Case number PHEH2012US020892 is an initial spontaneous report received from a pharmacist on 17 Oct 2012, and with a follow up report received from QA department on 02 Jun 2014: This report refers to a male patient of unknown age group. He was vaccinated with FLUVIRIN (batch number: unknown) at a dose of 0.5 ml intramuscularly on 10 Oct 2012. On the same day after vaccination he experienced dizziness, upset stomach, tiredness, flushed face, hot, feeling of exhaustion, exhausted, cheeks red, rash (itching), redness all over, hives, whelps, light headedness, rash on neck and arms and was unable to breathe. Hence he was taken to the emergency room. No further information about outcome, causality and seriousness was reported. The batch number 1206161 provided in initial report was not a valid batch number. Therefore the batch investigation was not performed. Follow up report received from QA department on 02 Jun 2014: Batch number deleted (not valid). Therefore the batch investigation was not performed.
17MAR93 pt recvd vax 16JUN92 & 12 hrs p/vax woke up crying & had elevated temp of 104.7 R; APAP & cool bath given; also exp cont w/occasional dozing off & one over the 12 hr episode & crying;
becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate; any new supplement or drug she tries he has a reaction dermatologically; arms burn like sunburn; rash under the skin; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate), SKIN REACTION (any new supplement or drug she tries he has a reaction dermatologically), BURNING SENSATION (arms burn like sunburn) and RASH (rash under the skin) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate), SKIN REACTION (any new supplement or drug she tries he has a reaction dermatologically), BURNING SENSATION (arms burn like sunburn) and RASH (rash under the skin). At the time of the report, HYPERSENSITIVITY (becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate), SKIN REACTION (any new supplement or drug she tries he has a reaction dermatologically), BURNING SENSATION (arms burn like sunburn) and RASH (rash under the skin) outcome was unknown.        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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-239128 (Patient Link).
Thrombosis, right hepatic vein, Hepatic Abscess ( 10 cm)
Pt came in to have vaccine from Janssen. Pt was seen at 1540, received vaccine at 1545.   At 1550, it was noticed that the Janssen vaccine expired at 1510. I requested for the patient to remain at the facility until the manufacturer was contacted.   Janssen manufacturer stated that there was no research or study to indicate what to do, and that it was up to health care professionals at the facility.  It was determined that the vaccine was probably stiff efficacious as it had only been 30 mins and that the vaccine vial had remained in the fridge at all times except when drawing vaccine from administration.  Pt was still doing well at 1605.  Pt was released from the facility after explaining that he had received the vaccine post approved expiration time.  Pt was ok and said not a problem.
Itchy rash came a week after, about 2 inches wide and 3 inches long; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash came a week after, about 2 inches wide and 3 inches long) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OL1L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], FISH OIL, MAGNESIUM and MELATONIN for an unknown indication.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Itchy rash came a week after, about 2 inches wide and 3 inches long). The patient was treated with CALAMINE, ZINC OXIDE (CALADRYL [CALAMINE;ZINC OXIDE]) for Itching, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 25 mg, 3 tabs. At the time of the report, RASH PRURITIC (Itchy rash came a week after, about 2 inches wide and 3 inches long) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Itchy rash came a week after vaccination.
Eyes dilated for about 3 hours; metallic taste in mouth for 1 day; Headache for 3 days; Felt tired; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old, non-pregnant female patient received her unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 04Mar2021 at 10:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patients medical history included CMT disease (Charcot-Marie-Tooth disease). The patient was allergic to Sulfa. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and duloxetine hydrochloride (CYMBALTA), all started on an unknown date for an unknown indication. The patient did not receive any other vaccine in four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 04Mar2021 at 10:45, the patients eyes dilated for about 3 hours, experienced a metallic taste in the mouth for a day, experienced headache for 3 days and felt tired. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event dilated pupils recovered on 04Mar2021. The clinical outcome of the event metallic taste in mouth recovered on 05Mar2021. The clinical outcome of the event headache recovered on 07Mar2021. The clinical outcome of the event felt tired recovered on an unknown date in Mar2021.  No follow-up attempts are possible; information about the lot number cannot be obtained.
I started feeling feverish around 6-7 PM on the evening I received the vaccination. I was unusually tired. I went to bed and awoke around 3 AM , my heart was racing, my ears were ringing, and I felt dizzy and anxious.  I got out of bed at 7:00 AM. As I stood up, I saw stars and almost passed out twice.  I was weak and my eyes were unusually puffy, I felt as though I would faint.  I had to sit for awhile. The symptoms finally subsided later that morning, around 11:00 AM. Did not feel any symptoms after that.
patient developed dyspnea and pleuritic chest pain 4 days after 2nd dose.  improved on steroids then worsened after steroid completion.  diagnosed with P.E. (Pulmonary Embolism) today in ED visit.    patient is a physician
LIGHT HEADED, BLANK STARE, CODE GREEN CALLED, SYMPTOMS RESOLVED, REFUSED TRANSPORT.
8 x 8.5 cm erythema and swelling left deltoid at injection site.
moderate arm soar; headache; pain moving into armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A child female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "moderate arm soar"; HEADACHE (non-serious), outcome "unknown", described as "headache"; AXILLARY PAIN (non-serious), outcome "unknown", described as "pain moving into armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.