chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 78 year old female consumer reporting on herself who about 7 years ago (in approximately 2004), was vaccinated with a dose of ZOSTAVAX (Merck) (route, dose and lot number not reported). The consumer reported that last year and this year over the last 15 months (since approximately August 2010), the patient had been experiencing shingles outbreaks. The consumer said that the episodes had come and go. In December 2010, the patient underwent a bypass surgery. In January 2011, the patient underwent a pacemaker surgery. The patient had been taking acyclovir 800 mg and it had been helping with the pain. The consumer stated that the most recent rash was in the area of her pacemaker. The patient went to an unspecified dermatologist due to the rash who said it was not "shingles". The consumer and her husband no longer resided where they used to and did not give permission to contact the physician. At the time of the report the patient had not recovered from the recurrence of shingles and rash. At the time of the report, the outcome of bypass surgery and pacemaker was unknown. Upon internal review, bypass surgery and pacemaker were determined as other important medical events. No further information is available.
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 01-JUL-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA001345: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004691: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA004707: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
feeling light headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "feeling light headed".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 2 weeks of the 2nd Dose, Pfizer, I had a sinus infection and respiratory infection. I was on antibiotic and nebulizer treatment. I had to follow up several times because I wasn't getting better. I was on antibiotics more than once overall and I wasn't' feeling well for the longest time. I have gotten sick several times with respiratory symptoms since I had the vaccine. I have recovered from the vaccine, but I have been off and on having respiratory problems. It's been continual. I continue to feel fatigue since the vaccine.
cranky, tired evening 17NOV92 onset violent vomiting x 3 during noc; 18NOV92 t104 orally, vomited APAP; seen @ ER; instructed by MD to receive Acellular DTP in future;
felt rotten/ have woken up almost as rotten as last week; I just don't feel very well at all; very lethargic; arthritis has bothered me quite a bit this week; very sore arm/body aches; headache; a little queasy; fatigue/very tired/more tired than usual; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt rotten/ have woken up almost as rotten as last week), MALAISE (I just don't feel very well at all), LETHARGY (very lethargic), ARTHRITIS (arthritis has bothered me quite a bit this week) and MYALGIA (very sore arm/body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 031M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included POTASSIUM CITRATE, VITAMINS NOS, METFORMIN and ROSUVASTATIN for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt rotten/ have woken up almost as rotten as last week), MALAISE (I just don't feel very well at all), LETHARGY (very lethargic), ARTHRITIS (arthritis has bothered me quite a bit this week), MYALGIA (very sore arm/body aches), HEADACHE (headache), NAUSEA (a little queasy) and FATIGUE (fatigue/very tired/more tired than usual). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt rotten/ have woken up almost as rotten as last week), MALAISE (I just don't feel very well at all), LETHARGY (very lethargic), ARTHRITIS (arthritis has bothered me quite a bit this week), MYALGIA (very sore arm/body aches), HEADACHE (headache), NAUSEA (a little queasy) and FATIGUE (fatigue/very tired/more tired than usual) outcome was unknown.
Information has been received from a nurse concerning a 14 year old female who on 15-MAY-2007 was vaccinated with her first dose of GARDASIL. There was no other vaccination to the patient on that day. On 15-MAY-2007, immediately post vaccination, the patient developed slurred speech for 10 minutes, paralysis of left side for 30 to 40 minutes and a migraine. Subsequently, the patient recovered from the events. Unspecified medical attention was sought. Upon internal review, hemiplegia was determined to be an other important medical event. Additional information has been requested. 8/13/08-records received for DOS 8/15/07-neurology clinic visit for evaluation of two spells associated with headache as well as third severe headache in past 3 months. First spell occurred in June of 2007 when her speech became slurred and developed ;numbness or loss of sensation in entire left lower extremity followed by entire left upper extremity. Speech problem resolved within 10 minutes and loss of sensation persisted for 30 minutes and as this was resolving developed a severe headache over left temple migrated to right temple. Felt like bright light burning directly into left side of head, severe photophobia, vomiting and severely nauseous. Evaluated in ED with head CT which was unremarkable. The next episode occurred in July with no speech problems, only sensation loss in left leg and foot and arm. Fell asleep for 2 hours and up awakening no sensory abnormalities. Seen in ED and repeat CT scan. Two weeks prior to this office visit had significant headache and sensory symptoms. PE normal. Consistent with classic migraine with aura.
EXPIRED VACCINE USED; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 66 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 17-FEB-2022 for prophylactic vaccination. No concomitant medications were reported. On 17-FEB-2022, the patient experienced expired vaccine used, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine used and off label use was not reported. This report was non-serious.
Patient experienced fatigue, vomiting, face swelling, fever, sensation of bugs crawling on him and biting him. Patient was taken to the ER by paramedics and had work up there.
Erythema, swelling and pruritus just inferior to injection site beginning 24-36 hours after injection. No treatment given, watchful waiting.
Came down with varicella even after being vaccinated at one years of age. Information from missing data report states: Information not available. VAERS form was reporting varicella disease 8 yers after immunization in another state.
Fever of 104.5 measured axillary for approximately 24 hours. No other symptoms noted. The fever was first noted at 2am on 01/24/2020 (16 hours after vaccine administration) and ended the morning of 01/25/2020.
At the time of the first round of my Moderna vaccine, I immediately became dizzy with a headache and a sore arm. Once I left the pharmacy I developed a fever and nausea. That night I got hives. I had a fever nausea and lack of energy (Flu like symptoms) for a month making it difficult to do everyday tasks and maintain my composure at work.  The second dose was the same, minus hives.  I have not fully recovered from the vaccine that I took months ago. Since receiving the vaccine I have felt drained of energy and am often dizzy.  The vaccine took a toll on my health, I lost a very unhealthy amount of weight over the month of flu like symptoms, had I been in worse health at the time of vaccine it may have taken longer for the flu like symptoms to leave jeopardizing my ability to pay rent. Had I been in bad health, the vaccine might have killed me.  I did not see a doctor, as I cannot afford one. I should have.
dizzy, h/a, n/v, diarrhea, SOB, tachycardia;
chest pain, started mild/intermittent, became severe acute on 11/7, hospitalized overnight for cardiac workup, chest pains still present but mild/intermittent
Extreme dizziness in morning on Day 3 and 4, lost sense of balance.  This lasted 2 days. Other than that, light headedness and headaches have been daily since vaccination.
This case was reported by a physician via call center representative and described the occurrence of anaphylaxis in a 22-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had an anaphylactic reaction to a flu vaccine received 30 years ago and did not know which one it was or who made it. The patient stated that he was 22 years old at the time of the anaphylactic reaction. No additional details were provided.
I wasn?t given a lot number for my first dose  But the primary point is that not too long after my first dose I began a menstrual cycle outside of my very regular cycle which had ended more than a week prior to this one. My sister and I were talking and she had the same reaction, and I think a good thing to note is that we have birth control implants though they?re different brands I think
having a Hard time sleeping.; Patient can hardly move her arm; left arm is very sore and painful after her first bivalent booster dose/Pain is 8 or 9 out of 10; This spontaneous case was reported by a patient and describes the occurrence of SLEEP DISORDER (having a hard time sleeping.), VACCINATION SITE MOVEMENT IMPAIRMENT (Patient can hardly move her arm) and VACCINATION SITE PAIN (left arm is very sore and painful after her first bivalent booster dose/Pain is 8 or 9 out of 10) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Sep-2022, the patient experienced SLEEP DISORDER (having a Hard of a time sleeping.), VACCINATION SITE MOVEMENT IMPAIRMENT (Patient can hardly move her arm) and VACCINATION SITE PAIN (left arm is very sore and painful after her first bivalent booster dose/Pain is 8 or 9 out of 10). At the time of the report, SLEEP DISORDER (having a Hard of a time sleeping.), VACCINATION SITE MOVEMENT IMPAIRMENT (Patient can hardly move her arm) and VACCINATION SITE PAIN (left arm is very sore and painful after her first bivalent booster dose/Pain is 8 or 9 out of 10) outcome was unknown.            Patient received 1st dose on 23-Jan-2021 with lot number 005C21A. Patient received 2nd dose on 20-Feb-2021 with lot number 007M20A. Patient received 1st booster on 26-Oct-2021 with lot number 939903. Patient received 2nd booster on 01-Apr-2022 with lot number 048L21A. The patient received all of the doses in the left arm. Concomitant medication list was not provided. Treatment information was not provided.      Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2022: Live follow up received: added batch lot number.
Moderna COVID-19 vaccine 1st dose on 02-MAY 2021, 2nd dose on 08-JUN-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna COVID-19 vaccine 1st dose on 02-MAY 2021, 2nd dose on 08-JUN-2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna COVID-19 vaccine 1st dose on 02-MAY 2021, 2nd dose on 08-JUN-2021). On 08-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna COVID-19 vaccine 1st dose on 02-MAY 2021, 2nd dose on 08-JUN-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she took 3rd dose/ booster (0.25ml) 19-Jan-2022 at the same time with the flu shot and she about to receive another 0.25ml dose of the Moderna COVID-19 vaccine as the pharmacist considered the patient was an immunocompromised. No treatment information was provided.
Patient complained of high fevers , aches 102*F starting the day she was immunized and lasting 2 weeks. She claims her hospice doctor instructed her not to get her 2nd dose.
Throat numbness; Lymph node swelling; Felt flush; This is a spontaneous report from a non-contactable consumer. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 17Dec2020 at 15:15 (at the age of 28-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced throat numbness, lymph node swelling, and felt flush on 17Dec2020 at 15:15. The events were reported as non-serious. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of throat numbness, lymph node swelling, and felt flush was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information expected.
The injection site and  3-4" around it was incredibly sore  had difficulty moving that arm. Patient reports to be drowsy last night, went to bed early, awoke this morning after about 10 hours of sleep with body aches, extreme chills, headache and exhausted.
Fever x 4 days, crying, irritability, and complained of abdominal pain with decreased appetite.
Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: 1/15- Mild arm pain, 1/16 HA, fatigue, nausea and diarrhea, 1/18 mild HA & mild fatigue, 1/19 mild HA & mild fatigue. 1/20 mild HA & mild fatigue, 1/21- rash @ injection sight-hot, red, tender to touch.
Major Anxiety flare up after not having anxiety for two years . Oral Inflammation . Tingling sensation all over body. Very heavy menstrual cycle including large clots.
This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unknown patients of unknown age. On an multiple unknown dates, these patients were vaccinated with RECOMBIVAX HB (lot # M000442, Exp: 31-MAR-2018; lot # M010671, Exp:02-JUN-2018). It was called because of a Digital Data Logger. These vaccines were stored under 1.2 degree Celsius for one hour. There was no temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I developed a singular large, red, swollen, warm, circular, itchy rash that increased in size the next day. I have had the rash for about 1 week now, but it is healing.
Patient specifies that she felt fever, headaches, body aches and edema on right arm.
Round red rash near  where the injection was given  that appeared 8 days after the vaccination. It disappeared after 2 days. It was slightly itchy but did not hurt.
Presented to the ER department at hospital around 2300 9/24/2014 with (per patient report) - The area around the injection site was baseball sized, red, flaming hot, and I had a 102 temperature and high blood pressure, which I'm assuming was due to the fever and stress.  And my ankles started swelling.  She could not lift her arm.  Ankles were also swollen.
Symptoms on 12/15/21 which included shortness of breath, fatigue, and loss of appetite. Hospitalized for covid pneumonia on 12/22/21.
12/19/13 aprox 7:30 pm Sudden onset inconsolable crying for approximately 30 minutes.  12/24/13 another crying episode shorter but the same cry as on 12/19. 12/26/13 I noticed leg jerking during sleep. 12/27/13 baby was repeatedly trying to head butt the wall (and my head) during the day. 12/27/13 baby's arm started jerking violently when laid down to sleep.
first dose was administered Late Summer 2020 / second dose approximately two months later / On April 12, 2021 shingles / suspected vaccination failure; shingles / "on the inner lip of my crotch" moving outward; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis.   The patient's past medical history included chickenpox (experienced at 15 year age).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On 12th April 2021, the patient received the 1st dose of COVID-19 VACCINE PFIZER. In April 2021, less than a year after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination for 1st dose was 56 years and for 2nd dose could be 56 or 57 years. In late Summer of 2020, the patient received 1st dose and approximately 2 months later, the patient received 2nd dose of Shingrix. Several days later after receiving Pfizer COVID-19 vaccine, the patient developed shingles. The patient reported that the outbreak was on the inner lip of her crotch moving outward and the patient admitted to being unable to use the correct anatomic terminology to describe the outbreak. The shingles outbreak had improved, though symptoms persist, and the patient was seeing the healthcare professional on day after reporting date. On 4th May 2021, the patient received the 2nd dose of Pfizer COVID-19 vaccine and planned to report the shingles outbreak to the CDC (Centers for Disease Control and Prevention) for monitoring purposes. It was unknown if the reporter considered the vaccination shingles related to Pfizer COVID-19 vaccine. The reporter consented to follow up. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting.
This report describes the inability of an adult pt of unspecified gender to respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's relevant medical history, concurrent conditions, and concurrent medications were unknown. Reportedly, the pt received a 3-injection series of Engerix-B. It was reported that 1 to 2 months after the 3rd injection of Engerix-B, a titer revealed that the pt "did not seroconvert."
Red rash on arm, minor swelling and tenderness about 3 by 7 inches in size
Patient experienced weakness and mental status changes approximately 15-30 minutes after administration to the point where ems needed to be summoned, Never lost consciousness.   Patient transported to emergency room. Status unknown at time of report .
4/26 33y.o. G4P2012 at 38w3d by LMP presenting to triage for scheduled repeat C-section. The indication for C-section is elective repeat with IUD placement intraoperatively.  Baby delivered 4/26,
Pt was nervous upon vaccination.  After vaccine mother reported she passed out.  Daughter went to sit down in post waiting area, after maybe 5 minutes mother said she wasn't feeling well .  Pt reported feeling nauseous.  Took her blood pressure twice and low at 70's/50's.  Pt also has sweat on upper lip and clammy.  Called emergency number.  Pt never lost consciousness and felt better once arriving at hospital and was discharged