chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Granuloma Annulare; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA ANNULARE (Granuloma Annulare) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced GRANULOMA ANNULARE (Granuloma Annulare). At the time of the report, GRANULOMA ANNULARE (Granuloma Annulare) outcome was unknown.            The patient developed Granuloma annulare that has been diagnosed by their dermatologist. The exact timetable of this condition is not fully known by the patient, but the rash is currently up their left leg, stomach, some of the right leg, and part of their front side. The patient believes it may have started as a strange pimple on their left thigh sometime after the first dose of the vaccine. After the second dose, the patient noticed this skin condition was more prominent. The patient has had screws put into their leg, so they are not entirely sure if the rash is related to the vaccine.   This case was linked to MOD-2021-181993 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up document was added with no new information
Patient tolerated well after the vaccination for 15minutes and left the clinic. Patient went to gym class and ran. Patient complained of changes of vision after the running and came back to health suite. She could see, but unable to see clearly. She said she saw 2 fingers when I showed one finger. She was able to walk and pick up tissue without problem. Her normal vision came back in 15-20minutes, but guardian came to take the student to home.
Subsequent to receiving first and second doses of varicella virus vaccine live, pt sought medical attention and a serum VZV antibodies test revealed negative titers.
Injection site-pain, 1 inch welt, tingling down arm and joint pain in elbow and fingers.
Fever of 103.5, chills, extreme fatigue, headache - 5 days after vaccine was administered - all symptoms gone within 24 hours
Pt has a hx right arm pain and limitation of mobility after pneumovax vaccination on 12/4/20. She was seen by NP and Dr  on 12/18/20 - at that time she was slowly improving.  She was taking high dose ibuprofen and prescribed Pepcid to reduce rhe risk of GI side effects from the ibuprofen She reports that her arm pain has not improved much and she still has pain and limitation with moving her arm forward. Her physical therapist, who she sees her for a separate problem, advised her to use an arm rest and heat, which has not given significant relief.  She needs to sleep in a recliner to relieve the pain.  She is interested in a prescription for PT specifically for her right arm.
Worse side effects after first booster; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Worse side effects after first booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Worse side effects after first booster). At the time of the report, IMMUNISATION REACTION (Worse side effects after first booster) outcome was unknown.            No concomitant medication was reported. No treatment medications was reported.   Reporter did not allow further contact
Effected my menstrual cycle. My periods always last 7 to 9 days and after I got the JJ Vaccine, my periods lasted only 3 days and became irregular. Now it is back to normal.
1.5 hours after shots child was vomiting and developed rash all over the body with wheezing.
Developed increasing mild soreness at site, also slight redness from injection site extending to elbow. Now slight itchness. continues to date.
Patient woke in middle of night with fever of 101. Mom treated with Tylenol and patient went back to sleep. Awoke 6AM perfectly fine and eager to go to school.
sore throat; congestion in throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 20Sep2023 as dose 1, single; IBUPROFEN; ACETAMINOPHEN; FLUORIDE [SODIUM FLUORIDE]. The following information was reported: UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 19Oct2023 at 06:30, outcome "recovering", described as "congestion in throat"; OROPHARYNGEAL PAIN (non-serious) with onset 19Oct2023 at 06:30, outcome "recovering", described as "sore throat". Therapeutic measures were not taken as a result of oropharyngeal pain, upper respiratory tract congestion. Additional information: No known allergies. It was also reported the patient experienced sore throat, congestion in throat at "14hrs" after vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Given 3rd shot accidentally; 3rd shot accidentally; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Given 3rd shot accidentally) and ACCIDENTAL OVERDOSE (3rd shot accidentally) in a 97-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced OFF LABEL USE (Given 3rd shot accidentally) and ACCIDENTAL OVERDOSE (3rd shot accidentally). On 07-May-2021, OFF LABEL USE (Given 3rd shot accidentally) and ACCIDENTAL OVERDOSE (3rd shot accidentally) outcome was unknown. Not Provided          No concomitant medication were reported. No treatment information was provided.
Experienced dizziness and nausea Husband picked the patient up and transported her to see a doctor.
Injection site was warm; Red circle around the injection site; Injection site perhaps a little bit raised; injection wite like a mosquito bite, wanted to scratch because it was itchy; Injection site a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was warm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesteraemia. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was warm). At the time of the report, VACCINATION SITE WARMTH (Injection site was warm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug included cholesterol medicine. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-JUN-2021 contains non-significant information.
administering it to a patient, some of it came out and patient didn't get the full dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 60-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 997A5, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th November 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 8th November 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.    This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment: The registered pharmacist called and requested information regarding revaccination with Fluarix QIV.  When administered it to a patient, some of it came out and patient did not received the full dose The reporter consent to follow-up. Additional Supportive information: When the patient received Fluarix Quadrivalent some of it came out and patient did not receive the full dose, which led to accidental underdose.
headache, cough, fever, diarrhea.  Told her to take Tylenol and anti diarrhea medication and consult doctor if it doesn't resolve.
No adverse events known at this time. Patient given accidental dose of HIB instead of the Polio dose that was needed. Doctor and Parents aware of situation. Patient contacted and aware of mistake. Advised us to make sure to fill out VAERS. Parents of Patient advised to bring patient in if any adverse reactions arise but none at this time.
pt arm checked 2 days p/vax & pt arm had erythema, redness & swelling which was hard to touch;the swelling measured 2.5in by 1.75in;pt mom advised to use cold compress
After about 24hrs severe headache, hot and cold sweats and Asthma that I did not have since I was kid. Felt like being hit by a bus. Severe muscle ache all over my body. Asthma subsided after about 18 hours. Today (2 day after vaccination) still coughing with substance. But definitely better. If the second shot is going to be worse - not sure I want it!
Information has been received from a physician concerning a female with a history of "simple childhood illnesses" who in approximately June 1997 (at 15 months), was vaccinated with MMR II. Concomitant therapy included children's multivitamins. Subsequently the pt developed hives and erythema multiforme, which resolved. Additional info has been requested.
Had awful flu symptoms; Bad headache; This case was reported by a consumer and described the occurrence of flu symptoms in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced flu symptoms and headache. On an unknown date, the outcome of the flu symptoms and headache were recovered/resolved.   The reporter considered the flu symptoms and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient herself. The age at vaccination was not reported but it could be 71 or 72 years old. The patient had awful flu symptoms and bad headache for 2 weeks with first dose of Shingrix. The patient was afraid to get the second dose at the time of reporting. The reporter consented to follow-up.
Rash on right arm. Light flaking, dry skin. Diameter approximately 3 inches.; Rash on right arm. Light flaking, dry skin. Diameter approximately 3 inches.; Rash on right arm. Light flaking, dry skin. Diameter approximately 3 inches.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2022 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, lot unknown reason: Unable to locate or read the details, Vaccine location: Left Arm , Administration Time: 06:00 PM), administration date: 07May2021, when the patient was 35-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, lot unknown reason: Unable to locate or read the details, Vaccine location: Left Arm , Administration Time: 08:00 PM), administration date: 13Apr2021, when the patient was 35-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious), DRY SKIN (non-serious), SKIN EXFOLIATION (non-serious) all with onset 25Feb2022 at 12:00, outcome "recovered" (2022) and all described as "Rash on right arm. Light flaking, dry skin. Diameter approximately 3 inches.". Therapeutic measures were not taken as a result of rash, dry skin, skin exfoliation.  Additional information: The patient was not received other vaccine in four weeks. The patient had no other medications in two weeks. The patient was not covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sick with the flu; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sick with the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that Got the flu shot once. Sick with the flu. Not for everyone. Freedom of choice. And no thanks.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
12/30/2021: Event occurred after 2nd vaccine.  89-year-old male with a history of mechanical falls on Eliquis for pacemaker presenting for a fall at approximately 3 hours ago. He was too weak to get up after he fell. He states that he fell this time because of weakness and denies any syncope or shortness of breath . He also has a new onset cough and recent exposure to Covid positive people. Patient denies: vomiting, Diarrhea, fever, urinary symptoms, blurred vision, sore throat, back pain, palpitations, dizziness, shortness of breath, rash. COVID test positive in ED.  01/06/2021: remains in hospital.
Pt received a flu vaccine at 2:15. Had itchy face, head, chest within 10-15 minutes. It became progressive. Gave Benadryl approx 35 minutes after vaccine. Itchiness subsided within 10 minutes.
A nurse reported that a 24 month old child received the 1st dose of Prevnar and subsequently, developed an injection site reaction characterized by an area of redness and swelling which was "the size of a baseball". No further information was available at the date of this report. This is 1 of 2 reports from this facility of injection site reactions following receipt of Prevnar.
What was thought to be normal arm pain immediately - which then lasted (and still lasts).  The pain is worse at night.  Started a self prescribed treatment while traveling of ibuprofen.  We were traveling from Oct 31 through Nov 10.  Patient called the administering clinic on the 11th or 12th and was told to contact her primary care doc.  She called her on the same day and went in.  Dr. Prescribed Aleve for 14 days (1 every 12 hours).  That night the pain was very intense and the next day patient call Dr. again and was prescribed Tylanol #3 - 30 Mgs.  That helps with the night pain.   The pain persists - with some nights my wife asking me to start the movement of her arm for her, because she cannot get it to move.  Once i get it started she can move it - but with great pain.  The Aleve treatment schedule ends in 3 or 4 days.
Loss of appetite, headache, chills, feeling lethargic, running nose, sneezing, itchy throat
had slight fever; headache; muscle and joint ache; muscle and joint ache; chills; a bit of stomach problem; extreme pain on the injection site; This is a spontaneous report from a consumer (Patient) via Pfizer-sponsored program.   A patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: UNKNOWN) via an unspecified route of administration at left arm, on 03Apr2021(Saturday), as a SINGLE DOSE for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient stated that one day before this report (04Apr2021), she  had slight fever, headache, muscle and joint ache, chills, a bit of stomach problem and extreme pain on the injection site (left arm). At the time of this report events outcome was unknown.  No follow up attempts needed. No further information expected.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 14-DEC-2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 05-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 804 hours, the lowest recorded temperature was 20 degree F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Adverse event: acute myocarditis/pericarditis. 2 days after receiving Pfizer #2, dev substernal chest pain, largely positional with positional dry cough. Also had left arm numbness/paresthesia after second vaccine. Treatments: 1 dose enoxaparin, IVF, ondansetron x 1, then placed on/discharged from hospital on colchine Never had fever or tachycardia
This case was reported by a other health professional via call center representative and described the occurrence of rash in a 59-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concomitant products included Atorvastatin, Diltiazem and Ramipril. On 9th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 9th March 2018, 6 hrs after receiving SHINGRIX, the patient experienced rash, pain in arm and intramuscular formulation administered by other route. On an unknown date, the outcome of the rash and pain in arm were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the rash and pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. Six hours later, rash and arm tenderness presented on the whole underside of (left) arm. Rash described as 12 inches in diameter. The reporter thinks SHINGRIX may have been administered subcutaneously but unable to fully confirm unknown route of administration, which led to incorrect route of administration. The patient required emergency room visit. The reported SHINGRIX batch number (374KL) did not exist in the sales database and was updated to 3Z4KL.
Left arm has rash at injection site. Hard itchy ball bump. Similar to a mosquito bite that has swollen up.
Rash, hives head, to toe, seen ER and given Benadryl shot and additional and over counter 50 mg to be used.
Patient received Flu shot on 9/13/11 & call the pharmacy on 9/21/11 complaining of sore arm and a tingling feeling on lower arm to the fingers on left arm. She said she had no swelling at injection site. Her arm hurt so bad she was unable to sleep on 9/19/11. She added it was some better in afternoon on 9/21/11.
No pain at time of injection (2/12/21, 4:30p) , pain/soreness started approx 3 to 4 hours after time of injection just below injection site. Next morning (2/13/21 10a) massive increase in pain, so much so it interfered with daily life. Could not move arm at all without searing pain. Had some lunch, then took 400mg of Ibuprofen and majority of pain disappeared, but some remained.
The worst miagrain in the world for 5 days...  started almost 24 hrs later none of my medication that typically works for a normal miagrains worked. I capped out on dosage
within 5 days of vaccine. severe joint pain in toes, ankles. knees, hips, base of spine, upper back, neck, shoulders, elbows, wrists and fingers.  pain has worsened. also pain in left leg, burning and soreness just behind the knee still persists
Pt was given flu shot 1-15-18. Later that evening pt. began showing signs of swelling in upper arm w/erythema. Has Hx of injection site reaction, although very minor. Pt was taken to pediatrician and BENADRYL was given. Pt improving but still  has swelling as of 1-18-18.
Nausea, vomiting, weakness, syncope, dizziness, bradycardia
Patient complains of localized itching over right deltoid immediately following 2nd covid vaccine. Itching spread to upper back with no rash or respiratory changes. Gave 25mg benadryl and symptoms quickly resolved. Patient was stable and released after monitoring for 30 minutes