chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough COVID case: I first noticed a fever 101.3 at 08:38PM on the 25th of December. On the 26th, my fever got the highest at 103.6. Later that day, I took ibuprofen. When I stopped having a fever, it was on the 29th. On the 29th of December, I drove down and had a COVID test and it was positive. Then, I got monoclonal antibodies the first part of January. I think it was January 3rd.
extreme headache w/ blurred vision and vertigo for first three days,  followed by headache for next 30 consecutive days. Menstrual cylces every 10 days, however prior to this I was not having any menstrual cycle due to partial hysterectomy/ablasion.
24 hours following vaccine administration the (L) upper arm was swollen, red, indurated and itchy. Patient also felt dizzy and when he sneezed "the room went rd".
2/26/2019 ADVERSE RXN CONSULTATION:  pt called pharmacy to state that he's experiencing a bad reaction to the SHINGRIX shot he got earlier today. Patient stated that even during the 10 minutes after the shot while he was waiting in the wait room, he said that he felt a little "tingling" but thought it would go away. Pt called at 4:30pm to state that he now has a quarter size "bubble" or welt on the back side of his hand, above his wrist. Pain is now constant and has been getting worse, at a 4-5 out of 1-10 scale. Pt confirmed allergy to doxycycline and NO food allergies. NO vaccine rxn like this before. Transferred to the front clinic to take it from here. 2/26/19 4:38pm phone note: (per NP) Spoke with patient re: arm soreness where he got SHINGRIX vaccine today. Noticed a quarter size welt on the hand of that arm. No respiratory compromise or swelling or numbness. Advised to take OTC antihistamine and some ibuprofen to help manage sxs. ED precautions discussed and advised him to call back tomorrow if symptoms do not improve. 2/27/2019 at 1:37pm: (per NP) Follow up on symptoms s/p adverse reaction to SHINGRIX. Awaiting call back.
Pt recvd vax & 90 mins post inject exp hives which were treated w/DPH & resolved;
Diverticulitis a couple weeks after the first vaccine. I then felt better after being hospitalized and then had the second vaccine and the diverticulitis flared up again.
left arm was Itchy; hot to the touch; believes that she had cellulitis on the left arm; her left arm was red; had a headache; had muscle pain/Body ache; felt like she had the flu; she woke up with a swollen left arm; pain in the legs; left arm injection site was sore; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (felt like she had the flu), VACCINATION SITE PRURITUS (left arm was Itchy), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE CELLULITIS (believes that she had cellulitis on the left arm) and PAIN IN EXTREMITY (pain in the legs) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy and Sulfonamide allergy (allergic to Sulfa).    On 26-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced VACCINATION SITE PAIN (left arm injection site was sore). On 27-Oct-2022, the patient experienced INFLUENZA (felt like she had the flu), PAIN IN EXTREMITY (pain in the legs), VACCINATION SITE SWELLING (she woke up with a swollen left arm), HEADACHE (had a headache) and MYALGIA (had muscle pain/Body ache). On 28-Oct-2022, the patient experienced VACCINATION SITE PRURITUS (left arm was Itchy), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE CELLULITIS (believes that she had cellulitis on the left arm) and VACCINATION SITE ERYTHEMA (her left arm was red). The patient was treated with PARACETAMOL (TYLENOL) on 29-Oct-2022 for Vaccination site pain, at an unspecified dose and frequency; PREDNISONE on 29-Oct-2022 at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) on 29-Oct-2022 at an unspecified dose and frequency; LORATADINE (CLARITINE ALLERGY) on 29-Oct-2022 at an unspecified dose and frequency and AZITHROMYCIN (ZITHROMAX) on 29-Oct-2022 at an unspecified dose and frequency. On 29-Oct-2022, MYALGIA (had muscle pain/Body ache) had resolved. At the time of the report, INFLUENZA (felt like she had the flu), VACCINATION SITE PRURITUS (left arm was Itchy), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE CELLULITIS (believes that she had cellulitis on the left arm), PAIN IN EXTREMITY (pain in the legs), VACCINATION SITE PAIN (left arm injection site was sore), VACCINATION SITE SWELLING (she woke up with a swollen left arm), VACCINATION SITE ERYTHEMA (her left arm was red) and HEADACHE (had a headache) outcome was unknown.            Concomitant medication was not reported. Urgent care gave her nasal spray (does not recall the name).   This case was linked to MOD-2022-667370 (Patient Link).
This case was reported by a healthcare professional and described the occurrence of urticaria in a 10-year-old female subject who was vaccinated with ENGERIX B, GlaxoSmithKline.  On 22 September the subject received 1st dose of ENGERIX B at 10 mcg.  On 23 September 2000, 1 day after vaccination with ENGERIX B, the subject experienced urticaria, raised red bumps, itching and feeling unwell.  The events resolved within a few days.  The subject did not believe that the events were related to treatment with ENGERIX B.
This non-serious spontaneous case, initially received from other health professional via pharmaceutical manufacturer Novartis on 22-Sep-2018 and concerns a 75-year-old, elderly patient of an unspecified gender. On an unspecified date, the patient was administered FLUAD (TIV) [route of administration, anatomical location, dose, batch number and expiry date: not reported]. On an unspecified date, the patient experienced fever of 100 degrees and nausea (reported as: in the evening). It was reported that the patient felt better by late morning (date unspecified). At the time of this report, the patient was recovering from the events. This case was considered as lost to follow-up since the reporter has not given consent to provide further information.
w/projectile vomiting; taken to peds office; sent home; later sz began; no fever; taken to ER adm; seizures not dected again until next evening; CT scan done; emerg surgery to place shunt for hydrocephalaus; Phenobarb given for sz; DT only
My due date is Sept 25, 2021. I delivered my baby prematurely and my baby was diagnosed with subclinical hypothyroidism afterwards. My husband and I , we don't have any thyroid issues.
Low grade fever; rash below site of injection 6 x 6; soreness in right arm.
This spontaneous report has been received from a pharmacist referring to an 62 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 23-APR-2017 the patient was vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M037014, expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (DILUENT MRK) (lot# and expiration date were not provided). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 30 degrees Fahrenheit for 4 hours. The doses of vaccine experienced also previous temperature excursion: from 15 to 46 degrees Fahrenheit for 15 minutes. Digital data logger was involved. The pharmacist stated that the vaccine was cleared, so they had vaccinated patients since the excursion. This is one of several reports from the same reporter. Additional information is not expected as all the information has been received.; Sender's Comments: US-009507513-1704USA006516: US-009507513-1705USA013608: US-009507513-1705USA013609: US-009507513-1705USA013610: US-009507513-1705USA013606:
Patient states that the vaccine was administered into the shoulder joint instead of the muscle. Patient has experienced shoulder pain and has undergone physical therapy and surgery after the administeration of the vaccine.
Sever chills, sweating,  headache, fever 101-102.5, arm pain and redness that extended into shoulder and axilla.
4 weeks following 2nd Moderna Vaccine, I started having symptomatic Bigeminal PVC's that lasted approximately 45 minutes. Symptoms included dizziness, near syncope, palpitations, and shortness of breath. After 2 ED visits, I was referred to a cardiologist who ran tests to include a Holter monitor, and echocardiogram. I followed up with a Cardiac Electrophysiology Doctor who prescribed Flecainide to control the PVC's. I have been on Flecainide since early March, which has controlled the PVC's to a tolerable level (roughly 100/day). Before the Flecainide use, I was having roughly 1,000 PVC's a day, and had multiple episodes of Bigeminy.
Mother brought her son to get his first Pfizer Covid-19 vaccination. She filled out his Informed Consent for Immunization with Covid-19 vaccination form and stated on it that he is 16 years old. Pharmacy technician who is certified immunizer took all the information and administered the shot. When she attempted to process the shot she realized that patient is not 16 years old yet( He is 15 years old). When the mother initially requested the vaccination for her son she was informed by the pharmacist(myself) that her son must be 16 years or older to receive the vaccination.
Started having a fever and sore throat. Took a home COVID-19 test and was positive. Doctor prescribed PAXLOVID, took full course. Took another COVID-19 test and was negative. Felt fine for a week then started feeling symptoms again and tested positive for COVID-19. Had a chest X-ray and it was clear. Rested and tested negative a week later.
Pt returned to pharmacy with what appeared to be a local allergic reaction at the injection site on 9/4/13.  I recommended Benadryl and requested her to come in the next day so that I could take a look at it.  The reaction appeared slightly worse on 9/5/13 so I contacted her PCP and scheduled a same day appointment so that the office could take a look at it. Diagnosed as local allergic reaction and pt was recommended otc antihistamine therapy.
He was sweating; Felt like he was hit by 2 by 4; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (He was sweating), FEELING ABNORMAL (Felt like he was hit by 2 by 4) and FATIGUE (Felt tired) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HYPERHIDROSIS (He was sweating), FEELING ABNORMAL (Felt like he was hit by 2 by 4) and FATIGUE (Felt tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and SOTALOL for Heart rate high, at a dose of 40 mg. At the time of the report, HYPERHIDROSIS (He was sweating), FEELING ABNORMAL (Felt like he was hit by 2 by 4) and FATIGUE (Felt tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood test: unknown (Inconclusive) unknown. On 26-Feb-2021, Chest X-ray: inconclusive (Inconclusive) Inconclusive. On 26-Feb-2021, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On 26-Feb-2021, Heart rate: 126 (abnormal) went up to 126 and high (High) Only lasted about 5-7 hours.         No concomitant medications were reported. Patient was on heart monitor for two weeks.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received updated event outcome and treatment dosage details.
Erythema with induration, itchiing at MMR injection site beginning one hour after injection. Cold compress and topical hydrocortisone ointment applied. Symptoms reduced in 1 hour.
suspected vaccination failure/took both shots and get shingles; Shingles/still get shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, 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 not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient took both shingles shots and still get shingles. The patient stated that they were not as bad but they were there. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Pfizer Covid 19 vaccine given too early .  Gave this dose 3 weeks after dose given 11-8-21
Pt was given a 3rd dose of the 2-dose series of varicella. Provider was notified. Then Patient was then contacted, denies sign and symptoms of reaction to varicella vaccine. Educated pt on what to assess for.
Had Vx years ago, then shingles/suspected vaccination failure; shingles/just got shingles; sores on back, stomach, legs, have dressings changed; my legs are so sore, have dressings changed; been out of work for 4 months; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin ulcer, leg pain and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, shingles, skin ulcer and leg pain were unknown and the outcome of the activities of daily living impaired was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, skin ulcer, leg pain and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shingles vaccine a couple years ago from reporting and just got shingles. The patient had been out of work for 4 months. The patient did not thought that's right, he/she had got sores on his/her back sores, sores on stomach and legs were so sore. The patient had to have dressings changed on them every day. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Information has been received from a physician concerning now a 4 year old male with a history of recent exposure to a family viral infection who on 06/10/1998 was vaccinated in the right arm with varicella vaccine. The pt developed rash 42 days post vaccination. On 08/09/2001 the child developed lesions on his right shoulder. On 08/10/2001, he had a fever, vomiting, and lesions extending down the right arm to the wrist. He was seen by the local doctor and prescribed Acyclovir. On 08/11/2001 the child's temperature was 102.5 deg F and he was lethargic. By 08/12/2001 the child's activity had increased and by Monday the 08/13/2001 the child was well. On the 08/13/2001, the pt was seen by another physician who collected the specimens for PCR analysis. The herpes zoster specimen was adequate and it isolated VZV. The vaccine strain was identified by PCR analysis. The reporter felt that fever, vomiting, and lethargy were attributable to another viral illness that the family members were experiencing. It was noted that the pt's sibling was vaccinated with varicella vaccine and has not experienced any adverse reactions. Additional info has been requested.
I DID NOT ADMINISTER VACCINE.   PRESENTED TO ME FOR CARE.  DX WITH HERPES ZOSTER. TX WITH VALTREX.
Blistering lesions erupted on face and neck. They continued to come and go until Dec 03. In Apr 03 developed clusters of other lesions on trunk, axilla, back and arms. In Jun04 began having intermittent blistering lesions erupt on buccal mucosa, under tongue and under lips. These lesions continue to the present.
Swollen Uvula, swollen tongue, ulcers in mouth and uvula, fatigue
Day of injection severe pain at injection site. Next day after injection tightness in chest and congestion accompanied with headache. Pain in right groin down right leg. Day two after injection chest pain pain along back and neck pain down into left shoulder. Severe pain in left shoulder unable to lay on left side and ringing in the ears. Diarrhea first and second day after injection.
injection site is very painful; body aches and other pains; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site is very painful) and PAIN (body aches and other pains) in a male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site is very painful) and PAIN (body aches and other pains). At the time of the report, VACCINATION SITE PAIN (injection site is very painful) and PAIN (body aches and other pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Shoulder pain in rotator cuff area.  Unable to perform certain functions dressing and doing routine chores.   Still on-going.  Have had cold laser treatments - xrays.  Still hurts as bad as it did when I receive injection.
Fever, body aches, dizziness, swelling, and redness around injection site, chills, light headedness. Left arm sore to touch around injection site. Started feeling better on 4/3/00. Injection site still swollen and sore to touch.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Feb2021 13:15 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number-1, Time-01:30 PM, Anatomical site of injection- Left arm, Route of administration: Intramuscular), administration date: 19Jan2021, for COVID-19 Immunization, reaction(s): "Fatigue".The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Feb2021, outcome "unknown", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information:Prior vaccinations within in 4 weeks and Relevant tests was none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site pain in first hour. extreme headache, body ache and skin tenderness  starting about 6 hours after injection.  sleepless night with symptoms worsening . almost unbearable headache  and full body soreness for next 72 hours .  first time i ever felt suicidal. sleepless second night with intense  skin itching  and  hundreds of raised itching bumps appeared second morning  on all of my body.  those spots have maddening sharp pain/itch . one week  later and pain/itching come in waves .  bumps starting to dissipate on day 8.
Patient received the vaccination and after he got up from the chair, he passed out and fell to the floor. The intern notified the pharmacist. When I went to see that patient, he was laying on the floor with his eyes rolled in the back of his head and was unresponsive. He was not alert. He started having a mild seizure and I rolled him over on his left side. While I was bracing the patient, pharmacist came in and administered an Epi-pen to his left thigh. Patient stopped seizing so I rolled him back on his back. He became alert and was able to provide me his name, DOB and what he was at the pharmacy for. I rested my hand under his head and monitored his pulse until the paramedics arrived
Patient was administered a dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) 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 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
17 days p/vax pt devel a varicella like rash w/unspecified number of lesions. no fever
After 48 hours, 2/3 of upper arm was still red, swollen and hot to the touch. Pt complained it hurt. Treatment was ice pack.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8729), in right arm and on 03Dec2021 as dose 3 (booster), single (Lot number: FH8036) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Mild asthma. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti viral details: Product: COVID 19 treatment. COVID vaccine details: Vaccine brand: Pfizer / BioNTech. No known allergies reported.