chrisvoncsefalvay/vaers-outcomes huggingface dataset:
27 yo M w/ h/o anxiety, septal deviation, mild asthma, and mild idiopathic thrombocytopenia who reported that approx 7-10 days after booster dose of Pfizer Covid vaccine he developed chest pain and palpitations. Seen in ED 8/29/2021. EKG "normal sinus rhythm without evidence of ischemia or arrhythmia." Lab work notable for negative d-dimer and normal/negative troponin. Bedside ultrasound showed no pericardial effusion, global systolic function intact. Saw cardiology at hospital 12/22/21. Noted persistent mild hypertension (130s-140/70-80). Exam again normal.  Likelihood his transient tachycardia and chest discomfort were related to vaccine is debatable (especially given normal evaluation in the ED at the time of symptoms, including ultrasound and troponin labs). Neither I nor his cardiologist thought it likely that his mild hypertension was related to the vaccine (patient was certain it was related).  Patient has pushed for report of "adverse effect" from vaccine.
consumer exp fever 104 for 3 days & fever of 100 for 3 days, heart palpitations, muscle & joint pain lasting 3 months & stiffness; dx by MD as serum sickness-like reaction; last tetanus vax 6 yrs ago;
cannot focus with her eyes; full body aches and pains; This is a spontaneous report from a contactable consumer. A non-pregnant 97-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the right arm on 18Feb2021 at 15:00 (at the age of 97-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer survivor from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID. It was unknown if the patient had any allergies. Concomitant medications included pilocarpine hydrochloride 1% ophthalmic from an unknown date for an unknown indication and levothyroxine from an unknown date for an unknown indication. The patient had not received other vaccines in four weeks. The reporter stated that her mother said she could not focus with her eyes and had full body aches and pain on 21Feb2021 at 09:00; further reporting she is generally in good health without any complaints. No treatment was provided for the events. The clinical outcomes of cannot focus with her eyes and full body aches and pains were not recovered. It was also reported the patient was not COVID-tested post vaccination.
Patient reported swollen arm, red, itchy, and hot to the touch. Patient went  to another pharmacy (ours was closed for Labor Day, 9/2/19), and was told to take Benadryl. Patient reports taking Benadryl and issue resolved after one week (week of 9/9/19).
The day after the administration of the vaccine, I felt dizzy, weak in the legs, frequent headaches, pain in the frontal area of the head, pain in the right side of the upper ear, lack of strength in the hands.
Severe headache; This case was reported by a nurse via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2019, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccination and experienced a severe headache that has not resolved at time of report.  The patient did not have a history of headaches, nor was he prone to getting headaches. The headache is somewhat relieved by exercise but can last up to 9 hours. The reporter consented to follow up.
expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 3A333, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 25th July 2022, the patient received the 1st dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 25th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 27-Jul-2022 Reporter's comment: The office manager stated that an expired dose of Rotarix was administered to a patient. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Rotarix, which led to expired vaccine used. The case was linked with case US2022111765, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022111765:Same reporter
Moderate joint and muscle pain.  Will treat with over the counter NSAIDs. Started upon waking up this morning ~6:00 am CDT.
Within 18 hours of dose 1, I woke with fever, chills, shaking, and body aches.
Tachycardia on 1/1/21 and another tachycardia event 13 days later.  I have rapid heart rate at random times now throughout the day. Shingles out break 1/14
On 05/12/2022 - I had chills, headache, congested and a sore throat. I did not have a fever but I felt chills. On 5/15/2022 I took a home Covid-19 test and I was positive. I had a video visit with a Clinic on 05/16/2022. The doctor gave me info on supportive measure to help my symptoms and ordered a PCR test to be done. The PCR test was done on 05/17/2022 and on Wednesday, 05/18 I had a positive result. Treatment: nasal spray, cough drops, Tylenol for fever and headaches and rest and fluids. Two nurses followed up with me over the phone. I have not recovered from my COVID-19 symptoms. I am still congested, sore throat, and a little cough and fatigue.
A rash the size ~4 inches x 5 inches around administration site appeared 1/21/21 (one week after administration) late in the day. Experienced sx itching and pain to the touch. Rash went away by 1/24/21. Pain to touch gradually decreased but I am still having tenderness when touched.
Patient received the first dose on SHINGRIX on Friday, 8/24/18. On Saturday, 8/25/18, she developed a rash on her legs from ankle to knee without any pain or itchiness. The rash continued on 8/26/18, when she called the pharmacy to report the event.
Information has been received from a physician via a company representative referring to a patient of unknown age. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patient was vaccinated with the first and second dose of GARDASIL 9 (lot#, dose and route unknown). The second dose was administered in the patient's right arm. About a month after the second dose of GARDASIL 9, the patient developed strep throat. As treatment, patient was administered a penicillin injection (unspecified manufacturer) in her right leg. The patient then developed cellulitis at the GARDASIL 9 injection site in her right arm an unspecified amount of time following the administration of the penicillin injection. The patient had a third dose of GARDASIL 9 administered on an unspecified date in her left arm, and had no additional adverse reaction. The outcome of the events was unknown. Additional information has been requested.
Within 1 hr after pt left office per pt she experienced dizziness, sweating, SOB and throat swelling. Pt had to use albuterol inhaler.
This spontaneous report as received from a registered nurse refers to a patient of unknown age an gender. On 28-NOV-2012, 01-MAy-2013 and 15-JUL-2013 the patient was vaccinated with the three doses of GARDASIL respectively. No adverse effects were reported. Additional information has been requested.
she noticed that her vision was blurry; Double vision while driving/ saw 2 green lights instead of one; Ocular Migraine; This spontaneous case was reported by a patient and describes the occurrence of VISION BLURRED (she noticed that her vision was blurry), DIPLOPIA (Double vision while driving/ saw 2 green lights instead of one) and OPHTHALMIC MIGRAINE (Ocular Migraine) in a 68-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     The patient's past medical history included Ocular migraine (Prior to vaccination she seldom had them.).    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Sep-2022, the patient experienced VISION BLURRED (she noticed that her vision was blurry), DIPLOPIA (Double vision while driving/ saw 2 green lights instead of one) and OPHTHALMIC MIGRAINE (Ocular Migraine). On 11-Sep-2022, VISION BLURRED (she noticed that her vision was blurry) and DIPLOPIA (Double vision while driving/ saw 2 green lights instead of one) had resolved. On 12-Sep-2022, OPHTHALMIC MIGRAINE (Ocular Migraine) had resolved.            No concomitant medication was reported. First dose: On 04 Jan 2021 (Lot# 025J202A & Exp. Date: unknown). 2nd shot: On 29 Jan 2021 (Lot# 030L20A & Exp. Date: unknown). First Booster shot: On 27 Oct 2021 (Lot#939906 & Exp. Date: unknown). 2nd booster shot: On 06 Apr 2022 (Lot# 007J21-2A & Exp. Date: unknown). The symptoms cleared and she did not need to see a doctor. No treatment information was reported.
10/22/02 Received pneumococcal vaccine right deltoid. Came in on 10/23/02 right arm swollen from shoulder down to elbow. Red and warm to touch. Had fever last night. Husband stated all this started last night. Gave Zyrtec in office. Took Tylenol last night. Prescription written for antibiotic, Zyrtec and Tylenol.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Patient was sleeping in the same room with me because we were visiting family. He began to fuss around 2:30 AM, so I took him out of his pack n play and laid down on the couch with him. He fell asleep on my chest and woke up app an hour later with a breathing problem.  He was having a hard time catching his breath, almost as if he had been crying hysterically, but wasn't.  He was more or less gasping for air for app 10 minutes.  I went down to get him a cold drink of water and the problem subsided.  It hasn't returned, but he has developed a bumpy rash on his cheeks today.  This happened less than 48 hours after receiving his MMR and chicken pox vaccinations. I read the information sheet on the vaccinations, and saw difficulty breathing listed as a side effect.  That's why I decided to report it--just in case something else comes up.
DIZZINESS OBSERVED, PATIENT ADVISED TO WAIT EXTRA 15 MINUTES, PATIENT FELT FINE
pt admitted to hospital with c/o abdominal pain; pt has dementia and failure to thrive due to inadequate home care; COVID positive; pt's condition worsened and he was placed on comfort care; pt expired in the hospital
Quarter size bruise looking  area on Left breast.  No known trauma to area.  Was not there the night before, notice after shower.  Had PA look at it and confirmed it was not a rash.
intestinal blockage; severe constipation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 11:15 (Lot number: ER8736) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "known allergies" (unspecified if ongoing). No COVID prior to vaccination and was not tested post vaccination. The patient took unspecified concomitant medications. The following information was reported: INTESTINAL OBSTRUCTION (medically significant) with onset 02Apr2021, outcome "recovered with sequelae", described as "intestinal blockage"; CONSTIPATION (medically significant) with onset 02Apr2021, outcome "recovered with sequelae", described as "severe constipation". The events "intestinal blockage" and "severe constipation" were evaluated at the physician office visit. Treatment for events included enema, laxative, antibiotics. The patient received dose 2 of BNT162B2 administered in arm left, administration date 21Apr2021 16:00 (Lot number: ER8737).  No follow-up attempts are possible. No further information is expected.
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old patient who was vaccinated with 0.5 ml dose of MENACTRA (Lot number: U5848AA; expiry date: 11-Mar-2019) via intramuscular route in the right deltoid on 21-Jun-2018. The patient was also previously vaccinated with a dose of MENACTRA on 16-Oct-2017. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients concomitant medications included GARDASIL for Immunisation. It was a case of actual medication error due to extra dose administered. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
headache; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose on unknown date, refer case US2020AMR229311). Concurrent medical conditions included shingles.   In November 2020, the patient received the 2nd dose of Shingrix. In November 2020, 1 day after receiving Shingrix, the patient experienced headache and upset stomach. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache and upset stomach were recovering/resolving.   It was unknown if the reporter considered the headache and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix a week ago and had headache and an upset stomach. The patient starting to feel better. The reporter did not consent to follow up. The reporter refused to provide any demographics, declined any additional information for these adverse events for this case. This case linked with US2020AMR229312, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR229312:Husband's case US-GLAXOSMITHKLINE-US2020AMR229311:same reporter
Stiffening of the right side from the shoulder to the arm on the first day. Stiffening of the hand and shoulder 3 days later. Diarrhea on everyday for about 10 days. Bleeding in anal area. Abdominal cramps on left side and rash on chest were also noted.
Pfizer vaccine was injected into sodium chloride diluent vial.  Pt was given 0.3 ml of vaccine solution.
Mom noticed reddness and swelling to left arm area round with even border on 05/06/2003.  Mom gave benadryl in evening.  On 05/07/2003 AM, mom noticed area more reddened, swelling, large and irregular shape over most of upper outer arm.  She also noticed him tapping left feet like it was numb.
Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment medication was not provided.
pregnant patient was given FLUZONE QUADRIVALENT, no AE; Initial information regarding an unsolicited valid non-serious case received from a pharmacist via Health Authority (Reference number- 00322387) and transmitted to Sanofi on 19-Oct-2020.  This case involves a female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] when she was pregnant (exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The gestation period during exposure was unknown. The date of last menstrual period was not reported. The estimated due date was not reported.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  In Jul-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE batch number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy.  It was also reported that the nursing program she attends won't accept that as a viable vaccine because it was too early in the season.   It was not reported whether patient experienced any adverse reaction after the vaccination.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  Information on the batch number was requested.
This spontaneous report as received from a pharmacist refers to a female patient of over 60 years. Her medical history was unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX, lot # J000444, 0.65 ml, subcutaneous. No co-suspected or concomitant medications were reported. After receiving the vaccination, the patient experienced redness and a lump on the arm at the injection site. The patient went back to the pharmacy because of the event. The event ws treated with BENADRYL. The outcome of redness and a lump on the arm at the injection site was unknown and a causality assessment was not provided. This case report is cross-linked with case 1310USA010377, received from the same reporter, also reporting a female patient of over 60, who experienced the same adverse event about a month earlier, receiving ZOSTAVAX (lot number unknown). Additional information has been requested.
A few minutes after vaccine, patient became pale and dizzy. She approached the pharmacy counter and nearly fell from feeling faint. I guided her to the consultation room to lay down. She said her heart was racing but she was not having any trouble breathing. I called EMS and they came in to check her out. When they arrived, she was already feeling better but they continued to examine her anyway and check her vitals. She was fine after about 15 minutes and was able to leave on her own.
Information has been received from a health professional concerning a 13 year old female who on 10-JUL-2007 was vaccinated intramuscularly with her first dose of Gardasil (Lot # 653735/0688F).  On an unspecified date, the patient developed a wart on her upper lip.  On an unspecified date, the patient was vaccinated with her second dose of Gardasil.  Subsequently, a biopsy was performed on the wart which determined it was an HPV wart.  The patient had the wart removed.  No further information was provided.  Additional information has been requested.