chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experiencing pain on my right side, middle of the back; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 18Apr2021 at 09:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 19Apr2021 at 00:00, the patient was experiencing pain on right side, middle of the back. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event experiencing pain on right side, middle of the back was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
mom reported pt entire rt leg inflamed & red, to touch-hot, rxn occurred 48hr p/vax;mom states a blue streak ran from rt hip to rt ankle;pt crying uncontrollably;advised mom to take to ER;MD reports mild swelling to rt thigh;r/o aller
Post-menopausal bleeding. I had no periods for 308 days, and then 2 days after the booster, I started to bleed.
p/vax pt exp an itchy rash on vax arm;pt sought unspecified medical attention;
Increased heart rate a couple minutes after first dose. I thought it was my nerves/anxiety. Dizziness and fatigue that day and the next, by the second day, I had dizziness, sweats, chills, hives, rash and throat swelling/closing. I went to Urgent Care on 1/14/21 and presented. I was given Medrol Dosepak and told to also use otc antihistamines.
Pt recv vax on 5/29/97; subsequently pt exp injection site rx of swelling,redness &pain; pt seen by M.D.;unspecified tx.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant products were not reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday as reported from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, lot numbers unknown to the health care professional. Spikevax COVID19 vaccine bivalent, the dosage given in ml was unknown to the HCP.  This case contains information for patient 59 out of 100 patients reported by the reporter.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Lips and face swelling on 1-25 and then hands swelling , r ight wrist on 01-29 21 /left wrist red and swelling on 01/31/21 and swelling continued on Feb 1st and visited  to see healthcare provider. On Feb 3rd /FEB 17- Saw DR    - suggested I go to hand specialist and suggested taking Advil/Feb 24, saw PA with Hand specialist, he gave me shot in both hands and said it may be arthritis/March 1st, swelling of left hand and trigger finger/March 8th, left hand and wrist swelling and red /March 9th, saw healthcare provider/March 18 and 19, pain in both legs above knee caps.
Nose bleed for 10 minutes on 4/28/02 at 04:30. Last nose bleed was about 30 years ago. He thinks it's related to Anthrax or drugs from IND. No ER, hospital or doctor visit.
fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient did not want to provide any additional information. The patient did not consent to follow up.
Red, sore but symptoms resolved by 3rd day and evening of 4th day became markedly red, size of an orange, no fever. Placed on Keflex, much better this morning. 7x7.5cm area of erythema with no warmth, tenderness or streaking.
Appoximately 30 minutes after receiveing vaccine, employee developed numbness that spread over body, difficulty breathing that required medical treatment.  Received Benadryl and steroid injection at physician office for emergency care.
Received a phone call stating that the patient complained of not feeling well on 3/11/21 while at work and that the patient died that night while at home.
Cellulitis at injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was unknown.   It was unknown if the reporter considered the injection site cellulitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but as per indication of the vaccine the age group was captured as adult. The patient received Shingrix and developed cellulitis at the injection site. No patient information was provided.
Tinnitus; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 06Aug2021 at 16:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Aug2021 the patient experienced tinnitus. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the event tinnitus was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Arm/shoulder pain and weakness in the arm the shot was injected.  Started an hour after injection and a month later still exists.  Severe pain to raise arm above head and contant deep ache.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 22-OCT-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010362: Original Case: 1903USA004795; US-009507513-1903USA010363: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA010361: Original Case: 1903USA004795; US-009507513-1903USA010365: Original Case: 1903USA004795; US-009507513-1903USA010358: Original Case: 1903USA004795; US-009507513-1903USA010359: Original Case: 1903USA004795.
No adverse event; 2 doses of the vaccine were given today after they expired on 13FEB2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023).    No concomitant medications was reported.  Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had no reported symptoms.   No additional medications, doses, or treatments medications was reported.  This case contains information for the 2nd out of 2 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-711019 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711019:Master case - 1st child
7 days after vaccine, after injection site/arm pain had subsided, vaccination site and surrounding area on arm became extremely sore, sensitive, itchy, and burning -- almost like a bee sting. This area of my arm is very heavily tattooed so it's a bit tough to what's going on on the skin itself, but it appeared there may have been a rash -- bumps/texture and possible redness. This lasted about 3 days and then resolved completely.
Sat. 3/4/17 Flu like SX. Sun 3/5/17 Trouble swallowing (golf ball feeling in throat). Mon - Sat 3/11/17 Muscle pain/joint pain patient stated they cannot walk.
After MMRV subQ admin to LA, few minutes later patient had reaction of two hives appearing near site of admin. Two Hives about 8mm in diameter, and about 5mm. NP then administered Benadryl to patient; ice packs were placed on arm. Patient was observed for another 30m, post reaction. No further reactions, or symptoms noted.
had dizziness since prior to her first vaccination and was on an antibiotic but after her vaccination she stopped her antibiotic and her dizziness went away; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Light headed" (unspecified if ongoing); "She feels the ways she does" (unspecified if ongoing), notes: Has been having some medical testing performed to investigate why she feels the ways she does.; "Dizziness" (unspecified if ongoing), notes: Prior to her first vaccination. The patient took concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "had dizziness since prior to her first vaccination and was on an antibiotic but after her vaccination she stopped her antibiotic and her dizziness went away". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient received her first vaccine dose last Sunday. But since before that she has been feeling lightheaded and has been having some medical testing performed to investigate why she feels the ways she does. She reported that after her vaccination she stopped her antibiotic, and the dizziness went away. She has had dizziness since prior to her first vaccination and was on an antibiotic but after her vaccination she stopped her antibiotic and her dizziness went away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
In mid March, approximately six weeks after vaccination, patient developed a blistering skin rash in axilla and groin, clinically consistent with Bullous a pemphigoid. She has no prior history of similar condition. She is homebound so did not have a skin biopsy done. She has required prednisone, topical steroids, and follow up. I do not know the ultimate outcome of this condition in her.
A report has been received from a Health Professional concerning a 10 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. FLUMIST quadrivalent was administered to a patient but the patient moved and turned their head as the dose was being administered and only half the dose was able to be administered into one nostril which started on 27-Sep-2013. The outcome of the event of only half the dose was administered into one nostril is unknown. The report was considered to be non-serious, by the reporter.
I feel dizzy; and my heart is pounding; and very tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I feel dizzy), PALPITATIONS (and my heart is pounding) and FATIGUE (and very tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I feel dizzy), PALPITATIONS (and my heart is pounding) and FATIGUE (and very tired). At the time of the report, DIZZINESS (I feel dizzy), PALPITATIONS (and my heart is pounding) and FATIGUE (and very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
fever 103 ax, screaming unless held for 3 1/2 hrs, refused to walk on leg involved;
Patient suffered a syncope episode - patient seemed to be unconscious and seemed to have decrease breathing. Patient was given orange juice and water after regaining consciousness. Paramedics was called - patient's blood pressure and blood sugar was taken. Patient seemed to have fully recovered after 20 minutes.
Felt a rush in my arm 5 minutes after. Then one hour following the injection I started getting dizzy and vertigo. Driving home I felt like something was very wrong like impending doom. My heart started racing almost pounding out of my chest. I was extremely dizzy and almost fainted. Flushed feeling and tightness in my chest followed. Flushed feeling felt all day. Also had a rash on my neck and chest.
COVID arm; Biggest ball in her arm, the size of a baseball; itchy; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (COVID arm), PERIPHERAL SWELLING (Biggest ball in her arm, the size of a baseball) and PRURITUS (itchy) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (COVID arm), PERIPHERAL SWELLING (Biggest ball in her arm, the size of a baseball) and PRURITUS (itchy). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (COVID arm), PERIPHERAL SWELLING (Biggest ball in her arm, the size of a baseball) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   This case was linked to MOD-2021-035978 (E2B Linked Report).
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were unknown. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route, lot number and expiry date were not reported) for prophylaxis. The reporter did not have any information about the excursion details. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008828: US-009507513-1612USA008828: US-009507513-1612USA009620.
red rash adjacent to and touching  site of vaccination, about 1/2 inch in diameter
- Coughing & shortness of breath 3 hours after shot given; patient alleviated by sitting in car with AC on. - Chills & sweaty about 4-5 hours after shot that went away on its own.
5 days After injection, Diffusely red and swollen rash developed on the upper left arm, followed by a maculopapular rash covering the whole body . Prior to this I experienced headaches for 4 days, no fever,
headache; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine the day prior to the report and she got a headache. The event outcome was unknown.   Information on the lot/batch number has been requested.
Lost smell and taste Fever Cough Cold sweats  Running nose  Muscle aches  Headache
had no energy and laid around; felt like he had the flu; ached; started coughing; fever up to 101.3 degrees F; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (had no energy and laid around), INFLUENZA (felt like he had the flu), PAIN (ached), COUGH (started coughing) and VACCINATION SITE PAIN (vaccination site pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.     On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 20-Aug-2021, the patient experienced INFLUENZA (felt like he had the flu), PAIN (ached) and COUGH (started coughing). 20-Aug-2021, the patient experienced PYREXIA (fever up to 101.3 degrees F). On 21-Aug-2021, the patient experienced ASTHENIA (had no energy and laid around). The patient was treated with PARACETAMOL (TYLENOL) on 20-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 20-Aug-2021, COUGH (started coughing) had resolved. On 22-Aug-2021, ASTHENIA (had no energy and laid around), INFLUENZA (felt like he had the flu), PAIN (ached), VACCINATION SITE PAIN (vaccination site pain) and PYREXIA (fever up to 101.3 degrees F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: up to 101.3 (High) 101.3 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported.
Fever. A pharmacist reported that her son received injection of Prevnar on 3/21/01. Within 24 hrs of vaccine the child developed irritability and a fever of 101F to 102F. He also developed trouble walking and bending down. The mother treated the child with advil . This is 1 of 2 pt from this facility who had an adverse experience following receipt of Prevnar.