chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 69 year old male patient (race unknown) received intramuscular PREVNAR 13 at 0.5 ml single dose. On 14Oct2013. Relevant medical history and concomitant medications were unknown. It was reported that the patient received PREVNAR 13 (in his right arm) and an unspecified flu injection (on his left arm) on 14Oct2013 after which since 15Oct2013 he had severe headache, fever, pain, swelling, itching and redness in right arm. Relevant laboratory data was unknown. Therapeutic measures taken, if any, were unknown. The patient recovered from severe headache, fever, pain, swelling since 17Oct2013 however did not recover from the other reported events at the time if report. Follow-up (13DEC2013): Follow-up attempts completed. No further information expected.
Chills; Muscle aches; Fever; Nausea; This is a spontaneous report from a contactable consumer was received via a sales representative.  A 48-year-old patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via intramuscular on 07Apr2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included covid-19 vaccine for COVID-19 immunization. It was reported that on an unspecified date the patient experienced chills, muscle aches, fever, nausea. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
N/A  COVID19 (Pfizer) was not recorded is system, patient didn't bring in any immunization record including COVID19 (white) Card. Extra dose of COVID19 was given.
had exposure to positive person. Tested positive on 4/26,  dept health confirmed the case was variant strain.
Fever started 3 days ago, red area with 4 tiny pimples inside, very painful to touch.  Physician prescribed po Bactrim today and return precautions.  No other symptoms per Mom besides decreased appetite since yesterday.
Pt recv vax on 4/5/99; on 4/6/99 pt exp blotchy/ red/ raised rash on face & body w/ itching; tx=Benadryl
really dizzy; pale; sweaty; weak; lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (really dizzy), PALLOR (pale), HYPERHIDROSIS (sweaty), ASTHENIA (weak) and DIZZINESS (lightheaded) 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 20-Aug-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced DIZZINESS (really dizzy), PALLOR (pale), HYPERHIDROSIS (sweaty), ASTHENIA (weak) and DIZZINESS (lightheaded). At the time of the report, DIZZINESS (really dizzy), PALLOR (pale), HYPERHIDROSIS (sweaty), ASTHENIA (weak) and DIZZINESS (lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment information was mentioned. Patient laid down and feels a little better now.
The date reported is the 2nd dose.  Patient started complaining of severe pain in the back of his next a few days after the shot.  We would treat it with heating pads, or advil.   On 6/22 and 6/23/21 he suffered multiple strokes which then lead into a series of other events (eg craniectomy)
My first does was Moderna. The form I had to sign today said Moderna-2nd dose. My vaccine card says Moderna.  Why was I given Pfizer!  This is a huge problem and it is not acceptable! I did not choose to have the Pfizer vaccine and it was given to me against my will.  I suffer from anxiety and had a panic attack.  Now I can not stop thinking about all of the adverse effect I am going to have have.
3/7/15 HPI from fast track (urgent care): 47 year old female presents complaining of right arm pain in the deltoid after getting immunization to right arm this morning. No fevers, no chills, no N/V. Denies any shortness of breath. Denies chest pain. 3/17/15 HPI from PCP 1) Arthus Reaction:  Classic history and exam for arthus reaction. She is allergic to this (hep B) vaccine so I will not give her #3.
Extreme fatigue, severe nausea, chills, and severe headache. Dry mouth as well
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot numbers included were lot# N000238, expiry date25-OCT-2019, lot# N007750, expiry date: 29-NOV-2019, lot# M046134, expiry date: 27-SEP-2019, and lot# N000235,  expiry date: 26-OCT-2019; for prophylaxis. The vaccines were exposed to temperature of  "47°F to 77°F (71.4 F)" for a time frame of 10 hours. Previous temperature excursion was reported which was of  "47°F to 77°F (73F)" for 13 hours. Data logger was involved. No adverse effect reported. No product quality complaint was present. No further details provided.
"tingling" in face; face felt numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. This consumer reported similar events for three patients. This is the second of three reports.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as ""tingling" in face"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "face felt numb". The reporter spoke with two of her colleagues who reported feeling the same thing.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021258997 same reporter, drug, similar events, and different patient;US-PFIZER INC-202101257727 same reporter, drug, similar events, and different patient;US-PFIZER INC-202101257727 same reporter, drug, similar events, and different patient.
Pt received Anthrax B on 05/20/03. She left office with no reactions. She returned to the office stating site was hot and itchy. She also states it had never happened before from the previous 6 last Anthrax vaccinations. Pt states she had exercised that afternoon. She denies having a fever or any other symptoms. She was also seen that day for wart removal. Will follow with pt on Tuesday.
L arm pain, fever, chills, muscle ache, weakness,  No treatment other than Tylenol and bed rest.  All symptoms began  about 24 hrs  after vaccine administered and less arm pain still exists 48 hrs later
2-3 cm ertythmetous area with warmth, swelling and pain. Symptomatic care with pain reliever and cool compress.
Bell's Palsy paralysis of right side of face, with difficulty eating/drinking/speaking and closing right eye.  Currently being treated with Prednisone (20 MG tablets - 3 tablets per day for 7 days, then 2 tablets per day for 3 days, then 1 tablet per day for 3 days) and Valacyclovire HCL 1 gram tablet every 8 hours (21 tablets) Eye being treated with Refresh Celluvisc lubricant eye gel and Refresh P.M. lubricant eye ointment as needed, with eye being taped shut at night.  Patient has had 2 prior cases of Bell's  Palsy which fully resolved (1st case in early 1990's, more recent case in 2019).
This spontaneous report as received from an executive via a company representative refers to a baby (infant) of unknown age and gender. Medical history and concurrent condition was unspecified. On an unknown date, the patient was vaccinated with a dose of ROTATEQ, orally (lot# not reported). Concomitant medication was unspecified. On an unknown date, after the vaccination, the patient subsequently contracted the virus. Further, the patient had to be hospitalized due to dehydration and vomiting, and also, lost three pounds of body weight (hospitalization details unspecified). The executive could not confirm or deny that the vaccine was ROTATEQ. The outcome of dehydration, vomiting, viral infection and weight decreased was unknown. Causality was not provided by the reporter. Product quality complaint was not filed. Additional information has been requested.
pt recvd vax 19OCT92 early AM on 20OCT92; pt devel painful muscle spasms in lt arm & leg, vertigo, difficulty in breathing; pt taken to ER;
Arm hurt; Diarrhea; Irregular heart rate; Palpitations; Nausea; Vomiting; Little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), DIARRHOEA (Diarrhea), HEART RATE ABNORMAL (Irregular heart rate), PALPITATIONS (Palpitations) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN from 2019 to an unknown date, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) from 2020 to an unknown date, CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIPLEFLEX) from 2019 to an unknown date, ZINC from 2021 to an unknown date and VITAMIN C [ASCORBIC ACID] from 2021 to an unknown date for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt), DIARRHOEA (Diarrhea), HEART RATE ABNORMAL (Irregular heart rate), PALPITATIONS (Palpitations), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Little bit tired). On 30-Apr-2021, DIARRHOEA (Diarrhea), HEART RATE ABNORMAL (Irregular heart rate), PALPITATIONS (Palpitations), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Little bit tired) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: abnormal (abnormal) Irregular heart rate.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-066517 (Patient Link).
Fine red itchy rash over all of upper torso; Fine red itchy rash over all of upper torso; Body aches; Arm sore; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 16Apr2021 at 10:45 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril/hydrochlorothiazide (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN) and vitamin C (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication and unknown if ongoing. On 17Apr2021, the patient experienced arm sore. On 18Apr2021, the patient experienced body aches. On 19Apr2021 at 00:00, the patient experienced a fine red itchy rash over all of upper torso. On 24Apr2021, the patient saw nurse practitioner due to rash increasing. The patient took off work for one week. The patient reported that had been taking zinc from pharmacy but 1 week ago switched to different brand and stopped it all together till this rash was gone. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of adverse events and included treatment with fexofenadine (ALLEGRA) in "am", diphenhydramine (BENADRYL), oatmeal baths, and triamcinolone (MANUFACTURER UNKNOWN) ointment. The clinical outcome of the events arm sore, body aches and fine red itchy rash over all of upper torso were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Left arm at and around the sight of injection is red and swollen.  A very large section of my arm is swollen and red.  It also itches.  I have not been to the doctor.
This spontaneous report was received from a physician assistant via company representative and refers to male patient of an unknown age. The patient's medical history included quadriplegia. The patient was at  numerous unspecified medications. On an unknown date, approximately in 2015 (reported as "about 2 years ago"), at the age of 59 years old, the patient was vaccinated once with a dose of ZOSTAVAX 0.65 ml, subcutaneously to prevent shingles (site of administration, lot # and expiration date were not reported). On an unknown date, two weeks after receiving the vaccine, the patient broke out in a rash on "numerous areas on the right side of his body." The outcome of the event and the relatedness between the event and ZOSTAVAX were not reported. Additional information has been requested.
Day 2 - Fatigue Day 8 - large, itchy, red hard/ swollen patch around injection site
this is one of three pt who recv vax & devel a fever of 103 to 104 & an inj site rxn characterized by swelling & itching;
Severe dizziness, vertigo, malaise which continues 10 days after receiving the vaccine. Patient placed on Prednisone 20 mg for 5 days and ATIVAN 0.5 mg as needed for dizziness or anxiety.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 4 (booster), single (Lot number: BIR5GJ6742) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Apr2023 to 12Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300154221 same reporter/patient,different drug/event.;
BP fell with severe vomiting  Fatigue, and inability to see because of spots in my eyes.  Had to crawl to bathroom unable to walk
One week after my first shot, I got my period and it was very heavy bleeding with clotting for days 2,3, 4 and some of 5. I had major back ache and the same thing but worse occurred one week after my second shot. I have bad periods but the last 3 years it?s gotten better where I don?t have to take Advil. I had to take advil for my last two periods which also gave me major Advil side affects such as pain in my spine into my neck and shoulders, sharp pains in my head and long lasting headache. Advil side effects went away after the second day I stopped taking it. I was taking 4 200mg pills a day 2 in the morning and 2 10-12 hours later. My period pains were extreme, worse I?ve felt in 3 years and I usually have bad pains and heavy bleeding but nothing like the two periods I experienced one week after each shot. I?m hoping my 3rd period isn?t going to like my last one because this was awful.
Received Shingrix vaccine 9/16/2020. Later that day noted dragging right leg when walking. By following day had weakness in right leg and right arm. Presented to ED 9/22/2020 and found to have left frontal intraparenchymal hemorrhage measuring 2.7 x 2.2 x 2.6 cm. Subsequent imaging showed 7 x 10 mm left centrum semiovale cavernoma. Patient has had good recovery without residual weakness and did not require intervention during 6 days of hospitalization.
Seriousness criteria: Other-Medically Significant Initial report received on 05 March 2008 regarding a literature article. Verbatim from the case report. "A 53-year-old man received DTaP vaccine (dosage not stated). On day 8 following vaccination, he presented with progressive shoulder pain, localized dermatitis and dysesthesias in his vaccinated arm. An examination of his left deltoid area revealed several raised oedematous and erythematous plaques. Some plaques had central papulovesicular changes. He had mild aggravation of his left forearm/wrist area with a left nerve root tension sign. These symptoms were consistent with mild brachial neuritis. His CH50 level was 14 U/mL. A punch biopsy revealed vascular changes that were consistent with small vessel vasculitis. [Patient outcome not stated.]"
I had a sore arm and headache which three or four days. I took TYLENOL to help with the symptoms. Tested positive for COVID-19 via home test x 2 on 08/22/2022. I had a telehealth visit with a NP and was not prescribed anything. My symptoms started on 08/18/2022. I had a headache, sore throat and runny nose. I did not have a fever.
2hrs p/vax pt devel small hive like lesions;RTC 4 days later cont to have hive like rash;clustered around inj site
Soreness at site began few hours after injection. Not given by this reporting RN but by another. May have been given a little low, tip of deltoid or bicep/ tricep area. Pain with arm movement over her head. ADLs effected. Now two weeks out and still can't put pull-on shirt over her head. Too painful to push off chair when arising  with rt arm, instead rolls to side to get up. Today no redness or swelling. To palpable mass in tissue. Painful to deep touch. Tried heat, massage, and aleve. Aleve helps pain temporarily. Constant ache of 3/10 but with movement as described as 8/10 pain. Changes how she does her job, has to lift with arm in a different matter. Encouraged to see her PCP. She is declining at this time.
This spontaneous report as received from a pharmacy technician (also reported as healthcare worker) refers to an unspecified number of patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K024552, Expiry: 22-OCT-2016). No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning an 8 year old male with no known allergies or medical history who on 14-DEC-1998 was vaccinated IM in the left thigh with a first dose of Varivax (Oka/Merck) (lot# 626688/0650H). There was no concomitant medication of illness at the time of vaccination. On 06-FEB-2006 the patient experienced rash. Medical attention was not sought. No lab tests or diagnostic tests were performed. It was reported that the patient had no adverse events following prior vaccination. The patient's outcome was not reported. Additional information from the physician indicated that no further information is available regarding any adverse event.
1150 - MMR given subQ (L) arm, varicella given sub Q (R) arm. 1100 - Local reaction both sites just above band-aids, erythematous with hive-like wheal in center (L) 1 1/2cm and (R) 2cm in diameter. 1115 - Diphenhydramine 12.5mg PO given. 1130 - Decreased swelling and hives.
On January 21, 2021 at the COVID 19 Vaccine Clinic, an orthopedic PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator (a RN). The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the RN inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The RN then alerted the lead APRN, who escalated the situation to the operations manager. The operations manager then contacted the Chief Quality Officer.  The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL.  After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them.  Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a ?near miss? event and is being reported out of an abundance of caution
Twinrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose January 2023).   In APR-2023, the patient received the 2nd dose of Twinrix. In APR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix - Late second dose). The outcome of the drug dose administration interval too long 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: 4th August 2023 A pharmacist asked for information regarding a couple of patients who received the first dose of Twinrix in January 2023. Then, the HCP mentioned that the 2nd dose was administered in April 2023. The reporter said that patient wanted to receive the third dose on the day of reporting, and asked what was the recommended minimum interval between the second and third dose. The reporter did not provide information about the patient involved in this situation.  The permission to follow up was not requested. The patient received 2nd dose late which led to lengthening of vaccination schedule
10 y/o male seen in office 6/23 with acute "attenuated" varicella with approximately 25 varicella lesions only a few of which had typical pustules. Had no systemic S or Sx other than pruritis. Txed with Acyclovir 200mg 5x/day x 5d. Vaccine Failure.
Extreme dizziness, unable to stand for about an hour; nausea, violent chills and shaking on and off with just inability to get warm over couple of hours; feeling in fingertips of thumbs and first two fingers on both hands as if had been hit by a hammer. On morning of 09/13/2013 awoke feeling weak and general malaise. Blue crescent-shaped lines  noted in center of each of the nail beds of the aforementioned sore fingers. Same fingers also slightly dusky on pads of tips. Appeared to have broken blood vessels in nail beds of those fingers which have slowly faded. Soreness has also slowly subsided.
Information has been received from a physician via a company field representative referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date (reported as a few years back), the patient was vaccinated with GARDASIL (strength, dose, frequency, route, lot# and expire date were not reported) for prophylaxis. On an unknown date (reported as later), the patient went to the emergency room with symptoms of body aches and pains and the inability to walk. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown by the reporter. The outcome of the events was unknown. Causality assessment was not provided.