chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 76 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 14:15 (Lot number: EN6206, Expiration Date: Jun2021) at the age of 75 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Mild heart attack stent" (unspecified if ongoing); "Mild heart attack stent" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot Number: EN6198, Expiration date: 30Jun2021 intramuscularly in left arm at 14:15 as dose 1, single), administration date: 25Feb2021, when the patient was 75 years old, for COVID-19 Immunisation, reaction: "AFIB", "Atopic dermatitis / rash on leg then entire body". The patient had no prior vaccinations. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "not recovered", described as "some AFib"; ECZEMA NUMMULAR (non-serious) with onset 08Sep2021, outcome "not recovered", described as "nummular eczema / rash on entire body". On 08Nov2021, rash on entire body was still experienced and was still ongoing. It was reported that the patient had no previous skin related rashes until his vaccination on 25Feb2021, patient had been to dermatologist 8 times with no real solution. The rash goes away with prednisolone but returns within a week or so. Patient experienced some health issues with the continued use of prednisone. AFib occurred only after vaccination and was possibly linked to use of prednisone 20 mg. The patient underwent the following laboratory tests and procedures: allergy test: (08Nov2021) no allergies except balsam of peru; biopsy: (08Jul2021) no lupus, no cancer, no fungus; blood test: (08Jul2021) atopic dermatitis. Therapeutic measures were taken as a result of atrial fibrillation, eczema nummular which included prednisone 20 mg (also reported as taking for allergic skin break out) from 27Apr2021 to 06May2021. It was reported that  patient had cardioversion on 25May2021, but still had some AFib. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202101169206 same patient and drug; similar events, different dose.
Fever, body/joint aches, chills, weakness/fatigue. Treatment: Rest, fluids and OTC analgesics. Injection site erythematous, tender, fluctuant. Treatment: Ice and OTC analgesics.
devel large area of erythema & edema (6"x6") @ site of inj LUA w/in 3hr from time of inj;also exp facial edema, dizziness & nervousness;
Events were: Paralyzation of lower of half of body and upper body, blurred vision, inconsistent heart rate. Treatments: 5 rounds of IVIG treatment. Outcomes: paralyzation of lower body and sometimes blurred vision.
He was inadvertently given Pfizer as the second dose of his series.  His first dose was Moderna and was given 26 days earlier on 2/4/21.  There was an administration error.  There was no adverse outcome.  Patient was informed and understands.
This case was reported by a healthcare professional and described the occurrence of petechiae in a 4-month-old female subject who was vaccinated with Pediarix for prophylaxis.  Concurrent vaccination included Prevnar given on 27 March 2007.  On 27 March 2007 the subject received 2nd dose of Pediarix at 0.5 ml in the left thigh.  In 2007, at an unspecified time after vaccination with Pediarix, the subject experienced petechiae on the bilateral lower extremities.  The event resolved within one week without treatment.  The healthcare professional considered the event was probably related to vaccination with Pediarix.
Pt returned to work after CoVid vaccine injection; returned to clinic @13:34. Reports chest tightness that began upon return to work. Denies HA, lightheadedness, dizziness, SOB, difficulty breathing, hx of known cardiac conditions (pt reports no findings from full cardiac work up after c/o chronic "skipped beats" and palpitations to PCP). States "skipping beats" sensation has increased in frequency, now occurs every 2 weeks. States she has had inadequate fluid intake today but only a couple of cookies about an hour before injection.  Pt given famotidine, benadryl, dexamethasone, 1000ml NaCl IV.  Pt symptoms resolved and pt was sent home with EpiPen (2), Loratadine, prednisone.
Started with very sore arm, next day right shoulder and right side of waist hurt pretty bad (throbbing pain), next day all of that hurt plus right hip and buttocks very painful.  Hurts to walk, go up steps, and even hurts to sit.  I have been taking IBprofen every 6 hours.  Came home from work half day today to try and rest.
Wrong age group Pfizer Covid-19 vaccine selected and administered by MA. Administered 6mo-4yr old age group Pfizer Covid-19 vaccine to a 5year old. No adverse reaction noted.
Patient had no adverse effects or other symptoms as a result of administration; Vaccine was administered following multiple temperature excursions; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, previous drug reactions or allergies were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 22-JUN-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-Merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) 0.5ml once, lot number W006583, expiration date 23-AUG-2023 (strength, route of administration, and anatomical location were not provided) administered as prophylaxis.  The measles, mumps, rubella and varicella (oka-Merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) vaccine experienced multiple temperature excursions: on 11-MAY-2022 was stored at a temperature of 5.7 degrees Fahrenheit (F) for 7 minutes, 27-MAY-2022 5.7 F for 5 minutes, 06-JUN-2022 5.9 F for 6 minutes, 09-JUN-2022 5.4 F for 4 minutes, 14-JUN-2022 5.7 F for 7 minutes, 17-JUN-2022 29.1 F for 39 minutes, 20-JUN-2022 7.2 F for 10 minutes, and 22-JUN-2022 8.4 F for 15 minutes. Total excursion time was 96 minutes. No temperature excursion occurred prior to 11-MAY-2022.  No additional adverse events were reported  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007867: US-009507513-2207USA007847: US-009507513-2207USA007985: US-009507513-2207USA007729: US-009507513-2207USA007826: US-009507513-2207USA008018: US-009507513-2207USA007975: US-009507513-2207USA008097: US-009507513-2207USA007928: US-009507513-2207USA007847:
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 77-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 at 14:00 as dose 5 (booster), single (Lot number: FJ9943) at the age of 77 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: Treatment with Paxlovid.
Approximately 4 hours after the Moderna vaccine administration, there was a brief  (2 minute) fine motor skill dysfunction involving fingers of one hand.
pt recvd vax on 21OCT92 & devel sore throat, enlarged lymph nodes in neck, facial numbness, dry cough;
Generalized itch all over body starting 14 days after Moderna booster. Hives appeared when skin was scratched. Symptoms have persisted for over 6 weeks. Diagnosed with Dermatographia on 2/16.
Swelling around injection has not gone away in four days. The area has grown and covers half of my bicep. It is painful and hinders movement of my arm. Fever peaking at 102. Hot flashes with sweat and chills, muscle aches, nausea, headache.
Vomiting; Nausea; Pain at injection site; Fever; Chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208; Dose: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 16:00, (at the age of 25 years old) as a single dose for COVID-19 immunisation. Medical history included asthma and irritable bowel syndrome. The patient was allergic to dairy products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, the patient experienced pain at injection site, fever, chills, headache, and fatigue. On 22Mar2021, the patient experienced vomiting, and nausea. No therapeutic measures were taken as result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events pain at injection site, fever, chills, and headache was recovered on 21Mar2021.  The clinical outcome of fatigue, vomiting, and nausea was recovering.   No follow-up attempts are possible. No further information is expected.
apparent 11/10/99 papules w/occ vesicle of chickenpox 2wk post vax 10/25/99;supposed to be on albuterol/intal BID;
Blisters and Swelling on left arm , Diarrhea, Vomiting for 1d.   Treatment : Amoxicillin, diphenhydrAMINE, Ondansetron
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 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: QJ3277), in right arm for COVID-19 immunization; 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 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jan2023) Negative, notes: antigen test negative on 02Jan2022. On 07Jan runny nose; positive antigen test; (07Jan2023) Positive, notes: antigen test negative on 02Jan2022. On 07Jan runny nose; positive antigen test; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient did not receive other medication in 2weeks. Patient received Anti-viral medication Paxlovid as treatment of COVID-19; treatment start date 27Dec2022 and stop date was 31Dec2022. Original symptoms were resolved and antigen test negative on 02Jan2022. On 07Jan runny nose; positive antigen test.
Fever of 102. Body aches, chills., weakness, feeling of falling, joint pain, neck pain.  All on 9/17/2021 On 9/18/2021.  My right axilla is swollen, right breast and scapula pain.  It?s difficult to sleep due to the swelling in the axilla. Injection was in right deltoid.
Itching on my back; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itching on my back) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHAMBUTOL, AZITHROMYCIN, RIFAMPIN, METOPROLOL and ALPRAZOLAM for an unknown indication.   On 12-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRURITUS (Itching on my back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching on my back) was resolving.            No treatment medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up source document contains no new information
A few hours after receiving vaccine, pt c/o extreme arm pain, temp 100.5, abd pain, and vomited 3 times. Woke up next day with fatigue.
Pt failed to convert p/receiving 3 doses of Engerix-B & converted to HBSAB pos p/4th dose;
now he's tested positive for Covid as well; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 17Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported has been exposed to someone who has covid on 29Mar2021 and now he's tested positive for Covid as well. Since is living in the same house with husband, she was quarantined because of that and she can not make the 2nd dose on time. She wanted to Know that they're in this kind of situation are they still going to have the 2nd dose. Their 2nd doses were on 07Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test was tested positive on an unspecified date. The outcome of event was unknown.
Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. The nurse reported that the patient developed swelling at the injection site, high fever, extreme pain and rash down his arm after getting PNEUMOVAX 23. The patient was hospitalized for 5 days. At the time of reporting the outcome was unknown. This is one of two reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a 11-year-old male who, on an unspecified date, was vaccinated with a dose of Varivax. In April 2006, the patient developed a mild breakthrough case of varicella. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Accidental Underdose/Patient took booster instead of third dose; Inappropriate schedule of vaccine administartion/patient took booster instaed of third full dose; Lymphedema; sick; Flu; Vaccination adverse reaction; Red blotches; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (Lymphedema), ILLNESS (sick), INFLUENZA (Flu), IMMUNISATION REACTION (Vaccination adverse reaction) and RASH MACULAR (Red blotches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Concurrent medical conditions included Immunocompromised. Concomitant products included PALBOCICLIB (IBRANCE) for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced LYMPHOEDEMA (Lymphedema), ILLNESS (sick), INFLUENZA (Flu), IMMUNISATION REACTION (Vaccination adverse reaction) and RASH MACULAR (Red blotches). On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Accidental Underdose/Patient took booster instead of third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administartion/patient took booster instaed of third full dose). At the time of the report, LYMPHOEDEMA (Lymphedema), ILLNESS (sick), IMMUNISATION REACTION (Vaccination adverse reaction), RASH MACULAR (Red blotches), ACCIDENTAL UNDERDOSE (Accidental Underdose/Patient took booster instead of third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administartion/patient took booster instaed of third full dose) outcome was unknown and INFLUENZA (Flu) had resolved.            The patient got an injection every three months for the bones every three months.  The patient had received 2 doses of Moderna vaccine as well as the booster shot due to being immunocompromised. When the patient received the bosster shot she also got the flu vaccine. The patient stated had quite the reactions to the combination of the two and felt like had the flu for about a day and half. The patient had lymphedema in the left arm that would become red and blotchy at times when patient was sick. The patient thought this was due to the flu vaccine or the combination of the two.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624962 (Patient Link).
Pt received MMR injection on 08/15/2002. By 08/16/2002 and 08/17/2002 complained of sore throat, body ache, and fever. Afebrile by 08/17/2002. Pt stated felt better by 08/20/2002.
No additional AE; Temperature excursions; Information has been received from a medical assistant concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported.   On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Lot  No. S014430, exp. date 09-MAY-2021) (rHA) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot No. S030243, exp. date 26-SEP-2021) that went through temperature excursion (product storage error). Temperature excursions occurred between August and September 2020. The issue was identified on 12-AUG-2020. No additional adverse event information was reported.  Temperature: 6.5F Time frame: for 45 minutes
wheezing as if I had Asthma; Pfizer: 28Oct2022. Moderna: 28Oct2022; Pfizer - Dose Number: 4; Moderna - Dose Number: 3; Pfizer: 28Oct2022. Moderna: 28Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 15:00 as dose 4 (booster), single (Lot number: GH9697) at the age of 25 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Lot number: 031C20H) for 1 day, as dose 2, single (Lot number: 003B21A) for 1 day and as dose 3 (booster), single (Lot number: 031H21H) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 28Oct2022, outcome "unknown", described as "Pfizer - Dose Number: 4; Moderna - Dose Number: 3"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 28Oct2022, outcome "unknown" and all described as "Pfizer: 28Oct2022. Moderna: 28Oct2022"; WHEEZING (non-serious) with onset 30Oct2022 at 10:00, outcome "unknown", described as "wheezing as if I had Asthma". Therapeutic measures were not taken as a result of wheezing.  Additional Information: It was reported that the patient went on a run two days after receiving the vaccine and she began wheezing as if she had asthma. She had never wheezed during a run before, and this type of run was a regular part of her routine. She had known allergies to Penicillin. Patient had no other vaccines in 4 weeks and no other medications in two weeks. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post the vaccination. No treatment was received for the adverse event wheezing. Follow-up attempts are completed. No further information is expected.
Atregistration for this drive-through event in Oregon,  site lead and  employee identified the patient as being under 18 years of age. The patient's mother,  was therefore provided with paperwork to fill out for her son, to receive the first dose of the Pfizer COVID-19 vaccine. At the vaccination station, RN, spoke with Pt mother about vaccine side effects, answered several questions, and reviewed pt health history. She was drawing up the Pfizer vaccine when another nurse came over and told her that the patient's mother wanted him to have the Janssen vaccine. (see continuation page for additional details)
Rash, finger swelling, throat swelling sensation, chest pressure, and short of breath.
Mom took pt to ER, blood test was done that showed URI, fever of 105 lasted 3 days;
Woken from sleep with tinnitus and head pressure. Went back to sleep after 3 hours of being awake with tinnitus. Tinnitus resolved upon waking. Head pressure remains.
Felt dull joint pain when she gave me the shot. It was the worst pain I have ever felt! Not a slight burn as she had warned me about. Still cannot use my arm completely.