chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101206085 (Pfizer).A female patient received bnt162b2 (BNT162B2), administration date 14Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: 2020 (unspecified if ongoing), notes: She is just getting over a case of Covid she had 12-13 months ago.; "asthma" (unspecified if ongoing), notes: she has asthma and allergies and does take allergy injections.; "allergies" (unspecified if ongoing), notes: she has asthma and allergies and does take allergy injections.; "short of breath" (unspecified if ongoing), notes: just went back to work after 13 months because she was short of breath.; "heart disease" (unspecified if ongoing), notes: She states she has asthma and heart disease. The patient's concomitant medications were not reported.The following information was reported: PRURITUS (non-serious) with onset 14Sep2021, outcome "unknown", described as "is having some itching"; DIZZINESS (non-serious) with onset 14Sep2021, outcome "recovered" (14Sep2021), described as "she got a little light headed"; FATIGUE (non-serious) with onset 14Sep2021, outcome "unknown", described as "fatigue".Additional information: The patient stated that she got itchy when she was at the vaccine and had to wait about 30 minutes as she got a little lightheaded too after taking the vaccine and fatigue. The patient stated the lightheadedness had gone away because she was laying down. The report not related to a study or programme. Investigation assessment not provided. It was reported that she had her 1st Pfizer Covid vaccine this morning and she is having some itching. Reporter was asking is it ok to itch, she knows not to scratch and asking is this a side effect. Report declines to make a report.This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Right deltoid skin and soft tissue infection with likely extension into the muscle following influenza and pneumococcal vaccines.
rapid test positive; rapid test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 21Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: ER8731) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "pre diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; METOPROLOL. Past drug history included: Cephalexin, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "rapid test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive, notes: Positive; (10Jun2022) Positive, notes: Positive; (12Jun2022) Positive, notes: June 12 was very faint; (14Jun2022) Negative, notes: Negative; (18Jun2022) Positive, notes: Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course: The patient had other medication in 2 weeks. Covid rebound after completing paxlovid treatment. Tested positive initially 07Jun2022, paxlovid started that date, taken through 12Jun2022. Positive rapid tests on 10Jun2022 and 12Jun2022 (June 12 was very faint). On 14Jun2022, rapid test negative. All symptoms resolved. On 17Jun2022, symptoms returned (runny nose, cough, sore throat), rapid test positive on 18Jun2022. Restarted isolation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a certified medical assistant, refers to an unspecified number of patients, of unknown age and gender. Medical history and concurrent conditions were not reported. The medical assistant reported that on an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL, lot#: K008931, expiration date: 04-MAR-2017 and Lot #K006960 expiration date: 19-FEB-2017 (strength, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a healthcare worker at a physician office, who is not a health care professional, refers to unspecified number of patients of unknown demographics. On an unknown date in 2013 (reported as recently), the patient was vaccinated with dose of PNEUMOVAX 23 (Lot number, expiry date, route and dose were not reported). On an unknown date in 2013 (reported as recently), the patient have experienced more redness at the injection site after the administration of PNEUMOVAX 23. The outcome of more redness at the injection site after the administration of PNEUMOVAX 23 was unknown. Additional information has been requested.
pt recvd vax in lt arm-pt had redness starting @ approx 6PM 27OCT95 & @ inj site;swelling devel shortly thereafter extending around inj site & to elbow;swelling down by 30OCT95 w/no residual effects;
Pt rec'd DTaP 3/5/04 R arm. Parent went to local ER 3/7/04 with R upper swelling and erythema. Per ER report: local rxn vs cellulitis pt tx'd with Keflex. Since report, daily contact with mom.
Patient inadvertently received a 1.0 mL dose instead of the prescribed 0.5 mL dose. Patient was originally cleared to leave the office after having no symptoms or complaints for 15 minutes following inject. Once dose error was caught, patient was contacted by clinic physician. Patient notified of error, possible side effects reviewed and advised to go to ER if symptoms develop. Patient had no current symptoms or complaints at that time. Staff followed up with patient several times over the course of the next 24 hours. Was unable to reach patients until 04/09/21 approx. 1030 am.  Patient doing OK, tired, but no other symptoms or complaints.
itching all stemming; weakness; dizziness; difficulty in breathing; sore throat; fast heartbeats at the night; headache; legs feel very heavy/feels like walking on something that is very heavy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), DYSPNOEA (difficulty in breathing), OROPHARYNGEAL PAIN (sore throat), HEART RATE INCREASED (fast heartbeats at the night) and PRURITUS (itching all stemming) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROPINIROLE for Restless leg syndrome, QUETIAPINE FUMARATE (SEROQUEL), PRAZOSIN, CLONAZEPAM, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and VALACICLOVIR HYDROCHLORIDE (PRO-VALACYCLOVIR) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (headache), HEART RATE INCREASED (fast heartbeats at the night) and PERIPHERAL SWELLING (legs feel very heavy/feels like walking on something that is very heavy). On an unknown date, the patient experienced DYSPNOEA (difficulty in breathing), OROPHARYNGEAL PAIN (sore throat), PRURITUS (itching all stemming), ASTHENIA (weakness) and DIZZINESS (dizziness). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form and LAVENDER OIL for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (headache) and OROPHARYNGEAL PAIN (sore throat) had not resolved and DYSPNOEA (difficulty in breathing), HEART RATE INCREASED (fast heartbeats at the night), PRURITUS (itching all stemming), ASTHENIA (weakness), DIZZINESS (dizziness) and PERIPHERAL SWELLING (legs feel very heavy/feels like walking on something that is very heavy) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non significant follow up received on 07-JUN-2021, no new information
Pt developed a macular, erythematous, warm rash at site of inject about 40 hours after injection. This has enlarged and is painful and swollen. Pt's brother had diagnosed cellulitis 2 weeks prior. Pt worked in cleaning a pig pen same day of vaccination after the shot.
Systemic: Fainting / Unresponsive-Severe, Systemic: Passed out-loss of consciousness-epi given paramedics called-Severe, Systemic: Weakness-Severe, Additional Details: Patient loss consciousness-stopped breathing for approx 15 secs-epi given-instant rebound-paramedics came took to ambulance for observation-released to wife-followed up with wife, patient is ok-sleeping now
Moderna 1/12/21, 2/5/21, 9/22/21. Positive on 2/23/22
AFLURIA immunization 10/6/14. Patient experienced pain and stiffness immediately. Pain has not decreased since 10/6/14.
I was positive for COVID-19 on 06/26/2022. I had  nasal congestions;  mild fever few hours  and  after 2-3 days I had cough. I also had rash for 1/2 a day  on my skin.   On  06/27/2022 I did a telemedicine with  my doctor  he prescribed me  Azelastine  and PAXLOVID.  We discussed  about taking the medications  but since I had  mild symptoms  I didn't take it.  I  took Fluticasone for nasal congestions. I  also went to see  my specialist  because my nasal congestions got worst.  He gave me steroids   to reduce the congestions.
Patient reported that on 7/15/22 she received the Pfizer vaccine (2nd booster) at the health department (given by  contracted staff). She reported the next day she did not feel well and started having vertigo symptoms. She thought she would "wait it out" on Saturday 7/16/22. She woke up on 7/17/22 and continued to have worsening vertigo symptoms, to the point where she felt that she needed to be seen by a provider. She called an ambulance to her home who transported her to the local ER. While she was there they gave her motion sickness medication. They told her "sometimes this just happens." Two days later she saw her primary doctor who made a referral for therapy. She did not have any symptoms other than a sore arm with the first 3 Pfizer vaccines and she does not report any underlying conditions that would have contributed to vertigo. She stated she looked at the CDC website which showed a small percentage of people who got vertigo because of the vaccine. She is feeling better now, however, states it is not completely resolved but she continues to go to therapy.
Within first minute after giving Hepatitis B injection child experienced syncope. Positioned to improve blood flow to head. Patient then had mild tonic-clonic movements of arms and head for less than 5 seconds followed by return to alert state of consciousness. No further problems noted.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive COVID results as well as; Negative, notes: At end of course was testing negative and felt no symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
typical reactions and side effects after the booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (typical reactions and side effects after the booster dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (typical reactions and side effects after the booster dose). At the time of the report, VACCINATION COMPLICATION (typical reactions and side effects after the booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.   Reporter did not allow further contact
Pt recvd vax & exp numbness & heaviness in the lt arm; no treatment given;
Fever, Swelling, at injection site/ 0 drainage, 0 discharge, warm to touch.
Fever (103) Pounding headache Dizzy (very) Aches and pains
This morning I woke up to some little bumps on the side of my face; some little bumps on the side of my face as like in an allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 18-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0162), via an unspecified route on 10May2021 (at the age of 18-years) as dose 2, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 12Apr2021 (at the age of 18-years) as dose 1, single for covid-19 immunisation. On 11May2021, the patient experienced and stated "I received her second vaccine yesterday and this morning I woke up with little dots to some little bumps on the side of my face as like in an allergic reaction. But it was only in the side of my face. It's not where my injection site is or anywhere else in my body, just my face". Patient did not received treatment for events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Received both the 1st and 2nd of Moderna vaccine under 18 years of age; Received both the 1st and 2nd of Moderna vaccine under 18 years of age; This spontaneous case was reported by a health care professional and describes the occurrence of the first episode of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received both the 1st and 2nd of Moderna vaccine under 18 years of age) and the second episode of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received both the 1st and 2nd of Moderna vaccine under 18 years of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced the first episode of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received both the 1st and 2nd of Moderna vaccine under 18 years of age). On 06-Mar-2021, the patient experienced the second episode of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received both the 1st and 2nd of Moderna vaccine under 18 years of age). On 06-Mar-2021, last episode of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received both the 1st and 2nd of Moderna vaccine under 18 years of age) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  Description: The patient received both the first and second dose of Moderna vaccine under 18 years of age. No symptoms were reported after receiving both doses of Moderna vaccine.  No treatment information provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-068174 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068174:Same reporter
Patient experiencing dizziness and diaphoresis immediately following vaccine. Patient reports "numbness" in left arm for about 10 minutes, which then turned to "tingling" for 20 minutes. Patient instructed to follow up with PCP.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 77-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805416 was crossed linked to original cases 201804863 due to same reporter.
Headache, weakening,tiredness, chills. Pain in the vaccione area only one day..Took only panadol the first night.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 02/22/2021 and 03/22/2021.  They presented to emergency department on 02/02/2022 with a primary complaint of weakness. They were admitted to hospital on 02/02/2022 and tested positive for COVID-19 via both antigen and PCR tests upon admission. They remained hospitalized until their death on 02/06/2022 (some of the clinical notes indicate date of death as 02/05/2022).
Information has been received from a nurse practitioner concerning a 10 month old female, who on 31-MAY-2007 was vaccinated with a first dose of PEDVAXHIB (Lot# 655397/0073U). On 08-OCT-2007 the patient was vaccinated with a second dose of PEDVAXHIB (Lot# 655078/1273F). On 14-FEB-2008 the patient was seen in the office and diagnosed with septicemia with a positive blood culture for Haemophilus influenzae type b. The patient was hospitalized and treated with multiple unspecified antibiotics. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Moderna COVID-19 Vaccine Nausea, vomiting, stomach cramps, dry heaves - lasted about 4-5 hours then subsided to fatigue and faint nausea.  Treated at home. no doctor engagement
Woke up on 1/26/03 with complaint of a very sore arm. It had slight redness. Woke up on 1/27/03, with a large area of redness and warm to touch that began on right arm. Per medical records: Arm stiffness, sore and red. Denies fever, chill, nausea or chest pain. Initially felt SOB. Denies itching and does not have tenderness. Lungs were clear, apex regular. Right arm erythematous, tender and slightly swollen (measuring 12" on right forearm and 12" on left forearm and 10 1/2" circumference. Area of erythema 8" from mid-upper arm and almost all around arm. No central clearing, Arm tender, hot to touch, FROM. No erythema below elbow area. Plan: Zyrtec 10mg daily; 2 day sample given; ibuprofen 200mg bid prn, 2 day sample given; ice pack to site and hydrocortisone 0.1% to site.
After the vaccine she got covid; After the vaccine she got covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 09:00 (Lot number: FK5127) at the age of 10 years as dose 2, single and administered in arm left, administration date 15Nov2021 10:15 (Lot number: FK5618) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "Otitis media" (unspecified if ongoing), notes: Otitis media. The patient took concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "After the vaccine she got covid". The event "after the vaccine she got covid" and "after the vaccine she got covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive, notes: SWAB. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course : Treatment received 600 ML OF IBUPROPHEN, IRON AND MULTIVITAMINS.
Hives/& swelling all over. Next am 6-17 fever 101.
Pt reported redness around injection site after 2 wks of vaccination. Pt will take BENADRYL & follow up w/ MD.
This spontaneous report as received from a consumer refers to a patient of unknown age and gender (consumer's friend's physician). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). The consumer reported that, on an unknown date, the patient (consumer's friend's physician, unspecified) was diagnosed with shingles after receiving ZOSTAVAX. The outcome of the event was unknown. The relatedness between the shingles and the vaccination with ZOSTAVAX was unknown. Additional information is not expected because the reporter declined to answering any further questions.