chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was diluted incorrectly with less Normal Saline than require. This error was not noticed until person mixing vaccine said they were out of vaccine and did not have enough to get 5 dosages of 0.3ml. Two people mixed one vial of vaccine together demonstrating to the other. It appears the person making the error did not notice they did not have 1.8ml of NS but must have had some air and did not realize it. The error was noticed when all the vaccines were given and one person had not completed pulling up the vaccine. So, 2 of 7 patients received the incorrect dose of vaccine and it could not be determined which two received the incorrect dose. Reported sore arm for several days but it resolved.
Arthralgia, Swelling at the site, chills, loss of appetite and fatigue Narrative:
Fever; Aching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: EP6955) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: CJ1686), administration date: 12Mar2021, when the patient was 62-year-old, for Covid-19 Immunisation, reaction(s): "Fever", "Aching". The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered", described as "Aching"; PYREXIA (non-serious) with onset 2021, outcome "recovered", described as "Fever".  Additional information: The patient stated that with the first two vaccines she had the basic reactions to the first two, a little bit of fever and aching, took a nap never takes naps. Patient stated that with the first two doses the symptoms only lasted about a day. No other vaccines received.
Pt received moderna vaccines on 02/03/2021 and 03/03/2021. Pt presented to the ED with complaints of SOB. pt was found tobe COVID positive.
flu/covid like symptoms; Covid like symptoms; loss of taste and smell; loss of taste and smell; This is a spontaneous report from a Pfizer sponsored program.  A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu/covid like symptoms in Apr2021 after vaccination. He indicated they have taken nasal decongestant and have loss of taste and smell in Apr2021. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 28-JAN-2015, the patient was vaccinated with an improperly stored dose of VAQTA (dose, lot number, expiration date were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
nausea & pain/erythema @ inject site are reported in a pt receiving 1 dose of flu vax; pt recvd vax on 29SEP93 & on 30SEP93 exp reaction;
Slightly sore left arm/sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slightly sore left arm/sore left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 012M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Slightly sore left arm/sore left arm). At the time of the report, VACCINATION SITE PAIN (Slightly sore left arm/sore left arm) outcome was unknown.            No concomitant product was reported.  The patient experienced sore left arm on 23-Aug-2021, after first Moderna COVID-19 vaccine booster.  The patient received second Moderna COVID-19 vaccine booster dose on 27-Apr-2022 in left arm. Patient had no adverse reactions.  The patient received first Moderna COVID-19 bivalent vaccine booster dose on 17-Oct-2022 (Batch number- 050D22A) in left arm. Patient had no adverse reactions.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-661802 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661802:Same reporter
Patient was seen in our clinic and provider ordered Adult Hep A to be given. Information was not verified and patient was given wrong vaccine. Patient received adult dose was given. Should have been Ped/adol dose.
Mother of the girl takes her to the ER since on June 8th the girl received some vaccines and a cellulitis developed on the right arm and where the doctor helped her due to complaints of pain and inflammation on the arm.
Right Bell's palsy: unable to raise eyebrow, difficulty closing eyelid; unable to smile.
Area around shot site became mildly red with mild hive like appearance around site of Hepatitis A shot (second of 2/ final shot).
She just feels terrible; Trouble walking; Splitting headache; Shortness of breath; Cough; She can't do her daily activities/she feels out of sorts; This is a spontaneous report from a contactable consumer. This 82-year-old female consumer (patient) reported.  A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH, COVID-19 vaccine, solution for injection; Batch/Lot number: EN5318), via intramuscular, administered in Right arm on 07Feb2021 at 14:00 (at the age of 82-year-old) as 1st dose, single for covid-19 immunisation. The patient Medical history included cough from 19Jan2021 to an unknown date, dyspnoea from 19Jan2021 to an unknown date, malaise from 19Jan2021 to an unknown date. On the 19Jan2021, she was not feeling well and went to a medical facility and had blood work, a chest x-ray, and a Covid-19 swab done. They said that she probably had Covid, but they weren't sure. She was sent to another facility and had a antigen test. Her swab came back from the swab test a few days later and came back positive. On the 20Jan2021 they did a throat swab and it came back negative that she did not have Covid-19. She went back to the first facility about 10 days later and they did another throat swab and she tested negative. The concomitant medications were not reported. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No Prior Vaccinations (within 4 weeks). The patient was not ill at the time of vaccination. On 08Feb2021, the patient experienced splitting headache, felt terrible, Trouble walking. The reporter stated that the Covid-19 Vaccine and reported that she had the vaccine on 07Feb2021 and on 08Feb2021, she was feeling so horrible that she went to her physician. She said that she had a splitting headache and does not know if it is associated with the vaccine. It is Thursday, and she still has a headache, shortness of breath, and she just feels terrible. The patient reported that she also had cough. She said that she can't do her daily activities and she feels out of sorts. She feels like she does not want to do anything and the headache hurts. She does not know if it is a migraine or what, but it hurts. She reported that she has been having trouble walking. She stated that this started this past week since she had the vaccine, since 08Feb2021 and stated that it is persisting. The headache is driving her crazy. The adverse events resulted to visit physician office. They prescribed her a Z-pack of Azithromycin and an albuterol Inhaler. The outcome of the events Splitting headache, She just feels terrible, Trouble walking were not resolved and other events were unknown.  Follow-up: Follow-up attempts completed. No further information expected.
General aches; Intense headache; Chills in spine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (General aches), CHILLS (Chills in spine) and HEADACHE (Intense headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in June 2020 and Fracture.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CHILLS (Chills in spine). On 25-Mar-2021, the patient experienced PAIN (General aches) and HEADACHE (Intense headache). On 25-Mar-2021, CHILLS (Chills in spine) had resolved. At the time of the report, PAIN (General aches) and HEADACHE (Intense headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was an oncological chronical patient. Her physician reported that her immunoglobulins where high so he suspended the oncological treatment. No concomitant medications are provided by the reporter. Treatment to the events are provided as 2 Painkillers for the night aches.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information includes reporter address.
Severe cough since April up to now, shortness of breath, Pleural effusion, Bilateral pulmonary embolism. 3 times hospital admissions. April 26th after the first dose, May 25th after the second dose, and June 16th after confirming the pulmonary embolism. I have not been able to work since April 25 to date.
Body tingling, dizziness, within 5 minutes of injection; body aches, stomach pain, nausea, tiredness, feeling unwell, 3 days after injection.
Contracting COVID-19 after receiving the Moderna Covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracting COVID-19 after receiving the Moderna Covid-19 vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracting COVID-19 after receiving the Moderna Covid-19 vaccine). At the time of the report, COVID-19 (Contracting COVID-19 after receiving the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
Patient received a dose  that was stored at room temperature for more than 12 hours; the syringe was kept at room temperature but the vial was returned to fridge.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose  that was stored at room temperature for more than 12 hours) and PRODUCT STORAGE ERROR (the syringe was kept at room temperature but the vial was returned to fridge.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose  that was stored at room temperature for more than 12 hours) and PRODUCT STORAGE ERROR (the syringe was kept at room temperature but the vial was returned to fridge.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a dose  that was stored at room temperature for more than 12 hours) and PRODUCT STORAGE ERROR (the syringe was kept at room temperature but the vial was returned to fridge.) 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 did not provide any causality assessments.   Concomitant medications were not reported. treatment drugs were not reported.
I had expected side effects including headache,  fever, and soreness. I have also developed tinnitus in my right ear on the Sunday after my second vaccine shot(6/6/21). The tinnitus followed after my fever came and went on mid to late Saturday(6/5/21).
Baby started forceful projectile vomiting with every feeding. There was no change in feeding according to mom.
S/SX: Pain and swelling in right arm at injection site. TX: ice and BENADRYL.
Friday - 2 hour after irritated at injection site, bruising at site after ice pack (had brace on same arm). Ragweed / shrimp fried rice.
Pt. was given Tdap on 1/11/16 - arm started having redness and irritation 5 days post shot peaked at 7 days post shot - warm compresses. Advised to call if worse.
Patient presented on 6/23/06 with c/o fever, chills, HA, body aches. Afebrile at time of visit. L arm smallpox vaccination site with medium size pustule, no drainage. Tender erythema approximately 7cm in diameter. Reported that Sunday site had some streaking present. Axillary negative LAD noted. Diagnoses probable early cellulitis at injection site. Tylenol prn, Quarters x 24 hours. Hydrate and hot showers, RTC in am for reeval.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 26-FEB-2014 the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route not reported) and a dose of PROQUAD (Merck) (lot #, dose and route not reported) during the same visit. No symptoms reported. Additional information has been requested.
Patient reports palpitations and shortness of breath after 1st dose upon admission for 2nd dose. Received second dose 6/10/21 (at her request) with no adverse event reported.
This spontaneous case, initially received from other health professional on 27-Feb-2018, concerning an 18-months infant male patient. The patient's historical condition included: cold. Historical drug included: flu vaccine for an unknown indication. Current condition included: plagiocephaly and gross motor developmental delay. Concomitant medications included: CLARITIN, Albuterol, Saline and unspecified nasal spray. On 26-Feb-2018, the patient (under 5 years of age) was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195235, expiry date: 31-May-2018 (explicitly coded as inappropriate age at vaccine administration). The reporter assessed the event as non-serious.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Headache", "Also developed tinnitus on right after 1st vaccine which has been constant". The following information was reported: HEADACHE (non-serious), outcome "unknown".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300176335 Same patient, different dose number/event;
When I first got the shot Oct 28, within 10-12 hours I started with a fever, flu like symptoms in bed for 3 days until Tuesday. Then on Nov 25th I started having abdominal pain and it was an 8/10 so I went to the emergency room. They did a cat scan and said I had a 5 by 7mm stone stuck in my ureter. I had pain and vomiting with it and it is still in me.
HA, dizziness, malaise, swelling of lymph nodes day of injection.  Involuntary muscle twitching seizure on Saturday.
This spontaneous report was received from a nurse via a company representative and refers to a male patient of unknown age. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patient received 3 doses of GARDASIL injection (doses, route of administration, lot# and expiration dates were not provided), which were not given accordingly to the schedule as per recommended in the prescribing information. The patient received the third dose of GARDASIL on an unknown date in 2013. On an unknown date, 10 days after receiving the third dose of the vaccine, the patient presented with unspecified Bell's palsy symptoms. The patient received an unspecified treatment for the event. The outcome of the event was not recovered. The causality between the adverse event and GARDASIL was not provided. Upon internal review, the event of Bell's palsy symptoms was considered to be medically significant. Additional information has been requested.
Hot, red, rashy area on right arm. Took BENADRYL and prednisone.
persistent cough. The cough got worse after getting the second dose.; fever; weakness; aching; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown, Expiration date: Unknown), via an unspecified route on 23Jun2021 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EW0196, Expiration date: Unknown), via an unspecified route in the left arm on 15Jul2021 (age at vaccination: 65-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 24Jun2021, patient experienced persistent cough, fever, weakness and aching after getting both doses. The cough got worse after getting the second dose. She wanted to know how long will this last and was asking for treatment recommendations. Patient said she already called up her doctor and they gave him cough medicine which was only masking the problem. She said that this has nothing to do with her health as this is vaccine related. The clinical outcome of the persistent cough got worsened, fever and achiness lasted for about 3 days and weakness lasted for a week.   No follow-up attempts are possible. No further information is expected.
Fever; LYMPH NODES SWOLLEN UNDER BOTH ARM PITS/MORE ON LEFT ARM WHERE SHOT WAS GIVEN; HEADACHE; FATIGUE; BODY ACHES; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), LYMPHADENOPATHY (LYMPH NODES SWOLLEN UNDER BOTH ARM PITS/MORE ON LEFT ARM WHERE SHOT WAS GIVEN), HEADACHE (HEADACHE), FATIGUE (FATIGUE) and MYALGIA (BODY ACHES) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In August 2021, the patient experienced PYREXIA (Fever), LYMPHADENOPATHY (LYMPH NODES SWOLLEN UNDER BOTH ARM PITS/MORE ON LEFT ARM WHERE SHOT WAS GIVEN), HEADACHE (HEADACHE), FATIGUE (FATIGUE) and MYALGIA (BODY ACHES). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In September 2021, PYREXIA (Fever), LYMPHADENOPATHY (LYMPH NODES SWOLLEN UNDER BOTH ARM PITS/MORE ON LEFT ARM WHERE SHOT WAS GIVEN), HEADACHE (HEADACHE), FATIGUE (FATIGUE) and MYALGIA (BODY ACHES) had resolved.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of Lymphadenopathy axillary,fever, Headache, Fatigue, body ache was not reported for cosuspect humira. 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-2021-622532 (Patient Link).   Reporter did not allow further contact
Covid-19 Pneumonia; Fainted twice and hit his head a few times/Oxygen level went below 53; Hit his head a few times from fainting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (Covid-19 Pneumonia) and SYNCOPE (Fainted twice and hit his head a few times/Oxygen level went below 53) in an 82-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.     The patient's past medical history included No adverse event (no medical history was reported).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 PNEUMONIA (Covid-19 Pneumonia) (seriousness criterion hospitalization) and SYNCOPE (Fainted twice and hit his head a few times/Oxygen level went below 53) (seriousness criterion hospitalization). an unknown date, the patient experienced HEAD INJURY (Hit his head a few times from fainting). The patient was hospitalized for 15 days due to COVID-19 PNEUMONIA and SYNCOPE. At the time of the report, COVID-19 PNEUMONIA (Covid-19 Pneumonia) outcome was unknown and SYNCOPE (Fainted twice and hit his head a few times/Oxygen level went below 53) and HEAD INJURY (Hit his head a few times from fainting) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: below 53% (Low) below 53%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and medical history were not reported. The patient felt that he had COVID-19 before he took the vaccine because his family members had it as well.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.