chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lupus erythematosus; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2K-163-4373609-00.  A 51-year-old female patient received BNT162b2 (BNT162B2), 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) at the age of 51 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "not recovered", described as "Lupus erythematosus". The action taken for adalimumab was unknown.  The reporter considered "lupus erythematosus" related to BNT162b2.  Causality for humira (adalimumab): The reporter(s) causality for the event(s) of lupus was possible opinion is that the event of lupus is not assessable.  Causality for Pfizer BioNTech covid-19 vaccine (Tozinameran): The reporter(s) causality for the event(s) of lupus was possible and manufacturer causality not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Employee experienced dizziness and nausea approximately 15 minutes after the 2nd dose of the series. Employee was unable to work and had to go home due to inability to work.
Headache 7pm 04-16-21 Arm sore and swollen  3pm 04-16-21 Achy 8am 04-17-21 Arm sore and swollen continued 04-17-21 Light  headed 04-17-21
Left deltoid region began burning (by patient history I did not witness) and hurting went to ED by car at 11:55 PM.
pt recv vax 22JUL92 & stated devel an allerg rxn & discontinued the vax series; No further details were provided;
Fever (101.3 F), chills, headache, tiredness, injection site pain, injection site swelling. Lasted for approximately 12 hours.
My platelets dropped from 382k to under 10k 2 days after receiving Moderna Covid-19 Vaccine. I experienced bloody nose, Petechia, oral blood blisters, bruising, bleeding gums and was bedridden with fatigue.
weakness and lightheaded. 11/2/09: headache 12/8/09 ER recs received for date 11/2/09. DX: HA, high BP. Chief c/o acute onset HA, elevated BP this AM. Assessment: (+)HA,(+)blurred vision.
local reaction consisting of skin irritation.  Skin warm to touch.  Patient did not have a fever.
Half of patient's arm was swollen and red. It was the same arm the vaccine was administered.
C/O URTICARIA, FLUSH, RASH AND PRURITIS arm, trunk, and legs.
Pfizer / BioNTech - Dose Number: 4 / Moderna - Dose Number: 3; 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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE. Past drug history included: Tetracycline, reaction(s): "known allergies"; Coedine, reaction(s): "known allergies"; Percoset, reaction(s): "known allergies". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech - Dose Number: 4 / Moderna - Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included COVID-19 treatment (Paxlovid) from 20Nov2022 to 24Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On the CDC sheets, Patient checked that he had an  allergic  reaction to the first dose and is allergic to polysorbate that can be found in some vaccine. We should have not given the second dose.
- Woke up morning (10/14)  after vaccine administration  with severe migraine,  chest pain (tightness/heaviness center/beneath sternum**), and some light headedness/brain fog.  - Treated Migraine with Ibuproferen (600 mg). Migraine returned 10/18* - Chest pain is more noticeable when laying down but can be felt sitting and standing as well.  - As of today (10/19) Chest pain and light headedness has continued  since 10/14, while it has lessened and is now periodic it still causes discomfort and concern.  - I saw my PCP on 10/17 to address my concerns.  *Please note, I do not get chronic migraines. The last time I had a migraine was when I contracted COVID for the first time in January 2023.  **Similar chest pain/heaviness was felt when I contracted COVID for the first time in January 2023.  ***I did not have these side effects with previous booster/COVID shots.
This spontaneous report as received from certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M005732, expiration date 19-OCT-2017)  (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 15 minutes. Also there was previous temperature excursion from 32 Fahrenheit (°F) degrees to 35 Fahrenheit (°F) degrees for 19 hours and 30 minutes and from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 1 hour and 45 minutes. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA009372: US-009507513-1709USA010095:
HMS DISCHARGE SUMMARY -- Hospital     Admitted: 9/29/2023 Discharge Date: 10/02/23    PCP Handoff    Recommended Outpatient Testing o None   Results Pending At Discharge o None       Clinical Summary  Patient is a 72 y.o. male patient of MD with history of Parkinson's disease, hyperlipidemia presented to Hospital with cough, sore throat for a few days and severe weakness that started earlier today.  Found to be COVID positive at PCP office.  Found to have elevated CPK likely due to underlying COVID infection and decreased fluid intake.  CPK trending down with IV fluids.  Sore throat resolved.  Read by therapy with no further recommendations.  To be discharged home with outpatient follow-up   Covid-19 Virus Infection with pneumonia  Date of onset of symptoms: 9/27/23 Symptoms present on admission: Cough, sore throat Date of covid positive test: 9/29/23 Imaging: Chest x-ray 9/29 with minimal atelectasis of the left lung base Oxygen requirements on admission: None Current oxygen requirements: room air Medical therapy: Continued outpatient Paxlovid Anticipated special isolation end date: 10/7/23   Possible aspiration pneumonia/superimposed bacterial pneumonia Sepsis, POA (tachycardia, tachypnea, leukocytosis) Patient says he has some issues with swallowing related to the Parkinson's disease Weakness has been much worse due to the COVID Significant productive cough, sepsis on presentation Chest x-ray without any infiltrate CT soft tissue neck done for severe sore throat without any acute findings.  Blood cultures no growth today SLP consulted for swallow evaluation-appreciate recommendations.  No further speech therapy needs or diet modifications.   Rhabdomyolysis Weakness Severe weakness that led to patient not being able to get up from the floor earlier on the day of admission CPK 18K on admission Appreciate neurology follow-up. PT/OT  Parkinson's disease Continue home carbidopa levodopa, Artane Patient has had gradual weakness over the last few weeks.  Appreciate neurology follow-up , continue home medications and follow-up with neurology as outpatient.     Had brief episodes of altered state while inpatient likely due to acute infection versus steroid use.  Symptoms now resolved Outpatient follow-up with neurology
Left arm hurt, was swollen, red from shoulder to elbow, and arm was warm to touch
Friday evening after vaccination patient began experiencing pain at injection site, redness and heat at injection site began Saturday morning, and patient went to clinic Sunday afternoon - suspected cellulitis. Clinic provider prescribed cephalexin 500 mg every 6 hours for 10 days.
pt recvd vax & complained of rash w/ itchness over body; went to er; tx in er unk;
Starting 07/02/2022, I was very tired, weak, had a headache and sinus congestion. I went to the hospital and had 3 IV bags of remdesivir due to testing positive both at home and in the hospital for COVID-19. I was in the hospital for 3 days. I was discharged after that and most of my symptoms were resolved after the 3rd dose of the antiviral; however, the tiredness lingered for about 3-4 days.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-DEC-2018, the patient was vaccinated with expired VAQTA intramuscularly (dose was not reported, lot # N016805, expiration date 04-SEP-2018) for prophylaxis. The vaccine was stored properly. No adverse effects reported.
This spontaneous report as received from a registered nurse refers to patients with unknown age and sex. On unknown dates patients were vaccinated with PROQUAD (Merck) (lot#, route and dose unknown) which had been exposed to temperatures above 5 Fahrenheit. No adverse experience had been reported. It was not specified if patients sought for medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
she had to call out from work the next day; Vomiting; Myalgia; Shivers; she was still very tired; injection site was Red; injection site was / Swelling; injection site was / hot from injection site to the elbow; This case was reported by a other health professional and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced vomiting, myalgia and shivers. On 4th December 2020, the patient experienced activities of daily living impaired. In December 2020, the patient experienced injection site erythema, injection site swelling, extremities hot feeling of and fatigue. On an unknown date, the outcome of the injection site erythema, injection site swelling, extremities hot feeling of, vomiting, myalgia, shivers, fatigue and activities of daily living impaired were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, extremities hot feeling of, vomiting, myalgia, shivers, fatigue and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient was a health care professional. On the night after receiving the Shingrix vaccine, the patient had shivers, myalgia and vomiting. The patient stated that she had to call out from work the next day. Patient was able to get out of bed on the third day, but she was still very tired. She also stated that the injection site was red, swollen, and hot from the injection site to the elbow. The reporter did not consent to follow up.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 29-JUL-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M004883, expiration date on 02-OCT-2017) orally, which was exposed to a temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
give me half the booster amount; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (give me half the booster amount) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.Concurrent medical conditions included COPD.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 ACCIDENTAL UNDERDOSE (give me half the booster amount). At the time of the report, ACCIDENTAL UNDERDOSE (give me half the booster amount) had resolved. 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.No concomitant medications were reported. No treatment medications were reported.
Horrible insomnia; A spontaneous report was received from a Consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On unspecified date the patient experienced horrible insomnia. On Friday night, 29 Jan 2021, the patient slept 2.5 to 3 hours, was in and out of sleep. On saturday night the patient could not sleep had to take naps throughout the day. On sunday the patient slept from 10pm to 2am.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event horrible insomnia, she was in and out of sleep, could not sleep were unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further No follow up is possible.
MIGRAINE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, and other pre-existing medical conditions included history of migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraine was not reported. This report was non-serious.
This spontaneous report was received from a Licensed Practical Nurse and refers to a 67-year-old patient. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (dose and route of administration were not reported) lot # N024384 with expiration date on 18-MAY-2019. The vaccine underwent a temperature excursion of 0.1 degrees Celsius for 6 hours. Digital data logger was involved in the recording of the excursion. Unspecified previous excursions were reported. No adverse events were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1712USA001308 :
Pt has a full chicken pox break out, which includes 500+ pox. Patient has no fever or other symptoms.
Patient developed fever on 11-5-17 and tested positive for Flu on 11-6-17 per lab respiratory panel testing.
Slight headache that day (4/1).  The next day (4/2), weakness in left leg and arm. On 4/3 went to ER, admitted to NeuroScience ICU. Diagnosed with small blood clot and small bleed in brain--- dural venous sinus thrombosis. The neurology team said this was very unusual and very rare in this part of brain--where the blood flows back to the heart from the brain. They did alot of tests on every part of my body looking for the cause and found nothing. They think it was vacine induced and repoted it to the CDC. Left leg and arm weakness remains with no changes yet. Now taking blood thinner and doing physical therapy
Within 24 hours: Loss of taste and smell, headache, dizziness, nausea, numbness of the right side of the face and gums, temporary tooth pain, fingertips numb on both hands and feeling unwell.
Violent vomiting at the same time as her friend who got the shot at the same time.
Arm was swollen and stiff. He could not move it. He took BENADRYL every 6 hours.
Diffuse very itchy maculopapular eruption starting on hips and spreading over entire torso, arms, legs. Raised rough erythematous. No hives no vesicles no bullae. Requiring High dose steroid and hi dose H1 and H2 antihistamines for weeks.
Information has been received from a female pharmacist of unknown age referring to herself. There was no medical history or drug reaction reported. On unknown dates, she was vaccinated with full three dose series of Hep B vaccine (manufacturer unknown) (dosage, strength, route and lot # were not reported) as an adult. There was no concomitant medication reported. On an unknown date the pharmacist had negative titers for hepatitis B. At the time of the report, the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter didn't wish to contact.
patient is in pain says on the injection site and bones. states that she has fever too. advised to take Tylenol or OTC pain medication, and let us know if she feels better or worse. Told patient that we will contact her from time to time to see how she is doing.
Client verbalized having a metallic taste in his mouth immediately after receiving vaccine.  Client seen by EMT and refused to be assessed and stated that taste went away as soon as he drank some water.  Cleared to go home by EMT.
Less than 72hrs post injection, I had terrible body shaking, hallucinations,  would wake up screaming, hot and sweaty , body aches, not able to get comfortable.
Outbreak of vesicular rash consistent with "chicken pox". Treatment - BENADRYL, AVEENO baths, TYLENOL.
Vaccine administered 10/26/12 (R) deltoid. Adverse reaction noted 10/27/12; Resident noted with localized swelling redness & heat. Resident c/o soreness - no changes in vital signs noted. Dr ordered: KEFLEX 250 mg PO q 6 hours x 10 days. BENADRYL 25 mg po q 6 hours x 24. BENADRYL 25 mg po q 6 hours - prn after 24 hours.
This spontaneous report as received from an about 50 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (Lot# and route not reported). No other co-suspects were reported. No concomitant medications were reported. The patient developed an injection site reaction when vaccinated with ZOSTAVAX. The injection site reaction was an inflamed red area which resolved in about a week. It was not painful. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 2-month-old female patient who received HAVRIX (batch number X9LB7, expiry date 10th February 2017). On an unknown date, the patient received HAVRIX (unknown). On an unknown date, an unkonwn time after receiving HAVRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: HCP reported that HAVRIX was given to a 2 month old patient by accident. They meant to give the patient a Hepatitis B vaccine.
she can't grip she can still grip things but she has to shake her arm to wake it up; A feeling of pins and needles at the finger tips; Hand was numb and tingly; Hand was numb and tingly; Arm felt like it was falling asleep/felt like her arm was going to sleep; Arm is going numb; Her hand and is like it is falling asleep; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer (patient) reported that: A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982) via an unspecified route of administration in left upper arm on 22Jan2021 at 14:45-15:00 as single dose for COVID-19 immunization. Patient's Medical History (including any illness at time of vaccination) and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 she reports that her arm is going numb and her hand and is like it is falling asleep. On Monday(25Jan2021) she had to shake it to wake it up, arm felt like it was falling asleep and her hand was numb and tingly, she had the same feeling in the arm she had the injection. Tuesday and Wednesday it was ok and she had no issues but today(28Jan2021) felt like her arm was going to sleep. She had to shake it to wake it up and there was a feeling of pins and needles at the fingertips. It is not like she can't grip she can still grip things but she has to shake her arm to wake it up. She wants to know is this some known side effect and is it safe to have the shot in the same arm, her second dose is due on 08Feb2021. Outcome of the events were unknown.
Blood and mucous noted in stool the day after receiving ROTATEQ. Symptoms persisted for two weeks.
On 1/3/2021, I broke out with shingles outbreak in my face. I have never had this before.