chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slept for 2 days; stomach pain; felt lethargic for 3 days; low grade fever 100.1; chills; headache; Initial information was received on 03-Sep-2021 regarding an unsolicited valid non-serious case received from a Patient via Global Medical Information (GMI) (Reference number- 00754167) and transmitted to Sanofi on 03-Sep-2021 in the United States.  This case involves a 72-year-old female patient who experienced slept for 2 days (Hypersomnia), stomach pain (Abdominal pain upper), felt lethargic for 3 days (Lethargy), low grade fever 100.1 (Pyrexia), chills and headache while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient slept for 2 days (Hypersomnia), stomach pain (Abdominal pain upper), felt lethargic for 3 days (Lethargy), low grade fever 100.1 (Pyrexia), chills and headache (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, "Caller states she is 72 years old with a body like a 62 year old; she states last year flu rates were down because of people wearing masks but she got the flu on Christmas day; she states she got it from being in the doctors office for cataract surgery and that she was there for 4 hours, afterwards, she reports that she felt lethargic for 3 days and slept for 2 and her symptoms included a low grade fever 100.1 (which she states is unusual for her as her normal temperature runs around 97 or 98 degrees), stomach pain, chills, and headache, she states that she had no nausea or vomiting, she states that at that time she was tested for Covid and had a negative test result, so she states for certain it was the flu, even though she was vaccinated, she states that she has a terrible reaction to "mega doses" and when she even takes a 300 mg Tylenol pill it puts her to sleep, she states she does not know if she should take the Fluzone HD or the Fluzone regular dose, she states she does not want to have a reaction with the Fluzone HD and wants to know the antigen used, her primary HCP is out of the office until 10Aug2021 but she really wants the Flu vaccine on the earlier side this year as compared when she received the vaccine in October last year, she states she wants a middle dose of the antigen and does want the vaccine to be egg based, she is requesting information on the antigen used in the formulation of the vaccines."  Relevant laboratory test results included: Body temperature - On an unknown date: 100.1 UNK [low grade fever 100.1] SARS-CoV-2 test - On an unknown date: Negative  The patient was treated with PARACETAMOL (TYLENOL).  At the time of report, the outcome of events was unknown.
Information has been received on 04-APR-2017 from a registered nurse who reported that a 12-month old male patient was given VARIVAX (Inj), intramuscular (Site of administration, Lot number, and Expiration date were not reported) and PROQUAD (Route, site of administration, Lot number, Expiration date were not reported) vaccinations at same time. (The nurse also reported that the patient received the vaccines "concomitantly".) No dates or times of vaccinations reported) for prophylaxis. No symptoms reported. No product quality complaint (PQC) was reported. No further information was provided. Additional information has been requested.
28JUL98 pt recv vax & 3hr p/vax pt had apneic episode;adm to hosp ER;EEG nl;UA nl;spinal tap nl;CBC & SMA nl;
Chronic Orthostatic Hypotension; Chronic Pain in the  Arm that got the shot still; Dizziness; Cannot walk without support and fall to my knees to prevent falling; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 20Mar2021 12:00 (at the age of 79-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included seizure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included midodrine; levetiracetam; doxazosin; finasteride, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right in Feb2021 at 12.00 (at the age of 79-years-old) (Batch/Lot number was not reported) for COVID-19 immunisation. Since 15Apr2021, 12:00 PM, the patient experienced chronic orthostatic hypotension, chronic pain in the arm that got the shot still, dizziness, cannot walk without support and fall to my knees to prevent falling. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hosp, Disability or permanent damage. The patient was hospitalized for 10 days. The patient received treatment for AE, adjusted medications. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  Information on lot/batch number has been requested.
Burning; Sever cramping  in right  hand; Fingers were stiffed in the  morning; Has not received second dose due the side effects; Red wrinkled skin around his neck which got spread to his chest and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Burning ), MUSCLE SPASMS (Sever cramping  in right  hand), MUSCULOSKELETAL STIFFNESS (Fingers were stiffed in the  morning), INTENTIONAL PRODUCT USE ISSUE (Has not received second dose due the side effects) and ERYTHEMA (Red wrinkled skin around his neck which got spread to his chest and shoulder) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Burning ) and ERYTHEMA (Red wrinkled skin around his neck which got spread to his chest and shoulder). an unknown date, the patient experienced MUSCLE SPASMS (Sever cramping  in right  hand), MUSCULOSKELETAL STIFFNESS (Fingers were stiffed in the  morning) and INTENTIONAL PRODUCT USE ISSUE (Has not received second dose due the side effects). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARAFFIN (VASELINE [PARAFFIN]) at an unspecified dose and frequency. At the time of the report, SKIN BURNING SENSATION (Burning ), MUSCLE SPASMS (Sever cramping  in right  hand), MUSCULOSKELETAL STIFFNESS (Fingers were stiffed in the  morning) and ERYTHEMA (Red wrinkled skin around his neck which got spread to his chest and shoulder) was resolving and INTENTIONAL PRODUCT USE ISSUE (Has not received second dose due the side effects) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. Treatment medications included Steroid cream and herbal tea for arthritis along with above mentioned medications. Patient also had to do exercise to loosen joints and his stiffed fingers. Patient was supposed to receive the second dose of the Moderna Covid-19 vaccine on 13 July 2021.
pt recvd vax during a travel clinic program; the following day exp swelling in throat; c/o ea time swallows, feels like something is in the way; breathing not compromised; sx persisting 12 days (off & on); pt recovered;
Patient was admitted to hospital with hypoxic failure and COVID-19 .  Poor baseline health prior to COVID. Hypoxemia worsed; was initially treated with remdesivir, decadron and baricitnib. Possible secondary bacterial pneumonia so baricitinib stopped and bacterial antibiotics started. Prior decubitus present upon admit. Murmur with severe aortic stenosis. Acute Kidney Injury with hyperkalemia; not a dialysis candidate. Patient made comfort care. Admitted to hospital 9/17/21. Died 9/30/2021. CEntral LIne placed 9/28/21
Pt found to be cold & limp by mother who checked on him during his nap. Arrived in ER in asystole, DOA. 07/06/2000 Call from reporter today to say she finally obtained autopsy report and will fax it to us.  07/07/2000 autopsy report received from coroner. COD acute pulmonary decompensation due to DAD. Case complete.
Information has been received from a Licensed Practical Nurse referring to an unknown number of patients of unknown age and gender. Medical history and concurrent conditions of the patients were not reported. It was reported that since 30-JUL-2014 the patients were vaccinated with ROTATEQ (dose, frequency, lot# and expiry date unknown) orally for prophylaxis, which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
chills; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2021 18:30 (Lot number: EL9269) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 11Feb2021, outcome "recovered" (12Feb2021), described as "chills"; FATIGUE (non-serious) with onset 11Feb2021, outcome "recovered" (12Feb2021), described as "extreme fatigue".  Additional Information: Prior vaccinations (within 4 weeks) was reported as none. Relevant tests was reported as none. Specific relevant test for thromboembolic events with thrombocytopenia was reported as none.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 14-OCT-2016, the patient was vaccinated with an expired dose of M-M-R II, lot # K016154, expiration date: 24-SEP-2016, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Narrative:  Patient reported should pain on same arm of injection following injection of moderna covid-19 vaccine.
Notice large area of swelling, redness, and heat approximately 8 hours after injection, Measured 40X50 mm. Itiching after 24 hrs.
Information has been received from a Certified Medical Assistant concerning a female patient who, on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # unspecified). Medical assistant reported that the patient developed shingles "six weeks after" receiving a dose of ZOSTAVAX (Merck) (date unspecified). At the time of the report patient's outcome was not specified. Patient sought for unspecified medical attention. Additional information is not expected.
Lightheaded; Fogginess in head; Fluid behind ears; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration in the left arm on 28Dec2020 08:30 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced lightheaded, fogginess in head, and fluid behind ears with no infection on 05Jan2021 19:00. Therapeutic measures were taken as a result of the adverse events and included treatment with methylprednisolone dose pack. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
pt recvd vax 12JUL95 & 13JUL95 broke out in large hives all over back, legs & ears, etc.;no further details were provided;
Client presented to clinic and requested to receive his second dose of the COVID vaccine. The client had previously received his first dose of Pfizer on 10/26/21. It was explained that Pfizer was not available at today?s vaccine clinic and programmatic staff tried to assist the individual in exploring options to receive his second dose. The client verbalized that it was unlikely that he would follow through in exploring any of the available options since he was unable to leave the facility and therefore was unlikely to get his second dose of the COVID vaccine. Staff explained the potential risks and benefits of mixing vaccines and the client opted to proceed with getting Moderna as his second dose.  Client waited for 15 minute monitoring period and no adverse reactions noted.
Client mistakenly received an expired vaccine. The expiration date on the vaccine was 03/06/2021, and the vaccine was given 03/15/2021.
had 3 Pfizer shots, 2 Moderna boosters; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) 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) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "bipolar" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "had 3 Pfizer shots, 2 Moderna boosters"; 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: (19Dec2022) Negative; (20Dec2022) Negative; (21Dec2022) Negative; (22Dec2022) Negative; (26Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 17Dec2022 to 21Dec2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Above and right below the shot, the area got hard, red, and painful. The reaction lasted from the day of getting the shot to a few days after, then just went away.
Mother reports 2 episodes of stiffening, brief but with clenched fists and raised hands.  Also had 2 episodes of staring for approximately 10 seconds-Not behavior she has seen before.  Mother is a nurse and looked like seizures to mother. Mother reports no further unusual behavior.
red rash and swelling around injection site; Rash around vaccine site; red rash and swelling around injection site; provider suggested cold compress and OTC benadryl for itching; This spontaneous report was received from a nurse practitioner and refers to a 4-year-old female patient. Concurrent condition included constipation. The patient was not ill at time of vaccination. Concomitant medication included polyethylene glycol 3350 (MIRALAX). There was no information about the patient's medical history.  On 09-APR-2019, the patient was vaccinated with a first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneously in the right thigh for vaccination (lot no. R021101 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD), expiration date not reported, but upon internal validation established as 20-JAN-2020) (formulation and dose  were not reported). Other suspect vaccine received on the same date included diphtheria toxoid, pertussis acellular 1-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (DTAP-IPV) intramuscularly in the left thigh (formulation, dose and indication were not reported).  On 11-APR-2019, the patient experienced red rash and swelling around injection site, provider suggested cold compress and over the counter (OTC) diphenhydramine (BENADRYL) for itching and to return to clinic for evaluation if no improvement. The patient did not received any prescription drug treatment for the events. On 13-APR-2019, the patient was in office and swelling, rash at injection site resolved. The outcome of red rash and itching and was not reported. The causality assessment  was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA002505:
Severe hives, severe itch, redness on right breast, entire stomach area, right thigh, back, between breast bone, neck, under chin, left side of neck.
dizziness; weakness; pain in injection site; redness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), VACCINATION SITE PAIN (pain in injection site) and VACCINATION SITE ERYTHEMA (redness in injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025620-4) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), VACCINATION SITE PAIN (pain in injection site) and VACCINATION SITE ERYTHEMA (redness in injection site). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), VACCINATION SITE PAIN (pain in injection site) and VACCINATION SITE ERYTHEMA (redness in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
tightness in chest; mild nausea; This is a spontaneous report from a contactable consumer.   This consumer reported for a 17-year-old (17.9years) daughter (patient) (non-pregnant) female patient that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration into the left arm on 23Mar2021 at 13:00 (at the age of 17-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included known allergies to peanut, tree nut, environmental allergies. Concomitant medications were not reported. On 23Mar2021, 10 hours post vaccination at around 10:00 PM, the patient experienced tightness in chest (pro air albuterol used, no relief) and mild nausea. No other vaccine in four weeks. Other medications within 2 weeks of vaccination immunotherapy, breo elipta, pro air (albuterol). Treatment given was pro air albuterol used, no relief. No covid prior vaccination, no covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome was not resolved for both the events.  No follow-up attempts are needed. No further information is expected.
Pt states got Pfizer #2 @ Employee Vaccine Clinic as above vax administered by RN who asked "pt did she feel that - I hit your bone" She said she did not feel pain out of ordinary @ time of vaccine. No redness. No shock like pain. Developed normal shot soreness over next day in upper arm, but soreness has not gone away. 1/10 pain @ rest in Deltoid/tricep region increases to 6/10 with reaching movements. No weakness numbness or tingling. No better No worse
Pfizer-BioNTech COVID-19 Vaccine EUA Debilitating Exhaustion/Fatigue  loss of appetite symptoms presented 16 hours after 2nd dose and continued for 48 hours.
Patient had syncope for about 3-5 seconds. Doctor was informed about the incident. Orthostatic vitals was measured and glucose was checked. Doctor assessed the patient before the patient left the office.
bruise at injection site; consumer having a complete dose of Fluzone High-Dose due to after the injection having just a little bit of fluid to come back out; consumer having a complete dose of Fluzone High-Dose due to after the injection having just a little bit of fluid to come back out; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 70 years old female patient who experienced bruise at injection site (vaccination site bruising), consumer having a complete dose of fluzone high-dose due to after the injection having just a little bit of fluid to come back out (underdose and exposure via skin contact) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and while treated with ACETYLSALICYLIC ACID [ASPRIN].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ238AB via intramuscular route in the left arm.  On an unknown date, The patient developed a non-serious bruise at injection site (vaccination site bruising) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was a case of actual medication error due to underdose and exposure via skin contact.   Final diagnosis was consumer having a complete dose of fluzone high-dose due to after the injection having just a little bit of fluid to come back out and bruise at injection site.  On an unknown date, the patient started taking ASPRIN (ACETYLSALICYLIC ACID) dosage unknown (with an unknown batch number). as corrective treatment  The patient outcome is reported as Unknown for bruise at injection site.