chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost all muscle control; fell out of bed on to the floor; don't remember any of it; normal side effects; injury to elbow and hip; injury to back; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of ATAXIA (lost all muscle control), FALL (fell out of bed on to the floor), MEMORY IMPAIRMENT (don't remember any of it), VACCINATION COMPLICATION (normal side effects) and JOINT INJURY (injury to elbow and hip) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (positive) on 19-Oct-2020, Back ache since 14-Mar-2021, Angioplasty since 2001 and Stent placement since May 2019. Concurrent medical conditions included Crohn's disease since 2017. Concomitant products included HYDROCODONE for Back pain, LOSARTAN for Blood pressure, ATORVASTATIN for Cholesterol, METFORMIN and INSULIN for Diabetes.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATAXIA (lost all muscle control), MEMORY IMPAIRMENT (don't remember any of it), VACCINATION COMPLICATION (normal side effects), JOINT INJURY (injury to elbow and hip), BACK INJURY (injury to back) and PYREXIA (High Fever). an unknown date, the patient experienced FALL (fell out of bed on to the floor). At the time of the report, ATAXIA (lost all muscle control), FALL (fell out of bed on to the floor), MEMORY IMPAIRMENT (don't remember any of it), VACCINATION COMPLICATION (normal side effects), JOINT INJURY (injury to elbow and hip), BACK INJURY (injury to back) and PYREXIA (High Fever) outcome was unknown.            No treatment information was provided Action taken with mRNA-1273 in response to events were not applicable   This case was linked to MOD-2021-082315, MOD-2021-082653 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Significant follow up appendedpatient information was updated. second dose events were updatedconcomitants were updated
No longer hold a cup of coffee; Felt a little uncomfortable; His arm has been tingling and painful; His arm has been tingling and painful; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT BEARING DIFFICULTY (No longer hold a cup of coffee), DISCOMFORT (Felt a little uncomfortable), PARAESTHESIA (His arm has been tingling and painful) and PAIN IN EXTREMITY (His arm has been tingling and painful) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 WEIGHT BEARING DIFFICULTY (No longer hold a cup of coffee), DISCOMFORT (Felt a little uncomfortable), PARAESTHESIA (His arm has been tingling and painful) and PAIN IN EXTREMITY (His arm has been tingling and painful). At the time of the report, WEIGHT BEARING DIFFICULTY (No longer hold a cup of coffee), DISCOMFORT (Felt a little uncomfortable), PARAESTHESIA (His arm has been tingling and painful) and PAIN IN EXTREMITY (His arm has been tingling and painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient came to ER because of arm has been tingling and painful for over a week now. No longer hold a cup of coffee. Nurse gave him a full physical exam in the brown recliner, which made him self-conscious about having his shirt lifted up in front of strangers. Patient felt a little uncomfortable.  No treatment medications were reported.  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 US-MODERNATX, INC.-MOD-2021-623953 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-623953:Same reporter
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 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "severe sinusitis" (unspecified if ongoing), notes: severe. The patient's concomitant medications were not reported. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 20Aug2023 to 24Aug2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 12 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date for prophylaxis. Subjects' medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2, and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism for flare, therapeutic selection or development.
Felt dizzy and passed out, skin turned pale.  Was given juice and was told to lay down.
after the fist shot i felt a bit out of breath and i had a bit of achiness in between my shoulder blades which i didn't think anything of because of Christmas and all then after my 2nd shot i felt more out of breath and my chest and throat felt achy if i pressed down on it
Patient received 3rd booster vaccine on 9/8, on 9/10 she was seen in the outpatient breast clinic setting and directed to report to MD for admission given abnormal labs which included elevated serum creatinine, dehydration, hyperkalemia, and hyponatremia. The AKI and electrolyte imbalances were primarily thought to be due to her receiving paracentesis on 9/7 for malignant ascites and poor hydration status.
Extreme malaise, extreme fatigue, headache, upset stomach, swelling, redness and pain at injection site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing), notes: other medical history: DM; "HTN" (unspecified if ongoing), notes: other medical history: HTN; "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; ATORVASTATIN; METFORMIN; LOSARTAN; JARDIANCE; TRAZODONE. Past drug history included: Known allergies: prednisone, reaction(s): "Known allergies: Prednisone", notes: Known allergies: Prednisone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Negative at day 9 and 10; (2022) Positive, notes: Positive at day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Antiviral details: Product: COVID 19 Treatment, brand=Pfizer, Treatment start date: 03Jun2022, Treatment stop date: 09Jun2022, Indication: Treatment of COVID-19.  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 pharmacist referring to a 51 year old female patient. Concomitant medication, pertinent medical history and drug allergies were unknown by the reporter. On 15-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R017900, expiration date 26-MAR-2020 (strength, dose, frequency and route were not reported) for prophylaxis. On 17-OCT-2018, the patient experienced a fever which had lasted 8 days since the administration of PNEUMOVAX 23 and no treatment was given. The outcome of fever was reported as not recovered. The causality assessment was not provided.
fever: Tmax= 103.3 F  chills, rigors disorientation headache
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Moderna ordered date was 01-Nov-2021 and 15-Nov-2021 The BUD of the vaccines was reported as 01-Dec-2021 to 15-Dec-2021. No concomitant medications information was reported.  Reporter stated that they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed. They were preparing for a CDC audit and wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures.   Reporter queried whether they need to take any action since they stored them in the freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment medications were provided.
Gave PNEUMOVAX 10/20/11 4:30PM. Patient called at 8PM - stated arm was real sore went into neck - nerves in hand tingled still had a hard time moving arm the next day.
Shingles on right side of stomach and lower back. Prescribed generic brand of Valtrex.
Vomited at 1:30 AM, then fever up to 101.8 all night. Racing heartbeat and unable to sleep until morning.
pt recv vax p/24hr devel fever 102 & severe h/a;both lasted 48hr then felt weak & debilitated;next day when getting out of bed, felt sharp stabbing pain @ base of skull, local erythema 100mm x 70mm;rx APAP, hydorcortisone cream;
I was having a chronic cough and chest pain. I went to the ER and was diagnosed with bronchitis not to rule out pneumonia. I was prescribed inhalers.
Dizziness/dizzy; Real weak; Feeling sluggish; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported for a 71-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date (at age of 71-years-old) as DOSE 1, SINGLE for COVID-19 immunization. No medical history and concomitant medications were reported. Reporter was calling on behalf of her husband. He has been having some issues since he got his first vaccine, a week or 2 after of first dose he started feeling sluggish was real weak and was now dizzy on an unspecified date. Stated last Thursday he went and got this second dose of the vaccine, still dizzy. Wanted to know if this was something he should be concerned about, where should he go from here. Caller was encouraged to reach out to his healthcare provider for medical advice. Caller stated they need to go so she could call her husband's doctor. The outcome of al events was unknown.  Information about batch/lot number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacist via a field employee refers to a 54 year old female patient. The patient's pertinent medical history and drug allergies were unspecified. On 01-SEP-2015, the patient was vaccinated with ZOSTAVAX, (route, dose and anatomical location not reported). On 02-SEP-2015 (reported as the following day after administration), the patient experienced swelling and rash at the injection site. The patient sought medical attention by speaking to the physician. The outcome of swelling and rash at the injection site. The causality assessment was not provided. Additional information has been requested.
First COVID vaccine dose on 19Jan2021/ Second vaccine was 02Feb2021; After the 2nd vaccine, he had toe nail fungus that started to disappear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Lot number: EN9581) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Toe fungus" (unspecified if ongoing), notes: had toe fungus for 20 years. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Lot number EC9231, UNKNOWN MANUFACTURER), administration date: 19Jan2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "After the 2nd vaccine, he had toe nail fungus that started to disappear"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Feb2021, outcome "unknown", described as "First COVID vaccine dose on 19Jan2021/ Second vaccine was 02Feb2021".  Additional Information: He has had toe fungus for 20 years while he was active duty military service, and for 20 years after that. After the 2nd vaccine, he had toe nail fungus that started to disappear. It started on all of his small digits , and he even started to grow new toenails. His big toes started to get better as well, and the toe nail fungus is 1/4 gone. He is getting a new nail on his big toes too. He has done nothing different with his medical care or anything. The only thing that changed was the vaccine. He got his first COVID vaccine dose on 19Jan2021 with lot number EC9231, and his follow up for the second vaccine was 02Feb2021, with lot number EN9581. He got the COVID booster 18Oct2021 with lot number EP7533. He noticed an improvement in his toenail fungus probably 1.5-2 months after the second COVID vaccine. The toenail fungus was beginning to improve, and has continued to improve. He has not received any other vaccines. He had an appointment at the VA this morning. His rheumatoid arthritis doctor, said her 15 year old young son had the Pfizer vaccines as well, that his toe nail fungus is starting to improve too. He doesn't have further information to do a report on him, but he is going to message his doctor the Pfizer safety department number because she said she would report it. He has pictures of his toes as well if he gets contacted by Pfizer.No follow-up attempts are possible. No further information is expected.
Rash on my body especially my neck, chest, back, arm and leg. It is itchy and wakes me up from my sleep. It is painful.
chills and a fever of 100.9 roughly 12 hours after the shot. Fever and chills lasted about 15 hours
Baby started losing color and turning pale. Then went completely limp. He wouldn't open his eyes or respond to anything. It came on quickly, within 2 minutes from totally normal to pale and limp.  No warnings whatsoever. Called 911 and taken by ambulance to hospital. Probably within about 30 minutes he was coming back to normal. He was admitted and observed overnight. Had his oxygen monitored the entire time. Had 2 X-rays, an echo, and EKG, EEG, and lots of blood work. Everything came back normal.
Onset of fever (to 102 degrees), headache, sore throat, nausea, diarrhea < 12 hr after receiving TIV/Flu vaccine - EHOL?; Coincidental.
Vaccinated on Dec 17, 2009. On Dec 18, 2009, in the afternoon, developed a fever, sore throat, ear pain, body aches, weakness and decreased appetite.
Developed Strep throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGITIS STREPTOCOCCAL (Developed Strep throat) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGITIS STREPTOCOCCAL (Developed Strep throat). At the time of the report, PHARYNGITIS STREPTOCOCCAL (Developed Strep throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Approximately 10 to 20 minutes after receiving flu vaccine, patient complained of numbness, tingling, and pruritus to upper extremities; blood pressure was measured and was low (hypotensive). He was placed on O2 and given 400 ml NS but this did not provide much improvement. Patient remained awake, alert, and oriented x 3. Respirations were event an unlabored. MD was called; orders for epinephrine 1 mg provided and recommendation for patient to go to ER. Patient refused epinephrine but agreed to go to ER. Patient was transported to ER by transport.
No symptomatic AEs reported.; PROQUAD was inadvertently co-administered with MMR-II.; This spontaneous report was received from a medical assistant referring to a patient whom gender, age, race and age group were unknown. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 14-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) plus an sterile diluent (MRK), subcutaneous injection, (lot #U024509, expiration date: 02-FEB-2023) and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection ,(lot #T025930, expiration date: 30-JUL-2022), (dose, frequency, strength, anatomical location and route of administration were not provided for any of the vaccines administered) both given as prophylaxis.  On the same day, the patient was inadvertently co-administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (accidental overdose). no symptomatic AEs reported. (no adverse event).