chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He has an eyelid edema also referred as a swelling in the eyelid; Eyebrow edema, more pronounced on the same side as the vaccination injection (left hand side).; DOSE 1, DOSE 2, DOSE 3: BNT162B2; DOSE 4: Moderna vaccine; DOSE 5: BNT162B2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 18:15 as dose 5 (booster), single (Lot number: GJ6665) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seminoma of testis", start date: 20Jun2012 (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included: BENADRYL; ADVIL 12 HORAS. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EN6206, Anatomical location: Right arm), administration date: 09Mar2021, when the patient was 49-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE; Lot Number: ER8733, Anatomical location: Left arm), administration date: 30Mar2021, when the patient was 49-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot Number: FF2593, Anatomical location: Left arm), administration date: 17Oct2021, when the patient was 50-year-old, for COVID-19 immunisation; coviD-19 vaccine moderna (DOSE 4 (BOOSTER), SINGLE; Lot Number: 048L21A, Anatomical location: Left arm), administration date: 31Mar2022, when the patient was 50-year-old, for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Nov2022 at 18:15, outcome "unknown", described as "DOSE 1, DOSE 2, DOSE 3: BNT162B2; DOSE 4: Moderna vaccine; DOSE 5: BNT162B2"; SWELLING FACE (non-serious) with onset 15Nov2022 at 23:00, outcome "recovering", described as "Eyebrow edema, more pronounced on the same side as the vaccination injection (left hand side)."; SWELLING OF EYELID (non-serious), outcome "unknown", described as "He has an eyelid edema also referred as a swelling in the eyelid". Therapeutic measures were not taken as a result of swelling face.  Additional information: The patient had no known allergy. The patient did not receive any other vaccine within the four weeks of vaccination. The patient had eyebrow edema, has an eyelid edema also referred as a swelling in the eyelid more pronounced on the same side as the vaccination injection (left hand side). Since the vaccination, the patient had not been tested for COVID-19.
6/2/10-tightness around arm, then redness and pain. Seen by clinician 6/4/10-cellulitis-treated with AUGMENTIN.
Patient was treated for anaphylaxis in an unspecified emergency room after administration of unspecified version of GARDASIL; This spontaneous report was received from a nurse practitioner (conflicting information also reported as nurse prescriber referring to a female patient of unknown age. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.     On an unknown date, the patient was vaccinated with unidentified Merck hpv vaccine administered (lot number not provided, name reported as unspecified version of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)) as prophylaxis (dose, vaccination scheme frequency, route of administration, anatomical location of administration and expiration date were not reported).   On an unknown date, the patient experienced anaphylaxis (anaphylactic reaction) after vaccination, the patient was treated for the event in the emergency room.   At the time of this report, the outcome of anaphylactic reaction was not reported.     As the patient had an anaphylactic reaction to the unidentified Merck hpv vaccine administered therefore the causality was considered as related.  Upon internal review, anaphylactic reaction was determined to be medically significant.
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment details were provided
Dry cough/Persistent dry cough; received 2 dose more than 35 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough/Persistent dry cough) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 dose more than 35 days after 1st dose) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 052BZZA and 016J212A) for COVID-19 prophylaxis.     Patient had no known allergies. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 in 2021 and Skin disorder. Concomitant products included PARACETAMOL (TYLENOL) and NAPROXEN SODIUM (ALEVE) for Headache.   On 28-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 10-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 10-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 dose more than 35 days after 1st dose). On 11-Aug-2022, the patient experienced COUGH (Dry cough/Persistent dry cough). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Dry cough/Persistent dry cough) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 dose more than 35 days after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: (Positive) Positive.         It was reported that they tried to get patient vaccinated sooner but were not able to. Patient had COVID test before vaccines in Summer of 2021. Not hospitalized, was sick for 2 weeks. Symptoms lasted 2 weeks, however, cough lingered for 1 month.
Approximately 12 hours after receiving the vaccine, I was awakened with a soreness in my upper left arm where I had been vaccinated. At that time I also began experiencing flu-like symptoms (primarily aching and fatigue) and by the next morning I was experiencing severe flu-like symptoms, causing me to primarily sleep through that day and experiencing no appetite. This continued through the next day (causing me to miss a day of work). While I am feeling much better, I am still experiencing from time to time some slight flu-like symptoms including fatigue. Within a couple of days of the vaccine, my upper left arm also swelled up quite a bit and was hard to the touch as well as very red.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, 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 had no relevant medical history. Concomitant medication(s) included: PROGESTERONE, start date: 01Jul2021, stop date: 28Jul2022; SERTRALINE, start date: 02May2021, stop date: 28Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: 2 days after Paxlovid, patient's symptoms came back.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information causal association between the reported events and suspect drug cannot be totally excluded
Extreme Pain in Left arm- very hard to lift my hard, very sore to touch, cannot put any weight on that side. Took Motrin at 9:30 p.m. Chills- 1:45 am-4:45 am Fever- 4:15 a.m. Took Motrin at this time. Fever broke around 5:30 a.m. Nauseous- 2:00 a.m.- 8:00 a,.m. Headache when I woke up around 8:00 a.m.  Body ache- 2:00 a.m.- present
This case was reported by a consumer and described the occurrence of allergic reaction in a female patient who received Shingrix for prophylaxis. Previously administered products included Shingles vaccine (vaccinated a few years ago before the date of reporting, the patient had no reaction to the same). On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a week after receiving Shingrix, the patient experienced allergic reaction (serious criteria life threatening), feeling unwell, generalized rash, pain in arm and respiratory symptom. The patient was treated with Benadryl and prednisone. On an unknown date, the outcome of the allergic reaction, feeling unwell, generalized rash, pain in arm and respiratory symptom were unknown. It was unknown if the reporter considered the allergic reaction, feeling unwell, generalized rash, pain in arm and respiratory symptom to be related to Shingrix. Additional information was reported as follows: The age at vaccination was not reported. The patient stated that she became very ill after vaccination with Shingrix. The patient stated that she had a near death allergic reaction. The patient stated that she could show the picture of rash that covered her body. She thought the reaction experienced by her was normal as the literature stated a rash might be accompanied with the vaccination. The pain in her arm was agonizing but she thought that it was normal. The patient was away from home and far from the health care unit, so the patient took Benadryl considering it was an allergic reaction, but nothing helped. On the second or the third day after the vaccination, the reaction moved to her lungs so they drove to a critical care location, where the patient had used an inhaler until they arrived to the critical care location. The patient was immediately administered Prednisone their. The patient stated that, she knew she cannot get the second shot of Shingrix. The patient lastly inquired that what could be the ingredient from the vaccine, that caused the allergic reaction.
Right thigh swelling within 2-4 hours after injections.  Swelling peaked at 2 days.  As swelling decreased, mom noticed hard, dime sized lumps in thigh.  Lump has lasted for more than 6 weeks.  Swelling gone.  No treatment.  Using leg normally.
first night: vomiting chills diarrhea dizziness, rash developed with profound itchiness, steroid cream didnt work, similar to moderna arm
When coming back for second shot she claimed that 7 days after injection she had the flu, body aches, headache, fever, nausea. She had no flu shot. But claimed sick x 2 weeks.
no adverse event; Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report that Moderna Bivalent vaccine was administered after expiration date).    No patient details were provided.  Concomitant product use was not provided by the reporter.  It was reported that dose was administered after 30-day Use by Date or after manufacturer Date of Expiry. Individual vial size was reported as 2.5 ml. Dates vial was initially stored was 19-Jun-2023, 22-Jun-2023, and 23-Jun-2023. Vial did not undergo any temperature excursions. Vials were administered on 19-Jun-2023 (1Patient), 22-Jun-2023 (2 patients), and 23-Jun-2023 (2 Patients). Reporter stated that he wanted to wait on the assessment as it was just 1 day after expiration date.  Treatment information was not provided.  This case contains information about patient 3rd out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730746 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730746:Master case (Patient 1)
After administering vaccine, we were informed that the vaccine had experienced a temperature monitoring issue outside of our facility.  Per recommendation, patient informed and offered revaccination.  Received additional vaccination on 10/18/22.
Patient came into clinic for triage for possible allergic reaction following a vaccine that was given on 06/29/23. Patient stated having flu like symptoms right after vaccine given followed by body aches later that night. vaccine given on right deltoid/ upper arm  site is warm to touch, swollen and red. Patient also complains of burning  sensations, itching and hard to lift arm. Vitals were taken and escalated to provider.
5 mins after receiving shot pt started to experience dizziness and coldness in her hands. pt was told to lay down, brought jacket to cover up with  and observed for worsening of symptoms. at 11:40 pt stated she felt better so she sat up but then felt dizzy again so asked pt to stay put and gave her some water to drink. at around 12 pt said she felt better so I had pt stand up slowly and walk back and forth down the hall to see if she had recovered fully. she then started to clear her throat constantly and stated she felt she had something in her throat that she couldn't clear, after about 20 mins she said it felt like it was getting worse so she was given 25 mg of Benadryl and laid back down. at 12:30 pt said she started to feel a pain in her chest but went away after about a min. and for for the next hour pt experienced dizziness and coldness off and on. at about 2: 30 pt was picked up by husband and taken home, since symptoms were not getting worse.
Severe Hives all over the body diffuse wide spread after 2 weeks of Vaccine
dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, TAMSULOSIN, OMEPRAZOLE and LISINOPRIL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I continue to have shortness of breath with any kind of physical activity.  This has been going on since the first vaccine. After the second booster, my symptoms of shortness of breath got a little bit worse. I have difficulty walking in general. About two months ago, I had trouble with getting lightheaded. I have tried to get in touch with Moderna either by email, phone call or faxing but have not got a response.
Swelling of the left ganglion accompanied by the red and black area. I feel burning inside my armpit. I have infection in the blood. Currently I have also felt pains in my heart.
Red, raised, blotchy rash on face, arms, back & stomach.  Benadryl 20mg IM
Nasal & airway congestion, wheezing with production of thick mucus, chest tightness, muscle pain, red eyes & blurred vision, sore throat, severe headache, hard shaking chills, possible fever, cough.
I had sinus pressure with a dry frequent cough and a headache. This happened in October and went away. Then it came back in March and the cough was productive and I was having trouble sleeping. I went to the emergency department. I was diagnosed with bronchitis. I tried an antibiotic and then I was treated for a week with prednisone. I was also treated with inhalers.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: After completing the medication and testing negative two full days of feeling good; Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: After completing the medication and testing negative two full days of feeling good. Started a fever 101.8 tested positive sneezing, coughing and very stuffy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
71- year old woman with past medical significant for hypertension on 10 mg of Lisinopril daily for many years. She had her first dose of Pfizer vaccine two weeks prior to admission (3/11/21). After her vaccination, patient felt unwell and dizzy in the mornings. She felt persistent fatigue and had a decreased appetite. The week prior to admission she noticed a decrease in her urine output. She denied NSAID use. Her primary care physician ordered blood week and her Cr was found to be 16.54 and BUN of 163, phosphate of 17.5. Her last known Cr prior to her admission was 18 months prior and was 1.17. She was asked to present to the emergency room. Renal ultrasound showed no hydronephrosis or stones. Urinalysis showed 1+ protein, spec grav of 1.023 with a urine protein/creatinine ratio of 0.09. Urine sediment was unremarkable. Her temperature was 95.6 and her BP was as low as 75/46 and she was put on a low dose of levo. CRP was 202.3. COVID was negative. CK wnl.  ANA + to 1:160 (dsDNA, Smith, RNP, SS-A, SS-B all negative). Blood smear was negative. Cultures were all negative. Echo showed an EF of 68% with trivial pericardial effusion. Patient was oliguric, and then initiated on hemodialysis. Renal biopsy was performed.   The biopsy consists of one fragment which is stained with H&E, PAS, Trichrome, Jones Silver, and HPS stains. Review of all stains reveals 12 glomeruli, one of which is globally sclerotic. The architecture of the kidney is well-preserved. There is  interstitial fibrosis with proportional atrophy involving 10% of the biopsy tissue. There is a focal interstitial infiltrate consisting of lymphocytes involving <5% of the interstitium. The tubules show diffuse acute tubular injury.  Calcium oxalate  crystals are present in seven tubular profiles. The glomeruli show expansion of Bowman's capsule. The mesangium shows normal cellularity. The vessels show no abnormalities.   IMMUNOFLUORESCENCE MICROSCOPY:   Frozen sections are stained for IgA, IgG, IgM, C3, C1q, kappa, lambda, and fibrinogen. All immunofluorescence stains are negative.   ELECTRON MICROSCOPY:   Specimens are prepared for electron microscopy and semi-thin sections stained with toluidine blue are reviewed prior to thin sectioning for ultrastructural examination. Electron microscopy demonstrates patent capillary loops. The glomerular architecture  demonstrates segmental corrugation of basement membranes with increase in lamina rara interna.  No subepithelial deposits and no intramembranous deposits are identified. The tubules show dilated mitochondria and injury. There is segmental effacement of  foot processes. There are no subendothelial deposits. Mesangial electron dense deposits are not identified.   Patient received three dialysis treatments and Creatinine began to improved down to 1.46 within 8 days.
Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 10:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis.  The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced dizziness. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
No symptomatic side effects. No additional AE; patient was administered VARIVAX intramuscularly instead of subcutaneously.; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not provided.   On 10-MAY-2022, the patient received a dose of varicella virus vaccine live (Oka/Merck) injection, by intramuscular route as prophylaxis (lot number U007471 which has been verified to be valid, expiration date reported and validated as 08-MAR-2023) (dose was unknown by the reporter; strength, vaccination scheme, and anatomical site of injection were not reported) (incorrect route of product administration). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), lot number T030955 and expiration date 23-APR-2023 (dose was unknown by the reporter). The reporter mentioned that the patient had no symptomatic side effects (no adverse event).