chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported .
Information has been received from a health professional concerning a 6 year old male with no pertinent medical history and allergies to horses, deer and dust, who at 18 months of age was vaccinated subcutaneously with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On January 09, 2006, the patient developed a breakthrough case of chickenpox. The outcome was reported as not recovered. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint involved. This report is related to WAES #0601USA01072 (sibling). Additional information has been requested.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 26Sep2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 12Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea/Vomiting/HA/Muscle aches/Fever 102 degree/pain at site of vaccination
10 x 12 cm fluctuant swelling, pain, tenderness deltoid muscle, Fever.
Headache, high fever, hallucinations, chills, swollen face, itchy face
Breakthrough case admission after three vaccines Pfizer 2/26/21 Lot# EN6201;  Pfizer 3/19/21 Lot# EN6198;  Pfizer 9/24/21 Lot# FC3153
Headache, Muscle Aches, Stuffy nose. Still going on. So below does not apply as yet.
Extremely heavy period symptoms. I have my second mirena IUD and have been using this method of birth control for the last 7 years. I stopped having periods all together. I would still get irritated and slightly more emotional during my cycle, but I would only spot once every 6 months or so. Since getting my first dose of phizer 2 days ago now I have had a significant amount of discharge (not blood) extremely severe abdominal cramping, that almost made me go into the ER (and I typically avoid that place like the plague) extreme emotional swings, increased depression and self harm urges, and mood swings.
increase in symptoms and complaints of chronic illnesses.  Increase fatigue and pain. Exacerbation of anxiety and depression. Increase in panic attack, general/Increased malaise.  Additional joint pain and swelling. Stomach complaints. Itching, inflammation.
Patient received hepatitis B vaccination.  One hour later the mother called RN's in because she notice that the child was not breathing.  CPR was performed, patient was intubated, atropine was give.  Patient flinched arms/legs and bit OET rhythmically.  Blood glucose was 26.  Dextrose given.  Patient was transferred to the Neonatal Intensive care unit for further evaluation.  No new seizures at this time.  Investigation is ongoing.  03/10/2008 MR received for DOS 2/28/08 with Impression: Apnea and cardiac arrest probably 2' to hypoglycemia. 2 day old newborn infant found by mom to be limp and not breathing.  No apical pulse detected. Code Blue was called and pt bagged until intubation and resuscitation initiated. After Atropine, a pulse was detected. Accucheck 26 and D25 initiated  IV. Pt placed on vent. Tonic-clonic movements of all extremities noted ~2 hours after episode. Transfered to higher level of care.  4/1/2008 MR received for NICU stay 2/28-3/23/2008 with D/C DX: 1) Neonatal Seizures. 2)Clinical Sepsis/Presumptive Meningitis. 3) Respiratory Insufficiency 2' to neonatal seizures/high dose phenobarb. 4) Laryngotracheal malacia 5) Systolic murmur. 6) Altered tone. 7) Mild hypomagnesemia and hypophosphatemia. 8) Anemia. 9) Delayed enteral feeds and gavage feed dependent. 10) Conjunctivitis bilat. 11) Reri-anal rash-improving. Infant transfered to current facility after above incident. Multiple abnormal EEGs but improving. Severly hypotonic on admission, nearly normal by d/c except decreased truncal tone.
Metallic taste in mouth, facial and eye burning, facial flushing, fatigue worse.
10 minutes after moderna vaccine IM injection in left deltoid  Pt has SOB with tachycardia of 150 and BP 181/125. Given 50 mg Benadryl, and 60 mg solumedrol and transported via EMS to ER. No hives, no wheezes, no angioedema.
Pt had shot and left pharmacy with not symptoms.   He called the pharmacy from home stating he had light headedness, sweating, and fainted for 2-3 minutes.  He had no other allergic symptoms signs or symptoms. He was told to call 911 but the refused.
This spontaneous report as received from a pharmacist refers to a currently 74-year-old male patient. The patient's concurrent conditions included chronic obstructive pulmonary disease and osteoporosis. The patient's medical history and concomitant therapies were not reported. On an unknown date in 2013 (reported as about 3 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, strength, dose and frequency were not reported) subcutaneously. On an unknown date, the patient experienced a nodule at the injection site that appeared almost right away and had never gone away which was found by the pharmacist on 30-JUN-2016 during the patient's visit. There was not treatment given for the adverse event and no diagnostic were performed. The outcome of the event was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX and event was not reported. Additional information has been requested.
rt arm w/circular pale-raised area (4cm)-non-tender w/pin size red dot directly in center (deltoid muscle) surrounding tissue to rt elbow red, warm to touch c/o itching, t99 in AM to MD 19APR96 w/dx of cellulitis;started on Amoxicillin
husband had adverse events; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (husband had adverse events) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (husband had adverse events). At the time of the report, VACCINATION COMPLICATION (husband had adverse events) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided. She mentioned that her husband had adverse events before but did not want to report the adverse events and did not provide any information about her husband.
first one had herpes like outbreak on chest; it was like an infected Eczema Hepatica Skin Disorder; it was like an infected Eczema Hepatica Skin Disorder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 91 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL9266) at the age of 90 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetic" (ongoing); "Lung Condition" (ongoing); "Eczema" (ongoing). The patient took concomitant medications. The following information was reported: HERPES DERMATITIS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "first one had herpes like outbreak on chest"; ECZEMA INFECTED (non-serious), SKIN DISORDER (non-serious) all with onset Feb2021, outcome "recovered" (2021) and all described as "it was like an infected Eczema Hepatica Skin Disorder". Therapeutic measures were taken as a result of herpes dermatitis, eczema infected.  Additional information: Patient had received all 3 doses of Pfizer covid 19 vaccine: second dose on 13Mar2021, lot: EX6208 and booster dose on 15Nov2021, lot: FH8027. First one had herpes like outbreak on chest, went away with witch hazel and alcohol. Patient states with the first dose, she had a  herpes outbreak on her chest. Also her states it was like an infected eczema hepatica skin disorder. It started a few days after the dose and it lasted for a couple of weeks and she got rid of it by treating it with different things like alcohol and witch hazel.  Follow-up attempts are completed. No further information is expected.
No known adverse effect.  6-11 year old serum delivered to 5 year old
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by Regulatory Authority for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
It seems that I got a UTI, it started on the 25th of October, and it continued until I went to the doctor, and I got my antibiotics. By the 4th of November it was okay. They prescribed an antibiotic Sulfamethoxazole. I was in pain, and it was for 3 days. I had extreme high fever and that's when I went to the doctor and that's when they prescribed the medication.
N/A- Vaccine administration error only- patient given Pfizer Bivalent Booster after the BUD.
Patient is stating that the injection  "hit a nerve" and she now has lost feeling in her arm
terrible pain; having clothes touch me is excruciating; 1st shot, shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than 5 months after receiving Shingles vaccine, the patient experienced shingles and touch sensitivity increased. On an unknown date, the patient experienced pain. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles was unknown and the outcome of the pain and touch sensitivity increased were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain and touch sensitivity increased to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the 1st of 2 shots in April and came down with shingles last week. The patient was in terrible pain, they gave him anti viral drug. They said hopefully between getting 1 shot and medications the patient had a mild case. The patient could not believe this was mild. The patient stated that just having clothes touch him/her was excruciating. Additional supportive information: The follow-up could not be possible as no contact details were available.
Pt recvd vax & exp burning @ the inject site for 45 ins to 1 hr & aching @ the inject site for 2 to 3 days;
Pt. reported scratchy throat, but states it may be seasonal allergies. No difficulty breathing, rash or SOB. Evaluated by EMS, 0 interventions. Remains in observation. Pt. left at stable condition at 11:00 A.M.  Recorded by RN.
Fever 101 deg F; red injection site; syncope but had labs drawn 15 hours  and told PPD was positive; 22 Ga 1" needle
No adverse outcome. 2nd GARDASIL given too soon. Supposed to be 1-2 months from the 1st GARDASIL shot which was administered on 4/12/18. Merck recommends giving the 2nd injection again at least 1 month after the last injection administered. Scheduled to re-administer the 2nd GARDASIL on May 29, 2018.
Narrative: COVID infection following COVID vaccine series 05/05, Pfizer, dose #1 06/02 , Pfizer, dose #2 08/19 COVID swab, result: not detected 09/01 pt cc: cough, myalgias, rhinorrhea exposure: co worker 09/02 COVID swab, result: detected 09/02 SARS-COV-2 LINEAGE result: AY10 09/02 SARS-COV-2 CLADE result: 21 J (DELTA)
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: According to patient, she woke up this morning with redness and warm to touch on her injection site. When she presented to the pharmacy she stated it was a little bit better. When examined her her arm was still red and warm to touch.
Swollen tongue, numbness of tongue, sore throat, difficulty swallowing, body aches, stomach upset, puffiness,
Tinnitus; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (Tinnitus) 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) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (Tinnitus) 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) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
She began to feel dizzy. She became pale , diaphoretic,  hypotensive, and bradycardic. Patient responsive with slurred speech. Patient placed on 2 L of O2. Symptoms began to improve and vitals stable after 5 min. Patient evaluated by EMS and she declined to go to ER fro evaluation as symptoms resolved. Vasovagual response
Throat tightness within 5 minutes of vaccine, mild to moderate, 5/10. No shortness of breath and was swallowing and moving air fine.
patient received an improperly stored dose of proquad; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 13-MAY-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type: recombinant human albumin (rHA)) of lot# S027462 and expiration date reported as 02-MAR-2021, 1 vial for prophylaxis (strength, dose, frequency, anatomical location and route were not reported) (product storage error). The concomitant medication included sterile diluent(STERILE DILUENT) (lot# T003594 and expiration date 07-JUL-2022). The outcome of product storage error was unknown. It was reported that the vaccine was exposed to a temperature of 6 degree Fahrenheit (F) to 14 degree F for a time frame of 16 hours and 17 minutes and 15 degree F to 46 degree F (16.7F) for a time frame of 1 hour and 21 minutes. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.
Within 5 minutes of COVID vaccine shot, the fingers in that arm went numb.  About 2 hours later around my mouth went numb.  That night Both hands went numb as well as my feet.  I also had chills, aches and pains and a fever that  lasted into the next day.
Just today a rash appeared on the arm where I was injected. The rash is a bit below the injection site but is red, swollen and warm to the touch, diameter like 3 months. I have not had a rash at all prior to today.
Presents to the ED 4 days after 1st covid vaccine with aches, flushing, abdominal cramps (currently undergoing chemo for prostate cancer), cough, nasal congestion, fever. Admitted for possible sepsis, low suspicion. Dischaged home next day in stable condition.
Flu like symptoms.  Tired, swelling, redness, hot, sore arm and muscle.  Place warm clothes.
w/in 3min of vax pt became cold, clammy unresponsive, but not unconscious c/o h/a;pt given epi & 911 was called;pt transported by amb to hosp where recovered & was sent home;
pt recv vax  inadvertently into the shoulder joint & w/in 1 to 2hr of vax pt devel joint swelling & pain & was hosp;pt had 10cc aspirated out of joint & the swelling disappeared;
Severe cramping; Mood changes; Premenstrual syndrome; Mensuration changes; This spontaneous case was reported by a pharmacist and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Mensuration changes), DYSMENORRHOEA (Severe cramping), MOOD ALTERED (Mood changes) and PREMENSTRUAL SYNDROME (Premenstrual syndrome) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083c21a) for COVID-19 vaccination.     The patient's past medical history included Bleeding and C-section. Concurrent medical conditions included Drug allergy (fexofenadine). Concomitant products included IBUPROFEN, PHENTERMINE, DULOXETINE, MONTELUKAST SODIUM (SINGULAIR) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 23-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Mensuration changes). On an unknown date, the patient experienced DYSMENORRHOEA (Severe cramping), MOOD ALTERED (Mood changes) and PREMENSTRUAL SYNDROME (Premenstrual syndrome). At the time of the report, HEAVY MENSTRUAL BLEEDING (Mensuration changes), DYSMENORRHOEA (Severe cramping), MOOD ALTERED (Mood changes) and PREMENSTRUAL SYNDROME (Premenstrual syndrome) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information does not provided.
been 5 days and still having  tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having  tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having  tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having  tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having  tiredness headaches joint pain nausea and feeling annoyed; This is a spontaneous report from a contactable consumer (patient). A 89-year-old female patient received unspecified dose number of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) via an unspecified route of administration on an unknown date (at the age of 89-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received the vaccine last Friday and it had been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed. The outcome of the events were not recovered.  Information on Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
RASH ON FACE following vaccine (had left facility after 15min monitoring and returned) GIVEN DIPHENYADRAMINE (9:30AM) LIGHT HEADED (ASTHMATIC) USED ALBUTEROL INHALER, PT LEFT AT 9:50am FELT MUCH BETTER WAS GOING TO WORK
Within 24 hours of receiving vaccine pt developed redness & swelling at site of injection 72 hrs later site 4x4 cm center firm red surrounded by 15cm x 8cm erythema.
LT(left) foot toe pain. Rheumatoid arthritis?; LT(left) foot toe pain; This is a spontaneous report from a contactable nurse (patient). A 76-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 76 years of age), intramuscular, administered in Deltoid Left on 08Feb2021 at noon (Batch/Lot Number: EM9810) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included hypertension from 1980 and ongoing; and toes diagnosis of bursitis before the 1st Covid vaccine. Concomitant medications included enalapril taken for blood pressure increased and amlodipine (AMLODIPINE) taken for blood pressure increased, both from an unspecified start date and ongoing. The toes diagnosis of bursitis may have actually been RA (Rheumatoid Arthritis) beginning - before the 1st Covid vaccine. The patient experienced "LT (left) foot toe pain. Rheumatoid arthritis?". Onset date was 18Feb2021. The LT (left) foot toe pain was reported as not serious which required Physician office visit. The second dose of the vaccine was given on 28Feb2021.The patient had RA (Rheumatic arthritis) with an onset on 05Mar2021 which the patient had not recovered from. The RA was reported serious per Persistent/significant disability/ incapacity. The patient received Prednisone 6 day tab (tablet) for the RA. Therapeutic measures were taken as a result of the event LT (left) foot toe pain; with unknown outcome. Treatment: Yes, Orthotic, Diagnosis bursitis.; Sender's Comments: The information provided is limited to make a meaningful medical assessment. The reported event is likely an intercurrent medical condition and unrelated to BNT162B2. Case will be re-assess once additional information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.