chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; chills; lightheaded; muscle aches; joint pain; diarrhea; lethargy; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), intramuscular in the left arm on 08Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EK5730, expiry date not reported), intramuscular in the left arm on 18Dec2020 12:00 at single dose for COVID-19 immunisation. The patient previously took cefalexin (KEFLEX), clindamycin and codeine and experienced drug allergies. On 09Jan2021 12:00, the patient experienced fever, chills, was lightheaded, muscle aches, joint pain, diarrhea and lethargy. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
Migraine, extreme fatigue, nausea, unusually sore muscles generating from injection shot and moving through underarm, shoulder to chest.
Local reaction measuring 6 cm x 7 cm, smooth edges urticarial rash covering trunk, face, and extremities. Treatment - BENADRYL didn't help. Mom to monitor - if gets worse Dr. will treat with Prednisone.
Felt like throat was swelling after 5 minutes, difficulty breathing after 15 minutes continuing on for several hours
Hives that are itchy started at injection site with large whales. Spread to my back, neck, face, legs, feet and torso. My ears are itching really bad. I took Benadryl and took a cool bath in baking soda, oatmeal and witch hazel. The whales went down for about two hours and started itching again at injection site after and my legs and feet.
severe HA, localized to Right side of head;  MRI confirmed Right transverse dural sinus thrombosis
she lost a couple of pounds; swollen abdomen; Nausea; vomiting,Vomits two or three times a day; gases; she isn't able to eat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FLATULENCE (gases), FEEDING DISORDER (she isn't able to eat), WEIGHT DECREASED (she lost a couple of pounds), ABDOMINAL DISTENSION (swollen abdomen) and NAUSEA (Nausea) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced FLATULENCE (gases), FEEDING DISORDER (she isn't able to eat), WEIGHT DECREASED (she lost a couple of pounds), ABDOMINAL DISTENSION (swollen abdomen), NAUSEA (Nausea) and VOMITING (vomiting,Vomits two or three times a day). The patient was treated with ONDANSETRON (oral) for Nausea, at an unspecified dose and frequency. At the time of the report, FLATULENCE (gases), FEEDING DISORDER (she isn't able to eat), WEIGHT DECREASED (she lost a couple of pounds), ABDOMINAL DISTENSION (swollen abdomen), NAUSEA (Nausea) and VOMITING (vomiting,Vomits two or three times a day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Abdomen scan: negative (Negative) Results are normal. In April 2021, Blood test: negative (Negative) Results are normal. In April 2021, Urine analysis: negative (Negative) Results are normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
No pain or symptoms for the first couple of days, the began having  muscle/ joint pain and inflammation with severe fatigue. On the 5th day I developed a rash on both arms that felt hot. The rash was gone after a few days but the pain/ inflammation / fatigue continue to persist after 3 weeks. I have seen  a tele doctor and am scheduled to see my GP this week.
Eyes started to burn"; "Eyes all red"; "Itching so bad I want to poke my eye out"; Watering also a lot, my eyes"; "Very light cold-like something"; This spontaneous case was reported by a consumer and describes the occurrence of THERMAL BURNS OF EYE (Eyes started to burn"), OCULAR HYPERAEMIA ("Eyes all red"), EYE PRURITUS ("Itching so bad I want to poke my eye out"), LACRIMATION INCREASED (Watering also a lot, my eyes") and FEELING COLD ("Very light cold-like something") in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Eye infection.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING COLD ("Very light cold-like something"). On 05-May-2021, the patient experienced THERMAL BURNS OF EYE (Eyes started to burn"), OCULAR HYPERAEMIA ("Eyes all red"), EYE PRURITUS ("Itching so bad I want to poke my eye out") and LACRIMATION INCREASED (Watering also a lot, my eyes"). On 07-Apr-2021, FEELING COLD ("Very light cold-like something") had resolved. At the time of the report, THERMAL BURNS OF EYE (Eyes started to burn"), OCULAR HYPERAEMIA ("Eyes all red"), EYE PRURITUS ("Itching so bad I want to poke my eye out") and LACRIMATION INCREASED (Watering also a lot, my eyes") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-106388 (Patient Link).
Child presented to clinic with parents with complaints of reaction to either the menveo and bexsero vaccine she received on 6/29/19 by her PCP.   Reports pain in the left arm immediately following the injection with tingling down left arm. Denies any problems with right arm.  Reports fatigue, HA, chills, diarrhea and myalgias.  Unable to abduct left arm.  States she woke in the middle of the night short of breath, took some advil and returned to sleep.   Denies any further sob or difficulty breathing.  Pain has been worsening the last couple of days.  She is taking ibuprofen 400 mg every 4-5 hours.  Also taking tylenol PM at night.  Sleeping well.  Reports experiencing an adverse reaction from the menactra vaccine earlier this year requiring an ER visit.  She was prescribed a muscle relaxer which helped her pain and allowed her return to normal activity level.
Injection site redness; Injection site with a rash-like appearance; Burning; Itchy; Blotches of red; Swelling; Sore arm; Difficult to raise her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site burning, injection site itching, red blotches and swelling. On 24th August 2019, the patient experienced pain in arm and movements reduced. On an unknown date, the outcome of the pain in arm, movements reduced, red blotches and swelling were recovered/resolved and the outcome of the injection site erythema, injection site rash, injection site burning and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, movements reduced, injection site erythema, injection site rash, injection site burning, injection site itching, red blotches and swelling to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of the Shingrix vaccine and within 1 hour, her arm became sore and she noted it was difficult to raise her arm. These symptoms resolved within 2 to 3 days. Approximately 2 to 3 days after receiving the vaccination, the injection site became red with a rash-like appearance.  The patient estimated the area was approximately 5 inches long and 3 to 4 inches wide, but in blotches of red. The patient noted that the redness had gotten darker and more prominent over time. It was reported that, the red area had became itchy and it burns. The reporter consented to follow up.
This spontaneous report as received from a physician via Medical Representative refers to a patient of unknown age and gender. There were no medical history, drug reaction, allergies and concomitant medication reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route of administration were not reported). On an unknown date reported as "a year later", the patient was vaccinated with the second dose of ZOSTAVAX (lot#, expiration date, dose and route of administration were not reported). No adverse effect was reported. No product quality complaint was involved in this case. Additional information has been requested.
improperly stored vaccine administered to patient; This spontaneous report was received from a physician referring to a 58 years old patient with unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.     Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at temperature of 48.39 Fahrenheit (F) for 1 hour and 45 minutes. The was no previous temperature excursion.   On 24-AUG-2020, the patient was vaccinated with the improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter, lot # T009744, expiration date 28-JAN-2022) via unknown route for prophylaxis (Improper storage of product in use). This call was because a data logger. No product quality complaint (PQC) was reported. The outcome of the event was unknown. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
left eye itchy on 1/4, left eye swollen on Wednesday and red, resolved on own, no treatment.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 65-year-old male patient who received SHINGRIX (batch number 22AZ9, expiry date 19th March 2021) for prophylaxis. On 3rd March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd March 2019, less than a day after receiving SHINGRIX, the patient experienced tiredness, insomnia and injection site pain. On 4th March 2019, the patient experienced weakness and inability to work. On an unknown date, the outcome of the tiredness, weakness and injection site pain were not recovered/not resolved and the outcome of the insomnia and inability to work were unknown. It was unknown if the reporter considered the tiredness, insomnia, weakness, inability to work and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on the left arm. Around 4:00 pm of the vaccination day, the patient started to feel tired and laid down for approximately an hour. In the evening of the day of vaccination, the patient started experiencing pain at the injection site. When the patient went to bed that night, he could not sleep, describing that his eyes were wide open. On the day of reporting, 4th March 2019, 1 day after receiving SHINGRIX, he felt weak and tired so he did not go into work. The pain at the injection site was worse than it was yesterday. The reporter gave permission to contact his physician.
got the 3rd dose of the Moderna Covid-19 which she thought was the booster dose and does not consider herself in an immunocompromised sate; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (got the 3rd dose of the Moderna Covid-19 which she thought was the booster dose and does not consider herself in an immunocompromised sate) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 040821A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure increased and Overweight (Slightly).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced OFF LABEL USE (got the 3rd dose of the Moderna Covid-19 which she thought was the booster dose and does not consider herself in an immunocompromised sate). On 24-Aug-2021, OFF LABEL USE (got the 3rd dose of the Moderna Covid-19 which she thought was the booster dose and does not consider herself in an immunocompromised sate) had resolved.            Concomitant medication details were not provided. Treatment details were not provided.
nausea, chest tightness, fever, diarrhea, vomiting, hot and cold flashes, mile severity, came on suddenly after second dose, resting with moderate improvement, lethargic, moderate appetite
Still having injection site pain as of today goes away after  15 - 20 minutes repeating every 2 - 3 wks since getting vaccine
fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue. The patient was treated with diphenhydramine hydrochloride + paracetamol (Tylenol Pm). On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not wish to provide dob, no vaccine information was available. The pharmacist who was a patient reported that he had fatigue the day after receiving a dose of Shingrix. Also took a tylenol pm the night after receiving the dose of Shingrix. The reporter did not consent to follow-up. The reporter did not wish to provide dob, no vaccine information was available.
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 YEAR OLD); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced drug administered to patient of inappropriate age (17 year old). On 25-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administered to patient of inappropriate age (17 year old) and off label use was not reported. This report was non-serious.
Initial report received on 3/29/2006 from a healthcare professional. A 55 year old female patient with a history of diabetes and asthma, who was taking albuterol, insulin, metformin, glyburide and aspirin at the time of the vaccination, had received her first administration (route not reported) of Adacel, lot number C2454AA, in the left deltoid, on 3/14/2006. That evening, she experienced a fever of 102 degrees F, headache, increased blood sugar 300, and generalized flat, red, tender, circular lesions that were forming over her old scars and over the plates in the left arm and right leg. She was referred to an orthopedic and infectious disease specialists. The patient was seen by her primary care physician for the adverse events on three different dates, 3/19/2006, 3/20/2006 and 3/27/2006. She had a CVC completed (no results provided), her CRP was 5.4 and the sedimentation rate was 39. Per the reporter, the headache and fever subsided after 10 days, and the other symptoms were still present but getting better at the time of the initial report.
Vaccination site pain /Hurt so much; Joint pain; Decreased muscle tone; Arm discomfort / Arm not functioning; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, joint pain, decreased muscle tone and arm discomfort. On an unknown date, the outcome of the injection site pain, joint pain, decreased muscle tone and arm discomfort were unknown.   It was unknown if the reporter considered the injection site pain, joint pain, decreased muscle tone and arm discomfort to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but the it could be 83 or 84 years. The patient received vaccine in unknown arm. The patient received their first dose, it destroyed their arm. It described as the patient did not have a lot of muscle and when she got it, it hurt so much and it went to her joints and something happened. So the doctor said don't do it again in the arm. The patient's arm was still not functioning 100 percent. It was reported that there was no further information to provide regarding the product or event at this time. The reporter gave permission to follow up.
2cm erythematous nodule on 2JUL96 -local rxn;also treating for poss early infect-keflex , DPH given
pt recvd vax & devel fever, chills & feeling of disorientation; pt exp recurrence of symptoms w/ 2nd dose of vax;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 14-MAR-2013, the patient was vaccinated with a first dose of (merck) VARIVAX (Lot number, expiry date were not reported) 0.5 milliliter (ml) subcutaneously. The patient who was an adult employee was given a second dose of (merck) VARIVAX early on 22-MAR-2013. Patient was not experiencing any adverse reaction. Additional information has been requested.
PSORIASIS BREAKOUT; HIVES OUTBREAK/BROKE OUT IN HIVES ON ARMS/CHEST AND BACK; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS BREAKOUT) and URTICARIA (HIVES OUTBREAK/BROKE OUT IN HIVES ON ARMS/CHEST AND BACK) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis.    The patient's past medical history included Hives, Sepsis, Unevaluable reaction and Heart valve operation. Concurrent medical conditions included Drug allergy, Plaque psoriasis and Psoriatic arthritis.   On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced PSORIASIS (PSORIASIS BREAKOUT) and URTICARIA (HIVES OUTBREAK/BROKE OUT IN HIVES ON ARMS/CHEST AND BACK). At the time of the report, PSORIASIS (PSORIASIS BREAKOUT) and URTICARIA (HIVES OUTBREAK/BROKE OUT IN HIVES ON ARMS/CHEST AND BACK) had not resolved.            Concomitant medication was not reported.  The patient was on previous medication that led to similar psoriasis or hives breakout that led to sepsis and it leading to heart valve surgeries.   It was not sure if psoriasis or hives breakout could be due to the second vaccine however, he previously took other medication with similar adverse event that led to other severe complications. HUMIRA seemed to be working on his psoriasis arthritis and got better then recurred with worse flare up on feet. Treatment details not reported.  Primary reporter wondered if adverse event could be due to the vaccine, although another medication caused similar adverse event.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Live follow-up added.
melanoma; Fever under 100 degrees; very mild fatigue; Rash extending down left arm; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of MALIGNANT MELANOMA (melanoma) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's disease on 01-Jan-1961. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Allergy to antibiotic (Allergic to Levaquin, erthromyicin). Concomitant products included LEVOTHYROXINE and LIOTHYRONINE for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced RASH (Rash). On 09-Feb-2021, the patient experienced RASH (Rash extending down left arm). On 10-Feb-2021, the patient experienced PYREXIA (Fever under 100 degrees) and FATIGUE (very mild fatigue). On 01-Mar-2021, the patient experienced MALIGNANT MELANOMA (melanoma) (seriousness criterion medically significant). On 09-Feb-2021, RASH (Rash extending down left arm) had resolved. On 10-Feb-2021, PYREXIA (Fever under 100 degrees) and FATIGUE (very mild fatigue) had resolved. At the time of the report, MALIGNANT MELANOMA (melanoma) outcome was unknown and RASH (Rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100 (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included diphenhydramine and famotidine prophylactically.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-09215 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: case upgraded to serious from  NS; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-09215: