chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fine after vaccination on Jan. 26. On Feb. 5 woke up with quite severe neck pain and lethargy. Limited range of motion. Difficultly in standing and moving. No fever. Lost appetite. Taste okay, but slightly nauseous. Pain and symptoms have persisted. Today, Feb. 8, woke with extreme headache and even less mobility. Blood pressure is 122/91 and pulse was 110 in morning. Later this evening developed a fever at 99.7 (normal is 96.6)  Pain and stiffness has expanded from neck region to lower back. Mobility is even less, despite efforts at walking and stretching. If possible, please contact us as to whether other people have had a delayed reaction like this.  We can't find documentation. Okay to have 2nd shot Feb. 22?
Patient tested positive for Covid on 11/24/2021.  Was admitted to  hospital same day. Patient is listed as having cancer.  Symptoms were marked yes, not specific.  Patient died 12/04/2021
It started with involuntary head movements at school. Friday September 11 in the afternoon.  At 8:30 that evening we noticed nonstop tapping.  Then by Saturday 9/12/15 the involuntary head movement was non stop. Sunday morning at 9:30 AM constant snapping of fingers started.  Sunday evening at around 6 PM involuntary lifting of right hand would make him hit things when it rose. He was not able to attend school Monday September 13. Facial twitching Monday September 13 started while at doctor appointment we scheduled at 5 PM.  Tuesday September 14 returned to school after working with school staff. Vocal tic clicking of the tongue and having to say "moo". The vocal tic didn't last. However, the continued involuntary head movement, snapping and right arm lifting has.
Adult Hep A dose given to a person 18 years and 9 months of age. No adverse reactions reported.
First 2 shots were Pfizer. Pharmacy I went to only had Moderna for booster.  Since it has been stated it's OK to mix and match I decided to move forward with Moderna booster.  I was fine for first 12 hours after the booster.  Was out and about all day.  Late that evening I started to get a headache and chills.  Then it got progressively worse over next 24 hours.  Developed low-grade fever.  Body was very achy.   Injection site was sore for 2+ days.  Developed a wet cough day after getting booster.  Chills, fever, body ache when away on 11/25 but still have the cough.
Arm aching Fatigue Minor hives for three days   Treated with Zyrtec and Benedryl
Tachycardia, shortness of breath, malaise ("achy"), fever (101.8 degrees F), chills, eyes burning & red.
BACK PAIN GOT WORSE; BODY ACHES AND PAIN; SPASM IN LEGS AND BACK; PAIN IN RIGHT ARM  WHERE GOT INJECTION AND GOT WORSE; FEVER; WEAKNESS IN LEG; MASS IN ARM LIKE LUMP; This spontaneous report received from a patient concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included back injury, and bulging discs in back. The patient was previously treated with stem cells nos for back injury. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced weakness in leg. On JUN-2021, the subject experienced mass in arm like lump. On 04-JUN-2021, the subject experienced body aches and pain. On 04-JUN-2021, the subject experienced spasm in legs and back. On 04-JUN-2021, the subject experienced pain in right arm where got injection and got worse. On 04-JUN-2021, the subject experienced fever. On 07-JUN-2021, the subject experienced back pain got worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches and pain, and fever on JUN-2021, had not recovered from back pain got worse, pain in right arm where got injection and got worse, and spasm in legs and back, and the outcome of weakness in leg and mass in arm like lump was not reported. This report was non-serious.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient fainted after receiving flu shot for about 5-10 seconds. patient came back to and was lightheaded and dizzy for 10-15min after. patient was able to leave store with father and no further issues reported
Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 45-year-old) on 13Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included penicillin allergy. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Jan2021 at 06:00 PM patient experienced nausea, vomiting, shortness of breath, fainting and hand spasms. Events resulted in Emergency room/department or urgent care. Patient was treated at emergency room (ER) with diphenhydramine hydrochloride (BENADRYL), Steroid and Anti nausea. Patient was not tested for Covid post vaccination. Patient recovered on unknown date in 2021 from the reported events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
Mother claims muscular atrophy occurred from KINRIX vaccine. She showed me on daughter-claims vaccine was given at distal deltoid. Atrophy is mid body. Area appx. 1 x 2 cm.
Tiredness; Nausea; Light cold; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 14:00, the patient experienced tiredness, nausea and light cold for 3 hours. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome for the events tiredness, nausea and cold were recovered on 12May2021.   No follow-up attempts are possible. No further information is expected.
administration of expired vaccine/ vial was stored at room temperature; administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) and PRODUCT STORAGE ERROR (administration of expired vaccine/ vial was stored at room temperature ) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 022C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2022 at 2:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administration of expired vaccine/ vial was stored at room temperature ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) and PRODUCT STORAGE ERROR (administration of expired vaccine/ vial was stored at room temperature ) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies. Patient had no history of covid.  No treatments were given. No concomitant meds taken.  It was reported that a vial that was opened at 9am of 22Feb2022 was administered to a patient earlier around 2:45pm of 23Feb2022. The vial was used for 1-2 doses last 22Feb2022 and was stored at room temperature thereafter. Then around 2:45pm of 23Feb2022, they used it to administer a booster shot to a patient. AE did not cause to seek medical care. No other AE after the administration. Patient had no primary doctor in the area.
High Fever, body aches, headaches, bilateral arm numbness, dizziness, chest pain, chest palpitations
Significant swelling at base of skull with severe headache starting 11 hrs after vaccination.    Superficial swelling of vein on left forearm started 46 hrs after vaccination in left upper arm. This vein had a clot that proceeded to swell and burst causing significance pooling of blood with tracking on inside of L forearm.  Left arm remains warm and throbbing.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284735, 2018SA284736 and 2018SA277767 (same reporter). This case involves a 11 years old patient who (gender not reported) was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Shortness of breath a few days after booster; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (Shortness of breath a few days after booster) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker (totally healthy and non smoker).   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced DYSPNOEA (Shortness of breath a few days after booster). At the time of the report, DYSPNOEA (Shortness of breath a few days after booster) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: clear (normal) clear. In 2021, Echocardiogram: clear (normal) clear.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that he still had shortness of breath and can not figure out what was wrong with him. No concomitant medication information was provided. No treatment medication information was provided. Lab tests Echo and cardiogram were all clear.   Reporter did not allow further contact
chills; muscle aches; headache; stomach upset; This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced chills, myalgia, headache and upset stomach. On an unknown date, the outcome of the chills, myalgia, headache and upset stomach were unknown.   It was unknown if the reporter considered the chills, myalgia, headache and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient experienced headache , muscle aches, chills , stomach upset. The patient enquired how long symptoms would last.
Fourth Hib immunization given before 1 year of age.  Mother reported fever ranging 101 to less than 103 on 4/11/05 and 4/12/05.  On 4/12/05 she stated that child seemed to be okay.  Child is taking fluids.
Arthralgias; Fever (Unknown T -max); This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (Arthralgias) and PYREXIA (Fever (Unknown T -max)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (Arthralgias) and PYREXIA (Fever (Unknown T -max)). On 22-Jan-2021, ARTHRALGIA (Arthralgias) and PYREXIA (Fever (Unknown T -max)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications and treatment details were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: This follow-up was received by safety on 19-APR-2021 which reported the dose 1 & 2 details (date of administration, route of administration and anatomical location of vaccine administration).
Pain in  Shoulder blade  area-day 2 , Headaches & ear aches-7 days,  chills-2 days, eye pain-7 days and then onset of Bell's Palsy which started on day (Monday,4/25). Treatments: steroids, antibiotics, ear and eye drops  Seen at Urgent care-day 2 and ER-day 3 and primary care physician-day 7
developed hives on the insiden of the calf of both legs; rash on my lower legs; This case was reported by a consumer via call center representative and described the occurrence of hives in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced hives and rash. On an unknown date, the outcome of the hives was unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the hives and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed hives on the inside of the calf of both legs from knee to ankle. The patient still had a rash on my lower legs it did not itch and no blisters.
Patient fainted in the bathroom around 2:00am.  When we heard the thump, we ran to her and my husband picked her up.    She wasn't talking much, she started gagging and fainted again and her body started convulsing.  We believe she was having a seizure.  Patient has never had a seizure, her fever was high.  It only lasted probably 20-30 seconds.  When she stopped, she was able to walk with assistance back to her room.  We quickly gave her some medicine to bring down her fever.  Wet wash cloth and a fan on her.  I failed to take her temperature.  I was too concerned at what was going on.
Begun one day after injection: vomiting first day, nausea continuing at least three days, complete loss of appetite, soreness at the injection site, extreme fatigue. Symptoms persisted, although increasingly diminished, for two to three weeks.
2 hours after, pain increased in arm to point of unbearable. Became clammy, shaking, and when I stood up, all went white but did not pass out. Taken to Urgent Card, heart rate and BP very LOW.   Ambulance was called to take me to ER. IV inserted in right arm. Given meds to get rate up but not working, IV had "blown" and my entire arm swelled up. In ER blood taken (3 attempts), EKG etc. They got heart rate and BP up. Admitted to hospital for overnight observation. Another EKG, tests, etc. Was unable to move arm away from body and if assisted, very painful. Orthopedic Dr called in to examine and xray. It is believed that they hit a nerve when giving the injection or hit scar tissue from shoulder surgery. They are not sure that vaccine was at fault but reporting it as a precaution. Arm is still hurting but hopeful it will return to normal in time.
Pharmacy did not disclose the brand of flu shot or provide me with any paperwork following the injection. I guessed from the options above.   Fatigue for 1.5 days beginning 2 hours after shot. Low-grade fever for 3 hours beginning 12 hours after shot.  Soreness and mild swelling in cheeks/tear troughs for 2 days beginning 1 day after shot. This is where I had 1 syringe of Restalyne injections placed 5 months prior.
Patient came to pharmacy day after ZOSTAVAX immunization complained of redness around injection site. Counseled patient that sometimes irritation occurs at injection site and to see MD if not better. Patient comes back 11/28/14 four days after immunization and presents two prescriptions for antibiotics and states she was diagnosed with an infection. Asked patient if she had any pain or discomfort she responded that she was concerned with the redness. Patient understanding of situation and seemed in good spirits. Counseled her on antibiotics and told her if she had any questions to call or come in.
Patient experienced tremendous pain in the arm about 1 hour after the injection. The patient pain continued for about 4 days after the injection and required use of Vicodin. The patient has a polyneuropathy syndrome and has had surgery in the same arm for carpal tunnel syndrome about 4 months ago.
Itching/hives/dermatographia- intense at first, still having symptoms but seemed to have lessened slightly
Fierce head fever, tingling in lips, face, and extremities, muscle weakness, slight nausea, debilitating fatigue, numb impassiveness. Treatment: Rest, involving occasional naps; Acetaminophen. Outcome: Symptoms began to appreciably abate Thursday night, the 5th. As of the night of the 6th, the fatigue and muscle weakness, and impassiveness are what remain, but are abating slowly.
This spontaneous report was received from a female patient of unknown age regarding herself. Information on pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced swelling, soreness and erythema at the injection after receiving PNEUMOVAX 23. The outcome of injection site swelling, injection site erythema and injection site pain were unknown. Causality assessment between the events and the PNEUMOVAX 23 was not reported. Product quality complaint not involved.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown. 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 details were reported.
This is an instance of breakthrough COVID-19 disease after which death occurred.  The individual was vaccinated with the Moderna product on 02/02/2021 and 03/02/2021. The individual became symptomatic for COVID-19 disease on 08/19/2021 and tested positive twice on 08/22/2021 via PCR. They were admitted to hospital on 08/23/2021 and died on later on the same day. They had experienced complications of a pulmonary embolism.