chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines were stored in the fridge on 30Jun2021 and administer on 09-Aug-2021.; No adverse event; patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 09-Aug-2021.) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 09-Aug-2021.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 09-Aug-2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 30Jun2021 and administer on 09-Aug-2021.).    No concomitant was reported. 40 patients received the Moderna monovalent vaccines (1st and  2nd doses) after being more than 30 days stored in the fridge. Vaccines were stored in the fridge on 30Jun2021, there were different administration dates, starting on 02Aug2021 until 20Sep2021 being the last one. Patients did not report any side effects.  The case reported for 6 of 31 patient.  No treatment detain was reported.   This case was linked to MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698994:Master case
CHEST FELT TIGHTER, UNCOMFORTABLE; SHAKING IN BOTH ARMS/HANDS; SHORTNESS OF BREATH; CHEST PAIN; This spontaneous report received from a patient concerned a female of unspecified age. 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced shortness of breath. On 22-JUN-2021, the subject experienced chest pain. On 22-JUN-2021, the subject experienced chest felt tighter, uncomfortable. On 22-JUN-2021, the subject experienced shaking in both arms/hands. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, chest pain, shaking in both arms/hands, and chest felt tighter, uncomfortable. This report was non-serious.
felt tingling in left side of head; developed muscle twitch in left palm below thumb; developed sudden onset lower back, abdominal pain; abdominal pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 (Lot number: 33030BD) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: LEVOTHYROXINE. Past drug history included: No, reaction(s): "Allergy". The following information was reported: PARAESTHESIA (non-serious) with onset 02Dec2021 12:00, outcome "unknown", described as "felt tingling in left side of head"; MUSCLE TWITCHING (non-serious) with onset 02Dec2021 12:00, outcome "unknown", described as "developed muscle twitch in left palm below thumb"; BACK PAIN (non-serious) with onset 02Dec2021 12:00, outcome "unknown", described as "developed sudden onset lower back, abdominal pain"; ABDOMINAL PAIN (non-serious) with onset 02Dec2021 12:00, outcome "recovered" (2021), described as "abdominal pain". The events "felt tingling in left side of head", "developed muscle twitch in left palm below thumb", "developed sudden onset lower back, abdominal pain" and "abdominal pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, muscle twitching, back pain, abdominal pain.  Additional information:  2 days after vaccine, 02Dec2021, felt tingling in left side of head, periodically, lasting 1-2 days. 4 days after vaccine, 04Dec2021, developed muscle twitch in left palm below thumb. 7 days after vaccine, 08Dec2021, developed sudden onset lower back, abdominal pain which improved after 2-3 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had covid prior to vaccination. Patient was tested Covid post vaccination. Patient had no known allergies.   Follow-Up: Follow-up attempts are completed. No further information is expected.
12yo patient given pediatric pfizer (age 5-11) dose. Observed x 15 minutes. No reaction or symptoms noted. Reviewed guideline and recommendation that no additional doses is recommended for patient.
suspected vaccination failure/shingles; shingles; hurts so bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria medically significant), shingles and pain. On an unknown date, the outcome of the suspected vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the suspected vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and still got shingles  The patient stated that it hurt so bad. Consent to follow up was not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Insulin resistance; blood sugar  out of control; This is a spontaneous report from a contactable consumer, the patient. A 64-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208) via unspecified route of administration in the left arm on 15Mar2021 at 13:45 (at the age of 64-years-old) as a single dose for Covid-19 immunisation. The patients medical history included type 1 diabetes. Concomitant medications included insulin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) for unknown indication. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, at 1200 the patient experienced that the blood sugar was out of control and the patient had an insulin resistance that occurred right after administration of first shot. The patients last two A1C tests were 6.4 and 5.9. The patient never had a problem like that and the patient was sure the shot was behind that. The patient was very scared. The patient did not receive treatment for the reported events. The events neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of insulin resistance and blood sugar out of control was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient received the Tdap shot on 08/12/08, Eight days later he started coughing. He was tested for whopping cough on 09/09/08 and put on a 5 day Z-Pac. We got a positive result on 09/15/08 and they put him on another 5 day Z-Pac. He was tested again on 10/28/08, we havent received the results yet. He is still coughing as of today 11/02/08.
Vaccine administration was uneventful. Patient and son confirmed that patient was cleared for vaccine and that she was well during and after the observation period. No signs of distress and no abnormality of breathing.
Immediate brief episode of syncope without hitting head or injury. Monitored for 30 minutes with full recovery.
pt recv vax;approx 3 hr later, adm to hosp;dx=r/o gastrodehydration;r/o vax rxn;pt hosp for 4 days; pt may have had a viral infect by R N;
Persistent upper body itching; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) and other contactable consumer. The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 13:00 (Batch/Lot number: unknown) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included polymyalgia rheumatica (unspecified if ongoing); inactive sarcoidosis (unspecified if ongoing). The patient took concomitant medications. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 03:15 PM), administration date: 02Mar2021, when the patient was 77 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available, provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 09:15 AM), administration date: 12Feb2021, when the patient was 77 years old, for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 29Sep2021 13:00, outcome unknown; PRURITUS (non-serious) with onset 06Nov2021 12:00, outcome not recovered. The event persistent upper body itching was evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus.  No other vaccine in four weeks. Other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies. AE treatment included Claritin and Cortizone 10.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
8/24/2021 Severe shoulder pain (R) could not be touched 8/26/2021 shortness of breath 8/27/2021 still not feeling well, headache 8/28/2021 Shortness of breath, chest pressure 8/29/2021 not feeling well, rested 8/30/2021 Went to the ER with full body sweats (could visually see beads of sweat) shortness of breath, irregular heartbeat. Blood pressure was high, so was given a med to help bring his blood pressure down. Diagnosed with pneumonia (even though there was no congestion or cough present, white blood count normal to slightly elevated) sent home with a prescription of Z pak. Started the first dose that evening. Symptoms did not subside. Felt the medicine was making him feel worse.  Didn't not continue with other doses. 9/1/2021 Left work mid afternoon to go home and rest as pt. was still not feeling well. I received a call from pt. between 4-5 PM. He could barely speak, was very winded. I was able to understand he had called the ambulance. I asked him if he wanted me to call my daughter, as she wasn't home at the time. He said yes. I called my daughter, told her pt. had called me, he could barely speak, was very short of breath. He was able to tell me the ambulance had been called. Fortunately she was a short distance from their house. When she pulled up to the house, pt. was outside without any clothes on. She said he was very sweaty and barely coherent. She ran in the house to get him a shirt. She also attempted to find aspirin to give him as she was aware if it was a heart attack if aspirin is given in a certain window of time, it might prevent a heart attack. She was not able to find any. When she returned, pt. was down on the ground with one of the paramedics supporting him. He was wide eyed and had lost control of his bowels. She helped assist put him on the gurney, where he took his last breath. All of this happened in a small window of time.  We still have no answers as to why the paramedics didn't attempt to do CPR or use the shock paddles. She still had hope that once they got him into the ambulance they would be attempting something to bring him back. He was taken to a local hospital 40 minutes away, where he was pronounced DOA. While in the ER saying our goodbyes to pt, We were familiar with the immunization data base. We asked the nurse if she would be able to search the database and see if pt. had received one of the Covid immunizations. She attempted to and after several attempts said that his account had been locked. We found that a bit odd as he had only died hours before. We then called his employer to ask if they had mandated the immunizations and if he would have record of it. His employer said that it was voluntary, a personal choice and so didn't have record of pt. receiving a Covid immunization, but that pt. had told him he had.    His body was sent to coroner, where the findings of the autopsy came back as Myocarditis. There was no pneumonia found.  Pt. had received a full physical April 2021 to have a vasectomy performed. His physical came back without exception.
Information has been received from a 62 year old female physician who 2 years ago, approximately in September 2006, was vaccinated with ZOSTAVAX 0.65mL and about a year later, approximately in September 2007, she had a rash on hands and feet with vesicles that do not follow a pattern or dermatome. The episodes are sporadic lasting for undisclosed period of time. The rash the reoccurs from time to time. At time of reporting, the patient had no rash or lesions. There were no lab diagnostics studies performed. Additional information has been requested.
severe stomach issues; This is a spontaneous report received from a contactable reporter(s) (Physician).  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS", start date: 1978 (unspecified if ongoing), notes: medical history does include IBS with constipation since 1978; "constipation", start date: 1978 (unspecified if ongoing), notes: medical history does include IBS with constipation since 1978. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot unknown: True, Prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, Prev dose dose number: 1), for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "recovered", described as "severe stomach issues". The event "severe stomach issues" required physician office visit. It was unknown if therapeutic measures were taken as a result of abdominal discomfort.  Additional information: Patient received other vaccine in four weeks was unknown. Patient received other medications in two weeks was unknown. Prior vaccination, patient diagnosed with COVID-19 was unknown. Post vaccination, the patient was tested with COVID-19 was unknown. Patient received the following query from a site research coordinator participating in one of my non-COVID vaccine studies: "Subject 1 shared with the Sub-I that after her second Pfizer Covid-19 vaccine she had "severe stomach issues" that started three days after the shot and resolved by day eight. She did end up having to see her PCP and GI specialist that week for these issues. She denied any other vaccine reactions throughout her life and reports " the first Covid shot caused no issues at all." A diagnosis was never confirmed for this episode per subject. Her medical history does include IBS with constipation since 1978 but she had never had this sort of episode.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Myokymia in right lower eyelid  (Constant twitches in lower eyelid)  May 18- current
2-3 min after vaccination he started feeling tingling in the right side of his face. About one minute later he felt like he could not get a full breath and he felt the need to run away. We connected a heart monitor, did serial vital signs, listen to lung sounds. He symptoms seem to worsen. He did not have hives, his lungs were clear. His HR was normal but his B/P was elevated. We started and IV and gave him 25 mg mg of IV Benadryl. We contacted Dr. via phone. He talked to the patient and he agreed with our assessment and treatment.  He began feeling better about 10 min after the Benadryl and he symptoms cleared by 30 min after Benadryl. We kept him on the heart monitor for 1 hour.  He reported he felt fine and back to normal when he left to go home. He refused ambulance transport to the hospital. All reports will be filled out by me.
Patient given dose on 2/14/23 from a vial that was 4 days past the BUD.  Vial as removed from the freezer on 1/11/23 and should have been salvaged on 2/10/23.  Patient states that she has not experienced any adverse effects from the immunization as of 2/27/23.
After both shots I experienced severe vomiting, diarrhea for several hours. My second shot was on March 5. 3 weeks after the first shot on Feb.3 (taken to hospital emergency room by ambulance ) and One week after my second shot on March 5,  I experienced severe vomiting and diarrhea which I treated at home.
9 yr old inadvertently given adult dose of Pfizer covid vaccine. No immediate adverse effects.
Vomiting (many times..couldnt even keep a sip of water down), extreme sweating, fainting (twice), severe diarrhea (several times),  dizziness, chills, even with 3 long sleeve shirts, t-shirt, bra, winter coat, 3 blankets, pants socks, etc.  headache, fever, heart racing a little, couldn't stand up (husband had to help me)....12 hours.
Initial report was received 27 May 2009 from a consumer. A 23-year-old male patient had received an injection of IMOVAX RABIES VACCINE, lot number B0359-2 on 14 May 2009 and "since last week", has experienced a headache, nausea, dizziness and a fever. The patient reported they had been bitten by a bat and had received two doses of rabies vaccine (manufacturer and lot number not reported) while overseas during March 2009. He returned and received two additional doses of rabies vaccine (lot number and dates of administration not reported, manufacturer unknown) and two additional doses of RABAVERT (lot number and dates of administration not reported, manufacturer NOVARTIS) prior to receiving IMOVAX RABIES vaccine on 14 May 2009. The patient declined to provide their health care professionals contact information and no additional information was provided at the time of the report. The recovery status was reported as unknown on the VAERS form; however the reporter stated they had experienced their symptoms "since last week" at the time of the report. Follow-up information was received from the patient on 12 June 2009, and included contact information. The patient stated that he had been bitten by a bat on the left index finger, and the wound had been washed and cleansed at that time. In addition to the doses rabies vaccine noted previously, the patient stated he also received Rabies Immune Globulin (manufacturer and lot number not reported) in and around the wound site and in the deltoid. The bat had not been captured, and was not available for testing. At the time of the report, the fever, nausea, and dizziness had resolved; headache was ongoing. Documents held by sender: None.
Pt was given shot 3 days ago. Came to office and site is 40mm x 50mm red area around site, warm to touch. Pt thinks it is smaller today.
Cough, sore throat, sinus congestion, voice stopped working, rash all over body, itchiness. The rash and itchiness started about one week after receiving vaccine. Cough, sore throat, congestion, and loss of voice happened about one week ago. Rash has gone away, but other symptoms still persist.
Patient received vaccine in right arm.  Discharged from hospital where she developed pruritus, increased swelling, pain and warmth develop over the week.  Returned to the emergency department on 12/07 where she was prescribed clindamycin oral for suspected cellulitis.  Patient presents again on 12/09 with "failure" of antibiotic therapy.  Patient received vancomycin, was switched to clindamcyin and is set for discharge.
lost her taste; lost her smell two weeks after; She also got a sinus infection but she gets them every year; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost her taste), ANOSMIA (lost her smell two weeks after) and SINUSITIS (She also got a sinus infection but she gets them every year) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sinus infection (patient gets them every year). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 28-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On an unknown date, the patient experienced AGEUSIA (lost her taste), ANOSMIA (lost her smell two weeks after) and SINUSITIS (She also got a sinus infection but she gets them every year). At the time of the report, AGEUSIA (lost her taste) and ANOSMIA (lost her smell two weeks after) had not resolved and SINUSITIS (She also got a sinus infection but she gets them every year) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       After the first shot patient lost of taste and smell two weeks after. patient was tested for COVID-19 and it came up negative. patient said people  told her she might have gotten tested late though. She did not take any medications for this and still has no taste or smell. She also got a sinus infection but she gets them every year.   Patient  got the first and second Moderna COVID-19 vaccination at Pharmacy.   No treatment was reported by the reporter.
Patient had itching and hives. At 1140 vitals were HR 86, RR 16, BP 158/100, and 96 O2 sat. Was given Benadryl 50 mg 1150 by Dr. BP five minutes later was 140/90 and it was 131/84 10 minutes later.