chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of bulging anterior fontanel in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included HIB (non-GSK) ; non-GSK manufacturer; unknown; unknown given on 6 April 2012; live ROTARIX ; GlaxoSmithKline; unknown given on 6 April 2012; PREVNAR (non-gsk); non-GSK manufacturer; unknown; unknown given on 6 April 2012. There were no concurrent medications. On 6 April 2012 the subject received 2nd dose of PEDIARIX (unknown, left thigh); lot number was reported as "ACZ21B315DA". On 7 April 2012, 1 day after vaccination with PEDIARIX, the subject experienced bulging anterior fontanel and fever. The physician reported the subject was administered the standard dose of PEDIARIX on 06 April 2012. One day after the injection the mother brought the subject to the office, it was noted that the subject had a bulging anterior fontanel. The subject's axillary temperature was 99.7 degrees [fever]. The subject was sent to the emergency department. A spinal tap was done and showed nothing. It was negative. The subject was sent home. The physician noted the events resolved and when the subject had her six month physical, all events resolved. No other events were noted. The immunization series was delayed. At the time of reporting the bulging anterior fontanel and fever were resolved. The physician considered the events were possibly related to vaccination with PEDIARIX. Follow up information received from the physician on 03 July 2012. The physician reported that the subject was brought to the office on 07 April 2012, one day after receiving PEDIARIX with bulging fontanel and low grade fever. The subject was sent to the emergency room for spinal tap which was negative. The physician noted that the PREVNAR was given intramuscularly (IM), the ROTARIX was given orally and the haemophilus influenzae type b vaccine was given IM. Only the PEDIARIX was listed as a suspect product.
INJECTION SITE PAIN; INJECTION SITE SWELLING; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced injection site pain. On 12-APR-2021, the subject experienced injection site swelling. On 12-APR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, injection site swelling, and injection site redness. This report was non-serious.
Within two hours of receiving the vaccine, the patient experienced burning pain and weakness in both hands and then arms. Later that evening she felt a similar pain in her groin. She found that she could not use her hands to perform basic activities such as wiping herself after toileting or carrying household objects because her hands were so weak. She ended up going to the Emergency Department because she was so scared about the severity of pain and weakness in her hands, arms, and groin/upper thighs. This has slowly gotten better over the past week and she is able to function again. But she does not feel she is back to her previous baseline.
Have been in menopause for over 1.5 - 2 years and had menstruated on 5/5/2021 for a few days
booster she received was expired/Expired booster dose; 7 months pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster she received was expired/Expired booster dose) and MATERNAL EXPOSURE DURING PREGNANCY (7 months pregnant) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster she received was expired/Expired booster dose) and MATERNAL EXPOSURE DURING PREGNANCY (7 months pregnant). At the time of the report, EXPIRED PRODUCT ADMINISTERED (booster she received was expired/Expired booster dose) and MATERNAL EXPOSURE DURING PREGNANCY (7 months pregnant) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported. No concomitant medication reported.
numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; numbness, tingling and swelling on the right side of face and head down right arm and chest; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), via an unspecified route of administration on 08Mar2021 at 11:15 (at the age of 58 years) at a single dose in the right arm for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included irbesartan; nifedipine; spironolactone; and estradiol. The patient did not receive any other vaccines within 4 weeks prior COVID vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not pregnant at the time of vaccination. On 08Mar2021 at 11:30, the patient experienced numbness, tingling and swelling on the right side of face and head down right arm and chest. The events resulted to Emergency room/department or urgent care visit. The patient was hospitalized on an unspecified date due to the events. Patient was given Benadryl antihistamine w/IV Cat-Scan other work up as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
1 hour after patient received vaccine she developed itching of the jaw and neck. She took Benadryl 25 mg PO. 2 hours after vaccine the itching moved to her chest. 3 hours after vaccine she developed tongue swelling and throat itching and reported that she took another Benadryl 25 mg PO. This helped with the tongue and throat. Over the next couple days she continued to have itching of the jaw, neck, and chest but did not seek medical treatment.
Dx with Bell's palsy on 11-12-08.  Symptoms started 11-10-08 with facial drawing and left eye will not close completely.  Left side of face will not move when he smiles, tongue deviates to right side, taste buds more prominent on anterior part of the tongue. records received 11/18/08-for DOS 11/12/08-presented with C/O 2 day face drawing, right side of face drawing when smiling or cries. Left eye will not close all the way also watering a lot.  Assessment:Bell's palsy.
Information has been received from a certified medical assistant concerning a female co-worker who on 18-MAR-2008 splashed ZOSTAVAX in her eye while administering the vaccine. The patient experienced burning, but it may have been due to flushing it with water. No other symptoms noted. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. The reporter considered the patient events to be an other important medical events. Additional information has been requested.
2nd dose 2019, Shingles in 2021; 1st Shingles after COVID booster, single dermatome; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   Previously administered products included Covid-19 vaccine (received 5 times Covid vaccines in total since 2020).   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and COVID-19 BOOSTER. On an unknown date, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.       Additional Information: receipt date: 3-Feb-2023 Reporter's comment: The patient received the 2nd dose of Shingrix vaccine in 2019 just before COVID began. The patient had one occurrence of Shingles in 2021, one month after receiving a COVID booster. The reporter clarified to be sure that it was Shingrix (not Zostavax) that the patient received and whether he had previously reported it. It was definitely Shingrix, he said, and commented that it was never reported.  The reporter was happy for it to be reported and willing to provide any additional information, should any be needed.  The reporter commented that 3 independent seasoned clinicians confirmed the diagnosis to be shingles as he was very much an advocate of Shingrix (and still was) for his patients.  The reporter was surprised at the reoccurrences but believe them both to be true, fairly mild cases of shingles. Lots numbers were not available but the information was complete, per the form. The case was linked with case US2023AMR018087, reported by same reporter for second occurrence. The reporter consented to follow-up. Additional supportive information: It was unknown if the reporter considered the shingles to be related to Covid-19 booster.; Sender's Comments:  US-GSK-US2023AMR018087:Same reporter.
fever of 99.8°F; been throwing up all night; he has a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 99.8°F), VOMITING (been throwing up all night) and HEADACHE (he has a bad headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney dysfunction.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 99.8°F), VOMITING (been throwing up all night) and HEADACHE (he has a bad headache). At the time of the report, PYREXIA (fever of 99.8°F), VOMITING (been throwing up all night) and HEADACHE (he has a bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8°f (High) high 99.8°F.         Patient stated that was the first time  experienced adverse event after Moderna shot. Patient reported after three hours after received the Moderna shot experienced events. Concomitant medications was not reported. Treatment medications was not reported.
Towards the end of February 2021, I received my first vaccination and a few hours later, my arm was numb, swelling began in my armpit and shoulder, my hand had swollen up and the pain continued without letting up. I was given prednisone, and then when I received my second shot, I felt like I was burning up inside and my heart was racing to the point of almost going into cardiac arrest, and my blood pressure was extremely high. I then went to work the day after and I had to go home multiple times. X-rays showed internal swelling pushing on my spine and the doctors gave me gabapentin for the swelling. I was then given an MRI by my primary care. I had to stop taking the prednisone because I had gained too much weight. My feet are swollen and I am going to physical therapy. My shoulders and hips are now having issues as well. My symptoms have continued to get worse and I have gone to a nerve conduction study, my hands have swollen up so bad that I cannot even hold objects or steering wheel. Moderate to severe carpal tunnel in both hands. Newest update has been a higher gabapentin prescription and an additional MRI for swelling issues. The pain is coming from my neck and is leading down to my arms, hands, feet and middle of my spine.
pt recvd vax; 3 days later infant stopped sleeping during day & starting having bloody bowel movements;have abdo ultra-sound 18jan;day p/ vax t 100 R;some high pitched cries & mom stated MD had mentioned,might leave pertussis out next immun
56 adults patients received doses after its expiration date Jul 13, 2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Patient began having symptoms of chest tightness and throat tightness 4 hours after receiving her first dose of the Janssen vaccination. Patient went to the ER were she presented with fever, chills, lip tingling, finger tingling and feeling like her tongue was swelling 10 hours after getting the vaccine. Patient received antipyretics and Benadryl and began to feel better. On re-exam patient was still hot to the touch and tachycardic. Patient was diagnosed with a vigorous immune response to the vaccination.
Systemic: see additional comments-Medium, Additional Details: pt was given expired vial of moderna; it was punctured on may 30 2021
Rapid hearing loss, severely plugged ears, tinnitus. Audiogram on 01/13/2014 showed marked hearing loss. After 9 days with no improvement MD prescribed 8 day Prednisone treatment. After 6 weeks, no marked improvement except some of the plugged sensation resolved in right ear; left ear unchanged.
THE PATIENT CAME IN THE NEXT DAY COMPLAINING OF REDNESS IN HER ARM WHERE SHE RECEIVED THE VACCINE.  AFTER EXAMINING IT APPEARED RED.  THE VACCINE WAS ALSO ADMINISTERED LOWER THAN USUALLY GIVEN, AROUND THE MIDDLE OF HER ARM INSTEAD OF SHOULDER.
Mareo,  rigidez muscular, desmayo, debilidad corporal.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022A21A and 015M204) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Patient was reported to take the third/booster dose on 25-OCT-2021, lot no: A11C21A.  No concomitant medications were reported. No treatment details were provided.   This case was linked to MOD-2021-365201 (Patient Link).
I had leg pain beginning 3/16.  I also experienced a headache, body aches, fatigue and loss of appetite.  On, 3/17,  I experienced confusion.    On 3/31,  I began to experience body chills and congestion which lasted several days. On 4/3,  my symptoms increased with lower back pain and abdominal pain on my right side.  I went to a clinick on 4/3 and received a positive covid test.  My symptoms increased over the following weeks to include: temperature, body aches, sweating, headache, nausea, abdominal pain, fatigue, shortness of breath, coughing, dizziness and persistent diarrhea.  I went to the ER for care on 4/8 and have been receiving continued care from my physician regarding possible pneumonia, shortness of breath, and chest tightness.
Sweating. Chills. Malaise. Bizarre dreams. Soreness. Body aches. Fever.  Vomiting and nausea.  Headache. Weird taste in mouth like metal.  Left arm very painful.
No adverse event; patient received a children vaccine instead of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a children vaccine instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B, 039A21A, 045B21A and 012H21B) for COVID-19 vaccination.     It was unknown if patient had ever tested or diagnosed for COVID-19. Patient had no medical history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. In the last 4 weeks,patient did not received other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (patient received a children vaccine instead of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a children vaccine instead of the bivalent vaccine) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a children vaccine instead of the bivalent vaccine).    Concomitant medication was not provided. Treatment information was not provided.
Pregnancy; Alot of vomiting; Fever and chills; Fever and chills; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy), CHILLS (Fever and chills), VOMITING (Alot of vomiting) and PYREXIA (Fever and chills) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 013L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN B6 for Vomiting, DOXYLAMINE.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Aug-2021. On 19-Jan-2021, the patient experienced CHILLS (Fever and chills) and PYREXIA (Fever and chills). On 22-Jan-2021, the patient experienced VOMITING (Alot of vomiting). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). On 20-Jan-2021, CHILLS (Fever and chills) and PYREXIA (Fever and chills) had resolved. On 25-Jan-2021, VOMITING (Alot of vomiting) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient does not mention when she had a positive pregnancy test. Her last menstrual period and estimated date of conception was not provided. The patients estimated due date is 31 Aug 2021.  No laboratory details were  provided.
When pt woke next morning area was red, swollen, hot to touch with a lump size of quarter.
pain became worst till now; severe pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (severe pain) and PAIN (pain became worst till now) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-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) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (severe pain). On an unknown date, the patient experienced PAIN (pain became worst till now). At the time of the report, PAIN (severe pain) and PAIN (pain became worst till now) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was reported.       Reporter did not allow further contact
Right upper arm swelling with warmth and soreness stated on 8/8/03 in the A.M.  It also c/o n/a this A.M., mom stated pt. felt warm last night but did not take his temp. denes any vomiting, dizzness or stiff neck.  PHN too temp on 8/8/03 at 3:45 P.M. - 99.2 via ear.