chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine fridge went out of range and were possibly administered to patients; vaccine fridge went out of range and were possibly administered to patients; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number, unknown, single (Lot number: EY5069, Expiration Date: Feb2024), (Lot number: EX1979, Expiration Date: Dec2023) and (Lot number: EX1981, Expiration Date: Feb2024) for immunisation; meningococcal group b Rlp2086 (TRUMENBA), as dose number, unknown, single (Lot number: ER2621, Expiration Date: Dec2023) and (Lot number: CW3115, Expiration Date: Dec2022) for immunisation; BNT162b2 (BNT162B2), as dose number, unknown, single (Lot number: FK9729, Expiration Date: Sep2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT STORAGE ERROR (medically significant), POOR QUALITY PRODUCT ADMINISTERED (medically significant) and all described as "vaccine fridge went out of range and were possibly administered to patients".  Clinical comment: RN reporting the vaccine fridge went out of range for 8 hours. Temperature reached -0.4 degrees Celsius, fridge got too cold. This fridge stored three products: Prevnar 13, Trumenba, and the covid vaccine. When attempting to clarify which covid vaccine states the box is gray, she does not know the cap color since she did not look at it. When querying patient involvement, reports that patients possibly received some of the vaccines, staff is looking through it all now. She is not sure which vaccines may have been administered, if any. She does not have any patient details to provide. She has VFC and private vaccines so she has multiple lot numbers for Prevnar 13, clarifies she has three lot numbers for Prevnar 13. She does not personally know what the studies are and with vaccines being out of range.  No follow-up attempts are needed. No further information is expected.
Within several minutes of administration, patient expressed feeling lightheaded/"woozy", vision beginning to close off. Also tightness and tingling between her neck and left shoulder.  She was assisted into a prone position with feet elevated.  After some questioning, she was given 3 glucose tablets  and also some water once she felt certain she was improving and unlikely to loose conciousness.  She remained lying down for approximately  25  minutes, at which point she was feeling much better and wanted to try sitting up.  She sat on the floor another 10minutes or so, then moved to a chair where she was monitor approximately 15 more minutes.   She stated at that time that she was feeling "fine", "back to normal" .   She chose to leave at that time, but on request, called the pharmacy within about 35minutes to report that she arrived safely home and still felt fine.  At 2pm, she was contacted to  confirm information for this submission and again stated she felt fine.
After receiving TD injection, while at home, pt developed a rash (localized) itching and pain at the site of injection. Developed cellulitis at site. TD given on 2/20/01. Dx'd with cellulitis on 2/26/01. Treated with Augmentin 875mg X bid X 9 days. Symptoms lasted 7 days, per pt.
Shortness of breathe; Rapid heart rate; migraines; Fever; Chills; Body aches; Muscle tightness; Headaches; This is a spontaneous report from a contactable Other Health Professional (patient). A 35 years old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose (lot EK5230) via Intramuscular on 16Dec2020 11:30 in the left arm at single dose, second dose via Intramuscular on 06Jan2021 11:00 in the left arm at single dose for COVID-19 prophylaxis. Medical history and concomitant medications were none. Caller did not experience any side effects after the first dose.  After the second dose, caller experienced, fever, chills, body aches, muscle tightness and headache. Today the caller also experienced shortness of breathe and a rapid heart rate. Fever; She said that she noticed her fever at 0130 07Jan2021. He fever started at 100.3 at 0130 and at 0400 it was 100.8. She took it at 1000 and it was 101. She has not taken her temperature since. Chills: She woke her up at 0130 07Jan2021 she said that she sleeps with a electric heated blanket and she woke up cold. Body aches: She noticed that she had the body aches and pain at 0130 07Jan2021. She said that she has not been able to sleep because the pain has been so bad. Muscle tightness: She said that it hurts to stand up and walk. She stated that she had to get a Covid test this morning so she had to move. She noticed the muscle tightness at 0130 07Jan2021 along with the body aches. Headaches: caller said that she noticed her headache around 0130 07Jan2021. She said that it is a dull achy headache. She stated that she get migraines and thought it was because of her fever. Shortness Of Breath: She said that she noticed she was short of breath around 1230 07Jan2021. She stated that it is hard to breath right now and feels like someone is standing on her chest. Rapid heart rate: Her watch at 1230 07Jan2021 said that she had a 116 heart rate and that was at rest. Outcome of event Chills was recovering, while outcome of other events was not recovered.
Patient noticed rash on arms and legs approx 4 pm on 9/20/17. Patient took one children's Benadryl at approx 6 pm. At 10 pm, patient noticed large, red hives all over his back. He took two adult Benadryl. Rash was gone by next morning. In the afternoon on 9/21/17, rash had returned, but only on patient's arms. He took two adult Benadryl. Rash did not return after that point.
4.5x3cm area of erythema, mild edema.  Not warm to touch, not painful, but itchy.
Unsure of exact time stated as evening, had seizure lasting 3 minutes, hospitalized because responded slowly, and continued to act abnormalfor several days after seizure, no fever noted prior or during hospitalization
myocarditis; Initial information received on 27-Jan-2022 regarding an unsolicited valid social media serious case received from a consumer/non-health care professional via social media.  This case involves a 29 years old and unknown gender patient who had myocarditis afterreceiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (frequency, formulation, route, strength, lot number and expiry date was unknown) via unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date after vaccination patient had myocarditis (latency: unknown). This event was assessed as medically significant.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (myocarditis).  At time of reporting, the outcome was Unknown for the event myocarditis.; Sender's Comments: Sanofi company dated: 27-Jan-2022: This case involves 29 year old male patient who had myocarditis with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
I am reporting a break through Covid19 infection. I felt achy, cranky, headache and my skin hurt and that was indicative my fever. I ran about 100.8 fever. Symptoms began Saturday May 14th and on Monday the 16th I got tested Positive. As the days went on I got sicker and sicker. Lots of coughing. I called a doctor I work with and got some meds for coughing. Lungs were clear. Rapid heart rate happens and shortness of breath when I begin a new activity.
12/24/2020 she reports approx. 20 mins. after receiving the vaccine that she could feel her heart racing, became extremely dizzy and c/o increased SOB. She reports that after 30 mins. of resting she did have the feeling of her heart racing but cont. of c/o SOB. She noted at her injection site a knot on 12/24/2020  and a 6 in area of redness and swelling at the site.  She reports being nauseated on 12/24/2020 where she had an emesis basin available at all times. On 12/25/2020 she reports having nausea, dizziness and fevers of 99 degrees, plus the soreness in her arm. On 12/26/20 she was able to eat and s/s were "easing up".  12/28/2020 she reports other than the arm soreness she was feeling her normal self. On 01/02/2021 she reports having swelling in her arm at her injection site which she reports that the swelling had disappeared, she noted a hard lump in the area and itching at the site.
The following morning, I felt like I had the flu, but symptoms disappeared within 3 hours.
Shingles; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left on 18Jan2021 08:00 (Batch/Lot Number: EL3247; Expiration Date: 18Feb2021) as single dose for covid-19 immunisation. There were no medical history and concomitant medications. Family history included: older brother had shingles in his early to mid 30's and had mild symptoms. Patient previously had flu shot on 2020. The patient developed shingles on 31Jan2021. Patient was asking if it was okay to take the second dose on 08Feb2021 as she was taking valacyclovir 1gm 3 times a day by mouth for 7 days, started on 02Feb2021 for shingles. Event resulted to a physician's office visit. Outcome of the event was not recovered
Developed slight fever 99.6 and the following joints were achy for 2 days: left ankle, left and right knees, left hip and right shoulder. Also muscle pain left side of abdomen and back. Pain was managed by Advil and symptoms disappeared on the second day. Slight body itch and very small bumps at injection site.
DIARRHEA; CHILLS; LOW FEVER; A MASSIVE HEADACHE; EVERY BONE EVER BROKEN WAS THROBBING HORRIBLY; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight was 90 pounds, and height was 59 inches. 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, and batch number were not reported) dose was not reported, administered on 06-APR-2021 at 12:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced every bone ever broken was throbbing horribly. On 06-APR-2021 18:52, the subject experienced diarrhea. On 06-APR-2021 18:52, the subject experienced chills. On 06-APR-2021 18:52, the subject experienced low fever. On 06-APR-2021 18:52, the subject experienced a massive headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low fever, chills, diarrhea, a massive headache and every bone ever broken was throbbing horribly was not reported. This report was non-serious.
On  04/10 (10 days post vaccination), widespread hives appeared on both legs and top of feet. Red, raised welts were very itchy and got progressively worse. Symptoms resolved about 1 hr after taking 1 Benadryl. Next morning, 04/11, widespread hives appeared again and were more extensive than in the previous day. Hives spread faster and were more severe affecting both legs, feet, and buttocks. Symptoms resolved about 90 min after taking 2 Benadryl tablets.  Hives may have been triggered by skin contact with plants (patient touched leaves of cucumber and tomato plants growing indoors while checking on them). Patient has no history of allergy or skin reaction to plants and touched the plants briefly with her fingers only.  Legs never came in contact with anything. No changes in diet or exposure to new foods.  Can't explain what triggered the hives and suspect immune system is behaving abnormally, perhaps as a result of Moderna vaccine.
This spontaneous report was received from a female patient of unknown age, who was reporting on herself. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date in 2016 (reported as "about a year ago"), the patient was vaccinated in her thigh with a dose of PNEUMOVAX 23 lot # K007262, expiration date 25-NOV-2015 (dose and route of administration were not provided), for prevention of pneumococcal disease. At the time of the report, she needed a needle biopsy of the thyroid for an unspecified reason (onset date was not reported). The outcome of the event was unknown. The relatedness between the vaccine and the unspecified event was not provided.
Information has been received from a registered nurse concerning an approximately 47 year old female patient who was vaccinated with three doses of hepatitis A virus vaccine inactivated. The registered nurse reported the patient has not responded. The reporter indicated she did not have the patient's chart in front of her since they are opening a new practice, and they have yet relocated all the old charts. The registered nurse also reported that there were no dates of immunization available at this time, and no additional information was provided. There was no product quality complaint reported. Unspecified medical attention was sought. The reporter also mentioned that the same patient had a similar experience following vaccination with hepatitis B virus vaccine. Additional information has been requested.
She had red and raised swelling and itchiness at site of injection that spread from shoulder to elbow that occurred half an hour after receiving vaccine. Referred her to urgent care.
Information has been received from a pharmacist concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was inadvertently vaccinated with a dialysis dose (40 mcg) of RECOMBIVAX HB as second dose in RECOMBIVAX HB immunization series where a standard dose (10mcg) was expected (route of administration, anatomical location, lot number and expiration date were not provided). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
pt was given an expired vaccine due to local vaccine recording having incorrect manufactures expiration date listed on site
Immunization: COVID-19 PF (Janssen/J&J), External Administration - Medical System    I82.409 ACUTE DVT, UNSPECIFIED VEIN 10/21/2021 DM 2 W EYE MANIFESTATION
swelling, redness & pain lt upper arm;advised to use ice packs/warm compress & Ibuprofen;pt had swelling & pain 28MAR97 & was seen on 16APR97;
12 hours later, extreme chills, 5 days later a bumpy red, itchy rash on upper chest, neck, face and itchy scalp. Scaly skin.  Day 7 applied Cortizone 10 cream.   Doctor appt. for March 8, 2021
swollen lymph node under arm pit. (left arm); Pain in arm (left arm); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node under arm pit. (left arm)) and PAIN IN EXTREMITY (Pain in arm (left arm)) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 26-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node under arm pit. (left arm)) and PAIN IN EXTREMITY (Pain in arm (left arm)). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph node under arm pit. (left arm)) and PAIN IN EXTREMITY (Pain in arm (left arm)) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.       Treatment information included Advil.   This case was linked to US-MODERNATX, INC.-MOD-2021-077735, US-MODERNATX, INC.-MOD-2021-077745, US-MODERNATX, INC.-MOD-2021-077940 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077735: US-MODERNATX, INC.-MOD-2021-077745: US-MODERNATX, INC.-MOD-2021-077940:
Pt had syncopal episode 2 minutes after injection given. Fell and hit back of head-had seizure lasting 1 min was unresponsive, not breathing x 30 min. Administered ammonia pads and called 911
Pt. passed out while leaving clinic. Mild headache, loss of bladder during syncopal episode brought back to exam room and monitored for 25 min.
COVID-19 rebound infection after Paxlovid treatment; COVID-19 rebound infection after Paxlovid treatment; COVID-19 rebound infection after Paxlovid treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing), notes: Other medical history: Type 1 diabetes; "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 rebound infection after Paxlovid treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "COVID-19 rebound infection after Paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 rebound infection after Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of interchange of vaccine products.  Clinical course: It was reported that if vaccine received: Yes. Other medication in 2weeks: Yes. Other medication in 2weeks product=Novolog insulin. Known allergies: Sulfa. Other medical history: Type 1 diabetes, COVID treatment: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Pt received injection of Pfizer Covid 19 vaccine at 10:28 am, complaint of feeling lethargic and coughing noted at 10:45. complaints of sore throat and difficulty swallowing. coughing getting worse, b/p 154/95, HR 133, o2 sat 100.  0.3 mg of epi given in right thigh @10:46, symptoms improved slightly .  bp@10:55 145/92, HR 122, o2 sat 100%. patient  starts to have difficulty breathing again and cough returned. 0.3 of EPI given again  @ 11:00 , still have complaints of difficulty breathing, 125 solumedrol given IM  right upper quad Gluteal muscle.  patient starts to improve, b/p 143/86, HR 118, o2 sat 100%.  patient monitored for an additional hr because she stated that she did not want to be transferred to the hospital due to lack of insurance. monitored from 11: 15 til 12:20. Discharged home accompanied by daughter, B/P @ 1215 127/90, HR 108, o2 sat 100%. Symptoms all resolved no complaints at the time of discharge. she was able to go to the restroom without issues.
This spontaneous report was received from a physician via company representative regarding a female patient of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml/one time injection, subcutaneous injection. No concomitant medication was reported. On an unknown date the patient experienced shingles. Unspecified treatment was given to the patient and she also called physician to seek medical attention. The outcome of shingles was unknown. Causality between shingles and ZOSTAVAX was unknown. Additional information has been requested.
It was like a bad sinus headache. Then I lost my taste and smell. These lasted for about 10 days. I had a COVID-19 test done, positive result.
The pt sustained a temperature of 103F and slept for 5 hours, following shot. He then began to lose language, throw tantrums and exhibit odd behaviors in the months following. He has since been dx'd with autism, neurological damage and heavy metal (Mercury) poisoning. He did have DTP, OPV and HBPV, 2 months earlier on 5/13/97. Also diagnosed with ADHD.
#non-specific rash erythematous, dry, scaly, excoriated rash, with regions of peeling appearing 1 day after varicella vaccine.  pt denies itchiness, pain, burning, or systemic sx.  Unclear etiology whether if rash 2/2 varicella vaccine or timing was coincidental. If were to treat with anti-viral, could stunt immune response to varicella vaccine. Given asx will do triamcinolone and have close f/u.  -triamcionlone .1% BID -f/u in 1 week-- > if no improvement consider valacyclovir.  -pt to send images to be imported in chart
c/o grogginess, fatigue, aches in joints & all over body; felt jumpy, tingling hands, arms, dropping things; tired-in bed about a week most of the day; h/a, noc sweats;
Pt.'s Mother states that after receiving the 2nd dose of Phizer 08/14/2021, started experiencing symptoms 08/14/2021 3mins after injection of dizziness, head jerking (seizure activity), confusion, and blueish color to the lips. Vitals were taking, possibly blood sugar suggested being low. 10mins later pt. states everything was blurry and not bright. Treated with a Poweraid, 15mins vision finally clearing with 15mins of observation. Pt. and Mother stayed for 45mins to continue to monitor. Symptoms have subsided besides a headache. (Appt. for 04:10pm, Mother was told that facility was out of vaccinations but then @ 04:30pm was administered, questioning expiration dates of vaccines provided.)
At 1:30 am, he awoke covered in hives. Took Claritin. Burning stopped, but itching continued. Developed stomach cramps and vomited. Continued with itchy hives the next day- relief of the itch obtained with Benadryl. Advised to call his physician to discuss treatment options. Pt was in the woods on 4-1-04 collecting environmental samples. Not sure if hives are from Td or exposure to something in the woods. He also has many food allergies. Had previous Td without any reaction.