chrisvoncsefalvay/vaers-outcomes huggingface dataset:
as a result of moving broken vials of VARIVAX. The AE consisted of a cut finger; as a result of moving broken vials of VARIVAX. The AE consisted of a cut finger; This spontaneous report was received from an office manager and refers to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 05-JUL-2023, she got a cut of her finger (skin laceration) while she was moving broken vials of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection that were used as prophylaxis.  She recovered from the event on an unspecified date of July 2023. The causal relationship between the event of skin laceration and the suspect vaccine was not provided.
Pt received vaccine at approx 8:30am.  At approx 7:30pm she noticed hives on her lower torso.
The pt developed  generalized itchy blister rash and treated with benadryl and aveeno.
Ache in the arm side of the shot for few days, followed by headache 3-4 days later associated with tremors. Then was seen by a health care provider on Jan 28th, Symptoms worsen, and was admitted to ER on January 31, 2020. The situation persists. She has not shown neurological symptoms prior.
fever 103 R, lt thigh swollen hard, same red, started 1-1 1/2 hrs p/shot, lack of appetite; put on ATB (may have ear infect); fever stopped on 12SEP91 during nite;
1 of 9 pts immunized from same lot 366949; not the same vial; who exp induration & poss erythematous nodule approx 2 inches in diameter @ inj site; nodule persisted 6-8wks;
Information has been received on 26-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions and concomitant medications are unknown. The patient had a medical history of a skin condition in 2013 that was inconclusively determined that it could be shingles. The patient was informed that the ZOSTAVAX could be effective in preventing the recurrence of shingles if the episode was herpes zoster. On or about 13-AUG-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of future shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster that persisted for years in duration. On or about 28-DEC-2013, the patient was treated by a physician and again further treated by another physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 22-SEP-2014, the patient was again treated by a physician for ongoing and worsening symptoms of shingles, at which time she was given the additional diagnosis of post-herpetic neuralgia, a chronic condition of residual pain and nerve damage secondary to zoster infections. The patient was hospitalized for the severity of her post-herpetic neuralgia. On or about 08-AUG-2016, the patient sought subsequent treatment for ongoing and uncontrolled symptoms of post-herpetic interfering with her daily life. The patient has been prescribed NORCO, VALTREX and hydrocodone for management of her painful breakouts. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
pt appeared last noc, pale, pink raised rash surrounding site where vax given-3"-4" diameter;took to ER told nothing they could do & to take pt home;pt denies itching or pain @ site;throat sl red & gland palpable under lt mandible;
pt recv vax 1115AM @ time of school physical;fidgeting & nervous a/shots;11:30 felt faint & dizzy, VS BP 90/58;@ 11:55 BP 94/64, HR 80, RR 20;
This spontaneous report was received from a licensed nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 days (192 hours, worst case), and a temperature excursion of 47 to 77 degrees Fahrenheit for 1 hour, however it was reported that no previous temperature excursion was performed. The call was because of a "data logger". This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA013302: US-009507513-1707USA013303: US-009507513-1707USA013214.
Fine sand paper rash back, face neck on set go after 5th dose ZITHROMAX after immun. Vaccine sites at thighs without any rash No dyspnea.
Started having sudden extreme high blood pressure spikes. I have developed a heart arrhythmia. My heart is misfiring (PVC?s/PAC?s)
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was Cardinal refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved  for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
shingles; WORST PAIN; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced shingles. The patient stated that it was by far the worst pain he/she had ever endured and was going on 4 weeks now. The follow-up would not possible as no contact details were available.
Patient went to ER on 11/07/14 for severe pain and swelling at site of vaccines. Fever > 102 F. Ultrasound of site performed and subcutaneous edema is identified without evidence of mass, lesion, or focal fluid collection.
On June 28 2022, the night before I was feeling a bit sniffly.  That morning I felt like I had a very bad head cold and I had a cough.  I tested positive for COVID-19 on my home test.  I reached out and had a video visit with a PA I asked about Paxlovid.  It was prescribed and by the next day I was feeling a lot better.  Within two to three days I felt like I had never been sick.  I also had body aches.
Immediately felt like her throat was swelling, hard to swallow. States this has been frequently happening to her since March, unrelated to illness or medications. Is under treatment by ENT to discover etiology.
This spontaneous report as received from a pharmacist refers to an unspecified group of patients. No demographic information was provided. It was stated that unspecified patients were vaccinated with RECOMBIVAX HB pediatric formulation that was exposed to 51F for 15 minutes. No adverse effects were reported. No further information was provided. Additional information has been requested.
Swelling, warmth at Rt deltoid injection site 5 min after vaccine administration. Then c/o numbness, tingling in rt wrist area 45 min after mild pain @ injection site. Ice pack given.
A report was received from a consumer on 1/7/02, concerning a 28 year old male pt who experienced headaches, sore throat, tonsillitis, vomiting and numbness from the chest down, 36 hours after receiving the Fluvirin vaccine on 11/14/01, which resulted in hospitalization and disability. He also, at one point, was unable to move his right leg. 16 days, post vax, the pt was admitted to the hospital on the 11/30/01 and remained there for 3 weeks. The pt had not recovered at the time of reporting. There was insufficient information to determine the reporter's causality assessment. A follow-up report was received on 1/28/02. Further to the symptoms already noted, the pt experienced a severe reaction to the Fluvirin vaccine resulting in swelling of gums, fever, dehydration, chills (shivering) and the inability to control body temperature, tiredness and lack of energy, at the time of reporting, his vomiting meant he could not take any liquids, he suffered pins and needles/numbness all over the body below T3. His inability to move his right leg meant he could not walk for several weeks. At the time of reporting, the pt had ongoing numbness of the right leg and right side. He was dx'd with transverse myelitis. The pt was discharged from the hospital on 12/19/01. A 2nd follow-up report was received from a health professional on 4/15/02. A consultant neurologist dx'd the pt with transverse myelitis. The pt was admitted to the hospital on 12/5/01 and was discharged on 12/20/01. At the time of reporting, the pt's condition had "settled to almost complete resolution" but minor numbness at the front of the leg remains. The pt has no previous relevant previous history and was taking no concurrent medications at the time of the event. The reporter assessed the causality as probable.
Patient reported that she started with fever and soreness to the arm, she as felt very tied... as going to the next day her fever become very high and she has rash on breast thighs and virginial area... she stated that the rash is red and hot to the touch
Site: Swelling at Injection Site-Medium, Additional Details: Patient showed up prior to pharmacy close, seen by opening pharmacists at around 8:10 am. Patient experienced pain at injection site immediately after vaccination. woke up to a large fluid filled sac around injection site in the morning with continued pain. Note: Pt had applied biofreeze the night before. Also, there seemed to be some discoloration of the skin surrounding injection site, not sure if due to biofreeze or vaccine. Pt will be going to a nearby minute clinic for further evaluation.
Patient given refrigerated Moderna vaccine expired beyond the date of 01/27/2022. Vial placed into fridge on 12/28/2021, but not removed from fridge in time for 'beyond use' expiry date. It was inadvertently administered. Manufacturer's expiry date is March 25, 2022. Provider informed. Moderna affirmed 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.' Patient notified and no adverse effects noted.
Rabavert has not been given at this time; Case reference number US-BN-2021-001681 is a spontaneous case report initially received on 10-May-2021 from a pharmacist via Agency (reference number: USBAV21-0206) and concerned a male patient of unspecified age.   The patient's medical history was not reported.  The patient's concomitant medication included HRIG (immunoglobulin human anti-rabies) for post-exposure.  On unspecified date, the patient was supposed to receive Rabavert (Rabies Virus (Inactivated, Strain Flury LEP) (PCEC); batch number: not reported) at unknown dose for post-exposure, but the vaccine was not given (explicitly coded as 'Product dose omission issue').  The reporter did not give consent for further follow-up.  This case is linked to the case US-BN-2021-001682 (the same reporter).   No further information was provided.; Reporter's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received only HRIG for post-exposure and RabAvert was not administered. That is considered to be missed dose. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.; Sender's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received only HRIG for post-exposure and RabAvert was not administered. That is considered to be missed dose. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (expired vaccine used) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031H21A) for COVID-19 immunization. No medical history reported. On Jan 11, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 11, 2022, patient experienced administered expired product (expired vaccine used). On Jan 11, 2022, administered expired product (expired vaccine used): resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter stated her clinic administered vaccinations past the expiration date for the Moderna COVID-19 vaccine. HCP stated some patients reported flu-like symptoms after receiving the vaccination but she did not have those details.
Left shoulder swelling, redness, tenderness, nausea, malaise, fever to 102. Treated with IV and PO antibiotics as cellulitis both complete improvement.
About 1 week later, my daughter developed a rash at the injection site. It does not itch or hurt.
ON JULY 28/2021 IN THE MORNING AROUND 10:30AM HE STARTED COMPLAINING ABOUT CHEST PAIN AND TIGHTNESS, HE CALL FIRE RESCUE THEY CHECK HIM BUT DIDN'T TAKE HIM TO THE HOSPITAL.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 18-JUN-2012, the patient was vaccinated with a first dose of VAQTA 25 U Injection (lot #, dose and route not reported). On 14-NOV-2012, the patient received a second dose of VAQTA 25 U Injection. No other co-suspects were reported. No concomitant medications were reported. The patient received two doses of VAQTA less than 6 months apart. No adverse effects. No additional information provided. Additional information is not expected.
3 hrs sweating, SOB & pulse 110; duratin was 4 to 5 hrs;
The shoulder where the shot was given became slightly sore and progressed to an extreme sore later in the evening about 8:00 PM. It has been 2 full days and my shoulder is still very sore.
Pustulant rash on trunk, chest, and thigh area. Also, had fever per mom.
Vomiting; Upset stomach; loss of appetite; she cannot have her on the school campus like that.; Nausea; This is a spontaneous report from a contactable nurse (patient's mother). A 16-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Aug2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Bnt162b2, Solution for injection) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 03Aug2021 she started vomiting. On an unspecified date in Aug2021, the patient experienced nausea, upset stomach, loss of appetite, she cannot have her on the school campus like that. She was still felt nauseous like she was going to throw up. Outcome of the events loss of appetite and she cannot have her on the school campus like that were unknown and outcome of rest all events were not resolved.  Follow-up attempts had been completed and no further information was expected.
A day after receiving vaccination, experienced swelling and restriction of movement in right arm, could not move shoulder above head, celecoxib prescribed and exercises recommended, as of 9/24/18 still experiencing restriction but swelling has reduced but not resolved.
Hypersensitivity reaction; This spontaneous case was reported by a dentist and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 041L20A) for COVID-19 vaccination.     Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for Bladder disorder NOS, ROSUVASTATIN CALCIUM (CRESTOR) for Hypercholesterolaemia, GABAPENTIN for Spinal disorder NOS, OMEGA-3-ACID ETHYL ESTER (LOVAZA), PANTOPRAZOLE, FISH OIL and VITAMIN D NOS for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021 at 11:00 AM, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) from 14-Jan-2021 to January 2021 for Adverse event, at a dose of 1 dosage form; METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) 03-Feb-2021 for Adverse event, at an unspecified dose and frequency; IBUPROFEN at a dose of 2 dosage form and NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 2 dosage form. On 16-Jan-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient informed that her arm started to itch and when she scratched it, it was very warm and red. She experienced symptoms of hypersensitivity reaction including itching/pruritis, rashes, arm was warm (hot localized), indurated hive at injection site, photo sensitivity to sun, hot pink look on the skin/red. The side effects of sensitivity was stronger at time of first dose but caused no skin damage, just a quick dark pink button color to skin exposed to sun. Patient's vitals including body temperature, heart rate, respiratory rate and blood pressure on 14-Jan-2021, were reported within limits. She reported that her symptoms of 'itchy red, warm to touch, elevated hive' were eliminated two days after taking Medrol pack.  The Medrol pack was taken at the time of second vaccine and there were no side effects at all. Also, she reported that the sun sensitivity was not as strong with the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2021: Additional reporter details, action taken and concomitant medication details were updated. Final diagnosis of 'hypersensitivity reaction' was captured as the only event.
VERBALIZED BIG RED SPOT AT INJECTION SITE; INCORRECT ROUTE OF DRUG ADMINISTRATION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, subcutaneous, batch number was not reported) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On 11-JUN-2021, the patient experienced incorrect route of drug administration. On an unspecified date, the patient experienced verbalized big red spot at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed.. The patient had not recovered from verbalized big red spot at injection site, and the outcome of incorrect route of drug administration was not reported. This report was non-serious.
pt recvd vax 3OCT95;10OCT95 pt came to the clinic & reported that on 4OCT lt arm was real sore & 3 fingers were numb; went to PMD & was told the inj was given close to a nerve;
patient c/o heart racing that lasted about 3 mins in duration. administered a total of 50mg of IM Benadryl. after 10 minutes, patients heart rate went from 142bpm  to 74 bpm.
5 minutes post vaccination patient complained of chest and bladder pain described as short and hot. 10 minutes post vaccination patient felt an urgent need to urinate. 15 minutes post vaccination patient begin to urinate, projectile vomit and have extreme diarrhea. This was followed by shortness of breath. Patient projectile vomited 4 times within a 15 minutes span. Patient defecated twice within the same 15 minutes span. Patient shortness of breath lasted approximately 15 to 20 minutes. EMTs arrived approximately 40 minutes after onset of allergic reaction. Patient transported to Hospital for observation and follow up.
Booster in September On December 4, I felt like i had a heavy head and chest cold.  Sneezing, yucky phlegm.  By Tuesday I went to doctor as I had a cruise coming up and wanted to make sure my cold wouldn't get worse with my asthma.  But I tested positive for COVID.  The doctor gave me paxlovid and aside from one day feeling like the flu, I was negative by Saturday.  On Friday, December 16, it started again, but this time I tested immediately and was positive.  Also this time, I felt very sick with Flu for 4 days before I felt better.  The doctor called in antibiotics to help my lungs.  I am negative now, but still coughing up a little gunk.
Dad called clinic reported left arm closer to the top injection site was swollen, red, hot and firm. No raised. Size of 2 golf balls. Acting fine otherwise. 7-20-07 Spoke with Dad - doing better, has decreased in size.
First shot on 01/18/21: Very mild case of hives across upper chest from shoulder to shoulder Second shot on 02/13/21:  More severe but still mild case of hives across entire chest from shoulder to shoulder  NB:  Have never previously experienced a case of hives or any adverse reaction to vaccination in my entire life
C/o nausea and extreme dry mouth. EMS evaluated.  Vitals stable given water. Felt better.  Left with companion to home.
pt devel a single urticaria on rt this w/erythema immed p/getting vax;given DPH which had to be repeated d/t emesis;observed x 45min;no further sx redness;
Occipital Lymph node on left side swelled and was very painful. It lasted about a week and a half or approximately 10 days