chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Still has nerve pain goes down both legs to toes; Two lesions on one thigh and one lesion on the other thigh; 2 shots in 2019, then shingles a month ago/suspected vaccination failure; Developed shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had history of several cases of internal shingles prior to Shingrix vaccine). Concurrent medical conditions included diabetes and immunocompromised.   In APR-2019, the patient received the 2nd dose of Shingrix (left arm). In FEB-2019, the patient received the 1st dose of Shingrix (left arm). In MAR-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: 2 shots in 2019, then shingles a month ago/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Developed shingles) and skin lesion (Verbatim: Two lesions on one thigh and one lesion on the other thigh). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Still has nerve pain goes down both legs to toes). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved and the outcome of the skin lesion was resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and skin lesion to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia and skin lesion to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 20-Apr-2023 and 21-Apr-2023 The reporter reported that the patient is diabetic and had a history of several cases of internal shingles prior to receiving both Shingrix vaccines. The patient received two doses of Shingrix on left arm. The patient had no issue since second dose and no flair ups of shingles until my wedding 1 month ago. The reporter reported that the patient developed a case of shingles about 1 month ago in March 2023. The reporter reported that patient had two lesions on one thigh and one lesion on the other thigh. The lesion had resolved now and still had a nerve pain that goes down to both legs to toes. The patient was reading about vaccine lifespan, as patient was diabetic. The patient was wondering about effectiveness of the vaccine for diabetic and the immune compromised. The patient would like to get a third shot, but my pharmacy had issue with this and they quote CDC guidelines. The patient found online comment about the vaccine being 89 percent effective for healthy adults 70 and older after 4 years. The patient would love to have on this and the chance or renewing my vaccine. This case was considered as vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
pts are c/o about a burning sensation @ the inject site following vax; all pts vax from the same lot (298910);
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not reported, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 11-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Patient got ZOSTAVAX on 7-4-11 11:AM, went to church that night got blood pressure taken on same arm. 7-5-11 woke up with bruise and red inflamed area, painful at injection site. Went to MD 7-6-11 & got Rx for SEPTRA DS.
ADMINISTRATION ERROR/ADMINISTERED THE DOSE AFTER 6 HOUR EXPIRATION TIME WINDOW.; MEDICATION ERROR; This spontaneous report received from a health care professional concerned a 23 year old of unspecified sex. 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced administration error/administered the dose after 6 hour expiration time window. On 27-MAY-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error/administered the dose after 6 hour expiration time window. and medication error was not reported. This report was non-serious.
Patient reports she has a DVT, which was found on 2/17/22. Unsure if related to the vaccine, which was given 5/2021
Shoulder pain during injection at the point of vaccination.  Vaccinator never felt for the muscle and injection was administered forcefully.  Experienced 2 days of fatigue after injection along with continued Shoulder and arm pain.  Since then, pain radiating from injection site through bicep and to the wrist affecting ring and middle fingers.  Pain on 10 point likert scale averages 8 per day and has impacted sleep quality and ability to do daily activities.
Right arm at the injection site got pink; Right arm at the injection site got hot; Itches like a mosquito bite; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Right arm at the injection site got pink), VACCINATION SITE WARMTH (Right arm at the injection site got hot) and PRURITUS (Itches like a mosquito bite) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Macular degeneration. Concomitant products included LOSARTAN for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Right arm at the injection site got pink), VACCINATION SITE WARMTH (Right arm at the injection site got hot) and PRURITUS (Itches like a mosquito bite). The patient was treated with Wound care for Vaccination site erythema. At the time of the report, VACCINATION SITE ERYTHEMA (Right arm at the injection site got pink), VACCINATION SITE WARMTH (Right arm at the injection site got hot) and PRURITUS (Itches like a mosquito bite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient is taking shots in the eyes for muscular degeneration and putting an ice pack on the arm.
This spontaneous report as received from a medical assistant via company representative refers to a patient of unknown age and gender/ No information on their medical history or concurrent conditions was provided. On 19-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous, which expired on24-JAN-2015, lot/batch number not provided, expiration date 24-JAN-2015. No adverse effect was reported. Additional information has been requested.
Patient received incorrect product/dosage, resulting in a higher-than-authorized dose. Patient received Pfizer vaccine authorized for 12+ years old when patient is 9 years old. Patient received 0.2ml of 0.3ml of typical 12+ Pfizer dose. Meaning patient received 20mcg when typical 5-11 year old dose is 10mcg.
Grandmother came to clinic on 9/30/2014 with child, said child got rash the day after the vaccines was administered. Generalized papular rash noted to include head and soles of feet.
13 hours after reviving the vaccine I was awoken from my sleep with severe vertigo. I felt as if the room was spinning while I was falling off a cliff. I woke my husband up by calling his name. He tried to help me sit up at which point I screamed because I felt as if I had fallen out of an airplane and was dropping. I needed assistance to even walk to the bathroom that first 24-48 hours. I was hugging the walls and extremely sick to my stomach. The room would not stop moving. After 72 hours the severe spinning let up and now I feel as if I am on a boat, with the severe airplane drops happening only occasionally. (About 3 times a day). I have much improved but the vaccine induced vertigo is still here. I need to use a cane to keep my balance when I walk. Even though I have a history of vertigo,  I had not had vertigo prior to the vaccine for over a year. I also have NEVER had vertigo come on this suddenly or this severe before.
This spontaneous report was received from a pharmacist via a consumer refers to a patient of an unknown age and number. On an unknown date patient was vaccinated with ZOSTAVAX (lot#, expiration date and route not reported). The pharmacist stated that the patient got sick after getting an injection on an unknown date from the same batch. He was sending the batch to Centre For Disease Control (CDC). The outcome of the event was unknown. Causality was unknown. This is one of the several reports from the same source. Additional information has been requested.
Became extremely fatigued starting approximately 12 hours after receiving 2nd dose of Pfizer Covid vaccine.  Fatigue lasted 48 hours, sleeping nearly 18 hours each day.  Experienced a mild headache approximately. 12 hours after 2nd dose of Pfizer Covid vaccine.  I took Tylenol 325 mg, headache resolved  4 hours later.
Initial report received from Literature on 17 July 2014. The following verbatim obtained from article abstract: Report of case: A 31-year-old physician presented with progressive daytime sleepiness 2-3 months after receiving an adjuvanted H5N1 Influenza vaccine in a clinical trial. When his sleepiness began, he had episodes of syncope and falls without loss of consciousness, one resulting in a wrist fracture. Cardiac evaluation revealed asymptomatic bradycardia and high vagal tone. Despite trials of Methylxanthine therapy, his symptoms progressed. Over the following year, his weight increased 21 kg but was subsequently improved with intensive exercise. He reported variable sleep latency and 8-9 hours of total sleep time. He had frequent sleep attacks that resolved with napping, nightly hypnagogic hallucinations and episodes of sleep paralysis. His wife denied snoring, apneas or abnormal movements. Exam revealed a heart rate of 50, normal oxygen saturation, body mass index of 23 kg/square meter and class 1 Mallampati score. His initial Epworth sleepiness scale score was 21. Overnight polysomnogram showed a sleep latency of 10.5 minutes, 92% sleep efficiency, REM latency of 145 minutes with 4 discrete REM periods, with no evidence of sleep disordered breathing or movement disorder. Multiple sleep latency testing revealed a mean sleep latency of 8 minutes with 2 sleep-onset REM periods. He was diagnosed with narcolepsy and modafinil was initiated. After 12 weeks of therapy, daytime sleepiness was improved; however, the patient had worsening hypnagogic hallucinations, sleep paralysis and cataplexy without syncope. Sodium oxybate was added to modafinil. Conclusion: Beginning in 2010, there has been an increased incidence of narcolepsy in patients receiving an adjuvanted H1N1 influenza vaccine. In November 2013, the FDA approved the first adjuvanted influenza vaccine (H5N1) for use. This is the first reported case or narcolepsy following administration of an adjuvanted H5N1 influenza vaccine. Documents held by sender: None.
Right deltoid swollen hot to touch. Child not playing gets up goes back to bed. Eating habits changed eats less, fever very low grade. Fussy, painful.
Red, swollen, hot area at site Varicella was given, in right arm.   - 1 day after vaccine was given.
Information has been received through the pregnancy registry for GARDASIL from a registered nurse concerning a 14 year old female with no pertinent medical history and no history of drug reactions or allergies who on 18-AUG-2008 was vaccinated with the first dose of GARDASIL (lot#: 659653/1448U) 0.5ml IM. There was no concomitant medication. A subsequent pregnancy test on the same day was positive. No problems were reported. The LMP was "3 weeks ago" (on approximately 29-JUL-2008). The EDD is 05-MAY-2009. The patient sought unspecified medical attention. Follow up information has been received from a registered nurse concerning the 14 year old female patient who on an unspecified date had a pregnancy termination. Upon internal review, pregnancy terminated was considered to be an other important medical event. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 10-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II, albumin status recombinant human albumin (rHA), lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA008742.
Raised, angry red around the site of injection. Painful if touched. Dimensions of redness: 6 in. length x 3 in. wide lasting approximately 48 hours but improving each day.
a little discomfort around injection site; injection site pain; This is a spontaneous report from a Pfizer Sponsored program. A contactable male consumer reported for himself. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: unknown; Expiration Date: unknown), via an unspecified route of administration on an unspecified date, as SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications took Tylenol 2 hours before vaccine. On an unspecified date patient received first dose of BNT162b2 as single dose for covid-19 immunization. On an unspecified date, the patient experienced a little discomfort around injection site, and injection site pain. Patient stated that he did not see in the guidance prior to vaccine not to take tylenol, caller took tylenol 2 hours before vaccine. Patient wanted to know if there is any info on the specific effects that might have happen as he said he is now aware that people should not take pain killers before getting the covid vaccine. The outcome of the events was unknown.  Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8730), on 15Apr2021 as dose 2, single (Lot number: ER8731) and on 28Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: product=COVID 19 Treatment, brand=Paxlovid, Treatment start date=07Jun2022, treatment stop date=12Jun2022.
Patient had symptoms of shortness of breath and palpitations which lasted for 2 to 3 days initially and most of the day. He still reports some occasional intermittent symptoms
severely ill; Initial information was received on 24-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.  This case is linked to 2020SA308167, 2020SA308163, 2020SA308169, 2020SA308170, 2020SA308171, 2020SA308172, 2020SA308173, 2020SA308174, 2020SA308175 and 2020SA308176 (same reporter).  This case involves a patient (age and gender unspecified) who gets severely ill (illness) after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.   On an unknown date, it was reported that the patient used to get ill (illness) (intensity: severe) (unknown latency, non-serious event) after receiving INFLUENZA VACCINE.   She does better without the vaccine.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the lot number for this case.
After receiving vaccination, 2 minutes later, patient fainted at 1123. Nurse elevated patient's legs, cold compress applied to back of neck. Patient regained consciousness within the next minute. Patient denied feeling dizziness and lightheadedness. First set of vital signs initiated. BP, RR, pulse ox all WNL. HR was 50, but patient reported that is her baseline as she states she "runs and exercises often".   Second and third set of vital signs initiated and both WNL. Patient reported feeling better and brought to observation at 1140 where patient stayed an extra 15 minutes. Patient left in stable condition at 1155.
Dizziness, continues fever after 4 days, intense, full body  aches,  swollen, red, hot, itchy arm with a red area that covers most of the upper arm.
Low fever; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she knew running a fever after this vaccine was a side effect and asked if this fever make a person contagious. The patient stated that she was not sick so she would assume she was not contagious.
During first shot, I got covid arm about 1 week after shot.  After second shot, I had fever, headache and nausea for 2 days-onset within 3 hours of shot. Took 3-4 days to regain strength from fatigue. All of which was to be expected based on literature. However, two weeks later I got hive-like spots resembling a bug bite. They only appeared on my lower left arm.  There are about 20-25 small raised itchy spots. Currently they have been there for 4 days. They are less itchy than onset but get worse with heat or added clothes layers.
Rash covering upper arm-shoulder to elbow after 10 days Fatigue - After 10 days generally feeling unwell - after 10 days
Patient experienced pain radiating up the neck, down the arm on day 1. Noon on day 3, pain radiated down to the knee and hip on the same side. She also described a transient paralysis on the same side.
PT WAS GIVEN THE MODERN COVID19 VACCINE, WHICH IS NOT FDA APPROVED FOR ANY PERSONS UNDER THE AGE OF 18 YEARS OLD. AT THE TIME OF ADMINISTRATION, PATIENT WAS 16 YEARS OLD. PT HAD BODY ACHES, FATIGUE AND A LOW GRADE FEVER AFTER ADMINISTRATION OF THE VACCINE. SYMPTOMS SUBSIDED  ABOUT 12 HOURS AFTER ADMINITRATION. PER PATIENT'S MOTHER, SHE IS OKAY WITH PATIENT RECEIVING THE SECOND MODERNA COVID19 VACCINE WHEN APPROPRIATE.
It is my first pregnancy. I am 21 weeks along and due March 17, 2023. The morning after receiving my booster shot (my fourth shot total) for the COVID vaccine, I experienced extreme pain in both my arms and hands. I could not move or pick anything up. On the third day, the pain subsided in my left arm but was higher and concentrated to my right arm. If I kept my arm very still for an extended period of time, the pain would lessen. I could not move my arm and it was debilitating pain. For the two days following my vaccination, I would say my pain levels were at a 10 (on a scale of 1-10).  By the fourth day, the pain had gotten better (level 7 or 8) and wasn?t covering my entire arm and hands. It was only in certain spots on my arm and in my hand. However, I still could not grip anything nor could I pick things up so I decided to see a doctor. I didn?t have a primary care physician at the time so I went to the Emergency Room. They suspected it may be carpal tunnel and treated it as such. They gave me acetaminophen, a lidocaine patch, and a wrist brace. It provided temporary relief. I am now on my fifth day out from my vaccination and I am still having wrist pain in both wrists (level 5 or 6), along with arm pain in the arm I got my shot in.
Information has been received from a registered nurse through a Merck Pregnancy Registry concerning a 23 year old female with allergies to sulfamethoxazole (+) trimethoprim (BACTRIM) and nitrofurantoin (MACROBID) high blood pressure but no current blood pressure medication. Rhesus antibodies (RH) negative, and a history of cervical dysplasia, urinary tract infections and Caesarian (C) section for first child, year 2006, who on 25-AUG-2006 was vaccinated with HPV vaccine (yeast). The nurse reported that the patient was scheduled for a leep procedure, due to cervical dysplasia on 20-SEP-2006 and before the procedure a blood serum pregnancy test was taken, and result was positive for pregnancy. Additional information has been requested.
interchange of vaccine products; Revaccination with different COVID-19 vaccine; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Biontech and AstraZeneca vaccin (Vaxzevria). Past adverse reactions to the above products included No adverse event with AstraZeneca vaccin (Vaxzevria) and Biontech.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications was reported. No treatment medications was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.