chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she received her 3rd dose of the Mdoerna vaccine due to being immunocompromised due to steroids.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (she received her 3rd dose of the Mdoerna vaccine due to being immunocompromised due to steroids.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088O21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Immunocompromised due to steroids).   On 16-Aug-2021, the patient received third 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. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (she received her 3rd dose of the Mdoerna vaccine due to being immunocompromised due to steroids.). On 16-Aug-2021, EXTRA DOSE ADMINISTERED (she received her 3rd dose of the Mdoerna vaccine due to being immunocompromised due to steroids.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient felt that the pharmacy was not following best practice after the vial is punctured.  She stated there was news of a pharmacist who gave saline injection instead of Moderna vaccine but said the saline injection was Moderna vaccine.  Concomitant medication included unspecified steroids.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received and contains no new information.
Patient's mother originally signed up for Pfizer for her 12 year old daughter's first covid vaccine.  On arrival, patient's mother requested to change it to Moderna vaccine because patient's mother heard that Moderna has less side effects than Pfizer. Intern Pharmacist did not check the age requirement for Moderna vaccine and proceeded to administer to the pediatric patient. After the administration, patient's mother asked the intern when her daughter can get the next dose. Intern replied and said after 28 days. Mother wanted to her daughter to get 2 doses of vaccine prior to her daughter's trip, as 2 covid vaccinations were requirement for the trip. The daughter had to get fully vaccinated 2 weeks prior to departure. Intern pharmacist did not report about this incidence to the pharmacist. As I, the pharmacist, was processing vaccination documentations, I realized that patient was underaged for the Moderna vaccine. Patient's mother was contacted again to get more information.  No serious side effects was discussed during conversation.
Redness in the arm after 9 days. Itching a little bit and disappear after 2 days. Skin in that area was dry.
First few days:  Extreme weakness, cold/flu  like symptoms, No strength in arms, legs.  After 2nd week took her to the Hospital, vital signs normal, but by this time could not walk or talk.  No appetite, getting weaker & weaker.  Cough with white phlegm . Dr. put her on Aerosol & antibiotics. 3rd & 4th week, Dementia symptoms.  No Bowel control by then and totally incoherent.  Now total Dementia, she had no history of Dementia, Totally handicap, can not walk or talk difficulty in eating only liquids. Bed ridden, she was a vibrant woman before this Covid Vaccine .
feels very tired/extremely fatigued/feels tired all the time; muscle pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feels very tired/extremely fatigued/feels tired all the time) and MYALGIA (muscle pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 3 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Sep-2021, the patient experienced FATIGUE (feels very tired/extremely fatigued/feels tired all the time) and MYALGIA (muscle pain). At the time of the report, FATIGUE (feels very tired/extremely fatigued/feels tired all the time) and MYALGIA (muscle pain) outcome was unknown.            Caller is calling regarding their mother who took the third Moderna COVID-19 vaccine shot on 02Sep2021t as she is immunocompromised. There had passed 5 months and a week between the 2nd and the 3rd shot. She still feels very tired since that date. The caller does not have their mother's card so more details of the doses could not be gathered. The patient had blood tests done to check what could be happening but everything came back normal. country after the shot.  Concomitant medication use was unknown Treatment information was unknown
It Started with numbness and tingling in left hand and foot the afternoon after getting 1st shot. My left hand is no longer tingling/ numb, but my left foot continues to be tingling/numb.
feel light headache(last for 2 days), nauseate(last for a day), chill(last for one day). arm swelling and pain.
received only the adjuvant component; received only the adjuvant component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number L4LHS, expiry date unknown) for prophylaxis.   On 17th June 2021, the patient received Shingrix. On 17th June 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No expiration date was reported. The reporter consented to follow up.
On 6/19/22 patient was out to dinner and experienced a choking episode. Seen at local County Hospital and diagnosed with a food impaction. No PEDS GI available to transported by parents to alternate Hospital. Kept overnight. Impaction was removed and a biopsy was done by endoscopy on 6/20. Diagnosed with EOE. No history of EOE or food allergies previously. Had f/u visit and repeat endoscopy in September 2021. Absolutely no EOE seen on biopsy and no symptoms since original episode. No new foods or medicines prior to 6/19 episode. Seen by allergist and no allergies found.  Allergist concluded this may have been related to the Pfizer vaccine.
Body aches; 101.7 temp; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Mar2021 12:30 (Batch/Lot number and expiry date not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a public health clinic/veterans administration facility. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. Concomitant medications included sertraline taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route, left arm, on 15Feb2021 12:00 (at the age of 63 years) as dose 1, single for COVID-19 immunization. The patient experienced body aches on 09Mar2021 12:00 with outcome of recovered on Mar2021, 101.7 temp on 09Mar2021 12:00 with outcome of recovered on Mar2021, and fatigue on 09Mar2021 12:00 with outcome of recovered on Mar2021. The patient underwent lab tests and procedures which included body temperature: 101.7 on an unspecified date. No therapeutic measures were taken as a result of the events. The events were assessed as non-serious.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
7/20/19 Febrile seizure - seen in ER. Also had vomiting + h/o recent diarrhea. Bloodwork, urine normal. Abd sono with mesenteric adenitis. T 100.3 in ER.
This spontaneous report was received from a physician referring to 12-month-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 28-JUL-2017, the patient was vaccinated with improperly stored doses of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
Six days later, she can still see it and still has some sensitivity in her left arm.; Faint redness still; Woke up with a red welt on my left arm; Welt started lessening and going down; Combination between an itchy rash and a welt; The first 24 hours was extremely painful; Woke up with a red welt on her left arm. It was itchy; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Woke up with a red welt on her left arm. It was itchy), VACCINATION SITE REACTION (Six days later, she can still see it and still has some sensitivity in her left arm.), ERYTHEMA (Faint redness still), VACCINATION SITE ERYTHEMA (Woke up with a red welt on my left arm) and URTICARIA (Welt started lessening and going down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049121A, 12T1213, 037C21A and 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, the patient experienced PRURITUS (Woke up with a red welt on her left arm. It was itchy), VACCINATION SITE ERYTHEMA (Woke up with a red welt on my left arm), URTICARIA (Welt started lessening and going down), RASH PRURITIC (Combination between an itchy rash and a welt) and VACCINATION SITE PAIN (The first 24 hours was extremely painful). On 25-May-2022, the patient experienced VACCINATION SITE REACTION (Six days later, she can still see it and still has some sensitivity in her left arm.) and ERYTHEMA (Faint redness still). At the time of the report, PRURITUS (Woke up with a red welt on her left arm. It was itchy), VACCINATION SITE ERYTHEMA (Woke up with a red welt on my left arm), RASH PRURITIC (Combination between an itchy rash and a welt) and VACCINATION SITE PAIN (The first 24 hours was extremely painful) had resolved, VACCINATION SITE REACTION (Six days later, she can still see it and still has some sensitivity in her left arm.) and ERYTHEMA (Faint redness still) had not resolved and URTICARIA (Welt started lessening and going down) was resolving.     Concomitant product use was not provided by the reporter.  The patient states she had side effects. She had no problems with any except the second booster. Twenty-four hours later, she woke up with a red welt on her left arm. It was itchy. It was combination between an itchy rash and a welt. Then the welt started lessening and going down within two days. Six days later, still had some sensitivity in her left arm. The welt was gone, but there was still a faint redness. The first 24 hours was extremely painful.   Treatment information was not provided.
pt fainted roughly 5 minutes following administration of covid dose. pt observation- pt gradually felt more like himself and took 1st bp @1:15pm (107/72 mmhg)  second reading @1:36pm (132/84 mmhg). paramedics were initially called and arrived at 1;20pm and pt refused treatment , paramedics also confirmed he was ok.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020) for prophylaxis. On 2nd June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that that patient received the 2nd dose of SHINGRIX and had arm pain which lasted for 2 days and then resolved.
Headache, diplopia, ataxia. Eventually diagnosed with Bickerstaff brainstem encephalitis.
30 hours after vaccination, redness and strong itchy feeling at vaccination site, subsided in 12 hours  +-7 days  after vaccination, redness and strong itchy feeling at vaccination site returned, subsided in 12 hours  Nothing since
swollen lymph glands; This case was reported by a consumer via interactive digital media and described the occurrence of enlargement of lymph nodes in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. On 23rd June 2020 at 12:03:57 PM, the patient asked, are the swollen lymph glands was a side effect of Shingrix.
Large red circle/splotch at the injection site. Tender. Appeared 13 days after injection.
I had my vaccination on 09/30/2022. On 10/01/2022 I woke up from a nap and I could not move both legs as they were too weak. On 10/02/2022 that evening I vomited with an episode of diarrhea. I was having blood work done every 2 weeks. On 10/03/2023 my blood panel showed that my T Cells had decreased. Nothing was provided in regard to HIV medications. I was provided compassion care for when HIV medication does not work and this course of treatment worked. It is 2 injections administered twice a year. The results were favorable and increased my T Cells.
First dose was uneventful.  After the second dose of vaccine I experienced neck and back of head pain.  It's always there.  Ibuprofen does not take the entire ache away.  Hoping that this will subside.  Trying massage, yoga, and home heat massage.  It's like a tooth ache.
Pt complained of pain immediately upon receiving vaccine. Stated she had never had any adverse reactions to vaccines previously. Pain mostly in the back. Head felt full she said. Did not want us to call EMS. Had her sit  and although pt did not feel dizzy/faint we put an ice pack on her neck, gave her water and juice. Stayed with her til she felt better and then called and checked on her later. She stated she still felt weak about 3 hrs later but was improving with time. Told her to call us if any further issues
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2007, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On unknown dates during 2007 and in 2014, the patient was treated by a hospital for vesicular outbreaks, which were diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
Work up to a rash on forearms, legs & hands 3 days after Booster shot. Hands were the worst with raised bumps that felt like burns.
on or about June 26 my neck started to swell below my jaw and two nodules, one near C4 cervical spine and a secondone  below neck swelling became palpable increasingly throught the week. I experienced difficulty swallowing, dryness and irritation on the back of the left side of my throat. I used some Afrin and nasal spray because it seemed to be related to post nasal drip. The swelling became more prominent and tender. I set an appt with my primary care, Dr for the following week. By the weekend my throat was inflammed the swelling more painful and concerning,  no fever or other symptoms. I went to the ER July 3rd where they performed labs, US and CT scan.  I was sent to ENT Dr  for a biopsy on July 7 with a B cell lymphoma result . PET scan was performed on 7/27 and awaiting results.
she fell down and blacked out; dehydration; Dizzy; weak; woke up 3 different times to use the bathroom; Broke out in terrible sweat twice; was bruised up; Fever; Really sore arm; flu like symptoms; A spontaneous report was received from a consumer concerning an 82-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms, a really sore arm, fever, woke up 3 different times to use the bathroom, felt like she would pass out, felt dizzy, weak, blacked out, bruised up, broke out in a terrible sweat twice, and dehydration.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 13 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient experienced flu-like symptoms and a really sore arm. The following two days she "was okay".   On 17 Jan 2021, the patient had a fever of 99 degrees F; it was reported that she was already taking acetaminophen. She woke up three times in the middle of the night to use the bathroom, which was unusual for her. The third time she woke up, she could not get off the toilet; she felt dizzy and weak, and thought she was going to pass out. While she was trying to return to the bedroom, she blacked out and fell down. She was bruised up and "broke out in terrible sweat twice". It was reported that she drank water and orange juice to help with dehydration.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events flu-like symptoms, a really sore arm, fever, woke up 3 different times to use the bathroom, felt like she would pass out, felt dizzy, weak, blacked out, bruised up, broke out in a terrible sweat twice, and dehydration were not reported.; Reporter's Comments: Company Comment: This spontaneous report concerns a 82-Year-old, female patient who experienced unexpected serious event of blacked out and non-serious events of flu-like symptoms, a really sore arm, fever, woke up 3 different times to use the bathroom, felt like she would pass out, felt dizzy, weak, bruised up, broke out in a terrible sweat twice and dehydration. The patient developed flu-like symptoms and a really sore arm 1 day after the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). The other events developed 4 days after vaccine initiation. No treatment was provided, and the outcome of the events was not reported. There is limited information to assess all events in the absence of the patient's medical history and advanced age.  Based on the information provided which includes a temporal association and in the absence of any other etiology, a causal association between the other reported events and the administration of mRNA-1273 vaccine cannot be excluded. The event of fever is consistent with the safety profile of mRNA-1273 vaccine.
The area of the  injection site of the pneumovax 23 was red and sore.
My son was lethargic for three days after receiving the Hib (0655R) and PCV 7 (Prevnar B08635H) vaccines.  He ran a fever of 102.5 degrees.  He lost his appetite, became dehyrated, fussy, had trouble sleeping and appeared to be in constant pain.  Most side effects appeared to subside after three days.
Began with slight swelling of joints in hands/joints/thumbs and started hurting. By 10/4/2012, hands & thumbs so swollen couldn't use.  Also swelling progressed to legs and feet.  By 10/5/12 toes were purple so swollen and couldn't walk.  He also stated his liver started swelling, as if onset of Hepatitis. Went to see MD/Rheumatologist.  Knee so swollen couldn't walk. Knee joint fluid drained and was put on steroids. MD also drew a large amount of blood for work-up at that time.
Itching - redness - swelling - ALLEGRA - Ibuprofen 800 mg.
This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 30-SEP-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Dizziness, nausea, vomitting, dysarthria, I.E. brain stem dysfunction, requiring mechanical ventilation;