chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient who received the 1st dose of SHINGRIX/ in 2019 and a 2nd dose in 2021, about 1.5 years apart.; This case was reported by a pharmacist via other manufacturer and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in 2019).   In 2021, the patient received the 2nd dose of Shingrix. In 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, the patient received the 2nd dose in 2021 almost 1.5 years apart later than the recommended interval, which led to lengthening of the vaccination schedule. The reporter asked should patient receive a 3rd dose.
Pt had VARICELLA vaccine administered 12/10/09 (RT VL subque). Pt came to clinic on 12/21/09 with vaccine area red, swollen  hot to touch (4cm x 2cm). Pt also had fever 99 to 100 @ home. Pt also dx with sinus infection while here: pt put on ZITHROMAX.
Moderna COVID-19 Vaccine EUA  Multiple red spots appeared on left arm and chest. Spots present 1+ month since the injection, sometimes itchy and more red on certain days. Spots spread to other arm and back as well.
08/05/2016 Severe headache, nausea, and vomiting leading to dehydration and ER visit.
Information has been received from a medical assistant referring to an unknown number of patients. The patients' concurrent conditions and medical history were not reported. Since 09-FEB-2016 the patients were vaccinated with GARDASIL 9 (lot # L013429 with expiration date 21-JUL-2017, dose, frequency and route were unknown) which were improperly stored. No adverse effects reported. Additional information has been requested.
This spontaneous case was initially received on 28-Oct-2015. The case report was received from a Health Professional and concerns a male patient. Weight: not provided, Height: not provided. The patient has a medical history of High blood pressure and Unspecified nasal problem. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received Influenza vaccine. PNEUMOVAX. On an unknown date, after starting treatment with Unspecified flu vaccine the patient experienced Unspecified swollen glands, Achiness all over his body, Fever. Paracetamol 500 mg every six hours for the fever. For relevant test results see appropriate report section.
Outdated Varivax given to pt on 8/28/03, lot #0971L 1/7/03 (3 other patients this happened to as well).
STROKE/NUMBNESS OF LEFT SIDE OF BODY/INABILITY TO WALK; This spontaneous report received from a patient concerned a 44 year old. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAY-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-JUN-2021, the patient woke up with numbness in left side of the body. The patient visited emergency room and diagnosed with stroke, and was hospitalized in intensive care unit (ICU) (date unspecified). The patient also experienced inability to walk after the stroke and visited physician's office and currently in rehabilitation. The number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke/numbness of left side of body/inability to walk. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210716287-Covid-19 vaccine ad26.cov2.s-Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Client describes hives when she woke up the following morning following vaccination.  Describes as hives on chin and throat and back of left thigh.  States hives lasted one week
Fever 100.2 on day 8 . Raised and red rash on upper left arm and was very painful.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm 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: "Known allergies: Walnuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: COVID 19 treatment included Paxlovid from 14Feb2023 to 18Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
A mother reported that 30 minutes subsequent to receiving Prevnar and two other unknown vaccines, the pt developed a rash on the palms of the hands. The rash lasted for 10 days and was still present to the date of this report. She also mentioned that the health care provider did not know the cause of the rash. She declined to give additional information.
Patient given double dose of Hib. One through PENTACEL & one ACTHIB. Medical assistant followed provider order. Sanofi contacted and informed us no increase reaction should occur.
Patient received 2 doses of the pfizer 5-11yo on 12/11/21 and 11/20/21. Her mother scheduled her to receive a Moderna booster at the clinic and selected the 6mo-5yo visit type. Mother confirmed she wanted to switch to Moderna from Pfizer, however both the registration person and vaccinator did not catch her age, therefore the patient received the 6mo-5yo vaccine at the age of 6.
Pt. stated that he developed shingles after received flu shot (AFLURIA). Shingles were developed at site of injection.
Subsequent to receiving vax, pt rolled his head back with a moaning sound, dropped eyes forward, then rolled eyes backward, body went limp. Pt was unresponsive for about 30 seconds. Face was flushed, color changed pale, skin clammy, pt alert and stated he felt like he was dreaming. Pt was advised to see physician.
Had woken up with chest pains, then came and go and took deep breaths and felt shooting pain. Something was wrong, so I saw my PCP , then was tested with an EKG which was a little abnormal, so then I was sent to my Cardiologist.
pt recv vax 2DEC98 & devel apnea & was hosp;CBC w/differential revealed neutropenia;pt recovered
Significant swelling & redness of left upper arm from elbow to shoulder, warm to touch > 24 hrs after vaccine. Started on Keflex.
Information has been received from a licensed practical nurse concerning an 18 month old male with no pertinent medical history who on 29-MAY-2007 was vaccinated IM with a 0.5 ml PedvaxHib (lot # 654678/1125F). There was no concomitant medication. Several hours after receiving PedvaxHib the patient experienced a fever of 104 F with shaking chills. The patient became afebrile after alternating treatment with acetaminophen (TYLENOL) and ibuprofen (MOTRIN). On 30-MAY-2007 the fever returned and an evaluation was set up with the physician. After the patient was sent home his fever spiked. The patient was then admitted to the hospital. Overnight, the fever dissipated, and he was released from the hospital the morning of 31-MAY-2007. Additional information has been requested.
Patient sat down after getting shot and after sitting a few minutes the person with her yelled help.  When I arrived, she was slumped over on the bench leaning on the person with her.  I called her name and she woke up but was a bit confused and her lips were pale.  After resting for approximately 10 mintues, she felt completely fine and was able to walk away.
Severe flu like symptoms (head ache , body aches, light headed, lethargic, head congestion). Symtoms slowly progressed through out the afternoon and evening, peaking in the evening. Symptoms continued into the following day, 10/20/07, but severity was far less (very tired, heavy head, mild body ache).
Treated in ED with BENADRYL for c/o blurry vision. Rash on hands & back / tongue swollen.
her right arm began having a shooting pain that went up to her neck and left breast; her right arm began having a shooting pain that went up to her neck and left breast; her right arm began having a shooting pain that went up to her neck and left breast; Indigestion; dry mouth; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982) via an unspecified route of administration on the left arm on 15Jan2021 at a single dose for COVID-19 vaccination. Medical history included ongoing heart murmur. There were no concomitant medications. She received the first dose of COVID vaccine on 15Jan2021 in her left arm. Patient stated that 15 minutes after receiving COVID vaccine her right arm began having a shooting pain that went up to her neck and left breast. She was given 4 Aspirin and a Nitroglycerin tablet. She was then transported to (Institute Name Withheld) by ambulance from vaccination facility. While at the hospital blood work was obtained and her pancreas was checked. Patient stated she was there for three hours. She would like to know if she should receive the second dose of the COVID vaccine? Reported she had an adverse event 15 minutes after receiving her first dose of the COVID-19 Vaccine. She said she had pain in her right arm. She said the pain went up to her neck. She said she had pain under left breast. She said she felt like she had indigestion. She said she was told to chew 4 aspirins, clarifying she was given 4 aspirins by the ambulance staff that was at the scene to treat her. Reported she was told her blood pressure was high. She said she doesn't know what her blood pressure reading was because the ambulance staff would not tell her. Reported she noticed she had a dry mouth while she was being transported in the ambulance to the hospital. Reported she was transported by ambulance to the hospital emergency room in (City Name Withheld), (State Name Withheld). She said she was treated and released from the emergency room. Reported her neck pain was gone first, but she still felt like she had indigestion while being treated in the emergency room. Treatment: Reported the hospital staff had her drink something, and then her indigestion, and arm pain went away. She said the hospital did blood work and checked her pancreas. She said she has no information on her blood work results, saying the emergency room doctor didn't share her results with her. She said the emergency room doctor only mentioned that he was checking her pancreas. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event pain in arm was recovered in 15Jan2021, patient recovered from neck pain, breast pain, indigestion and dry mouth in Jan2021; and unknown for the other event.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "78-year-old female with dementia who presents with acute encephalopathy, somnolence.  Suspect influenza with over-sedation.  Wean down psychotropic medications.  Her mental status improved although she did have outbreaks of yelling.  Tamiflu x5 days.  Hypernatremia and AKI resolved with IV fluids and was stable without IV fluids.  Recommend outpatient neuropsych testing and psychiatric consultation.  I suspect progression of patient's dementia is causing many of her symptoms.   Incidentally tested positive for COVID on day of discharge, was negative on admission.  Question if false positive as she had no change in her respiratory status."
Baby got vaccine, developed fever in night, by next day fever raised to 106 - went to emergency room for tests, antibiotics in case it was an infection and a steroid in case it was croup.
Vaccine expired per site visit 8/12/2022. Shipping label has date of 12/31/2069.
At 32 weeks of my pregnancy I tested positive for COVID-19. I had head and nasal congestion, loss of taste and smell and fatigue. My due date is on 01/08/2023, however my Cesarean section is scheduled for 01/01/2023.
had a metallic taste in her mouth; that it is interfering with her eating; lost 10  pounds; Everything tastes awful; This is a spontaneous report from a contactable consumer(patient) via medical information team. A 68-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, lot number: EW0150) via an unspecified route of administration, administered in Arm Right on 06Apr2021 (at the age of 68-year-old) as dose 2, single for COVID-19 vaccination. Medical history included ongoing rheumatoid arthritis (reported as about 9 years ago it became pronounced enough that she needed medication), ongoing hypothyroidism (reported as she did not get diagnosed until 6 or 7 years ago), ongoing atrial fibrillation (reported as she had that since she was 24) and COVID-19. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. Historical vaccine included bnt162b2 (Solution for injection, lot number: EN6207) via an unspecified route of administration, administered in arm right as dose 1, single on 13Mar2021 (at the age of 68-year-old) for Covid-19 immunization and experienced metallic taste in mouth. The patient had Covid and she lost her sense of taste and smell, but it was coming back. Patient had the second vaccine on 06Apr2021, and the metallic taste got so severe to the point she could barely eat. The reporter stated metallic taste got worse within a week of getting the second dose. Everything tastes awful. She had lost 10 pounds. Patient was wondered if Pfizer had any information about it and if anything, they learned can help her to get over this. Patient just continued to lose weight. Patient had Covid, but she was told she had no antibodies in her blood. On unknown date in 2021, the patient experienced a metallic taste in her mouth that it was interfering with her eating, lost 10 pounds, everything tastes awful. Patient had regular bloodwork because of her arthritis and doctor sent her to an ENT doctor who did a CT scan of her sinuses to see if there was anything wrong that could affect her smell and taste. Outcome for event lost 10 pounds was not recovered while unknown for rest of the event.  Follow-up attempts are completed. No further information is expected.
Pt called pharmacy and reported that around 10pm the night of the vaccination, he experienced pain in his leg from the knee to the upper thigh.  He went to bed, and woke up in the middle of the night.  The pain/discomfort was so great, he had to have is wife help him to the bathroom as he could not walk on his own.  This morning he is getting around with a walker.  A hot shower helped him move around much better.  The called this morning around 9:20 after taking the shower.  Pt has not seen a doctor yet, but if symptoms persist through the end of the day, he will go in to urgent care/ER.
After receiving the vaccine, patient's arm felt sore and has continued to feel sore for the past 3 weeks. Symptoms present as possible vaccine that was administered too high. Patient will be contacting their provider for further instructions.
Severe vertigo when I woke up less than 48 hours.   Stayed in bed for 2 days (Saturday and Sunday).  Took approximately until July 7 to begin feeling better.  Symptoms reappeared 4 weeks later and lasted for 2 days.    Self medicated with meclizine and performed the Epley method.
This spontaneous report as received from a nurse practitioner refers to a 11 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided.On 12-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature exucrsion (incorrect product storage). No information on patient's concomitant mediation was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a female physician via a company representative refers to herself. In 1999 (exact date unspecified, reported as 15 years ago) the patient was vaccinated with a first dose and in 2000 (exact date unspecified, reported as a year apart) the patient was vaccinated with second dose of VARIVAX (Merck) (exact dosage, route of administration, anatomical location, lot number were not reported). On an unknown date, the patient's titers came back negative when testing was done. The outcome of event was not reported. The relatedness between event and VARIVAX (Merck) was not reported. Additional information has been requested.
Red, itchy rash on right shoulder, progressing to center of chest over 2 week period. Sharp stabbing pains in chest and groin. One large burning lesion in left vulvar area appeared on 02/10/08. UPPER respiratory infection began on 02/01/2008 and has not yet cleared up. Rash on shoulder and chest has gone. This is in follow-up to report(s) previously submitted on 6/24/2008. Initial information has been received from a 69 year old female concerning herself and follow up information was received from her physician. The patient had no known drug reactions/allergies and breast cancer since 09-MAY-2007, on the morning of 27-DEC-2007 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (LOT# 658838/1412U). Vaccination included influenza virus vaccine (unspecified) and pneumococcal 23v polysaccharide vaccine (manufacturer unknown) on 18-DEC-2007. Concomitant therapy included atenolol and "aromansin". There was no illness at the time of vaccination. On 20-JAN-2008 the patient stated she got a very red itchy rash on her right shoulder and right chest area. After a few days, it turned yellow and continued to itch. Another large patch broke out on 27-JAN-2008 on the right side below the first patch. On 01-FEB-2008 she had an upper respiratory tract infection. On 05-FEB-2008, a red, itchy, rash broke out in the middle of her chest between her breasts. On 09-FEB-2008 she had an extremely sharp pain in her groin areas and the next day (10-FEB-2010) she felt a huge blister in the left vulva area, it did not itch but it burned. That cleared up about ten days later. The physician reported that the patient was seen on 18-FEB-2008. The rash did not appear like varicella. On an unspecified date, the patient recovered from the events. There were no lab studies performed. The patient stated that she is not on chemotherapy and is taking oral medication for cancer. There was no product quality complaint involved. Additional information is not expected.
Driving home, I felt like my eyes were getting harder to keep open and I blacked out.  Woke up due to my car veering into on coming traffic, hitting two cars.
About 3-4 days after receiving injection, patient noticed an itchy area and scab at site of injection. It itched for weeks although the scab was gone in a matter of days.
This spontaneous report was received from a healthcare professional refers to a patient of unknown age. On 11-JUN-2013, the patient was vaccinated with a dose of M-M-R II, (lot # H010135, expiry date 17-MAY-2014, route was not reported) which may have been improperly stored at 8.5 degrees Celsius and 9.1 degrees Celsius for 720 hours. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Presented for bivalent vaccine. Vaccine card presented after administration showed previous bivalent vaccine 9/20/2022. Denies no side effects following previous bivalent vaccine. Instructed to monitor for and report any side effects.
I took an Aleve about 7 pm (about 8 hours after injection) due to my sore arm. A fever started about 14 hours after injection, accompanied by very sore muscles; this made it very hard to sleep. I didn't take my temperature during the peak of the fever but the next morning when it had diminished somewhat it was 100.8 (about 6:30 am, about 18 hours after injection) .  I also had a general feeling of not being well (fatigue, etc.). I took Tylenol when I got up, and again 6 hours and 12 hours later. Although symptoms gradually diminished through the day, I was unable to go about my normal routine for the entire day and evening. From the onset of the fever, the course lasted about 20 to 24 hours.
SHAKINESS (LIKE SEIZURE); CHEST AND RIBS BEING PAINFUL; FELLING COLD; FEELING AWFUL; This spontaneous report received from a patient and concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced shakiness (like seizure), chest and ribs being painful, felling cold and feeling awful. The patient felt "gassed out", but not as "offal as yesterday". The action taken with COVID-19 vaccine ad26.cov2.s was not reported. The patient recovered from shakiness (like seizure) on 06-MAR-2021, and chest and ribs being painful on 07-MAR-2021, and was recovering from felling cold, and feeling awful. This report was serious (Other Medically Important Condition).; Sender's Comments: Shakiness (like seizure), chest and ribs being painful, felling cold and feeling awful. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug.
Pt stated she was feeling tingling on her lips, tongue and the inside of her mouth.   VS at time of event were BP: 122/80 HR:100 SPO2: 99%. Vitals showed pt was slightly tachycardic. Pt was monitored and vitals were taken at 1225  BP:124/84 HR: 115 SPO2 98% then taken again at 1231 BP: 122/86 HR: 116 SPO2 97%. Pt was given liquid Benadryl and was monitored. Pt stated that symptoms were persisting so the pt was transported to the Emergency Department. VS at transport 122/84 HR:96 SPO2 97% Temp: 98.1.