chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states she "fainted" while standing in her kitchen.  was seen by MD, total of  3 stitches on the back of her head and CT scan of the head done. Vaccine received on May 2nd at around 2:20. Episode occurred  On May 3rd after she woke up at 2:45am.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unknown dates, the unspecified patients might had been vaccinated with improperly stored doses of PEDVAXHIB injection for prophylaxis (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided) and M-M-R II injection for prophylaxis (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided). It was reported that sterile diluent (MERCK) was properly stored. No adverse effects were reported. Both vaccines underwent a temperature excursion 47.6° C for a time frame of 27 minutes. None previous temperature excursion and data logger yes was reported.
pt recv vax 19MAR98 & on 20MAR98 pt exp dizziness, blurred vision & twitching on rt eye;30APR98 dizziness persists;
Swelling, shoulder to elbow; Redness, shoulder to elbow; Pain, shoulder to elbow; This non-serious case was reported by a nurse via sales rep and described the occurrence of swelling arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to animal (Hamster).   In APR-2023, the patient received the 2nd dose of Shingrix. In APR-2023, an unknown time after receiving Shingrix, the patient experienced swelling arm (Verbatim: Swelling, shoulder to elbow), erythema of extremities (Verbatim: Redness, shoulder to elbow) and pain in arm (Verbatim: Pain, shoulder to elbow). In APR-2023, the outcome of the swelling arm, erythema of extremities and pain in arm were resolved (duration 6 days).   It was unknown if the reporter considered the swelling arm, erythema of extremities and pain in arm to be related to Shingrix.     It was unknown if the company considered the swelling arm, erythema of extremities and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-APR-2023 Registered nurse reported this case for herself.  The patient received her second dose of Shingrix about 2 weeks from reporting and experienced pain, redness, and swelling from her shoulder to her elbow for about 5 to 6 days. The reporter consented to follow up.
Employee received Fluzone Quadrivalent flu vaccine on 10/18/2019 (2 ½ weeks ago). Employee has been experiencing left shoulder pain and stiffness since receiving the flu vaccine. He states the vaccine was given ?well above the deltoid?. He feels the vaccine went in the left shoulder joint space. He has been having ?significant pain and stiffness? in his left shoulder since the time of vaccination. Employee has limited ROM of his left shoulder. He cannot abduct his left arm past 30 degrees, he cannot flex past 45 degrees and he cannot extend his shoulder. He has limited internal and external rotation of his left shoulder due to the pain. He has been taking high doses of Ibuprofen and doing stretches without any improvement. He rates his pain as ?significant? especially at night. He is not sleeping well due to the pain. Employee was referred to Orthopedics for evaluation and treatment.
pt had suffered a reported syncople episde according ro rn staff administering shot. pt was with mother/\.  pt was pale but responsive and ao*4. pt vitasl were taken and pt was considered stable. pt had been eating a cracker and drinking water at time of ems crew arrival. pt then claimed to be "feeling better" pt was considered stable and no indication or report of pt hitting head. pt reportedly "slythered" to the ground by rn staff. pt was deemed stable, however twice more requested ems evaluation. pt and pts mother was advised to accept ems transport. pts mother consented to er rescue transport and pt was transported to hospital by ems.
severe heahdache; elevated blood pressure; This is a spontaneous report from a Pfizer-sponsored program. A contactable Physician reported an 18-year old patient received meningococcal group b rlp2086 (TRUMENBA, reported as Meningococcal Group B Vaccine) via an unspecific route of administration on an unspecific date at single dose for immunization. Medical history and concomitant drug were not reported. Physician mentioned that a patient had Trumenba administer had an adverse reaction. He said that the 18 years old patient had after 45 min of the administration of the vaccine a severe headache and elevated blood pressure that took the patient the ER (Emergency Room). Now the patient is fine but he wants to know if that has been reported. Outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possible causal association between administration of Trumenba and the onset of headache and elevated blood pressure cannot be excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
6hrs later his arm started to get sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (6hrs later his arm started to get sore) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Loose bowel (loose bowel movement). Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Loose bowel.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (6hrs later his arm started to get sore). At the time of the report, VACCINATION SITE PAIN (6hrs later his arm started to get sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
leg swelling; the patient could not walk after one of her shots; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 3 years old female patient who had leg swelling and could not walk after one of her shots after receiving diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] and HIB (PRP/T) vaccine [ACT-HIB].  The patient's past vaccination(s) included Rotavirus vaccine and Pentacel for immunization. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection and HIB (PRP/T) vaccine, powder and solvent for solution for injection via unknown route in unknown administration site for prophylactic vaccination (strength, dose, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient had leg swelling (peripheral swelling) and could not walk after one of her shots (gait disturbance) (unknown latency).  Reportedly, rotavirus vaccine, PENTACEL, and possibly Prevnar-13 (the patient's mother knew she received 3 vaccines, but as unsure if Prevnar-13 was the name of the 3rd vaccine); after these shots, the patient developed seizures. When the patient developed seizures. at night the patient would arch her back, her eyes would open, and her body would lock up. The patient was hooked up to electrodes, and they confirmed that they saw seizure activity. The seizure activity was off and on, and at one point it occurred every day for a couple of months. The patient's mother reports that since these events occurred after the patient received PENTACEL.The patient's mother reported that even with the individual vaccines (DAPTACEL, ACT-HIB), the patient still had some reactions like leg swelling; states that the patient could not walk after one of her shots  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (peripheral swelling, gait disturbance).  At time of reporting, the outcome was Unknown for the events peripheral swelling, gait disturbance
On 09/17/2021, exactly 8 days after patient's first injection of Pfizer Covid-19 vaccine, the patient suddenly had numb hands and left side of face was droopy.  I called 911. Patient became unresponsive in the ambulance and required intubation. CT results determined that he suffered a wet stroke from a massive brain bleed on the right side of brain. He died the next day on  09/18/2021
VERY tired the next day; This is a spontaneous report from a non-contactable consumer (patient).  A 68-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318), via an unspecified route of administration, in Right Arm on 06Feb2021 at 16:00 (at 68 years) at single dose for covid-19 immunisation. Medical history included Stage 4 polycystic kidney disease (PKD), osteoporosis, hypothyroidism, breast cancer survivor.  Patient had no covid prior vaccination and was not covid tested post vaccination. Known allergies to erythromycin. Patient received other unspecified medication in two weeks. On 07Feb2021 the patient was very tired. No treatment given and patient recovered on an unspecified date in Feb2021.No follow-up attempts are possible. No further information is expected.
pt recv vax 5SEP95& 4JAN97 it was reported that pt had malaise & a low grade fever;pt devel a rash w/50-60 lesions primarily on the trunk, face, & extremities on 5JAN97;pt dx w/varicella;
2225 lower lip numbness, spread to top left.  aching pain left cheek, then left sided head pain.  Pressure in head especially forehead,  tingling in feet. 2228 trouble swallowing.  taken to ED: 2256 prednisone 20 mg x 1 Pepcid 20 mg iv x 1 Benadryl 25 mg x 1, NS 1000 ml bolus.  0123 felt like new woman, took nap feels better.
Client vaccinated with Pfizer vaccines x 2 in July 2021.  Symptoms started 12/18 - sore throat, nasal congestion, headache, myalgia, fatigue, nausea, fever.
Headache noted the night of vaccine and continues to present time. General fatigue noted 1/5/21 with some body aches. Around 4:30pm on 1/5/21 took 1g acetaminophen for headache.  At 5pm 1/5/21 temperature of 99.4 noted. By 6pm 1/5/21 temperature was 99.9 (despite acetaminophen in system).  Difficulty sleeping 1/5/21 and awoke with intense chills followed a couple hours later with sweats and temp 100.3. Increased sinus congestion also noted, unrelieved by Sudafed.
PEG reaction; Arm is red, swollen, itchy; Arm  is red, swollen, itchy; Arm is red, swollen, itchy; A spontaneous report was received from a consumer, concerning herself, a 59-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced PEG reaction (Drug hypersensitivity), red (Pruritus), swollen (Erythema) and itchy arm (Peripheral swelling).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07-Jan-2021, after vaccination, the patient went to primary care physician and got a confirmation that she has PEG reaction, where her arm was red, swollen and itchy. However, patient was feeling well and did not get sick or nauseous or feverish. Treatment medications were not reported.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events PEG reaction, arm is red, swollen and itchy were not reported.; Reporter's Comments: This case concerns a 59-year-old female who experienced NS expected events of pruritus, erythema, and peripheral swelling. Event onset occurred 9 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a physician concerning an approx 75 year old male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot649732/0513P). Subsequently the pt c/o injection site pain, redness and swelling toward the elbow. Medical attention was sought and the pt was treated with warm compresses and ibuprofen (Advil). The AE's resolved after 5 days. No product quality complaint was involved. It was also reported that within the same week two other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) and developed AE's (WAES0411USA00719 and 0410USA02673). Additional information has been requested.
arm was very red and in alot of pain; arm was very red and in alot of pain; infection at insertion site requiring antibiotics; This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13 lot number: AG8365, expiration date: 01Jun2020, NDC number: 13: 0005-197102), intramuscular in the left deltoid on 06Oct2019 at 0.5 ml, single for vaccination for pneumonia. Patient has no medical history, no investigation assessment, and no concomitant medications. The pharmacist stated that the patient got her vaccine on Sunday 06Oct2019, and came in yesterday, 08Oct2019, and talked to another pharmacist. Patient stated that her arm was very red and she was in a lot of pain on 08Oct2019. The patient came in stating that she went to the emergency room and got an infection in her arm at the insertion site and was now taking antibiotics (not specified). Outcome of the events was recovering.
Flumist was administered at the Greensburg clinic to a 6-month old male. This product is not supposed to be used under the age of 2 per manufacturer recommendations.
Eye bulging out of socket Swelling on right side of face Next day DEATH 08/19/2021
Patient with 2 Moderna COVID vaccinations, last dose 05/31/22, who admitted to hospital with COVID complications.  Provider d/c note below:  "Elderly diabetic woman previously vaccinated against COVID, recently diagnosed with acute COVID, started on prednisone for the same.  Presents with hyperglycemia in 500s, admitted and placed on insulin with control of blood sugar.  Steroids stopped.  No evidence of COVID pneumonitis on imaging.  Rapidly improved, weaned to room air and tolerated activity and ambulation on room air.  Patient requested discharge to home.  Patient released home on her chronic medications without further steroids or antivirals.  Patient completed her ten days of recommended quarantine while in the hospital"
Sore throat, persistent cough, needed to use hand held nebulized asthma medicine.
6/3/21 PMHx CKD, asthma, IDDM presents to ER by EMS for elevated blood sugar and hypotension
Felt a wave come over my body and immediately felt like I was going to pass out about 3-5 min after receiving injection. I drank water and ate some chocolate and felt a little better. For the next 24 hours had several bouts of  dizziness, headaches and body aches. Just felt very off and could not focus or concentrate .
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-JUN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # L008660, expiration date 10-NOV-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 920, 34 and R; 168, 32 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Stomach pains; Severe back spasms / have not resolved; Fever; Chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 5th February 2021, less than a day after receiving Shingrix, the patient experienced fever and chills. On 6th February 2021, the patient experienced stomach pain and spasms. The patient was treated with paracetamol (Tylenol). On 6th February 2021, the outcome of the fever, chills and stomach pain were recovered/resolved. On an unknown date, the outcome of the spasms was not recovered/not resolved.   The reporter considered the fever, chills and stomach pain to be related to Shingrix. It was unknown if the reporter considered the spasms to be related to Shingrix.  Additional details were provided as follows:  This case was reported by patient himself. The patient received 2nd dose of Shingrix in left arm and on the same day evening, the patient experienced fever and chills, that resolved by the next morning. 1 day after receiving Shingrix, in the morning the patient experiencing stomach pains that resolved by evening and on the same day evening, the patient began experiencing severe back spasms, which had not resolved over 5 days. The reporter did not give permission to contact HCP. The reporter did not consent to follow up.
Nausea. Lightheaded. Vomited. Attempted to take Pepto Bismol, vomited right after.
Rash on right side of face...red, feels warm, slightly bumpy. Noticed when I woke up around 7:30am on 11/1/21. Other symptoms were pain at injection site and surrounding area for about 48 hours following injection. Body aches that set in about 24 hours after vaccine and lasted about 24 hours.
A 66 year old female reported that she received an injection of Tetanus toxoid adsorbed, purogenated on 06/11/2001 the reporter indicated that the vaccine had not been stored in the refrigerator for 3 months. On 06/13/2001, she developed chills, lymph node swelling of the right arm, and severe muscle pain in her legs, veins, and body. She also developed an injection site reaction characterized by warmth, pain, swelling, and redness that extended
Pain in arm; Sleepiness; Injection site movement impairmen; Vaccination site swelling; Vaccination site erythema; Exhaustion; Low grade fever; Nausea; Headache; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (Sleepiness), INJECTION SITE MOVEMENT IMPAIRMENT (Injection site movement impairmen), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (Left scar damage) on 24-Dec-1999, Endometrial cancer in 2007, Rotator cuff repair (Rotator cuff surgery) in 2019, Surgery (Surgery for an artificial right ankle) in 2009 and Surgery (Surgery for a left knee prosthetic) in 2011. Concurrent medical conditions included Lymphocytic colitis (Autoimmune lymphatic colitis) and Asthma (needs a rescue inhaler). Concomitant products included PREDNISONE and EPINEPHRINE (EPIPEN) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 20-Feb-2021, the patient experienced INJECTION SITE MOVEMENT IMPAIRMENT (Injection site movement impairmen), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Exhaustion), PYREXIA (Low grade fever), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and SOMNOLENCE (Sleepiness). On 21-Feb-2021, PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved. On 22-Feb-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, SOMNOLENCE (Sleepiness), INJECTION SITE MOVEMENT IMPAIRMENT (Injection site movement impairmen), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE SWELLING (Vaccination site swelling), FATIGUE (Exhaustion) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication including allergy shots and rescue Inhaler was reported   This case was linked to MOD-2021-057061 (Patient Link).
pain; sleeping a lot; This case was reported by a consumer via call center representative and described the occurrence of pain in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced pain and sleep excessive. On an unknown date, the outcome of the pain and sleep excessive were unknown.   It was unknown if the reporter considered the pain and sleep excessive to be related to Shingrix.  Additional details were provided as follows: After vaccination with Shingrix, the patient slept for 14 hours at last night before the reporting and had only been awake for 5 hours. The patient felt like again go back to slept for 14 hours.
Per his parents, patient started feeling nauseous an hour or two after the vaccine and at night around 10pm it worsened where he felt nauseous, had shivers and he vomited in the middle of the night. He then vomited again the next day and continued to not feel well the next couple of days. On 4/20/2021 at around 4:20pm he called his mother, his girlfriend and his mentor that he was not feeling well, was nauseous and dizzy and had shivers and was going to pull over on his car to get something to drink. He then stopped answering his phone and was found dead in his car later on that day. Police is investigating the case.
6.27.13 started with vomiting; 6.28.13 vomiting and very fussy, dehydrated. Sent to hospital for evaluation and IV rehydration. Intussusception diagnosed and treated by barium enema.