chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received SHINGRIX (batch number 5737X, expiry date 23rd January 2021) for prophylaxis. On 23rd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site swelling, injection site reaction and arthralgia multiple. On an unknown date, the outcome of the injection site swelling, injection site reaction and arthralgia multiple were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site reaction and arthralgia multiple to be related to SHINGRIX. Additional details were provided as follows: The healthcare (HCP) reported that patient received a dose of SHINGRIX and experienced a severe injection site reaction along with swelling. The patient also experienced hip and knee pain. The patient described these adverse events and coming and going and not resolved at the time of reporting. The HCP mentioned that the dose that was administered was 1 vial after reconstituting with adjuvant, she was not sure if it was 0.5ml, but stated that they gave 1 normal dose. They mentioned it as 1 in their documentation so she was thinking it was 1ml but then stated that it was probably meant as 1 vial for billing purposes.
Sleepy; Dizziness; Bones hurting; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), DIZZINESS (Dizziness), BONE PAIN (Bones hurting) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced SOMNOLENCE (Sleepy), DIZZINESS (Dizziness), BONE PAIN (Bones hurting) and NAUSEA (Nauseous). At the time of the report, SOMNOLENCE (Sleepy), DIZZINESS (Dizziness), BONE PAIN (Bones hurting) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (dizziness, bone pain and nausea), a causal relationship cannot be excluded. Very limited information regarding this event (somnolence) has been provided at this time.  Further information has been requested.
PATIENT REPORTS HAVING A SORE ARM SINCE RECEIVING VACCINE ON 10/1/19. HE STATED HE ALSO HAD A FALL TWO WEEKS PRIOR TO VACCINE. NO BRUISING REPORTED FROM VACCINE.
6 days after, under my right arm and breast was inflamed, The lymph nodes. Limited use very scary. Went to urgent care on 18th. Achy to painful.
got two series of vaccine, still got shingles/ Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 05-Jun-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient stated that although he/she got the two series of Shingles vaccine, still got shingles. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Soreness at injection site; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 61-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Flu vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced soreness at the injection site following previous flu shots. The caller did not provide any additional details. The reporter denied permission to follow up. This was 1 of the 3 cases reported by same reporter.
After inquiring about side effects for the shingles vaccine and being told that there were none, I took the vaccine; shortly thereafter, I developed Bell's Palsy. My face has returned to normal, but my eye has not. Additionally, my eye is extremely light sensitive, something that was not prior to the vaccine. I went to the emergency room and was prescribed a steroid; PREDNISONE, to be taken for 10 days. I required 4 additional visits to my doctor.
NEUROLOGICAL SHAKING; LOSS OF APPETITE; WEAKNESS; This spontaneous report received from a consumer concerned a 49 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808941 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced neurological shaking. On 09-APR-2021, the subject experienced loss of appetite. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neurological shaking, loss of appetite, and weakness. This report was non-serious.
Ringing in ears began sometime between 4/17/21 and 4/23/21 in the evening. Loud ringing began in left ear initially. Then ringing softened, but continued in both ears and has persisted since start date. Current ringing is not loud but annoying. Also, I have noticed that I can't hear as well as before the ringing began, so there is possible partial hearing loss. I have yet to speak to my primary care physician about this issue, so I have not yet been tested for hearing loss.
One week later, patient ran a very high fever within a matter of a few minutes which caused a seizure to occur. During seizure patient was convulsing. Seizure and fever took place around midnight exactly one week after he received vaccinations of MMR, chickenpox, influenzae type b, dtp and pneumococcal conjugate. Within 10 minutes the seizure had stopped and the fever dropped to normal. The following morning, patient started to get another fever and then had another seizure around 9:30 am, at which point we took him to the ER. The administered some medicine to stop the seizure and ran some tests and then sent us to Hospital to be examined further, where we stayed for 3 days.  04/03/2007 MRs received from PCP for well child check on 01/10/2007.  Meeting developmental milestones.  PE: WNL.  Vax given. F/U for hospitalization for atypical febrile seizure, prolonged and recurrent. Assessment:  Complex Febrile Convulsions. Neurology Consult with assessment of Atypical Febrile Seizures. F/U with PCP 3/19/07-no further seizures reported.  MR received from hospitalization of 3 days for fever and seizure activity x 2.  With the first seizure, the child had a temp of 103.8 ax., and consisted of twitching involving the entire body.  This lasted ~20 minutes and resolved.  Post-ictal for ~20 minutes. 2nd similar seizure in the morning which lasted ~ 40 minutes. To ER via EMS in status epilepticus. Txd with Ativan, Cerebyx, phenytoin and antibiotics. Discharge DX: 1) Status epilepticus, resolved. 2) Seizure disorder. 3) Asthma. 4) Febrile illness.  R/o sepsis.
2day p/vax pt devel L AT area w/20cm erythema, warm/firm to touch. benadryl given office. applied cold compress
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 08-FEB-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
2/3/00, 11:45 am, Pt had temp 104. Advised to give Motrin & tub bath & continue to try to reach pt MD. 3:30 pm, Mom called, temp 99.8 (ax), denies any other signs of infection. Advised to continue w/Motrin & if unsuccesful w/MD, go to ER.
Tdap given 3/25/10 Increased swelling, pain and redness in arm also hot to the touch.  Severe pain and tenderness traveled to underarm and left side of torso over next 24 hours.  About 30 hours after vaccination marked dizziness required cessation of activity lasting several hours.  The following day pain continued though dizziness had subsided.  Currently at 80 hours post-vaccine.  Still redness and swelling (3" diameter) tender to touch and still considerable soreness of underarm and lymph areas.  Symptoms seem to be diminishing slowly.
Erythema/ swelling from triceps (shot location) complained of mid post ulnar radius. Treatment Benadryl + Motrin. Large local reaction. No systemic symptoms.
1) Profound fatigue - onset 6 hours -> Resolved in 5 days. 2) Left chest base, area of apex of heart - onset 3 days -> resolved in 3 months. 3) Dyspnea with exertion - onset 3 days -> improved after 3 1/2 months but still with symptoms 4) Left index finger redness, swelling and pain at MCP jt. - onset 1 week -> resolved in 2 months.
Dizziness & NauseaVomiting Employee in COVID vaccine clinic observation area started to feel nauseated and a little dizzy. Also had a metallic taste in her mouth. She felt her pulse elevate but felt a little anxious after her symptoms started. She declined to lay down and declined antiemetic medication. She was given a peppermint and water. She was observed for 2 hours. She was contacted later in the evening and her symptoms had improved, but felt fatigue with a stomach ache.
Mild soreness in right arm; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 30Mar2021 at 09:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient was allergic to pollen and dust mites. Concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 09Mar2021 at 09:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 21:00, about 705 minutes after the second dose of vaccination (approximately 10 hours post injection as reported), the patient experienced mild soreness in the right arm and lasting into the next morning. Soreness continues to diminish. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event mild soreness in right arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
On 12-8-09 received H1N1 vaccine left arm. 12-9-09 AM fatigue. 12-10-09 nasal congestion. 12-11-09 sinus and chest congestion. 12-12-09 AM laryngitis. Seen 12-13-09 chest congestion 12-14-09 and 12-15-09 coughing up yellow sputum. Never had fever. Temp today 98.7. She took Tylenol for symptoms.
Pt became shaky, feeling weak, unsteady on her feet, difficulty breathing, speaking  and tongue swelling approximately 15 minutes after receiving the injection.  We called 911 and the paramedics came and transferred her to a local hospital.  Paramedics did administer patient's own medication ( EpiPen JR).  Patient did not want us to administer EpiPen 3mg, she wanted to use her pen, she stated the regular adult dose is too strong for her.  Pt has had anaphylaxis reactions in the past.  She later in the day was released from the hospital and came back to the pharmacy to pick up the meds ordered for her at the hospital (Benadryl, Pepcid, and a steroid prescription).  She said she felt much better when she returned to our pharmacy and that she had been instructed not to have the 2nd dose of the Moderna vaccine.
We were all packed outside. After attending a wedding waiting on the reception to start. I felt hot nausea and very weak. The very next day I woke up with a scratchy throat nasal congestion and diarrhea. I took Imodium for the diarrhea, and it helped some, but I was still having the issues for a few days. I still felt bad so for the cold symptoms I took Coricidin and Tylenol. The symptoms were very mild.  On Sunday I took an at home COVID-19 test and it was positive. Given my age and health concerns I felt I needed to get Paxlovid. I went to a Urgent Care Center and they gave me the medication and I started taking it right away. I kept having diarrhea and some congestion On Monday June 20 of last week once the first time I tested negative. All symptoms were gone with the acceptation of the diarrhea. I went back to work on June 22,2022 I felt fine then on the 23 I start having nasal congestion and I tested again, and it was positive. I started isolation and I continued that, and the nasal congestion went away. I tested every day since Sunday the 26 and I tested negative as of June 302022
Pt reported "flu-like symptoms" aches and pains, chills, fatigue, light headedness, chest tightness (shortness of breath) after exertion, injection site pain, pain on underside of arm (swollen lymph node?). Symptoms most severe on day after immunization and continuing the following day, but all but fatigue and arm pain resolved after 2 days.
Patient received the vaccine.  He walked into the monitoring area and passed out prior to sitting down.  Patient responded and woke up in a few seconds.  Vital signs were normal.  Patient then started reporting chest heaviness and loss of hearing.  EMS was contacted.  Patient refused care by EMS and transport to ED.  Patient left the vaccine clinic on his own.
Patient came in for the second dose of her Covid 19 vaccine on 04/26/2021. She was counseled and asked all the questions. After screening the vaccine was administered. Immediately after the administration she appeared lost. On asking how is she feeling ? She informed feeling dizzy and lightheaded. Her Pulse was fine.  She sat in the chair for sometime with head down and was feeling better. She asked for water and was monitored for another 30 minutes. She went home and called back to report she is feeling fine. On 05/03/2021 she called back and told me that on 04/27/2021 she had an episode of vertigo at her desk . She lay down for a short period and drank water and was ok but had a second episode at 6.30pm. On 04/28/2021 she had another episode which was brief and lasted a few seconds. Since then every afternoon when she is not distracted she feels a little off balance . She has history of Epilepsy which is controlled and she called her Neurologist and was told to call pharmacy . They just made a note in her chart.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:22 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 77.59  Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 02 PM, temperature was 35, total doses given for the day was not reported , condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 09 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  On 11-Jan-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: Not reported, 9 AM: 34, 10 AM: 37, 11 AM: 37, 12 AM: 35, 1PM: 36, 2 PM: 37, 3 PM: 37, 4 PM: not reported and 5 PM: Not reported.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
chills started at approximately 8:30 p.m and fever with  Max 102 by 11:00 p.m. Nause and vomiting.  She took some Tyenol and motrin and did well until tonight. Fever came back again at 5:00 p.m  If there is long term sequela on this, I want my wife taken care of and about 60 seconds.
This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. On 12-JUN-2013, the patient was vaccinated with the first dose of ROTATEQ (dose, route, lot number and indication were not specified). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K008621, expiration date 04-MAR-2017), dose, route and anatomical location were not provided. No concomitant medication was reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
PATIENT RECEIVED FIRST MODERNA COVID VACCINE 1/18/21 AT PREMIER MEDICAL GROUP AND THEN SUBSEQUENTLY VISITED COUNTY HEALTH DEPARTMENT'S COVID VACCINATION SITE ON 1/26/21 AND RECEIVED A PFIZER COVID VACCINE. PATIENT THEN RETURNED TO MCHD ON 2/23/21 AND RECEIVED A SECOND DOSE OF PFIZER COVID VACCINE, RECEIVING A TOTAL OF 3 COVID VACCINATIONS WITHIN 5 WEEKS TIME.
Then, pimple type spots on forehead day 5; Large rash area on right cheek 4 days after vaccine; Headaches are ongoing.; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date were not reported), via an unspecified route of administration on 09Feb2021 16:00 (at the age of 82-years-old), as dose number unknown, single for COVID-19 immunisation. Medical history included dementia, penicillin allergy. Concomitant medications included donepezil; memantine; omeprazole; iron; zinc; unspecified medication (reported as "c"), all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced large rash area on right cheek 4 days after vaccine, headaches are ongoing on 13Feb2021, then, pimple type spots on forehead day 5 on 14Feb2021. Events resulted to administration of steroids, emergency room, and physician office visit. The outcome of headaches were not recovered while the rest of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash started on cheeks and neck, Noticed on buttocks 2 days later, Child c/o "itching and it hurts" Temp 98.4 (ear probe). Bactroban to face tid. Push fluids, rest and call if any signs of infection. If rash increases, needs to call the office.