chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headaches after the first dose for a couple of days; This is a spontaneous report from a contactable consumer (patient).  A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 20Apr2021 (at the age of 42-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Family medical history relevant to adverse event and relevant tests was none. The patient did not receive any other additional vaccines on 20Apr2021 other than the suspect product. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination no adverse event was there for the patient. The patient did not emergency room and physician office. The patient reported that "headaches after the first dose for a couple of days" on an unknown date in Apr2021. The outcome of the event was resolved on an unknown date in 2021.   Information about batch/lot number has been requested.
Initial report received from a healthcare professional on 16 January 2014. A female (initials, date of birth and age at the time of event was not reported) were not reported had received an intramuscular dose of FLUZONE HD (lot  number: U4785AA, expiry date: 06 December 2014 and dose in series was not reported) in the left deltoid on 26 November 2013. The patient had no illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On an unspecified date, shortly after receiving the vaccination, the patient developed pain in the left arm that feels like bone pain. No laboratory investigations were done and corrective medication was not reported. At the time of this report, the outcome was unknown. Documents held by sender: None.
Fever, chills, muscle aches, stiff neck, headache, loss of appetite,  nausea lasting approximately 36 hours.  Starting approximately 5-6 hours after injection.
Near syncope while waiting in the waiting room for 15 minutes post-vaccination. Taken to exam room, BP/HR unremarkable. Placed in Trendelenburg, given OJ. Monitored x 30 minutes; sat up for 5-10 minutes and started feeling faint again. Routed to ER for IVF/observation.
Day after was achy and arm hurt.  I've been having heart palpitations regularly after 2nd dose, fluttering over night.
Arm discomfort 2/10, arm and shoulder discomfort 2/11, 12, 13, neck discomfort 2/14, 15, 16, headache neck pain 2/17, 18, 19 worse. Hurts to move head.
After the vaccine it felt like I experienced a fever , exhaustion, nausea,  and body aches.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 3:37 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patients were given doses from vials that were stored in an ultracold freezer which was colder than should had been. Vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight. Storage condition at the time of the excursion was frozen storage and excursion duration was 1 month.  Date when vials moved from freezer to refrigerator was 19 NOV 2021 and Moderna Covid 19 vials went from the super cold freezer to the refrigerator. No vaccine state changes were noticed and vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  There was no concomitant list was provided by the reporter. No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Hospitalization: 11/8/2022 - 12/2/2022 (24 days) Presentation to the ED: complaints of lightheadedness and sustaining a mechanical fall followed by right shoulder pain. COVID + date: 11/8/22.  Treatment: none, asymptomatic.  Discharge to: SNF Deceased date: 12/13/2022.
Body aches, nausea, soreness in muscles at site of injection, headache, chills
Began with welt about one inch in diameter. Warm to touch. Has steadily grown. Now radiating arm pain and neck pain. Still warm to the touch.
Started running 101 degree temp 24 horus after Tdap injection. Extreme pain, redness, swelling at injection site.
Pt passed out/lost consciousness about 15 seconds after receiving the vaccine. He hit me as he was falling back, and landed on the table. No injury to the patient.
Patient received an additional bivalent booster dose when one was not needed. She received the bivalent booster in September 2022
Extreme Fatigue, sore feet, legs , hips, lower back, mid back, upper back neck into skull ........knees , shoulders , hands , fingers , wrists....Have not been seen by Dr...his office told me there was nothing they could do ......situation has not improved and doing normal things hurt like hell ...getting up and sitting down painful, getting in and out of car hurts .......I need and use a cane to walk.......how long does this side effect go on?????
red rash noticed on arms, legs, back and chest 6Nov23 at night, worse this morning,  Itching on back.  Vaccine received at Pharmacy.
Recipient arrived to vaccine site with his mother.  Recipient was given Moderna Vaccine Dose #1 on 6/22/2021.  He is under 18 years old.  His mother presented CDC card showing Dose #2 due on 7/6/2021.  Recipient received dose 14 days early.
2nd Bexsero vaccine 3 weeks later; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's comment: The reporter asked if a patient had 1st Bexsero then came back and got 2nd Bexsero vaccine 3 weeks later did the patient need to come for another Bexsero due to getting the 2nd vaccine too early. Additional Supportive Information: The patient received 2nd dose of Bexsero earlier than the recommended interval, which led to shortening of vaccination schedule. This case had been linked with case US2022001236, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001236:Same reporter
Later on that evening of the vaccine I started having the chills, body aches & feverish. The next morning when I woke up I had a headache. They lasted for more then 48 hours.
Red itchy eyes green goop extracting out of eyes slight headache, sore + aching muscles sinus cavity, back of throat, inside of mouth all very sore and felt lots of pressure. No Treatment after 24 hrs. all ways OK.
The day after my booster I noticed my arm was quite sore at the injection site and it was very hot. I watched it and just took Tylenol and iced it hoping it would resolve. The next day it was larger and hotter. I decided to go to the clinic.  Since the last time I had a vaccine I had an eye stroke, they were concerned I had a blood clot. I then went to Urgent Care. I was told it was probably just an allergic reaction and was given a cream/antihistamine (triamcinolone). And Tylenol as needed. The issue lasted through October 31, 2021 but as of today it has resolved.
On 08/07/00, days after vaccinations, the patient began running a very high fever (105+). The fever finally was controlled on 08/10 or 08/11. On 08/12, she had a seizure. She was taken to the ER, placed on O2 and given Ativan; duration was about 45 minutes. This patient's history was totally remarkable prior to this event. She had tolerated all prior immunizations well, with no obvious reactions. After sleeping post-ictally for about 4 hours, she was transferred to a hospital. She was placed under the care of a pediatric neurologist. Her second seizure occurred almost exactly 24 hours after the first one; eight hours later she had a series of 3-4 seizures back to back. She was given a loading of Dilantin IV of that time and followed up with maintenance doses every 12 hours. She went another day with no seizures, but they began a three day span where she had 10-20 per day. Her liver was chewing up the Dilantin fast. Free levels would not remain in the therapeutic range. The third day, in the afternoon, she began having seizures in serial fashion. She was then transferred to the PICU and loaded with Phenobarbital, did stop the seizures, she stayed in the PICU for five days. Topomax was added to the AED regimen. She was moved back to the floor for five more days, then discharged home on those three meds. During the 1st three days in the hospital, they did a repeat spinal tap, MRI, and an EEG. The infectious disease unit also got involved in the CSF and blood tests, sending out for all sorts of tests. She had a repeat EEG in her room on Thursday (day 5) which captured an 8 minute seizure. Her seizures were classified as complex partial, secondarily generalized, multifocal. She lost consciousness, and did experience tonic-clonic convulsive movements that were observed on both sides; but not simultaneously. During the first several episodes, she also lost bladder control and one time she vomited. She also received Diastat on several occasions to stop the seizures. Sometimes she seemed to respond to it; sometimes not. It is now six and a half months later, she is on her fifth different AED combination, and the seizures remain uncontrolled. She has epilepsy. The 60 day follow up states intractable seizures; AED therapy ongoing but ineffective; surgical evaluation opinion is unanimous in opposition to surgery in the pt's case. Doc 211184 states that seizures have diminished in frequency from a peak of 45-50 per month during 6 months; of 2001 (march-august) to 15-20 per month from september to the present. Diagnosed with encephalopathy of unknown origin.
Pt was vaccinated and had a syncopal episode in response. Pt was supported in her chair so that she did not experience a fall. Estimated syncope time of 8 seconds. Pt was taken to private observation area via wheelchair after she regained consciousness. Her vital signs and mentation  were monitored continuously. Upon leaving clinic, pt was AOx4 with stable vitals.
Patient tested positive for Covid19 even with the Pfizer vaccine EUA 04/15/2021-05/03/2021
TIRED; This spontaneous report received from a consumer concerned a 32 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21AA, expiry: 11-APR-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20211150020.
This is a spontaneous report from a non-contactable other hcp. A female patient of an unspecified age and ethnicity started to receive PREVNAR, via an unspecified route of administration from an unspecified date to an unspecified date at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced cellulitis (medically significant) on an unspecified date with outcome of unknown, may have given the vaccine subcutaneous (incorrect route of drug administration) (non-serious) on an unspecified date with outcome of unknown. The action taken in response to the event(s) for PREVNAR was not applicable.
This spontaneous case was reported by a patient and describes the occurrence of SKIN DISCOLORATION (Black and blue discoloration of skin on back of her left knee) and ARTHRALGIA (Left knee pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included OLMESARTAN, BUPROPION and ACYCLOVIR [ACICLOVIR] for an unknown indication. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, the patient experienced ARTHRALGIA (Left knee pain). On 15-Jun-2021, the patient experienced SKIN DISCOLORATION (Black and blue discoloration of skin on back of her left knee). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Knee pain, at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (Black and blue discoloration of skin on back of her left knee) and ARTHRALGIA (Left knee pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
sweating; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2022 as dose 1, single (Lot number: FP7139) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious) with onset 20Aug2022, outcome "recovered" (20Aug2022), described as "sweating".  Additional information: Approximately one minute after receiving the Pfizer vaccine, the patient started sweating significantly. It subsided after 15 minutes.  No follow-up attempts are possible. No further information is expected.
Received the vaccine on Monday afternoon at 4:30 and five minutes after it became very hot, that night I slept well, but woke up with pressure behind my eyes and a big headache. All morning Tuesday was very tired, my eyes hurt, headache lasted from Tuesday morning till Wednesday night. My muscles were achy and I pulled a muscle or something on my neck. Tuesday night from 5:20 till Wednesday at 4:30 am I shivered. At 5:am Wednesday I felt all the liquid drain from my eyes and the pressure was gone, but the headache remain. I was very tired Tuesday, Wednesday and Thursday. Went to bed at 6pm on Tuesday and Wednesday and had crazy dreams on those days. Thursday was more bearable, but my arm continues to be red and swollen.  It is now Friday 12:30 and my arm is now sore before it was hurting. It's still red, hot and now itchy. I'm afraid to have to go back for the next vaccine.
Genital lesions appeared one week after second dose; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on 21Apr2021 (at the age of 37 years) as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On an unspecified date 2021 the patient experienced genital lesions which appeared one week after second dose. The adverse event was resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated with steroids and topical ointments for the adverse event. The outcome of the event was not recovered.   The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Tested positive for COVID-19.; Tested positive for COVID-19.; Was treated for pain and inflammation.; Was treated for pain and inflammation.; This is a spontaneous report from a contactable consumer (Pfizer colleague). An adult male patient received bnt162b2 in Jun2021 (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was not reported whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine and the patient received any medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Admitted to ER approximately 6 weeks ago due to shortness of breath and fever. Lungs were determined to be clear. Was treated for pain and inflammation. Released approximately 12 hours later. Tested positive for COVID-19 in 2021. Patient received the treatment for the events including Ivermectin. The outcome of the events was recovered in 2021. The events did not result in death, hospitalization, disability, Congenital Anomaly. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M020101 with expiration date 07-MAR-2019; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. states she had aches, chills & fever of 102.5 - evening with aches, chills persisting; injection site sore w/o redness. Pt advised to take ibuprofen for aches/chills/fever.
Low grade fever, nasal congestion, muscle and joint pains. Consistent with upper respiratory tract infection, doubt vaccine reaction.
pt recvd vax & vomited @ 4PM & 7PM 13JAN93; t105 R 7PM 13JAn93; contacted family MD & was seen @ hosp; no other illness found; ER staff gave pt APAP; vomited 1 time & had lo grade fever;
first Moderna shot March 15th - but have not gotten the second shot  as of yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first Moderna shot March 15th - but have not gotten the second shot  as of yet) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first Moderna shot March 15th - but have not gotten the second shot  as of yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first Moderna shot March 15th - but have not gotten the second shot  as of yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment information not provided.
not feeling good; very tired; no appetite; started with severe horrible pain over her entire body; body aches; chills/severe chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), PAIN (started with severe horrible pain over her entire body), FEELING ABNORMAL (not feeling good), FATIGUE (very tired) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: jhonson and jhonson. Past adverse reactions to the above products included No adverse event with jhonson and jhonson.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced PAIN (started with severe horrible pain over her entire body), MYALGIA (body aches) and CHILLS (chills/severe chills). On an unknown date, the patient experienced DECREASED APPETITE (no appetite), FEELING ABNORMAL (not feeling good) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (no appetite), FEELING ABNORMAL (not feeling good) and FATIGUE (very tired) outcome was unknown and PAIN (started with severe horrible pain over her entire body), MYALGIA (body aches) and CHILLS (chills/severe chills) had not resolved.            Patient is taking some concomitant medication but did not specify what they are.   Reporter did not allow further contact
Approximately one hour after the patient received the flu vaccine he began shaking and his daughter called his nurse into the room. Upon entering the room the nurse he was found to be shaking and wheezing with an O2 saturation of 83% and developed an upper airway stridor.
Patient received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer on 06/17/2021. According to guidance from Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the patient will need to be re-vaccinated.
Extreme cramping pain in right abdominal area.  Pain lasted for 3 days dissipating with time.  Never experienced anything like it before.