chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Significant arm pain started within a few hours of receiving the vaccine.  Pain became so severe it restricted range of motion.  Pain has improved slightly initially but has remained constant since then.  Patient has been referred to neurology for an evaluation of brachial plexopathy.
Within 2 hrs post vaccine had temp spike 103F, less than 24hrs repeat evaluation revealed R hip pain. NL CBC. ESR-17, CRProtein, Hip ultrasound negative sign of fluid.
WHOLE BODY PAIN/ BODY ACHES; FACIAL SWELLING; LEGS SWELLING; DIZZINESS; DISORIENTED; CHILLS; FEVER; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was 190 pounds, and height was 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: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced whole body pain/ body aches. On 09-APR-2021, the subject experienced facial swelling. On 09-APR-2021, the subject experienced legs swelling. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced disoriented. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, facial swelling, legs swelling, fever, whole body pain/ body aches, dizziness, and disoriented. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
chills, fatigue, body aches, nausea, dizziness, lethargy, sore arm at the injection site - NSAID taken with mild improvement
Inability to walk, effectively communicate, raise my arms, suffered sustained premature ventricular tachycardia for a number of hours, life saving procedures enacted, no blood flow to extremities, severe pain, vomiting's, periods of unconsciousness
Baseball size welt at injection site, heat at injection site, itchiness and pain at injection site. Hardness of skin under welt.
Patient reports that she immediately experienced pain in her left arm. States later that night pain radiated to neck and hand. Saw MD and is being treated for bursitis.
Red, swollen LEFT arm starting from mid deltoid to elbow, inner arm only. Warm to touch. Painful.  -Per patient.
Developed Bell's Palsy 3 weeks after receipt of the inactivated influenza vaccine.  12/28/07 Reviewed medical records which reveal patient experienced left facial weakness, left eye tearing & left facial droop 11/11/07, 3 wks s/p flu vax.  Saw pcp on 11/13 for sinusitis then later tx w/antiviral & steroids. Returned to clinic 12/3 w/dry cough x 2 wks & was dx w/acute ethmoidal sinusitis.  FINAL DX: Bell's palsy.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. On an unknown date the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) (lot number unspecified) instead of ZOSTAVAX due to nursing error. No adverse effect reported. It was unknown if the patient had sought medical attention. This is one of several reports received from same source. Additional information has been requested.
Very fatigued and nauseated within hours of injection. Worsened next day and then waned over next couple days leaving only fatigue that still lingers
The pt returned to the office for swelling of left thigh and difficulty walking. On exam, the left leg was swollen from his hip to his knee and firm. He limped with ambulation. No redness or fever. He was treated with Augmentin.
I had no symptoms or adverse reactions following dose 1 or 2 .  However, 6 weeks post 2nd dose I tested positive for covid infection.  I was in close contact with someone who was positive for covid.  I went to drive thru testing site and got a positive diagnosis.  I had a runny nose for 1 week.  About 2 weeks later, I started having left heel pain when I walk.  I also noticed swelling in big toe and back of left heel.  It got worse over time. I went to the ER on 5/13/2021 since I was in so much pain. They took X-rays and it showed nothing and I went home. On 6/1/2021 my Achilles tendon tore, I heard a loud pop and fell to the floor.  The ambulance took me to the ER and they could not find anything.  I went to orthopedic to follow up and they did MRI which confirmed torn Achilles and I would need surgery.
Death from COVID S/P COVID vaccination ? Vaccines o 01/21/2021 Pfizer Lot EL9291 o 02/11/2021 Pfizer Lot EL9269 o 02/19/2022 Pfizer Lot FM0698
rash on buttocks; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) and (batch number J5255, expiry date 13th November 2022) for prophylaxis.   On 9th August 2021, the patient received the 1st dose of Shingrix.On an unknown date, the dose was an unknown dose. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the pharmacist. The pharmacist reported that patient received shingrix vaccine and developed a rash on her left buttocks.
Blanching maculopapular rash on arms, legs, trunk/back. Started day 4 after vaccine. Blanching rash at site of injection.
headaches a few days after the vaccine and continuing 3-4 times weekly, sinus congestion, ear infection, constant ringing in ears since receiving vaccine.
sick; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: spots on inner cheek-Severe, Additional Details: Patient previously reacted to first dose. MD recommend they continue to receive 2nd dose. Patient took Benedryl (~5min) before arrival. Immunizing RPh waited an additional 10min before administering. 911 was called but caregiver took patient to ER themselves
Fluzone High-dose around 230pm. Per pt - woke up from pain, body ache , chills around 3 am -- was feeling better around 10am when she called.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 2:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 2:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) 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 94.11   Concomitant products were not provided.  On 12-Feb-2021 Excursion time was reported at 10.00 am, and 11.00 am with  temperature as 35 and 35 degrees Fahrenheit, total doses given for the day was 55, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, and the  vial was moved to clinic on 12-Feb-2021. 3 vials were sent to clinic. Vaccine BUD date was on 10-Mar-2021.  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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-NOV-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R006209, expiry date 16-MAR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
Father called to report that for 20 seconds patient held arms above his head and had hives that disappeared quickly ten days after receiving vaccine. Episode was brief.
Narrative: 5/22/19 PPSV23 given in the right arm 5/25/19-5/28/19 admitted for RUE cellulitis with sepsis, CT of the RUE showing mild swelling, but no gas, no drainable abscess.
vestibular neuritis; Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 07-JUN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the prevention of shingles. Shortly thereafter, the patient suffered a severe rash. On an unspecified date in or around June 2017, the patient presented to her doctor because of the rash and she was diagnosed with shingles. Subsequently, she began having troubles hearing and was diagnosed with vestibular neuritis. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of Zoster Vaccine Live (ZOSTAVAX.) At the reporting time, the patient had not recovered from the events of shingles and vestibular neuritis. The reporter considered the event of shingles and vestibular neuritis to be related to zoster vaccine live (ZOSTAVAX).   The reporter considered shingles and vestibular neuritis to be disability events.  Additional information has been requested.
back pain; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), CHILLS (chills) and MYALGIA (body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (chills) and MYALGIA (body aches). On an unknown date, the patient experienced BACK PAIN (back pain). At the time of the report, BACK PAIN (back pain), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Reportedly, the patient hasn't taken anything for treatment of his symptoms.   The patient's back pain is not constant but only when he rides or sits down.
States RECOMBIVAX HB injection #3 received on 5/22/08 from Employee health, Health dept. L deltoid site ached after injection. (#1 and #2 ached for 3 days only) and continues to still ache. No treatment obtained.
Patient came in for her second dose of COVID vaccine. However, she was supposed to get Pfizer and accidentally received Moderna instead. Patient is doing well, she has not experienced any adverse effects.
Initially she passed out following the vaccine - within 90 seconds- she has a history of passing out with injections and blood draws. Around noon she had a seizure. She describes a feeling of darkness and dread closing in on her and she was unable to speak or move. She was on the stairs at the time. I witnessed her stiffen, then go limp and fall between the electric stair hair and the wall. She hit the hardwood floor face first then she began to shake/twitch. She was unconscious. She awoke screaming, incoherent speech, and flailing limbs. It took about 5 minutes to calm her and be able to understand her speech. She only remembers the darkness and waking up scared and feeling awful. She was put supine on the floor with feet elevated, blood pressure monitored, given juice to drink, and vitals checked routinely. After about an hour supine and conscious, she felt good enough to sit up. She sat up for 15 minutes before she was able to stand with assistance. Family physician was notified immediately and we are still waiting for a response. She has a goose egg sized knot on her forehead, a bruise on the side of her face and a black eye from hitting the floor. She has a huge bruise on her outer thigh and lower leg where she hit the stair chair and then seized and it it repeatedly on the metal. She has underarm pain from where her armpit hit the edge of the stairs when she fell and seized. She has no history of any types of seizures.
pain above left clavicle; Lymph nodes in neck are severely swollen, golf ball size; body aches; fever; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (fever), FATIGUE (exhaustion), PAIN (pain above left clavicle) and LYMPHADENOPATHY (Lymph nodes in neck are severely swollen, golf ball size) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced MYALGIA (body aches), PYREXIA (fever) and FATIGUE (exhaustion). On 24-Mar-2021, the patient experienced PAIN (pain above left clavicle) and LYMPHADENOPATHY (Lymph nodes in neck are severely swollen, golf ball size). At the time of the report, MYALGIA (body aches), PYREXIA (fever), FATIGUE (exhaustion), PAIN (pain above left clavicle) and LYMPHADENOPATHY (Lymph nodes in neck are severely swollen, golf ball size) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs included no treatment included
Fourth vaccination on 21-JUL-2021/Four doses of moderna; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Fourth vaccination on 21-JUL-2021/Four doses of moderna) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXTRA DOSE ADMINISTERED (Fourth vaccination on 21-JUL-2021/Four doses of moderna). At the time of the report, EXTRA DOSE ADMINISTERED (Fourth vaccination on 21-JUL-2021/Four doses of moderna) had resolved.            Concomitant medication was not provided Treatment information was not reported   This case was linked to MOD-2021-265485 (Patient Link).
Local inflammatory reaction; swollen, red around site of injection, about 4 cm in diameter.
Patient states has had excruciating and debilitating shoulder/arm pain since the moment of injection.  Patient has not yet felt the need to seek medical attention and has not been seen by any physician.
After my first shot (only one I have received), I had nausea, vomiting, the shakes, chills, and fatigue.  I also developed "COVID Rash" on my arm around the injection site about a week later.  It is now almost completely gone.
Patient got the high dose flu vaccine and she reports within 4 hours of getting the vaccine she was trembling and had diarrhea which resulted in her son calling EMS. They told her she had the flu and she was not transported to the hospital. She reports her symptoms lasted about 3 days. This has not been the first report of these types of symptoms following the high dose flu vaccine this year so wanted to report this to the FDA Medwatch.
This spontaneous case reported by a consumer, describes the occurrence of dizziness (had a little bit of lightheadedness and dizziness), postural dizziness (this morning, it's worse and cannot get up and move around), malaise (feels like she might pass-out or throw-up) and nausea (feels like she might pass-out or throw-up) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 16, 2021, patient experienced dizziness (had a little bit of lightheadedness and dizziness). On Jan 19, 2021, the patient experienced postural dizziness (this morning, it's worse and cannot get up and move around), malaise (feels like she might pass-out or throw-up) and nausea (feels like she might pass-out or throw-up). At the time of the report, dizziness (had a little bit of lightheadedness and dizziness), postural dizziness (this morning, it's worse and cannot get up and move around), malaise (feels like she might pass-out or throw-up) and nausea (feels like she might pass-out or throw-up) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported.
Fever of 102.9; Chills; Head in a fog; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2022 (Lot number: FK9729) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN; VIT D [COLECALCIFEROL]; B12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (Dose Number: 2, Brand: Pfizer, Batch/Lot No: EN6203), administration date: 18Mar2021, when the patient was 50 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Brand: Pfizer, Batch/Lot No: EL3247), administration date: 25Feb2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 10Mar2022, outcome "recovering", described as "Fever of 102.9"; CHILLS (non-serious) with onset 10Mar2022, outcome "recovering", described as "Chills"; FEELING ABNORMAL (non-serious) with onset 10Mar2022, outcome "recovering", described as "Head in a fog". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination: multi vitamin.  No follow-up attempts are possible. No further information is expected.
DIARRHEA; FELT TIRED; FEELING QUEASY; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 14:30 on right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced slight headache. On 18-MAR-2021 05:00, the subject experienced diarrhea. On 18-MAR-2021 05:00, the subject experienced felt tired. On 18-MAR-2021 05:00, the subject experienced feeling queasy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 10-MAR-2021, and had not recovered from felt tired, diarrhea, and feeling queasy. This report was non-serious.
Hives on scalp face neck and right arm. Immediate area of vaccine became raised, red, and bumpy after 1 week of no symptoms. Started at 3 or 4pm, got worse in evening. Improved with Benadryl. Same thing happening today, 8 days out.