chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started having symptoms about an hour after receiving the shot.  Bad pain, chills, swelling, headache, tiredness and feeling unwell, etc.  About Thursday, I noticed bumps starting to appear on me.  IT was just a few and I was trying  to deal with all of the other symptoms.  By Friday, they started to appear more and more and are progressing as the days go on.  I'm covered in bumps/rash.
Three months after completion of vaccination 2 doses of Moderna, a blood test for CoviD 19 antibodies showed a totally negative result. Both types of antibodies (IgG and IgM) were tested and found negative.
got the flu; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involves a patient of an unknown demographic who got the flu (Influenza) after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site.    On an unknown date, (unknown latency) patient got the flu.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Pt presented with classical herpes zoster on 07/24/2000. He had a history of receiving chicken pox vaccine, but no history of wild virus induced disease.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 23-DEC-2014, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had two temperature excursions: 24 and 48 hours respectively. The lowest recorded temperature was 34 (1.111111111 Celsius degrees). The highest recorded temperature was 47 (8.333333333 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
a couple of days p/vax pt exp some redness & pain in arm radiating up into neck. treated w/tylenol
That night I woke up 4am with serve chills and I was shaking and couldn't breathe, I had a major headache. I went to the ER and they said my respiratory  was fine but If I wanted to see a doctor it would be a 20 hour wait. scheduled a telephone visit with Doctor. Doctor didn't know what to say, and didn't know if it was from the vaccine, he prescribed me Ativan. I felt tired for 2-3 days and didn't eat for 2 day.  The hospitals are too packed right now to get any type of service. Tested for Covid but tested negative, I had Covid MArch 2020
Anaphylaxis.  Initially, pt experienced palpitations and tightness in throat after vaccination  and wasn't sure if she was experiencing swelling in her arms.  BP was 130/79 and HR 93 initially.  Pt started to feel better without intervention but given diphenhydramine as a precaution while we continued to monitor her.  10 mins later she started to have tingling in lips and tongue and visible lip swelling  in addition to palpitations.   Immediately administered Epipen (0.3mg) x 1.  EMS was called.  No worsening but not improvement after 5 mins so a second dose of Epipen (0.3mg) was administered.  By the time EMS arrived (9 mins after first epipen dose) pt was feeling better, swelling had resolved, no throat tightness.  Pt was transported to local hospital by EMS for monitoring.
1st dose on Oct/Nov2021, 2nd not received/ Inappropriate Schedule of Vaccine; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received intramuscularly in October or November of 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's comment: The patient self-reported this case. The patient reported that he received his 1st Shingrix vaccine in October or November of 2021.  The patient also stated that he had not yet received their second Shingrix vaccine. (Inappropriate Schedule of Vaccine). The patient did not give permission to contact HCP (Health Care Professional). Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination. This case had been linked with case US2022AMR138448, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR138448:Same reporter/ wife case
Received flu vaccine on 10/20/15. Initially post flu shot my arm was tender as it had been for previous flu shots. However, pain began to increase steadily and did not subside. Severe and throbbing pain in left arm with diminished range of motion. Heated, iced and took ibuprofen. Treated with physical therapy and shoulder injection.
Member presented to COVID Vaccination site, received vaccination and approx 10 min after while sitting in chair, per Member "everything went black" and he unexpectedly fell forward.  Knees hit floor first and head hit support wall. No immediate abrasion nor bruising noted, LE elevated, no c/o head pain.  Assisted to wheelchair, at which time member again lost consciousness, LE re-elevated, member escorted to exam room.  After approx 30 min member evaluated By Physician and determined safe discharge home.
It was reported by the patient she was administered Fluzone SV '01-'02 on 11/28/01. Later that evening, she stated she felt very agitated and sleepless. Her upper arm at the injection site became very red, hot and swollen. She reports taking Ibuprofen and applying cold packs. The area included 3" above elbow to 1 below shoulder. The site is down to 3 x 3 now. General Malaise and bone ache was also part of the symptoms.
Pt having angioedema (rear of tongue), complained of tightness in throat. Pt has had idiopathic angioedema in past. The patient came back approximately 10 minutes after I gave her the shot and said she was having angioedema (specifically tongue swelling toward the back of tongue) and that she felt like her throat was closing. She did not have swelling, redness or warmth at site of injection. She said she had had angioedema in the past and said that her doctor said when she had it to use an epipen but did not have one. She stated that last year she got a localized reaction last year when she got a flu shot but attributed that to "the person giving the shot" I administered epinephrine 0.3 mg into the muscle of right thigh. Pt said she thought swelling had gone down and was feeling better. Pt stayed in area with me for approximately 20 minutes so I could assess whether or not shot working. Declined ambulance/ driving her home. Epipen lot 2mg670 exp 5/14.
Patient stated that she immediately felt a lot of pain in her arm after vaccination followed by bruising. The bruising has since resolved but the pain has not. The patient visited her PCP and was told that a nerve was likely hit and it would take a while to resolve.
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    Concomitant medication was not provided.  Pharmacist reported that 20 adult patients  received 0.25 ml instead of 0.5 ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.  Treatment information was not provided.  This case contains information for the 17th patient of twenty adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662849, US-MODERNATX, INC.-MOD-2022-662875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662849:Patient 1 US-MODERNATX, INC.-MOD-2022-662875:Patient 11
Profusely sweat; Body aches; Chills; Get hives on my face and chest; Had a low grade fever. 100.2 F; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), intramuscularly on left arm at 20:00 on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included cefalexin monohydrate (LEXIPRON), lisdexamfetamine mesilate (VYVANSE) and medication for birth control. The patient previously took Keflex and experienced drug allergy, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BLO140), intramuscularly on left arm at 06:00 AM on 21Dec2021 for COVID-19 immunization. An hour after the vaccination at 21:00 on 08Jan2021, the patient started to profusely sweat and get body aches and chills. The patient then started to get hives on her face and chest. The patient took Tylenol and Benadryl which helped the hives. The patient also had a low grade fever 100.2 F. The events were reported as non-serious. The outcome of events sweating, generalized aching, chills, hives and low grade fever was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19.
had no antibodies, serology showed no antibodies/a faint line of IgG but no IgM antibodies with reference to a control; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration first dose on 30Dec2020 and second dose on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. One month after first vaccine dose and 2 weeks after second dose the patient still has no antibodies, serology showed no antibodies. Has a question about the Pfizer Covid vaccine. HCP received her 1st vaccine dose on 30Dec2020. 3 weeks later she received her 2nd vaccine dose. Lab results per HCP: "SARS- COV-2(Covid 19) AB total IGG/IGM/IGA your sample does not contain any antibodies." She needed to know what to do next. The patient got the first dose of vaccine 30Dec2020 and second dose was 3 weeks later and now one month after 1st dose, 2 weeks after 2nd dose (Feb2021), still no anti-bodies per serology test. She wanted to volunteer to give vaccinations but wanted to ensure she's fully covered before she does. She received the first dose of the vaccine on 30Dec2021 and the second dose on 20Jan2021. She had no reaction after either injection, which she realized can be normal. She had a covid-19 finger stick drug store test for antibodies through (Name), not designed for the vaccine, but to show IGG/IGM antibodies. This was done 2 weeks after the second vaccine. There was a faint line of IgG but no IgM antibodies with reference to a control. The internist ordered a serology blood draw for SARS-COV-2 antibodies which she had done through (Name) and this did not contain detectable SAR-COV-2. She stated she is not immunosuppressed so it seemed it must be a problem with the vaccine or the process. She stated she got a response (from "the local analogy of Dr. (Name)") stating that the (Name) test that was ordered tests for nucleocapsid protein but not caps protein so the test would not be useful to test for the vaccine. She wants to volunteer to give the vaccine, but she does not know if she was adequately covered. She asked how she knows if she needs another dose and asked what the next steps are. She needs evidence-based information to be able to determine if she needs another dose. Outcome of the event was unknown.  Information about lot/batch number has been requested.
3 cm x 6 cm hive/swelling, warm to the touch, itchy. Instructions: take BENADRYL.
administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter reported  that date the vial was initially stored in the refrigerator: 02-Sep-2021.  Number of doses/vials 10-dose vial  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-345460, MOD-2021-345910, MOD-2021-345833, MOD-2021-345457, MOD-2021-345456, MOD-2021-345931, MOD-2021-345620, MOD-2021-345565, MOD-2021-345619, MOD-2021-345642, MOD-2021-345666 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Significant follow-up appended _ Reported added & Batch No. updated
Sore arm for 6 days. Right arm also sore at shoulder for 2 Days.  Left  Arm still somewhat weak Very tired 1 day after injection
lesions; swelling; pain; difficulty walking; lesions and rash spread to her ankles and lower legs; rash on feet; This spontaneous case was reported by a physician and describes the occurrence of LESION EXCISION (lesions), SWELLING (swelling), PAIN (pain), GAIT DISTURBANCE (difficulty walking) and RASH (lesions and rash spread to her ankles and lower legs) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cryoglobulinemia.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced LESION EXCISION (lesions), SWELLING (swelling), PAIN (pain), GAIT DISTURBANCE (difficulty walking), RASH (lesions and rash spread to her ankles and lower legs) and RASH (rash on feet). On 25-Mar-2021, SWELLING (swelling), PAIN (pain), GAIT DISTURBANCE (difficulty walking) and RASH (lesions and rash spread to her ankles and lower legs) had resolved. At the time of the report, LESION EXCISION (lesions) and RASH (rash on feet) outcome was unknown.        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.   No concomitant medication has provided. No treatment medication has provided.
Fever up to 102.8F with chills 24 hours after 2nd vaccine and body aches. All Symptoms went away within another 24 hours and treatments were OTC medicines including Tylenol and ibuprofen.
Fever of 102 within 12 hours. Developed hives on whole body (chest, neck, torso) including swelling of face and mouth 33 hours after vaccine. Have not resolved.
When I woke on 3/31/21 at around 8:00am, I had a bad headache (which happens to me sometimes so that wasn?t a big deal). But then, I started to feel very nauseous and feverish. I ended up not being able to go to work that night and had a fever ranging from 100.4-102.8 degrees Fahrenheit. I took Nauzene to help with the nausea. I took 12 of them throughout the night. You can take them every 15 minutes and they are supposed to kick in after 4. I took excedrin to help with the headache and try to keep my fever down. I woke up at 10 am on 4/1/21 feeling better only slightly nauseous.
I tested positive for COVID-19 on 7/20/22. I had a headache, congestion, cough, body aches, and lethargy. I contacted my doctor and was prescribed Paxlovid. Everything went away within 24 hours except the congestion.
Information has been received from a registered nurse concerning a 25 year old female with atypical squamous cells of undetermined significance and no known drug allergies who on 15-MAR-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast) (Lot# not reported). On 17-May-2007, the patient was vaccinated with her second dose of GARDASIL vaccine (yeast) (Lot# not reported) and delivered a baby in April 2008. Unknown medical attention was sought in a clinic. It was reported that a PAP test, ultrasound, amniocentesis and Maternal Serum Alpha-Petoprotein Screening (MSAFP) were performed (no results provided). Follow-up information was received from the registered nurse. The patient only received vaccination with GARDASIL vaccine (yeast) there, not obstetrician care. Telephone call follow-up information was received from a healthcare professional at the obstetrician's office, who reported that the patient was last seen on 30-MAY-2008 for her 6 week postpartum check up. The patient had a full term elective induction, and delivered a healthy and normal baby, weighing 3135 grams, whose Apgar assessments were 8.9 and 9. No additional information is expected.
Pt w/ onset of Infantile Spasms 10/06/2006.  Received 6 mo immunizations 9/29/2006.  Now seizures have resolved. Pt w/ severe neurological delays.  07/05/2007 MR received from PCP with several WCCs prior to 9/2006.  Next visit 1/4/07 with mention of daily seizures which include jerking and drawing in of arms and legs and dilated pupils.  Last up to 5 minutes. Not smiling at mother.  Assessment: Epilepsy, NEC.  GERD.  Delayed childhood milestones. GI Consult of 1/10/07 for fussiness, burping, & flatulance.  Reports abnormal EEG in 10/2006. WCC 6/27/2007 with persistant delayed childhood milestones. 07/23/2007 MR received for DOS 10/6-9/2006 who presented with 1 week hx of having spells where childs hands and arms swing out and head bends forward.  Multiple episodes the DOA led to ER visit and admission.  PE (+) for brisk DTRs.  Discharge DX:  Infantile Spasms, cryptogenic in nature. Neuro F/U 12/06/2006 reportedly doing well with occasional jerking related feeding/burping.  Wearing helmet for plagiocephaly.
Went to the PMD a day later for routine blood work and found I have significantly elevated LFTs with ALT and AST 400s
Warmth, redness, induration and pain R anterio lateral thigh approx 36 hours after vaccine.
She has been feeling rotten for a few days; This is a spontaneous report from a Pfizer-sponsored program via a contactable physician reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included ongoing COVID positive since 22Dec2020. She was COVID positive before she got the vaccine. She got tested for COVID Corona Virus, because they do it weekly. She does weekly self-testing as part of a study she is in. There was an outbreak at her office and that is why she had to get a whole other test. On 22Dec2020 she did a nasal swab. She didn't get the results from the nasal swab until the day of report. The patient's concomitant medications were not reported. It was reported she was having an immune reaction to the vaccine and she was expecting it and said it was ok. On the 23rd she had symptoms. On the 24th, the rapid test was positive. The results from the nasal swab on 22Dec2020 was positive, so she was COVID positive before she got the vaccine. She has been feeling rotten for a few days and couldn't reach out before today. The patient wanted to know if it would be effective for her to receive the second dose of the COVID vaccine after being positive for the COVID virus. Outcome of the event was unknown.  Information on the batch/lot number has been requested.
BODY ACHES; FEVER (103F); FATIGUE; SORE ARM; FEELING BAD; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. 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-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced fever (103f). On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced sore arm. On 09-MAR-2021, the subject experienced feeling bad. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fatigue, sore arm, and feeling bad on 11-MAR-2021, and fever (103f) on 10-MAR-2021. This report was non-serious.  Version created to amend previously reported information on 11/MAR/2021. Upon review, the following information was amended: Reporter's first name and last name updated,  route of administration and unit dose of suspect product updated, DD schedule updated.