chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient recently in hospital from 07/17 until 7/21.  During that time she was here for headache/nausea/vomiting and possible mastoiditis. Note: SARS COV2 PCR negative at prior visit 7/18/21 7/25/21: She re-presented to hospital 7/25/21 for continued nausea and vomiting. ED vital signs revealed tachycardia but otherwise unremarkable and was found COVID Positive 7/25/21, prior COVID results from recent admission were negative. Of note patient did have recent contact with COVID positive individuals.   7/26/21: patient discharged
Lost hearing in left ear.  Equilibrium imbalance.  No improvement since first dose on 3/24/2021
pt recvd vax & in OCT92 lab eval revealed inc liver enzymes; No further details were provided;
Aches and stiffness in the joints. Muscle aches. At the outset I was barely able to walk very slowly around my apartment.  Couldn't stay on my feet longer than a couple of minutes. It got  less severe with time, but not very fast. I was able to take a walk outside again for the first time 6 days after the shot. Today, a week after the shot, my knees still hurt, and I still don't feel like I can run.
after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number cm7cm, expiry date 29th July 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was administrated with Boostrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 26 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
Severe/prolonged pain in upper left arm.  > Day of injection - Immediately after injection, experienced severe shooting pain that lasted approximately 10-15 minutes, then mostly subsided.  > 1 Day after injection - Arm pain became constant and severe for duration of the week. 3 days after injection, began taking ibuprofen/tylenol and Icy Hot to see if it would help. Usually it did not do much.  > 1 week after injection - Arm pain subsided and seemed to be back to normal. > 5/1/21 - Participated in an activity in which left arm was used differently than usual / required "unusual" muscle usage. (Outdoor marching band event. Flip folder used for reading music was attached to my left arm. which was used as a "music stand" and held up at chest level for an extended period of time).  Pain started again after the event and continues as of 5/3/21.
This spontaneous report as received from a physician refers to a 5 years old female patient. Patient's pertinent medical history and drug reactions or allergies were not provided. On 30-AUG-2012, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX instead of the intended VARIVAX (Merck). No adverse effects reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Local reaction at left deltoid, 9cm X 9.5cm erythema, induration and pruritus.
Became lightheaded during 15 minute observation; stated did not eat much prior to leaving for vaccination
Pt. passed out for about 10 seconds. Paramedics arrived within 5 minutes. Pt.  basically fainted from shot. Breathing was and vitals were all normal. Paramedics released under his own will.
She came back to the pharmacy 5 days after vaccination.  She states her arm hurts really bad and she has had no energy since vaccination. She showed me her arm  and it had a 6 inch diameter welt. It was red and swollen.  We suggested ibuprofen for pain and inflammation. We said use ice for swelling and see the physician if it gets worse or doesn't heal.
Extremely loud ringing in my ears started about 10 am Wednesday.  Today, the 22nd I awoke with the most painful burning sensation all over my body.  I have had the most extreme pain I have ever had in my life, at least an 8 on pain scale.  The ringing in my ears still persists.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult female patient of unspecified age. This refers 56 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
15NOV92 less than 24 hrs p/vax pt devel reddened swollen, painful area; no fever, no chills; treatment w/warm compress; pain w/movement, nausea, dizziness, 1 cm abscess w/inc temp, erythema lt triceps;
Information has received from a nurse referring to a patient of unknown age and gender. On 05-JUN-2015 the patient was vaccinated with an expired dose of ROTATEQ (lot# J013587, expire date 03-JUN-2015, dose, frequency were not reported) orally (Expired vaccine used). No adverse effects were reported. Additional information has been requested.
w/in 48 hrs of receiving 1st dose of Engerix-B & devel diffuse, spreading rash over lower extremities; rash cleared & pt is all better;
NECK TURNED BLACK; RASH; This spontaneous report received from a patient via a company representative from social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The patient experienced severe reaction with neuropathy following vaccination with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced rash and neck turned black (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash and neck turned black was not reported. This report was non-serious. This case, involving the same patient is linked to 20220207073 (dose number in series 1).
presented with increasing SOB, sore throat; husband diagnosed with COVID earlier in week; patient positive for COVID; HX of A Fib; pneumonia due to COVID; acute hypoxemia respiratory failure
After pt got vaccine that day, that night shot site started hurting, on 3/27/11 noticed swelling & golf ball size knot under armpit - pain radiated from armpit to (L) breast, pt used cold & warm compresses.
Janssen-Covid 19- EUA 53  yo Female who recieved single dose of Janseen lot # 180890 at approx 12:10 this morning.  During observation pt had complaint of facial numbness shortly after vaccination Pt denied any sob,diff breathing.  No signs of hives noted.  no swelling in the mouth or difficulty swallowing.
Left arm was sore 4/18 after injection and extremely sore 4/19 AM. On 4/20 75mm x 75mm redness and swelling about 70mm below the injection site. Also felt tired and myaleia on 4/20. Ok by 4/23.
Within 24 hours of receiving the Prevnar Vaccine, we noticed Pt left eye drifting outward, eventually getting the diagnosis of strabismus. We had never seen her eye drifting outward until the day of the vaccine and after that, we saw it multiple times a day. Pt eventually needed eye muscle surgery to correct the strabismus and will most likely need another surgery in the future because the first surgery was only partially successful.
Not doing too good; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not doing too good) and HEADACHE (Headache) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not doing too good) and HEADACHE (Headache). At the time of the report, MALAISE (Not doing too good) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were provided.  No treatment information was provided.   This case was linked to MOD-2021-108228 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received on 06-MAY-2021 and included information regarding second dose of the vaccine and additional event(headache).
Patient received Varivax vaccine. Prior to receipt of vaccine, patient had stated she had fainted before from  a past vaccination, but nothing major resulted from the past episode. Patient was a bit anxious prior to dose, but dose was administered initially with no s/sx. After 30 seconds - 1 minute, patient reported feeling impending fainting episode (due to past familiarity with similar event). Requested pt to sit, and shortly afterwards, patient proceeded to faint. S/sx during episode included difficulty breathing, urination, loss of consciousness, and mini-convulsions with rigidity. Administed Epi-Pen into patient left upper thigh and called EMS. After 1-2 minutes, pt regained consciousness. Pt stated she was feeling "slightly nauseous," but reported no other complications. EMTs arrived at scene after placing EMS call in ~1-2 minutes and took over evaluation of patient from henceforth.
ZERO SLEEP; WOOZY; BODY ACHE; SWEAT; FEVER; SLIGHT NAUSEA; SLIGHT HEADACHE; FATIGUE; DISCOMFORT ON THE UPPER ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced discomfort on the upper arm. On AUG-2021, the patient experienced slight headache. On AUG-2021, the patient experienced fatigue. On 06-AUG-2021, the patient experienced zero sleep. On 06-AUG-2021, the patient experienced woozy. On 06-AUG-2021, the patient experienced body ache. On 06-AUG-2021, the patient experienced sweat. On 06-AUG-2021, the patient experienced fever. On 06-AUG-2021, the patient experienced slight nausea. The action taken with covid-19 vaccine was not applicable. The patient was recovering from discomfort on the upper arm, zero sleep, woozy, fever, body ache, and sweat, and had not recovered from slight nausea, slight headache, and fatigue. This report was non-serious.
Tested positive; Tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 54 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 16Feb2021 as dose 2, single (Lot number: EL9268), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FC3183), in left arm and on 27May2022 as dose 4 (booster), single (Lot number: FJ4991), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "cardiac arrhythmia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Negative, notes: I tested negative the next day (07Dec); (11Dec2022) Positive, notes: I went back to urgent care & tested positive again (11Dec). Therapeutic measures were taken as a result of vaccination failure, covid-19, the patient received paxlovid.
This started with chills. I started to get a little lightheaded and my oxygen level was low. I went to see the doctor who asked for chest x rays that revealed pneumonia. Tested positive on a PCR COVID-19 test. The next day I felt much better with my energy returned. Symptoms pretty much cleared up within a week.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. 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 (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020, expiry: unknown) dose was not reported, 1 total administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The patient also received non-company suspect vaccine included: BNT 162 (Dose number in series 2) (form of admin, route of admin were not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 29-DEC-2021 for prophylactic vaccination. On 17-JAN-2022, the patient started experiencing sniffly nose. Followed by on 18-JAN-2022, experienced sore throat, sinus congestion, headache, and body aches coded as suspected covid-19 infection and suspected clinical vaccination failure (Dose number in series 1). Laboratory data included: COVID-19 rapid POC (Point-of-care) (Binaxnow) test (NR: not provided) Positive. It was reported that symptoms were not resolved yet (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000212818.; Sender's Comments: V0: 20220133895-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
SLIGHT FEVER, EXCESSIVE DIZZINESS, BODY ACHES, FATIGUE, HEADACHE, CHILLS.  I HAVE ALSO RECOVERED FROM THE COVID VIRUS.
Pt's husband states pt had extreme fatigue, unable to get out of bed, HA/Migraine, Weak/slow breathing from 10/21 to 10/25.  Pt took Ibuprofen 600mg and felt better and now without issues.  Pt's husband was counseled to continue monitoring the pt and to inform of other issues as they appear.  Pt did not visit the md since she's better.
3 patients got a booster dose from an expired Moderna vial.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients got a booster dose from an expired Moderna vial.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients got a booster dose from an expired Moderna vial.). On 15-Jan-2022, EXPIRED PRODUCT ADMINISTERED (3 patients got a booster dose from an expired Moderna vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.   This case was linked to MOD-2022-455209, MOD-2022-455278 (Patient Link).
Bivalent given on 9/12/2023 before communication sent in regards to discontinuation of bivalent Pfizer Covid vaccines on 9/12 PM.  No adverse events.
No adverse event occurred. Reporting patient was underage before the 05/12/21 approval for [12-15yr olds] Pfizer vaccine.
CHILLS; LOW GRADE TEMPERATURE (99.5F AND 100.8F); HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 21 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 18:00 for prophylactic vaccination. No concomitant medications were reported.  On 14-AUG-2021, the patient experienced chills. On 14-AUG-2021, the patient experienced low grade temperature (99.5f and 100.8f). On 14-AUG-2021, the patient experienced headache. On 14-AUG-2021, the patient experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 99.5 F, 100.8 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, low grade temperature, headache, and fatigue on 15-AUG-2021. This report was non-serious.
Patient received Pfizer COVID-19 vaccination on 10/30/21. She developed upper chest pain on 11/21/21 and presented to emergency room. She was diagnosed with acute mild pericarditis.
The shot hurt in an unusually painfull way from when I have ever received the shot in the past. My shoulder hurts so bad to lift my arm is almost impossible. This has been going on for a little over a week now.
she's losing height; arm was a little sore where they put the needle in; Balance problems/ has a feeling of unbalance like she'll just strike the floor/ sense of being off-balance; stomach issues; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered on the left arm, first dose on 06Mar2021 (Lot Number: EN6206; Expiration Date: Jun2021) and second dose on 27Mar2021 15:35 (Lot Number: EP6955) at a single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. She had her first dose on 06Mar2021 and her second dose on 27Mar2021. She was calling because she was wondering if anyone was having balance problems or problems with equilibrium. She had a balance problems on an unspecified date. She's not dizzy. She hasn't heard anything on the news about a balance problem. She had no reaction to either COVID 19 vaccine. She thought the balance problems started about 10 days ago. She reported she's losing height. She stated she's never had anything related to balance problems. She just has a feeling of unbalance like she'll just strike the floor and she hasn't heard this on the news. She reported her arm was a little sore where they put the needle in. Other than that, she had no side effects. She had stomach issues for about a day and a half and then it went away. She experienced a sense of being off-balance, emphasizing that she was not dizzy. The patient asked if this was one of the side effects of the COVID vaccine. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require visit to emergency room and physician office. Prior to vaccination, the patient was not diagnosed with COVID-19. No relevant tests done. Outcome of the event arm was a little sore where they put the needle in was unknown, stomach issues recovered on an unspecified date while for the other events was not recovered.
06/03/2022 I had severe body aches, vertigo, coughing, weakness, fatigue and dizziness. 06/04/2023 I reached out to my PCP and was prescribed Symbicort and Prednisone for 5 days. I was feeling better, but I have had recurring episodes of Asthmatic Bronchitis. I have also notice that my stamina and endurance not like it was prior to COVID-19.  02/03/2023 I went to my PCP for a follow up and received a tentative diagnosis of PMR.
Patient gets faint when he gets shots or has a blood draw.  After vaccination, Patient did feel faint and became diaphoretic, he had no lasting effects and  feels this is same as other events when he receives shots or has a blood draw.
Needle / syringe separated during administration resulting in employee not receiving the full dose.  Narrative:
Rash down both of my sides that was itchy and painful, onset maybe a couple of hours after administration of vaccine.  With exercise, rash spread and itchy sensation became worse. By the following morning, rash was very red and stretched almost all the way around my abdomen. I took two Benadryl the evening after receiving the vaccine, and the redness died down. Remaining now is dry skin that looks similar to eczema.