chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild headache in the evening; a bit tired; temperature of 99.5-100.4; second dose on 22Feb2021; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration, administered in Arm Left on 22Feb2021 10:00 (at the age of 64 years old) as dose 2, single for COVID-19 immunisation at hospital. Medical history included allergy to penicillin. There were no concomitant medications. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN9581) via an unspecified route of administration, administered in Arm Left on 04Jan2021 10:00 (at the age of 64 years old) as single for COVID-19 immunisation. Patient did not have COVID prior to vaccination. The patient experienced as, second dose on 22Feb2021, mild headache in the evening, a bit tired, temperature of 99.5-100.4 on 23Feb2021. Reported as, day of vaccine 2 - mild headache in the evening. A bit tired. Temperature of 99.5-100.4 on day 2,3,4. No treatment were given for the adverse events. Patient did not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 99.5-100.4 on 23Feb2021. Outcome of events mild headache in the evening, a bit tired, temperature of 99.5-100.4 were not recovered.  No follow up attempts are needed. No further information is expected.
60 days past first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (60 days past first dose) in a 43-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (60 days past first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (60 days past first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
weakness; fatigue; brain fog; collapsed/ Had no control of the body/ just before fainting; imbalance; vertigo; urine foams which is the protein leaked from his kidneys; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received third dose bnt162b2 (BNT162B2), via an unspecified route of administration on 31Aug2021 (Batch/Lot number was not reported) (at 62-year-old) as DOSE 3, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose and experienced headache, foggy feeling in head, dizziness, second dose and experienced fatigue, joint pain, trouble falling asleep, confusion. The next night following the booster dose, patient tried to get out of bed and collapsed. Had no control of the body, imbalance, vertigo, no control, but was able to get back into the bed. Patient collapsed, just before fainting. If fainting is a 10 he was at a 9.5. He had the feeling and sensation of feeling like fainting. Later some weakness and fatigue, not like first episode. He was still experiencing brain fog and fatigue it's like "somebody gave you a narcotic injection to sleep, like an anesthesia it was bazaar". Patient's urine foams which is the protein leaked from his kidneys and that this is a side effect of the vaccine and he wants to know if it is temporary or reversible. The outcome of faint and brain fog was not recovered, other events outcome was unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 84-year-old female patient who received Shingrix (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 10th August 2018, the patient received Shingrix (intramuscular). On 10th August 2018, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On 11th August 2018, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash, inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the injection site rash to be related to Shingrix. Additional information was received as follows: The healthcare professional reported that she mixed 2 adjuvant of Shingrix and administered it to the patient, which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered. The patient experienced the rash at injection site. On 12th August 2018, the patient did receive the properly reconstituted dose of Shingrix.
Low blood sugar (didn?t eat before hand) Uneasy stomach and low energy into the next day
Arm very sore (prevented patient from sleeping that night) and slight pink coloration at injection site.
02/11/2005-Mild itching to Left arm no swelling, no redness, no warmth at injection site. Pt given ice pack, diphenhydramine 25mg PO x1 Pt watched for 15 minutes with no improvement in pt condition. 02/15/2005- Itching to left arm, feeling weak, dizzy, mild nausea and low grade fever. Pt treated by physician with Kenalog 60mg IM after consulting CDC-yellow fever- 02/17/2005 small area of redness noted around  injection site. States no c/o shortness of breath just itching hydrocortisone cream 1% given apply BID, follow up ER if shortness of breath or other signs or symptoms.
This is a spontaneous report from a contactable nurse on behalf of the physician. A 71 years old female patient (75 kg weight, 158.75 cm height) received a single dose of PREVNAR13,( lot H45098, exp date 01MAY2015) intramuscular, in the right deltoid muscle on 25NOV2014 at 15.15 and TDAP in the left deltoid muscle intramuscular on 25NOV2014. Medical history included hyperlipidemia, depression, simple liver cyst right lobe stable on 3 US 2014, vaginal hysterectomy with bilateral salpingo-oophorectomy due to fibroids, basal cell removal left antecubital fossa, myringotomy tube2 in 2004, cataract surgery bilateral in 2011, hemorrhoids. She never smoked. She was allergic to erythromycin. Concomitant medications included ANUSOL-HC 2.5% rectal cream with applicator, for hemorrhoids twice daily for 10 days and then as needed,gabapentin 100 mg oral capsule twice daily, melatonin 5 mg oral tablet, nortriptyline 50 mg oral capsule once daily, PREMARIN 0.624 mg/g) vaginal cream with applicator, 0.5 g twice weekly (Monday and Thursday), simvastatin 40 mg oral tablet once daily (nightly). The vaccines were administered by the nurse at their facility. The nurse mentioned that she had no prior documentation whether the patient had experienced same adverse event before. On unknown date the patient had a reaction and redness at the site of the injection, the spot was square in shape and couple of inches in size. The patient was not  hospitalized. The patient denied fever. There was a 15,9 cm erythematous ring just inferior to the site of injection. on the right upper extreme, non-tender and slight swelling locally. The patient was evaluated for an itchy rash that came up after immunization with PREVNAR13, noted 6 days after vaccination. It has been gradually expanding for the past 2 days, itchy, mild localized swelling since yesterday, no swelling of lips/tongue, or shortness of breath. Patient also reported generalized dry skin at this time of year as normal for her. Patient reported reduced swelling and lessened redness. Now area red "swollen" x 2 days. PREVNAR13 local allergic reaction was reported. The patient received CLARITIN at 10 mg from 03DEC2014 and was still taking it as recommended by the physician. The patient has noticed improvement since she started taking loratadine. The patient was advised to take BENADRYL as needed, but she declined to this at this time, citing side effects. Lab data underwent by the patient included; blood pressure at 128/74, pulse at 84, respiratory rate at 16, BMI: 29.7. The nurse had no idea whether the reaction was due to PREVNAR13 or not. Follow-up (15DEC2014): New information from the same contactable nurse on behalf of the physician incldues: medical history, concomitant medications, additional events, treatment received and events details.
mild headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD22-025425 (Moderna).  A male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 2, single (Lot number: EN6198) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Antidepressant" (unspecified if ongoing); "digestion" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; SIMVASTATIN taken for blood cholesterol; SERTRALINE taken for depression; OMEPRAZOLE taken for dyspepsia; VITAMIN D3. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6201), administration date: 10Feb2021, for COVID-19 immunization, reaction(s): "mild headache". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "mild headache".  Additional information: It was reported that the patient only experienced a mild headache after receiving the Pfizer vaccines. The patient had no allergies (medications, food and other products). The patient had never had COVID positive test or diagnosis. The patient had no history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200076049 same patient/event, differnt dose numer;
Patient came to the pharmacy and said it's time for her second dose of Shingrix, but she had pretty bad side effects from the first dose and wondered if she should get the second dose.  She said at first she thought she was having a heart attack.  She had intense pain in her left upper chest area that radiated across her chest over the following 6 days and then faded away.  She took Tylenol the first few days to help with the pain.  She did not contact a doctor or the pharmacy and was not seen or evaluated by a healthcare professional.  She said she feels fine now..
Progressive leg weakness and shortness of breath starting shortly after Tdap administered 5/2016.
PATIENT RECEIVED THE VACCINE, AND WILL SITTING IN THE RECOVERY ROOM, FELT HOT, DIZZY AND SWEATY AS WELL AS OBTUNDED. BP 90/42, HR 55 SAT 97 RR12 DIAPHORETIC, AROUSABLE, COHERENT CV PULSE DIFFICULT TO PALPATE, BRADYCARDIC PHYSICAL EXAM OTHERWISE UNREMARKABLE PLACED ON STRETCHER. MENTAL STATUS IMPROVED. VS 115/97, 75, 12, SAT 98 TRASNFERRED TO EMERGENCY ROOM FOR EVALUATION
Patient is a 44 y.o. female with a history of relapsing-remitting MS on Ocrevus, chronic fatigue on Adderall, hypothyroidism, depression/insomnia, who presented to a HCF on 7/19/23 for worsening shortness of breath, found to be COVID+ with multifocal PNA on CTPA, negative for PE.    1. COVID pneumonia: Test positive 7/19/23, symptom worsening 3-4 days prior to admit, though subacute cough for the month prior. CT chest with multifocal pneumonia. Normal WBC. Immunosuppressed while on Ocrevus (anti-CD20) for MS. Stable on room air during admission. Received remdesivir x 3d. Deferred antibiotics without clear signs of bacterial pneumonia. ID consulted. Dr. not convinced that Sx are 100% related to . ID consulted. Dr. not convinced that Sx are 100% related to COVID. Respiratory PCR panel neg. Blastomyces, Cryptococcus, histoplasma, coccidioides pending on dc. Covid-19 cycle threshold with elevated viral load. Transitioned to paxlovid 7/22/23 x 5d. Patient will be called if any other serologies come back positive. 2. Subacute cough, fevers: Per patient, ongoing for 1 month, started after she came back from a trip end of 6/2023. Immunosuppressed. Doubt COVID caused the original symptoms with multiple negative home tests. Crypto neg. Coccidioides, Histo, blasto pending. ID consulted as above. Symptomatic care. 3. RUE DVT: extravasation of IV into right arm with pain and swelling. RUE duplex + DVT 7/22/23. Eliquis x 3mo per PVC. Entire 3mo script given on dc, as were coupons. 4. Hypokalemia: POA. Replaced and monitored 5. Chronic fatigue: Due to MS, worsened by infection. Continued home Adderall, though patient only takes PRN. 6. Urinary retention: Prescribed Flomax, no longer uses. Thought possible adverse effect to scopolamine patch previously. 7. Hypothyroidism: Continued home thyroid supplement.  8. Depression with insomnia: Continued home Wellbutrin, Ambien.  9. Obesity: BMI 39. Weight loss upon discharge as able..
debilitating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 05Oct2023, outcome "unknown", described as "debilitating".  Additional Information: An adverse side effect from the latest COVID vaccine that has been somewhat debilitating since 05Oct when the vaccine was administered. Asked if that was common and if they have any advise on treatments.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient presented with large 2.5 x 2 inch swollen rash approximately two inches under the site of injection. She said it itched her but it did not feel hot. I advised patient to use cold compress, antihistamine (BENADRYL), and ADVIL or TYLENOL.
10 cm localized reaction with red raised rash 3 days after vaccine. No vesicles yet, but looks like it is forming some.
PATIENT REPORTED VISUAL DISTURBANCES (DARKENING OF VISUAL FIELD), SWEATING, AND WEAKNESS ABOUT 5 MINUTES AFTER VACCINE WAS GIVEN.
Nausea, chest pain and mid-abdomen pain. Patient's skin: moist, cool and clammy. VS obtained; 88/52, 52 irregular and 99 SpO2 on RA, RR even and nonlabored. EMS called at 13:59, on scene at 14:06 to assume care.
Patient developed severe localized reaction 24 hours after vaccine. C/o fever school called to tell mom child had low grade temp (had HPV and MENACTRA B yesterday), feels somewhat myalgic, says legs hurt and arms hurt too.  Denies: nasal congestion, cough, sore throat.
CLIENT RECIEVED IMMUNIZATIONS 9/12/2016. AWOKE THE NEXT MORNING WITH DIME SIZED FLUID FILLED BLISTER ON RT ARM IN APPROXIMATE AREA WHERE MENACTRA WOULD HAVE BEEN GIVEN. NO FEVER NOTED BY MOM.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Unknown number of patients might have been administered M-M-R II (lot number, expiry date, route and dose were not reported) since 08-FEB-2013, that had been improperly stored. No adverse effects reported. The reporter was unable to confirm the exact number or the identities of the patients involved at the time of this report. Additional information has been requested.
Since 2003, hearing loss, sleep disorders, neurological problems, headaches, muscle joint pains, fatigue, muscle spasms, recurring skin lesions, chills or fever, nausea, constipation, diarrhea, change in vision, vomiting, discogenic disease, blood in feces, stomach hernia. 2/17/09-records received-presents to clinic with nasal congestion, eye itching and increased lacrimations. Previously seen for C/O dyspepsia, tinea, back pain, disc disease, foot pain, depression, marijuana abuse, rhinitis.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. The reporter considered the sickness to be possibly related to SHINGRIX. Additional details were provided as follows: The reporter was the wife of the patient. The age at vaccination was not reported. The patient experienced sick. The reporter wanted to report the event that she would call GlaxoSmithKline. The patient had denied permission to contact their physician.
Headache, nausea, swollen lymph nodes, tender/painful breasts, lump in left breast, tight chest/heart
area around inj site swollen, red, tender & hard, pt w/o sx of systemic rxn no fever, itching;
Site injection soreness in arm; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via Regulatory Agency. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Mar2021, outcome "recovering", described as "Site injection soreness in arm"; FATIGUE (non-serious) with onset 04Mar2021, outcome "recovering", described as "Tiredness". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Additional information: No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient not diagnosed with COVID-19 and since the vaccination, the patient not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Blood clot at site of injection; Soreness and tenderness at her arm of injection; A spontaneous report (United States) was received from a consumer concerning a 74-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness and tenderness at her arm of injection and a blood clot at site of injection.  The patient's medical history was not provided. Concomitant product use was not provided.  On 03 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot number 11M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 04 Feb 2021, after the administration of vaccine, the patient experienced soreness and tenderness at her arm of injection. On 05 Feb2021, she also got a blood clot at the site of injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of these events, soreness and tenderness at her arm of injection and a blood clot at site of injection were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Booster; losing control over her urine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Jan2021 (Lot number: EL9262) at the age of 70 years as dose 1, single, intramuscular, administered in arm left, administration date 21Feb2021 (Lot number: EN6201) as dose 2, single and administered in arm, administration date 29Sep2021 (Lot number: FF2588) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, administration date 29Sep2021. The following information was reported: IMMUNISATION (medically significant) with onset 29Sep2021, outcome "unknown", described as "She did get the Pfizer COVID booster on 29Sep2021"; URINARY INCONTINENCE (medically significant) with onset 01Feb2021, outcome "recovered" (13Nov2021), described as "losing control over her urine". The event "losing control over her urine" was evaluated at the physician office visit. The clinical course was reported as follows: caller had her first COVID vaccine shot 31Jan2021. On 01Feb2021, the day after, she started losing control of her urine. This has never happened to her. She has never had a problem like that in her life. This went on for 8-10 days, and then it stopped for 8-10 days. Then it would come back for 8-10 days, and then stop for 8-10 days. This went on and on. She got the second COVID vaccine on 21Feb2021. She didn't notice it change any after the second dose. She didn't have pain or anything. She just had no advance warning she had to pee. She would just be sitting there and go. Like one time she was working on a puzzle. She turned sideways and didn't know she had to go and went all over herself. She did get the Pfizer COVID booster on 29Sep2021, she got a flu shot that same day. Then, on 13Nov2021, it stopped, and she hasn't had problems since. She feels like she has recovered completely.   No follow-up attempts are possible. No further information is expected.
I got body aches, developed a low grade fever, felt fatigue, headache and I also developed a swollen lymph node in my left armpit.
Patient stated that she had blurred vision, dizzy , nausea and that her throat was hurting
I had about 4 eye floaters about a week after receiving the Pfizer 3rd shot. I had previously also had eye floaters about a week after my second shot in the series. I had never had eye floaters before this time. In late December 2021, I had some flashes of light, especially in somewhat darkened rooms/other areas. When I went to see the doctor of optometry on 12/29/2021, she told me it was because of the floaters in my eye. (I had wanted my eyes checked to make sure it wasn't a problem with my retina.) I have not had additional eye floaters since the ones I had after the 3rd shot. I still can see the eye floaters, but they are becoming less noticeable. For item 21 below, I put disability or permanent damage. I do not know if it is permanent. I can still see, so it is not a major disability. I did not know how to represent that it has not totally resolved for the item. You can decide how to code it.
Rash face/both arms/back, pain joints including ankles right hip and lower back, pain at injection site,  mild headache,