chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe vomiting; abdomen pain / severe intestinal pain; fatigue; swollen lymph nodes; headache; joint/muscle soreness; joint/muscle soreness; disrupted bowel movements; This is a spontaneous report from a contactable consumer (patient).  This 43-year-old non-pregnant female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Mar2021 at 14:15, at the age of 43 years, at single dose, in left arm, for COVID-19 immunisation. Medical history included unspecified auto immune disorder, Hashimoto disease, allergy to minocycline hydrochloride (SOLODYN) and emergency surgery. The patient did not have COVID prior vaccination. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine sodium (SYNTHROID), bupropion hydrochloride (WELLBUTRIN) and polycarbophil calcium (FIBER), HRT and prob. No other vaccine was administered in 4 weeks. The patient had typical symptoms listed that started on 2nd day post shot, on an unspecified date in Mar2021: fatigue, swollen lymph nodes, headache, joint/muscle soreness, etc. Then a week after, on 09Apr2021 at 04:00, she had severe vomiting and abdomen pain. She went to ER with pain and no physical cause (it was only the second time he had ever been to an ER, first resulted in an emergency surgery so this was very unusual for me). Dr said perhaps food poisoning or a virus but she had not been out of house except for vaccine shot and ate same as husband that did not got sick at all (and they were in close proximity so likely not a virus). She had never had this issue before. She experienced 2.5 days vomiting even with nausea medicine and severe intestinal pain and disrupted bowel movements for 4-5 days. The events resulted in Emergency room/department or urgent care. Treatment included pain, anti-spasm and anti-nausea injections + IV. The events resolved on an unspecified date in 2021. COVID was not tested post vaccination.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Triggered his autoimmune response; Pain kept him from sleep for 3 nights; He was frozen (could not roll in bed) this weekend; So much pain; Fatigue; Arm hurts really bad for 3 days; Diagnosed him with joint inflammation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GLOMERULONEPHRITIS MEMBRANOUS (Triggered his autoimmune response) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Membranous nephropathy (glomerular membranous nephropathy).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced ARTHRALGIA (Diagnosed him with joint inflammation). On an unknown date, the patient experienced GLOMERULONEPHRITIS MEMBRANOUS (Triggered his autoimmune response) (seriousness criteria hospitalization, disability and medically significant), INSOMNIA (Pain kept him from sleep for 3 nights), HYPOKINESIA (He was frozen (could not roll in bed) this weekend), PAIN (So much pain), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm hurts really bad for 3 days). At the time of the report, GLOMERULONEPHRITIS MEMBRANOUS (Triggered his autoimmune response), INSOMNIA (Pain kept him from sleep for 3 nights), HYPOKINESIA (He was frozen (could not roll in bed) this weekend), PAIN (So much pain), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm hurts really bad for 3 days) and ARTHRALGIA (Diagnosed him with joint inflammation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, C-reactive protein: high (High) Very High.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment - Based on current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 31-AUG-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 30-SEP-2016, the patient was treated by a physician at a clinic for the onset of varicella pneumonia which is caused by the varicella zoster virus. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, varicella pneumonia was considered to be a medically significant event. Additional information has been requested.
1/5 Chill-fever 101.6 @6:45A Reaction 9pm 116 Resolved. Went to ED, covid rapid (-) prior covid (-) Antibodies result (-) 2nd dose
Erythema, inflammation, and induration from the right hip to the right knee, patient was crying for hours from pain and was irritable and inconsolable.
Received #3 Rabies vaccine 9/22/10. 28 hours after vaccine she developed a urticarial rash. She was seen 9/30/10 and was given RX for BENADRYL 25 mg PO. The following day hives doubled in size and spread down torso. Pt taken to emergency room for ER 10/1/10.
I received my second Moderna booster for COVID-19 on 4/27/2022. On the same day, I also received a vaccine for either shingles or pneumonia, but I don't remember which. On the night of 9/28/2022, I had chills. They lasted for a while and then went away, so I didn't think much of it. On 9/29/2022, I had a sore throat and sneezing. On 10/1/2022, I felt lightheaded and fatigued. I also felt feverish, but I took my temperature, and no fever was detected. I took a home test for COVID-19 and got a positive result and then called my doctor to request an antiviral. I was prescribed PAXLOVID, which I began taking that day. I then had a gradual improvement, and after 3 days, I felt better. About 4 days after that, I had a rebound, which included sneezing, fatigue, and a mild cough. I then started to gradually improve over the following 3 or 4 days. On the seventh day, I took another home test and got a negative result and resumed my normal activities.
Pt admitted for induction of labor and was found to be positive for covid. Had previously been vaccinated
After 2 hours, congestion and headache followed by numb throat and thumb around 4 hours after vaccine,  dizziness, feeling of tightness in throat, swollen throat /difficulty swallowing, and some trouble breathing. Symptoms persisted until about 9 hours after vaccine
expired pentacel administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via consumer/non-hcp on 16-Mar-2023. GMI number: 01535664.  This case involves 4 months old female patient to whom expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; and Rotavirus Vaccine Live Reassort Oral 5V (Rotateq) for Prophylactic vaccination. On 16-Mar-2023, the patient was administered expired second dose suspect Pentacel vaccine Suspension for injection at 0.5ml dose once (lot: U719AA, expiry date: 28-Feb-2023) via intramuscular route in the left thigh for prophylactic vaccination with no reported adverse event (expired product administered) at same day latency.  Action taken: Not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the event expired product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
severe gout attack in right foot - I'm on day 11 with no end in sight; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 16Apr2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received second dose of  bnt162b2 (Lot Number: ew0150), via an unspecified route of administration, administered in arm left on 05Apr2021 12:15 as single dose for covid-19 immunisation. The patient medical history included penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: en6208) on 15mar2021 12:30 PM in left arm for covid-19 immunisation. The patient experienced severe gout attack in right foot - I'm on day 11 with no end in sight on 06Apr2021 20:00. The patient reported she had pretty severe, she just got 2nd shot Monday last week ago, and 2 days later (as reported) she got a very severe gout reaction and she never had that in her life, she wanted to know that was the known side effect of the Covid vaccine. No fever. Repeated as she got a very severe gout reaction in her foot, was in the red skin cause, its more than a rash, it's incredibly painful and her entire foot get swollen. And she had been to the doctor, they diagnosed her for the gout. She never had a gout previously in her life, she did not have any other food trigger or anything else that they think and cause, so she just wondering was that, It was known reaction that continually determined. She was just trying to figure out, why this was happening? She couldn't walk. The adverse event result in Doctor or other healthcare professional office/clinic visit Emergency room/department or urgent care. Treatment received for the adverse event included Indomethacine- Prednisone. The outcome of event goat was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient received vaccine early afternoon. After dinner patient told mom he wasn't feeling well. Complained of severe headache and body ache. Mom observed patient had chills and felt clammy to the touch. Patient work up complaining of headache, tingling fingers, feeling nauseous and weak. Pharmacist recommended acetaminophen 500 to 1000mg every six hours and to keep patient very hydrated. Also advised that if symptoms persist or worsen to take patient to emergency room.
Pt reported a skin infection (redness and swelling) at site of injection, saw MD and was prescribed abx, KEFLEX 500mg 1 QID, this was on Sunday 10/6/13 temp 102-103 degrees F, Mon (10/7) temp decreased to 100 degrees F. Temp normal 10/7 16:00.
Very sleepy after injection; Some discomfort at injection site; Felt tired for rest o f the day; Swelling at injection site; couldn't stay awake/drowsy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Very sleepy after injection), SOMNOLENCE (couldn't stay awake/drowsy), INJECTION SITE DISCOMFORT (Some discomfort at injection site), INJECTION SITE SWELLING (Swelling at injection site) and FATIGUE (Felt tired for rest o f the day) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced SOMNOLENCE (couldn't stay awake/drowsy) and INJECTION SITE SWELLING (Swelling at injection site). On an unknown date, the patient experienced SOMNOLENCE (Very sleepy after injection), INJECTION SITE DISCOMFORT (Some discomfort at injection site) and FATIGUE (Felt tired for rest o f the day). At the time of the report, SOMNOLENCE (Very sleepy after injection), SOMNOLENCE (couldn't stay awake/drowsy), INJECTION SITE DISCOMFORT (Some discomfort at injection site), INJECTION SITE SWELLING (Swelling at injection site) and FATIGUE (Felt tired for rest o f the day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Additional initial
Local swelling, warmth, tenderness around DTaP site (approximately 10 cm area).
Worst flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Worst flu symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Worst flu symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Worst flu symptoms) had resolved.            Concomitant medication and treatment drugs were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Upon internal review on 26-May-2022, significant correction was performed. Report type updated as Spontaneous. Outcome of event updated. Suspect coding and dose details updated. narrative regenerated.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 13JUL2022 and administration of vaccine on 24AUG2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. AR4504B) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (initially stored in the refrigerator on 13JUL2022 and administration of vaccine on 24AUG2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 13JUL2022 and administration of vaccine on 24AUG2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (received a dose of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (initially stored in the refrigerator on 13JUL2022 and administration of vaccine on 24AUG2022). Concomitant medications were not reported. The vaccine was past the 30 day use by date. Number of dose was 1. The vial did not undergo any temperature excursions. No other adverse reactions were reported.  Treatment medications were not reported.
Janssen COVID-19 Vaccine EUA received on Saturday around 4pm  2am- convulsing with chills, nasusa then started, 100.3 fever  230am- vomiting for about 2 hours, fever continued  6 am- sweating profusely and fever went down to 99  Fever stayed around 99 for 24 hours  Unable to eat/drink water the follow day (Sunday) tried to drink water but couldn't keep it down. Took Zofran to help with nausea and vomiting stop  It's now Monday morning and I'm finally able to eat and drink water and I have a feeling I can only relate to as feeling hungover
Pt became shaky, lightheaded immediately following vaccine Pt was given water, laid down=resolved sx Vitals @1250 HR 87, Resp 18, BP 148/97 O2 97% 1305 HR 89 BO 137/92, O2 100% 1318 HR 85 BP 143/101 O2 100%  Pt sent home at 1315-self
Primary Progressive Multiple Sclerosis; This is a spontaneous report from a non-contactable consumer. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Feb2021 (Batch/Lot number was not reported) (at the age of 71 years old) as single dose, and the second dose via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) (at the age of 71 years old) as single dose for covid-19 immunisation. Medical history included took LSD in the 1960's, mitral valve repair, prostate type operations due to urinating too frequently, high blood pressure, a lot of operations including shoulder operation, left knee injured playing basketball, fuzzy vision, multiple sclerosis affecting his memory, major multiple sclerosis attack that made him hot all the time, gastroesophageal reflux, and A-fib (atrial fibrillation). Concomitant medication included ocrelizumab taken for an unspecified indication, start and stop date were not reported. After the two doses of vaccine, the patient experienced primary progressive multiple sclerosis on an unknown date in 2021. The patient underwent lab tests which included SARS 19 lgG: no antibodies in Jul2021. Outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Monday 11/8/21 received immunizations  Tuesday 11/9/21 started to have a rash to abdomen, diaper, back areas, DTaP immunization site started to have erythema and rash  ER visit 11/10 and was started on prednisolone and benadryl  5 ml of benadryl caused drowsiness  mom decrease dose to 2.5  Outcome: PENDING- patient was to f/u today but did not show.
It was discovered that bivalent dose given less than 2 months since last booster dose. No adverse reactions reported at this time.
REPORTED THAT PT HAD STARTED HAVING ASTHMA ATTACK. PT WENT TO ER FOR EVALUATION AT HOSPITAL.
Patient had a reaction on Right thigh measuring 4 1/4cm down and 5 1/2cm wide.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 31-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N032956 and expiration date 13-JUL-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018   was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709:
Entire body became numb/Her legs are numb and tingly when shes walking, and her arms.; Fingertips and toes are ice cold/ her fingers are ice cold; Having a hard time moving her legs/ it feels like she is walking through water or sand on the beach; Her entire body went numb and tingly, all extremities; Shes moving in slow motion; Shes a little stressed; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0175) dose 1 via an unspecified route of administration in left arm on 03May2021 at 09:00 (at the age of 36-year-old) as single dose for COVID-19 immunisation. Medical history was none. Concomitant medications included ongoing multivitamin gummy to have vitamins. No prior vaccinations within 4 weeks. No events following prior vaccinations. She received the first dose this morning at 9 am on 03May2021. She waited at the vaccination site for 15 minutes and she felt fine. About 20 minutes after as she walked to her car her entire body became numb and her fingertips and toes were ice cold and she was having a hard time moving her legs. It felt like she was walking through water or sand on the beach. This has persisted since leaving the vaccination site. She would also like to know if she should receive the second dose due to her reaction. She does not have a doctor or health insurance so she feels like she is being left alone to deal with her reaction. She was trying to follow directions in getting vaccinated. She was calling to make sure some side effects are normal. About 15 minutes ago, her entire body went numb and tingly, all her extremities. It was like she was moving in slow motion, little stressed, she needs to make sure its normal or if she needs to go to the doctor. Her legs were numb and tingly when she was walking, and her arms. Her fingers are ice cold. All of her symptoms are on-going and persisting. She would like to know if she should go to a doctor for her reaction the Pfizer COVID vaccine. A visit to emergency room or physician office was not required. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 8/16/2021, and 9/13/2021. Presented to ED on 12/26/2021 for SOB, Covid+ 1 week prior, symptoms x2 weeks. PMHx HTN, CAD w/CABG and ablation, CKD, DM2 and obesity. Admitted for acute respiratory failure due to Covid-19 and sepsis. Intubated 12/29/21. Treated with remdesivir, baricitinib, and dexamethasone. Subsequently developed leukocytosis and worsening AKI. Expired 01/06/2022.