chrisvoncsefalvay/vaers-outcomes huggingface dataset:
that in the third she didn't but she did spend 2 weeks on bed; 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 72-year-old female patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization. The following information was reported: BEDRIDDEN (non-serious), outcome "unknown", described as "that in the third she didn't but she did spend 2 weeks on bed".  Additional information: Call was transferred from agent, #, Report #. Call was previously transferred from Support. Caller on the line was a 72 years old female that already had 3 doses of the Pfizer COVID-19 Vaccine but got sick after and ended up in the emergency room. Caller wanted to know if the ingredients could have caused this. Caller added that when she got the first 2 doses she ended up in the Emergency Room, and that in the third she did not but she did spend 2 weeks on bed. Caller added that she was concerned about the possible allergies because she was the only one that got a bad reaction in her family from taking the Pfizer COVID-19 Vaccine. Caller also said that before getting COVID-19, her blood was on normal levels and that during her disease, her blood oxygen dropped to 88. She wanted to get another booster to avoid "end being another statistic", stating even that she prefers to feel sick for a week or two with the vaccine than getting COVID-19. While transfer was being made, caller told agent that her Doctor prescribed her Doxycycline Hyclate once she was diagnosed with COVID-19. Caller stated reading about the possibility of patients with her age getting the monoclonal shot instead of Pfizer's.: agent stated caller wanted to know if Pfizer pays emergency rooms visits related to the Pfizer COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200579860 similar report from same reporter
Sore arm facial flushing muscle pain joint pain nausea diarrhea vomiting fatigue
Approximately 5 minutes after vaccines were given patient was in waiting room with mom and siblings when she had witnessed collapse by medical staff, ma. Episode lasting less than 30 seconds. Mom reports patient was pale and vomited clear liquid. Mom and patient brought back to exam room with provider present when patient again had another syncopal episode lasting 15-30 seconds. Patient pale in color. Respirations 20 clear, HR 74 RRR, BP 88/64, Sp02 98%. Patient responding to loud voice and shaking by mom. Patient talking and responding to mom/provider. Mom denies patient having any similar reaction prior to vaccines. Mom reporting she is going to drive patient to ED. Mother very frantic and upset. Discussed with mother patient being transported via EMS over mother driving due to mother's state and incase patient were to have another syncopal episode. Mother reports concern as patient's sister has seizure disorder. Mother agreeable to transport via EMS. EMS notified. Repeat vitals 88/48, 84, 24, 97%. EMS arrived and confirmed with mother her desire for patient to be transported to hospital and patient/parent left with EMS. **documented by CRNP on 11/12/2020 immediately after visit**
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates the patients were vaccinated with doses of improperly  stored (Oka/Merck) VARIVAX (lot# L048466, Expiration date: 02-DEC-2017; Lot# reported as L050956, Expiration date: 17-DEC-2017; Lot# L029472, Expiration date: 06-AUG-2017) (dose and route were not unspecified). The vaccine has been stored in -13.2 degree centigrade for 26 hours. This is one of several reports received from the same source. Additional information has been requested.
4/16/21 developed loss of taste and smell worsening weakness fatigue, muscle aches  citalopram hydrobromide 10 mg oral Daily  hydroxyzine HCl 10 mg oral 4 times daily
Pt's mom states the day after receiving the shots (8/24/18) she noticed a little redness and slight warmth on his Left arm. The next day (8/25/18) the redness was increased a lot and the area was quite warm and swollen. The swelling extended to his wrist. She took him to the ER and he was prescribed Amoxicillin. She states today (8/29/18) she can barely see the redness.
I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono); I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; I was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono; This is a spontaneous report from a contactable Other HCP reported for herself and fetus. This is mother case. A 40-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El9266), via an unspecified route of administration on Left arm on 20Feb2021 08:00 at single dose for covid-19 immunisation administered at Hospital. Medical history includes Shellfish Allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El3248), via an unspecified route of administration on Left arm on 27Jan2021 09:30 at single dose for covid-19 immunisation. Concomitant medications in two weeks include ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported, she was 7 weeks pregnant at time of 2nd vaccine. Baby stop growing 3 days later (7 weeks 3 days per sono) on 24Feb2021 08:00 on visit of Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received Dilation and curettage (D&C) treatment for the events. Last menstrual date was 04Jan2021. Delivery date is Oct2021. Gestational period was 7 weeks. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient had COVID tested/nasal swab post vaccination with results pending on12Mar2021. The outcome of event Miscarriage was resolving and for the other events it was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Induced abortion cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021278790 Same reporter/drug, different patient /event (Fetus case)
Migraine headaches lasting 3-4 days, angioedema (lips and both eyes), right index finger joint inflammation.
patient got sick every time patient got one; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a patient of unknown age who got one and got sick (illness), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that every time patient got one patient got sick (illness), (latency: unknown) following the administration of suspect vaccine.  No laboratory was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 64 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Inh, reaction(s): "Known allergies: INH". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: Tested positive for Covid 19 four days after completion of 5 day paxlovid treatment; (Sep2023) negative, notes: negative Covid test. Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.
A friend had let me know they had tested positive for COVID-19, and I was around them, so I took a COVID-19 home test and it was positive. That night I had a lot of diarrhea, a runny nose, a ton of sneezing, and runny eyes. I did have a cough that now that I think about it may have started the day before because it was different than my normal allergy cough. I called my doctor that same day and they did give me PAXLOVID which I started Friday after adjusting the normal medications I take. I started that on Friday as instructed and I did not really notice if it made a difference or not. I probably about 80% better at this point, I am achy and I do not have a lot of energy but the runny nose, sneezing and coughing are gone.
Patient received 2nd dose of COVID vaccine on 5/5/21 outside of our clinic. Developed severe abdominal pain and emesis on 5/6/21 per family. Evaluated medical facility on 5/7/21 and abdominal pain was subsiding, able to tolerate PO intake by that time.
Arm sore/upper arm sore; itching surrounding vaccine site; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1686, via an unspecified route of administration in the right arm on 30Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included an allergy to tegaderm. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), naproxen, zinc, methocarbamol (ROBAXIN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took chlorhexidine and experience allergies. On 30Dec2020 at 21:30, the patient experienced arm sore/upper arm sore, itching surrounding vaccine site. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the arm sore/upper arm sore, itching surrounding vaccine site was unknown.
She denied further adverse event/No further adverse event. No product quality complaint. No additional adverse events reported.; a patient received expired PNEUMOVAX 23 on 30APR2021; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of pertinent medical history, current condition, concomitant therapy and drug reactions/allergies was not reported.  On 30-APR-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 milliliter, lot # S018405, expiration date: 28-MAR-2021, strength, frequency and route were unknown) for prophylaxis (Expired vaccine used). The reporter denied further adverse event. The reporter was provided with the not supported expired disclaimer. No further adverse event. No product quality complaint. No additional adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S018405; expirationdate: 28-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
ED visit (5.6.22);  Hospitalized w/ COVID (5.8.22);  COVID-19 positive (5.1.22 / 5.8.22); Fully vaccinated PLUS two boosters. BRIEF OVERVIEW: Discharge Provider:  Primary Care Provider: Admission Date: 5/8/2022; Discharge Date: May 13, 2022; DETAILS OF HOSPITAL STAY:PRESENTING PROBLEM: Hypoxia [R09.02]; Pneumonia due to COVID-19 virus [U07.1, J12.82]; COVID-19 [U07.1]; HOSPITAL COURSE: Pt is a 78 yr old F with PMHx of chronic hypoxic respiratory failure on 8L via NC at baseline, COPD, CAD, CHF, A-Fib, HTN, HLD, depression, OSA and obesity, presented to the ER on 5/8 with c/o worsening dyspnea. She is fully vaccinated, tested  positive on 5/1 for COVID-19 and received molnupiravir (an antiviral) on 5/3 as outpatient.  However, she continued to experience fatigue, hypoxia which prompted her ED visit.   In the ER, she was borderline febrile, normotensive, tachycardic and tachypneic, maintaining appropriate oxygen saturations on 15 L/min NRB mask.  Initial venous gas showed normal serum pH with likely chronically elevated pCO2 of 56 and bicarbonate of 30. Other initial labs show stable renal dysfunction, elevated proBNP, normal procalcitonin, normocytic anemia, and her COVID-19 screen is again positive.  EKG showed A-Fib with RVR.  CXR shows patchy bibasilar opacities suggestive of atelectasis vs infiltrate/pneumonia without significant interval change from imaging 2 days ago. Admitted for further management - started on Decadron x 10 days, Remdesivir x 5 days for COVID-19 PNA. There was concern for superimposed bacterial infection - Pulmonary consulted and empiric IV Cefepime/Doxycycline initiated. Sputum cultured attempted but unsuccessful. Clinically - her symptoms improved with return to baseline of her oxygen demands. On 5/11 - patient had left shoulder pain while attempting to move in bed. X ray concerning for left shoulder dislocation. Ortho consulted - felt it was chronic left rotator cuff tear with plans for outpatient follow up. PT/OT recommend Home with assist and home health. She was transitioned to oral Ceftin/Doxycyline for 3 more days to complete a total of 7 days of Antibiotics, as well as Decadron for total of 10 days. We reviewed stopping Amlodipine and reducing Lisinopril to 10 mg once daily as blood pressures well controlled in the hospital. Also discussed resuming Azithromycin daily once completion of current antibiotics - patient and son voiced understanding. She is discharged on 05/13/2022 in stable condition.
Vaccine given on 4-15-11 in (R) thigh. On Sat mom called triage line & was advised to take child to ER for evaluation. Thigh swollen, painful, unable to put pressure on the leg. ER gave meds. Fever also present. Had 3 PCV7 vaccines previously.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site erythema (1st dose refer case, US2019015763). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was reporting adverse event for herself and her husband. After receiving the first and second dose of SHINGRIX vaccine the patient experienced redness at the injection site. This lasted for about a week. No further details were provided. The reporter also mentioned that her husband heard from someone that someone had a stroke from SHINGRIX and someone had died from SHINGRIX vaccine. Her husband did not know who the exact person was or any details. The reporter did not consent to follow up. This case has been linked with the case US2019015771, reported her husband.
Site: Bruising at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild
Information has been received from a registered nurse concerning a 26 year old female with no known drug allergies and no pertinent medical history who in November 2004, was vaccinated with first dose of Varivax (Oka/Merck) (lot number not provided). In January 2005, the patient was vaccianted with a second dose of Varivax (Oka/Merck) (lot number not provided). There was no concomitant medication. In June 2006, the patient had ELISA titer test which showed failure to seroconvert. There was no product complaint involved. Additional information has been requested.
no other adverse events reported; a dose of MMR II was administered today via IM route versus subcutaneous route as ecommended in the prescribing information; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On 19-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(recombinant human albumin (rHA))(strength and dosing schedule were not reported) lot # T012808, expiration date: 14-APR-2022, 0.5 milliliter, intramuscularly for prophylaxis. The dose was administered intramuscular (IM) versus subcutaneous route as recommended in the prescribing information. No other adverse events reported.
Menstral cycle had gone from regular to irregular with light to nearly bleeding to death blood flow. After the first vaccination shot is when the issues began and as of the 2nd shot on June 8th, 2021, the problem became compounded. Also as of mid-June 2021, On a visit to a doctors office regarding the sudden cycle changes, I was informed that a spot was detected on my liver that was not present on previous visit.
Pt stopped breathing @ 1 min /p vax. Pt pale. Pt came to /p being shaken, took 2 breaths. Put on O2 & admitted to ER. Released to parents w/no further problems
The Menomune (meningococcal vaccine) was received on 1/14 afternoon. That evening, nausea and vomited once. next day, she had abdominal cramps. On 1/16 AM, she developed generalized hives; was seen in office at 1:15PM. Also complained of throat getting swollen, sore throat, tightness of throat. Was given SC Epinephrine shot; Benadryl IM; Oral steroid. Sent home on Zyrtec and Prednisone.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was pneumonia.
Rapid heart rate of 120 - 160 BPM (while sitting down) for over an hour.  Difficulty remaining conscious and numbness in my face.
This spontaneous report was received from a physician via a company employee and refers to a 11 year old female patient. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) for prevention of human papillomavirus (HPV). Concomitant therapies included ADACEL and MENACTRA vaccines. On an unknown date, after receiving GARDASIL 9, the patient developed a rash around her ankles and feet. The reporter stated that the rash looked like Granuloma Annulare, however it was not confirmed. The outcome of the event of rash looked like a Granuloma Annulare was reported as recovered on an unknown date (also reported as the rash lasted for "a few weeks" before the patient recovered). The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Strange reaction; almost immediately after the shot right side of her neck shoulder blade got stiff, but she could; lower leg from knee to her toe was feeling like somebody is scrapping her leg with knife, had bad pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Strange reaction), MUSCULOSKELETAL STIFFNESS (almost immediately after the shot right side of her neck shoulder blade got stiff, but she could) and PAIN IN EXTREMITY (lower leg from knee to her toe was feeling like somebody is scrapping her leg with knife, had bad pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION COMPLICATION (Strange reaction), MUSCULOSKELETAL STIFFNESS (almost immediately after the shot right side of her neck shoulder blade got stiff, but she could) and PAIN IN EXTREMITY (lower leg from knee to her toe was feeling like somebody is scrapping her leg with knife, had bad pain). At the time of the report, VACCINATION COMPLICATION (Strange reaction) and MUSCULOSKELETAL STIFFNESS (almost immediately after the shot right side of her neck shoulder blade got stiff, but she could) outcome was unknown and PAIN IN EXTREMITY (lower leg from knee to her toe was feeling like somebody is scrapping her leg with knife, had bad pain) had resolved with sequelae.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Tylenol , it helped and it's fine now like 90% better than before.   Patient  also takes COQ10 every day .
Patient started after pain in her left feet. Both fee have pain but the left foot is more painful then the right. Foot is also swollen.