chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 at 14:00 as dose 1, single (Lot number: EM9809), in left arm, on 26Feb2021 at 13:00 as dose 2, single (Lot number: EN6300), in left arm and on 02Sep2021 at 13:00 as dose 3 (booster), single (Lot number: EW0185) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Feb2022 at 10:00 as dose 4 (booster), single (Lot number: 060H21A), in left arm and on 11Sep2022 at 10:00 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Feb2022 at 10:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid for COVID-19 treatment from 10Apr2023 to 15Apr2023.  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0185 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, an analysis of complaint history for the reported lot and analytical release test results. The final scope included the reported finished goods lot EW0185, EM9809, fill lot EP8735, EM9807, and the formulated drug product lot EP8616, EM9805. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Lot provided as EN6300 is invalid as per SAP.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE), Interchange of vaccine products and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300165019 same reporter/patient, different product/AE;
Patient was given shingles vaccine ON 5/21/2019 and developed a rash that started in his lower back at the beginning of July. It began as an erythematous rash and was itchy. It then spread becoming generalized and pruritic. Patient contacted provider on 8/30 via phone and was advised to take Benadryl. Patient was contacted again for follow up on 9/3 and rash did not improve. Provider prescribed methylprednisolone and triamcinolone and rash has since resolved. No additional therapy was required.
Reported to Dr's office on 9-4 arm was inflamed, swollen + warm.  Dr stated localized topical reaction.  Tx w/ BENADRYL - O.T.C  Follow up on 9-8 reaction resolved.
At 12 Hours Post-Vaccination the following adverse effects were experienced for approximately 48 hours: Moderate Fever, Severe Fatigue, Moderate Chills, Moderate Body Aches, Mild Nausea, Mild Headache  Onset 3 Days Post-Vaccination: Mouth and Tongue Ulcers
Redness and swelling on arm of injection site  about The size of a quarter showed up within 24 hours. Two weeks later the size had grown to. 2 1/2 inches by 4 inches.
headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nausea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and PARACETAMOL (TYLENOL) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol used as a Treatment Medication.
Myalgias, profound  fatigue, muscle weakness (extremities), parasthesias, all suggestive of GUILLEAN BARRE. Creatine Kinase was also wildly elevated.
Lack of efficacy.  Tested positive for Covid on 21Dec2021; Lack of efficacy.  Tested positive for Covid on 21Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EL3247) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid tested post vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: RP6953, Location of injection: Arm Right), administration date: 30Mar2021, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Dec2021, outcome "recovering" and all described as "Lack of efficacy. Tested positive for Covid on 21Dec2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient had not received any other vaccine within 4 weeks. No List of any other medications the patient received within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Arthralgia, Fever,  NauseaVomiting, Severe tightness in chest Narrative:
I noticed my son falling asleep throughout the day, talking and laughing in his sleep. Also I was receiving reports from his teachers that he was sleeping in class. He was taken to the ER. Several sleep studies and a MRI was performed. The daytime study showed that he has narcolepsy. He is now on medication to help him stay awake.
The patient requested a flu shot, stating his doctor told him he hadn't had a flu shot since 2021. We gave him the shot and on 02/09/23 he came in with paper work from a different pharmacy showing that he had a flu shot back in 09/2022. The patient said he hasn't been experiencing any side effects other than a slightly sore arm. I am filling out this form to report that the patient has received two flu shots in one season, but the patient reports no side effects.
Swelling, redness, severe pain, anterior tibial areas bilaterally and dorsal feet bilaterally
Per pt report, received the Moderna booster on Thursday 11/4  and by Friday and Saturday following she felt both ears feeling bruised and tender to the touch. Her taste felt salty, feels like "tounge feels burnt" even until 11/10 Wednesday almost week after injection.
Cellulitis. Muscle cramps, uncontrolled hypertension, nausea and vomiting, withdrawal from opioids, infection, pneumonia. Patient was administered vaccination and six days later went to the emergency room with burn thigh severely. She went to her doctor the next day and then was sent to the hospital for four days.
Information has been received from a doctor of pharmacy concerning a patient who on an unknown date was vaccinated with a dose PNEUMOVAX. On an unknown date, 2 hours post-vaccination, the patient developed extreme fatigue. It was reported that the patient also developed muscle weakness, so that "could not pick up a carton of milk" and experienced extreme weight loss of 45 pounds in one month. The pharmacist stated that the patient attributed the weight loss due to decrease of appetite after being vaccinated with PNEUMOVAX. On an unknown date, the patient was hospitalized due to the patient's adverse effects. At the time of reporting the patient had not recovered. No further information is available.
pt recv vax & approx 3 to 3 1/2 wk post vax pt exp a diffuse rash of 60-70 lesions;pt was not systemically sick & had not had any WTV exposure;
Patient was vaccinated by coworker at 1:52pm. At the time when reporting health status patient reports having Hypoglycemia and Migraine. Patient was in observation area and reports having pain in left arm. She applied ice. Immediately the patient fainted and first aid was provided with the ambulance. Patients pressure was 80/50 saturation 99 and pulse 52. Patient indicates having anxiety. At a stable position arterial pressure 110/70 saturation 99 and pulse 72. Patient was transported by ambulance and was provided with oxygen and first aid.
Patient got a PNEUMOVAX 23 immunization on 4/19/17 has inflammation and heat in elbow on the same arm. It looks like it could be the result of the vaccine or the scratch on her arm.
nausea, sore arm (injection site), other sore muscles, headache, no appetite, eyes sensitive to light.  Affect for about 12 hours.
Had COVID-19 vaccine and a yearly Flu vaccine in the same arm on the same day. Didn't feel comfortable, but Pharmacy Technician said it should be fine. Started having reaction 5 hours after vaccinations, arm was swollen and had a red rash and about 3-5 inches; 2nd day the rash became larger and softer but still red; On the 3rd day redness got larger and started to itch. Went to Urgent Care and was prescribed Cetirizine HCL Antihistimine tablets. After going to Primary Care Physician, my Dr said that I should have never gotten both vaccines in the same arm on the same day.
Nausea, vomiting, chills, no fever for about 12 hours that started about 4 hours after vaccination.
Within 24 hours pt had fatigue, fever, body aches, within 3 days cutaneous skin started sloughing on LUE then whole BSA face, arms, neck, upper, lower extremities and trunk. NO mucous involvement, no oral, vaginal, rectal involvement. No abd pain, n/v. No cough or respiratory problems. No difficulty swallowing
60 x 50 mm of red, swollen, and hot to touch area in upper (R) arm in deltoid area, parents of child instructed by pediatric nurse practitioner to use cold compress in site of injection and give BENADRYL Children Rx.
My left arm went numb and I felt lightheaded then my heart started to race really fast. That was immediate effect, heart rate went down in about 30 minutes. Had vertigo for about 4 wees afterwards. Also had extreme joint pain that lasted for 10 days.
Patient is an 18-year-old who got a flu shot on 1/9/23 whose had increasing redness swelling and tenderness over the site since.  It is also itchy. Treated in PCP clinic with Albuterol Inhaler, Cephlexin Oral, Singulair, Iron Chews
chills; mild swelling at injection site; moderate headache; back aches; swelling under left arm pit; This is a spontaneous report from a non-contactable consumer (patient).  A 26-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration, in left arm on 16Feb2021 at 14:45 at single dose for covid-19 immunisation. Medical history included frequent premature ventricular contraction (PVC's,heart). No Covid prior vaccination. Patient was not Covid tested post vaccination. No known allergies. Concomitant medication included diltiazem taken for an unspecified indication, start and stop date were not reported. On 17Feb2021 at 08:30 the patient experienced chills, mild swelling at injection site, moderate headache, back aches and swelling under left arm pit. The final outcome of all the events was recovering. No follow-up attempts are possible. No further information is expected.
Presents w/ worsening sxs of dyspnea, fever, previous covid + dx. Dx w/ tachycardia, rt. Hepatic cyst, rt hemithorax, pleural effusion. Started on abx.
This was reported by a pharmacist and described the occurrence of low grade fever in a 30-year-old male subject who was vaccinated with BOOSTRIX. On 1 May 2013 at 19:30 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left arm). Lot number was reported as "739Y2". On 2 May 2013, less than on one day after vaccination with BOOSTRIX, the subject experienced low grade fever, tiredness, sore left arm, upper body pains and back pain. The pharmacist reported that a subject vaccinated on 01 May 2013 at 19:30 and called on 02 May 2013 at 14:30 to report the adverse events. No other details were available at the time of the report. At the time of reporting the outcome of the low grade fever, tiredness, sore left arm, upper body pains and back pain were unspecified. The pharmacist considered the events were probably related to vaccination with BOOSTRIX. Follow-up information was received on 03 June 2013 via healthcare professional who reported the subject had an allergic reaction or severe side effect on 02 May 2013 after receiving IM vaccination of BOOSTRIX. The events resolved on 04 May 2013. The reporting healthcare professional attributed the events to "just had a baby. Probably lack of sleep and tiredness post-partum delivery". No laboratory tests were performed. The reporting healthcare professional considered the events probably related to vaccination with BOOSTRIX, but did not consider them to be serious.
Felt like she was going to black out; Felt like she was dying; Generalized hotness / whole body was super hot; Lightheadedness/dizziness; Vision troubles/ couldn't see; Nervous; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 29Jul2021 (at the age of 42 years old) (Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 29Jul2021, patient got the vaccine, and was driving she felt generalized hotness (whole body was super hot), dizziness, lightheadedness, vision troubles (couldn't see), nervous, felt like she was dying and felt like she was going to black out. She had these complaints for five minutes and denied the events at the time of reporting. The outcome of the events was recovered on 29Jul2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This initial spontaneous case, was received from other non-health professional on 25-Oct-2017, concerning a 47-year-old adult female patient. The patient's medical history included an unspecified allergies and never reacted to the any vaccines in the past. The patient's concomitant medication included metformin for an unknown indication. On 24-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195129, expiry date: May-2018 and anatomical location: deltoid). On 25-Oct 2017, after 2 days of vaccination, the patient experienced redness about the size of a quarter, hardness, pain at the injection site and no treatment was taken. On an unspecified date (reported as a couple of days), the patient recovered from the events. The reporter assessed the events as non-serious and considered the causality of the events as related. Follow-up received on 13-Nov-2017: The event outcome was changed from not recovered to recovered. Narrative amended accordingly.
This spontaneous report as received from a other health professional refers to unspecified multiple patients of unknown ages.  On 27-JUL-2017 the patients' were vaccinated with VAQTA for prophylaxis. Concomitant therapies included sterile diluent. On 27-JUL-2017, the patients experienced incorrect product storage. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Sender's Comments: US-009507513-1709USA001606: US-009507513-1709USA000361.
congestive heart failure; Coma; serious neurological problems; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to an elderly patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 09-SEP-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for the following injuries: serious neurological problems, congestive heart failure and coma. The outcome cardiac failure congestive, coma, and nervous system disorder were not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, cardiac failure congestive, coma, and nervous system disorder were determined to be medically significant events.
None stated.  9/18/07 T/C to reporter/provider to clarify reported death.  Box 7 blank on form.  Message left for return call.  9/20/07 T/C to reporter.  Message left.  9/25/07 T/C to reporter.  Stated patient did expire.  Autopsy requested.  Preliminary COD is pending but coroner indicated to MD that is probably SIDS.  Reporter stated patient had no health problems or birth complications.  Letter faxed to request vax record./ss  9/28/07 Linked w/291475.  10/9/07 Reviewed pcp medical records which reveal patient experienced good health on day of vax.  Vax records indicate RO dose & lot # correct as reported but other vax corrections made in VAERS database.  11/6/07 Reviewed Autopsy report which states COD as sudden unexplained death in infancy.  Had been placed in crib face up & then found unresponsive when later checked.
After I received the vaccine, about a day or so afterwards, I started to feel the same symptoms after having Covid except I had no fever, coughing, or nausea. This time I had severe body aches, joint pain, and an extreme headache. My doctor recommended me not to get the 2nd shot.
BODY ACHES; HORRIBLY SICK; CHILLS; FEVER; BAD HEADACHE; This spontaneous report received from a parent concerned a male of unspecified age. 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, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the patient experienced body aches, horribly sick, chills, fever, and bad headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from horribly sick, and the outcome of fever, chills, body aches and bad headache was not reported. This report was non-serious.
Symptoms were total body aches, low grade fever, headache, sore and swollen lymph node in left armpit
Hospitalized (9.27.21);  COVID-19 positive (9.27.21);  Fully Vaccinated  CHIEF COMPLAINT SOB. Cough. Fever HISTORY OF PRESENT ILLNESS Patient is a 72 y.o. female who presents today with cough, SOB and fever. Patient has a PMHx significant for diastolic CHF, CAD status post CABG x 3, DM ll and anxiety. The patient states that two days ago she started having a sore throat and has since developed fever, chills, generalized weakness, SOB, cough, arthralgias and diarrhea. The patient states that she was feeling so SOB that she decided to come to the ED to be evaluated.    Upon arrival to the ED Na  133. K 4.4. BNP 3856. Procal 0.12. WBC 9.26. CXR possible left and/or right LL pneumonia. CT abdomen/pelvis shows abnormal lung bases. Changes status post right nephrectomy for neoplasm. Diverticulosis. Fragmentation of proximal femur suggesting ununited fracture status post ORIF. The patient was hypoxic requiring supplemental oxygen. She has otherwise remained hemodynamically stable. The patient is being admitted for further management and evaluation.  PLAN Covid Pneumonia Acute Respiratory Failure Symptom onset: 9/25 + PCR 9/27 Vaccinated moderna.  Remdesivir x 4 doses Decadron 6mg daily Prone as tolerated Wean supplemental oxygen as able Note from 9/30/21: ASSESSMENT / PLAN: Principal Problem:   Pneumonia due to COVID-19 virus   Covid Pneumonia Acute Respiratory Failure with hypoxia secondary, currently on 2 L nasal cannula Symptom onset: 9/25 + PCR 9/27 Vaccinated moderna.  Remdesivir x 5 doses Decadron 6mg daily for 10 doses Prone as tolerated, incentive spirometry Wean supplemental oxygen as able  Trend CRP, D-dimer
symptoms of an infection on my right thigh; This case was reported by a consumer via interactive digital media and described the occurrence of infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced infection. On an unknown date, the outcome of the infection was unknown.   It was unknown if the reporter considered the infection to be related to Shingrix.  Narrative suggestion : Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingrix 2 months ago and experienced potential symptoms of infection on right thigh. The patient enquired would the first shot reduce his/her potential outbreak or should he/she get the 2nd shot now. Follow-up would not be possible as no contact details available.
tested positive for Covid; tested positive for Covid; Had What I believed to be a sinus infection or strep throat; Had What I believed to be a sinus infection or strep throat; ringing in my ears; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported that an unspecified age and gender patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 14Mar2021 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization. Patient stated that Had my 2nd Pfizer shot 14Mar2021. I believed to be a sinus infection or strep throat on an unspecified date in 2021 and on 11Apr2021 went to doctor tested positive for COVID. Also have a ringing in my ears cannot say exactly if it is from the shots or not. On a good note had sinus like symptoms for only three days and that was the worst of it so apparently the Pfizer vaccine worked. Outcome of events vaccination failure, COVID-19 and Ringing in ears was unknown and for other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.