chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer / BioNTech / Paxlovid Date of start of drug 11Jun2022; Pfizer / BioNTech / Paxlovid Date of start of drug 11Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), on 22Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022, outcome "not recovered" and all described as "Pfizer / BioNTech / Paxlovid Date of start of drug 11Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2022) Negative; (19Jun2022) Positive; (29Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After patient was given the injection, she passed out within 3 seconds and started jerking (about 7-8 times) after being limp for 5-6 seconds. She then came to within 30-45 seconds. She had no color in her face (looked flush). After drinking water, her color came back in her face. The patient and the patient's mother refused to get emergency medical treatment, The patient was observed for 20 minutes to make sure she was okay before leaving the pharmacy,
10/11/2005 red, swollen at vaccination site told to use ice and Tylenol. 10/13/2005 went to ER with 5cm erythematous firm and tender to touch on shoulder.
I was notified of vaccines administered outside age range. Report showed 6yr old given 12+covid vaccine on 12/18/2021.
Tested covid positive recently; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested covid positive recently) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested covid positive recently). At the time of the report, COVID-19 (Tested covid positive recently) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.; Sender's Comments: This case concerns a patient (demographics not provided) with no relevant medical history, who experienced the unexpected Non-serious AESI event of COVID-19 (SARS-COV-2 test positive)). The event occurred at unknown interval after a dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after a dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Patient developed symptoms concerning for Acute COVID-19 in mid August of 2021. He had a positive test outside of our system. He had a mild course with cough and nasal congestion (parents also had infection around the same time). He fully recovered, but developed symptoms again on 9/11/21 that culminated in admission to our hospital, and subsequent diagnosis of MIS-C on 9/19
Splotchy red raised area on left thigh, denies any itching, denies any fever. Recommended child be seen by PCP so rash could be evaluated. Parent emailed a picture to HD.
Severe nausea, severe intestinal cramping.  Lasted 7 weeks.  Ultimately
cough, tiredness, fatigue, ear ache, muscle pain, chills, joint pain, fever, feeling unwell, decreased appetite, diarrhea  Swollen lymph nodes. Kidney pain lower rightside of back.  These side effects started on the wve of 07/26/2022 and have persisted to the time of this writing. the kidney pain started 07/28/2022.
4 days p/vax 5 vesicles appeared small in size;there were no new over day 5;
A report was received from a health care professional on 10/28/2003 concerning a 40 year old male vaccinee who experienced pruritic urticaria 12 hours after receiving Fluvirin on 10/27/2003. On 10/28/2003, the vaccinee experienced pruritic urticaria on both his legs and arms 12 hours after receiving Fluvirin. The vaccinee took Clarinex which alleviated the symptoms. The vaccinee has received influenza vaccinations in the past without any difficulties. At the time of the report the vaccinee had not recovered. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 01/05/04: A follow up report was received from a health care professional concerning a vaccinee who developed urticaria after receiving Fluvirin on 10/27/2003. The follow up report indicated that the patient stated on 10/29/03 the family members (who did not have the flu vaccine) also had similar "itching" in the same time frame. The reporter's causality assessment on the follow up report indicated that the adverse experience were probably not due to the flu shot. Follow up pending.
started experiencing tingling in both hands and feet; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (started experiencing tingling in both hands and feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Tingling in November 2020.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PARAESTHESIA (started experiencing tingling in both hands and feet). At the time of the report, PARAESTHESIA (started experiencing tingling in both hands and feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided No  Concomitant medications were provided
Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (Merck). On approximately 06-APR-2009 ("two weeks ago") the patient experienced shingles outbreak. On unknown date, the patient recovered. This patient had been enrolled in a study on ZOSTAVAX (Merck) which has been closed. The protocol # was V211009 and the allocation # was 12341. Additional information has been requested.
Tested positive for COVID-19 07/09/2022 I received my 4th dose on 04/21/2022 and my COVID-19 symptoms started on 07/06/2022  extreme fatigue; headache; facial pain; Extremely tired. on 07/10/2022 i went to the Urgent care   where they prescribed me PAXLOVIC but I didn't take because I was feeling better.  Instead  I took  ibuprofens for my symptoms and drank a lot  of liquids.  I tested  on 07/14/2022-07/16/2022 negative for positive.
12MAR92 recvd 1st dose of Engerix-B & 3PM devel flushing, redness, t102, sores all over the inside of mouth & did not feel well; seen by MD; given DPH; by 20AMR92 sx resolved; also itching;
Narrative: 73yo oncology patient died on 10/10/2021. Pt with problem list below: History of antineoplastic chemotherapy (ulnar neuropathy of right arm (SCT 292651000119108) Marginal zone lymphoma (SCT 447100004) Smokes tobacco daily (SCT 449868002) Abnormal findings on diagnostic imaging ENCOUNTER FOR DENTAL EXAMINATION AND CLEANING WITHOUT ABNORMAL FINDINGS (ICD-10-CM Z01.20) CHRONIC PERIODONITITS, GENERALIZED, UNSPNeuropathy (SCT 386033004) Clostridium difficile diarrhea (SCT 5891Vitamin D deficiency (SCT 34713006) Benign essential hypertension (SCT 12010Adjustment disorder with mixed emotional features (SCT 55668003) Posttraumatic stress disorder (SCT 47505Chest pain at rest (SCT 9267009) Ulnar neuropathy (SCT 359837005) Chronic obstructive lung disease (SCT 13645005) Osteoarthritis, unspecified whether geneDiabetes mellitus (SCT 73211009) Respiratory Insufficiency (ICD-9 518.Refractive Errors (ICD-9-CM 367.9) Depressive Disorder NOS (ICD-9-CM 311.) Diabetes Mellitus Type II or unspecified (ICD-9-CM 250.00) Basal cell carcinoma - primary (AO) (ICDHyperlipidemia (SCT 55822004) Osteoarthrosis, localized, primary, invoSkin Lesion (ICD-9-CM 709.9) Non-Hodgkin's lymphoma (clinical) (SCT 1) Pt had received covid vaccines on 2/14/21 & 3/13/21. Death is not related to covid vaccines given pt's cancer diagnosis, advanced age and long time distance between death and vaccine admin dates.
Vaccine administered 8/21/08 right triceps SQ; Patient mother telephoned 8/22/08 and advised injection site red, swollen and itchy - No pain, Afebrile; Patient returned to clinic on 8/23/08 - On exam 14mm bullous lesion - Cut - impressive erythema right tricep; 8/25/08 considerably improved
Was contacted by employee's mother who said employee had had a "migraine" headache for one week post influenza vaccination. Employee does not have a history of migraines.
"Patient is a 69 y/o female with a past medical history significant for sjogrens, hypothyroidism, HTN, asthma and depression. She presented to the ED due to weakness and nausea/vomiting. She states on Wednesday she had a migraine and was unable to get out of bed, she also had nausea with non bloody vomiting. The headache resolved but she continued to have nausea and vomiting with progressively worsening generalized weakness. She denies any abdominal pain. She does admit to 2 black stools, 2 days ago and yesterday, nothing today. She denies any frequent NSAID use. She felt too weak to shower today so she presented to the ED. She also admits to myalgias and congestion. She denies any shortness of breath but does admit to a dry cough. In ED patient was found to be hyponatremic so will be admitted for further evaluation. "
This spontaneous report as received from a pharmacist via a company representative refers to a 2 patients of unknown age and gender. On an unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration dates not reported). In 2014, over the past month, the patients experienced severe injection site reactions. At the time of the report the outcome of severe injection site reactions was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. became pale, limp, with pronounced peri-oral cyanosis immediately after the vaccines were given and then rapidly returned to normal within a few minutes, while held by mom.
COVID-19 twice May2020, mild symptoms and tired and slept for week and 5th of Nov2020 , 2nd one long haul symptoms severely sick loss taste and smell and fever, brain fog and tachycardia, 80 percent loss of hair and lethargy meds for nalcalyse. Have lethargic. Only have one kidney after vaccine, sick 28Oct2021, UTI and still going on now for 30days. Aug 2021  Kidney infection with UTI. UTI right kidney pain, had UTI before but this time was really bad with fever to 102.4, 3 specific infection, nausea and urine frequency, cloudy, blood. Went to doctor today. When stopped taking antibiotics, the UTI returned and still have symptoms and not back to normal. I am not peeing a lot although I was drinking water.
Presented to clinic on 6/24 with complaints of fever and rash for 2 days. Fever with temperature max of 102.7 F and fine erythematous papular rash that started on face and spread on the body. No URI a symptoms, child N activity and good PO intake.
Moderna COVID-19 Vaccine EUA  Swollen, painful lymph nodes in left armpit, headache, body aches
Patient was given MENACTRA, varicella, TDAP in office. Slumped in the chair and had a 5 sec. seizure. Dr monitored pt. in office for 1-2 hours and was discharged to home. No injury occurred.
About 5 min. after vaccine #1 my throat felt irritated and scratchy and I had a pain running down my right back shoulder blade. Within 30 min. these symptoms disappeared.
Client reported that her lips and tongue were tingling and that the left side of her throat felt thick.  B/P 128/84 pulse 110.  Respirations even and unlabored. Skin pink, warm and dry.  States this is her normal reaction when she has an allergic reaction.  Client monitored further.  6:09 stated she was feeling better.  6:15 B/P 136/102 stated the only symptom remaining was a tingling tongue.  Had client ambulate to make sure she felt ok.  She stated she was fine and that her adderall makes her blood pressure high normally.  Stated she was fine and did not want to stay for further monitoring
grandma said pt started having szs & stopped breathing in middle of the noc p/had inj was adm to hosp then transferred to hosp
Patient reported to pharmacy that her arm had became swollen and red. Had a circular rash like area
This case was reported by a other health professional and described the occurrence of expired vaccine used in a male patient who received ENGERIX B (batch number AHBVC103AA, expiry date 30th May 2014). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: HCP stated that 7 doses of expired ENGERIX-B were administered to patients. She said that her office does not pay attention to expiration dates very well. All patients received a dose from the same lot number and expiration date.
About 3 days after I received the vaccination I started to experience knots in the chest and breast area. I experienced body aching in my joints. The knots are on my right side of my body and they are still here. I also had blood in my urine this month on  01/14/2022 and I did get labs done on 01/18/2022 but no infection found. It feels like a UTI but not a UTI. I feel the sensation of having to go to the bathroom but does not have to go. I did as well have a culture done.
Unclear when received exactly but records indicate 2 shots from Pfizer with first appointment 3/15/21 Hospitalized 12/16/21
Headache, Myalgia, Fever, RIGHT AXILLA SWELLING, PAINFUL LYMPH NODE Narrative:
Adverse event: Within minutes of the patient receiving the Moderna vaccine she became dizzy and then began coughing. Following those symptoms, patient then began having difficulty swallowing and breathing. Treatment: Patient was given water for her cough. When she could not tolerate PO fluid it was decided to take her to the hospital ED. Outcome: Patient was treated with Benadryl, Solumedrol, and Pepcid. She was monitored and released from the ED to home with follow-up with her PCP.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-FEB-2008, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the 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 condition of herpes zoster. On an unknown date in 2012, the patient was treated in the center for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. 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 had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
W/in 2 hrs of DTP/HIB/OPV pt devel fever to 106 ax, temp resolved w/APAP & tepid bath, redness of 3cm diameter noted by mom around DPT inject site;
Shot was in left arm, 2 hours later right arm starts to go numb. This sensation spread to right middle back, next morning the numbness/sensation is worse. I left for work at 5:15 am, the numbness spread to my neck and up to the base of my skull. My throat started to constrict. I called 911 and transported to the hospital. I have episodes of mild Bell's palsy. My right eye lid does not open all the way. I smile asymmetrical. The right-side of my head feels swollen continuously. Around my right eye and cheek it feels partly paralyzed. I have right arm and back nerve pain intermittently; and jaw pain at times. My throat constricts randomly. I have symptoms of cranial nerve issues. Neurologist wrote and medical exemption due to adverse reaction causing neurological issues. I can't work now as a firefighter until I am fully vaccinated.
Hives appeared, 2 days post vax, varying in mild to severe outbreaks. Treated with Claritin and Benadryl followed by Allegra, Singular and Zantac. Outbreaks still, at 9 months post vax.
tingling from the shoulder to the fingers tip; sore arm; sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling from the shoulder to the fingers tip), VACCINATION SITE PAIN (sore arm) and ARTHRALGIA (sore shoulder) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and ARTHRALGIA (sore shoulder). On 28-Jan-2021, the patient experienced PARAESTHESIA (tingling from the shoulder to the fingers tip). At the time of the report, PARAESTHESIA (tingling from the shoulder to the fingers tip), VACCINATION SITE PAIN (sore arm) and ARTHRALGIA (sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Immediately after vaccination @14:25 pt reported dizziness.  Vitals: 109/72, 70, 16 Pt stable and released from the vaccination site.
Hematoma left Kidney, the patient was transferred via ambulance to a higher lever of care.
This is the first of two reports from the same reporter. This is a spontaneous report from a contactable medical assistant. A 6-month-old male patient received a third single dose of PREVNAR 13, intramuscular, on 29Apr2011 along with a dose of PEDIARIX, intramuscular, on 29Apr 2011. The patient had previously received two doses of PREVNAR 13 and two previous doses of PEDIARIX. Information on adverse events following the previous doses was not provided. Vaccines taken within the last four weeks were unknown. Relevant medical history was unknown. Relevant concomitant medications were unknown. On an unknown date, after administration of PREVNAR 13, the patient experienced a gastric problem. On 30Apr2011, the patient experienced diarrhea for 5 days. Diarrhea was considered medically significant. No treatment for diarrhea was administered. Relevant laboratory data was unknown. At the time of the report the outcome of the gastric disorder was unknown. The outcome of the event of diarrhea was recovered with sequelae (not further specified). Follow-up (23May2011): New information was received and includes: patient details including birthdate and age, updated event details with event onset date and recovery status for the event of diarrhea, product details including date of administration and number of previous doses, and additional suspect vaccine.
Pt vax w/ 1st + 2nd hepta B; devel n/v, arthralgia /p both.
I  felt woozy when walking up a flight of stairs , I got down on my knees to finish the last three steps, then i grab the hand rail and walked to my bedroom at which time everything went black. I woke up on the floor. Not really sure how long I was down for.I think it was just a few minutes.
From initial information received on 10Aug04 from another manufacturer, it was initially reported by a health care professional that a four month old female pt received a dose of Acthib, lot UE384AA; a dose of Pediarix, lot 21936A2 and a dose of Prevnar lot A57560A, administered on 19Jul04. The lot number provided for Acthib does not match the manf product. The sites and routes of admin were not provided for any of the products. The next day, on 20Jul04, the pt's mother called the physician's office and stated that the pt had been screaming for an hour and her temp was 100.3 degrees F. She was treated with Motrin 60mg every six hours. The pt's recovery status is unk and the pt's mother has not responded to messages left by the physicians office. From additional information received on 13Sep04 from the initial reporter, the pt was seen by a physician following the adverse events. She did not have any lab work or diagnostic testing done. No other medical information was provided and it was not reported whether the pt recovered from these events. No further information is anticipated, this case is considered closed.
Sore right arm muscle;  pain in right shoulder rotator cuff : pain in right SI joint above the hip,; high fever-100.5, 101.7, 102.7, 103.7;  pain in both knees; pain in both arms and elbows; many muscles were sore ans stiff.
Her shot was yesterday at 10 am. She was fine while waiting her 15 minutes. She started getting a headache that turned severe and got nauseated on way home. Last evening noticed ankles swollen. All these symptoms are gone this am. She states her Blood Sugar was up this am- 174. It usually runs 110-130
Information has been received from a physician concerning a 90 year old female who on 14-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot number: 658082/0744U). On 20-AUG-2007 the patient developed shingles in the lower quadrant of her body. On 23-AUG-2007 the patient was hospitalized, but it was not specified how long the hospital stay was. The physician also reported that before receiving the vaccination, the patient had complained of non-descript pain in her lower quadrant of her body. No further adverse event information. There was no product quality complaint. The event was considered to be disabling by the reporter. Additional information has been requested.