chrisvoncsefalvay/vaers-outcomes huggingface dataset:
week later did positive to Covid-19; This is a spontaneous report from a contactable consumer or other non-HCP. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN), via an unspecified route of administration on 29Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced week later did positive to covid-19 (covid-19) (non-serious) on an unspecified date. The outcome of the event was recovered.
Information has been received from a medical assistant concerning a patient who on 07-DEC-2007 was vaccinated with the first dose of GARDASIL. On 29-JUL-2008, the patient was vaccinated with the second dose of GARDASIL and on 06-NOV-2008 the patient was vaccinated with the third dose of GARDASIL. On 18-AUG-2009 the patient received the fourth dose of GARDASIL. No adverse effect was reported. Follow up information received on 25-SEP-2009 from a physician indicated that the patient was a 11 year old female student, with no medical history or allergies and no illness at the time of vaccination. One week after injection the patient presented in the emergency room complained of sore throat. The patient recovered on an unspecified date. No further information is available.
Irritable and fever from 100.8-105.6 since 4/9/11. Extreme fussiness. Ataxic gait at times.
chills Narrative:  Chills on 3rd day after 1st vaccine, that were resolved by the 4th day.
low grade fever 101, for 3 days. Felt like I had been hit by a truck. Muscle aches and pains. Headache, sleepy, no energy. Out of work for 3 days was miserable. I'm on day 10 after the first shot of the vaccine and still feel foggy headed, low energy and tired.
pt recvd vax; "high pitched" crying x 8 hrs; constant protruding tongue; fever up to 103 R; lt leg area red/tender at inject site; seen by MD; tx w/ Motrin; by 48 hrs, all sxs gone
Rash after immunization. Petechiae on eyelids and neck. Observed patient for 15 minutes rash not progressed.
arm started out hurting like hit hard. later in the evening started to turn red and swell up from shoulder to elbow. next morning redness, swelling and pain increased and started to get hot. symptoms started to recede on friday about mid-day. by saturday the only sympton left was sorness. doctor said to take benadryl and motrin.
I've been feeling nauseous and with a migraine 3 days now, I don't have insurance so I haven't gone to the hospital, I've been taking just Tylenol for pain.
Information has been received from a physician assistant and a health professional via company representative referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, lot number and route not provided). The patient experienced an episode of syncope immediately after receiving a dose of GARDASIL 9 in office. The patient sought medical attention in the office. The outcome of syncope was reported as recovered/resolved on an unknown date. Additional information has been requested.
Flu vaccine - 2018, given at place of employment. Headache, body ache, chills, fever, diarrhea, loss of appetite. All within 24 of being administered the vaccine. Most happened within 12 hours of be given the vaccine.
I experienced shingles on my left-side. It affected my face and the back of my neck. The shingles were very itchy and painful. My lymph nodes became very swollen. I have not received any vaccines or taken any medication since I received the two COVID-19 vaccines.
24 hrs after vax developed erythematous raised plaque: 9 mm X 6 mm, warm to touch, mildly tender: No other sx: Improved daily.
Rash all over face, chest, neck, and back which is continually getting worse. The rash is warm to the touch and is beginning to itch.
Approx 6 hrs following vaccine he developed rash over upper chest and upper arms.  Approx 10 hrs after receiving vaccine he developed chest pain that progressed over 2 hrs to become quite severe. At the time the chest pain had become severe pt also developed chills.  PT also noted fever at the same time as rash occurred. PT noted restlessness throughout the night. Around 6-7 hrs after receiving vaccine he developed what he felt was throat swelling.
I couldn't breathe and they did every test in the world and diagnosis me with Pleural Effusions and treated me with IV Diuretic Pulmonary Doctor Seen-  Cardiologist Doctor Seen
Hospitalized on 4/12/2021 [10-days after vaccination] for Hypoglossal Nerve Palsey, Neck pain on right side, and other dysphagia. Due to brain stem electrical event on 4/12/2021.  Symptom onset 4-hours after vaccination on 4/2/2021 w/chills, headache, lightheadedness. Fever w/in 24-hours of 101.6 for 4-days. Accompanied by nausea, chills, persistent headache, extreme fatigue, joint stiffness, and achy  muscles.
Both legs tenderness and pain, swellings/lumps, difficulty walking.  Treated by Primary physician, seen by surgeon for tests, Orthopedic, Rheumatologist.  Blood work uncovered some abnormalities.  This all began less than 2 week following second Pfizer injection.
Boostrix given to newborn instead of Energix-B by nurse.  Poison Control contacted. Stated to monitor infant for apnea, difficulty feeding,, poor tone,  and to keep infant on monitor for about an hour.   infant satting 100% on room air.  no injection site reactions.
Extreme fatigue - unable to function at all on 10/8/11. Still extreme fatigue on 10/9/11; however could function somewhat. Went to work on 10/10/11; however was extremely tired. Much better on 10/11/11. 10/8 and 10/9 - slept most of the time.
I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/26/2023 MENINGIOMA
Headache, Diarrhea, NauseaVomiting, Chills Narrative:  Other Relevant History:
Slight swelling; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Slight swelling) and PAIN IN EXTREMITY (Pain in the arm) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 06-Oct-2023, the patient experienced SWELLING (Slight swelling) and PAIN IN EXTREMITY (Pain in the arm). At the time of the report, SWELLING (Slight swelling) and PAIN IN EXTREMITY (Pain in the arm) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-744800 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744800:Husband case
Missed the 4th dose due to pandemic; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 3 accelerated doses on an unknown date).   On an unknown date, the patient did not receive the 4th dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient had 3 accelerated doses but he/she missed the 4th due to the pandemic. The patient stated that he/she was looking for help with Twinrix.. The patient traveled in 2019.  The patient had asked doctors and pharmacists if he/she was still protected or if he/she need to had the entire dosing again.  The patient had been told different things. The patient asked if he/she just need the 4th shot or he/she need a booster or he/she would need to start again and had all the doses. The patient also asked could he/she please get clarification on what to do as he/she was going away at the end of this month. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Approximately 13 hours after the injection I experienced severe chills and body (muscle/bone) aches.  I did not take my temperature.   The chills subsided after I got my body warm in bed.  The morning following the injection I experienced headache and nausea.  The body aches continued the day after the injection, albeit somewhat reduced.  The chills did not return the day after the injection.
Severe headache and body ache (muscle, joint, all my body) with fever 100.4 F.  I couldn?t sleep all night due to intense pain in my body from my head to toes. I couldn?t lift my head and sit up in the bed next day. I have not experienced anything like this in my life.  Additional symptoms include arm pain, fatigue, weakness, and nausea. Second day: Intense headache, fever  99.5 F, arm pain and fatigue.
After less than 24 hour employee's left arm middle upper portion of tricep toward back  became swollen , red , hot to the touch. per the nurse who administered the vaccine.  After my assessment of the area involved with the reaction was not where the deltoid is located. I believe the vaccine could have been given  in the wrong site. So I recommended that ibuprofen  and benadryl be started immediately since the arm was already the size of a coke can and to reassess the arm in 24 hours.As antiboitics may need to be started . After additional 24 hours there was some improvement and the employee  agreed it had as well- we opted to start  the antibiotics given it was the same size had not gone down. The redness had improved some. Keflex 500mg  2 capsules BID x10 days
This spontaneous report was received from a medical assistant referring to 10 patients (demographics unknown). Patient's pertinent medical history, drugs reactions and allergies were no reported. On multiple unknown dates the patients were vaccinated with improperly stored (Temperature: 8.4 degrees F, time fame 108 minutes) doses of VARIVAX (lot # M007287, expiry date 12-FEB-2018). Doses and routes of administration were no reported. No adverse effects were reported. Additional information has been requested.
fatigue; headache; chills; This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 31Mar2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 31Mar2021, outcome "unknown", described as "headache"; CHILLS (non-serious) with onset 31Mar2021, outcome "unknown", described as "chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day of vaccination, she was very tired, less appetite and low fever. The next day she continued to have a low fever. She was very fussy and cried alot, vomited twice. Two days after the shots she was still out of it (less alert), pale and low appetite. It was finally the third day she was back to herself. Only given her Infant Motrin to handle fever and only Formula for food.
patient received expired dose of Ipol/ no adverse event; Initial information was regarding an unsolicited valid non-serious case was received on 31-Mar-2021 from a Other Health Care Professional (Medical Assistant) via Global Medical Information (GMI) (Reference number- 00542928) and transmitted to Sanofi on 31-Mar-2021 in the United States   This case involves a 2 month-old female patient who was vaccinated with expired dose of IPV (VERO) [IPOL] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); HIB VACCINE (HIB) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  On 30-Mar-2021, the patient received 0.5 mL (once) total dose of suspect IPV (VERO) (lot R1B25 and expiry date 13-Mar-2021) via an intramuscular route at the left vastus lateralis for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  It was also reported that the caller reported that the IPOL was delivered to the clinic on 16-Nov-2020 and it was not suspected to expire so soon on 13-Mar-2021. Product was not still in use.  At the time of report, no adverse event reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
tested Covid positive; tested Covid positive; bad runny nose; cough; congestion; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from product quality group received via COVID-19 Adverse Event Self-Reporting. The reporter is the parent.  A 6-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2021 as dose 2, single (Lot number: FK5618) at the age of 6 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. No other medical history. No other vaccine in four weeks. There were no concomitant medications. No other medications in two weeks. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 12Nov2021, when the patient was 6-year-old, for COVID-19 Immunization. The patient was not pregnant at the time of vaccination.   The following information was reported: RHINORRHOEA (non-serious) with onset 06May2022, outcome "not recovered", described as "bad runny nose"; NASAL CONGESTION (non-serious) with onset 06May2022, outcome "not recovered", described as "congestion"; COUGH (non-serious) with onset 06May2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 06May2022, outcome "not recovered", COVID-19 (medically significant) with onset 06May2022, outcome "not recovered" and all described as "tested Covid positive". Patient on 06May2022 started to experience really bad runny nose, cough and congestion. On 07May2022 was tested Covid positive. The events "tested covid positive", "bad runny nose", "cough" and "congestion" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive. Therapeutic measures were taken as a result of covid-19, rhinorrhoea, cough, nasal congestion. AE treatment: Acetaminophen and Mucinex. No covid prior vaccination. Patient tested for covid post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162b2  cannot be excluded for the reported events of covid-19 and drug ineffective.
fever,chills,arm sore,weakness,t101;APAP,heparin lock
12/12/2001-client's mother called health center. She stated that the client had broken out in "hives" vaccine had been administered on 12/11/2001. Doctor called mother and instructed to give Benadryl. Mother states that the doctor feels like the medicine (Cephalosporin) which the child was taking at time of the vaccination was the cause of the rash. 12/13/2001-Child was without any symptoms
acute hearing loss in the left ear; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced acute hearing loss in the left ear about ten days after getting the vaccine. The physician was wondering how common this was and if there was any advice for re-treatment or further testing. Outcome of the event was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the event hearing loss cannot be excluded. 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.
This spontaneous report as received from a nurse refers to a patient of unknown age, who usually experienced a rash after swimming at one particular pool. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot #, dose, route and site of administration were not reported). Concomitant medications were not reported. On the same day by 18:00 and after swimming at the particular pool, the patient experienced hives and rash. The outcome of hives was unknown. The relatedness between the hives and GARDASIL 9 was not reported. Additional information has been requested.
He had status epilepticus, arrested and was intubated on a ventilator. He was then put in an induced coma to control the seizures. But it was too late, the MRI showed encephalitis and brain injury. He never really woke up. He is left with dystonia and corticol blindness. Is wheelchair bound and unable to speak or communicate. My son was a healthy, walking, talking 4 year old before all of this!
Joint pain; trouble swallowing; Upset stomach; Suspected COVID-19; drug ineffective; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4258612-00.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Nov2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single, intramuscular, administration date 18Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 28Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "drug ineffective"; SUSPECTED COVID-19 (medically significant) with onset Dec2021, outcome "recovered", described as "Suspected COVID-19"; ARTHRALGIA (non-serious), outcome "recovering", described as "Joint pain"; DYSPHAGIA (non-serious), outcome "unknown", described as "trouble swallowing"; ABDOMINAL DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "Upset stomach". The action taken for upadacitinib was unknown.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of joint pain, covid, trouble swallowing and upset stomach with Rinvoq (Upadacitinib) was no reasonable possibility. Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event(s) of joint pain, covid, trouble swallowing and upset stomach with Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was Possible.The reporter considered "drug ineffective", "suspected covid-19", "joint pain", "trouble swallowing" and "upset stomach" related to bnt162b2.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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.
This study case was received from the investigator in a trial on 29 May 2013. A 31-year-old female subject was found to have chest pain, unspecified 11 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 06 February 2013. Treatments were not reported. Troponin I, ECG and echocardiogram were not available. Past medical history included eczema and headaches. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Started with slight itching Sunday afternoon.  By Monday evening swelling and warm to touch at injection site.  Tuesday morning,swelling area hard to touch and some pain around swelling.
Nausea, vomiting and diarrhea; Nausea, vomiting and diarrhea; Nausea, vomiting and diarrhea; This spontaneous case was received on 17-Sep-2021 from pharmacist via Med Communications (reference number: SEQW21-02439) and concerned a 59-year-old, male patient.  The patient's medical history was not reported. The patient's concomitant medication included Hydrocodone (hydrocodone bitartrate), nifedipine, Cymbalta (duloxetine hydrochloride) and Losartan (losartan potassium), all used for unreported indication.  On 10-Sep-2021, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was P100360857 and expiry date was 30-Jun-2022.   On the same date, after receiving Afluria Quadrivalent, the patient had severe nausea, vomiting and diarrhea.  On 12-Sep-2021, the patient recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  This case is linked to the case 202103051 (the same reporter).  Company comment: Events nausea, vomiting and diarrhea are considered as related to Afluria Quadrivalent.; Sender's Comments: Events nausea, vomiting and diarrhea are considered as related to Afluria Quadrivalent.