chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown gender and age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an inadvertently RECOMBIVAX HB, lot number K009953, expiration date 03-APR-2016 which had been improperly stored. There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same reporter (case # 1511USA004005). Additional information has been requested.
Within 30-45 minutes hives on neck, tightness in throat, immediate body flush and heart palpitations. All reactions are still present at 20:08 on 10/18/2021.
Patient received the first dose of the 2-dose Pfizer Covid-19 series and immediately complained of feeling hot.  She was taken to a private area and observed by a nurse.  Blood pressure initially was 124/77, but the third blood pressure 20 minutes later had dropped to 95/62.  Patient and her husband (in attendance) were advised to go to the ED in the same hospital which they agreed to do.
Information has been received from a physician concerning a 56 year old female patient with no known drug allergies who on 4/1/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently on 4/01/02, within minutes of the vaccination, the patient developed a site reaction. No description of the reaction was available at the time of the report. Unspecified medical attention was sought. Additional information has been requested.
Pt recvd 3 doses of Engerix-B 8JAN91 & 8FEB91, & 8JUL91 & AUG91? pt exp paresthesia in arms, hand & trunk;
Patient began seizing , fell over from chair and hit her head on the floor; right forehead. Patient seized for 1 minute and a half.  Upon patient coming to she was then placed in chair and vitals were taken:  BP 130/80, respiration 21, Pulse 77, O2 98%. Ice pack was placed on her forehead to keep her cool. EMS was called, patient was evaluated and transported.
broke out into hives; throat began to swell; breathing became difficult; anaphylaxis; patient age: 15; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217), dose 2 via an unspecified route of administration, administered in left arm on 03Jun2021 14:30 (at 15-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included low growth hormone production, and known allergies: many foods. Concomitant medications included somatropin (NORDITROPIN); anastrozole (ANASTRAZOLE DENK); olopatadine; levocetirizine dihydrochloride (XYZAL); diclofenac sodium, heparin sodium (ALLE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173), via an unspecified route of administration, administered in left arm on 13May2021 17:30 (at 15-year-old) as 1st dose, single dose for COVID-19 immunization. On 03Jun2021 at 17:30, the patient experienced 3-4 hours after dose, broke out into hives. He took benadryl. Throat began to swell and breathing became difficult. He used epi-pen to stop anaphylaxis. The seriousness criteria of the events was reported as life threatening. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events hives, throat began to swell, breathing became difficult, anaphylaxis was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Narrative: Patient had end stage frontotemporal dementia and was on hospice care at time of death.
Patient received influenza  vaccination on 10/22/21.  Patient  received Pfizer COVID-19 booster on 10/22/21.   Patient developed respiratory dyspneic symptoms one week later.  Patient presented to the emergency department  on 11/4/21 for dyspnea and again on 11/6/21.   Patient was diagnosed with deep vein thrombosis on 11/6/21?CT angiography  chest showing large burden of bilateral acute pulmonary emboli involving all  lobes.
Patient admitted to the hospital on 01/14/2022 with cough the only symptom recorded. Patient has underlying health condition: hypertension. No interview obtained; attempted: 01/18/2022. Unknown days spent at hospital.
I still got the flu, but it was mild; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves adult patient (unknown gender and unknown age) who experienced "I still got the flu, but it was mild" (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious I still got the flu, but it was mild (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "I still got the flu, but it was mild and only lasted about three days. So much better than the year it took me three months to recover."  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
Chest pain, shortness of breath, fatigue resulted in ER visit which ruled out life threatening causes. Treating ER physician suspected pericarditis based on pain worsening while prone and decreased pain after taking NSAID.
Fever as high as 103.7, normal fever in 100-101.5 range, hot and cold flashes, sore arm and swelling in left hand, diarrhea, head aches
Erythema + warmth on L UE on extensor side from axilla to elbow and over into axilla.
No known adverse event. Employee health staff gave a LAIV vaccine to a pregnant staff member (12 weeks at time of inoculation).
Arm started hurting the next day.  Hard to lift arm above shoulder.   Did not get better.  After a month I called the dr. and  was told to take 2 naproxen twice a day to relive  swelling.  T his helped, but when I stopped the pain came back.  Does not hurt just sitting, only when I try to lift something.  Think injection was given in a muscle.  Hurts when I left arm above shoulder.
On 5/1499, the pt received her 1st shot with Lymerix with no untoward effects. In June 1999, she received her 2nd dose of Lymerix and about 8 months later, in February 2000, the pt had experienced malaise, stiff neck, muscle aches, nausea, night sweats, confusion, fever and in about April 2000, she experienced numbness in her great toes. She went to the ER on 4/13/2000 and her complaints were muscle pain, numbness, and a stiff neck. She was admitted to the hospital for joint pain, fatigue (weakness), and for a neurological evaluation. A physician exam revealed swollen shoulder joints, left wrist, and swollen cervical spine. She was dx'd with polymyalgia rheumatica and was treated with prednisone. She was discharged from the hospital after 3 days on sulfemethoxazole and trimethoprim 2 X/day (Septra DS), paracetamol and Vicodin and a prednisone taper. The most recent information received on 6/21/2000, reported the symptoms resolved.
Immediately post vax, the pt experienced vomiting, malaise, sore ears, headache, muscle ache, and parotid salivary gland tenderness. The pt was afebrile. It was indicated that the pt's symptoms subsided within two days from the onset of episodes.
This spontaneous report as received from an other health professional refers to a 4 years old female patient with no illness at the time of vaccination and unknown pre-existing allergies or birth defects or medical condition. The patient was subcutaneously vaccinated in the left thigh with dose 2 MMR II (Lot number 0648AE and expiry date 24-MAR-2014) on 25-OCT-2012. No other co-suspects were reported. No pre-existing allergies, birth defects and medical conditions were reported. No concomitant mediations were reported. On 26-OCT-2012 the patient experienced swelling, 14 hrs 57 min after onset of therapy, very hot to the touch, redness and rash. The patient required emergency room/doctors visit. The outcome of swelling, very hot to the touch, redness and rash is unknown. The relatedness for swelling, very hot to the touch, redness and rash was unknown for MMR II. Additional information has been requested.
p/vax pt exp pyelonephritis & was hosp; devel rash while in hosp; rash resolved p/1 day; @ time of rpt pt still hosp
Hives in mouth, throat and on lips; Lips chapping; Mild heart palpitation; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO161) via an unspecified route of administration in the left arm on 16Apr2021 at 18:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mangoes and cashews. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 20:30, the patient experienced hives in mouth, throat and on lips, lips chapping and mild heart palpitation. The patient had lips chapping for 2 days and mild heart palpitations was there over 2 days. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events hives and palpitation were resolved on an unknown date in Apr2021, whereas the event chapped lips was resolved on 18Apr2021.   No follow-up attempts are possible. No further information is expected.
Headache, UrticariaPruritus, 12-29-20 awakended with body aches and temp of 101.9 Narrative:  Received Moderna Vaccine #1 at approx. 9:15 am. Headache started around 1030, generalized itching around noon. Benadryl 50mg PO q4h PRN prescribed x 1 day. Called today, 12-20 reporting body aches and temp of 101.9. Itching has improved since yesterday. Patient states, "I feel like I've been hit by a truck."
11hrs post injection - headache, fever, nausea, arm paint, whole body joint pain.  90% resolved at 28 hrs post injection. 42 hrs post injection (could have happened sooner as I was asleep) Rash covering trunk front and back.  Skin itched where there was no rash.  Looks like morbilliform.  Per doctor took Benedryl at bedtime. 68 hrs post injection - rash has filled in more and  can be seen slightly on my face and both arms in addition to my trunk.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 69-year-old female patient who received Shingrix (batch number CH2X7, expiry date 25th April 2020) and (batch number D3G59, expiry date unknown) for prophylaxis. On 9th May 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site rash and pruritus. On an unknown date, the outcome of the injection site rash was recovered/resolved and the outcome of the pruritus was not recovered/not resolved. It was unknown if the reporter considered the injection site rash and pruritus to be related to Shingrix. Additional details were provided as follows: The patient received the first dose of Shingrix and beginning an unknown date, the patient experienced a mild rash in the injection site area which lasted a few weeks and was resolved at the time of the report. The patient also experienced itching which remained ongoing at the time of the reporting.
Patient was given her Dose 1 of the Covid 19 Pfizer vaccine and was sitting down for her 15 minutes of monitoring. The patient was with her son and within five minutes decided to stand up for a moment, where then she fainted and fell down and hit her head on the ground. The pharmacist promptly brought her emergency kit and had 911 called. The customer sat down back on her chair as soon as the pharmacist attended to her and was given water. Once the paramedics arrived her blood pressure was low and she stated she had not eaten anything this morning. The pharmacist gave her some crackers as she continued drinking her water. She was advised to go to the hospital for any additional check ups but the patient declined, as she stated she was feeling fine. Pharmacist had the patient remain for an additional 15 minutes once the paramedics left.
Red, swollen, itchy patch on injection site arm.  About 2 1/2 inches in diameter
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 05-MAY-2014 was vaccinated with PROQUAD lot # J015595, expiration date 05-Jun-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F), (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
First dose resulted in shoulder injury. Severe arm pain began evening after the first dose, followed by pain in the shoulder joint when raising arms above head which has persisted for 23 days. Second dose resulted in fever, chills, nausea, swelling of hands and flushing sensation in hands/feet,  with maximum fever of 100.2 F documented 24 hours after the second dose. Fever and chills resolved about 36 hours after the injection.
right arm still feels like a pulled muscle; right arm was sore; right arm stung like a wasp sting; sharp pain in right arm; dull ache and dull throb of her right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (dull ache and dull throb of her right arm), MUSCLE SPASMS (right arm still feels like a pulled muscle), PAIN IN EXTREMITY (right arm was sore), FEELING ABNORMAL (right arm stung like a wasp sting) and VACCINATION SITE PAIN (sharp pain in right arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), METOPROLOL SUCCINATE (TOPROL XL), AMLODIPINE, ATORVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (dull ache and dull throb of her right arm), PAIN IN EXTREMITY (right arm was sore), FEELING ABNORMAL (right arm stung like a wasp sting) and VACCINATION SITE PAIN (sharp pain in right arm). On 31-Mar-2021, the patient experienced MUSCLE SPASMS (right arm still feels like a pulled muscle). On 29-Mar-2021, FEELING ABNORMAL (right arm stung like a wasp sting) and VACCINATION SITE PAIN (sharp pain in right arm) had resolved. At the time of the report, PAIN IN EXTREMITY (dull ache and dull throb of her right arm), MUSCLE SPASMS (right arm still feels like a pulled muscle) and PAIN IN EXTREMITY (right arm was sore) outcome was unknown.        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.   Other concomitant medication include Multivitamin Fish oil  Probiotic.
received 2nd dose 2 days after the 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 54-year-old female patient who received HAB (Twinrix adult) (batch number hsg9, expiry date 3rd January 2025) 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.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX ADULT).   On 19th January 2023, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 19th January 2023, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 23-FEB-2023 Reporter's Comment: The reporter wanted to ask if the vaccine considered valid if Twinrix adult second dose two days apart the first Twinrix adult. On 17th January 2023, the patient received 1st dose of Twinrix adult. Phone number was available. No further information was available. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Twinrix adult before than the recommended schedule, which led to shortening of vaccination schedule.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 23-NOV-2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed acyclovir and tramadol for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Hallucinations; extremely tired/extremely lethargic; extremely tired/extremely lethargic; she wasn't making any sense; UTI; This is a spontaneous report from a contactable consumer.  A 88-years-old female patient (mother) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. Medical history included dementia. The patient's concomitant medications were not reported. Reporter was asking if Hallucinations are a side effect of the vaccine. Her mother (patient) got the first dose of the covid vaccine on 23Jan2021. She reported that after getting the vaccine her mother was initially extremely tired but she was still able to carry on regular conversation until this morning when she wasn't making any sense. Reporter stated that this may be due to a possible UTI but she just wanted to see if older people with dementia were having hallucinations after getting the vaccine. It was reported that patient was extremely lethargic and having hallucinations. Reporter was wondering if this could be a reaction to the vaccine. All event from Jan2021. The outcome of the events was unknown.   Information on batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to event hallucinations cannot be completely excluded. The case will be reevaluated should additional information become 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.
Information has been received from a nurse practitioner concerning a 9 month old female who on 10/28/02, was vaccinated with her third dose of hep B vaccine. On 10/28/02, one hour following the vaccination, the pt developed a rash around the injection site. This rash spread to her legs, arms, trunk, palms of her hands and soles of her feet. The pt did not have a fever and was not hospitalized. The registered nurse reported that the pt was "fine." Unknown medical attention was sought. Additional info has been requested.
arm is itchy; arm / swollen slightly; This case was reported by a consumer via interactive digital media and described the occurrence of itchy upper limbs in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced itchy upper limbs and swelling arm. On an unknown date, the outcome of the itchy upper limbs and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the itchy upper limbs and swelling arm to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The age at vaccination was not reported. The patient experienced arm was itchy and swollen slightly.  The patient would like to know what should do.
Information has been received from a physician concerning a 13 year old female patient who on 09-OCT-2008 was vaccinated with the first dose of GARDASIL (lot number unspecified). Concomitant therapy included VARIVAX (MSD), DTAP and meningococcal vaccine (unspecified). Two months after received the first dose the patient came into the office to receive the second dose. But at that time the patient was not ready for the second dose since after the first dose the patient experienced a fever for two days. No medical attention was sought. The patient did not receive the second dose of GARDASIL until 13-JUL-2009. Additional information has been requested.