chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient. Other Case identifier(s): 2022-0572117. A 58-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation; Ambrisentan (AMBRISENTAN), since 08Jun2020 (ongoing) (Lot number: 28382, Expiration Date: 30Nov2023) at 10 mg 1x/day for pulmonary hypertension; docusate sodium, sennoside A+B (LAXATIVE STOOL SOFTENER WITH SENNA), (Batch/Lot number: unknown) for constipation. The patient's relevant medical history included: "Pulmonary hypertension Secondary" (ongoing), notes: current condition; "Connective tissue disorder" (ongoing), notes: current condition; "Scleroderma" (ongoing), notes: current condition; "right ventricular dysfunction" (ongoing), notes: current condition; "Dysphagia" (ongoing), notes: current condition; "Interstitial lung disease" (ongoing), notes: current condition; "hypertension" (ongoing), notes: current condition. Concomitant medication(s) included: TYVASO (ongoing); REVATIO (ongoing); SILDENAFIL [SILDENAFIL CITRATE] taken for interstitial lung disease (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has both vaccines and did not have this reaction when she had Covid last year". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Patient diagnosed with COVID last Wednesday; she had Covid last year. The action taken for Ambrisentan was dosage not changed; for docusate sodium, sennoside A+B was unknown. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient diagnosed with COVID last Wednesday and started taking Paxlovid and is now having side effects like heart rate going up and oxygen level going down along with swelling. She started she has both vaccines and did not have this reaction when she had Covid last year so believes it is due to Paxlovid. No further details provided. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Left thigh red on top to distal area, positive edema, positive warmth, and positive tenderness.
approximately 1 week post 1st dose, patient had sensation of foreign body in throat; some pain in neck; & facial swelling
Pt stated she had chest tightness Friday night (1-18-13) and a headache and now today she has a rash on her torso (1-20-13) rash cleared on 1-21-13.
COVID-19; COVID-19; This is a spontaneous report from contactable pharmacist. This pharmacist reported similar events for 2 patients. This is the 2nd of 2 reports. A 16-year-old patient of an unspecified gender received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date 2 weeks after vaccination with outcome of unknown. The patient showed minimal symptoms. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unspecified date 2 weeks after vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events drug ineffective and Covid 19 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101169498 Same reporter/product/event, different patient
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Induration at injection site and erythema from injection site to elbow on outer arm lasting approximately 10 days
Severely swollen and painful arm, fever (100.3), headache, felt bad enough that she almost went to the emergency room.
Redness, swelling, hot on upper left arm. Pain worsen over 2 days. Sent to urgent care clinic.
Sore arm. Headache that started about 11 hours after the vaccine and continued for the next 24 hours.
Information has been received from a physician concerning a 13 month old male with no relevant medical history reported who on 06-JUL-2004 was vaccinated inadvertently with 2 separate doses of MMR II (lot 643391/0944M). The physician reported that the pt had no ill effects at the time of vaccination. He indicated that the pt's parents reported to him the pt developed a light fever the evening of 06-JUL-2004. Unspecified medical attention was sought. Additional information has been requested.
Pt employee in CCU. Pt stated seeing stars, laid on floor, became flushed, vomited and lost consciousness. Rush to ER - 1000 cc normal saline, AQ adrenalin 0.3 SQ, Benadryl 25mg, Xopenex aerosol, Decadron 4 mg IV.  Pt called at 3:15 doing well.
Left arm reddened, hot to touch, swollen, painful. T 98 degrees. Augmentin CS 600/5cc 2/12tsp BID 7 days.
Patient with hives face, ears, neck, chest, trunk. Vomited x1. BENADRYL 12.5mg/5ml, 5ml PO x1 hives responding within 5-10 min.
This spontaneous report was received from a pharmacist via agency employee and refers to a patient (age reported as under 65 years old) of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, exact dose and route of administration were not reported). On an unknown date, the patient experienced injection site pain, injection site peeling of skin, injection site warmth and injection site swelling. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same source. Additional information has been requested.
Progressive numbness and tingling in hands and feet 5 hours after recieving the flu vacine. Seen in the ED, consult to neurology. Returned to work 2 days later.
Syncope episode while sitting after patient given influenza vaccination, patient given ice pack to put on neck and remained sitting until able to ambulate.
2 days post vaccination, pt presented with 7cm area of redness on (L) deltoid with warmth/redness.
Fever, chills, severe headache, body aches (teeth also) nausea and vomiting, low abdominal pain, fatigue, some symptoms lasted for 3 to 4 days. Lymphadenopathy. Took Tylenol and aspirin for fevers and pain.  Took protonix to protect stomach from aspirin.
Was due to get 2nd vacc May 7; Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Was due to get 2nd vacc May 7). The patient was treated with Surgery (Stent Placement 3 Stents) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Was due to get 2nd vacc May 7) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information were not provided. Patient had 3 stent placement.  Company Comment: Very limited information regarding these events has been provided at this time. Patient age and medical history could be confounding factors. Further information has been requested.   This case was linked to MOD-2021-239153 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient age and medical history could be confounding factors. Further information has been requested.
Pt was fully vaccinated with the Moderna Covid-19 vaccine (on 2/10/2021 and 3/10/2021 respectively).  Pt still became ill with COVID-19 and required hospitalization.
5 years old received Adacel inadvertently and  the patient should have received Infanrix; 5 years old received Adacel inadvertently and  the patient should have received Infanrix; Initial information received on 03-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a five years old male patient who was vaccinated with a once 0.5 ml fifth dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6273AA and Exp. Date 24-Apr-2021) instead of INFANRIX via unknown route in the left deltoid on 02-Jul-2019.  The patient did not received concomitant medications and patient history included first, second and third doses of Dtap vaccine received on unknown dates and fourth dose received on 26-Aug-2015.  It was an actual medication error case due wrong vaccine administered and inappropriate age at vaccine administration.  It was unknown whether the patient experienced any adverse event post vaccination.  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 and Module VI of the 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.  List of documents held by sender: none.
Initial unsolicited misuse report received from a non-healthcare professional (medical assistant) on 17 November 2016. This case involves a 3-years-old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QIV (batch number- U5691AB expiration date-27 March-2017) (route of administration was not reported) in left thigh on 17 November 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Concomitant medications were not reported. On 17 November 2016, it was reported administered product into left thigh while mother was holding child and after needle entered leg, mother let go of child, and he pulled the needle out of his leg before the product was administered and the patient sustained a scratch on leg. Relevant laboratory data was reported as none. It was reported Band Aid was applied as corrective treatment. The outcome of event was reported as unknown. List of documents held by sender: none.
This case was reported by a physician and described the occurrence of asthma type reaction in a 44-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to erythromycin, asthma, heart murmur and migraine. Previous and/or concurrent vaccination included FLUVIRIN; Novartis; unknown; unknown given on 8 October 2010; TYPHIM Vi; Sanofi Pasteur MSD; unknown; unknown given on 8 October 2010. Concurrent medications included LIPITOR and TRIPLEX. On 8 October 2010 at 12:00 the subject received 1st dose of TWINRIX (1 cc, unknown, right arm). On 9 October 2010, 1 day after vaccination with TWINRIX, the subject experienced asthma type reaction, wheezing, shortness of breath and cough. The physician reported that the subject was given a TWINRIX injection on 08 October 2010. On the evening of 09 October 2010 the subject began to experience asthma-like reaction consisting of shortness of breath, wheezing, and cough. The subject was seen by the physician and treated with XOPENEX, nebulized albuterol, prednisone and unknown inhaled corticosteroid. The physician considered the events were life threatening and clinically significant (or requiring intervention). On an unspecified date in October 2010, the asthma type reaction, wheezing, shortness of breath and cough were resolved.
Mild hives and generalized itchiness developed, especially on the side of the body that the vaccine was administered. Continued throughout the following 12 hours (which is when I am filing this report). No treatment measures have been taken.
No adverse event; Expired product administered; Product preparation error; This spontaneous report was received from a pharmacy student regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 02-DEC-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number S018593 and expiration date: 17-JUN-2021) reconstituted with expired Diluent MRK (STERILE DILUENT) (lot number M009800 and expiration date: 12-SEP-2018) (strength, dose, route of administration and anatomical location were not reported) as prophylaxis (expired product administered and product preparation error). No additional adverse events were reported.
Severe muscle spasms in the left shoulder, neck, and left side of the face starting occasionally within 24 hours and progressively became more constant and intense. Vasovagal syncope-like events starting at the same time as muscle spasms, but are less frequent and have occurred multiple times. Exhaustion. No reduction in symptoms after two weeks (present date).
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in 2015 (reported as between 27-OCT-2015 and 18-NOV-2015) the patients were vaccinated with unspecified doses in the series of ROTATEQ (lot # L004466 with expiry date of 02-AUG-2016 or lot # L008059 with expiry date of 18-DEC-2016 or lot # L009119 with expiry date of 17-DEC-2016) (oral, unknown strength) which were improperly stored. No adverse effects were reported. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
pt recvd vax & devel fever in the pm; seen at clinic 27oct94 w/ fever & diarrhea; dx w/ gastroenteritis; 28oct94 still w/ fever & had sz & fever of 104.5; was ok when sent to er;
On 12/28/2022 I had a head cold, headache, felt sluggish. Then on 12/30/2022 diarrhea, sick to the stomach I tested positive for COVID-19 that day. Called provided and prescribed LAGEVRIO.
Within 3 or 4 minutes I receiving the vaccine, I fainted. Then I was very weak and broke out in a sweat.  I was unable to drive for two hours. I had a dull headache for 6 hours.
I just had a sore arm for a day or two after receiving the vaccine. I had a headache off and on two days prior to testing positive for COVID-19 which is unusual for me. I tested positive on 01/07/2023 with a home test. Two days later at the clinic they tested be again and COVID-19 and it was positive, so they got a prescription for PAXLOVID. I tolerated the medication, but it left a metallic taste in my mouth. As of today, I still have fatigue and the headaches.
redness & swelling lt upper thigh 1 x 1/4cm not hot or glossy, no fever w/surrounding skin colored swelling 2cm;
Mother of child reports that child got a rash around 4pm on 4/7/08 that was on the child's entire body.  The rash is reported to come and go.  The mother describes the rash as red with white bumps and a few red bumps.  Mom reports that child did not sleep well on the night of 4/7/08 because the child itched all night.  Mother of child reports that child does not have a fever and that child id "acts fine".
She got her vaccine, her arm was stiff, had chills, fever, body aches, low grade fever.  It went on for about 3 days.  The 4th day she started feeling better.  She called the doctor and she asked if she had the reaction paper and she found it and called us.  Everything on the paper was what she was experiencing.  She drank ginger tea and ate chicken noodle soup.  After drinking the tea she felt like she was sweating.   She is having sniffles and some sputum production.  She said she felt like she had the flu or cold, and felt that she had COVID, but she took a test and was negative.  She has had all COVID vaccines, and she did not have any reactions to them.
6 weeks after receiving vaccine, I was outside with both arms and hands exposed in the sun for a few hours. The next morning, the muscles and joints in both arms and hands were extremely sore and painful. This was not like a sunburn which is painful at the surface level. It is muscle and joint aches similar to the side effects I had within 48 hours of the initial vaccine, but only in the areas that had been exposed to the sun for an extended period of time.
Headache/teeny-tiny headache /last night and have a terrible headache; Arm soreness; Nauseated; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.   A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on 15Feb2021 (Lot Number: EN6201, at the age of 47-year-old), as single dose for COVID-19 immunization. Medical history included psoriasis from an unknown date and unknown if ongoing. Concomitant medications included clarithromycin (CLARITIN [CLARITHROMYCIN]) and vitamins taken for an unspecified indication, start and stop date were not reported. 19Feb2021, she had headache/teeny-tiny headache /last night and have a terrible headache. Unknown date in Feb2021, she had arm soreness, nauseated. Monday at 11 in the morning, the patient had just really mild symptoms nothing unmanageable at all, just arm soreness and maybe just a teeny-tiny headache and a little bit nauseated, but not bad at all. The patient could go to work and do everything, but the patient went to bed last night and had a terrible headache this morning think so, and the patient did not usually get headaches. The patient reported that it was been five days. The patient was asking if it was possible to be side effect, five days later. It feels migraineish. The patient reported that it was a little better now and that the patient took some Advil (treatment) to help. So, the patient just wondered how long after the vaccine could expect to possibly have symptoms. Therapeutic measures were taken as a result of headache/teeny-tiny headache /last night and have a terrible headache. The clinical outcome of headache/teeny-tiny headache /last night and have a terrible headache was not recovered while not arm soreness, nauseated was unknown.  No follow-up attempts are possible. No further information is expected.
Presented w c/o shortness of breath and weakness.  Patient has a history of interstitial lung disease and normally requires 2-4 L of oxygen via nc; diagnosed with pneumonia secondary to COVID-19 virus.  Tx w/ steorids, zinc, advair, singular, remdesivir, abx, O2; weaned down to 2 L of oxygen via nasal cannula; dc'd to SNF.
Information has been received from a nurse in office concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported).  The patient had syncopal events after vaccination.  It was unknown if medical attention was sought.  The outcome of the patient was not reported.  This is one of several reports from the same source.  Additional information has been requested.
1 day after vaccine redness & swelling noted & seen in office 3/25/11 - 5 cm x 3 cm redness (+). No streaks noted.
Lightheaded; Developed dizziness and headache immediately post vaccine . Patient without other symptoms . Patient noted to have good oxygenation.  Symptoms almost completely resolved after 20 . ER precautions given
Patient received vaccine at 4pm without any adverse rxn. At 9pm she felt like she had a lump in her throat and throat was sore on swallowing. Took a BENADRYL at 10 PM and went to sleep. Upon awakening in morning she felt ok.
Headache in the lower portion of my head next to the neck.  This has been going on for many weeks now.  Recently have dizzy spells and is very close to vertigo symptoms.  I have dismissed these symptoms but two days ago I had numbness in right arm and aching pain between my shoulder and my elbow on the underside of my arm.  Today i have a bit of numbness in my right wrist.
Started with inmediate swelling, redness and rash on the wrist of the left arm. The itching and redness passed to the forearm on the right, redness on the face.  The doctor in charge, administered 50 mg of Benadryl; waited 30 minutes and the simptoms disappeared. He asked me if I wanted to go to the hospital if I was not feeling well, but I refused and went home.
Lupus; Hashimoto's; Allergic reaction; Hives; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team from a Pfizer sponsored program (005570). The reporter is the patient.  A 47-year-old female patient received BNT162B2 (BNT162B2), administration date Feb2021 (Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, single; manufacturer unknown), for COVID-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset 2021, outcome "unknown", described as "Lupus"; AUTOIMMUNE THYROIDITIS (medically significant) with onset 2021, outcome "unknown", described as "Hashimoto's"; HYPERSENSITIVITY (medically significant) with onset 2021, outcome "not recovered", described as "Allergic reaction"; URTICARIA (medically significant) with onset 2021, outcome "not recovered", described as "Hives". Therapeutic measures were taken as a result of hypersensitivity, urticaria. Clinical course: The patient reported that she received the 2nd dose of the Pfizer-BioNTech COVID-19 vaccine in Feb2021 and experienced severe hives on a daily basis ever since. She had to get Xolair shots monthly. The patient believes she was having an allergic reaction because she broke out in hives everyday which was really bad and no meds or cream was helping. The patient also found out 2 autoimmmune - Hashimoto's and Lupus that she never had and trying to see if it was related to the vaccine.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely 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.