chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Oct2021 as dose 3 (booster), single (Lot number: Ff2590), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) Negative, notes: 5 days after feeling better and 2 days after testing negative; (14Jun2022) Positive, notes: The patient developed Covid symptoms and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 04Jun2022 to 08Jun2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19. 5 days after feeling better and 2 days after testing negative,  the patient developed COVID symptoms and tested positive again.
rash on the right thigh, pink, about 4cm in diameter.  that occurred immediately and the patient was given benadryl and that went away after about 2 hours.  That afternoon and evening (about 3-4 hours later) she became irritable, had a fever, and had twitching of her muscles every 30-60 seconds which lasted about 10 hours.  her irritability and fever lasted longer (about 24 hours post vaccination).  most of the symptoms were gone by about 30 hours post-vaccination
3RD DOSE OF PFIZER COVID VACCINE GIVEN 9/1/21, LOT #FF2588; pt brought to hospital with COPD exacerbation and found to be positive for COVID; despite aggressive treatments (O2 supplementation, steroids, Remdesivir, diuretics, IV magnesium) pt made no improvements; was dc'd to a Hospice facility locally with comfort measures only; pt passed away in hospice
Pt states that the day after he received his Fluzone HD (in right arm) and Prevnar (in left arm) vaccines his left arm was sore.  The soreness has subsided but has not completely gone away.  He can lift his arm but it is sore. He states the arm feels weak a couple of inches below the site of injection.  He has not yet had this examined by his physician.
Bexsero was subQ instead of IM; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero (subcutaneous) and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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: 15-Nov-2022 Reporter's Comment: Bexsero was given subcutaneous instead of intramuscular. The reporter asked what possible side effects were. Additional Supportive Information: the patient received Bexsero was given subcutaneous instead of intramuscular, which led to intramuscular formulation administered by other route.
Patient administered undiluted 0.2mL dose. No symptoms as of 3 hours later. Patient's parents advised to keep watch for any worsening symptoms.
It was reported that a pt 3 of 4 received a Rabies Imovax ID vaccination. Reportedly 24 hours following immunization the pt developed swelling of the arm, malaise and flu-like symptoms. Further information requested.
feel yucky; heavy chest; hard to breathe; breath would hurt; body aches; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 5G7A7, expiry date 18th May 2021) and (batch number 9CC72, expiry date 18th May 2021) for prophylaxis.   On 9th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 9th May 2019, less than a day after receiving Shingrix, the patient experienced general body pain. On 10th May 2019, the patient experienced feeling bad, chest heaviness, difficulty breathing and painful respiration. On an unknown date, the outcome of the general body pain, feeling bad, chest heaviness, difficulty breathing and painful respiration were recovered/resolved.   It was unknown if the reporter considered the general body pain, feeling bad, chest heaviness, difficulty breathing and painful respiration to be related to Shingrix.  Additional details were provided as follows:  After receiving the Shingrix, the patient experienced body aches.  The next day, he started to feel yucky and he had a heavy chest and it was hard to breathe.He reported that when he would breath it would hurt to take in a deep breath.  His symptoms resolved but the registered pharmacist. was unaware of the timeframe.  The reporter consented to follow up.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 78-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 16th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was not recovered/not resolved. It was unknown if the reporter considered the injection site bruising to be related to SHINGRIX. Additional details were provided as follows: The patient had the vaccine on Monday and she came into the pharmacy that morning with a large bruise at the site of injection. It was not prescribed by a doctor but her doctor expressed his wishes for her to be vaccinated. When asked about causality, there was no answer but he began to ask other questions and seemed confused by the question so I left it unanswered but clearly he thought it was caused by the vaccination.
THE FLU SHOT WAS GIVEN DIRECTLY IN TO MY LEFT SHOULDER, UP VERY HIGH, AND BEHIND. I NOW HAVE A TEAR ON MY SUPRASPINATUS AND INFRASPINATUS MUSCLES, AND A PERFORATION ON MY ROTATOR CUFF TENDON. I FELT EXTREME PAIN WITHIN AN HOUR OF RECEIVING THIS IMMUNIZATION. I AM NOW IN PHYSICAL THERAPY, AND I AM GOING TO HAVE SURGERY TO REPAIR IT. I AM SURPRISED AT THE NUMBER OF PEOPLE WITH SHOULDER INJURIES FROM IMMUNIZATIONS. BETTER TRAINING NEEDS TO BE AVAILABLE TO ALL HEALTH CARE PERSONNEL ADMINISTERING THESE IMMUNIZATIONS. THEY ARE CAUSING MORE HARM, THEN GOOD.
Neurocardiogenic syncope; heart block; Worsening of symptoms with subsequent vaccination; low blood pressures (<90/50); Pre-syncope prodrome; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in arm right on 24Dec2020 13:00 (at the age of 54-years-old) as dose 1, single for covid-19 immunization. The vaccine was administered at the workplace clinic. The patient medical history included neurocardiogenic syncope with heart block requiring pacemaker. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. On 24Dec2020 13:15, pre-syncope prodrome within 15 minutes of administration with low blood pressures (<90/50) for 4 days post vaccination despite hydration, salt, and compression stockings. Formal diagnosis of neurocardiogenic syncope with heart block and pacemaker prior to vaccination. No symptoms of disease prior to vaccination. Worsening of symptoms with subsequent vaccination. No treatment was provided for the events. The outcome of the events was recovered with sequel. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The event of Syncope, Atrioventricular block, Condition aggravated, Hypotension are assessed as possibly related to the suspect drug BNT162B2  based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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.
2 hrs after received Adacel and Menactra developed ear pain, migraine, vomiting, generalized weakness, cold fingers, stomache, fever. Lasted 48 hrs ear pain persisted and had acute otitis media acute exam 2/9/07.
Patient reported today that 2 days after receiving her fluzone HD immunization, she started swelling in the upper arm and up her neck.   She confirmed that no swelling occurred until 2 days after injection.
4days p/vax pt exp flu like sx, fever, aches, n/v, diarrhea, groin pain, nasal congestion
Pink round skin blotch outer thigh, not itchy. Flaking, very slowly diminishing. Abdominal pain, followed by chills then vomiting. This occurred 5 days after the shot. Subsided after about 24 hours.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 21-MAY-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 intramuscularly, lot # N014946 with expiration date: 01-FEB-2019 (strength, dose and anatomical location were not reported) for prophylaxis. No known adverse effects. No further information provided. The temperature excursion occurred between 47°F to 77°F with a time frame of 63 hours. The was not given by a data logger and no previous temperature excursion occurred.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was provided. On 04-MAR-2019, the patient was vaccinated with expired dose of ROTATEQ vial, orally, lot # R000911, expiration date: 28-FEB-2019 (exact dose was not reported) for prophylaxis. The ROTATEQ did not have any temperature excursions prior to administration. No adverse symptoms reported.
High fever, nasal congestion, extreme fussiness, difficulty sleeping, loss of appetite.  Infant Advil administered.
pt recvd vax & 24hrs later exp swollen eyelids, eye irritation & trachea felt like it was closing off;tx @ urgent care clinic w/cortisone IM & DPH IM;pt was given DPH PO to self administer if needed;sxs lasted 2 days;
Blurry Vision; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the right arm on 16Mar2021 at 10:45 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration on right arm on an 19Feb2021 at 14:00 as a single dose for COVID-19 immunisation. On 17Mar2021 at 12:00, the patient experienced blurry vision. The patient did not receive any treatment for the reported event. The clinical outcome of the blurry vision was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected
Aug90 pt vax w/ 2nd hepta B; devel severe arthralgia.  Tx w/ nsaid, solu-cortef, colchicine.  Skin biopsy indicated erythema nodosum.
Patient was admitted to the hospital on 01/17/2022.  Symptoms:  respiratory distress, fever, cough, shortness of breath, fatigue.  Patient developed pneumonia.  Patient was interview for charting in database. No doctor records available in database.  Patient has several underlying health conditions.  Unknown the stay in the hospital was. Records incomplete.
Systemic: Fainting/Unresponsive-Medium. Additional details: Patient fainted after immunization given. Patient had some numbness in arms but was otherwise ok. Informed us at the store later in day that she was ok.
26Apr91 vaxs given-that evening & for days vomited,cough,runny nose.1 wk later had T 103,vomited.Broke out in hives several times.Cries alot-couple noc cried all noc.Hives on limbs.low grade T on&off 1st wk.Lost wt.Most ill 3May;
Difficulties moving her arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Difficulties moving her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Difficulties moving her arm). At the time of the report, HYPOKINESIA (Difficulties moving her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
pt recvd vax & whinny throughout the day;fever 101-102 ax x 5"; c/o legs hurting;APAP given & cool cloths applied; vomited x 1, T103 10PM; no sz reportedd
Inability to lift arm up to shoulder level. Cannot move arm backwards. Cannot stretch arm overhead while laying down without searing pain in upper arm muscle. Cannot put clothing on easily. Must keep left arm (where vaccine was administered) lower than shoulder when getting dressed. Unable to start with right arm in clothing, then left arm into clothing. No longer able to swim due to loss of arm movement.
Right arm was swollen, warm and red with a raised area of 5 cm below the injection site that started on 8-14-18. Injection was given at 9:59 on 8-13-18. She came in at 12:30 on 8-15-18 to have us look at it. She was given ZYRTEC Children's 10mg tablet to take today and once a day as long as needed. She was instructed to put ice on it and to take Children's Ibuprofen as directed for the discomfort.
Since receiving her first dose she has been experiencing elevated blood glucose levels; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: LANTUS. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Since receiving her first dose she has been experiencing elevated blood glucose levels". The event "since receiving her first dose she has been experiencing elevated blood glucose levels" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  Additional information: Patient, (age: 35, Unit: Unknown), with Type 2 diabetes, received first dose of Pfizer BioNTech Covid Vaccine on 24Mar2021. Since receiving her first dose, she has been experiencing elevated blood glucose levels.  Her blood sugar was usually in the 110s, but two hours after receiving the vaccine her blood sugar was 290.  She usually tests 2-4 times per day, and since then she has only had one reading in the "green zone."  They have now been in the 200s all they way up to the 300s.  She spoke with her doctor and they adjusted her LANTUS dose for a few days but she was still having high readings.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchiness on several parts of the body, mainly the legs.  Delayed reaction a few days after vaccination.  Still experiencing side effect 7 days later.
Acute CVA involving lt putamen, caudate lobe, corona radiata, and frontal cortex
Received Tdap and PPD left arm 2/11/08 am as part of routine vac update. Last TD >10 years ago. Monday evening left deltoid was sore and hurt to touch/lie on.  Woke up Tues 2/12 with fine red prickly rash to chest, breast, upper abdomen and neck that did not itch and lasted 24 hours, a knot to vac site with site redness and increasing tenderness. By Wed am c/o increased swelling & warm with axillary-cervical lymphadenopathy. She denied fevers, chills, n/v, arm weakness, numbness or tingling, and limited ROM due to pain only. No medications, heat or alternative therapy.
I got my shot on the 18th of October at 1145. That night I had the typical symptoms to include a headache that I would put as a 10 on the pain scale. The headache did not subside until Friday the 22nd. I then got dizzy and lightheaded on Saturday the 23rd in the morning slowly developing a headache. I thought maybe I was having a migraine even though I have never had one before. No pain killers seem to help it. It progressed into concussion like symptoms, sensitive to light and sound, dizziness, pain all around my head. I went to the ER on the 4th of November. They gave me a cocktail for migraines and released me. It did nothing to help. I experienced the concussion like symptoms for three weeks beginning the 23rd of October. Since then I still have headaches every day typically on the right side. I have also experienced bouts of lightheadedness.
One week post vax, pt developed fever and an injection site reaction characterized by redness and swelling after sustaining "severe" cat scratches and symptoms of infection were noted. She also, had an injection of Rocephin at that time.
Right arm and had difficulty moving and lifting her arm up after the injection; Pain in her right arm; This spontaneous case from, initially received from other health professional (pharmacist) on 14-Nov-2018, concerns a 59-year-old, adult female patient.   The patient had no relevant medical history. The patient did not receive any concomitant medications.  On 16-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: YF43409 and expiry date: 30-Jun-2019) for protection against seasonal influenza.  On the same day, after the vaccination, the patient developed pain in right arm and had difficulty in moving and lifting arm up after the injection. It was reported that these adverse reactions were persistent at the time of the report. The patient didn't receive any treatment.  At the time of the report, the patient had not recovered from the events.The reporter assessed the causality of the events as related (adverse reaction) to suspect vaccine.  The reporter assessed the case as non-serious.  Non-significant follow-up received on 02-Jan-2019: Two attempts were made to contact the patient but were unsuccessful. Hence, the case was considered lost to follow up. No changes were made in the narrative.  Non-significant case correction performed on 25-Nov-2019: Reference number SEQ19-06946 deleted from narrative and additional information.; Reporter's Comments: A 59-year-old female patient developed pain in right arm and had difficulty in moving and lifting arm up after receiving Afluria Quadrivalent. The company assessed the causality of the events as related to the suspect vaccine, considering the plausible temporal relationship.
tingling in tongue; no taste; Numb lips; Numb lips and tongue about 1/2 hourafter injection; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 17:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included hepatopancreatobiliary diseases (HPB) and penicillin allergy. The patient previously took ciprofloxacin and Bactrim and experienced allergy to the medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications within two weeks of vaccination, but the medications were unspecified. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 13:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. On 29Apr2021 at 17:45, the patient experienced numb lips and tongue about half an hour after injection, no taste and fatigue. On 30Apr2021, next day, numbness returned plus tingling in tongue. 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, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event numb lip and tongue, no taste, fatigue next day numbness returned plus tingling in tongue was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a nurse practitioner (NP) concerning a 16-year-old patient who was vaccinated with the first and second doses, respectively, of varicella virus vaccine live (Oka/Merck). The NP reported that the patient subsequently developed a breakthrough case of shingles. It was unknown if the medical attention was sought. At the time of this report, the outcome was unknown. No further information is available.