chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID-19 approximately 2 weeks after receiving her second dose of vaccine; Tested positive for COVID-19 approximately 2 weeks after receiving her second dose of vaccine; This is a spontaneous report from a contactable consumer. A 93-year-old female patient not pregnant received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date in Jan2021 (at age of 93-year-old) as a single dose for COVID-19 immunisation, lot number: unknown. Medical history and concomitant medications were not provided. It was unknown if patient received other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was tested positive for COVID-19 approximately two weeks after receiving her second dose of vaccine, onset date 30Jan2021. Event resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatments were administered. The patient underwent laboratory tests and procedures which included sars-cov-2 test: positive on 30Jan2021. Patient had not recovered at the time of the report.  Information on the lot/batch number has been requested.
side effects; Tired; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event and tiredness. On an unknown date, the outcome of the adverse event and tiredness were unknown.   It was unknown if the reporter considered the adverse event and tiredness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient experienced typical side effects and tiredness after receiving Shingrix.
fever. exhaustion. MAIN CONCERN- RASH all over the back torso & now the front chest & neck
Information has been received from a physician concerning a female in her "mid 60's" who in 2008 (reported as "6 months to one year ago"), was vaccinated with a 0.65mL dose of ZOSTAVAX (Merck) (route and lot number not reported). A "few days after vaccination", the patient experienced redness, inflammation and warmth to the touch at the injection site. The physician reported that the inflammation was the size of an egg and lasted for about three weeks. The patient recovered from the events on an unspecified date. The patient sought unspecified medical attention. Additional information has been requested.
loss of feeling on entire left side; Acute nonhemorrhagic right Thalamic lacunar infarct; Right Lacunar Stroke; This case was received via VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.  This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (loss of feeling on entire left side), LACUNAR INFARCTION (Acute nonhemorrhagic right Thalamic lacunar infarct) and LACUNAR STROKE (Right Lacunar Stroke) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 01UM20A) for COVID-19 vaccination.   Concurrent medical conditions included Drug allergy, Type 2 diabetes mellitus and Hypothyroidism. Concomitant products included METOPROLOL, LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HYPOAESTHESIA (loss of feeling on entire left side) (seriousness criteria hospitalization and disability), LACUNAR INFARCTION (Acute nonhemorrhagic right Thalamic lacunar infarct) (seriousness criteria hospitalization, disability and medically significant) and LACUNAR STROKE (Right Lacunar Stroke) (seriousness criteria hospitalization, disability and medically significant). At the time of the report, HYPOAESTHESIA (loss of feeling on entire left side), LACUNAR INFARCTION (Acute nonhemorrhagic right Thalamic lacunar infarct) and LACUNAR STROKE (Right Lacunar Stroke) had not resolved.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Computerised tomogram head: no hemorrhagic stroke evidence. On 19-Mar-2021, Magnetic resonance imaging head: (abnormal) Acute nonhemorrhagic right Thalamic lacunar infarc.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No treatment information was provided.  The patient had right lacunar stroke causing loss of feeling on entire left side. Most feeling had returned except in left forearm and hand which has only partially recovered.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Between Aug90 + Nov90 pt vax w/ 3rd hepta B from expired lot.  No adverse reaction.
covid-19; covid-19; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years 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's relevant medical history included: "Chronic Sensory Neuropathic Cough" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Sep2023) and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: finished the medication on Wednesday and tested negative on Saturday. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 02Sep2023 to 06Sep2023 as COVID 19 Treatment.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300320654 same patient, different drug/event;
Patient comes back about an hour later and complains of dizziness. Felt bad flu like symptoms for 5 days after. Day 2 of vaccination he stated he had chest pains but did not go to the doctor.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 3/11/2021, 4/8/2021 and 11/12/2021. Presented to ED on 1/31/2022, admitted for failure to thrive secondary to COVID sequela and Covid PNA. Hospital day2, became hypoxic. CXR showed worsening bilateral pulmonary infiltrates and procalcitonin trended up concerning for superimposed bacterial infection, antibiotics started. Recurrent issues swallowing concerning for aspiration/choking, status changed to NPO, ST consulted. During the night, O2 demands escalated 2/2 Covid and bacterial PNA and possible aspiration. Given declining respiratory status and prognosis transitioned to comfort care, expired 2/3/22.
Information has been received from a 78 year old female patient referring to herself. The patient's concurrent condition included high blood pressure, hypothyroidism, very low immune system and allergy to penicillin (unspecified), DEMEROL, and ALEVE. The patient's medical history included acid reflux. On 23-JUN-2015 the patient was vaccinated with ZOSTAVAX (dose and lot # were not reported, once, subcutaneous). Concomitant therapies included SYNTHROID and atenolol. On 26-JUN-2015, (also reported as 3 to 4 days after the vaccination), the patient became very nauseous. On 30-JUN-2015 (reported as a week later), the patient had rash like bumps on her body and the rash lasted over a week. An unspecified over the counter anti itch cream was given as treatment. No lab diagnostics studies were performed. The patient had not sought medical attention. The outcome of the events was reported as recovering. Additional information is not expected because there was no patient or physician's contact information.
Injection site reddened, swollen, warm to touch, tender to touch, bruising. Advised to keep area covered, take Tylenol as needed for discomfort, follow up with PCP.
This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received first dose of BNT162B2 via an unspecified route of administration, administered in arm left on 19Mar2021 13:30 (age at 24 years old, Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient had peanuts, shellfish, shrimp allergies. Medical history also included asthma, autoimmune issues. The patient was not diagnosed with COVID-19 prior to vaccination and the patient did not test for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included loratadine (CLARITIN); Vitamin D nos (VITAMIN D); Vitamin B12 nos (VITAMIN B12). About 20 minutes after vaccination (19Mar2021 13:45), the patient experienced a loss of feeling in mouth and lips. This occurred intermittently over the next three days. Four days after the injection on 23Mar2021, the numbness spread to entire face and to extremities. The sensation was akin to getting an anesthetic like novocaine which was just starting to wear off. The events needed doctor or other healthcare professional office/clinic visit. Steroid (prednisone) was taken to reduce inflammation. Both events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fibromyalgia flare up. I am still in pain 5 weeks later. Taking anti inflammatory meds and physical therapy. Not helping.
Patient received Pneumovax on 11/19/20. Noticed chills and fever starting on 11/20/20, as well as some arm pain and redness at injection site.
Originally vaccinated with Janssen COVID19 vaccine on 4/1/21 - no issues Boosted with same on 11/11/21 - no issues Sunday May 8, 2022 developed sore throat, and congestion.  Tested positive for COVID with test kit provided by local agency.  Had 2 prior negative tests after being informed of exposure.  After testing positive did develop fever this week.  All symptoms have subsided.  I don't call this an adverse reaction to the vaccine.  I was exposed and current sub variants are infecting those vaccinated. I should now have higher natural immunity for next several months.
(L) arm red, swollen, warm on injection site. Denies other symptomatology post upper left arm-47 mm across 50 mm vertical.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 16-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) and ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
After having slight headaches(normal side effects) with dull eye pain from 11pm thru overnight of March 23,  at 10:30 I went out drving in car and my eyes were squinting. with heavy dark clouds(not bright) outside.   I looked at my pupils and they were pinpoint to slightly bigger.   My glasses are auto tint, but not so much behind car windows.   When I got home I sat in a dim room(lights off, but sliding door blinds closed but some light coming in) for an hour eating lunch.  I then checked my pupils and they were about a third the size of my iris.    Mild headache, dull eye pain and squinting continued.   I searched the internet and found no details about eye problems.  I called, ask a nurse and was told they found no information about eye problems at CDC or internet related to vaccine, but perhaps it is headache causing eye problems.    Seems like this should be listed somewher!  Or do I need to see my opthalmologist?   You should be complete in side effects that eye problems are possible.   I had no problems prior to vaccine.    Do with this what you will(likely ignore it as you are bidens cdc).
A week later her right arm where she had the pneumonia vaccine had a 50 cent piece sized area of erythema, swelling, yellow/greenish drainage, and pain. She developed an abscess and a lot of induration after the vaccine and was treated with antibiotics. She then used hot packs on the area and had a scab for a long time. Recently the scab fell off and she realized she has a hole in her arm. Its not really painful.
Sore arm, fatigue, headache, nasal congestion, chest congestion, sore throat, cough, diarrhea
redness at injections site developed day of injection (01/09) . Pt reports redness  has spread since then.
Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 3 years old (reported as 3 years and 3 months old) female patient who was vaccinated with 0.25 ml dose of FLUZONE QUADRIVALENT (batch number: UT6315RA and expiry date: 14-Jun-2019) via intramuscular route on 14-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to vaccine underdose because the patient should be vaccinated with recommended 0.5 ml dose. It was unknown if any adverse event occurred or not following the 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 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. Documents held by sender: none.
Patient described muscle weakness, fever, chest tightening. Patient was about to visit a Dr. to see what illness she contracted. The symptoms have lasted 10 days.
Right arm was extremely sore to any movement; This is a spontaneous report from a 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: ER2613) via an unspecified route of administration in the right arm on 30Mar2021 at 08:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any medications within two weeks of vaccination. Patient had no allergies to food, medication or other products. 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 31Mar2021 at 08:00, the patient had pain in arm. Its reported that the patient had right arm which was extremely sore to any movement and had not gotten it better in 8 days. The patient did not receive any treatment for the event. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event of pain in arm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
low grade fever, rash vesicular & pustular distribution, thorax, buttocks, abd (day 2);
Soreness and swelling at injection area. She returned on 8/11/11 for evaluation. The tricep area at the injection site was red and inflamed 10 x 6 cm. No abscess or fluctuance. Antibiotics given.
27jul90 pt vax 2nd hepta B. pt ex severe dizziness, h/a, hyperventilation.  pt tx w/ apap. 28jul90 pt to er w/ h/a and bp of 153/102, and recv unspecified injection.  pt complained of numbness in the perioral area.  See worm...
Redness and swelling noticed on 02/10/05 AM by patient. Mom brought in to our office on 02/11/05, she noted redness and swelling decreased, right arm 1"x2" and left arm 1.5cm x2cm.
Patient was given vaccine that was over 12 hours old so not viable to use. Did not review the open date and time on vial. Patient is physically fine.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Doses of GARDASIL (dose, frequency, lot# and route were not reported) which were exposed to temperatures outside of the recommended range, were administered to unspecified patients for prophylaxis on unspecified date since 09-APR-2015. No adverse experience had been observed or reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Initial case was received from a healthcare professional on 04 January 2013. The reporter for this case is the same as for cases: 2012-10730, 2013-00361 and 2013-00363. A patient (age, birth date, and gender not reported), whose medical history was not reported, received an injection of INFLUENZA VACCINE (manufacturer unknown, (lot number, route, site, side and dose in series not reported) on an unspecified date. On an unspecified date, the patient experienced unspecified "symptoms post flu shot". Laboratory, diagnostic testing or treatments were not reported. The patient's outcome was not reported. Follow-up information received on 29 March 2013 from a healthcare professional. A 34-year-old female patient received an injection of FLUZONE, Sanofi Pasteur (lot number UH731AB) on 08 October 2012. On 10 October 2012, the patient experienced left shoulder pain. The patient had a magnetic resonance imaging (MRI) ON 7 November 2012 and results showed Teres minor tendinosis and thickening of left subscapularis tendon. The patient had an office visit on 12 November 2012. A MEDROL DOSEPAK and physical therapy were prescribed by personal physician on 12 November 2012. The patient was released by personal physician on 18 December 2012 and full recovery was confirmed on 18 December 2012. The patient's outcome was recovered on 18 December 2012. Documents held by sender: None.
Dizziness and disorientation 3 minutes after shot. Near fainting 30 minutes later. Some muscle pain in back right after and throughout the day. At 5:30 am following shot my back had tightened significantly and when I woke up around 9 am that day I had severe inflammation in my SI joints. I was unable to get out of bed and called an ambulance that afternoon. The ER gave me fentanyl and morphine and a muscle relaxer with no effect. Finally, around 9 pm that night they gave me vicodin and prednisone and that relieved the inflammation enough that I could be discharged. The pain continued at that level (from the point of discharge) for a few days and it took me 2 months for the inflammation to fully go away.
hot to the touch; swollen arm for 4 days; red arm for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot to the touch), PERIPHERAL SWELLING (swollen arm for 4 days) and ERYTHEMA (red arm for 4 days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thyroid cancer. Concurrent medical conditions included Immunocompromised and AFib. Concomitant products included METOPROLOL, ATORVASTATIN and APIXABAN (ELIQUIS) for AFib, LEVOTHYROXINE SODIUM (SYNTHROID) from April 2021 to an unknown date for an unknown indication.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot to the touch), PERIPHERAL SWELLING (swollen arm for 4 days) and ERYTHEMA (red arm for 4 days). At the time of the report, FEELING HOT (hot to the touch) outcome was unknown and PERIPHERAL SWELLING (swollen arm for 4 days) and ERYTHEMA (red arm for 4 days) had resolved.            No treatment drugs were reported. Patient medical history contains thyroid cancer surgery 29 Apr 2021. Patient has been smelling cigarette smoke every day for the past 3 to 4 months. Dose 3 was taken in mid December.   This case was linked to MOD-2022-463116, MOD-2022-463070 (Patient Link).
My daughter had a couple dry coughs and then stating that she was having difficulty swallowing. I administered the epi-pen, returned to the clinic and was sent to the ER by ambulance. Symptoms resolved with the epi-pen.
This spontaneous report was received from a physician and refers to a 5 year old patient of unknown gender. No medical history, current conditions and concomitant therapies were reported. On 07-JUL-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, expiration date, dose and anatomical location were not reported) subcutaneously, in addition to a dose of PROQUAD (Merck) (lot #, expiration date, dose, route of administration and anatomical location were not reported) received on the same day. No adverse effects were reported. Additional information has been requested.
Pt expired Pt was on hospice for end of life cares and death was anticipated Pt was in long term care facility so vaccine was administered due to congregate living environment
Patient given COVID-19 vaccine by Pfizer in error. He intended to get a Fluzone vaccine.
Arm/shoulder pain, numbness, stiff arm/shoulder, tingling in fingers, decreased range of motion, weakening of arm, unable to lift, etc. Received flu vaccine on 11/12/2021  instant pain right after injection, shoulder got worse the next day 11/13/2021, stiff, painful, unable to lift arm etc
Initial misuse report received from a healthcare professional on 30 May 2013. Some vaccine squirted on a female patient's face and might be in her mouth while was taking the cap off. No adverse event was reported. List of documents held by sender: none.
I started feeling a numbing of my feet and lower legs (calves).  On the morning of May 31s, I awoke to an excruciating painful calf cramp.  In the past, whenever I've had these, they would fade in pain within one or two hours.  The pain from this cramp lingered for several days.  I soon noticed my feet afterwards becoming swollen and feeling even more numb and for entire days.  On June 11, I couldn't fit my feet into my shoes.  I put on some loose-fitting sneakers and took myself to the Emergency Room.