chrisvoncsefalvay/vaers-outcomes huggingface dataset:
viral rebound; viral rebound; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "viral rebound".  Clinical course: Description of Event: The office reported at least 3 cases of viral rebound. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events and suspect drug cannot be excluded completely,Linked Report(s) : US-PFIZER INC-PV202200025379 Same reporter/ drug/ AE, different patient;
Weeks later he was going really sick; 3 and a half weeks after, he had heart murmurs; Four weeks after he got Covid.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Weeks later he was going really sick), CARDIAC MURMUR (3 and a half weeks after, he had heart murmurs) and COVID-19 (Four weeks after he got Covid.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Weeks later he was going really sick), CARDIAC MURMUR (3 and a half weeks after, he had heart murmurs) and COVID-19 (Four weeks after he got Covid.). At the time of the report, ILLNESS (Weeks later he was going really sick), CARDIAC MURMUR (3 and a half weeks after, he had heart murmurs) and COVID-19 (Four weeks after he got Covid.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2021: Updated date of first dose.; Sender's Comments: This case concerns a male patient of unknown age with no relevant medical history, who experienced the unexpected non-serious AESI event COVID-19. The event occurred within unknown period after the first dose of Moderna COVID-19 Vaccine administration on unknown date. The rechallenge was unknown since information on the second dose and doses sequence order was not provided. The benefit-risk relationship is not affected by this report.
This spontaneous report was received from a pharmacist refers to a 38-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 05-JUN-2018 the patient was vaccinated with first dose of M-M-R II at another unspecified site and a titer drawn was negative. The exact date of the titer was unknown but it was known that the titer was after the dose on 05-JUN-2018. No treatment was given for the event. The outcome of the event a titer drawn was negative was unknown. The causality of the event titer drawn was negative M-M-R II was not reported. No product quality complaint was reported.
On 12/22/2020 I had arm pain fever and chills for the first 24hrs after on 12/23/2020 I noticed that if i bend down or looked around fast I would get dizzy also got headaches on 12/24/20 & 12/25/2020 everything was worse I had people taking care of me because I had really bad migraines I didn't even want to talk or do anything because I would get very dizzy & bad migraines. On 12/25/2020 my doctor wanted to send me to the ER but I didn't go and on 12/26/20 everything went away I felt better.
I felt extreme fatigue- really tired.  I first got the fever, then chills, the fever, then chills again.  Finally, after the fever and chills, I got a very intense headache for about 18 hours.  The fever and chills lasted for about 36 hours.
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 07Jul2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL BLISTERING (medically significant) with onset Aug2021, outcome "recovering", described as "blisters on her throat/Blisters in throat"; PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "recovering", described as "had a really sore arm"; EAR DISORDER (non-serious) with onset Aug2021, outcome "recovering", described as "fluid behind her ears"; OROPHARYNGEAL PAIN (non-serious) with onset Aug2021, outcome "recovering", described as "had a sore throat". The patient underwent the following laboratory tests and procedures: blood test: no antibodies; influenza virus test: negative; sars-cov-2 test: negative; streptococcus test: negative. Therapeutic measures were taken as a result of oropharyngeal blistering, pain in extremity, ear disorder, oropharyngeal pain. Clinical course was reported as, the reporter reported that after the first dose of the Pfizer COVID 19 vaccine on 07Jul2021, she had a really sore arm, and she took Tylenol and Ibuprofen. The patient reported that, she took Tylenol and Ibuprofen before she got the first dose so that maybe she wouldn't have as bad of side effects. She relays that a month after (also reported as about 4 weeks after) the first dose she had fluid behind her ears and blisters on her throat. The patient still had a sore throat and some drainage, but she is feeling much better after a Z-pack. The patient would like to get her second dose of the Pfizer COVID 19 vaccine but when she asked the pharmacy, they were unsure of when she should get it and wants to make sure the second shot is going to be as effective. The patient felt bad and went to the doctors when the time frame came to take the second shot. At the time of report she was better and Just got off a Z-pack last week. Follow-up attempts completed. No further information is expected.
Patient developed left sided facial droop and left eye droop/paralysis on 1/17/21. No medical treatment was necessary. Hospice and family were notified. Symptoms continued on 1/19/21 and the nurse practitioner ordered Refresh tears to left eye three times a day x 14 days, tape eye shut at night as tolerated and start Prednisone 40mg orally x 4 days then 20mg orally x 3 days.
Tingling on R side of brain/tingling down R arm to leg and along R side of body/ it jumped to L leg and it traveled up the L side of body and thru her left arm followed by numbness; Numbness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2, solution for injection), intramuscular, administered in deltoid right, administration date Jul2021 (Batch/Lot number: unknown) at the age of 40 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset Jul2021, outcome "not recovered", described as "Tingling on R side of brain/tingling down R arm to leg and along R side of body/ it jumped to L leg and it traveled up the L side of body and thru her left arm followed by numbness"; HYPOAESTHESIA (non-serious) with onset Jul2021, outcome "unknown", described as "Numbness".  Additional information: within 2 minutes patient had tingling on R side of brain; 25 minutes later had tingling down R arm to leg and along R side of body followed by numbness; then it jumped to L leg and it traveled up the L side of body and thru her left arm followed by numbness; this lasted 15-20 minutes; then her fingers started waking up and then numbness left; the only lingering effect is that monthly before her menstrual period, the tingling on the right side of brain returns for 2 days on and off.  Follow-up attempts completed. No further information is expected.
Initial report received on 29 November 2006 from another manufacturer, report number WAES0610USA05056. The initial reporter to this manufacturer had been a health care professional. A 19 year old male patient, with no preexisting medical conditions, had received a first dose, left deltoid, intramuscular injection of Decavac, lot number U1637A, (lot number matches Decavac although the product as reported as Tripedia, on 20 May 2006. On 22 June 2006 he also received a third dose, left deltoid, intramuscular injection of Recombivax HB, lot number 652093/1099R, and a second dose, left triceps, subcutaneous injection of Varivax, lot number 653516/0347F. Sixty eight days post vaccination with Decavac and 35 days after Recombivax Hb and Varivax, the patient experienced dizziness, vertigo and ataxia. The following day his symptoms included dizziness, gait ataxia, and inability to keep balance. Reportedly MRI and spinal tap results were normal. The event required hospitalization of an unknown number of days. Gait ataxia was considered to be disabling. The patient recovered from the events.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 52.28 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Some psorias has developed on hands and feet; Tooth pain after filling; Lump in throat; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Some psorias has developed on hands and feet), PROCEDURAL PAIN (Tooth pain after filling) and PHARYNGEAL MASS (Lump in throat) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe ).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Some psorias has developed on hands and feet), PROCEDURAL PAIN (Tooth pain after filling) and PHARYNGEAL MASS (Lump in throat). At the time of the report, PSORIASIS (Some psorias has developed on hands and feet), PROCEDURAL PAIN (Tooth pain after filling) and PHARYNGEAL MASS (Lump in throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of Tooth pain after filling, Lump in throat and Some psorias has developed on hands and feet with Humira was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. On 02-JAN-2015 the patient was inadvertently administered with a dose of LIQUID PEDVAXHIB (0.5 ml, intramuscular) and a dose of COMVAX. No adverse effects was reported. Additional  information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA 24-48hrs after: injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious/choking amounts of mucous from nose & throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F), sweating, chest pressure & back pain on left side from waist to neck, difficulty breathing, severe insomnia.  48-72hrs after: all of the above EXCEPT coughing/sneezing/mucous/vomiting/diarrhea. Soft stools w/loss of bowel control. Growing anxiety due to chest pressure/back pain on left side from waist to neck, difficulty breathing & severe insomnia.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot number not provided) 0.5 ml approximately in August 2012 "about 1 month ago" because only 0.5 ml could be withdrawn from a vial of ZOSTAVAX following reconstitution with the entire contents of the diluent vial (lot number H013939). No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient had sought medical attention. PQC is involved. This is one of several reports from the same source. Additional information is not expected.
PT PASSED AFTER BEING DIAGNOSED WITH COVID 19 AND COMPLICATIONS RELATED TO COLON CANCER WITH METS.
Swelling on upper arm where injected. Swelling is hard (like it is a flexed muscle). Size is about 6" x 4". Also a pink rash on both inner-side and outer-side of upper arm.
This 5-year-old pt received 3rd dose in series. Subsequently, the pt developed rash over the entire body and increased eczema. The pt sought unspecified medical attention. No further information is available.
Severe chills, total body ache, severe joint pain lasting for 3 hours, starting 24 hours after shot #1 Severe chills, total body ache, severe joint pain, sever migraine lasting for 15 hours, starting 12 hours after shot #2 Fluttering in chest continues since the shots
red, hot, reddened area on leg @ inj site that evening p/vax;pt devel same rxn w/prev vax inj according to mom;area of redness & hardness last for 1 1/2hrs;22MAR95 devel achiness & fever 101, vomiting & diarrhea;
sore arm; chills; low grade fever; tired; 2 vials of vaccine had doses which were administered after 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills), PYREXIA (low grade fever), FATIGUE (tired) and EXPIRED PRODUCT ADMINISTERED (2 vials of vaccine had doses which were administered after 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills), PYREXIA (low grade fever) and FATIGUE (tired). an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 vials of vaccine had doses which were administered after 12 hours post puncture). At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (chills), PYREXIA (low grade fever) and FATIGUE (tired) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (2 vials of vaccine had doses which were administered after 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter. .   This case was linked to MOD-2021-408462 (Patient Link).
I had extreme pain in the right shoulder where I received the vaccine. Days later, I developed a terrible rash and went to the doctor on 10/14/2022. They diagnosed me with post-vaccination shingles and prescribed me VALTREX. I've been taking the prescription; the rash seems to be getting better, not worse. It still feels sore and itchy but not as terrible as it was when it developed. I've developed some fatigue as well since diagnosis.
Resident was being transported to a doctor's appointment.  Residents seat belt became unlatched causing resident to slide from his w/c.  911 was notified and the residents was transported to the emergency room.
BODY ACHES 2 WEEKS AFTER  ADMINISTRATION; LEG PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 02-APR-2021, the subject experienced leg pain. On an unspecified date, the subject experienced body aches 2 weeks after administration. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine  was not applicable. The outcome of the leg pain and body aches 2 weeks after administration was not reported. This report was non-serious.
Onset of events occurred on the same day vaccinee rec'd her final vax (third dose in series) No tx given.
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2022, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. some patients had reported flu-like symptoms after receiving the vaccination but the reporter did not have details on that. The treatment information was unknown.
Have had a significant change to the way my long standing allergies manifest themselves.  Since early childhood they would manifest  with congestion and wheezing - typical asthmatic reaction to allergies. Now I am getting rashes and most importantly watery eyes.  I have never had watery eyes except in the most severe allergenic reactions like from peanuts or shellfish (anaphylactic shock) - and only for very short periods.  Now I am getting watery eyes. from even minor food and pollen allergenic reactions.  While not with the frequency of the watery eyes I am also getting rashes.  The watery eyes are to the point when I wake up in the morning my eyes are glued shut.  I never have had these reactions before.  Note: I waited several months to report this because I was hoping it was random events - the events are not random and nothing I have experienced in my 67 years before the vaccination.  With the long term health problems I have I am keenly aware of my allergenic  reactions.  I have always had them but never before with watery eyes and occasional rashes.
Feeling of numbness in left hand. Vital signs normal. Equal hand grip and strength. Normal capillary refill and range of motion. Symptoms resolved with time.
pt was given first dose of covid vaccine moderna, she developed tachycardia, pvc's, and sweaty . pt with history of non obstructive cad, pt was transported to ER and discharged in stable condition
3RD DOSE MODERNA COVID VACCINE GIVEN 10/18/21 #076C21A; 4TH DOSE MODERNA COVID VACCINE GIVEN 05/26/2022 #054A22A; pt had a recent hospitalization after an acute ischemic CVA, was dc'd to a rehab center; back to hospital on 10/18/22 with worsening mental status and high aspiration risk; pt continued to deteriorate; comfort measures; no interventions; pt passed away in the hospital
I have had a headache since the 1st shot daily i have been very nauseas outside of my normal nausea this started in evening after 1st dose i also did not work next day that night i was hot then cold all night tossed and turned. I am still feeling this way except for the Hot cold the headache is what is scaring  me   i had the pfizer vaccine
5 minutes post injection, pt became diaphoretic, pale, and c/o chest pressure.  She was placed on the floor with her legs elevated.  EMS was called, she was evaluated.  She was not transported and was released to go home after evaluation and complete resolution of her symptoms. I spoke with her today, she states she had a similar episode after her nasal piercing 2 years ago and she believes related to anxiety.  She states other than arm soreness and muscle aches today, no other symptoms persist.