chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5, on 29Sep2022 at 19:00 as dose 4 (booster), single (Lot number: GJ3277) at the age of 26 years, in left arm for covid-19 immunisation; BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 19Apr2021 as dose 1, single (Lot number: EW0164), on 11May2021 as dose 2, single (Lot number: EW0173) and on 02Dec2021 at 08:00 as dose 3 (booster), single (Lot number: FJ8762) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication included multivitamin from 01Jul2022 to 25Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid.  No follow-up attempts are possible. No further information is expected.
This was a vaccine error.  The Pfizer vaccine vial was diluted with 0.8 mL of saline (instead of 1.8 mL).  The pt received a 0.3 mL dose, so the dose was a higher-than-normal concentration due to the dilution error.
VACCINE ADMINISTERED WAS NOT RECONSTITUTED WITH 1.3ML OF 0.9% NaCl
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU)(dose and route of administration were not provided; lot # M032141, expiration date: 01-OCT-2017) reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. The doses of vaccine experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 1 hour and 45 minutes. The doses of vaccine had experienced also previous temperature excursion of 15 to 46 degrees Fahrenheit for 15 hours. Digital data logger was involved. Additional information has been requested.
Myalgia, Fever, Site pain and swelling with redness. Numbness in arms and legs, dizziness Narrative:
Patient developed headache, low-grade fever, and chills half hour after receiving the shot. The fever continued for 24 hours, headache for 2 days.
Since receiving the second dose of CoVid vaccine, my left are has not stopped hurting. It is not continuous, however it has been significant enough to distract me for my daily task. It gets worse at night, especially when I am sleeping. My functionality of that arm has been negatively affected as well. I am not able to comfortably lift the arm sideways as high and not able to lift heavy objects as well.
Patient was to be given a Shingrix vaccine. The MA who was covering DR Mistakenly gave the patient Adjuvant from 2 vials instead of mixing with the Anigen. We called the Manufacturer Glaxco smith Kline and received the Recommendations. There arent any for giving Just the Adjuvant to the patient. But there may be an adverse reaction so they recommend to give the shot again in 4 weeks. The patient was called and Dr had the patient come back and receive the injection again.
On 11/2/00, the pt presented with itching and hives on right thigh around injection site.
This case was reported by a healthcare professional at a dialysis unit and described the occurrence of HEPATITIS B antigen positive in a 77-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included diabetes.  In October 2006 the subject received unspecified dose of ENGERIX B (40 mcg, unknown, right arm).  At an unspecified time after vaccination with ENGERIX B, the subject experienced HEPATITIS B antigen positive.   At the time of reporting the outcome of the event was unspecified.
Covid19 Moderna vaccines given on 4/19/2021 and 5/18/2021.  Client tested positive PCR for Covid on 7/1 and has symptoms of Covid.
The next morning after the shot, she started to have hives and itching all over her body, she also experienced wheezing and cough, she contacted her doctor and was advised to take diphenhydramine and not to get the second shot. It was 1 week after and still patient have the cough and some itching, although patient did not see the doctor so no steroids was prescribed.
Her first dose was 21Jan2021 and the second dose was 14Feb2021. This past Saturday, 15May2021 she was diagnosed with Covid-19; Her first dose was 21Jan2021 and the second dose was 14Feb2021. This past Saturday, 15May2021 she was diagnosed with Covid-19; Headaches; Her nose was running continuously; When she got the headaches, she felt like her head was pounding or coming through her ears in her head; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 14Feb2021 probably around 1 or 1:30 (Batch/Lot Number: EN5318) as single dose, dose 1 via an unspecified route of administration, administered in arm right on 21Jan2021 10:00 (Batch/Lot Number: EL1283) as single dose for COVID-19 immunization. Medical history included atrial fibrillation (A-fib) has been diagnosed for approximately 2 years. Concomitant medications included metoprolol taken for atrial fibrillation for a couple of years; apixaban (ELIQUIS) taken for blood thinner for a couple of years; lovastatin; vitamins. Vaccine was injected by a nurse. No AEs following prior vaccinations. The patient has had both doses of the vaccine. Her first dose was 21Jan2021 and the second dose was 14Feb2021. This past Saturday, 15May2021 she was diagnosed positive with COVID-19 by a COVID-19 rapid test. No other tests reported. Patient stated the case she has was not too severe. She got a knee injection on the same day of the vaccine. She was not sure what medication it was but she thought it was cortisone. She stated it appeared her immune system didn't react properly so it made her feel she was not properly protected by the vaccine. Patient added that she had a couple of injections into her knee and she did not know if that can have any effect on the vaccine and break down immunity. Patient asked if she can get an additional shot since this one obviously did not work. Patient added that she did not want to get COVID19. She wanted to find out why did it breakdown, why did her immunity breakdown. Secondly, once this is all over, can she get another shot? She is not going to get comfortable based on what is going to happen. Diagnosed with COVID19 after receiving vaccines, patient stated that she had a few symptoms and was shocked it came back positive. She had no fever, she had no nausea. She had headaches, chills, and a really bad cough in 2021. Her nose was running continuously in 2021. When she got the headaches, she felt like her head was pounding or coming through her ears in her head. It was like something she never experienced before and it was out of the ordinary. She thought it was something more than an ordinary cold so she went and got tested. Patient was taking paracetamol (TYLENOL) and she took some Coricidin for treatment, and stated this was an over the counter decongestant. AEs did not require a visit to Emergency Room and Physician Office. Patient just went to the medical building.    Information on Lot/Batch number was available. Additional information has been requested.
Parents came in to get their son vaccinated. Parents stated three times that patient was 12 years old and completed form with 12 years of age. Upon billing, we realized patient would not be 12 until July. We called parents to inform them patient was only 11, and parents were certain their child was 12 at time of billing. Parents later called realizing their child was only 11 at time of first dose.
No additional AE; Caller reported PROQUAD was administered to an 18 year old.  No other information provided.  No Additional AEs or PQC reported.; lot # W010526, expiration date reported as 25-SEP-2023 but upon internal verification stablished as 25-SEP-2022 administered on 04-AUG-2023; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 04-AUG-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # W010526, expiration date reported as 25-SEP-2023 but upon internal verification stablished as 25-SEP-2022, therapy type stablished as rHA) administered subcutaneously (SQ) in the right arm as prophylaxis, at an age of 18 years old (product administered to patient of inappropriate age). No additional adverse event was reported.
Patient complaining of lightheadedness and chest tightness on the left upper chest and radiating to her left upper neck area as well as her left hand feels cold. Patient is awake and alert. Her vital signs are within normal limits.
Disseminated VZV; Patient is quite ill; This spontaneous report was received from a physician, and refers to a 33 year old male patient. The patient's concurrent conditions included seronegative inflammatory arthritis, and his concomitant medications included methotrexate, etanercept (ENBREL), and prednisone (all given for the concurrent condition). The patient had no prior history of primary varicella.  On an unknown date (reported as one month prior), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, route, anatomical location, lot #, and expiration date were not provided) as his serologies were negative for varicella.  On an unknown date, the patient experienced disseminated varicella zoster virus (VZV) and was quite ill (illness). Subsequently, on an unknown date, the patient was admitted to hospital because of the events.  The outcome of the events was unknown.  The reporter's causality assessment between the events and the suspect vaccine was not provided.  Upon internal review, disseminated varicella zoster virus (VZV) was determined to be a medically significant event.
9 days after injection had COVID  arm reaction which basically went  away in the middle but now  18 days later have a rash ring around my arm adjacent to the original reaction and is itchy
Pt was a resident of a facility.  Administered vaccine on 04/13/2022 at 10:10am, family picked him up to take to his relatives for the weekend.  His father reported that he got out of the shower on 04/14/2022 at  7:15 am and had a bad seizure and passed away.  Pt has a long history of severe seizures.  Facility reported that he almost had "daily" seizure activity of some type.  I do not know if the vaccine had any bearing on the situation, however I wanted to report it due to the proximity of time.
Really sore arm, could not sleep my mind was like in a dream, over and over the same thoughts. Had to have fever and was shivering. If I had known this was going to happen I would not have gotten the shot.
GIVEN LOWER IN ARM MORE SO IN TRICEP AREA. BECAME RED AND WARM TO TOUCH. ONE WEEK LATER, REDNESS, SWELLING, WARMTH AND ITCHING
Fever of 101.7 for more than 48 hours.  Crying/fussiness for more than 48 hours.
25-year-old female with history of asthma who presents with vaccine reaction that occurred just prior to arrival.  Patient states she received 2nd dose of COVID-19 vaccine at hospital earlier today, reports approximately 5 minutes later she felt very weak and lightheaded, and had episode of shortness of breath. She did use her inhaler (albuterol) which improved her symptoms.  Upon my initial assessment, she denies any complaints and states she feels back to baseline.  Denies any shortness of breath.  Patient never developed any rash.  No history of allergic reactions in the past.
Pt devel thrombocytopenia following vax w/Hep B vax;
Patient 15 years of age presented to COVID vaccine clinic for initial dose, received 0.5 mL dose of Moderna COVID vaccine.  Discussion with parents, pediatrician around plan for second dose and monitoring for any impact.  No know adverse effects noted from the vaccination.
lost hearing; This case was reported by a pharmacist via call center representative and described the occurrence of hearing loss in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 2nd dose of Shingrix. On 6th August 2019, less than a day after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were reported as follows: The immunizing pharmacist gave the 2nd dose of Shingrix to one of her customers last Tuesday before the reporting date and she said last Tuesday before the reporting date she lost hearing on the side where vaccine was given. The reporter wanted to know if this had been seen before filing adverse event.
headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Information has been received from a physician concerning a 4 month old male who on 26-SEP-2008 was vaccinated with the second dose of ROTATEQ.  The patient had blood and mucus in his stools 4 days after the 2nd vaccination with ROTATEQ.  Treatment is dietary modifications.  At time of reporting, the patient has not yet recovered.  The patient sought medical attention in office.  No product quality complaint was involved.  Upon internal review, blood in stools was considered an other important medical event.  Additional information has been requested.  10/21/08 Spoke w/MD reporter.  Continues to have mucus blood tinged stools despite couple of formula changes.  Currently on antibiotic for c. diff.  Patient being followed by peds GI who feels symptoms probable colitis but if no improvement when antibiotic complete, plans to do endoscopy.  Also provided lot #s for vaccines.
Started w/red,papular rash @ inj. site;spread to back of shoulder & down lt arm to elbow area.Pain scale 10 @ site;radiating down arm to fingers,numbness & tingling in fingers.Seen on 11/3 & still had rash,pain,& numbness.Tx w/Celestone
body aches,  temp of 101 even while alternating advil and tylenol, swollen lymph nodes, red painful swollen rash on arm that burns and itches
As the patient was receiving her injection she moved and the needle dislodge resulting in the patient getting less then the required dose.
"I developed throat tightness, wheezing and cough 4 hours after immunization."
when I take antibiotic for urinary tract infection my blood pressure goes up; felt burning sensation while urinating; red patch; slight pain; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Pain, injection site erythema, hypertension and Dysuria.      The patient's medical history included hypertension and urinary tract infection. Concomitant medications reported were Bystolic Nebivolol for HBP 10mg QD, Telmisartan Micardis 80mg QD, Cefadroxil 500mg BID for drug use for unknown indication.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the event, slight pain . On 1 Feb 2021, the patient experienced the event, red patch . On 12 Feb 2021, the patient experienced the events, when i take antibiotic for urinary tract infection my blood pressure goes up. felt burning sensation while urinating. On 13 Feb 2021, the patient experienced the event, bothered with blood pressure.  Treatment details included Benadryl 2 tablets for 25mg.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, slight pain, red patch,when i take antibiotic for urinary tract infection my blood pressure goes up,felt burning sensation while urinating,bothered with blood pressure was unknown.
rash under breast; myalgia; fever; shivering; headache; gastrointestinal symptoms; pain; redness; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2021, the patient received the 1st dose of Shingrix. On 6th October 2021, less than a day after receiving Shingrix, the patient experienced myalgia, fever, shivering, headache and gastrointestinal disorder. On 8th October 2021, the patient experienced rash. In October 2021, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, myalgia, fever, shivering, headache, gastrointestinal disorder and rash were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, myalgia, fever, shivering, headache, gastrointestinal disorder and rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient received her first Shingrix vaccine and within 12 hours of her vaccine she was experiencing pain, redness, and swelling at the injection site as well as myalgia, fever, shivering, headache, and gastrointestinal symptoms. The patient also stated that she woke up on the day of reporting, with a rash under her breast. The patient stated that she was feeling much better. The reporter consented to follow up.
Patient was possibly given underdiluted dose of covid 19 toddler vaccine resulting in a higher dose than indicated.  Upon speaking to the mother of the child the evening the same day the vaccine was given, no adverse events were reported.
SARS COV 2 RNA(COVID 19), QUALITATIVE NAAT test performed on 07/12/2021 at 12:00. Test came back positive. Case investigation interview with patient has not been conducted as of the time of this note.
I started having fatigue, muscle aches and a slight headache. I had a PCR COVID-19 test that came back positive and had a telehealth visit with my Primary Care Physician. She suggested that I go and have the monoclonial antibodies since I had passed the threshold for getting Paxlovid. I went in on June 21, 2022 for the infusion of the antibodies as of today I am feeling pretty good.
Small red patches (Rash erythematous); This case was reported by a consumer via other manufacturer and described the occurrence of red rash in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab (Dupixent) solution for injection for chronic sinusitis and nasal polyp.   Concurrent medical conditions included chronic sinusitis, nasal polyp, drug allergy (allergic to aspirin), allergy to animal dander (Cat dander allergy), ragweed allergy, allergy to molds and pollen allergy. Additional patient notes included race: Chinese. Concomitant products included diphenhydramine hydrochloride (Benadryl (Diphenhydramine Hydrochloride)), fexofenadine hydrochloride (Allegra Allergy), metformin hydrochloride, semaglutide (Ozempic), losartan potassium and triamcinolone acetonide (Nasacort).   On an unknown date, the patient received the 1st dose of Shingrix. On 28th December 2021, the patient started Dupixent (subcutaneous) 150 mg/ml 300 mg at an unknown frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced red rash. The patient was treated with cortisone (non-proprietary) (Cortisone Cream). Dupixent was continued with no change. On an unknown date, the outcome of the red rash was recovered/resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's comments: The Initial information was received regarding an unsolicited valid non-serious case.  The patient's age was reported as approximately 66 year old who received Shingrix (varicella zoster vaccine RGE (CHO)) and Dupixent via prefilled pen. In 2022, the patient had developed a non-serious event, small red patches (rash erythematous). It was reported that, when he got Shingrix vaccine last time it had caused a small red patches that did not last long with cortisone cream and had lasted a couple of days. It was not reported if the patient had received any corrective treatment for the event small red patches. The outcome was reported as recovered or resolved in 2022 for the event small red patches. The reporter had consented to follow-up. It was unknown reporter considered the red rash to be related to Dupixent.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 17-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Sore arm immediately upon injection.  Soreness travelled to fingertips within 4 hours. No treatment required. Headache within 2 hours.  Very distracting although not severe.  Prevented sleeping.  Took 1x advil 200mg. Resolved. Foggy head within 4 hours.  Trouble focusing eyes and thoughts while having a conversation with neighbor.  Resolved at 48 hours. Tiredness within 6 hours.  Resolved at 54 hours. Chills but no fever starting at ~27 hours from shot and lasting 4 hours.  Resolved.
Patient was quiet for 4 days and had a temp the 1st day of 100 deg, the sites of the injections were fine.
Pain in left shoulder and can not move left hand. Family Physician examined 12/05/2009 and reported shoulder pain from arthritis and tenderness at site of injection, also edema of soft tissue left cheek. Indicated it should abate in a few days.