chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 66-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension controlled by meds" (unspecified if ongoing), notes: hypertension controlled by meds; "high cholesterol controlled by meds" (unspecified if ongoing), notes: high cholesterol controlled by meds. Concomitant medication(s) included: DIOVAN; TADALAFIL; AMLODIPINE; PROTONIX [OMEPRAZOLE]; FAMOTIDINE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I have a "rebound case" of covid-19. I am still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information- It was reported that patient  took paxlovid for the prescribed 5 days from 05-09May2022. He started taking it within one day of the onset of covid 19 symptoms. He felt great for about 4-5 days after he finished the 5-day course of paxlovid, but now he believe Ihe had a "rebound case" of covid-19. He was still testing positive and now have runny nose and postnasal drip and scratchy throat, just 5 days after finishing the paxlovid. He believed this is what is being investigated as a "rebound" case of covid despite taking paxlovid on the same day of testing positive. (I am also fully vaccinated with four shots).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
10min p/shots given site became red, swollen, & tender in a 9cm x 9cm size; tx DPH & cold packs; rxn totally gone by bedtime;
Within an hour of getting the vaccine, I experienced the prodromal symptom I have had prior to an anaphylactic reaction to RITUXIN and Gentamicin which is deep painful right groin pain. I have had a chronic cough since the vaccination plus a weird neurological sensation on the skin on my face as well.
Pt described having a sudden fever, headache, chills and rash - treated with TYLENOL for fever and headache, and BENADRYL for rash.
Significant hair loss (75-80%)-beginning approx 2 weeks after shots. Tests ordered by pediatrician and biopsy performed by dermatologist.
Migraines- worse headache of my life even worse than when I had covid, feeling like bugs crawling on me, heart palpitations, feeling tingling and numbness in legs and arms, feeling like I was going to pass out even days after, nausea, extreme fatigue, body aches, shaking and chills
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: Other medical history: COPD; "HBP" (unspecified if ongoing), notes: Other medical history: HBP; "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity; "diabetes-2" (unspecified if ongoing), notes: Other medical history: diabetes-2. Concomitant medication(s) included: MUCINEX DM; ASPIRIN [ACETYLSALICYLIC ACID]; SYMBICORT; FLONASE [MOMETASONE FUROATE]. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: "paxlovid works. Despite having 2nd booster, with COPD, HBP, obesity, diabetes-2 & age 63, and symptoms that include everything-fever, body aches, thick lung congestions, breathing difficulties, sorest throat ever, cough, sneezing (which literally raked my throat every time-so bad the throat spray hurt worse than it helped), lethargy, dizziness, and stuffed sinuses with swallowing, I had a rough couple of days (really rough) but am sooo happy to say I think the worst is over! paxlovid leaves a bad, lingering, metallic aftertaste, the back of the throat but otherwise it was fine. Supplemented with mucinex-dm, aspirin, symbicort, & fluonase".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
high fever for 48hours even when treated w/tylenol and ibuprofen around the clock,severe headache for 48 hours, severe nausea,dizziness,arm pain, bilateral upper leg pain,weak,voice hurt to talk, stiff neck, photophobia,paleness,high pulse rate,fatigue.  Went to the ER 2 days in a row,continued with ibuprofen, tylenol,pain pill given.
terrible blood bleeding in both of her legs; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (terrible blood bleeding in both of her legs) 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 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced HAEMORRHAGE (terrible blood bleeding in both of her legs) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (terrible blood bleeding in both of her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter reported on 22-MAY-2021 that her mother woke up to terrible bleeding in both of her legs after she has received the first dose of Moderna Covid-19 vaccine on 20-MAY-2021. No treatment or concomitant medications were reported by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
My ankles started hurting and we're swollen for 3-4 weeks.  When I tried to get a booster the pharmacist at pharmacy suggested that I consult my doctor because I might have been having myocarditis reaction to the COVID-19 vaccine.
Day 1 Sneezing dry no mucous Day2 Cough dry no mucus Day 3 settled in bones -ache particularly old injury...neck, ribs, spine, hips
Nausea and vomiting, admitted to hospital through ER at 10:00 PM was released from hospital 2:00 PM next day
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/30/21pfizer,Lot#EL0142 2nd dose: 01/21/20 Pfizer,Lot# EL3247 Diagnosed covid positive:07/25/21 Symptom onset:07/24/21 Exposure:Home exposure Symptoms:cough, runny nose.
This spontaneous report as received from a physician via representative refers to a 1 year old female patient with frequent outbreaks of hives. The patient was vaccinated with her first dose of M-M-R II (lot# not reported) on 06-JAN-1997 and first dose of VARIVAX (Merck) (lot# not reported) on 13-JAN-1997. The patient received her second dose of M-M-R II on 08-JAN-2001 and second dose of VARIVAX (Merck) on 17-JAN-2007. The patient had "chronic hives over the years" as well as additional unspecified "issues". The patient's mother believed that her multiple unspecified "issues" may be due to the improper spacing of her first dose of M-M-R II and VARIVAX (Merck). No concomitant medications were reported. The patient sought medical attention via physician consultation. At time of the report, the patient's outcome was unknown. Additional information has been requested..
This spontaneous report as received from a pharmacist refers to a 57 year old female patient. The patient's pertinent medical history was not reported. She had none drug reactions or allergies. Concomitant therapies included zonisamide, lamotrigine, LYRICA, BETIMOL and vitamin d (unspecified). On 01-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose was unknown) subcutaneous, lot # K020186, expiration date 27-JAN-2016. On approximately 02-MAY-2015 (reported as "on either 02-MAY-2015 or 03-MAY-2015"), the patient began to develop a rash at the site of ZOSTAVAX injection. The patient sought medical attention - she called the pharmacist. None lab diagnostics studies were performed. The outcome of injection site rash was reported as not recovered. The relatedness between the adverse event and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
approx 2yrs p/vax pt devel full blown chickenpox generalized over body also pt exp exp minimal itching. no further info avail
The vaccine was administered into my left deltoid.  After researching the manufacturer's administration guidance, I saw that it should have been given subcutaneously, not intramuscular.  I called the health department to confirm if it was given into my muscle but I had to leave a detailed message.  I never received a return call and my vaccine record does show it was given as an Intramuscular shot instead of a subcutaneous shot.  I do not know if I need to repeat that dose in the series.
Menorrhagia.  Severe menstrual bleeding lasting approximately 4 hours, at onset of the 2nd menstrual cycle following the complete course of Covid vaccines.   Subsequent menstrual cycles were slightly heavier than baseline, and seem to have normalized after six months
Suspected vaccination failure; Shingles; Rash on left shoulder as well as left side/ original rash; Rash on left shoulder as well as left side/ original rash; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hepatic cirrhosis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, several weeks after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, red rash and itchy rash. The patient was treated with betamethasone dipropionate + clotrimazole (Clotrimazole And Betamethasone Dipropionate Cream). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, red rash and itchy rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, red rash and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had the 1st shot of Shingrix in April 2019.  Within a few weeks, the patient developed a red, itchy rash on left lower back.  The itching was intense.  The patient stated, the primary physician prescribed a cream, Clotrimazole-betamethasone and the patient used 3 tubes in a week and a half and the rash finally eased and started to dry up. The patient had Cirrhosis, so consulted with liver specialist and she said it was not shingles and the patient should receive the 2nd Shingrix shot. The patient's primary physician also agreed, as like hematologist but the patient's neurologist thought the patient had shingles. The patient received 2nd Shingrix shot and after the shot, the original rash returned and now was on patient's left shoulder as well as on left side. The patient used more of the cream and it slowly subsided. The day before the reporting date, the patient saw the dermatologist and she said the patient had shingles and also stated we could not list this as a possible side effect. The patient suggested that, Shingrix vaccine should not be recommended for someone who had Cirrhosis since the patient thought that this product was not suitable for some of them.
Began with painful knot in throat beneath adam's apple, then sore throat when swallowing, and excessive salivating.  Progressed to chills and extreme shaking, then nausea.
Acute respiratory failure with hypoxia (HCC) Overview Unclear etiology.  I suspect pulmonary edema by CT but cannot rule out CAP or COVID19 contributing.
Itching began on 3/6, followed by pustules extending from left shoulder to elbow. Pustules started small and are now much larger. Right sided facial numbness.
Patient received a 3rd dose of the Covid19 Pfizer vaccine due to facilities incomplete record keeping. Patient condition unknown at the time of reporting.
Information has been received from a consumer concerning her 13 year old daughter with acne with no pertinent medical history and no drug allergies or reaction who on 24-SEP-2010 was vaccinated intramuscularly with the first dose of GARDASIL (lot # and route not reported) and on 24-NOV-2010 with the second dose of GARDASIL (Lot # and route not reported). Concomitant therapy included doxycycline. On 09-NOV-2010 the patient experienced headache, fatigue and watering eyes and it get worse since the patient received the second dose of GARDASIL. At the time of the report, the patient had not recovered. No laboratory test were performed. The patient sought unspecified medical attention. Additional information has been requested.
Headache and body aches. Moderate reaction - a-dvised to manage symptoms w/ibuprofen, extra fluids and rest.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 19-FEB-2016, the patient was inadvertently administered a dose of PROQUAD (Merck) (lot number # L030592, expiration date 12-FEB-2017, dose and route not provided) and a dose of VARIVAX (Merck) (dose, lot number and route not provided) (overdose). Concomitant therapies were not provided. No adverse effects were reported. There was no product quality issue (PQC) involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to three unspecified patients of unknown age. On 04-AUG-2014 the three patient was inadvertently vaccinated with expired doses of RECOMBIVAX HB intramuscular. Lot# was 1741AA, and the vaccine was expired on 27-JUN-2014. No adverse effects reported. Additional information has been requested.
From telephone correspondence received at AP on 11/05/2002, it was reported that a 28 year old female adult received the second dose of IMOVAX RABIES Lot # U098612, on 10/31/2002 as part of a pre-exposure series.  On 11/02/2002, patient experienced joint pain and pain in right arm and hand swelling.  In the middle of the night, patient broke out in hives on waist, followed by arms and legs.  She went to ER on 11/03/2002 and was prescribed hydroxyzine.  On 11/04/2002 patient was seen by her family physician but received no additional treatment.  On 11/05/2002, patient called the health department and reported swelling of her lips, huge generalized hives, chills, and difficulty swallowing.  There were no symptoms reported after the first dose and she has no history of antibiotic allergies.  It was not reported whether the patient recovered.
Approx 30 min after immunizatioon, 2 mo old infant exp unconsolable crying which last 15 min and was irritable.  Infant was asymptomatic at time of this report.  Treated w/tylenol PRN.
I received the first dose of covid-19 vaccine (moderna) and several days after receiving it developed a rash on my neck with accompanying pain and pruritus. The rash has since been diagnosed by a physician as herpes zoster (shingles) reactivation. I had VZV and HSV as a child (>20 years ago). Of note, the covid-19 vaccine made me sick (chills, myalgia, fever).
Narrative: Per Emergency Department HPI on 11/27/21: "The patient presents with chest pain. The onset was 11/27/2021 06:45:00 . The course/duration of symptoms is resolved. Location: anterior. Radiating pain: none. The character of symptoms is tightness. The degree at onset was minimal. The degree is maximum was minimal. The degree at present is none. The exacerbating factor is none. The relieving factor is none. Risk factors consist of coronary artery disease, hypertension and Anxiety PTSD. Prior episodes: non-cardiac. Therapy today Valium 2.5 mg albuterol 1 puff. Associated symptoms: palpitations and Jittery anxiety. Additional history: Patient got his booster shot yesterday and he was rather nervous about it Moderna. he did have some soreness in his arm this morning he was doing well he got up breakfast he took 1 puff of his albuterol and start to get some chest tightness jittery heart racing anxious. He has never had a problem with albuterol before. He had a little sore throat earlier very transitory he did to a pulse oximeter is oxygen saturation was 98% heart rate 67 his blood pressure at the time was about 127/80. He states that he does tend to get anxious has panic attacks and PTSD he decided only to take 2.5 mg of his Valium although he can take up to 5 mg at a time he still feels anxious. He took his medicine is lisinopril amlodipine and carvedilol this morning he saw Dr yesterday and everything checked out fine. Primary Diagnosis: Chest pain, non-cardiac - ICD10-CM R07.89, Medical Anxiety - ICD10-CM F41.9, Medical Reactive hypertension - ICD10-CM I10, Medical ."
Headaches, dizziness, vax fog, feeling unbalanced. Started 3 days after 1st dose of Pfizer, currently have felt these symptoms daily for 8 days total.
Information has been received from a medical assistant concerning a 5 year old female patient who on 27-DEC-2001 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
22FEB97 AM unable to raise arm, unable to close hand, tender ax  inj site;swelling ax inj site;temp 99 ax;no fever this AM, all other sx still present;taking DPH & Ibuprofen, t98.4;pt seen 21FEB d/t vax rxn;swelling & pain in lt deltoid
Broke out in hives across upper arms, torso, and thighs. Clustered hives around injection site on RLE. Low grade fever for over 1 week (11/09/2012-11/19/2012) ranging from 99.8*F to 100.8*F. As of 11/21/2012, injection site is still red with cluster of hives/bumps, and still has several bumps on face, neck, and stomach.
Nerve damage in the eye; Shingles of the trigeminal nerve; Got shingles after two Shingrix doses/Suspected vaccination failure; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 7FY22, expiry date 25th April 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9XC39, expiry date 30th January 2020) for prophylaxis.   On 15th May 2018, the patient received the 2nd dose of Shingrix. On 31st January 2018, the patient received the 1st dose of Shingrix. On 25th September 2022, 1594 days after receiving Shingrix and 1698 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced optic nerve damage (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the optic nerve damage and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, optic nerve damage and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comment: The retired pharmacist reported that the patient received first and second dose of Shingrix at a local in 2018 and diagnosed with shingles of the trigeminal nerve and the patient was still struggling with some nerve damage in the eye, unfortunately. The reporter reported that the patient was her husband also a pharmacist. The reporter asked if a person got shingles even after having the two Shingrix doses, should he get another Shingrix vaccination after he recovers.  The reporter consented to follow up by postal.  Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding, laboratory test confirming shingles were unknown at the time of reporting.
I95.9 HYPOTENSION 1/24/2022 COVID-19 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 2/3/2022 COVID-19 PNEUMONIA
Patient reported rash at inj site the morning after it was given, then said she sustained chills and back/buttock pain leaving her unable to ambulate. She described the pain as burning and deep. Her primary care doctor saw her 9-12-15 and said they did not believe the symptoms to be connected to the ZOSTAVAX shot.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with,1 DF ZOSTAVAX (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced shingles. No treatment information was reported. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Follow up information was received from a pharmacist refers to a 60 year old female patient with a history of chickenpox long time ago. On 11-OCT-2012 the patient was subcutaneously vaccinated with a 0.6 ml dose of ZOSTAVAX in the left triceps (lot number reported as H011333). It was reported that there was no rash at the site of injection post vaccination. On approximately 11-OCT-2012, the patient experienced rash on the one side on hip and herpes zoster. At the time of the report the outcome of the event was unknown. Additional information has been requested.
From telephone contact with reporting nurse stated that a female PT received an Imovax Rabies vaccination on 6/8/01 and 6/15/01. Shortly after each vaccination the PT experienced metallic bitter taste in her mouth, muscle aches and nausea. These symptoms are unresolved.
Two and a half weeks of fatigue and diarrhea.  Loss of mental acuity the first week or so.
Premature ventricular contractions. 2000+ per day. Started about 1 month after second shot in series. No personal history of these. No family history of cardiac issues.