chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash all over the body/Severe rash; feeling miserable for several days; few spots on left arm; Itched; red; nipples were very tender; lymph glands in the breast area and under the armpits responded; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash all over the body/Severe rash), FEELING ABNORMAL (feeling miserable for several days), RASH MACULAR (few spots on left arm), RASH PRURITIC (Itched) and RASH ERYTHEMATOUS (red) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LOT# 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included SIMVASTATIN.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash all over the body/Severe rash), FEELING ABNORMAL (feeling miserable for several days), RASH MACULAR (few spots on left arm), RASH PRURITIC (Itched), RASH ERYTHEMATOUS (red), NIPPLE PAIN (nipples were very tender) and LYMPH NODE PAIN (lymph glands in the breast area and under the armpits responded). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash all over the body/Severe rash), FEELING ABNORMAL (feeling miserable for several days), RASH MACULAR (few spots on left arm), RASH PRURITIC (Itched), RASH ERYTHEMATOUS (red), NIPPLE PAIN (nipples were very tender) and LYMPH NODE PAIN (lymph glands in the breast area and under the armpits responded) outcome was unknown.
Cerebral venous sinus thrombosis that started 3.5 weeks after 2nd Moderna vaccine
patient reported that the next day after vaccine administration his body was itching all over including skin on the scalp. he started taking some loratadine 10 mg qd. but his body itch is still there and comes and goes. he also reported that his tongue feels stinging sensation or feeling like burning and his throat is having stinging pain. he also sais that some mornings he feels shortness of breath and wheeze but no mucus coming out. he also stated that his injection site still hurts.
This spontaneous report as received from a other health professional refers to a 4 months old patient of unknown gender. On 03-JUN-2014 the 4 month old patient of was vaccinated with first dose of ROTATEQ (oral, dose unknown). Pertinent medical history and concomitant medications were unknown. No drug allergies and diagnostic tests were reported. No adverse effects reported. No further information provided. The outcome of the events was unknown. Additional information has been requested.
Information has been received from a nurse concerning a female (age not reported) who on an unspecified date was vaccinated with a dose of Gardasil. Subsequently the patient experienced "ongoing seizures". Upon internal review, the patient's seizures were considered an other important medical event. Additional information has been requested.
Nauseous and lightheaded; Nauseous and lightheaded; Left arm sore; Horrible reflux and belching; made her reflux worse; Horrible reflux and belching; Not sleeping as well because she does not feel as good; Not sleeping as well because she does not feel as good; Weakness; burning into her esophagus; She does not hardly have any appetite; She has been sick ever since she got the shot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein (PREVNAR 13, Solution for injection in pre-filled syringe) via unspecified route of administration on 05Jan2021 at single dose in upper left arm for Routine vaccination at Doctor's office. Medical history included ongoing reflux in the past in 1998. Prior Vaccinations (within 4 weeks) was none. Patient previously got shingles shot. She did not have any problem with that. Family medical history was none. Concomitant medications were not reported. It was reported that patient had been sick ever since she got the shot in 2021. Her symptoms appeared as soon as she got into car. She had blood drawn after the shot, so it was probably 30 minutes after she got the shot. She started feeling nauseous and lightheaded on 05Jan2021. This progressed into reflux in Jan2021 and she was still lightheaded and cannot drive. She tried Omeprazole and it might have made her reflux worse in Jan2021. She has been to the doctor three times since then. She stopped taking it because it did not make her better. It was 20 mg. She may have thrown it away. It was in a pharmacy vial. The light-headedness was worse and nausea was about the same. It has gone into this horrible reflux and she has tons of belching. She does not hardly have any appetite in Jan2021. The horrible reflux and belching started in Jan2021. It has gone into burning into her esophagus and she has had tons of reflux in Jan2021. Not sleeping as well because she does not feel as good started end of Jan2021. Weakness probably started about the same time she could not sleep, which would be towards the end of Jan2021 for the last month. She then stated her left arm was sore for 3 days started on 05Jan2021. She noticed it more on 06Jan2021, and after a couple of days, it was not very noticeable. She has fought some reflux in the past. She was not on anything for it. It was just occasional. She has had this since 1998 mildly off and on. The patient underwent labs and procedures included blood test the second time, EKG (Electrocardiogram) to double check and ordered an ultrasound of her abdomen with result negative for all on unknown date. The outcome of sickness was unknown, pain in arm was recovered on 08Jan2021, while for other events was not recovered.  No follow-up attempts are needed. Information about lot/Batch number cannot be obtained.
Hives began at injection site (raised, red rash); spread to back - initially looking like pimples but when spread resembled site reaction. Now hives are on buttocks, legs, arms/hands; and scalp. Saw doctor yesterday (3/10/21). Prescribed Zyrtec and Pepcid. So far no relief.
Initial unsolicited report received from a health care professional via other company (Pfizer) (Manufacturer Report Number: 2016524310) on 05 December 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS TOXOID) (Batch number, expiry date, dose, route and site of administration was not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date after the vaccination, the patient had tetanus toxoid allergy/swelling. The patient lab tests and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
She also noted her arm was sore after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (She also noted her arm was sore after the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (a year ago).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced INJECTION SITE PAIN (She also noted her arm was sore after the vaccine). At the time of the report, INJECTION SITE PAIN (She also noted her arm was sore after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
This spontaneous report as received from a physician via company representative refers to a 62 year old female patient, who is a nurse. The patient's medical history included Lymphoma of the lung, lung removal and shingles. In July 2012 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose, lot number, expiration date not provided) for the preventions of shingles. There was no concomitant medication. On 07-SEP-2013 the patient experienced itching, blisters, rash and pain in a small line on her left side that lasted for a period of 2 days and healed within the 2 day period. The patient sought medical attention visited office. A treatment for adverse events included: hydrocodone 10 mg tablets taken 1 half tablet 3 times daily and Famciclovir 1000 mg taken 2 times daily. No lab diagnostic studies were performed. The outcome of itching, rash, pain and blisters were recovered on approximately 09-SEP-2013. Relatedness between vaccination with ZOSTAVAX and itching, blisters, rash and pain was not reported. Additional information has been requested.
Child received normal 15 months imm's at check up on 6/28/07 (DTaP/ HIB/ Prevnar) along with (MMR) catch up (refused before). 1 Hour after appointment itchy, eyes, swollen, ears very swollen. Rash all over. Diffuse hives head to toe. Benadryl given script, given for Orapred but never used, rash gone the next day. * Used just Benadryl.
8/11/21 PMH dermatomyositis, GERD, hepatic steatosis, hypothyroidism, LTACH placement, s/p intubation and tracheostomy subsequently reversed. Presented w/complaints of worsening encephalopathy, decreased PO intake, diarrhea, profound fatigue and weakness
Information has been received from a physician concerning a 35 year old female with latex allergy who on 10/28/2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (Lot # 642182/0774M).  On 10/28/2002 the patient experienced right arm tingling which shortly thereafter moved to the right side of her face.  As of 10/28/2002, the physician reported that the patient's experiences had abated.  The patient sought unspecified medical attention.  Additional information has been requested.
pt recv vax; 4-6 hrs later, became lethargic, devel fever of 104;was not himself for almost a week; fever broke after 3-4 days; MD reported that he had no knowledge of pt's exp;
Notable poor feeding and more sleepy and bulging anterior fontanelle on 3/31/2022 - send to the Pediatric ED for further evaluation - negative head US, admitted for sedated brain MRI - discharge on 4/1 after negative brain MRI and notable improvement
Narrative: 91 yo male with Hx of DM, HLD, HTN, gerd, prostate cancer, & tremor died on 11/06/21 with no info on place or cause of pt's death. Pt had received covid vaccines on 1/13/21 & 2/10/21. This death is likely not related to the vaccinations due to the patient's comorbidities, advanced age, and length of time from vaccine administration.
Immediately following  the second vaccination, the individual's arm felt heavy and she had pain at the injection site.  Around 10-11 hours later that evening, the individual started feeling dizzy, experienced fever and chills, had shooting  pain in her arm at the injection site, severe fatigue, appetite loss, headache and experienced diplopia.   These symptoms lasted about a day and a half.  The first 24 hours were the worst.
1 day after vaccine started with redness (L) thigh --> spread despite ice, BENADRYL - warm to touch 9 x11 cm.
Shaking chills that lasted about 2 1/2 hours, fever of 102 degrees F.  Headache lasting about 8 hours, cough (non-productive). Headache and fever lessened with Tylenol.  By the next afternoon symptoms had resolved.
Severe headache Body Aches Chills Fever Nausea  Diarrhea  Extreme tiredness Dizziness These all lasted only the one day after the injection. The following day, it was as though nothing happened. Except for the injection site. That remained swollen, hard, and painful. The second day also consisted of the site bruising in a small circle and a large red circle around the bruise. The swelling continued and it began itching. By day three, the swelling decreased. The fourth day the itching finally stopped. So far, this is day 4 and I still have the bruise colored circle with the red circle around that one.
"I have had a headache and been fatigued for about 4 days along with what feels like cramps in my arms and legs. My arm is red and lumped up but not as bad as it was second day. Also having cold chills as well."
Strong still ongoing dizziness/vertigo, muscle twitches/spasms in chest arms, head area, Burning pain  and pinching sensations on arms, fingers, legs, face and throat, joint pain on left wrist and fingers, redness and itchiness throughout upper body,
Large red rash on arm below vaccination site. Hot to touch. Advised to take Allegra and Tylenol by  Allergist MD via picture assessment-and took them. At time of this reporting, 2.5 hours after noticing the rash and taking medicine, still no sign of symptom alleviation.
HCP stated the Flublok was given to 3 kids who are under the age of 3 with no adverse event; Initial information received on 05-Nov-2019 and follow-up information received on 06-Nov-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves a 22 month old (gender not reported) patients who received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  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.  Information of the batch number was requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 26-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number, dose, injection site and indication were not reported) subcutaneously. On 26-JUN-2013 the patient might not have received a full dose of ZOSTAVAX due to vaccine "leaking" from the injection site or the needle hub or syringe. No adverse effect reported. The outcome and ation taken were not provided. Additional information has been requested.
receiving expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not provided.
redness, heat, tenderness and swelling over the injected area; redness, heat, tenderness and swelling over the injected area; redness, heat, tenderness and swelling over the injected area; swelling over the injected area; This is a spontaneous report from a contactable other hcp based on information received by Pfizer from Galderma. A 53-year-old female patient received second dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Jan2021 (at the age of 53-year-old) at dose 2, single for covid-19 immunisation; hyaluronic acid, lidocaine (RESTYLANE L), via an unspecified route of administration from 11Jan2021 to 11Jan2021, at 0.25 mL, via an unspecified route of administration from 26Jan2021 to 26Jan2021, at 0.25 mL, lot number is 17766 (Exp: 31Oct2022) for an unspecified indication. Medical history and concomitant medications were not reported. On 27Jan2021 the patient experienced redness, heat, tenderness and swelling over the injected area. Patient is a 53-year-old female that presented on 11Jan2021 for tear trough filler 0.25 ml of Restylane-L was injected in her bilateral tear troughs. Patient did not have any complaints following that injection. She followed up on 26Jan2021 and had an additional 0.25 ml (the rest of her 0.5 ml syringe) injected in her tear troughs. On the afternoon of 26Jan2021 the patient had her 2nd Covid-19 vaccine. She contacted our office on 28Jan2021 with reports of redness, heat, tenderness and swelling over the injected area. She reports that these symptoms started on 27Jan2021. A Medrol dose pak was prescribed. The patient reports that she only took one day of the medication and symptoms started to resolve. She did not continue the prescription after her first dose. At this point in time (01Feb2021) she is significantly improved and does not seem to have any residual side effects. Action taken with Restylane-L was unknown. Outcome of the events was resolved on an unspecified date in 2021.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Inability to lift the left arm to 45 degrees the first week and then the following week continued with pain radiating to upper left back after push-ups on Oct 24, 2017.
On 8/12 loss available to taste and smell and still not able to.  8/14 little tired 8/14 little anxiety on and off
Moderna on 2/12 and 3/12. Positive on 8/27 admitted 8/27 to current
Headache, Dizziness, Confusion, High Blood Pressure, Disorientation, Chest pain/discomfort, extreme fatigue, Started at 1PM on 10/8/2012, and still having symptoms.
Patient developed Guillain Barré after receiving influenza vaccine. Has now been in hospital for about 8 weeks. Can now use arms but is currently not walking.
NO ENERGY; TIREDNESS; LIGHT HEADED; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder, and sleep, and other pre-existing medical conditions included the patient had no known drug allergies. The patient was previously treated with alprazolam for sleep, and curcuma longa rhizome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) .5 ml, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced light headed. On 07-APR-2021, the subject experienced no energy. On 07-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed on 06-APR-2021, and no energy, and tiredness on 07-APR-2021. This report was non-serious.
This spontaneous report was received from a healthcare worker via company representative refers to an approximately 66 year old patient of unknown gender. No medical history was reported. On 13-MAR-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # J015868, exp date 25-FEB-2015) (0.5 ml, intramuscular). No concomitant therapy was reported. It was reported that PNEUMOVAX 23 was administered post expiry. No adverse effects were reported. The outcome of the events was unknown. The events were considered to be not related to PNEUMOVAX 23. No product quality issue was involved. Additional information has been requested.
Sore arm; Felt tired; This is a spontaneous report from a contactable consumer. This consumer (Patient's wife) reported for a 75-Year-old male patient that he (weight; 65.77 kg, height; 183 cm) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN5318), NDC number, UPC number, expiry date; unknown, via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunization. Is covid 19 vaccine a Pfizer product; Yes, covid 19 vaccine manufacturer: unspecified. Patient's medical history and concomitant medications were not reported. Patient experienced sore arm and felt tired on an unknown date. When probed for the concern, reporter stated, "Recently my husband (Name), we have different names. He went got his Covid shot with your type shot and he brought the information back home and I found this number. I do not have a computer that is why I am using this number to call and ask this question. First one I am 80 years old, I have an aortic stenosis, my heart valve not working exactly you know perfect and I wanted to know now here he had not too much of a reaction he has sore arm and felt tired this morning. He had the shot yesterday. Now I am sort of concerned about how my reactions going to be with the heart this way." When asked about receiving the shot, reporter stated, "No." Reporter stated, "First of all, I wonder why they had not called me. I am older than him and I wonder why they have not called me yet. My doctor said I am on the list but we are here in the (Place name) and that is where he went." The reporter was provided with the number of Pfizer Medical information as (Phone number) followed by option 3 and timings as 8 am to 11 pm Monday to Friday and 8 am to 8 pm on Saturday and Sunday as per EST. When paraphrased the concern, reporter stated, "Yeah but he is younger than I am he did enroll well but I am more concerned because of my heart." Email address: Reporter stated, "I do not have that right now." Height and weight: Reporter stated, "I want information for me not for him." Country of incidence: Reporter stated, "The only thing he had was the sore arm but I am not calling about him. I am calling about my heart not his experience." When told that no further probing would be done if do not want to proceed and when told about the Pfizer medical information department, caller stated, "That is mainly all I wanted was to call that number." Product details and pharmacy details could not be probed as the consumer was unwilling to complete the report. Hence limited information available over the call. The outcome of events was unknown.