chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (sulfa drugs) and Allergy (mild environmental allergies). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 27-Jan-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Nov-2020 and the estimated date of delivery was 13-Aug-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information  was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Pain at injection site within 6 hours that lasted about 3 days, lymphnode pain, temperature high of 101.8 and chills lasting 3 days, severe fatigue lasting 4 days, migraine headache 2 days, diarrhea 1 day, muscle pain 4 days, joint pain 2 days. Heart palpitations starting at approximately day 2 lasting for approximately 2 weeks.
rash, itching, redness on neck and chest.  Had a fever for a while.
Primary symptom is tinnitus in both ears (more left) that has increased slowly since second vaccination. Of possible relevance, two additional temporary symptoms occurred roughly one week following second dose: two separate incidences of scintillating scotoma (bilateral visual artifact on left side of visual periphery; each episode lasting approx. 40 minutes; occurred two days apart); and two or three incidences of very brief (5 sec.) SSHL (sudden sensorineural hearing loss) in right ear (incidences occurred approx. two days apart).
she received the booster dose on 08Sep2022 and got COVID in Dec2022; she received the booster dose on 08Sep2022 and got COVID in Dec2022; 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 in her 60's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose number unknown (booster), single (Lot number: GH9694) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: I am moderately immunocompromised; "reactive airway disease" (unspecified if ongoing), notes: reactive airway disease with an open throat where I cough horrendously; "Cough" (unspecified if ongoing), notes: reactive airway disease with an open throat where I cough horrendously; "COVID-19" (unspecified if ongoing), notes: 6 months prior. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "she received the booster dose on 08Sep2022 and got COVID in Dec2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller stated that she did get COVID in Dec2022 (after receiving the Pfizer COVID booster vaccine on 08Sep2022), it was not severe, like she got 6 months prior. She did get Paxlovid. But this time, she did not need it, because she got COVID in December. She was in my early 60's and she was moderately immunocompromised and at risk of severe COVID due to having a reactive airway disease with an open throat where she cough horrendously." Caller stated that she received the booster dose on 08Sep2022 and got COVID in Dec2022. Caller was wondering if she should be getting another bivalent booster since she got COVID again. Caller stated she's in her early 60's and is moderately immunocompromised and at risk of severe covid due to having a reactive airway disease with an open throat. Caller asking if Pfizer was working on the next vaccine at this point. Caller then stated no need for further research with no further inquiry. Response: Offered to research and place caller on hold, however, caller stated no need and did not want agent to research further. Thus, no further inquiry.
Pt broke out in large hives neck/trunk approx. 2hrs following Tdap injection. Denies difficulty breathing. Per v.o. Dr., pt to take oral Bendaryl, prednisone, and seek immediate medical attention should symptoms progress.
26 hours after injection of shot #1, the arm that received the injection became red from upper shoulder to the forearm. The rash was red, hot to the touch and very itchy. Rash was most concentrated in an oblong red welt in the middle of my upper arm, though not surrounding specific injection site. Symptoms are improving but ongoing 8 days after injection and have been treated intermittently with OTC hydrocortisone cream.
Site where vaccine given turned red, then arm swelled down to elbow and then area blistered. Treated at urgent care and family doctor given anti-viral med (sulfatendthoxizole). Missed a week of work.
edema of left side of face, upper eyelid; edema of left side of face, upper eyelid; edema of left axilla; This is a spontaneous report from a contactable physician. A 49-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 28Jan2021 08:45 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism, anxiety. Concomitant medication included tramadol (TRAMADOL), methylprednisolone (MEDROL), levothyroxine (LEVOTHYROXINE), clonazepam (CLONAZEPAM), baclofen (BACLOFEN). The patient experienced edema of left side of face, upper eyelid, edema of left axilla (oedema) (non-serious) on 30Jan2021 06:00. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient was not been tested for COVID-19 Since the vaccination. The outcome of the events was recovered.   Follow-up attempts are completed. No further information is expected.
He received the vaccine on 3/4/2021 and by Monday morning 3/15/2021 he was running a fever and not feeling well. Fever continued until Friday March 19 when he went to the dr. Dr did a lung xray and said he had cloudiness on his lungs so she started antibotics. On March 22 he was brought to the ER because he was too weak to walk and wasnt feeling well still had the fever. The switched his antibotics and he went home. On March 24 he was rushed back to the hospital via the ambulance and they admitted him. He stayed in the hospital until March 30 when they finally let him leave to a care center. He had finally not had a fever. Had confusion and weakness. The confusion comes and goes from day to day sometimes min to min.
normal side effects the next day tried and feel exhausted. Aches and pain on to the second day. On the third day, I was getting winded just walking around the house. Pulse up to 130. Walking around Walmart I was a little head and short on breath.
pneumococcal vaccine used in 15 months old patient; erythema multiforme; Literature report:   This literature marketed report has been received from authors of the literature article entitled as stated above and refers to a 15-month-old male patient. He was otherwise healthy. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) four doses (Inappropriate age) and hepatitis a vaccine, inactivated (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported for both) for prophylaxis. On an unknown date, he presented to dermatology with a 12-day history of a generalized eruption consisting of raised pruritic plaques. Several plaques had central and linear erosions. The patient had no other symptoms and was afebrile. The parents of the patient report no relevant changes in diet, linen, or environment, and no drugs had been administered prior to the outbreak, but the patient had recently received an initial dose of hepatitis a vaccine, inactivated (manufacturer unknown) and the 4th dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The rash was localized to lower extremities and temples 5 days post-vaccination, with an onset 3 days post-vaccination. Pediatricians advised applying hydrocortisone 1% cream to the plaques and giving colloidal oatmeal baths. Eight days post-vaccination new lesions formed. An oral H1 histamine antagonist, triamcinolone 0.1%, and mupirocin 2% ointments were added to the patient's treatment. Eleven days post-vaccination, new lesions continued to arise. The child was prescribed prednisone (15mg/5mL solution, 1mg/kg/dose, for 5 days) and referred to dermatology. During the physical examination, the patient was alert, afebrile, and appeared to be a healthy growing toddler. Physical examination revealed multiple well-defined, circular, erythematous plaques with a darker central vesicle on the extremities. Trunk, mucosal surfaces, and the palmoplantar regions were spared. Due to the history, physical findings, and the correlation of the eruption following vaccination, the patient was diagnosed with erythema multiforme (EM). Sixteen days post-vaccination, following a 10-day course of oral prednisone, most of the lesions had resolved with no new outbreaks. The authors considered the event of erythema multiforme to be related to suspect vaccines.  Upon internal review, the event of erythema multiforme was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
pt recvd vax 19OCT95 & later afternoon very tired, aching-both arms-more so-left;ice-pack & APAP 20OCT95 AM lt arm 1:30AM area @ swelling was approx 8cm x 8cm -cont swelling & red-Hismanal
Admitted to hospital with diarrhea, acute renal failure, pseudo-gout, later followed by diagnosis of Rheumatoid arthritis
slight fever; This is a spontaneous report received contactable female patient via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, lot/batch number not reported), dose 2 via an unspecified route of administration on 25Feb2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (dose 1) for COVID-19 immunisation. On an unknown date, after second shot of vaccination patient had slight fever of 98.8-degree F. It was reported that patient asked if she could take Tylenol for fever. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 85-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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) with onset 30May2022, outcome "unknown", COVID-19 (medically significant) with onset 30May2022, outcome "recovering" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive; (31May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not diagnosed Prior to vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200794138 same reporter/product/event, different patient
Covid Arm - arm got lumpy at vaccine site and red and itchy. It became hot too touch by night. After 4 days, still arm is itchy and red and the area seems to be becoming bigger, sore to touch, itchy and red.
Itching, throat itching. Benadryl 25mg po and Pepcid 40mg po given in clinic. Did not resolve. Trasport to ED Solumedrol 125mg IV push once, Benadryl 25mg IV Push once and Sodium Chloride 1000mL IV Bolus once. DC home
High fever; Muscle ache; Body aches; A spontaneous report from unspecified location was received from a Nurse concerning a 42-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high fever, muscle ache and body aches.   The patient's medical history and concomitant medication were not provided.    On 13-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly on right arm for prophylaxis of COVID-19 infection.    On 14-JAN-2021, approximately one day after receiving mRNA-1273, patient started experiencing high fever, muscle ache and body aches. Patient gave consent for safety follow-up with her.  Action taken with mRNA-1273 in response to the events was not reported.    Outcome of the event experienced high fever, muscle ache and body aches were considered unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
February 2021 I received my 2nd dose of Pfizer. A day later I experienced flu like symptoms which went away within 3 days. About a week later I experienced dizziness and nausea. I did not have an appetite and could not eat well for about 3 weeks. I got an upper endoscopy which found mild acid irritation to my stomach (gastritis) and I was placed on medication. I then proceeded to get a gastric stomach emptying test, HIDA scan for constant nausea.  I went to PT for dizziness. This is now July and I have been to an ENT doctor, received CT scan for dizziness checking my sinuses. Went to a neurologist for an MRI for headaches and dizziness. Everything came back fine but I am now to the point I can barley work and it is July. I have gone to acupuncture as well but nothing is working. On Friday I ate gummy bears and my heart rate went to 160, chest tightness, tongue itchy and shaking. The hospital did not find anything and reported this as an anxiety attack. I ate gummy bears again on Sunday and the same thing happened. I am wondering if the shot trigger this and how can I get help? I was fine before this and I am looking for answers. I am not blaming the shot, I would just like feedback on how to help. Thank you.
Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 3 of the five patients who experienced local reactions. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced local reactions. The outcome of local reactions was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
sick; Initial information regarding an unsolicited valid non-serious case received from a patient via social media on 03-Dec-2020.  This case was linked to case 2020SA350307 (case of older friend).  This case involves a patient of unknown demographics who was sick (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient reported of receiving the shot and was sick for three months (illness) (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Body aches, stuffy nose, fever, exhaustion, headache, swelling at site, joint stiffness.
pt recv vax 15JUL97 & the same day pt exp pain @ inj site & diff moving shoulder;
This spontaneous report as received from a pharmacist refers to a 2 patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot # H013949 and exp date 31-OCT-2013) subcutaneous (dose not reported). No other co suspects were reported. No concomitant therapy was reported. On an unknown date the patients experienced developed cellulitis-like reactions after receiving ZOSTAVAX. The patients had gone to emergency room (unspecified hospital) and were treated. The patients received unspecified oral biotics. The outcomes of developed cellulitis-like reactions after receiving ZOSTAVAX were unknown. It was reported that other patient had cellulitis with ZOSTAVAX (MARRS 1305USA010061). This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse RN concerning a 29 year old female with no allergies who on 08AUG2003 was vaccinated SC with the first dose of (0.5ml) of varicella virus vaccine live. The RN reported that on 22AUG2003 the patient presented to the Emergency Room ER with a rash all over her body. The patient was treated with acetaminophen, Tylenol, and diphenhydramine HCl, Benadryl, and was released. It was unknown if laboratory diagnostic tests were performed. On 08SEP2003, the patient presented to the office to receive the second dose of  varicella virus vaccine live. At that time, the patient was recovering, but some of the rash remained. Additional information has been requested.
Initial misuse report received from a healthcare professional on 28 October 2013. The cases were received on 21 March 2014 at GPV. A patient had received a dose of PENTACEL on an unspecified date. It was reported that the patient received DTaP/IPV without the HIB. No adverse event was reported. List of documents held by sender: none.
Tenivac that was administered had expired, with no adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 60-year-old male patient to whom DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [Tenivac] that was administered had expired, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine for Prophylactic vaccination.  On 13-Oct-2022, the patient received 0.5ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Drug Treatment Duration: once) (strength, formulation: unknown) (lot number: U6831AA and expiry date: 08-Oct-2022) via intramuscular route in the left deltoid for Immunization and that was administered had expired, with no adverse event (expired product administered; latency: same day).  Vaccine was administered by a medical assistant.   Action taken was Not applicable.  At time of reporting, the outcome was Unknown.  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 the 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.
24hrs after shot felt fine I til about  30hrs then felt lightheaded, dizzy, and nauseous. Vomited once. The next day (~42hrs after shot) spiked fever 101.2 and continued to feel dizzy but less nauseous. Took 800mg Motrin at 5am on 1/15/21
Patient reported redness, pain, itching, rash at proximity to injection site on (L) arm 24 hours after injection, so she sought treatment (type unknown) at urgent care clinic.
scratchy throat; runny nose; stuffy head; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A male patient of an unspecified age (reported as age of 72) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. Medical history included suspected COVID-19. The patient's concomitant medications were not reported. Patient saw his son six days ago (31Jan2021) who has since tested positive. The patient experienced scratchy throat, runny nose, and stuffy head on an unspecified date in Feb2021. Patient was going to get a COVID test and was inquiring if receiving a vaccine two days ago (04Feb2021) would cause a false positive. Events were assessed as non-serious. The outcome of the events reported was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.