chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Nausea; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st shot of covid vaccine, Lot unknown : false), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Headache"; NAUSEA (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Nausea". Therapeutic measures were not taken as a result of headache, nausea. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tested again on the 20Feb, this test was positive; tested again on the 20Feb, this test was positive; Head cold; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN3247), via unspecified route of administration in left arm on 04Feb2021 at 11:15 AM for COVID-19 immunisation. The patient's medical history was not reported. Patient had other vaccine in four weeks. The patient had no concomitant medications (there was no other medications in two weeks). The patient experienced head cold on 09Feb2021 and tested again on the 20Feb, this test was positive on 20Feb2021. Patient reported contracted a head cold about 5 days out on the 12 tested negative for covid. Then cold did not get any better. Tested again on the 20Feb2021, this test was positive. Still just feels like recovering from a cold. The patient did not receive any treatment. The patient did not have covid prior vaccination and patient tested for covid post vaccination. The patient underwent lab test and procedures nasal swab was negative on 12Feb2021 and positive on 20Feb2021. The outcome of the event was recovering.
MY bottom lip swoll up as well as 3 fingers on my left hand  I went to ER I was Administered Benadryl and prednisone 5 days 1 X per day
my left arm are broke out into rash and my forearm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9265), via an unspecified route of administration in left arm on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included metoprolol, one tablet a day, 50mg, orally taking about from 5 years for high blood pressure; amlodipine, 2.5 mg, one tablet a day, orally just started this at the same time when took Pfizer injection for high blood pressure. Reporter have got first shot of Pfizer injection on left arm are broke out into rash and forearm and then after patient got the second injection the first injection was in the first of the month last month and the last injection was on the 26th and patient got injected in the opposite arm and that broke up in rash. Patient still have the rash and want to see primary doctor and he suggested see a dermatologist. The patient had rash on both of arms. The patient have an appointment on 13th of this month to see a dermatologist. The patient had a reaction to the drug. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
WEAKNESS LETHARGY NAUSEA FLU-LIKE CHILLS HEADACHE
Throat closing ER Visit 1:  25 mg Benadryl pill ER Visit 2:  Epi Pen injection; IV PEPCID and MEDRA, Benadryl; Prescription for Famotidine, Methylprednisolone, continue Benadryl ER Visit 3:  IV MEDRAL and Benadryl; Prescription for Epi Pens Throat is slightly better.  Prednisone elevates my glucose levels, but am working real hard to keep  them low.
Information has been received from a physician and a licensed practical nurse concerning a patient who was vaccinated on an unspecified date with a dose of pneumococcal 23v polysaccharide vaccine (either lot 647797/0987N or 649698/0371P). Subsequently the patient developed bursitis and inability to move the arm and vomiting, The nurse also reported that the site was red, swollen and painful. The patient was treated with ice and anti inflammatory, The patients outcome was not reported. The physician reported that there seemed to be an increased in the number of AE's associated with these recent lots of pneumococcal 23v polysaccharide. Additionally, it was reported that several  also reported as 15-20 patients developed AE,s after vaccination with pneumococcal 23v polysaccharide vaccine from the same lots (WAES0410USA02100). The records of testing prior to release of these lots have been checked by Quality Assurance and found to be satisfactory, The lots comply with the standards of the Center for Biologics Evaluation and Research and were released. Additional information has been requested.
Patient stated he felt some of the vaccine drip down his arm. Vaccinator stated more than half of the dose was administered but did confirm a small portion of the dose leaked out of the needle. The recommendation was made to not re-dose the patient. Patient wanted to confirm he had been fully vaccinated.
Enlarged lower cervical node (3cm) and supraclavicular node (2.5cm) on left side. First noted 04/14/2021. Ultrasound guided biopsy of lower cervical node (FNA and core) came back benign. Performed: 05/07/2021 Both nodes less than 1 cm as of 05/12/2021
caller said she has COVID as well, but was vaccinated with both in Feb; caller said she has COVID as well, but was vaccinated with both in Feb; This is a spontaneous report from a contactable consumer (Patient).   A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 as 1st DOSE, SINGLE via an unspecified route of administration on Jan2021 and dose 2 on Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient had COVID, but was not affected that bad as she was already vaccinated. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
FIXED BULOUS ERUPTION Narrative: Allergy service was consulted for evaluation; recommended biopsy by dermatology
Tingling; Numbness; This case was reported by a consumer via call center representative and described the occurrence of tingling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced tingling and numbness. On an unknown date, the outcome of the tingling and numbness were recovered/resolved.   It was unknown if the reporter considered the tingling and numbness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022160202   Additional Information: GSK Receipt Date: 03-NOV-2022 Reporter's Comment: The reporter was a patient. The patient reported that she received pair of Shingrix vaccine in 2020. The patient stated that the numbness and tingling was not present before receive the Shingrix vaccine. The patient stated that before 10 months the tingling and numbness had been present for some time. The reporter did consent to follow up. Additional supportive information: for the tolerance of the 2nd dose, refer linked case US2022160202,  reported by same reporter.; Sender's Comments:  US-GSK-US2022160202:Same reporter
Patient was given lyophilize component of vaccine with sterile diluent.; Patient was given lyophilize component of vaccine with sterile diluent.; arm soreness; not feeling well; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adolescent female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA323A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo .5 ml. On an unknown date, unknown after receiving Menveo, the patient experienced pain in arm, feeling unwell, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain in arm and feeling unwell were recovered/resolved and the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was given lyophilize component of vaccine with sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  The patient experienced generalized not feeling well, arm soreness for four days. The reporter consented to follow up.
pt recvd vax & devel red lacy-like rash next day AM on face first w/forehead bright pink & raised like mild sun burn; rash on cheeks (slapped face look) rash more mild on rest of body; t97.6; no swelling @ inject site; no crying;
He was getting glucose checked when reported feeling dizzy. Given juice and snack. Placed head down to table then became incoherent and passed out. Was assisted to floor and felt elevated. Extremities cold and clammy and used smelling salts and came to.
1st shot SOB, tachycardia,, egg allergy once vaccine made effective. I ate eggs day of shot. 2nd shot made lymph nodes in throat swell to where I couldn't eat solid food. Had barium swallow done and had to have esophagus stretched in EGD.
None.    Patient states, unable to receive bivalent booster d/t allergy to the mRNA vaccines.
extreme chills.... Moderna COVID 19 Vaccine EUA  gave patient warm milk and put to bed...will monitor throughout the night
GARDASIL 9 was stored in fridge with needle attached for 19 days because a patient change her mind about getting the vaccine; No additional AE details; This spontaneous report was received from a registered nurse and refers to an adult female patient (exact age was unknown). There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date, the patient was supposed to be vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis, however she change her mind about getting the vaccine after the medication was already opened. It was reported, that the vaccine was put right back in the fridge with needle attached and has been stored like that for 19 days. No adverse event (AE) was reported.  The reporter asked how long could opened prefilled syringe (with sterile needle attached) be stored in the fridge and whether it could be still administered. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Getting "my" periods every two weeks/The last four months "I" have gotten "my" period every two weeks; Gotten "my" period every two weeks. Heavier; Gotten "my" period every two weeks. Heavier and more cramps; Headaches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included patient been on birth control and except when the patient was pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On an unknown date, the patient noticed getting periods every two weeks. The patient had been on birth control, except when the patient was pregnant for 12 years and was getting period on the dot with pills. Since last four months, the patient has gotten period every two weeks, heavier and more cramps and headaches as well. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 14Jun2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events getting periods every two weeks, last four months have gotten period every two weeks, heavier, more cramps and headaches was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
8/4/2021 Patient came to the emergency room on account of shortness of breath and acute hypoxemic respiratory failure.  Chest x-ray showed bilateral pulmonary infiltrates and was positive for Covid 19 pneumonitis on the day of admission.  She is on a heated high flow  15 L oxygen nasal cannula. She denies any chest pain no shortness of breath or palpitation no nausea no vomiting no diarrhea but was febrile when she came in. Of note, patient received Pfizer COVID vaccine, last dose administered March 2021. 8/16/2021: Patient still admitted as of this report submission.
I was hospitalized on January 20 with multiple pulmonary emboli in both lungs. I had been feeling poorly for weeks following my booster shot. I started to get short of breath and eventually had significant chest pain. My wife called an ambulance and I was transferred to the hospital where I was treated for the pulmonary emboli. The Emergency Room doctor and the on call Hematologist both diagnosed the blood clots as a result of the mRNA vaccine. Additionally, I had a significant reaction to the second Moderna shot in May 2021. I had a fever of 101.5 and chills and body aches for two days.
Itching back of knees and abdomen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching back of knees and abdomen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (Itching back of knees and abdomen). The patient was treated with HYDROCORTISONE for Pruritus, at a dose of UNK, qd; GABAPENTIN for Pruritus, at a dose of UNK dosage form, qd and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Pruritus, at a dose of UNK dosage form, qd. At the time of the report, PRURITUS (Itching back of knees and abdomen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.       Reporter did not allow further contact
Fever for 7 days up to 102.5 degrees F. Fussy and tired for two days, but now with normal activity. Only constant fevers, especially at night.
Soreness at injection site; headache; fatigue; slightly swollen tonsils; This is a spontaneous report from a contactable consumer. A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration on 26Jan2021 09:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of the vaccination. The patient had no covid prior to vaccination. Concomitant medication included loratadine and unspecified hormonal birth control. The patient had no other vaccine in four weeks. On 27Dec2021 06:00 AM, the patient experienced soreness at injection site, headache, fatigue, and slightly swollen tonsils. No treatments received in response to the events reported. The patient was not tested for covid post vaccination. The outcome of the events soreness at injection site, headache, fatigue, and slightly swollen tonsils was recovering.
a 79 years old female patient received 1 ml dose of Fluzone Quadrivalent instead a 0.5 mL dose, No AE; Initial information received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA263271, 2020SA263260 and 2020SA263253 (same reporter).  This case involves a 79 years old female patient who received a 1 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] Injection [lot UJ475AA, expiry date: 30-Jun-2021] instead of 0.5 mL via an intramuscular route at right deltoid, on 22-Sep-2020 for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  No other vaccines given to the patient.  It was a case of overdose (latency same day).   No adverse event symptoms experienced by the patient.  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.
About a month and 20 days after my second vaccine I had trouble breathing. I work in the hospital, so I thought maybe it was bronchitis, the mask made it harder to breathe. I had the weekend off and decided by Monday I would go to the doctor if not better. I woke up on Sunday, still achy, not wanting to move, couldn't really eat, I was just mostly drinking water. I woke up Monday and came back to bed, moved the blanket and then could barely breathe. My skin got very clamy, feeling scared and unsure if it was a heart attack. I called 911 and was taken to hospital to a shock trauma.  I am only back to work 4 hour days, and working with a pulmonologist.
Initial misuse report received from a nurse on 07 November 2013. The 2 and half-years-old patient had received FLUZONE 0.5 ml intradermal (site not provided). Reporter stated 2 1/2 year old was given 0.5ml dose of FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
low grade fever, chills, body aches, headache for 24 hours.  tylenol of little help
Heart palpitations/racing lasting the pup ugh the day of the injection. This was also accompanied chest pains which have persisted into day 2. On top of all this my head feels like I have a flu. (Cloudy vision, headache, and sinus pain)
Information has been received from a physician concerning a 68 year old female with hypothyroidism, autoimmune disorder and penicillin allergy who at 19:00 hours on 13-NOV-2007 received a subcutaneous dose in the right upper deltoid of ZOSTAVAX (lot#658862/1415U). It was reported that six hours later (1:00 A.M) on 14-NOV-2007, the patient developed an extreme rash that was very itchy on her back, head, neck, and arm (it was all over). She presented to an urgent care facility and was treated with BENADRYL. On 15-NOV-2007, she was seen in the office by her physician who reported that the rash and itching was gone, only some pink spots remained. A product quality complaint was not reported. Further information was not available. Additional information has been requested.
She got her vaccine, had some swelling, but that disappeared after about 3 days.  Then on Friday 4/16/21 started having coughing, which gradually got worse to where she was having difficulty breathing when she talked which caused more coughing, and feeling like her throat was closing.  She called her doctor and is waiting on a call back to go see him, but did go through a Pharmacy drive through to see if she had COVID, and if she's clear she will see her doctor when they call her back.
pt a female w/ hx of chicken pox whose child was vaccinated on 23aug95 was nursing her child & devel shingles;
Severe headache, nausea, vomiting, diarrhea, body rash, muscle soreness, joint stiffness and pain, malaise, fever, irritability. Went to local doctor and received Medrol dose pack.
acute hepatitis; This spontaneous case was reported by a physician and describes the occurrence of HEPATITIS ACUTE (acute hepatitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine).    No Medical History information was reported.  Concomitant medications included insulin glargine, acetylsalicylic acid, atorvastatin, and anastrozole.   On 11 Mar 2021, the patient received their first dose of dose of mRNA-1273 (Moderna COVID-19 Vaccine) intramuscular (Batch number unknown).  On 15-Mar-2021, the patient came in for a follow-up visit with her physician and she presented with acute hepatitis. Relevant laboratory results included  aspartate aminotransferase (AST) -1900, alanine aminotransferase (ALT)- 2562, bilirubin of 3, alkaline phosphatase  550, and mild elevation for amylase. She was admitted in the Emergency Room (ER )for 6 hours, to be accessed.  For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.  The outcome for the event of HEPATITIS ACUTE (acute hepatitis) was unknown.; Reporter'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.  Very limited information regarding this event has been provided at this time.  Further information has been requested.
This non-serious spontaneous case, was initially received on 09-Oct-2017, from Other Health Professional, concerning a 25-year-old, adult female patient. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: Intramuscular, anatomical location: deltoid, batch number: 195220, expiry date: 30-Apr-2018). It was reported that vaccine was administered that was exposed to 68F for 8 hours/temp excursion above 46F. Non-significant case correction received with IRD 09-Oct-2017: Batch number (195220) was captured in the case form and narrative was amended accordingly.
Mother stated that seven days after receiving the MMR and VZV child had a seizure. States that eyes rolled back and body jerking, ?length of time seizure lasted.Child was not taken to hospital. In speaking with the mom she stated that child had been sick and running a "high fever" on the day he had the seizure. Temp not taken.
Pt received varicella vaccine and returns to office with tension and warmth where she received the vaccine.