chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient threw up after receiving the vaccinations (5 total). Mother stated that he "usually feels that way after receiving any vaccines." Patient stayed additional observation time for 30 minutes and felt better after observation period.
Information has been received from a 45 year old female who on 05-NOV-2008 was vaccinated with ZOSTAVAX 0.65mL (Lot # not provided). After getting ZOSTAVAX on 05-NOV-2008, the patient experienced bitter taste. The patient's bitter taste persisted. The patient also reported that she was vaccinated at the age of 45 year old. The patient did not seek medical attention. No further information is available.
I just finished my period about 10 days ago.  I started spotting the day after my shot and continue to spot today (3 days after).  I am on oral birth control pills and spotting 10 days after I just had a period is highly irregular.
3CM induration with erythema and warm to touch. Also c/o headache, chest and neck discomfort
I experienced an acute case of COVID-19. It started with nasal congestion leading into a sore throat. Medium cough over a period of time. The acute symptoms lasted maybe 3 or 4 days.
pt recvd 3 doses of Hep B vax MAY90,JUN90,& 11DEC90. On 13DEC90 pt recvd 4th dose of vax.
High Blood Pressure; Left arm - soreness; fatigue; nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High Blood Pressure) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (Blood pressure was fine with pills (metoprolol 25mg p/o q day).) and Allergy (get allergic to a lot of things even). Concomitant products included CICLOSPORIN (RESTASIS) for Eye drop instillation.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced HYPERTENSION (High Blood Pressure) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm - soreness), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (Headache). The patient was hospitalized for 4 days due to HYPERTENSION. The patient was treated with METOPROLOL (oral) ongoing since an unknown date for Blood pressure management, at a dose of 25 mg once a day. At the time of the report, HYPERTENSION (High Blood Pressure) was resolving and VACCINATION SITE PAIN (Left arm - soreness), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Blood pressure measurement: increased (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vitamins were provided as concomitant product.  Company Comment: This case concerns a 72 year old female with relevant medical history of hypertension ( controlled with Metroprolol previously ) , who experienced Serious , unexpected event of Hypertension  which occurred 4 months 15  days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the events were unknown. The history of hypertension can be considered as a confounder for this case . The benefit-risk relationship of mRNA-1273 vaccine (Modenra Covid 19 Vaccine ) is not affected by this report.   This case was linked to MOD-2021-380253, MOD-2021-380502 (Patient Link).; Sender's Comments: This case concerns a 72 year old female with relevant medical history of hypertension ( controlled with Metroprolol previously ) , who experienced Serious , unexpected event of Hypertension  which occurred 4 months 15  days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the outcome of the events were unknown. The history of hypertension can be considered as a confounder for this case . The benefit-risk relationship of mRNA-1273 vaccine (Modenra Covid 19 Vaccine ) is not affected by this report.
When giving the first dose, the vaccine leaked from the needle.  Sprayed onto vaccinator and down patient arm. Unsure dose amount received.  Call placed to Moderna for further direction.
Very mild anphylaxis occurred after vaccine administration on 9/17/21.  Resolved without antihistamine, and patient avoided taking loratidine that evening as to not interfere with the vaccine.   On 10/11 patient's montelukast prescription manufacturer changed, and the new brand contained PEG while her old brand did not.  This was the only change in medications.  On or around 10/13 patient starting having allergic reaction symptoms including itchy throat and body, hoarse voice, and exhaustion.     Benadryl was taken and helped with itch symptoms but not exhaustion or hoarse voice.  Symptoms resumed  until manufacturer was changed back to the generic montelukast.   The total time of the allergic reaction was around 10 days, and patient has never had an allergic reaction last longer than 1-2 days, other than getting the flu vaccine and having asthma symptoms afterward.   Dr. advised to avoid PEG and increase loratidine to 20mg/day for 2 weeks until resolved, with methylpredinose boost added for labored breathing.   Patient did not change any PEG levels other than the vaccine, the generic asthma med, and some cosmetics items.
Patient developed arm pain at injection site with radiation distal as well as generalized fatigue and malaise. Patient was sent to Neurologist who performed several diagnostic tests. Initial screening bloodwork was stable, MEDROL DOSE PACK prescribed.
Day #56 post vaccination c/o severe pain in left arm since 02/10/2011 without improvment. When moves left arm has severe pain in shoulder 10/10 on pain scale radiating down arm r/o brachial neuritis.
"Extreme"  pain in all muscle and all joints for 5 days since the vaccine.
Severe, overwhelming sore back day after vaccine. Ongoing  severe back pain at 8 days after vaccine
Patient reported still having pain in arm with some limitation in movement since receiving immunization and will be following up with visit to physician.
5 days after being vaccinated I started feeling numbness and tingling in my fingers, down my arm, foot, toes, pain under my arm that radiates to my latissimus, behind my calf, breast sometimes. My hand and foot would go from warm to cold. Also a pulling sensation down my arm. These symptoms I have experienced is only on the right side of my body. They tend to come and go. I've had 3 deep tissue massages, chiropractor adjustment, acupuncture  and I stretch daily.  Which helped mostly but I am still experiencing these symptoms 7 weeks later
a couple of hr p/vax pt devel a bad h/a w/a rash covering torso, arms & legs;w/in 24hr entire body was covered;dermatologist dx it as vasculitis;a faint rash remains presently;
Woke up the day after first round of vaccination  with a headache and full body muscle soreness. I also have a low grade fever of 99.9.
Hives to lower Right and Left hand.  No treatment given monitored. No complaints of SOB, dizziness or abnormal CRT.
the patient took the required shots for little ones and he collapsed on the table; Initial information regarding an unsolicited valid serious social media case received was from a consumer and transmitted to Sanofi on 16-Dec-2020.  This case was linked to case 2020SA361491 (15 year old patient).  This case involved a 20 year old patient of unknown demographics who took the required shots of INFLUENZA VACCINE for little ones and collapsed on the table (syncope).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported), for little ones, via unknown route in unknown administration site for prophylactic vaccination and collapsed on the table (syncope), unknown latency following the administration of INFLUENZA VACCINE.  The event was assessed as medically significant as per important medical event (IME) list.  Relevant laboratory test was not reported.  Final diagnosis was syncope.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.; Sender's Comments: Sanofi company comment dated 20-Dec-2020: This case concerns a  20 year old patient who collapsed after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown. However, patient's medical condition, concomitant medication and laboratory tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 18-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
PATIENT WAS 17 YEARS AND 9 MONTHS AT TIME OF INJECTION.  NOT 18  PER EUA.  NO SIGNS/SYMPTOMS OF ADVERSE EFFECT.   WILL FOLLOW CDC GUIDELINE AND ADMINSTER 2ND MODERNA DOSE AS OFF-LABEL USE.
Redness, itching, burning distal to injection site - 12 hrs after injection. Achy within 1-2 hrs of vaccine.
Vaccinated arm was sore pretty quickly afterwards. Started with chills for 2 hours along with body aches. Next, developed a fever of 102 degrees F. I was restless when trying to sleep. I was tired the next day.
puffiness of face and neck; Redness; pain; Puffinessof neck/swelling going through her body; Fever; Enormous headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (puffiness of face and neck), ERYTHEMA (Redness), PAIN (pain), SWELLING (Puffinessof neck/swelling going through her body) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (\whole household have acquired COVID-19 so that she was really scared and worried about it). Concurrent medical conditions included Drug allergy (Sulfur medication).    On 01-Apr-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 SWELLING FACE (puffiness of face and neck), ERYTHEMA (Redness), PAIN (pain), SWELLING (Puffinessof neck/swelling going through her body), PYREXIA (Fever), HEADACHE (Enormous headache) and CHILLS (Chills). At the time of the report, SWELLING FACE (puffiness of face and neck), ERYTHEMA (Redness), PAIN (pain), SWELLING (Puffinessof neck/swelling going through her body), PYREXIA (Fever), HEADACHE (Enormous headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. The patient experienced puffiness of face and neck, redness, pain and swelling al going through body after first dose of the vaccine. There's also fever, enormous headache and chills after. No treatment information was provided.   This case was linked to MOD-2021-406944 (Patient Link).
Information has been received from a registered nurse (RN) concerning a 43-month-old black female who on 01-MAY-2003 was vaccinated subcutaneously in the right thigh with a first dose of Varivax (lot# 641712/0423M). Concomitant therapy included a dose of MMR II. On 15-OCT-2005 the patient had an adverse experience. Unspecified medical attention was sought and it was noted that there was "confirmation (at an) office visit." Subsequently, the patient recovered from the adverse experience on an unspecified date. Additional information has been requested.
crusty; woke up to them swollen; lips started to tingle; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH; Lot number: ek9231), via an unspecified route of administration in the left arm on 19Jan2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease (CKD). The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and levothyroxine sodium (SYNTHROID), for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH; Lot number: el1284), via an unspecified route of administration in the left arm on 29Dec2020 at 11:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Jan2021, three days after the vaccine, the patient's lips started to tingle and on 23Jan2021 (reported as fourth day), the patient woke up to them swollen and crusty. She went to 4 doctors over the last 2 months and finally the derm put her on steroids that seemed to work. No one could figure out what the pain and swelling was from until they found an article about another vaccinated person that had the same adverse events. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient visited 4 different MDs over 2 months. The patient was treated with antibiotics 2x, allergy medicines, rash cream and finally steroidal cream for the events lips started to tingle, woke up to them swollen and crusty. The clinical outcomes of the events lips started to tingle, woke up to them swollen and crusty were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021352672 same reporter/drug/AE with different patient
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On 21-JAN-2014, the patient was vaccinated with ZOSTAVAX lot number J011218, subcutaneous for vaccination. On 22-JAN-2014, the patient developed a small raised area of redness at the injection site. The patient came to the pharmacy and was advised to apply ice to the area of reaction. No lab diagnostics were performed. The outcome of developed a small raised area of redness at the injection site was reported as recovering/resolving. Additional information has been requested.
Pt was given first dose of SHINGRIX 0.5 ml IM on 1/15/19 after proper counseling and review of benefits VS risks. Pt stated that he developed a painful cluster of silver and red welts on his buttock a week later. No other clusters appeared on other parts of his body. Welts popped and produced eschar after a few more weeks. Pt denied other symptoms such as SOB or itching.
Entire right arm down to fingers very painful.; Right arm pit very painful.; Right side of neck stiff.; Entire body flu like aches; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 15Dec2021 at 14:30 (Lot number: unknown) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: ADVIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN; Anatomical location: Right arm), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: UNKNOWN; Anatomical location: Right arm), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 at 14:30, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Entire right arm down to fingers very painful"; AXILLARY PAIN (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Right arm pit very painful"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Right side of neck stiff"; INFLUENZA LIKE ILLNESS (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Entire body flu like aches". Therapeutic measures were not taken as a result of pain in extremity, axillary pain, musculoskeletal stiffness and influenza like illness. Additional Information: The patient had no known allergies to past drugs. 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 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
4:15- Pfizer coivd-19 vaccine placement to left Deltoid 4:40 Pt reported Right sided neck stiffness and tightness, HR 65, RR 32, BP WNL 4:45 Report right lower lip tingling, noted slight swelling to right lower lip. Airway clear. HR 77, 99% on RA, RR26, BP WNL.  5:00 25mg Benadryl IM given to right deltoid 5:05 reports lip tingling reducing, reports neck stiffness reducing. PT alert and oriented.  5:10 Vitals signs within normal limits.  5:15 Amb to BR with steady gait A&O. States symptoms improving. Swelling to Right lower lip reduced. Pt escorted home by friend and stayed with husband.
Sharp pain in her left arm where the injection/immense pain where shot was given; sciatica in the entire left side; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm on 27Apr2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated that from 28Apr2021 she had a sharp pain in her left arm where the injection was given and sciatica in the entire left side. The caller went to her chiropractor but needed something stronger, so she went and saw her primary care provider. The caller's primary care provider put the caller on steroids- methylprednisolone, the generic for Mediprol. The caller finished the steroid on 17May2021 and was scheduled for her second dose on 18May2021. The patient was on steroid so she knew it decreases the inflammation and wanted to know how long she should wait for the second dose of vaccine. The caller's pharmacist said nothing was going to happen to the caller after the second dose. The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Something is in her throat and was wondering if that was it closing up/some trouble with her throat; Something is in her throat and was wondering if that was it closing up/some trouble with her throat; Something is in her throat and was wondering if that was it closing up/some trouble with her throat; This is a spontaneous report from a contactable consumer (the patient). A 64-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration on 07Apr2021 (at the age of 64-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207) on 10Mar2021 for COVID-19 immunisation. On 04Jun2021, the patient experienced something is in her throat and was wondering if that was it closing up/some trouble with her throat. The patient stated the last dose she received was in April and she wanted to know would she be still having side effects because it seems like something was in her throat and was wondering if that was it closing up. She further stated she was having some trouble with her throat and she was wondering if that is a side effect from the Covid. She stated it was the week when (withheld) had all that rain, about 2 weeks ago and she started having trouble with it and its lasted quite some time. The patient stated she scheduled to see her regular primary care doctor next week on a Thursday. The patient stated it was worse the morning when she first called and as the day went on it got better. The outcome of events was resolving.  Information on lot/batch number was available. Additional information has been requested.