chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11:55am  Pt. reported feeling like he was "fading out and dizziness,"  denies SOB, chest pain.  Airway patent.  Patient and patient's Mother declined emergency care.  12:00pm.  122/82 58 21;  12:05pm  120/86 67 21;  12:15pm  122/82 72 20;  Disposition:  12:35pm.  Pt. in no distress, declined offers for emergent treatment.  Pt. left with Mother in no distress via personal vehicle.
15 minutes after the vaccine she had lip tingling and mild swelling and hives on her chest. Patient was given Benadryl and monitored for 30 minutes without symptom changes. 1 hour after symptoms remained the same and patient went home with instructions to seek emergency care if any other symptoms developed.
Patient received moderna vaccine. Patient experienced dizziness, lightheaded ness, weakness, strange taste in mouth (metalic taste), hard to focus. She was given oral diphenhydramine which may have made her more dizzy. Observed for several minutes, escorted to clinic on floor and continued observed up there. Continued dizziness 2 hours later.
Temp 101, chills, nausea, treatment Tylenol, Fluids.
Miscarriage; Left Arm pain; Nausea; Headache (HA); This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185), via an unspecified route of administration, administered in left arm on 20Aug2021 at 12:45 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient's concomitant medications were not reported. On 21Aug2021 at 08:00 the patient experienced left arm pain, nausea and headache (HA). The vents were resolved with sequelae on an unspecified date in Aug2021. On 22Aug2021 the patient experienced miscarriage. The mother reported she became pregnant while taking bnt162b2. The mother was 5 weeks pregnant at the onset of the event. The mother was due to deliver on 18Apr2022. The outcome of event miscarriage was reported as unknown. The patient did not receive treatment for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of event abortion spontaneous cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Had PENTACEL, Rotavirus, PREVNAR - Hep. B 12-2-10 that night had 102 temperature fussy lasted 2 days. Next set of (no Hep. B) shots done 12.2.11. Fever 104 - very fussy next day - came to office - Inj. sites looked fine.
Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: FC3180) via an unspecified route of administration, administered in arm left on 12Aug2021 18:30 (at the age of 61-year-old) at dose 1, single for covid-19 immunisation. Medical history included lichen planus. Patient had no known allergies. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for covid post vaccination. Concomitant medication included omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]) received in two weeks. On 15Aug2021 16:00 the patient experienced adverse event: Me and my Daughter has Vaccine same day and time. We both got pain under our left arm pit then 4days later got a lump under our left nipple and soreness. Patient had no treatment for the adverse events. Outcome of the events was unknown.  Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.
That night left foot/ankle became tingly and weak. Since that night it has slowly spread to my entire left side of my body. A neurologist confirmed it was a flu shot reaction on 10/27/09. Treatment as of now is Advil and to return to the neurologist on 11/2 and a possible nerve conduction test.11/5/2009 Neuro MD records from 10/27 and 11/4/2009 . Patient with c/o's lt face, arm and leg numbness. Neuro exam neg. Rx'd Ibuprofen.
Chills; Bad headache; Muscle ache/ whole body started hurting; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Bad headache) and MYALGIA (Muscle ache/ whole body started hurting) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced CHILLS (Chills), HEADACHE (Bad headache) and MYALGIA (Muscle ache/ whole body started hurting). At the time of the report, CHILLS (Chills), HEADACHE (Bad headache) and MYALGIA (Muscle ache/ whole body started hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were reported.   Reporter did not allow further contact
Inadvertent exposure to vaccine; Exposure via skin contact; Product Complaint; Cut her finger; some blood on the ring; This case was reported by a pharmacist via call center representative and described the occurrence of laceration of finger in a female patient who received Herpes zoster (Shingrix) (batch number 3B33N, expiry date 9th April 2022) and (batch number 2K9T2, expiry date 9th April 2022) for prophylaxis. This case was associated with a product complaint.   On 22nd November 2019, the patient received Shingrix. On 22nd November 2019, the dose was an unknown dose. On 22nd November 2019, immediately after receiving Shingrix, the patient experienced laceration of finger and wound bleeding. On an unknown date, the patient experienced inadvertent exposure to vaccine, exposure via skin contact and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger, wound bleeding, inadvertent exposure to vaccine, exposure via skin contact and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of finger and wound bleeding to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist was preparing to reconstitute a Shingrix vaccine and when she removed the blue-green cap from the adjuvant vial and the red ring also came off and it cut her finger which led to inadvertent exposure to vaccine and exposure via skin contact. The pharmacist just cleaned the wound and put a bandage on the wound. The reporter stated that there was some blood on the ring, so that adjuvant was discarded. There was no picture of the defect and antigen vial would be discarded. Conclusions of the QA statement were received as follows: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. The reporter consented to follow up.
click palpitations; heart skipping a beat; take my breath away; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Sep2021 19:30 (Lot number: FC3180) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number=1, lot number=EW0187,, administration time=01:30 PM,, vaccine location=Left arm), administration date: 07Aug2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported: PALPITATIONS (non-serious) with onset Sep2021, outcome "unknown", described as "click palpitations"; EXTRASYSTOLES (non-serious) with onset Sep2021, outcome "unknown", described as "heart skipping a beat"; DYSPNOEA (non-serious) with onset Sep2021, outcome "unknown", described as "take my breath away". The events "click palpitations", "heart skipping a beat" and "take my breath away" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of palpitations, extrasystoles, dyspnoea.  Clinical course: Within a few days of the second vaccine, the patient began to develop around the click palpitations, heart skipping a beat, especially at rest or before going to sleep. It would actually take the breath away. Pulse and blood pressure (BP) were always good though.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19, Since the vaccination. No known allergies and other medical history.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker (medical assistant) refers to unknown number of patients of unknown age. On unknown dates, the unknown number of patients were vaccinated with (Oka/Merck) VARIVAX (lot#, expiration date, dose, frequency, route not reported), that were stored outside of the temperature ranges indicated in the prescribing information. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to an 8 months 8 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
severe psoriatic arthritis flares; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "psoriatic arthritis" (ongoing). The patient's concomitant medications were not reported.  The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "severe psoriatic arthritis flares". Therapeutic measures were taken as a result of psoriatic arthropathy.  Clinical course: Patient started having severe psoriatic arthritis flares almost immediately after got the Pfizer coronavirus vaccine Seems it was not possible to seek any remedy for that but I was having difficulty accessing biologics for the psoriatic arthritis I was on Enbrel but my Dr was out of samples and it was difficult to obtain Thought it was worth asking if Pfizer would offer me a supply of their biosimilars for psa.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccines administered after temperature excursion (46.2 F). Vaccines involved :VAXELIS U7205AA and VAXELIS U7151AA 7.; This non-serious spontaneous safety report was received on 25-NOV-2022 from a physician.   The case is a follow up case number 02272790/ Interaction# 02272763 (MCM-004233)  It was reported that the patient did not experience any adverse event (Temperature excursion only).  Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004233, MCM-004326 and MCM-004327.  Further information is expected.
Patient presented to Clinic today 1/1/2020. She reports she received the 2nd dose of her Shingrix vaccine yesterday 12/31/2019 at 12:30 noon at another location. She reports starting yesterday at about 5:30 pm she experienced chills, nausea (no vomiting), intermittent dizziness and racing heart rate when lying down. She denies rash, shortness of breath, chest pain, or trouble swallowing.  She denies a similar reaction after getting the first shingrix vaccine. She is allergic to cefzil, clavulanic acid and ofloxacin, and gets GI upset with higher doses of acetaminophen.
Child given normal 4 yr imm. DTAP, MMR, IPV. Left office returned after 45 min to 1 hr had called before coming - stating c/o throat and eyes itching, When arrived at office eyes very puffy. Benadryl given PO and set to ER. Woman and Children  (across parking lot from office). Had called ER- waiting on him. Spoke to aunt next day - Stats child  did well through the night and no further problems.
About a week and a half after receiving the Moderna booster, my COPD went into hyperdrive.  normal activities that did not limit me were all of a sudden a struggle.  The only thing that changes was the receipt of the Moderna Booster.  I suffer the impact described above to this day which motivates me to file this report
About 6 cm area of redness, swelling, warmth, itching, and soreness on the left arm at injection site most noticeable around a week after shot
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient was non alcohol user, non-smoker. The patient did not have any drug abuse/illicit drug use. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had a blood test for something else and decided to test for antibodies as well (since she got vaccinated). Her antibody test came out negative (suspected immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210805266.; Sender's Comments: V0: 20210805141-covid-19 vaccine ad26.cov2.s -Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Headache, Myalgia, CHILLS/ LETHARGY/ SORE THROAT / PERIOD OF SHORTNESS OF BREATH Narrative:
Dizziness & HYPERtension Narrative:  BP at 1133: 160/106, HR 88
Area where the shot was given was red; Area where the shot was given was itching; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was 70 years old at the time of reporting. The patient received Flu vaccine from the same pharmacist who had administered Shingrix and Pneumonia vaccines. It was reported that, the area where the vaccine was administered was red and itchy. This case has been linked with case US2019093267 reported by the same reporter for the same patient.
Had shots, was ok. Woke up with fever. Temperature increase that evening 105 F. Next day 103 F then decreased 99-100 F X 3 days. Was given Tylenol for fever. No other symptoms.
itchy where she got the shot; huge bright red circle where she got the shot; Headache; Tired; Arm hurt like there was a huge knot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt like there was a huge knot), VACCINATION SITE ERYTHEMA (huge bright red circle where she got the shot), VACCINATION SITE PRURITUS (itchy where she got the shot), HEADACHE (Headache) and FATIGUE (Tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's medical history was not reported.  Concomitant products included METRONIDAZOLE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt like there was a huge knot). On 15-Jan-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tired). On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (huge bright red circle where she got the shot) and VACCINATION SITE PRURITUS (itchy where she got the shot). The patient was treated with PARACETAMOL (TYLENOL) in January 2021 for Adverse event, at a dose of UNK dosage form. On 15-Jan-2021, PAIN IN EXTREMITY (Arm hurt like there was a huge knot) had resolved. On 16-Jan-2021, HEADACHE (Headache) and FATIGUE (Tired) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (huge bright red circle where she got the shot) and VACCINATION SITE PRURITUS (itchy where she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that Tylenol helped. The huge bright red circle where she got the shot was not tender.   This case was linked to MOD-2021-020285 (Patient Link).
Painful joints, skin disorders, sleep disturbance, nails growth disturbance. Secondary degenerative joint disease. 10/13/06 Received medical records from VA which reveal patient treated since 2001 with c/o cough; papules on hands; arms & inguinal which were pruritic; and right knee pain.  Dx: tinea corporis; cellulitis of toe; right lateral epicondylitis; arthralgias of unknow origin; & tinea manus./ss
This case was reported by a healthcare professional and described the occurrence of injection site soreness in a female subject of unspecified age who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 5 October 2007 the subject received unspecified dose of Flulaval (.5 ml, unknown, unknown arm).  On 5 October 2007, less than one day after vaccination with Flulaval, the subject experienced injection site soreness that was considered to be extreme.  The reporter also noted that the arms continued to be tender.  Pharmaceutical product complaint was also identified.  It was unknown if the subjects had previously received any influenza injections.  Also any previous reactions following vaccinations was also unknown.  At the time of reporting the events were improved.  The healthcare professional considered the events were probably related to vaccination with Flulaval.  The reporter noted that this occurred in six patients.
knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (knee pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ARTHRALGIA (knee pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (knee pain) had resolved.            Treatment details include Tylenol and Advil to alleviate the pain but despite feeling somewhat better her knee pain had not really subsided to the usual degree of pain about a week.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: VAER
Patient required hospitalization due to breakthrough infection. She received Pfizer vaccine (third dose in series) on 02/24/2021. Hospitalized from 07/28/21 - 07/30/21. Below is copied from discharge summary:   Patient is a 79 y.o. female with a pmh of sigmoidal colon cancer (s/p colostomy 2019, chemoradiation 2020, currently on IV 5-FU and Avastin), multiple myeloma (on Revlimid), CKD, HTN and hx of PE (2020, Eliquis 5 BID) presents to ED for several days of fatigue. She was found to be COVID + in ED with desaturations to the mid 70's and was started on 3L NC. She was admitted to medicine for management and evaluation of COVID-19 pneumonia. Patient was started on antibiotics since she had a questionable R sided consolidation on CXR, as well as methylprednisolone and Lipitor. Patient also presented with bilateral LEx edema of unknown etiology. BNP was elevated from previous 547 (2020) to 800, TTE was unchanged from prior. Patient was started on Lasix 40 qd. PT was consulted and worked with patient, noting desats to 85, recommending patient be discharged with full time assistance (daughter), home health care and home O2. Patient was stable for d/c on 7/30.
Local swelling and redness around injection site. Mother used Benadryl and ice- area of reaction was right arm.