chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days after the vaccine tinnitus began and has continued (louder) to this date Significant hearing loss in the right ear
Duplicate order entered. Unclear if this was an IT glitch or provider error. During 1 month return visit duplicate order showed as "Pending" (not given). RN administered vaccine.
Swollen Lymph-Node under the Left Armpit after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph-Node under the Left Armpit after 2nd shot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A, 025B21A and 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph-Node under the Left Armpit after 2nd shot). At the time of the report, LYMPHADENOPATHY (Swollen Lymph-Node under the Left Armpit after 2nd shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After 2nd dose, He started having a Swollen Lymph-Node under the Left Armpit but he noticed it 2 months after second dose. After the booster, he had a small swelling under the right arm pit.   This case was linked to MOD-2021-405733 (Patient Link).
Participant reported headache  eight minutes after vaccine was administered. Reported taking six baby aspirins prior to arrival at clinic due to headache. Vital signs at 10:48 BP 212/98  P 70 R 24 Pulse OX 96%on  RA.. 10:50AM BP 220/108P77R24 Pulse Ox 97% on RA. 10:53AM Emergency Department RN arrived and transported patient to the ED in her own Wheelchair.
; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) ( No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided
burning in mouth; joint pains; cough; SOB; tongue swelling; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: FE3590) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN; LIPITOR. Past drug history included: Iodine, reaction(s): "known allergies: Iodine", notes: known allergies: Iodine. The following information was reported: BURNING SENSATION (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "burning in mouth"; ARTHRALGIA (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "joint pains"; COUGH (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "cough"; DYSPNOEA (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "SOB"; SWOLLEN TONGUE (medically significant) with onset Oct2021, outcome "recovered with sequelae", described as "tongue swelling". The events "burning in mouth", "joint pains", "cough", "sob" and "tongue swelling" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of burning sensation, arthralgia, cough, dyspnoea, swollen tongue. No other vaccine in four weeks. No Covid prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pyrexia (102*F); Shivering; Myalgia; Non productive cough; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 30Apr2021 at 19:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included HSV-2 Infection (patient reported no lesions or symptoms at time of vaccine or afterward) and COVID-19. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 at 12:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. On 01May2021 at 08:00,  within 12 hours, the patient experienced pyrexia 102*F, shivering, myalgia, non-productive cough and fatigue. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pyrexia 102*F, shivering, myalgia, non-productive cough and fatigue were recovered on 02May2021, all symptoms dissipated within 24 hours.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No pertinent medical history and no drug reactions or allergies. On 04-FEB-2014 the patient was vaccinated with ZOSTAVAX lot # J010447, 0.65 ml, subcutaneous. No concomitant medication. The pharmacist reported that the patient developed an injection site reaction. The patient described it to the pharmacist over the phone as, redness and swelling (not raised) about the size "of a half dollar" with pain. The patient described it as a "rash" but gave no details as to whether any lesions were present. No treatment was given. The outcome of the events was reported as not recovered/not resolved. The causal relationship was not provided. Additional information has been requested.
Vaccine received below 18 years of age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received below 18 years of age) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received below 18 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received below 18 years of age) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Incorrect Pfizer product was administered to an 11 year old male.  Client should have received 5-11 year old product and received >12 year old product.  Child was vaccinated on 1/4/22 and Mom emailed Health Officer on 1/5/22 that child woke up with a fever.
At 1AM on 7/8/10 parents noticed child screaming/crying - low grade temp after immunization of 100 (R). 7AM temp - looking to left - will not turn past midline - not using (R) arm eyes not focusing. Hospitalized with embolic stroke, seizures.
6CM AREA OF ERYTHEMA, TENDERNESS TO LEFT ARM.  SLIGHT NECK PAIN, BUT FULL RANGE OF MOTION
"COVID ARM" which started with soreness and pain on first day (6/6/21), then swelling/raised areas on day two (6/7/21), then itchy rash on day 3 (6/8/21). All symptoms  started one week (7 days) post first dose of Moderna. Symptoms persist as of 6/11/21.
Moderna COVID 19 Vaccine EUA Fever of 102, body aches, chills, injection site pain, bleeding sinuses, extreme tiredness This lasted for 2 days
pt states rt arm & hand began swelling 30mins p/inj;described hand as feeling heavy-had diff removing rings;to ER last noc was told inflammation;was given Ibuprofen-applying ice-swelling dec today;c/o itching can move hand but grip weak
urticaria; rashes; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (urticaria) and RASH (rashes) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product EPINEPHRINE (EPIPEN JR) for an unknown indication.    The patient's past medical history included COVID-19 on 02-Oct-2020. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Urticaria, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient started EPINEPHRINE (EPIPEN JR) (unknown route) at an unspecified dose. On 01-Oct-2021, the patient experienced URTICARIA (urticaria) and RASH (rashes). At the time of the report, URTICARIA (urticaria) and RASH (rashes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter considered URTICARIA (urticaria) and RASH (rashes) to be related.    Co-Suspect product included steroids. It has been reported that rashes began under eye of patient. Patient was treated with treatment medication steroids and the symptom was not resolved. Further symptom returned each time for patient.  Each time it turned as worse, and it eventually turned into urticaria. Patient visited allergist and for this underwent multiple rounds of allergy testing. Patient also visited ENT physician. It has ended up ruling this to likely be caused by Moderna vaccine. Patient had multiple rounds of not only allergy testing but also blood testing done to rule out other conditions and causes. Currently patient was taking six different antihistamines a day. It's more than two years later and patient still battling this. Treatment information was not provided.
Moderate muscular pain in the upper left arm, headache, shivering, upset stomach,  tired & weak.  Symptoms began within about 6 hours of the vaccination and continued throughout the night and next day.  It?s now about 26 hours since the vaccination and symptoms seem to be dissipating.
hot to touch; felt like hives; kind of itchy; a red oval on her upper arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, VACCINATION SITE URTICARIA, and VACCINATION SITE WARMTH in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition reported). Concomitant products included SIMVASTATIN for an unknown indication.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, VACCINATION SITE URTICARIA, and VACCINATION SITE WARMTH. On 05-Mar-2021, VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, VACCINATION SITE URTICARIA, and VACCINATION SITE WARMTH had resolved.            Treatment medication include Zyrtec and cold compresses.
Redness Swollen on L deltoid upper. Mom just noticed today upper to side on L arm. 0 fever, child active. Mom called today in office to let us know.
Very hot to touch; Flu like symptoms; Injection site was very red; Rash; Itchy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Very hot to touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Injection site was very red), VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included AMLODIPINE, METOPROLOL TARTRATE, INSULIN GLARGINE, OMEPRAZOLE, PIOGLITAZONE, HYDROCHLOROTHIAZIDE, GLIPIZIDE and TRAZODONE for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Very hot to touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Injection site was very red), VACCINATION SITE RASH (Rash), VACCINATION SITE PRURITUS (Itchy) and HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (Very hot to touch), INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Injection site was very red), VACCINATION SITE RASH (Rash), VACCINATION SITE PRURITUS (Itchy) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were reported   This case was linked to MOD-2021-029591, MOD-2021-056454 (Patient Link).
Rt thigh on 12/08/04, red, warm to touch, area about 10-12cm at injection site- DTaP given on 12/07/04.  Benadryl and warm compresses ordered by MD.
pt awoke w/rt ear pain & rt facial swelling/erythema & t101.2;no recent illness;dx w/mumps today, now 4 days p/vax;
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-Jul-2022).    No concomitant product use was reported. Patient received half dose. The number of doses/vials administered were 35 vials On 04 Jun 2022 the vials were initially stored in the refrigerator.The vaccines were administered from the 04 Jun 2022 until the 26 Jul 2022 Vial did not undergone any temperature excursions. No treatment information was provided.
Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 4/3/21). Patient was admitted to the hospital on 7/17/21 with 3 days of SOB, cough and fever and tested positive for SARS-CoV-2. On admission patient required HFNC however, developed rapidly escalating O2 requirements and was transitioned to BiPAP.  She was initiated on corticosteroids, anticoagulation (LMWH), remdesivir and tocilizumab. Today patient is afebrile, still requiring supplemental O2 with HFNC 100/60  and being continued on remdesivir (day #3 of 5).
Approx. 2 days, post vax, pt noticed red spot near site of IZ. Two days later, she had full blown hives from head to toe. MD prescribed Benadryl. Saw MD on 11/13/00 and was given cortisone shot and 6 days of oral prednisone.
feeling fatigued; arm pain in the injected arm; This case was reported by a consumer and described the occurrence of fatigue in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rib fracture. Concomitant products included codeine phosphate, paracetamol (Acetaminophen + Codeine).   On 21st December 2020, the patient received Shingrix (intramuscular). On 21st December 2020, 1 hr after receiving Shingrix, the patient experienced pain in arm. On 22nd December 2020, the patient experienced fatigue. On 23rd December 2020, the outcome of the fatigue and pain in arm were recovered/resolved.   It was unknown if the reporter considered the fatigue and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient experienced arm pain in the injected arm.  The reporter did not consent to follow-up. The lot number was not available.
Swollen lymp nodes in armpit, same side as injection. Swelling has progressively gotten worse/larger throughout the day. Slight tingling in left fingers in the evening.
Itching in the Waist Line; Hives around his waistline; Headache on the back of head; Elevated Blood Pressure; stressed out; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in the Waist Line), URTICARIA (Hives around his waistline), HEADACHE (Headache on the back of head), BLOOD PRESSURE INCREASED (Elevated Blood Pressure) and STRESS (stressed out) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PRURITUS (Itching in the Waist Line), URTICARIA (Hives around his waistline), HEADACHE (Headache on the back of head), BLOOD PRESSURE INCREASED (Elevated Blood Pressure) and STRESS (stressed out). At the time of the report, PRURITUS (Itching in the Waist Line), URTICARIA (Hives around his waistline), HEADACHE (Headache on the back of head), BLOOD PRESSURE INCREASED (Elevated Blood Pressure) and STRESS (stressed out) outcome was unknown. Not Provided   No treatment information was reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 04-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, Lot# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000884: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938:
became lethargic, hard to arouse 15-20min p/vax;sx circumoral cyanosis;pale, limp;cyanosis in hands;later back crunching noted;accompanied by high pitch cry & irritable;
Patient presented to pharmacy on 4/25/22 displaying an erythematous, swollen rash on his left arm where the Prevnar-20 had been administered on 4/19/22. He explained from 4/19/22 through 4/24/22 the area was only sore. He stated on 4/24/22, the red, swollen, itchy rash appeared. The rash was quite large, starting just below the site of administration on the left deltoid, down the arm to about an inch above the forearm.
Left arm red and swollen and blistered the day after immunization. Seen in ER.