chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received vaccine at 0733 and developed itchiness, swelling and hives on face and neck. 25mg of Benadryl given at 0800. Vitals signs within defined limits sating well on RA. Pt observed for an additional 15 minutes with no other side effects noted.
Rash to trunk and back that started about 4 days post smallpox VX.
Pt reported pain, redness and swelling at injection site for 6 days. Redness of arm was from injection site to 2 inches above the elbow. Pt was seen by a doctor on 7-16-19 and prescribed Keflex
Moderna Vaccine was administered after the beyond use date of 30 days at refrigerated temperature. BUD 10/01/2021
7 years with out menstruating , and I am now almost hemorrhaging and passing massive clots.   I have a call into the doctors.  The flow is not letting up.  This was not a adverse reaction that was listed in your companies information.
I have serious joint stiffness and soreness; I am 48 hours out from getting the vaccine and my neck still really hurts; I have serious joint stiffness and soreness; I am 48 hours out from getting the vaccine and my neck still really hurts; I have serious joint stiffness and soreness; I am 48 hours out from getting the vaccine and my neck still really hurts; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 24-years-old female patient received BNT162B2 (Batch/Lot Number: EW0187), dose 2 via an unspecified route of administration, administered in Arm Left on 21Jun2021 17:00 as dose 2, single for covid-19 immunization, first dose was taken on 31May2021 (LOT# EW0177) (Expiration Date: unknown). The patient medical history and concomitant medications were not reported. Patient reported family medical history and confirmed there were no other vaccinations 4 weeks prior to vaccination. On 23Jun2021 at 17:00 (48 hours after getting vaccine) patient experienced serious joint stiffness and soreness; neck hurts (neck pain) (joint stiffness), (arthralgia). Clinical course of events includes; " I am calling to report a reaction with the Pfizer vaccine, so I have serious joint stiffness and soreness and I am 48 hours out from getting the vaccine and my neck still really hurts". Patient reported that no treatment was taken for the events. The outcome of events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested
Developed Cellulitius. Severe swelling that traveled through shoulder and chest area. By August 5 - patient needed to go back to the Dr. for antibiotics to offset the Cellulitis that was traveling (for the second time to this shot - first reaction was to TD next Reaction was to Tdap).   Required another round of 7-10 days antibiotics and multiple visits to Dr.  Skin was peeling off by August 10th from the extreme swelling.  Benadryl was given for several days in conjunction. Prednisone was also prescribed.   Clearly - this child develops Cellulitis immediately with these immunizations.
Flu like symptoms (  myalgias, temp 103 F, sore throat, fatigue and anorexia) all since vaccine was given.
Pt received Zostavax 6/5/07 without problems.  Pt called nurse 6/7/07.  Complained of tingling and burning at same area she had shingles previously (around thigh toward pubic hairline), also complained of HA.  Referred to MD.  Saw MD evening of 6/7/07 with dx of shingles and rx'd with Valtrex.
Chest pain (started 48 hours after admin) with elevated troponin (noted 66 hours after admin). Normal Echo and EKG
Vasovagal syncope about 5 minutes after shot. Symptoms lasted about 5-7 minutes. Hypothensive. Diapharetic, Nausea,
lot of hair loss to the point where her hair is now only half an inch in thickness; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (lot of hair loss to the point where her hair is now only half an inch in thickness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 025L20A, 007M20A and 026D21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism, Blood pressure high and Cholesterol. Concomitant products included LOSARTAN and AMLODIPINE for Blood pressure high, PRAVASTATIN for Cholesterol, LEVOTHYROXINE for Hypothyroidism.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ALOPECIA (lot of hair loss to the point where her hair is now only half an inch in thickness). At the time of the report, ALOPECIA (lot of hair loss to the point where her hair is now only half an inch in thickness) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had 4 Moderna COVID-19 vaccines previously, including 2 primary doses and 2 boosters. Patient received her most recent booster dose on 10APR2022 and about a month later the patient started experiencing hair loss. The hair was almost down to the knees and had a thickness of at least 2 inches. Ever since the 2nd booster dose, having a lot of hair loss to the point where the hair was only half an inch in thickness. The patient had gone on a cruise and by the time,  got off the cruise  had lost so much hair and had to cut the hair off. The patient had finally the little hairs are coming back but it was still very thin. Some hair was still falling out as well. The diagnosis was called alopecia areata. The patient was concerned that she will continue to lose more hair if the patient goes for the updated Moderna COVID-19 bivalent booster. The patient had looked everywhere online and has not found any information on whether the bivalent booster was causing hair loss in people. No treatment medication was reported.
Feels like not getting enough air when breathing normally. This has been going on since the second dose in May 2021, so approximately 2 months now.
Employee complained of swollen upper lip and rash (hives) 24 hours after administration of Hepatitis b vaccine #3. Saw physician. Was treated with Benadryl
Severe lower back pain; "muscle spasms and tightness"; "muscle spasms and tightness"; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ewo158) via an unspecified route of administration in the right arm on 07Apr2021 at 14:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient received unspecified medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 05:00, the patient experienced severe lower back pain with muscle spasms and tightness. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events severe lower back pain with "muscle spasms and tightness" were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
High fever(unchecked with thermometer), upset stomach, arm sore and hot, no reddness or rash on arm, severe headache, dizziness, pain in ears and teeth.
Redness (diameter about 6cm by 4cm) egg shape on right arm. Started 24 hours after vaccination (area of IPV vaccine). Resolving after 48 hours.
impacted bowel, muscle fatigue, headache, abdominal cramps, nausea
4/22/21 - 1 week post vaccine - Daily/intermittent extremely sharp arm pain at shot location for 2 months. Pain gradually decreased to daily/intermittent dull throbbing pain but arm range of motion decreased significantly over 1 month.  8/2/21 - Rheumatology Dr. visit - Adhesive Capsulitis diagnosis (frozen shoulder). Received cortisone injection in shoulder and started physical therapy.
After receiving both PREVNAR 13 and FLUZONE HIGH DOSE the patient developed a raised, red, rash on her left arm in the spot where the vaccines were given. The rash is localized to the injection site. The patient describes the rash as itchy but not painful. The rash appeared to be 3.5in in diameter.
Breakthrough case admission after 2 vaccines Pfizer 6/14/21 Lot# Ew0172;  Pfizer 7/7/21 Lot3 Ew0173
Hives. No reaction at injection site. Loose stools, mild URI symptoms and hives occurred 10/7/2004.
Root canal surgery after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (Root canal surgery after vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced TOOTH DISORDER (Root canal surgery after vaccine). At the time of the report, TOOTH DISORDER (Root canal surgery after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Information has been received from a nurse concerning a 66 year old male patient who in at age 65 was vaccinated with his first dose of Pneumovax 23.  In 2006, at age 66, the patient received a second dose of Pneumovax 23 because he forgot he received a previous dose.  He developed fluid retention in his hands and ankles.  Medical attention was sought. Subsequently, the patient recovered.  Additional information has been requested.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No information was reported on date of the storage of vaccine in refrigerator. Vaccine was expired on 09-Nov-2021.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-Significant follow up received.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 32-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data, they would need to treat this issue as a temperature excursion. The data was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients. No treatment were reported.
Feeling pretty swamp; Went to 90-95 bpm; Body aches; Body temperature was raised over two degrees; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling pretty swamp), HEART RATE INCREASED (Went to 90-95 bpm), MYALGIA (Body aches), PYREXIA (Body temperature was raised over two degrees) and CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced MALAISE (Feeling pretty swamp), HEART RATE INCREASED (Went to 90-95 bpm), MYALGIA (Body aches), PYREXIA (Body temperature was raised over two degrees) and CHILLS (chills). On 25-Feb-2021, MALAISE (Feeling pretty swamp), HEART RATE INCREASED (Went to 90-95 bpm), MYALGIA (Body aches), PYREXIA (Body temperature was raised over two degrees) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 99.5 (High) 99.5°F. On 23-Feb-2021, Heart rate: 90-95 (High) Went to 90-95 bpm.         No Concomitant information  provided. No Treatment information  provided   This case was linked to MOD-2021-026064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up information received on 15 Jul 2021 and Patient intials were changed from JS to GS. Laboratory data Body temperature was added. Chills deleted as additional event.
Information has been received from a physician concerning a 6 yr old white female child with no medical history or allergies who on 10Jul00 was vaccinated SC in the left arm with a 0.5ml dose of varicella virus vaccine live (lot632611/1855J). Concomitant vaccinations given on the same day included: a third dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (lot634054/0297K) given IM in the right leg and a second dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (lot471209) given IM in the left leg. There was no illness at the time of vaccination. On 29Jan06 the pt developed vesicular and papular lesions on her right mid abdomen. Unspecified medical attention was sought, no lab or diagnostic tests were performed. It was reported that the lesions were painful and itchy. At the time of the report the pt's outcome was unk. No product quality complaint was involved. Additional information has been requested.
Nasal Swab: Positive (NOV2022); Nasal Swab: Positive (Nov2022); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN199gh), in left arm and on 02Nov2021 as dose 3, (booster) single (Lot number: FH8020) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve disease (stable and no issues until vaccine)" (unspecified if ongoing); "migraines; worse after vaccine" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing); "Mold allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Nov2022, outcome "unknown", described as "Nasal Swab: Positive (NOV2022)"; COVID-19 (medically significant) with onset Nov2022, outcome "unknown", described as "Nasal Swab: Positive (Nov2022)". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (Nov2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other vaccine in four weeks was reported as no. The patient received other medications in two weeks was reported as no. The patient received vaccine prior COVID was reported as no.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300354059 Same patient, same drug/different dose, different AEs.;US-PFIZER INC-202300354135 Same patient/drug/AE, event separated in time.;
3/6/23 I was at my yearly dermatology appointment. I had a spot on my face which was biopsied and diagnosed with basal cell carcinoma from sun damage. I am supposed to have Mohs Surgery on May 1, 2023.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 13-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-2021; 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; Sender's Comments:  US-009507513-2102USA004059:
Itchy and painful rash; preventing from sleeping in the evenings.; Severe skin rashes on the torso andneck, back of the head.; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6Z07) via an unspecified route of administration in the left arm on 30Mar2021(at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient had no known allergies. 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 vaccination. On 03Apr2021, 4 days after the vaccination, the patient experienced severe skin rashes on the torso and neck, back of the head. On 04Apr2021 the patient experienced Itchy and painful rash which preventing from sleeping in the evenings. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with triamcinolone acetonide 0.1 % (MANUFACTURER UNKNOWN) topical cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe skin rashes on the torso and neck, back of the head, Itchy and painful rash and preventing from sleeping in the evenings was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning a geriatric female pt who on 04-JAN-2005 was vaccinated with a first dose of Pneumovax 23 (lt # 649692/0371P). There were no other concomitant vaccinations reported. On 05-JAN-2005 the pt experienced "swelling, redness, warmth, fever, and pain in the injection site arm." It was reported that the pt was treated with prednisone. It was reported that one other female geriatric pt had a similar adverse experience following administration of Pneumovax 23 (lot# 649692/0371P) (WAES0501USA00578). Additional information has been requested.
Pt recvd vax & devel expanding area of erythema & itching @ inject site; lesion measured 66 x 44mm by 13MAY; poss hypersensitivity reaction & cellulitis;