chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling at the injection site/injection site looked puffy; injection site was also red; received the vaccine in his right arm 25Oct2019, he had a little pain; This is a spontaneous report from a Pfizer-sponsored program, Pfizer RXPathways received from a contactable consumer (patient's wife). A 73-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in the right arm on 25Oct2019 at about 14:00-14:30 at 0.5 ml, single for pneumonia shot, vaccinated on the pharmacy/drug store. The patient has no medical history. Concomitant medication included third dose of influenza vaccine (FLUZONE) on 25Oct2019, received the flu shot on the same day in the opposite arm (left) but didn't give a reaction; the first dose was in 2006 and the second dose in 2007. It was reported that the patient's arm was red and swollen and he had some type of reaction. The patient received the vaccine in his right arm 25Oct2019, he had a little pain on the day he received the shot. He still had a little pain if he moves his arm or touches the injection site. The injection site was also red on 26Oct2019, the day after he received the vaccine and was swollen on 27Oct2019, about 2 days after receiving the vaccine. At first, the reporter stated the swelling at the injection site was kind of expanding. She thought it has expanded since the day he received the vaccine but the patient stated that the swelling was about the same, maybe a little less. For the patient's wife, the area was scary looking, she stated "to me I thought the injection site looked puffy in the beginning and now it's less puffy". The  patient's wife wanted to know if there is anything the patient can do now to prevent the reaction from getting worse. She stated that the pharmacist suggested putting Hydrocortisone cream with aloe on the affected area. The cream was from a Pharmacy and it reads "Hydrocortisone cream with aloe; soothing relief for skin irration, rashes, redness and irritation". The patient asked if he could use Vicks Vapor Rub he bought the Vicks Vapor Rub asked the attendant could he use the product as treatment. Outcome of the event pain and redness was not recovered while recovering for other event.
pt recvd vax 3SEP92 & later that day following vax pt devel a rash, labored breathing, fever & sweating; tx DPH; no further details were provided;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-APR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fever of 100.7 deg F.; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100.7 deg F.) and HEADACHE (Terrible headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047*21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PYREXIA (Fever of 100.7 deg F.) and HEADACHE (Terrible headache). At the time of the report, PYREXIA (Fever of 100.7 deg F.) and HEADACHE (Terrible headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Pyrexia: 100.7 (High) fever of 100.7 deg F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. The patient did not receive any treatment.
8/23/2016: 1 yo female received routine vaccines: MMR lot# M008588, VAR lot # M019643; and Hep A lot at Z5DM2. 8/29/2016 (day 6): that evening, child had mild fever of 100.8 with several episodes diarrhea, and fussy. Symptoms resolved with MOTRIN and calming. 8/30/2016: 2AM: hot sweaty Temp 100.8F given MOTRIN, fever gone 530am. Took flight and she slept a lot, felt warm, given dose MOTRIN around 11am. During ride to friends home, she was hot to touch, sleepy, lethargic but would awaken acting normal-laughing. About 3pm (out shopping) mom noted her head turn sideways, pupils dilated, body stiffened-was tense and she began to tremble/twitch-seizure. 911 contacted and child removed from car seat, skin was red about chest/torso-cooled with tepid water/remove clothing and within 5 minutes the trembling stopped. EMS arrived: child was sleepy and unresponsive (not awake). Mom said EMS advised temp 102.4F, her lips blue, eyes bloodshot, and child stopped breathing/gasping and required BVM support. 8/30/2016 (day 7) Arrival ER: seized with tonic/clonic movements - given Lorazepam 2mg. Appeared post ictal, agonal breathing after lorazepam = intubated. Temp 103F and HR 240, Given TYLENOL, Ceftriaxone and 40cc/kg IVF with HR 170 - admitted, extubated. Labs: mild transaminitis and hepatitis. 8/3/2016: after a bath, pale/cool lethargic, HR 220 vagal maneuvers ineffective, given multiple doses of adenosine 0.6 mg/kg total w/o resolution. 9/1/2016: cardiology evaluation; child now alert crying vigorously, good pulses with spontaneous resolution SVT, HR 200-150 x 1 hr then SVT again. Treated Adenosine, milrinone diagnosed myocarditis. While in the PICU - developed ITP. 9/2/2016: on HFNC and CPAP; troponin (9/3/16 peaked at 1.48) and BNP elevated. DX myocarditis; steroids x2 days; 9/3/2016: MRI suggests viral encephalitis. 9/4/2016: In PICU: jaw locked up, became tense and hemiparetic moving only right arm, re-intubated - resolved with phenobarbital MRI normal. 9/6/2016 Treated with IVIG and pulse steroids. 9/8/2016 no seizure x 1 week. Extubated. ? problem with vision and hearing after extubated. Child not recognizing parents; noted to no longer blink to threat, fix or follow with concern for loss of vision after extubated and became more aware of surroundings. Fine and gross motor deficits were noted by the hospital therapists with recommendations for ongoing OT and PT.
VERY SICK; BRONCHITIS; This spontaneous report received from a patient concerned a 70 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: covid-19, and pneumonia (The patient said he received negligent care from well known entity, horrible care years ago and that is why his health was compromised from the pneumonia.), and other pre-existing medical conditions included: The patient reported that he was an athlete for a long time and enjoyed superior health and can still knock out at least 20 push ups on demand. He said he has a job that gives him unusual exposure to cold drafty air things that would be highly susceptible for people to get a cold. His line of work exposes him to that. He reported that his health was not what it used to be. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced very sick, and bronchitis with cold draft air hours upon hours (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very sick and bronchitis was not reported. This report was non-serious.
Pfizer-BioNTech COVID 19 vaccine EUA  Shortly after receiving this vaccine (about ten minutes or less) I felt tingling throughout my body for no more than 10 minutes. It lasted the longest in my legs. I didn't think much of it as it resolved in about 10 minutes and another woman said she felt it too. I am reporting because I have seen an article that medical center has halted vaccine administration due to workers experiencing this.
Grandmother of Pt called to say child is "covered in spots" 2 wks after MMR & VZV vaccines on 4/30/10.  Had temp of 103 X 2 days after shots ; cranky, fussy, runny nose since then.  Spots appeared around 5/14, non-vesicular, on torso, diaper area & arms and legs.
Tdap given (L) arm 1/12/12. Arm became painful then swelling began in upper (L) arm 1/13/12. Now swollen, inflamed, hot to touch and painful.
Severe chills, shaking lasting about 90 minutes. Symptoms stopped about 30 minutes after one dose of acetaminophen.
Tiredness; Headache; Muscle pain; Fever; This is a spontaneous report from a non-contactable consumer (patient).  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness, headaches, muscle pain, fever. The patient outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Right sided facial numbness and tingling, possible decreased hearing acuity of right ear only, accompanied by moderate headache, sedation
This is a 46-year-old gentleman who states that he has had 2 doses of the Pfizer vaccine in April.  States he did go to an amusement park a couple weeks ago and on 07/05, he started having symptoms of fever, chills, diarrhea, shortness of breath, so went to a local pharmacy and a couple days later was told that he was positive.  EMS was called to the house and his oxygen saturation was 60% on room air.  Patient was admitted on 7/12 to PCU and started on COVId treatment for pneumonia and respiratory failure. He was discharged 7/19.
Patient came to clinic on 01-25-07 inquiring about name and dosage of medication she received on 9/30/06. Patient stated had headache, chills, fever, fatigue and vomiting the day after vaccination. She did not seek medial attention. Instead she took some medication given by her mother. She stated felt better afterwards.
From telephone contact received at Aventis Pasteur Inc. on 02/28/02, it was reported that a 4 month old with an ActHIB vaccine, lot # UA 623AA on 02/07/02. The patient experienced high pitched cry, fussiness and couldn't sleep on 02/07/02. Physician prescribed Tylenol and compresses. This case is closed.
Vaccine error - Vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.
Approx. 24 mins into observation time client reported facial 'burning'. Client moved to private room and benadryl  administered.  Denied swelling or airway obstruction. EMS called/escorted client to hospital.
This was an administration error, not an adverse event. The Health Department had left over vaccine at the end of clinic and opened this up to employees and their families. These appointments were not registered using as per our usual practice, but were done as walk-ins on paper. The vaccinating nurse was a fully vetted retired RN who had undergone training many times and had worked at many clinics. The vacinee's age was stated on the requisition form but the vaccinator missed this and gave Moderna to a 17-yr-old. Employees training always includes discussion of target group and age requirements. This occured at the end of a busy clinic on a day that included both electronically registered and non-registered individuals, which is not our usual practice. We will avoid this practice in the future and will continue to address age requirement in trainings, stressing the importance of checking this parameter in people who did not register electronically. If this person had tried to register electronically, she would not have been able to proceed after entering her age. Writer discussed with CDC and was told to administer dose 2 as planned and to complete VAERS reports for each dose.
Left upper arm and chest developed a rash; Arm sore; Fever middle of the night; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (Left upper arm and chest developed a rash), VACCINATION SITE PAIN (Arm sore) and PYREXIA (Fever middle of the night) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Historical condition not reported.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm sore) and PYREXIA (Fever middle of the night). On 26-Mar-2021, the patient experienced RASH (Left upper arm and chest developed a rash). On 16-Mar-2021, VACCINATION SITE PAIN (Arm sore) and PYREXIA (Fever middle of the night) outcome was unknown. At the time of the report, RASH (Left upper arm and chest developed a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Caller states taking Saturday Zyrtec to help relieve side effects.
Pt recvd 3 doses of Engerix-B & 12MAR92 titer checked; neg for antibodies; may be given addtl doses;
Only time I got the flu was when I got the flu shot; Initial information received on 12-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via Agency.  This case involves adult patient (unknown demographic) who had got the flu was when patient got the flu shot after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s) 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] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious got the flu was when patient got the flu shot (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Only time I got the flu was when I got the flu shot. Never again. It's a crap shoot anyway. I am done lining big Pharma's pockets."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Had ER visit on 11/16/11 for large hive 14 x 15 cm on (L) anterior thigh post vaccine (MMR & tetanus) on 11/15/11. Treated w/NSAIDS, BENADRYL.
Patient was given three shots way before a booster was ever in the picture. I was entering a flu shot into our state data base today and while updating the patients profile I noticed that the patient had received 3 moderna vaccines the last being at the first of march. She received her first 2 doses from our facility but the third was administered by a Hospital. That third dose was administered in error
Developed chest pains, Rehabilitation Center moved to hospital on 4/13/2021. Took a turn for the worse in the evening  of 4/13/2021. Hospital found fluid on lung x ray. He was placed on ventilator overnight preformed CT Scan the afternoon of 4/14 and discovered several bloods clots In right lung. Patient still in hospital under sedation and on ventilator. Hospital has started him on Heparin.
Intense rash beginning 1 week after vaccine. Referred to Dr who diagnosed Serum Sickness.
PT REQUESTED  J& J VACCINE- VACCINE WAS GIVEN- HOWEVER, SHE IS 16 YEARS  OLD
26 hours post injection, my son experienced a fever of 99.9, chills and fatigue. He then walked upstairs in our home and passed out-he was out for around 30 seconds. Afterward, his temp was still 99.9 and he began to experience vertigo. The vertigo lasted until Friday May 21.
no adverse event; Improperly stored vaccines administered; This spontaneous report was received from other and refers to some patients. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 28-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, three dose series, lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 28-JUL-2023, 5 patients in total and additional patients were administered the affected hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from the lot involved in a temperature excursion at the same location (Product storage error). No adverse events reported (No adverse event).   This is a non-valid case due to no patient's identifiers.   Follow up information has been received from an other health professional on 09-AUG-2023 and refers to a 11-year-old female patient. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (lot # 213723, expiration date: 17-OCT-2025 via Right Deltoid) and meningococcal vaccine conj (lot # AMVA767A, expiration date: ??-DEC-2023 via Left Deltoid). The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via Left Deltoid.    This is one of several reports from same reporter. ; Sender's Comments:  US-009507513-2309USA000746: US-009507513-2309USA000745: US-009507513-2308USA001806: US-009507513-2309USA000747: US-009507513-2309USA000743: US-009507513-2309USA000748:
No additional adverse events reported; improperly stored vaccines may have been administered to the patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 26-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
tingling from feet to head, dizziness, difficulty speaking, redness, swelling to face, and hypertension (180/91). Within 30 minutes of receiving vaccine. Resolved within 2 hours after medicating with PO benadryl and IV pepcid
Swelling @ site of injection. Post 12-12 hours later redness, hot to touch and swelling.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67 year-old male patient received bnt162b2 (BNT162B2), administration date 21Aug2021 (Lot number: EWO196) at the age of 67 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing), notes: Verbatim: Glaucoma. Concomitant medication(s) included: LITHIUM; VOLTAREN [DICLOFENAC] taken for glaucoma. Vaccination history included: Flu vaccine (4-5 years ago I took the vaccination for the flu and I got sick), for flu, reaction(s): "Sick". The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Aug2021, outcome "unknown", described as "Consumer stated, "That was in my left shoulder"; DYSPNOEA (non-serious) with onset 26Aug2021, outcome "unknown", described as "Little short of breath"; RETCHING (non-serious) with onset 26Aug2021, outcome "unknown", described as "Dry heaves"; NAUSEA (non-serious) with onset 26Aug2021, outcome "unknown", described as "Nauseous". Therapeutic measures were not taken as a result of incorrect route of product administration, dyspnoea, retching, nausea. Additional information: vaccination facility was mentioned as clinic. Prior vaccinations (within 4 weeks) was none. Reporter stated, "I took the vaccine of Pfizer, the first shot on 21Aug and yesterday, the last couple of days I had like the dry heaves and what and when I exercise which I never had a problem exercising before and when I exercise I am little short of breath." Reporter confirmed the name of the product as Pfizer COVID vaccine. Reporter stated, "Two days ago, I felt nauseous and then dry heaves about 3 times and then last night I did again." Follow-up attempts are completed. No further information is expected.
Flu like symptoms, fever, myalgia, cough, fatigue, itchy skin eruptions.
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in unspecified number of patients who received FLUARIX quadrivalent. In 2015, the patients received FLUARIX quadrivalent. In 2015, less than a day after receiving FLUARIX quadrivalent, the patients experienced injection site swelling and injection site rash. On an unknown date, the outcome of the injection site swelling and injection site rash were unknown. It was unknown if the reporter considered the injection site swelling and injection site rash to be related to FLUARIX quadrivalent. Additional details were provided as follows: The healthcare professional reported the multiple patients who received the FLUARIX QIV complained of abnormal swelling and rash at the injection site within one day after receiving the vaccine. The healthcare professional reported that one patient experienced respiratory issues after vaccination with FLUARIX QIV (see case US2015GSK165000). The healthcare professional initially called to inquire if there had been a change in 2015 year's formulation or if there had been an increase in reports of these type of adverse reactions with patients receiving FLUARIX QIV. The healthcare professional reported that she was not having access to further patient identifiers or product details at the time of reporting. No further information was reported regarding the event.