chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial injection was incredibly painful. I had the normal arm pain that I expected for a few days after but then the pain never went away. I have no history of shoulder pain/injury and had done nothing to cause a chronic injury. I went to to my primary care first and she thought that it was most likely from the the injection. I then went to a shoulder specialist who agreed and prescribed physical therapy. I have been in physical therapy for about 4 weeks with almost no noticeable improvement.
skin puffiness, 6-7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch; skin red, 6-7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch; sensitive skin, 6-7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch; skin hot to touch, 6-7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in an elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included allergy (respiratory allergies).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site redness, injection site discomfort and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site redness, injection site discomfort and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site redness, injection site discomfort and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that an approximately 78-year-old patient developed an injection site reaction after receiving her 1st Shingrix vaccine 5 months before the date of reporting on an unknown date.  The patient received the Shingrix intramuscularly into the left deltoid. The following day after vaccination, the patient developed a 6 to 7 inch oval soft ball sized bright red, puffy area which was hot and sensitive to the touch.  The injection site reaction covered her deltoid and extended to the back side of her arm and covered her bicep. The patient was examined one month following her Shingrix injection by her health care professional and the injection site reaction had completely resolved without treatment or intervention. The patient had completely recovered. The pharmacist did not have patient's exact age as she was working from home when she called to report the event.
11/12/21 presents to local ED for "left-sided weakness". PMHx of "CVA, CAD, peripheral arterial disease status post bilateral BKA".
12/24- fatigue, joint aches, cough, diarrhea, headache 12/25- fatigue, less cough and aches, headache, some diarrhea  12/26- same 12/27 slightly better 12/28 loss of taste and smell. Positive Covid nasal swab test 12/29 headache, cough, fatigue, diarrhea
~5:00AM 10/17/2014, awakened by L arm pain, aching all joints, worse with movement (only minimal pain at injection site); flu like symptoms, all over body joint aching, extreme fatigue. Continuing through 10/17, 10/18 (severe aching, limiting movement), better but ongoing 10/19.
following vax pt became pale & diaphoretic w/o lose of consciousness;BP was 70/40 which improved to 120/82 p/5 min of pt lying recumbent;pt alert & oriented when discharged;
developed neuropathy in both feet; This is a spontaneous report from a contactable consumer.  This consumer (patient) of unspecified age and gender reported that received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on an unknown date at single dose for COVID-19 immunization. Medical history included shingles about 10 years before reporting. Other products were not provided. The consumer stated that developed neuropathy in both feet after receiving the Pfizer vaccine. Its been 2 months. The outcome of the event was unknown  Information on the lot/batch number has been requested
EVENT: BELL'S PALSY (LEFT SIDE OF THE FACE) TREATMENT: Acyclovir 400 mg oral tablet and Prednisone 10 mg oral tablet
Pt recvd 2nd dose of Hep B vax 20SEP91 devel a rash on arms, body, & legs, fatigue, a cough, body aches & pains, nasal congestion, diarrhea, nausea, fever, frequent urination, & hypotension; pt later recovered;
2hrs after taking the 2nd shot of Pfizer vaccine experienced a burning sensation across my upper back and lower right back. It only lasted 10seconds but I have never ever felt something like this before. 2nd dose in the right arm.
covid 19/ she has lung Covid and fatigue; got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose; slept almost the whole day; there was slight pain on the arm of the injection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19/ she has lung Covid and fatigue), SOMNOLENCE (slept almost the whole day), VACCINATION SITE PAIN (there was slight pain on the arm of the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was reported that patient was very healthy and is not taking any medications.    In February 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose). In 2021, the patient experienced SOMNOLENCE (slept almost the whole day) and VACCINATION SITE PAIN (there was slight pain on the arm of the injection). In August 2021, the patient experienced COVID-19 (covid 19/ she has lung Covid and fatigue). At the time of the report, COVID-19 (covid 19/ she has lung Covid and fatigue) and SOMNOLENCE (slept almost the whole day) had resolved and VACCINATION SITE PAIN (there was slight pain on the arm of the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: Positive. On 08-Dec-2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that patient did not remember if she got more shots between the Mar-2021 and Oct-2022. Patient was in good shape but has lung Covid fatigues which got when patient had Covid in Aug-2021 (delta strain) and 08-Dec-2021 (patient cannot remember what strain she had but that was before the Omicron). Patient reported that she had these 2 Covid episodes for one day each because she used Colloidal silver which she inhaled. Patient used it in until the symptoms gone away. Patient added that after she got the 1st dose there was zero pain, but she slept almost the whole day. After getting the 2nd dose there was slight pain on the arm of the injection but no pronounced fatigue.
experienced a hole in her arm at the injection site after her first COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE REACTION (medically significant), outcome "unknown", described as "experienced a hole in her arm at the injection site after her first COVID vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of event Vaccination site reaction cannot be 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Hospitalized for dyspnea, cough, chest tightness in conjunction with Covid pneumonia plus heart failure exacerbation.
Fever 99 degrees WITH 600mg Ibuprofen, chills, nausea, headache, fatigue,  raised and red area around injection site, pain at injection site. Duration approximately 14 hours
It was reported that a male patient received a Rabies Imovax IM vaccination on 11-Sept-2000. Approximately 14 hours after the vaccination the patient developed nausea and vomiting. Patient was seen in emergency room.
Two hours after receiving vaccine mother phoned stating site on arm is swollen and hive like- rxn. Pt. would not use arm. Recommended TYLENOL and BENADRYL (generic forms) and cool compress. Office visit the next day due to extension of local rxn. Improvement in ROM of arm. 4x5 cm induration. ZYRTEC daily with one dose BENADRYL at hs.
This spontaneous report was received from a nurse and  refers to an unknown number of patients (gender and age unknown). On an unknown date the patient or patients were vaccinated with improperly stored  PNEUMOVAX 23 (dose, route, application site, frequency,  and lot # were not reported) for prophylaxis. There were no adverse effects. The nurse reported that the PNEUMOVAX 23 was exposed to 0 to 2 °C for 67 hours. The call was due to a data logger. The patient or patients'  outcome was unknown. This is one three reports from the same reporting nurse. MARRS 1611USA000874 and 1702USA004999 Additional information has been requested.; Sender's Comments: US-009507513-1611USA000874: US-009507513-1702USA004999:
Dizzy , felt nauseated, numbness in right arm, burning .Stated "the same thing happened last time" on 3/27/2021. BP 118/78 HR 78 BP 140/85 HR 62- 30 mins later  Remained in the observation area for 30 mins
Vaccine was stored at -20 Degrees F so outside of the Temperature range; A spontaneous was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was stored at -20 degrees F, so outside of the temperature range.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The reporter stated the COVID-19 vaccine was stored at -20 degrees Fahrenheit; outside of the recommended temperature range. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine that was stored at -20 degrees F so outside of the temperature range, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.
16 year old employee inadvertently was given the Moderna product; A spontaneous report was received from a pharmacist concerning a 16-year-old, patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The pharmacist stated that a 16-year-old employee inadvertently was given the Moderna product. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, 16-year-old employee inadvertently was given the Moderna product, was considered resolved.; Reporter's Comments: This report refers to a case of 16-year-old employee inadvertently was given the first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. There were no reported AEs associated with this case of  "16-year-old employee inadvertently was given the Moderna product".
4:30pm Uneasy feeling, abdomen itchy. 5:15PM Abdomen and sides excoriated with hot red burning splotches, feeling of lethargy & chills. 6:00PM Called pharmacy with symptoms advised to take BENADRYL. Took one BENADRYL & 7:00 AM Woke up with headache, angioedema face, lips swollen, chills burning red splotches resolving somewhat. 12:00PM Injection site turns blood red with extreme burning sensation  when otherwise there was little sign of injection. Injection site, 3"x 2" oval, now scorching red with "fire bolts". 10-26-16 Still small fading red injection site with extreme painful "Fire Bolts" occasionally.
Papular skin rashes, noticed the day after vacc. on both anterior thighs.
Very fussy. Crying non-stop. Fever 101.3. Macular rash over entire body.
REDNESS, SWELLING, ITCHING, FEVER AROUND 8:00 PM ON 8/8/11.  RIGHT ARM
BOWELS UPSET AND YELLOW SLIME COMING OUT SINCE DAY OF SHOT; BURNING IN ARM; SEVERE PAIN IN ARM AT INJECTION SITE; PSORIASIS; NECK PAIN; BRUISE HAVING THE SIZE OF 50 CENT PIECE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, severe gastroparesis, internal tremors, and psoriasis, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203a21a, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Concomitant medications included adalimumab for psoriasis, ixekizumab for psoriasis, risankizumab for psoriasis, and ustekinumab for psoriasis.  On MAY-2021, the subject experienced neck pain. On MAY-2021, the subject experienced bruise having the size of 50 cent piece. On MAY-2021, the subject experienced psoriasis. On 10-MAY-2021, the subject experienced bowels upset and yellow slime coming out since day of shot. On 10-MAY-2021, the subject experienced burning in arm. On 10-MAY-2021, the subject experienced severe pain in arm at injection site. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from bowels upset and yellow slime coming out since day of shot, had not recovered from severe pain in arm at injection site, and burning in arm, and the outcome of psoriasis, neck pain and bruise having the size of 50 cent piece was not reported. This report was non-serious.
She said that she began vomiting and had diarrhea later that day, was better the next day, Dr wanted us to report.
got sick as a dog each time; Initial information received on 17-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who got sick as a dog each time after receiving vaccine Influenza vaccine.   The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received unknown dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, strength, formulation, route, expiry date and administration site not reported for flu (Influenza).  On an unknown date the patient had the flu shot 3 times in life, got sick as a dog each time (illness)" (unknown latency) following the administration of  Influenza vaccine.  It was reported that "I have also had the flu 3 times WITHOUT the flu shot. I am healthier without it."   It is unknown if there were lab data/results available.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 09:00 as dose 4 (booster), single (Lot number: GJ3277) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Mar2021 at 18:00 as dose 1, single (Lot number: 012A218), in left arm, on 02Apr2021 at 18:00 as dose 2, single (Lot number: 048A21A), in left arm and on 17Nov2021 at 09:00 as dose 3 (booster), single (Lot number: 069F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos Syndrome (hypermobility)" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Oct2022 at 09:00, outcome "recovered", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Aug2023, outcome "recovered" (28Aug2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Aug2023) positive, notes: First tested positive 23Aug2023; (28Aug2023) negative; (29Aug2023) negative; (30Aug2023) negative; (31Aug2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 23Aug2023 to 28Aug2023 for COVID-19 .; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291483 same patient, different drug/event;
Received Pfizer vaccines on 3/12/21, 4/2/21 Tested positive for COVID by PCR on 11/1/21 Admitted to hospital on 11/1/21 d/t weakness, acute COVID infection, Afib w/ RVR
vomiting, diarrhea, weight loss, overall irritability, lack of sleep, dehydration.from dec.19 to present, hospitalization required.treatment entailed, I.V, numerous tests, zantac liquid, formula switched to nutramigen, all unsuccessful.
Pt received 2nd Pfizer BioNTech Covid 19 EUA vaccine @1:50 pm; Pt released from Observation @2:09 pm. Approximately 2:18 pm RN called to parking  lot and observed pt having difficulties. Called for EMS & crash cart. Vitals taken 2:20 BP 83/55, no respirations noted, pt unresponsive. AED attached.  EMS arrived 2:22 and took over care of pt. and transported @2:40 pm to Hospital. Per wife, pt has history of PE in Oct. 2020, HTN, diabetes with insulin pump, obesity, gastroparesis, home oxygen and uses motorized scooter. Wife also said pt had allergy to iodine not previously reported, and MD had stopped Zarelto subsequent to 1st Pfizer vaccine 2/8/21 "due to  breathing difficulty". Patient was  unable to be resuscitated.  Time of death 14:59.
Covid positive as of 7/6.  Hospitalized as of 7/9 due to atrial flutter with rapid ventricular response, converted to sinus rhythm after receiving amiodarone
Patient had Pfizer for first vaccine on 06/02/21 and received Moderna for a second dose 06/29/21.
2 dose: pain in lungs for 24 hours after vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Lot number: EN6201) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seafood" (unspecified if ongoing), notes: Known allergies : Seafood, shellfish, pineapple; "shellfish" (unspecified if ongoing), notes: Known allergies : Seafood, shellfish, pineapple; "pineapple" (unspecified if ongoing), notes: Known allergies : Seafood, shellfish, pineapple. There were no concomitant medications. Vaccination history included: Covid19 vaccine (Dose Number: 1, Batch/Lot No: FK4175, Location of injection: Arm Left, tightness of chest and pain in lungs for 28 hours), administration date: Jan2021, when the patient was 23 years old, for COVID-19 Immunization, reaction(s): "tightness of chest"; Bnt162b2 (Dose Number: 1, Batch/Lot No: FK4175, Location of injection: Arm Left, tightness of chest and pain in lungs for 28 hours), administration date: Jan2021, when the patient was 23 years old, for COVID-19 Immunization, reaction(s): "pain in lungs".  The following information was reported: PULMONARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "2 dose: pain in lungs for 24 hours after vaccine".  Additional Information: No other medications in two weeks. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Immediately following shot I developed fever, muscle aches, runny nose, cough. Flu like symptoms!
Patient received moderna vaccine 2/6/21 and 3/6/21. Presented to ER on 5/20/22. FOund to be COVID positive. was admitted on 5/20/2022 presented with fever and COVID infection with hypoxia SpO2 88%.              CT chest negative for PE and COVID related changes.  Vaccinated against COVID-19.  H/O kidney transplant on chronic immunosuppressant. Given immunocompromised status,  remdesivir to continue until 05/25/2022.  Also continue dexamethasone             Bacteremia Staphylococcus epidermidis.  E coli UTI.  Antimicrobial completed as per ID.  Acute metabolic encephalopathy -resolved , baseline mild dementia.              Clinically improving.  Maintaining saturation on room air.  Pt evaluation recommended home health care.  Denies any new concerns. Patient is medically stable to be discharge Home with HHC. Discharged on 5/27/22
Mother reports that about 12-24 hours after the shot of MMR, Hep A, DTP and Polio and mother reports that she was told that she received DTaP in that leg.  Patient complained of pain the next day -- within 24 hours.  By about 36 hours, she had swelling and redness and tenderness of the leg.  She had temp to 99 degrees when seen in ER last night.  She presents in clinic due to increased swelling and redness of the leg.
No additional AE; Medical assistant calling to report PROQUAD administered to patient after TE occurred.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.       On 22-MAY-2023 the patient was vaccinated with wrongly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W032152 and expiration date 07-APR-2024  for prophylaxis (exact dose and route of administration were not provided) (product storage error and no adverse event).