chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose: Pain on arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:00 (Lot Number: EW0150; Expiration Date: Jul2021) as SINGLE DOSE for covid-19 immunisation. Medical history included colitis, high blood pressure. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for high blood pressure at 10/12.5mg, one tablet every morning, orally, start and stop date were not reported and she had been taking for about three years; delapril taken for high blood pressure at 240mg, one capsule every night, orally and she had been taking for about 20-25 years. The patient experienced pain on arm at injection site which began about one hour after receiving the covid vaccine around 06Apr2021 16:00. It hurt all that night and was gone by the next day. The outcome of the event was recovered on 07Apr2021.  No follow-up attempts are needed. No further information is expected.
Large localized reaction right thigh at injection site, erythema, mild edema, inflammation. Warm compresses. Advil
Fever of 99.9 degrees; Chills; Mild headache; Aches; Arm pain; Fatigue; Mild shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm on 07Apr2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and COVID - 19 infection. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN) for unknown indication, from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm on 17Mar2021 at 10:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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 07Apr2021 at 19:30 the patient experienced fever of 99.9 degrees Fahrenheit, chills, mild headache, aches, arm pain, fatigue and mild shortness of breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown, if the therapeutic measures were taken as a result of reported events. The clinical outcome of the events fever of 99.9 degrees Fahrenheit, chills, mild headache, aches, arm pain, fatigue and mild shortness of breath was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
@1025 Pt was placed on the gurney as a precaution. Denies any symptoms during 30 min observation period.  @1050 Pt ambulated and became nauseated. Assisted pt back in bed. Emesis bag provided. VS 137/61 (89) 70HR 98%RA 16.  @1055 Nausea resolved. Pt is feeling better. Trial ambulation done. Tol well. Asymptomatic. Pt and daughter confident on going home. Pt wants to go home. Made DOD aware of the situation. ED precautions provided. Daughter then told nurse that pt had a rash with the first vaccine and pt's PMD was aware. Instructed daughter to watch pt closely, go to ED as symptoms progressed or new symptoms arise, and take Benadryl as directed by their PMD. Daughter verbalized understanding. Daughter is confident on taking her home. Ambulated out of the obs room. Asymptomatic. No distress.
Pt recvd 2 doses of Engerix-B 7SEP91, 7OCT91 & p/1st dose & w/in 24 hrs of administration pt exp dizziness, blurry vision & hot flashes; In addition, events were again exp p/2nd dose; required treatment;
nausea and "sweating", diarrhea & abd cramps starting on 3/23. Taking imodium and pepto, able to eat and drink. Denies shortness of breath, chest pain, or fevers. Advised to continue taking OTC meds as directed and to contact PCP due to ongoing abd issues and diarrhea. -
it's the bottom of the patient foot and little scared to take the second dose,; it gave me like rashness upon the bottom of my feet; I had like an itchy on the bottom of my feet; it became red and I am not very allergic person; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date it was reported that it's the bottom of the patient foot and little scared to take the second dose, it gave the patient like rashness upon the bottom of feet and had like an itchy on the bottom of the patient feet and it became red and the patient was not very allergic person. The outcome of the events was unknown.  Information on lot/ batch number has been requested.
Client received TDAP.  After waiting in health department 20 minutes without problems.  Went to department store.  While in store, became weak, head felt "funny", dizzy, tunnel vision, "felt like pins and needles in chest and abdomen."  Episode lasting for 1 hour.
Raised, hard, red rash on upper arm, approximately 2 inches long and 1 inch wide. Began day of vaccine and still present 8 days later.
Patient received two vaccines, PREVNAR 13 and FLUZONE HD on 9/25/2018. The patient started to develop a rash the night of the vaccine, by the next day 9/26/2018 she had a large red rash approximately the size of a golf ball around the injection site. The rash was red and warm to the touch. The patient said that she also developed a headache and had flu like symptoms. She took TYLENOL the night of 9/26/2018 and started to feel better. By 9/27/2018 she had a rash and no other symptoms.
pt was given 1st dose of Engerix-B & 1 wk later c/o h/a & stiff neck; pt given 2nd dose w/same lot# & expiration date w/no untoward reaction; pt stated probably had a sinus infection @ the time of the 1st dose;
real bad muscle problem on the left leg; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (real bad muscle problem on the left leg) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 012A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  The patient's past medical history included Heart disorder.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MYALGIA (real bad muscle problem on the left leg). At the time of the report, MYALGIA (real bad muscle problem on the left leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product included heart medication. Treatment information was not provided.
My throat itching and feels swollen; My throat itching and feels swollen; lungs tightened; This is a spontaneous report from a contactable other-HCP (patient herself). A 40-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in right arm on 17Sep2021 15:30 (at the age of 40-years-old) as dose number unknown, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. Patient medical history included known allergies to Kiwi tape. The concomitant medications were not reported. On 17Sep2021 15:30, the patient experienced throat itching and feels swollen, and lungs tightened. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Therapeutic measures were not taken with respect to adverse events. The device date was reported as 17Sep2021. At the time of this report, the outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Pain in Left Upper Arm. Swelling noted in Anterior Left Elbow. Anterior Upper Left Arm where Smallpox vaccine was given is without abnormal findings.
5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure.  Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes.  2-3 hours after administration developed lip, face and tongue swelling.  Administered Zyrtec and tylenol.  Symptoms improved but continued into next day.  18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping.  These symptoms persisted for another 12 hours.  Tylenol was given to assist fever and pain.
This spontaneous report was received from a registered nurse refers to an approximately 56 year old male patient. The patient's medical history included cardiac history. There was no history of allergies. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot # J013555; expiry: 02-MAY-2015) intramuscular injection in the right deltoid, dose: 0.5 millilitres. The patient's concomitant medications included: unspecified cholesterol and blood pressure medications. On 13-MAY-2014 the Nurse states that patient was vaccinated with PNEUMOVAX 23 and that evening developed stomach issues and vomiting. No body aches at that time. Patient was informed to begin a bland diet. Yesterday (approximately on 15-MAY-2014), patient sought medical attention and was seen at the doctor office with vomiting, fever, chills, sweats, and injection site of right arm is blotchy and warm to touch. Patient was treated with ZOFRAN, Cortisone Cream and TYLENOL. Patient was being monitored, and was instructed to call the office if any other problems. The outcome of stomach issues, injection site of right arm warmth, injection site of right arm is blotchy, chills, fever, vomiting and sweats was reported as resolving. Causality assessment was not provided. Additional information has been requested.
Painful lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Oct2021 (Lot number: 301458A) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL0142, Location of injection: Arm Left), administration date: 11Jan2021, for covid-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EH9899, Location of injection: Arm Left), administration date: 21Dec2020, for covid-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 04Oct2021 01:00, outcome "not recovered", described as "Painful lymphadenopathy". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: : Painful lymphadenopathy beginning in the left axilla about 12-18 hours after injection. By 24-36 hours after injection the painful adenopathy spread to the left supraclavicular lymph nodes. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
5/1 - Patient will not wake up from nap time at school. He is often the first kid to wake up from naps at school. Teacher notified me of this strange symptom. 5/2 - Same as above. Patient begins slight stuttering in the evening. 5/3 - Patient begins to stutter more. Cannot form sentences. Very irritable, lots of outbursts and tantrums. Can't seem to follow through on simple tasks and follow sequences. 5/4 - Stuttering gets worse. Big big emotions, screaming, crying.  Loss of appetite. This is unusual.  Same as above with follow through on tasks and sequences 5/5  - Stuttering is terrible. Same symptoms as above. 5/6 - Stuttering begins to get marginally better.  Trouble focusing and following through with simple tasks and sequences at school. 5/7 - Stuttering gets a little better.  5/8 - Stuttering is now much less than after initial shot. 5/9 - Mild stuttering  Complaints of stomach aches often after MMR shot. Diet has not changed. In general, the neurological symptoms lasted a week and a half. The focus and attention issues that came up after MMR has now subsided a little, but was severe post MMR shot and lasted nearly 4 months.  5/5 - Stuttering gets even worse. Volatile emotions. Appetite is unstable.
Patient has aching, decreased Range of Motion in shoulder where vaccine was administered. Saw Dr. 11-7-07 for these complaints - given RX for antiinflammatory medication and physical therapy
The pneumonia shot given to me caused severe muscle spasms in my left arm, they were so bad I went to the ER. The muscle relaxers didn't work. I know can only lift my arm up a few inches as it's still very painful, hot and is sensitive.
First symptoms cold like, runny nose, sneezing, coughing. On 05/15/11 enlarged lymph nodes noticed, cold symptoms continued. Pimple like rash began on face 05/20/11, rash then flattened out to flat dry rash bumps (still on face) began 05/22/11. Rash then began like pimples then flattened out like face beginning on torso, then arms/hands, then goin area and lastly legs and feet. Rash was on complete body by 05/24/11. Rash lasted and did not begin to disipate until 05/29/11.
Patient experienced a 104 degree fever 12 hours after GARDASIL 9 was administered; This spontaneous report was received from a physician via company representative referring to a non-pregnant female patient of unknown age. The patient's concurrent conditions, past medical history and concomitant medications were not reported.   On an unspecified date in August 2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularlly (dose number, frequency, lot/batch # and expiration date) for prophylaxis. In approximately August 2018 (reported as approximately one year ago), the patient experienced a 104 degree fever 12 hours after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (pyrexia). It was unknown if treatment was given for the event. The outcome of pyrexia was reported as recovered (date was not reported).    The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Janssen Lot #043A21A COVID-19 vaccine administered Tuesday July 13, 2021 at 12:15pm. Wednesday July 14, 2021 - quarter sized spontaneous bruising to bilateral calves  Thursday July 15, 2021 - dollar sized spontaneous bruising to bilateral calves; petechial rash noted to bilateral ankles and calves Friday July 16, 2021 - continued bilateral calf bruising; petechial rash spread from ankles to mid thigh bilaterally and bilateral shoulders and back Saturday July 17, 2021 - patient presented to urgent care and referred directly to Emergency Department; platelets found to be 7,000; bilateral lower extremity ultrasound negative for thrombi; admitted to Hospital Sunday July 18, 2021 - platelets improved to 29,000; patient discharged to home for outpatient follow-up of new diagnosis of Immune Thrombocytopenia Purpura Tuesday July 20, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 198,000 Friday July 23, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 264,000 Monday July 26, 2021 - outpatient lab (see medical tests and laboratory results); platelets 45,000 initiated 40mg daily oral Prednisone
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left arm with 1st shot) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient breastfeeding administered with first 2 shots) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination. Concomitant products included MAGNESIUM and ZINC for Supplementation therapy. On 26-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Patient breastfeeding administered with first 2 shots). On 27-Dec-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm with 1st shot). On 26-Dec-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Patient breastfeeding administered with first 2 shots) had resolved. On 29-Dec-2021, PAIN IN EXTREMITY (Pain in the left arm with 1st shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication use was not provided by the reporter. Patient had accidentally got second dose on 10Jan2022, 2 weeks after first shot, earlier and out of the normal indications to get vaccinated, 1 month apart. She realized of that mistake and went to see 3 different physicians to ask them if there was anything wrong about it. All of the 3 HCPs told her there was no problem. Still, she was concern and mentioned currently breastfeeding when vaccinated and experienced just pain in left arm 1 day following vaccination, and it stopped 1 or 2 days after every shot. This case was linked to MOD-2022-449534 (Patient Link).
Patient is a 71 y.o. female patient of local MD with history of PAD, neuropathy, DM type 2, COPD and mood disorder who presented to Hospital with SOB.   Acute respiratory failure with hypoxia Due to COVID-19 virus infection and COPD exacerbation Found to have SPO2 of 58% on EMS arrival. Initially requiring oxygen via NC 6 lit, now weaned to RA    Covid-19 virus Infection Date of onset of symptoms: 12/1/2022 Symptoms present on admission: Fevers, chills, shortness of breath Date of covid positive test: 12/3 Vaccination status: vaccinated Imaging: CTPA showed early developing bilateral groundglass opacities Oxygen requirements on admission: 6 L Current oxygen requirements: RA Medical therapy: remdesivir and steroids. Tocilizumab x1 dose given per ID Consultants following: ID and pulmonology     Acute COPD exacerbation Albuterol HFA every 6 hours as needed Continue Decadron for COVID treatment Sputum cultures, Legionella and strep pneumonia antigen negative Pulmonology consulted   Right heel diabetic foot infection and osteomyelitis S/P debridement Bedside debridement and bone biopsy performed on 11/18 by podiatry at outpatient visit Abx: Invanz and vancomycin until 11/23 per ID She reports completing her treatment on 12/2 ID reconsulted to determine if further treatment is needed ET consulted. Apparently wound VAC was removed at ECF prior to transfer   AKI Most likely due to infection and dehydration Cr 1.37 on arrival Resolved  DM 2 w hyperglycemia and polyneuropathy Home regimen  metformin, A1C 7.2 Continue home dose metformin Continue Lantus 15 units SQ at bedtime for better blood glucose control while on steroids     Mood disorder Stable continue home venlafaxine   Chronic pain syndrome Continue home Norco 5 mg   Elevated BP Elevated BP with no diagnosis of hypertension Steroids could be contributing Monitor BP IV hydralazine as needed   Chronic HFpEF Stable Continue home medications
9-27-11 at 1:11 pm. Pt. left phone message wondering if flu & pneumo immunizations given caused him to feel "chilled to the bone" he stated he came home to go to bed because of his feeling badly. I returned call leaving message with VIS information for reactions. Left 2 messages to call back with how pt was doing - no return calls. Called feeling better 9-29-11.
throat and mouth tightening 8 minutes after injection of vaccine, difficulty talking, body tremors, and hive-like rash (patchy red blotches, not raised/swollen or itchy) appeared across chest and around the injection site. Took 25 mg liquid benadryl within a few minutes of reaction beginning. Took five minutes for sensation in mouth and throat to subside, rash cleared in about twenty and blood pressure came down.
No adverse event; 35 patients received a 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose from booster dose only presentation vial) 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 assessment was provided for ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose from booster dose only presentation vial).    No concomitant medications were reported. Vaccination dates were reported as between 22-Jul-2022 and 28-Jul-2022. It was reported that the patient had received 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose. It was unknown if patient experienced any symptoms after getting the vaccine. No treatment medications were reported.
PT. DEVELOPED INCREASED REDNESS, SWELLING, AND SOME PAIN AT INJECTION SITE THAT IS GETTING WORSE AND SPREADING DOWN ARM. WHEN PT. PRESENTED TO OFFICE SHE WAS RX'D ANTIBIOTIC AND STEROID.
TOOK UNREFRIGERATED DOSES; This spontaneous case report was received from a pharmacist (PVX2019-664) on 15-Mar-2019. It described an 11-year-old male consumer who "took unrefrigerated doses". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer took full course of unrefrigerated doses of Vivotif. The fourth dose was taken on 14-Mar-2019.  The action taken with Vivotif with respect to the event "took unrefrigerated doses" was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.