chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eyes began to itch; Redness of both eyes; SNEEZING,; WHEEZING; eyes became swollen shut.; Hypersensitivity reaction; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), SNEEZING (SNEEZING,), WHEEZING (WHEEZING), SWELLING OF EYELID (eyes became swollen shut.) and EYE PRURITUS (Eyes began to itch) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.  Concurrent medical conditions included Hypersensitivity reaction, Urticaria, Contrast media allergy (Hives) since 1985, Drug allergy (Rash and itching) since 1987, Allergy to antibiotic (Rash and itching.) since 1984 and Hypothyroidism since 1994. Concomitant products included DICYCLOMINE [DICYCLOVERINE] for Abdominal spasm, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for GERD, ATORVASTATIN CALCIUM (LIPITOR) and ASA for Prophylaxis, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On 02-Feb-2021 at 4:30 PM, the patient experienced SNEEZING (SNEEZING,), WHEEZING (WHEEZING) and SWELLING OF EYELID (eyes became swollen shut.). On an unknown date, the patient experienced EYE PRURITUS (Eyes began to itch) and OCULAR HYPERAEMIA (Redness of both eyes). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 02-Feb-2021 for Adverse event, at a dose of 50 milligram every six hours. On 05-Feb-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, SNEEZING (SNEEZING,), WHEEZING (WHEEZING), SWELLING OF EYELID (eyes became swollen shut.), EYE PRURITUS (Eyes began to itch) and OCULAR HYPERAEMIA (Redness of both eyes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Events added, diagnosis added, patient history updated, concomitant medications updated.
one day after vaccine, I experienced blurring of eyes. It stayed for about 25 minutes before it became normal; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included losartan potassium (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); both 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: EN6200) via an unspecified route of administration in the left arm on 03Mar2021 at 15:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 13:00, one day after vaccine, the patient experienced blurring of eyes. It stayed for about 25 minutes before it became normal. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blurring of eyes was recovered on 25Mar2021 at 13:25, after the duration of 25 minutes.   No follow-up attempts are needed. No further information is expected.
headaches; bodyaches; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. Facility type vaccine was at Hospital. Medical history and concomitant medications were not reported. The patient experienced headaches and bodyaches on 13Jan2021. It was unknown if treatment received for the events. The outcome of the events were resolving. If COVID prior vaccination was reported as No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
She felt a lump in her armpit on the same side as where she had the injection. The injection site and full arm are fine, but there is a lump in her armpit.
ADMINISTERED 1 HOUR PAST THE ALLOWED 6 HOURS STORAGE POST FIRST PUNCTURE; OFF LABEL USE; POTENTIALLY EXPIRED DRUG ADMINISTERED; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced administered 1 hour past the allowed 6 hours storage post first puncture. On 28-APR-2021, the subject experienced off label use. On 28-APR-2021, the subject experienced potentially expired drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 1 hour past the allowed 6 hours storage post first puncture, off label use and potentially expired drug administered was not reported. This report was non-serious.
Chest pain radiatinig down left arm since day after moderna vaccine. Took nitroglycerin twice. Some nausea. Presented to ER for chest pain for 2 days, paininto left arm, No acute changes in EKG, non-cardiac chest pain. Medication changes made per cardiologist.
h/a, nausea, chills, sweating, achy, dizzy, sore arm;
minor reaction of rash on his arm for 10 days after the  first shot of Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (minor reaction of rash on his arm for 10 days after the  first shot of Moderna COVID-19 Vaccine) in a 65-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (minor reaction of rash on his arm for 10 days after the  first shot of Moderna COVID-19 Vaccine). At the time of the report, RASH (minor reaction of rash on his arm for 10 days after the  first shot of Moderna COVID-19 Vaccine) had resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2022-653596, MOD-2022-653585 (Patient Link).   Reporter did not allow further contact
This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative. The medical assistant reported similar events for two patients. This is the second of two reports. A patient of unknown age, gender and race/ethnicity received a single dose of PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation at the physician's office. Medical history and concomitant medications were not reported. On an unknown date the patient had allergic reaction, arm was extremely swollen; it was really large and hot to the touch and very painful. Treatment was provided. Outcome was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017210371 different patient, same product, same event.
Information has been received from a health care professional concerning a 2 week old female patient who on 16-DEC-1998 was vaccinated with one dose of RECOMBIVAX HB vaccine IM in the thigh. Later that evening the patient experienced a fever on 102 degrees F. The patient sought unspecified medical attention. No further information is available.
Its 140, 138, beats per minute. It is persisting, her beats per minute has went up; Heart irregularities/ sky rocketing pulse rates and irregularity; Chest pain; Chest discomfort; Just uncomfortable/uneasy feeling; This is a spontaneous report from a contactable consumer. This contactable consumer (patients husband) reported for a 58-year-old female patient (reporters wife) that, A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FA7484) via an unspecified route of administration, administered in Arm Left on 26Jul2021 (at the age of 58-years-old) as single dose for COVID-19 immunization. Medical history included as none. There were no concomitant medications. It was reported that the patient received second dose of COVID vaccine (Lot number- FD8448). In Aug2021 the patient experienced its 140, 138, beats per minute. it is persisting, her beats per minute has went up (medically significant), In 2021 heart irregularities/ sky rocketing pulse rates and irregularity (intermittent and random morning and night), chest pain, chest discomfort, just uncomfortable/uneasy feeling in 2021. Caller was calling because his wife received the covid vaccine. She received her first dose on 26Jul2021 and her second dose on 16Aug2021. After the first dose she experienced an adverse event. She had heart irregularities, chest pain and chest discomfort. She went to her primary care provider and had a physical. She followed up with her physical based on her pulse. She was having skyrocketing pulse rates and irregularity. They are referring her to a cardiologist to fit her for a heart monitor device. It's been really erratic she can pull up her information from her heart rate. The event heart irregularities was started the first of august week after the dose. In the middle of the night, she was not in pain just uncomfortable and she looked at her watch and its 140, 138, beats per minute. It was persisting, her beats per minute have went up and it's an uneasy feeling. For the treatment it was reported not yet she was waiting for the appointment to be fitted for a heart monitoring device. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. The AE require a visit to physician Office. No Prior Vaccinations within 4 weeks. AE did not occur following prior vaccinations. Patient underwent lab test and procedure which included Heart rate 140,138 her beats per minute has went up 2021.The outcome of the event its 140, 138, beats per minute. it was persisting, her beats per minute has went up, Heart irregularities/ sky rocketing pulse rates and irregularity was reported as not recovered and the outcome of the events Chest pain, Chest discomfort and Just uncomfortable/uneasy feeling was reported as unknown.  No follow-up attempts are possible, no further information expected.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 20-MAR-2013, patient received improperly stored VARIVAX dose 2, from lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
After the vaccination,  urine started to come out with brown spots as if it had blood,  a severe pain began in my neck and a lymph node, growing in size and very painful, became inflamed.  strong pain all over the left side of the body, especially in my leg and in the place where the ganglion grew, accompanied by nausea.
Liquid diarrhea, vomiting, chills, fever from Friday morning until this morning Tuesday (4 days so far).
The day after receiving FLUVIRIN she began having headache, fever, malaise and redness, pain and swelling at the injection site. Two days after vaccine she returned to the pharmacy for symptoms. Injection site was red and raised approx. 5 cm x 3 cm.
I had severe dizziness/vertigo and lightheadedness on the afternoon of April 9th, 16 days after my 1st dose of Moderna Covid vaccine. The room appeared to be spinning very fast. I was either standing or walking when it started. I made my way to bed and tried sitting and lying down for a few minutes. That didn't help so I finally laid down, closed my eyes, and took a nap for about an hour. When I woke up my symptoms were gone. I don't know how long it took because I fell asleep. I have NEVER felt like this before. I really hope this doesn't happen again, or worse, after/if I get my second Moderna shot in a few days. I was so unnerved by this that I did some online research afterward and found a forum with a lot of people reporting that it is much worse after the second shot (lasts longer, vertigo is worse, hasn't gone away after weeks).
chickenpox inc amount of lesions;mom states30 children reported to have chickenpox @ child school;15 of the children have had vax & have inc amount of lesions;
Fever, Nausea, Fatigue, Arm soreness Fever and nausea lasted one day. fatigue and arm soreness lasted 4 days
This spontaneous report as received from a certified medical assistant (C.M.A), refers to a female patient of unknown age. It was reported that on 07-DEC-2012 the patient received her first dose of GARDASIL (lot # not reported) (0.5 ml, intramuscular route), on 29-JAN-2013 received the second dose of GARDASIL (lot # not reported) (0.5 ml, intramuscular route) and on 29-MAR-2013 received the third dose of GARDASIL (lot # not reported) (0.5 ml. intramuscular route). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
PMH:  HTN, BPH, CAD, ASPVD, COPD, OSA with CPAP, DM; diagnosed positive for COVID at hospital; COVID pneumonitis and progressive hypoxic respiratory failure; required intubation; placed on corticosteroids, remdesivir, baricitinib, colchicine, and antibiotics; DNR; went into A Fib, but was controlled with diltiazem; renal function worsened; eventually decided upon comfort measures; pt extubated and passed away shortly afterwards in the hosp
It was not an adverse event. It was an administration error. Upon administration, the needle started to leak the vaccine and led to the patient receiving less-than-half the dose. As a result (per consult with the manufacturer), the dose was re-given in the left arm.
1st attempt to administer dose: Unable to get plunger down (resistance) so gave 1/2 dose same arm similar area and was able to give dose. Pt stated her arm hurts for 2 months after Flu shot and usually pain resolved but not with this dose. Arm weak and painful.
8 x 10 cm indurated area with erythema - Rt thigh. Instructed to apply warm compresses to area. Rx: Duricef 250/5 cc BID x 5 days.
A non-serious spontaneous report of FLUMIST given to two children with asthma was received from a health professional concerning a nine-year-old male. The patient's medical history included asthma. No concomitant medications have been reported for this patient. On 12-Oct-2011, the patient with asthma received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Patient received a second booster dose, however does not meet the age requirement.  The patient was only 45 years old at the time of the vaccination, and is not immunocompromised.
Extreme jitters; fatigue; chills; cough due to phlegm buildup; This is a spontaneous report received from contactable consumer. A 68-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er2613) via an unspecified route of administration in the left arm on 19Mar2021 at 14:30 (at the age of 68-years-old), as single dose for COVID-19 immunisation. The patients medical history was reported as diabetes, high blood pressure, forrestiers disease since an unknown duration. Concomitant medications were Indemithecin (MANUFACTURER UNKNOWN), pantoprozole (MANUFACTURER UNKNOWN). The patient was allergic to Celebrex, lisinapril. Prior to 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 20Mar2021, at 13:15 the patient experienced extreme jitters, fatigue, chills, congestion, cough due to phlegm build-up. The patient was not tested for COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of extreme jitters, fatigue, chills, congestion, cough due to phlegm build-up were resolved at the time of report. No treatment was received for the adverse events.   No follow-up attempts are possible; No further information is expected.
HPI: erythematous site to RT thigh after receiving immunizations 2 days ago. Pt received MMR/VAR and DTAP/IPV on 9/17/19 and has since developed a pruritic, warm and red lesion to site where INJ were given. Mother has not given an antihistamines in response to reaction. Mother denies any angioedema, difficulty breathing or swallowing. PLAN:  pt may take prednisone <20 mg day <14 days for adverse reaction to live virus vaccine. Will treat adverse reaction with prednisone 5 mg daily x 5 days. Instructed mother to continue Benadryl as needed. Monitor reaction site and notify clinic if borders increase or systemic reaction occurs. Apply cool compresses to site. Encouraged mother to continue with Hep B immunization in one month. Risks vs benefits discussed. Adverse reaction reported to vaccine manufacturer. Mother v/u.
Warm to touch under the injection site; Arm started itching; Two little red marks on her arm/red baseball sized spot under the injection site; Arm muscle was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm started itching), MYALGIA (Arm muscle was a little sore), VACCINATION SITE ERYTHEMA (Two little red marks on her arm/red baseball sized spot under the injection site) and VACCINATION SITE WARMTH (Warm to touch under the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension. Concurrent medical conditions included Penicillin allergy and Drug allergy (ampicillin). Concomitant products included LOSARTAN for Hypertension, RIVAROXABAN (XARELTO), DIPHENHYDRAMINE and AMPICILLIN for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced MYALGIA (Arm muscle was a little sore). On 28-Mar-2021, the patient experienced PRURITUS (Arm started itching) and VACCINATION SITE ERYTHEMA (Two little red marks on her arm/red baseball sized spot under the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to touch under the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Arm started itching), MYALGIA (Arm muscle was a little sore), VACCINATION SITE ERYTHEMA (Two little red marks on her arm/red baseball sized spot under the injection site) and VACCINATION SITE WARMTH (Warm to touch under the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-171629, MOD-2021-171629 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: TCR received with additional information.
The day after my second dose of the Pfizer vaccine,  I experienced chills, severe body aches, stomach upset, vomiting. I had loss of sensitivity in my right thigh area that comes and goes. I also have brain fog, joint aches that overwhelming. Subsequently, I had Covid tests through my PCP which were negative but I had symptoms that mimicked Covid symptoms. My PCP recommended I go to the ER and I was admitted for two and a half days.  They monitored my heart, did lab work, liver test. I continue with headaches that are more profound. I still have loss of strength in my right thigh, which is intermittent, comes and goes. I still have itchiness on my right thigh and leg with loss of sensation lasting from three to five hours. I will be seeing a neurologist next month.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 12-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had four temperature excursions: 24, 48, 16 and 24 hours respectively. The lowest recorded temperatures were 34 (-1.111111111 Celsius degrees), 32 (0 Celsius degrees) and 33 (0.555555556 Celsius degrees). The highest recorded temperatures was 47 (8.333333333 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female patient who on an unknown date was vaccinated IM into the upper arm with an entire dose of Gardasil. After vaccination, the patient experienced syncope. Unspecified medical attention was sought. On an unknown date, the patient recovered. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.