chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Nurse reports possible administration of improperly stored vaccines; This spontaneous report was received from Other Health Professional, referring to unspecified patients.  Nurse reported possible administration of improperly stored vaccines. No additional adverse events were reported.   The names of vaccines involved (including lot/exp): hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9): Lot: 1775808  Expiration: 20-AUG-2023; Lot: T030749  expiration date: 16-MAR-2023; Lot: 1687293  expiration date: 30-APR-2023; hepatitis a vaccine, inactivated (VAQTA): Lot: T031202, expiration date; 14-JUN-2022, Lot: U026792 expiration date: 28-OCT-2022; hepatitis b vaccine (recombinant) (RECOMBIVAX HB): Lot: T021327, expiration date: 14-NOV-2022; Lot: U008328, expiration date: 16-DEC-2022.  All lot number were verified to be valid, (route and anatomical location were not reported) administered for prophylaxis.   It was reported that the vaccines had been incorrectly stored at -0.3C for 5 minutes and then at 0.3C for 45 minutes. There was no previous temperature excursion  Follow up information was received from the nurse on 09-JUN-2022.  The patient's demographics were provided for all the patients involved in previous event of improperly stored vaccines.  This spontaneous report was referring to a 8-year-old patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 02-MAY-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #U026792, expiration date: 28-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided).  This is one of multiple reports received from the same source.
Rx- Prednisone, BENADRYL Total Body Hives - Pruritic, red, raised, Urticarial rash - arms, legs, trunk, abdom. (sparing face and palms and soles).
Patient states arm was red and swollen.  She didn't have a fever or rash.  The swelling went all the way down to her elbow.  She didn't take anything for the swelling.  I advised her to go to urgent care/ER.  I called her the following Friday to check up on her and she had developed Cellulitis and is taking antibiotics.
Arm is red and swollen where injection given. Started at injection site and spread around the arm.
The vaccine was reconstituted and prepared in the syringe, and the expiration date and time was marked on the vaccine syringe.  The vaccine was administered to the patient after the recommended beyond-use time.
Shingles rash / Shingles outbreak; rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included autism.   On 11th February 2020, the patient received the 1st dose of Shingrix. On 9th June 2020, 119 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix  About a week ago from the date of reporting, the patient developed shingles rash. The patient had been treated for shingles outbreak for the last week. Treatment was unspecified. While the rash was active, the patient received the 2nd dose of Shingrix on 16th June 2020 (batch number 4ME42 expiry date 14th November 2021). No further symptoms were reported.  The reporter consent to follow up.
Immediately following vaccination, patient felt faint. Paramedics were called but patient requested call be canceled. She (pt.) rested quietly with cold water and recovered. Pt was warm, sweaty.
8/7/2013 - Fever, chills, general ill. 8/12/2013 - tingling/numbness in fingers, over the next few days, tightness of torso, loss of feeling in feet 8/14 and 8/17 - saw doctors, who did a number of blood tests. 8/20 - saw neurologist, had nerve conductive study. 8/22 - lumbar puncture 8/22 and 8/23 - IVIG treatments. 9/6 - started physical therapy 2X/week. 11/17 - now able to walk without a cane, balance still unsteady, fatigue easily, substantial paresthesia on front and back abdomen, numbness in right hand, arm, foot, left hand, little change in symptoms for several weeks.
Dizziness after vaccine and is getting worse; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness after vaccine and is getting worse) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 623M20A and 623M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (Dizziness after vaccine and is getting worse). At the time of the report, DIZZINESS (Dizziness after vaccine and is getting worse) had not resolved.            No concomitant medications were reported.   No treatment information was provided.
This spontaneous report as received from a nurse via company representative refers to a 11 year old male patient. The patient's concurrent conditions and concomitant medicines were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (lot# and expiry date were not provided), 0.5 ml, intramuscularly. On an unknown date, right after administration of GARDASIL 9, the patient turned white and fainted. Nurse laid the patient down, gave him cold compress on injection site and he regained consciousness within minutes. She also gave him some juice (after the patient regained consciousness) but he fainted again for the second time. The patient regained his consciousness within minutes again and nurse kept him in the office for additional 30 minutes for observation. He fully recovered within that 30 minutes and was sent home. The relatedness between the events and therapy with GARDASIL 9 was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Two days of feeling fatigued; Big area on her arm, in the injection site; itchy (area in the injection site); red (area in the injection site; hot (area in the injection site); swollen (area in the injection site); Really severe back pain; muscle plain that she had never experienced before; Chills; Nausea; Fever 99.8; Really bad headache; Fatigue; big welt, red (welt) and hot (welt); This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (big welt, red (welt) and hot (welt)), HEADACHE (Really bad headache), FATIGUE (Fatigue), INJECTION SITE REACTION (Big area on her arm, in the injection site) and INJECTION SITE PRURITUS (itchy (area in the injection site)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced URTICARIA (big welt, red (welt) and hot (welt)). On 12-Jan-2021, the patient experienced HEADACHE (Really bad headache), FATIGUE (Fatigue), INJECTION SITE PRURITUS (itchy (area in the injection site)), INJECTION SITE ERYTHEMA (red (area in the injection site), INJECTION SITE WARMTH (hot (area in the injection site)), INJECTION SITE SWELLING (swollen (area in the injection site)), BACK PAIN (Really severe back pain), MYALGIA (muscle plain that she had never experienced before), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever 99.8). On 18-Jan-2021, the patient experienced INJECTION SITE REACTION (Big area on her arm, in the injection site). On an unknown date, the patient experienced FATIGUE (Two days of feeling fatigued). On 08-Jan-2021, URTICARIA (big welt, red (welt) and hot (welt)) had resolved. On 17-Jan-2021, HEADACHE (Really bad headache), FATIGUE (Fatigue), INJECTION SITE PRURITUS (itchy (area in the injection site)), INJECTION SITE ERYTHEMA (red (area in the injection site), INJECTION SITE WARMTH (hot (area in the injection site)), INJECTION SITE SWELLING (swollen (area in the injection site)), BACK PAIN (Really severe back pain), MYALGIA (muscle plain that she had never experienced before), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever 99.8) had resolved. On 20-Jan-2021, INJECTION SITE REACTION (Big area on her arm, in the injection site) had resolved. At the time of the report, FATIGUE (Two days of feeling fatigued) 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.   No relevant concomitant medications were reported. Treatment details included Voltaren and Tylenol
Pt recvd vax pt exp serum sickness type react consisting of joint pain, weakness, &/or diarrhea; workup has included numerous test for collagen vascular disease, been non-diagnostic;
The patient told that she started developing fever, lips were breaking and felt discomfort in the arm that was vaccinated during the night. The next day (1/4/2019) she reported the adverse event to the pharmacy, She said that she took Acetaminophen for the fever and pain the day after she was vaccinated. It was recommended to the patient to visit the physician or other healthcare professional. She said that she was going to wait to see if the medications she took help her, if not, she was going to visit the physician.
This spontaneous report was received from a physician's purchasing agent via a company representative concerning two patients of unknown age and gender (query pending). On an unknown date, patients were vaccinated with single dose of 0.5 milliliter PNEUMOVAX 23, intramuscularly. No concomitant medications were reported. On an unknown date, immediately after the vaccination in the office, both the patients experienced redness, puffiness and became irritable. The physician questioned regarding the lot and requested for lot check. The physician wanted a replacement of that lot. The outcome of redness, puffiness and became irritable was unknown. The relatedness for redness, puffiness and became irritable was unknown for PNEUMOVAX 23. This is one of the two reports from the same reporter. Additional information has been requested.
Pt. was seen for immunization update. Per record previous doses of varicella was given on 10/23/1999 and 10/21/1999. Per ACIP recommendation pt. received 2nd dose early. Provider recommended repeating dose. The third dose of varicella was administered on 09/05/2017. Shortly after administration patient began experiencing local itching, 2 cm of erythema. Pt. states symptoms increased on 0/08/2017 pt school nurse suggested he schedule appt. with PCP. Pt. seen in our office by Dr. on 09/08/2017 at 10:00am. At time of visit patient had local swelling and erythema. Pt. stated he felt his throat was swollen and itched. Provider administered 2 tabs of diphenhydramine 25 mg in office and prescribed prednisone 20mg, epinephrine 0.3mg and BENADRYL 25mg. Pt. was given ED precautions and advised to never get the varicella immunization again.
face got warm; he felt tired; face got a little reddish; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (face got warm), ERYTHEMA (face got a little reddish) and FATIGUE (he felt tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Eye disorder. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, SELENOMETHIONINE (75 SE), XANTOFYL (LUTEIN-VISION) for Eye disorder.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced ERYTHEMA (face got a little reddish). On an unknown date, the patient experienced FEELING HOT (face got warm) and FATIGUE (he felt tired). At the time of the report, FEELING HOT (face got warm), ERYTHEMA (face got a little reddish) and FATIGUE (he felt tired) was resolving.            On an unspecified date, the patient felt tired and face got warm and after taking paracetamol he felt better. On 21-MAR-2021 night, his face got warm again and l little reddish and after taking paracetamol he felt better. Action taken with mRNA-1273 in response to events was not applicable.
On Sunday November 13 he began sneezing a lot. He began complaining about feeling bad and hot, I checked his head and he was burning up. His fever was 103. Monday he developed cough and congestion and still had the fever. Tuesday was about the same. Wednesday he seemed better so I sent him to school. He called about 11 in the morning unable to stop coughing and burning up. I got him into the doctor on Thursday. He tested positive for COVID-19 and Flu-A. We treated his symptoms with OTC meds. His fever was better by the weekend. His congestion cleared up  around November 24 and his cough finally cleared up around November 27.
typical post vaccination side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (typical post vaccination side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (typical post vaccination side effects). At the time of the report, VACCINATION COMPLICATION (typical post vaccination side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.   Reporter did not allow further contact
Pt received the second dose of Pfizer Covid Vaccine (LOT# FD0809, exp. 10/2021) at 1602. At approximately 1606, patient fell from chair to the floor. RN turned patient onto her left side. RN observed minimal shaking for approximately 10 seconds. Patient opened her eyes and sat up. RN assessed patient. RN saw urine on the floor and noted pallor of the face. Patient was alert and oriented to person, place, situation and time. Patient stated "my head hurts". Patient reported 6/10 head pain. Patient reported "I heard my ears ringing" and "saw colorful stuff" before she fell. Patient's father reported patient has no history of seizures, no current medical conditions, and no current medications. At approximately 1607, EMT activated EMS. Patient denied seizures after the first dose of Pfizer (LOT# EW0187, exp. 08/2021) administered on 08/12/2021. At 1610, RN assessed patient vital signs: blood pressure 120/88 mmHg, pulse 101 beats/minute, and SpO2 99%. RN educated patient and patient's father on signs/symptoms of when to seek emergency care, to follow up with primary care provider, and to sign up on v-safe. At approximately 1620, RN reassessed patient. Patient reported 1/10 head pain. At 1622, EMS arrived and assumed care. At approximately 1635, patient was transported to a hospital for further care. At 1635, patient left facility with unlabored breathing.
Swelling; redness; headache; This case was reported by a consumer via call center representative and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling, erythema and headache. On an unknown date, the outcome of the swelling, erythema and headache were unknown.   It was unknown if the reporter considered the swelling, erythema and headache to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had swelling, redness and headache. The reporter asked how long the swelling, redness and headache generally lasts.
BLOOD CLOT; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a male of unspecified age, race and ethnicity. 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after vaccination the patient experienced a blood clot when he had covid (suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000302026.; Sender's Comments: V0:20231076953-Blood clot. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Case previously recorded as MA2009-3283. Initial report received from newspaper article on 27 OCT 2009. An 8-month-old female patient was vaccinated i.m. with FLUVIRIN (batch no. Unknown) in 2009. The baby received the shot from a couple of nursing students in a pre-filled syringe. The patient received twice the normal dose for a baby, six other children ages 6 months to 9 years old were also double dosed, maybe due to similar packaging between the vaccines for adults and children. No adverse event was reported. The baby appeared healthy. Reference no: NA09-007089, MA2009-3284, MA2009-3285, MA2009-3286, MA2009-3287, MA2009-3288, MA2009-3289.
Severe headache; Fever up to 103 degrees F.; Body aches; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 18Mar2021 at 09:30 am (at the age of 45 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021 at 22:00 patient experienced severe headache, fever up to 103 degrees F., body aches. The patient underwent lab tests and procedures which included body temperature: 103 degrees Fahrenheit. Therapeutic measures were taken as a result of severe headache, fever up to 103 degrees f., body aches with 400 mg Advil on 19Mar2021 at 10.30 am. All symptoms resolved and did not return. The outcome of events was recovered on 19Mar2021 at 11:30.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Developed sensitivity/pain of the tongue as well as a change in the ability to taste some foods.  As of today these symptoms have been present for 3 weeks and continue to persist.
No other AE; The customer said that the patient missed the 3rd dose of GARDASIL 9 on 3/23/2021; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patient was vaccinated with first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact doses, injection sited, routes of administration, lot # and expiration dates were not provided) for prophylaxis.  On 23-MAR-2021, the patient missed the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), because the patient received the first dose of the Pfizer COVID 19 vaccine. The patient was scheduled to receive the second dose of the Pfizer COVID 19 vaccine on 18-APR-2021. No other adverse event was reported.
3 days after the shot my symptoms started. I wokeup and my vision was blurry in my right eye. I went to the eye doctor and was diagnosed with an occlusion. He ordered bloodwork for all kinds of clotting disorders and all except 2 were normal. A few days later I had a bad headache and my face around that eye hurt and felt numb. I went to th ER had more bloodwork done and a ct of my head and neck. Not long after that my right arm felt numb and my hand wasn't working right. Then my left arm. Then my right leg started hurting. Then my left leg was sore. My back started to hurt after that. Then my chest hurt. I thought i was having a heart attack and ended up in the emergency room again.  Had an ekg and a ct of my chest,all were normal. It's been one month and I've been to the ER three times, neurologist once,hematologist once, eye doctor twice, pcp about four times. And I still have follow up appointments with specialists.  I feel absolutely horrible I have no energy and struggle to get through work.
This case was reported by a physician via sales rep and described the occurrence of fever in a 2-year-old female patient who received PEDIARIX (batch number A4H53, expiry date unknown). On 14th January 2016, the patient experienced fever. On an unknown date, the outcome of the fever was recovered./resolved. The reporter considered the fever to be almost certainly related to PEDIARIX. Additional details provided were as follows: The patient experienced high fever. This was 1 of the 4 cases reported by the same reporter (US2016038401, US2016038402, US2016038403).
After first dose aside from sleeping and feeling badly, i had small loss of appetite and tiredness After second dose, i continued to have larger loss of appetite,  sore neck, uncomfortable swallow, very tired
This is a spontaneous report from a contactable pharmacist through a company representative. A 17-year-old female patient received first dose of TRUMENBA (batch/lot number: J28923, expiry date 30Jun2016) on 11Nov2015, at 0.5 ml single, probably intramuscularly in the left arm. Medical history and concomitant medications were not provided. The patient experienced nausea, back pain, tight chest, light headed, no appetite on unknown date in Nov2015. Events outcome was unknown. Follow-up (08Jan2016): New information from the same contactable pharmacist included: reporter's occupation, vaccination site. Follow-up attempts completed. No further information expected.