chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 15:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3248), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "pre diabetic" (unspecified if ongoing); "fatty liver" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 01Jan2018; PRINIVIL, start date: 01Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood cholesterol: (unspecified date) high; Influenza virus test: (unspecified date) Negative, notes: Flu swab negative; Oxygen saturation: (unspecified date) remained normal throughout; SARS-CoV-2 test: (unspecified date) Positive; (25Dec2022) Negative, notes: Took 5 days of Paxlovid, last dose am of 25Dec. Tested negative that evening; (28Dec2022) Positive, notes: Tested mildly positive on 28Dec; (30Dec2022) Positive, notes: Tested positive at Dr(s) office on 30Dec22, fatigue, chills, sx; (31Dec2022) Positive, notes: Symptoms worsened over next few days, tested strong positive on 31Dec. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid on 20Dec2022 to 25Dec2022. Clinical course: the patient had other medication in 2 weeks which includes Lisinopril, and Rosuvastatin. She has no known allergies.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Clinician inadvertently gave monovalent Pfizer Covid vaccine when patient was due for and was expected the bivalent booster
Pt recvd vax 8OCT92 & 24 to 48 hrs later pt exp severe h/a & flu-like sx;
Pt recvd vax in AM & would move legs, refused to walk; about 9PM put to bed given APAP mom noted eye rolled to back of head & pt stiff, didn't respond to name; called ER attempted to revive pt legs jerked, dec breathing, skin cold; t103 ear
Case number PHEH2016US033671, is a spontaneous report initially received from medical assistant on 21 Dec 2016. This report refers to a 53 years old male patient. Medical history was not reported. Vaccination history included administration of FLUCELVAX (batch number: not reported) which was tolerated. Concomitant medication was not reported. The patient was vaccinated with a single dose of expired FLUCELVAX (batch number: 173906, expiry date: May 2016) intramuscularly into left deltoid at a dose of 0.5 ml on 20 Dec 2016. It was reported that, there was not an adverse drug reaction, the patient received another flu vaccine and was tolerated well. The case was assessed as non serious. No adverse event was reported following this medication error. Follow up report received from a health care professional on 12 Jan 2017: Added vaccination history, updated vaccination site (left deltoid) and reporter's comment.
painfull; made me sick; first dose in November. Waited until March for the second dose but then we had a pandemic; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain, sickness and social problem. On an unknown date, the outcome of the pain, sickness and social problem were unknown.   It was unknown if the reporter considered the pain and sickness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported for 1st dose and not applicable for 2nd dose. The patient stated that 1st dose was very painful and made patient sick. The patient waited until march for the second dose but then had a pandemic and pharmacist could not give second dose. It had been 8 months and second shot was available. The patient wanted to know would it work or need to start over. The reporter consented to follow up.
Pt. states that she received the covid vaccine at 13:40 pm on 3/09/2021. Around 14:30 on 3/09/2021 patient developed redness to both ears  along with feeling flushed and sweaty. BP reportedly was in the 170s-180s/100s. Pt. was given benadryl  at 14:35 pm. Pt. states that around 14:40 pm she developed hives to face and itching. Pt. states that she feels as though her symptoms are improving. Patient denies shortness of breath, denies trouble breathing, denies chest pain.
11 by 8 centimeter red whelp at injection site, fever, chills, burning sensation in skin, body aches, severe headache consistently since the vaccination
he developed diarrhea; alot of gas; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (he developed diarrhea) and FLATULENCE (alot of gas) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 16767) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced DIARRHOEA (he developed diarrhea) and FLATULENCE (alot of gas). At the time of the report, DIARRHOEA (he developed diarrhea) and FLATULENCE (alot of gas) outcome was unknown.            Concomitant products included Statin for an unknown indication. No treatment details were reported.  Patient reported that he got the first shot as J&J on 09-Mar-2021. Age at time of onset of reaction/event were reported as 84 and weight were reported as 140 without units.
hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2022, the patient received Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingles vacc   Additional Information: GSK Receipt Date: 11-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles vaccine three days ago and he/she was having hives and wanted to know what he/she could do. Additional Supportive Information: The follow up would not possible as no contact details were available.
Injection site was very painful and it's blowing and my whole arm was hurting; Injection site was very painful and it's blowing and my whole arm was hurting; I have swelling in my whole arm; Weakness; Muscle soreness; Headache; This is a spontaneous report from a contactable consumer (patient, nurse's assistant). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Friday 18Dec2020 at about 09:58 at 0.3 ml, single for covid-19 immunization. This was the first dose. None medical history. There were no concomitant medications. In 2020, the patient stated the injection site itself, was very painful and it's blowing and in fact her whole arm, the whole arm was hurting and she has swelling in her whole arm and also she had like muscle soreness and weakness. The only other thing she felt was like headache and that's it. The patient was given aspirin for treatment. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Summary:  - Patient was seen at our Covid vaccine clinic on 10/10/2023. - He were scheduled to receive the Moderna Covid 12 year + vaccine. - However, he was mistakenly administered the Moderna 6 month - 11 year vaccine, which is half the dose. - The error was not identified until after they had left the office. - Dr. immediately contacted his mother to inform her of the mistake.  Follow-up Actions:  - On the morning of 10/11/2023, I contacted the medical team at Moderna, the CDC, and a nurse at Public Health. - All resources concurred that the appropriate course of action is for him to receive a full dose of the correct Moderna 12+ vaccine with no minimum wait time. - Dr. will discuss the vaccination schedule with hi mother to determine her preference.  Reporting and Office Actions:  - A VAERS report for an incorrect vaccine administration has been filed. - The Medical Assistant responsible for the incorrect vaccine administration has been counseled and subjected to a written reprimand. - As an office, we are implementing updated procedures to ensure such errors do not occur in the future.
tested positive yesterday afternoon for Covid; tested positive yesterday afternoon for Covid; receiving the booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "receiving the booster shot"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 08Jan2022, outcome "unknown" and all described as "tested positive yesterday afternoon for Covid". The patient reported they received the booster shot back in "late 2021." The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 09-AUG-2013 (lot # and exp. date not reported). This is one of the report from the same source, linked reports. Additional information is not expected.
This spontaneous case reported by a consumer, describes the occurrence of headache in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced headache. At the time of the report, headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. Reporter did not allow further contact.
p/vax pt exp pain in lt arm w/numbness & tingling in the lt hand; numbness & tingling continues through the present date; pain to the lt arm happens at intervals;
Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; Grew 4-5 times larger, raised, painful, red itched and tender/itches very badly; edge is now scaly and dry; edge is now scaly and dry; This is a spontaneous report from a contactable Other Health Professional (patient). A 36-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 21Jan2021 (Lot number: El3249) via an unspecified route of administration in the right arm at single doe for COVID-19 immunization. The patient had no medical condition. The patient had no allergies to medications, food, or other products. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Dec2020 08:00 AM (Lot number: EJ1685) via an unspecified route of administration in the left arm for COVID-19 immunization and at 31Dec2020 12:00 PM experienced small rash on left side of chest. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient concomitant medication included Levothyroxine sodium (Euthyrox, Strength: 150ug) and Drospirenone/ethinylestradiol (Nikki, Strength: 3mg/0.02mg). After first shot developed small rash on left side of chest. Persisted for three weeks and was starting to fade when she got second dose. Grew 4-5 times larger, raised, painful, red itched and tender. Now reaches my neck and breasts and shoulders. White normal skin in center, edge was now scaly and dry, itches very badly. Dr won't prescribe steroid fears it will dampen immune response. Taking Allegra, Benadryl and hydrocortisone cream. Does not help. Never had a reaction to a vaccine before. The patient was underwent COVID-19 (Nasal Swab) and PCR at pharmacy (nasal swab) test (test twice weekly for work) both on 29Jan2021 which were negative. The events were assessed as non-serious by the reporter. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
male patient over the age of 45, received two doses of Gardasil 9/his old doctor recommended for him; the patient is trying to received the third dose of GARDASIL 9; no additional AE reported; Spontaneous information has been received from a nurse referring a 53-year-old male patient. Information regarding the patient's medical history, concomitant therapies and drug allergies or reactions were not provided. The patient's pre-existing condition included condyloma.  On an unknown date, the patient received the first two doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, route, lot # and expiration date were not provided) (Product administered to patient of inappropriate). The patient was currently living in another area and was trying to get the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) but it was stated that in the area the patient was living was much stricter (product availability issue). No additional adverse event reported.
RN requested DPT vaccine but received DPT + Polio Vaccine -KINRIX-. Patient did not receive the vaccine as the RN double checked the drug content. DPT + Polio vaccine was returned to pharmacy and correct vaccine was sent to NICU.
Information has been received from a healthcare worker concerning four patients of unknown age and gender. The patients' current conditions, medical history and concomitant medication were not reported. On an unknown date, the physician received an order of PNEUMOVAX 23 vials and five of them were under-filled by 0.1ml, because the vials were under-filled the physician used another vial to withdraw the difference. On unknown dates, four patients were vaccinated with PNEUMOVAX 23 (strength, dose and frequency were unknown, lot # M007769, expiration date 27-JUN-2017 in this manner. No specific adverse event was reported. The product quality complaint was involved in the report. Additional information is not expected as we have no consent to contact the physician.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications (reported as no other medication in 2weeks). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  Clinical course: Patient had no known allergies. Patient received COVID-19 Treatment with oral Paxlovid from 26Dec2022 to 31Dec2022. Patient stated he was experiencing "Paxlovid Rebound" symptoms. He was symptom free and out of self isolation on 01Jan2023. Reported as Yesterday, 04Jan2023 patient started experiencing symptoms again: sever runny nose, aches, congestions and rough night on 04Jan2023. No fever. No treatment received for rebound symptoms.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
on 12/14/2020 the patient was hospitalized due to dehydration; experiencing respiratory distress as well; Caller states on 12/12/2020 the patient began experiencing vomiting and diarrhea; Caller states on 12/12/2020 the patient began experiencing vomiting and diarrhea; rotavirus test positive; This spontaneous report was received from a physician referring to a 9-week-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 10-DEC-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliters, orally, lot number 1684163, expiration date 26-JUN-2021 for rotavirus vaccination.         On 12-DEC-2020, patient experienced vomiting and diarrhoea. On 14-DEC-2020, the patient experienced dehydration and respiratory distress. On that same day, the patient was hospitalized due to dehydratation with continued vomiting and diarrhea.  In December 2020, the patient had a positive result for a rotavirus test (GIPCR) and unspecified tests that came back negative.      The outcome of vomiting, rotavirus test positive, respiratory distress, dehydration and diarrhoea was reported as not recovered. The causal relationship between rotavirus vaccine, live, oral, pentavalent(ROTATEQ) and the events was not provided.   Upon internal review, respiratory distress was considered medically significant.
Low grade fever 99-100's; Muscle aches; Fatigue; Chills; Malaise; This is a spontaneous report from a contactable Physician (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK5730/expiration date: unknown), via unknown route of administration, on 18Dec2020 at 02:00 PM (at the age of 43 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL0130/expiration date: unknown), via unknown route of administration, on 06Jan2021 at 03:45 PM (at the age of 43 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypertension (HTN) and GERD. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Metoprolol, Hydrochloride, Acetylsalicylic acid (ASPIRIN), Omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 12:00 PM, the patient experienced low-grade fever 99-100's, muscle aches, fatigue, chills, malaise. Treatment was received for the events low grade fever 99-100's, muscle aches, fatigue, chills, malaise included ibuprofen (ADVIL), acetaminophen (TYLENOL), rest and fluid. The outcome of the events fever 99-100's, muscle aches, fatigue, chills, malaise was recovering. Patient underwent COVID-19 PCR test which was pending result. Since the vaccination, the patient had not been tested for COVID-19.
woke up at 4:45 am with severe chills and a low fever (100.5). Throughout the next day was extremely tired, fever rose to 101 and chills were on and off throughout the day. GI accidents of inability to control bowel movements for two days after. Fever and chills lasted 24 hours.
First time patient had a flu shot she was very nervous and anxious about getting one.  I asked her to stay here for 15 min since it was her first one.  5 minutes later she said she felt light headed and hot.  I gave her a bottle of cold water and some crackers since she had not eaten lunch and it was around 3:30.  As soon as she had a few sips of water and ate the crackers she felt fine. Her dad did come pick her up.  I called her 1.5 hours later and she said she felt fine and thinks it was her nerves
RT ARM SWELLING AND REDNESS, AREA 8.5CM X 8CM. TREATED WITH BENADRYL AND COOL COMPRESSES. RECEIVED MENVEO IN RIGHT ARM.
Employee felt totally fine before getting the COVID vaccine but then within 5-10 minutes of getting the vaccine while sitting, he felt extremely lightheaded, warm, flushed, and diaphoretic.  He did not have a true syncopal event but felt near syncopal.  He was rushed to the emergency department.  He states that he felt immediately better after he was laid supine.  He does not have any known medical problems he does not have a primary care physician.  He denies any chest pain or shortness of breath, denies any neurologic deficits, no fevers chills or sweats.  He has no history of allergies to any vaccines, he does have a documented history to fire ants.
Red itchy splotchy rash area on left upper arm, encompassing approximately 3.5 inches x 3.0 inches of non-connective tissue. Used Benadryl for itchiness.
Convuls(3 episodes p/immun) & neurologic sx jittery episodes & abnormal nighttime sleep patterns w/screaming. No previous convuls in pt or hx of convuls in siblings or par. 2 prior dose recvd. Well except for residual sleep disturbances.
An hour after the shot I got a small bit feverish and super energetic and talkative and my ADHD was acting up a lot, i had trouble holdinf conversations. Within another hour i was slurring some words and very very depressed and despondent. Soon i began hallucinating that someone was going to kill me, i felt like i had lived all this before and that no matter what i do, it all leads to me death. I began fixating on my already prevalent existential angst and i was sobbing for awhile in my room, afraid to do anything. I had to call friends to help me be reminded of reality and monitor me. I never had a serious fever but after another few hours my head began clearing bit by bit, through the fog. Still this morning i feel groggy and a tiny bit flu-like symptoms persist. I hope this is helpful. It was scary.
Local reaction to Tdap shot swollen, red and warm. Used cold pack and resolved over the next week.