chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a Tdap instead of a Hep B vaccine. Notified and consulted with doctor and clinic supervisor. No adverse effect to patient. No treatment needed. Notified patient.
Patient stated she had her Covid Vaccine on Friday 12/18 at 930am. On Friday night she reports she had a terrible migraine, on Saturday she felt very fatigued. She reports Sunday was her worst day and she felt very achy & her body felt like it was on fire. On Monday (12/21) she reports feeling better, but today 12/22 she reports that she has a bad cough and chest tightness.
Shingrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix 5 years ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix - Late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2023 The pharmacist asked if the patient needed to restart the series. The reporter did not provide information about the first Shingrix dose (lot number, expiry date, date of administration). The reporter consented to follow up. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
swollen rash on injection shot, swollen lymph node near armpit (felt like a pulled muscle). so far it's been 2 days but the rash still persists, armpit pain mostly gone
We got the shot Saturday, March 28 @ 12:18p Shortly after I felt: panic-anxiety  Slightly disoriented  Around 4ish pm my resting heart rate spiked from typical 60s - 70s to 80s- 147  Around 11p: Fever  Chills Shaking Extreme arm pain Body aches Joint aches Fatigue Nausea  Sunday, March 29: Fever Body aches Joint aches Arm pain Fatigue  Slept so far from 8:30ish am - 2p still exhausted  Slept again from 3ispm -6ish pm Heart rate is still up
This spontaneous report was received from a registered nurse and refers to a 3-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
The patient received about half the dose due to syringe leak; The patient received about half the dose due to syringe leak; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (The patient received about half the dose due to syringe leak), SYRINGE ISSUE (The patient received about half the dose due to syringe leak) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced UNDERDOSE (The patient received about half the dose due to syringe leak), SYRINGE ISSUE (The patient received about half the dose due to syringe leak) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (The patient received about half the dose due to syringe leak), SYRINGE ISSUE (The patient received about half the dose due to syringe leak) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for UNDERDOSE (The patient received about half the dose due to syringe leak) and SYRINGE ISSUE (The patient received about half the dose due to syringe leak).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for UNDERDOSE (The patient received about half the dose due to syringe leak) and SYRINGE ISSUE (The patient received about half the dose due to syringe leak).    No concomitant medications were reported.  The Device problem code for Spikevax syringe include FDA code 1250, RA code A050401 which include Fluid Leak. The Spikevax syringe device was malfunctioned, and the type was CIRM.  The nurse practitioner called to report that the patient had not got the full dose as the syringe leaked and hence the patient received about half the dose. Patient wanted to re-vaccinate and the reporter asked whether it will be fine if the patient would be revaccinated since the patient had not received the full dose. The vaccine had been quarantined.  No treatment medications were reported.
03/04/21 - pain, swelling, redness , left arm   03/05/21 - pain, swelling, redness , left arm, fever 101 03/06/21 - pain, swelling, redness , left arm, fever 100 - 101, fever varied  03/07/21-03/14/21 - itchy left arm , pain left arm, fatigue, loss of appetite, dizziness  03/15/21 - fatigue, dizziness, general body aches
Rapid test on Day 11 (14May2022) was positive; tested Positive again today, 18May2022, Day 15 from initial Positive test on 03May2022; Rapid test on Day 11 (14May2022) was positive; tested Positive again today, 18May2022, Day 15 from initial Positive test on 03May2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: eI9263), in left arm, on 11Feb2021 as dose 2, single (Lot number: EM9809), in left arm and on 02Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Known Allergies: Bactrim", notes: Known Allergies: Bactrim. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03May2022, outcome "not recovered" and all described as "Rapid test on Day 11 (14May2022) was positive; tested Positive again today, 18May2022, Day 15 from initial Positive test on 03May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Negative; (12May2022) Negative; (03May2022) Positive; (18May2022) Positive; (14May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: It was reported that no other medication were received in 2 weeks.
Became sick with flu like symptoms the day of shot, went home from work sick.  A couple of weeks after shot, began to have tingling sensation in bottom of both feet.  Slowly progressed to numbness in legs, feet, ankles.  Has no feeling in legs but can still walk.  Saw first MD on 11/20/08 and again on 11/26/08 then referred to neurologist. After numerous tests Dr diagnosed client with ADEM (Acute Disseminated Encephalomyelitis). Symptoms have not improved. No treatment at this time.   3/20/08 Received Neuro consult medical records of 12/16-12/29/2008. FINAL DX: ADEM w/peripheral & central demyelination Records reveal patient experienced insidious onset plantar numbness bilaterally which ascended up legs x 4 wks.  Had experienced GI prodrome after foreign travel approx 2 wks prior to onset of symptoms.  Neuro exam revealed bilateral LE dysesthesias, distal sensory loss, DTRs brisk on L.
Information has been received from a registered pharmacist (R. Ph) concerning a 77 year old male patient who on 04-APR-2011, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml, (lot number and site of administration not reported). On 07-APR-2011, the patient developed redness at injection site. It was unspecified if the patient sought medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
covid-19; covid-19; This is a literature report for the following literature source(s):.  A 70-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "prostate cancer" (ongoing); "hypertension" (ongoing); "dyslipidemia" (ongoing); "obesity" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202200910725 Same patient;
This case was reported by a nurse and described a 45 year old male patient who did not respond to immunization with hepatitis B vaccine recombinant (Engerix B). On 04/22/2004, the patient received the first dose of Engerix B (lot ENG5553B2). On 05/24/2004, the patient received the second dose of Engerix B (lot ENG5520A2)  On 10/24/2004 the patient received the third dose of Engerix B (lot number not provided). On an unspecified date after 10/24/2004 and on or before April 7 2005, a hepatitis B surface antibody titer was negative. On an unspecified date in 2005, the patient received a booster dose (lot number not specified) of Engerix B.
hives starting all over the body from head to toe and its persisting.; continue to break out daily with new hives ranging from half a dollar to plum size; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives starting all over the body from head to toe and its persisting.) and URTICARIA (continue to break out daily with new hives ranging from half a dollar to plum size) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included SERTRALINE, MAGNESIUM, CYANOCOBALAMIN (COBALAMIN), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), FAMOTIDINE (PEPCID AC), GABAPENTIN, FAMOTIDINE, ATORVASTATIN, LEVOTHYROXINE, ATENOLOL, LOSARTAN, METFORMIN and INSULIN HUMAN (HUMULIN NORMAL) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced URTICARIA (hives starting all over the body from head to toe and its persisting.) and URTICARIA (continue to break out daily with new hives ranging from half a dollar to plum size). At the time of the report, URTICARIA (hives starting all over the body from head to toe and its persisting.) had not resolved and URTICARIA (continue to break out daily with new hives ranging from half a dollar to plum size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Redness appeared 5-5-16 and spreading. Sore deltoid (right).
Inadvertently child received 3 H1N1 inj. 1 @ HD and 2 at office. No reaction noted.
22 patients vaccinated using old vial from 09mar2021 to 19mar2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 09mar2021 to 19mar2021) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 09mar2021 to 19mar2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (22 patients vaccinated using old vial from 09mar2021 to 19mar2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Reporter mentioned that no adverse events were reported.   This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-207548, MOD-2021-258660 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19 Jul 2021. contains non significant information.
Approximately 2 hours after Vaccination developed body aches, feverish feeling, injection site pain Next morning woke up with severe body aches, fever 101degrees F
5 cm area of hot redness with underlying edema. Status post DTaP vaccine #4. *F/UP report on 4/1/03: Localized reaction only.*
I awakened early the morning of 05-14-2021 with Bell's Palsy.  That was 6 weeks after my second vaccination with the Pfizer vaccine.  I went to my general doctor at 11:15 that same day.  He prescribed 21 tablets of VALACYCLOVIR 1 GM.  I took 3 tablets a day for 7 days.  My symptoms have gradually diminished however, as of today 07-24-2021 my mouth remains somewhat droopy and the vision of my right eye is still blurred.  I was examined by my optometrist 05-30-2021.  He recommended using  retaine PM, an eye lubricant.   I am improved, but not back to normal vision.
rash on back from the belt line to under arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8727), via an unspecified route of administration, administered in left arm on 15Apr2021 13:00 (at the age of 65 years old) as dose 1, single for COVID-19 immunisation. Medical history included chronic pain in back and penicillin allergy/cholesterol drugs allergy. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medication included steroids. The patient experienced rash on back from the belt line to under arm on 16Apr2021 12:00. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of rash on back from the belt line to under arm and included treatment with cream. Outcome of the event was recovered on 2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a Registered pharmacist concerning a patient of unknown age who was vaccinated with a dose of 0.5 ml (Merck) VARIVAX, SQ (lot # not provided) on 08-DEC-2012 when suppose to get ZOSTAVAX. The patient was not experiencing any known symptoms. Additional information has been requested.
Had "ankylosing spondylitis and had a pretty significant reaction" Given Vicodin for pain and advised not to get a second COVID vaccination
Patient's arm was punctured by needle but there was no vaccine in the syringe.  I explained to the patient that she was not given the vaccine the first time and that I had to puncture her arm a second time to inject the vaccine. She understood the explanation and agreed to the second puncture to get the vaccine.
Received 1st Moderna Vaccine on 2-10-21.  On 2-19-21 woke up with itching, swelling and slight rash around injection site. Not as red or swollen today 2/20/21.  Wanted to know if this is normal and   okay to get second vaccine scheduled for 3/9/21
Patient received HIGH DOSE flu shot and about 2-5 min later slumped over in wheelchair, vomited x 2, weak and irregular pulse, decreased respirations, pupils constricted bilaterally. Granddaughter reports patient has hx of seizures. Began to respond in approx 2 min. Transported to hospital by EMS. Returned home that evening.
hot flash followed by dizziness then fainting.  These events occurred at 7:00 AM and again at 11:00 AM. No recurrence after these two episodes.
Day 8 thought I was getting a urinary tract infection. Started experiencing chills. The next day same symptoms. A couple days later went on for a week with fever and muscle ache.
This spontaneous report has been received from a physician refers to a 11 years old male who was vaccinated with a dose of GARDASIL. No other co-suspects were reported. No concomitant medications were reported. The patient was shaking prior to getting the GARDASIL and fainted after receiving the vaccine. The physician thought that the patient fainted because of being nervous and not due the vaccine. The patient sought medical attention by seeing the physician. At the time of report, the patient was recovered. Additional information is not expected.
101 degree fever, cold, shaking. Took 2 Advil. Ran 99.5 to 101 temp for about 10 hours. Was either cold or hot, changing back and forth all night. Stopped about 4am, felt ok, just tired from little sleep. Fever came back that afternoon about 3:15, it was 99.5-100.3 for several hours. Took 2 Advil, and was fine by 8:00pm, and slept well.
IBS symptoms started and continue to persist. Foot numbness and bruising as well. None of these things were ever an issue until after getting the vaccine. Also experienced heavy periods 1.5 weeks after both vaccines even though my birth control doesn?t have me having a period.
CHILLS, TREMORS, STRONG HEADACHE, FEVER 101.4, NAUSEA, MUSCLE PAIN, STRONG PAIN IN LEFT SIDE OF ABDOMEN
Hives appearing on chest/thighs/back after 30-48hrs, progressing on the 2nd day rapidly across whole body. Itchy and red. Went to urgent care evening of 2nd day, received 50mg diphenhydramine that suppressed itching enough to sleep. Woke up itching and red at 6am of 3rd day, took 25mg diphenhydramine. Took 40mg prednisone at 8am. Went to urgent care at 10am for worsening hives, spreading and covering torso and onto face. Received dexamethasone injection into glute and prednisone prescription was upped to 50mg daily for the next week.  Took OTC Zyrtec and Pepcid once following the second urgent care visit. Hives responded well after 2hrs post visit, assuming due to prednisone and dexamethasone. Day 4 (1/12/20) woke up with widespread hives that became further inflamed until an hour after prednisone taken with breakfast. Also woke up with slight sore throat and wheezing, both of which subsided. Currently scheduled to see an allergist on 1/13/20. No known allergies and no other known introduction of allergens in the past week.
This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose given >12 hours post puncture), PRODUCT STORAGE ERROR (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 days) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination. No Medical History information was reported. On 22-Aug-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose given >12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose given >12 hours post puncture), PRODUCT STORAGE ERROR (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 days) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (dose given >12 hours post puncture) and PRODUCT STORAGE ERROR (vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 days). No concomitant medications were provided by the reporter. Moderna vaccine for 6 months to 5 years old was first punctured on 19-Aug-2022 around 10 AM. It was unknown if the vial was initially stored in the refrigerator. The vial was stored at room temperature post puncture. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 3 days. Later the vaccine was administered on 22-Aug-2022 at 9 AM. No treatment medications were provided by the reporter.
T 97.1, 24/60 P80. 5/18/06 130P student states at 11:30P yesterday vomited x 2. JE VAX #2 had been given at 3:30P that day. Denies diarrhea, no HA, no abdominal pain. Lungs clear. BS x 4 non tender. Taking fluids and bland foods s difficulty. Advised cont with Bland diet. 5/19/06 11:00AM T 97.6, 98/68 P78. Feeling fine, activity normal, diet normal.
Noted palm size red swollen area to inner upper arm region above elbow. Per patient area that is red has moved down from upper deltoid region where injection was given. Pt told to take Tylenol, Benadryl, cold compresses.
I got tested after my partner tested positive. At the time, I was experiencing 0 symptoms. When my test results came back, I still was asymptomatic. Only the following day which was 3 days after I was tested did I exhibit symptoms, runny nose, congestion, cough, body aches.