chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drowsiness; uncharacteristic behavior/not aware of behavior; sensitivity to lights and sounds; sensitivity to lights and sounds; inability to speak; neck stiffness; vertigo; confusion; altered personality; hallucinations; memory loss; difficulty with word retrieval; migraines; recurring headaches; loss of appetite; difficulty concentrating; clumsiness; off balance; reduced speed of thought; This is a spontaneous report from a contactable consumer, reporting for herself.  A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: EP7534), via an unspecified route of administration in the left arm on 22Mar2021 14:30 at a single dose for covid-19 immunisation. The patient received the bnt162b2 in the hospital. The medical history was not reported. There were no allergies. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN) taken for an unspecified indication, start and stop date were not reported. On 25Mar2021 at 16:00, the patient experienced drowsiness, sensitivity to lights and sounds, inability to speak, neck stiffness, uncharacteristic behavior/ not aware of behavior, confusion, altered personality, hallucinations, memory loss, extreme sleepiness, difficulty with word retrieval, migraines and recurring headaches, loss of appetite, difficulty concentrating, clumsiness and off balance, reduced speed of thought, and vertigo, which were serious for disability. The events required emergency room and physician office visits. Therapeutic measures were taken as a result of the events and included treatment with fluids and acetaminophen (TYLENOL). There was no covid prior to or post vaccination with bnt162b2. The clinical outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Around 6pm, I started to feel confused and cloudy.  By 9pm, I was completely tired and needed to lay down.  Around midnight, I woke up with pain throughout my whole body and was unable to walk.   This was pain that I never felt before.  As I tried to walk my legs were shaky and I could not balance at all.  This lasted until about 9 a.m. the next morning.  I needed help to walk to the bathroom because my legs basically stopped working.  This happened several times during the night.  I also felt like I was hallucinating and still in the state of confusion.  I heavily cried due to the pain in my legs and contemplated going to the hospital.  I also had a type of headache on my left side that I never felt before in my life.  It was a different type of pain.  It lasted on and off for one week.  Also, my whole left side had lingering pain for one week.  This was very concerning and I'm frightened to get a booster shot, if needed.  I also experienced Covid Arm from my first vaccination but that did not happen in my second.  Covid arm lasted for 3 days.
The patient had VARIVAX today and has a rash all over the body at the evening consistent with chicken pox. The rash-is papules and vestibules all over the body/child is afebrile/no other concerns.
SICK; FEVERISH; TIRED; This spontaneous report received from a consumer concerned a 19 year old female. 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: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced sick. On APR-2021, the subject experienced feverish. On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, fever, and tired on APR-2021. This report was non-serious.
Case number PHEH2015US023189 is an initial spontaneous report received from physician on 06 Nov 2015 and Quality Assurance Department (QA, reference number: 1008487) on 10 Nov 2015 (combined report). This report refers to a 52 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX (batch number: 173538) intramuscularly on an unknown date within the last week. It was reported that during vaccination there was leakage of vaccine from where the needle was attached to the syringe. The case was assessed as non-serious. No adverse event was reported.
Right after the booster I felt a slightly sore arm. On 01/31/2022, I tested positive for COVID.
OPEN WOUNDS ON BOTH LOWER EXTREMITIES AND LEFT UPPER EXTREMITY BELOW ELBOW.
a rash all over my body; bad allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 05Aug2021 (Batch/Lot Number: FC318U; Expiration Date: 05Aug2021) at the of 26-years-old as dose 1, single for covid-19 immunisation. The patient has no medical history. There were no concomitant medications. On an unspecified date in Aug2021, the patient experienced a bad allergic reaction to the vaccine. The patient had a rash all over her body and is hesitant to take the second dose. The patient put cream (reported clotrimazole cream or something like that). The patient also reported he went to the urgent care where she was given a steroid shot which he believed was some cream (as reported). The outcome of the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
TWO DOSES OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned multiple patients. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On 2021, the subject experienced two doses of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two doses of vaccine administered was not reported. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (small welts on their left side of their body close to their armpit), RASH (rash on back) and HYPERSENSITIVITY (allergic reaction) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced URTICARIA (small welts on their left side of their body close to their armpit), RASH (rash on back) and HYPERSENSITIVITY (allergic reaction). At the time of the report, URTICARIA (small welts on their left side of their body close to their armpit), RASH (rash on back) and HYPERSENSITIVITY (allergic reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was provided as cetirizine hydrochloride.
Twelve Moderna vaccines were given in office today. Only 11 were drawn up this morning and the 12th dose was, most likely, a left over dose from yesterday. After incident was discovered, Moderna manufacturer was contacted per CDC recommendation. (Case #: MOD21-060693). Patient notified of the below message: The Moderna Vaccine Patient received may have been outside of the 6 hour thaw recommendation. We contacted the Moderna manufacturer and CDC. At this time, there are no recommendations for revaccination. Patient will still receive your 2nd dose as previously scheduled. Titers will be available at no cost in 2-3 months after your second vaccine.
1 hour after receiving vaccination(s) patient experienced chills, fever, body aches, inflammation and rash at injection site to her left arm. This was reported 9-14-2012 patient felt better, however inflammation and rash still present. Patient was advised to take BENADRYL and Ibu.
Initial report received from a nurse on 08 Jun 2010: This patient was vaccinated with MENVEO (batch number: 091001) unknown dose, intramuscularly on 08 Jun 2010. The patient only administered the diluent portion of MENVEO, rather than being reconstituted with the lyophilized portion. No adverse event occurred.
Discovered pt. was given a diluted dose of vaccine.  The day's prior vials were not properly discarded, so RPh (myself) mixed saline into a vial that wasn't a vial containing fresh vaccine to use.  So pt. did not receive proper dose, mostly just the saline.
17 month old infant presented on 3/17/22 to office for well-visit. MD ordered Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13), HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB), and DTaP vaccine less than 7yo IM (INFANRIX) to be given during visit. CMA prepared and administered the following immunizations: Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13) IM to patient's right thigh (LOT #ER7046), HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB) IM to patient's left thigh (LOT #U024091), and DTaP vaccine less than 7yo IM (INFANRIX) IM to patient's right thigh (LOT #23T73). On 1/11, parent sent message to office noting "pea-sized lump on patient's left thigh". Lump was non-tender and didn't seem to bother patient. Parent noted patient was afebrile, and no red streaks or marks noted.  Parent encouraged to massage the area and to return to office if did not improve in 2 more weeks.  Patient had received Hib vaccine in left thigh. Local injections site reaction including "Pain at injection site, erythema at injection site, swelling at injection site, tenderness at injection site".
shingles on the upper part of face; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: shingles on the upper part of face).  The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt date: 13-OCT-2023 A physician reported that in the past few weeks she had a case of shingles on the upper part of her face.  This patient are over 65 years old, according to the doctor, this occurred about one or two weeks after this patient are administered, according to the doctor, the first dose of shingrix.  For this reason and had knowledge of this claim by the doctor, he/she proceed to report it. The reporter agrees to follow up from GSK. This case was linked with case US2023AMR143598 with same reporter.; Sender's Comments:  US-GSK-US2023AMR143598:Same reporter.
pt exp burning @ the inj site which stopped upon completion of vax;w/in 2hr of vax pt devel h/a, gen malaise, low grade fever, dizziness, tiredness, blurred vision & nausea;fever resolved in 24hr & tiredness improving;muscle weakness;
Fever; This spontaneous case was reported by an other caregiver and describes the occurrence of PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jan-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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 103 (High) fever of 103..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Flu-like symptoms, slight fever, fatigue, headache, body aches. Lasted 48 hours, full recovery
Myalgia, Arthralgia, Fever, HYPERtension, SHORTNESS OF BREATH, CHILLS, HYPERTENSIVE 168/98 Narrative:
Built up issues started to get worst after each vaccination. 02/24/2023 lost feeling in left foot. Feet are freezing.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Pfizer COVID-19 Vaccine (Dose 1) on 22-Jan-2021, Pfizer COVID-19 Vaccine (Dose 2) on 11-Feb-2021 and Pfizer COVID-19 Vaccine (Dose 3) on 25-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine, Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine. On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. Date and time vial was first punctured was on 15-Jun-2022 at 9:15 AM. The vial was stored in portable fridge post puncture. The vaccine expiry date was reported as 05-Jul-2022. The vial undergo temperature excursions of plus 1.9C to plus 6.4 C for 15 minutes. Total amount of time the vial was exposed to room temperature range 8° to 25°C that is 46° to 77°F. Storage condition at the time of the excursion was Refrigerator. Vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial on 15-Jun-2022 Visual inspection noting any vaccine state change was thawed. No treatment medication were reported.
12:00 headache. 2:30 congestion, 5:30 extreme congestion all on injection day. Next day (1/29/2021) redness. Hot, swelling just below injection site
change in taste; weak; fever with body temperature 102.9 Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 22Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient previously took amoxicillin sodium;clavulanic acid (AUGMENTIN) and experienced drug allergy. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL9262) on an unspecified date for COVID-19 immunisation. On an unspecified date, patient experienced change in taste and was weak. On Feb2021, patient had fever with body temperature 102.9 Fahrenheit. Outcome of event fever was recovered on an unspecified date while the outcome of all other events was unknown.  No follow-up attempts are possible. No further information is expected.
A report was received from a health care professional on 12 November 2003 concerning a 52 year old female vaccinee who experienced loss of peripheral vision after receiving Fluvirin on 06 November 2003. On 06 November 2003 a female vaccinee received a single dose of Fluvirin, and that night the vaccinee experienced loss of peripheral vision. the loss of vision was due to a choked optic nerve as per an ophthalmologist and an eye care specialist. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Pt received vaccine at 2:10pm. Patient was receiving HPV9 for the first time, so patient was told to wait 15 minutes to make sure he felt OK. At 2:18pm patient fainted. Elevated patients leg while lying on the ground. BP obtained 88/60 O2 sat 99 HR 64. Patient started to come to approx 2 minutes after fainting. He began to talk and drank a sprite. BP obtained again at 2:30pm 100/60. Patient stated that he felt much better. Patient left facility at 2:40pm. Notified pt's mother the following day to check on patient. She stated that patient was totally fine.
Tinnitus (both ears) First vaccine.  Second vaccine due on April 19th.
Fever, fussy, decrease in appetite on 09/18/20 Loose, abnormal stools, multiple stools Diarrhea 9/21/20 Gelatinous spore in stool 9-21-20 Sleeping more, fussy, facial swelling w/viral exanthem 9-21-20
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 10:15 as dose 5 (booster), single (Lot number: GH9702) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EJ1686), in right arm, on 11Feb2021 as dose 2, single (Lot number: EJ1684), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 301308A), in right arm and on 15Apr2022 as dose 4 (booster), single (Lot number: BvFK9729), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Arrhythmia" (unspecified if ongoing); "Cardiomegaly" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "chronic rhinitis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "IBS-C" (unspecified if ongoing); "hx C Diff" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Known allergies: narcotics" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Oct2021; ZOLPIDEM, start date: 01Jul2020, stop date: 26Oct2022; PANTOPRAZOLE; LINZESS, start date: 05Apr2021; PRAVASTATIN NA, start date: 10Oct2021, stop date: 29Oct2022; MONTELUKAST, start date: 01Jan2017; METOPROLOL, start date: 02Sep2014; SLOW-MAG, start date: 18Oct2021; FEXOFENADINE HYDROCHLORIDE, start date: 01Jan2010; D3, start date: 02Mar2011; ASPIRIN [ACETYLSALICYLIC ACID], start date: 15Sep2015; CALCIUM CITRATE, start date: 11Oct2021; HFA DOBIPRO, start date: 01Jul2020; FLOVENT; IPRATROPIUM BROMIDE, start date: 01Nov2019; NASACORT, start date: 01Mar2022. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Reclast metoclopramide, reaction(s): "Known allergies: Reclast Metoclopramide"; Trazadone, reaction(s): "Known allergies: Trazadone"; Aleve, reaction(s): "Known allergies: Aleve"; Clindamycin, reaction(s): "Known allergies: Clindamycin"; Iv vancomycin, reaction(s): "Known allergies: IV vancomycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Oct2022) Positive, notes: Diagnosed with Covid using home antigen test 29Oct2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Diagnosed with Covid using home antigen test 29Oct2022. Started Paxlovid around noon.
On 10/4/2022 , Early morning, I woke up with chills and body aches.   I had around 99-degree fever which remained for a while. I took some Motrin and it helped. After taking more, it subsided after 24 hours and never returned.  By the evening of 10/5/22, I was doing better. I have recovered .
Product storage error; We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022) & gave 1 shot at 10:20a. We gave 1 shot this morning.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022) & gave 1 shot at 10:20a. We gave 1 shot this morning.) and PRODUCT STORAGE ERROR (Product storage error) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     No Medical History information was reported.  On 07-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022) & gave 1 shot at 10:20a. We gave 1 shot this morning.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We opened bottle of Moderna Covid-19 vaccine yesterday (06Jun2022) & gave 1 shot at 10:20a. We gave 1 shot this morning.) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-584212 (Patient Link).
Post vaccine pt developed sore throat. Denies any other symptoms. Transported to med obs via wc at 1335. Vitals obtained and monitored.  Upon discharge pt states sore throat resolved and now experiencing slight dry throat. Pt released to home with significant other at 1415. Vitals as follows: 1345 BP 122/83 HR 94 SPO2 99 1350 BP 106/73 HR 94 SPO2 96 1355 BP 108/76 HR 88 SPO2 99 1406 BP 111/76 HR 90 SPO2 99 1408 SITTING BP 101/72 HR 90 SPO2 99 1412 STANDING BP 108/76 HR 83 SPO2 99
p/vax pt broke out w/a rash 6-7hr later described as hives;instructed to give DPH;no diff breathing f/u appt given 9/24/99;