chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This is a spontaneous report from a sponsored program. A non-contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took dupilumab (DUPIXENT). The patient took dupilumab the day before the covid vaccine. She was concerned if it worked, is she can get the second dose. She experienced a headache after covid vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
No adverse effects were reported; one patient was inadvertently administered one dose of expired VARTVAX (lot N021318 exp 8/7/2019) on 24SEP2019; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions or allergies were provided. Concomitant therapies included sterile diluent.  On 24-SEP-2019, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # N021318 with an expiration date on 07-AUG-2019) for prophylaxis (dosage schedule, route and anatomical location were not reported). No adverse effects were reported.
Herpes Zoster; Post-Herpetic Neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 73-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 17-JUN-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for Herpes Zoster and Post-Herpetic Neuralgia resulting from her use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of  Herpes Zoster and Post-Herpetic Neuralgia was unknown. The reporter considered  Herpes Zoster and Post-Herpetic Neuralgia to be related to Zoster Vaccine Live(ZOSTAVAX).
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 11:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:47 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially moved to the fridge on 08-Jan-2021 and proposed beyond use date was 07-Feb-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. the vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
toothache; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient) reported for himself.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient asked if it's okay to take Amoxicillin before the 2nd dose scheduled on 13APR2021. He went to the dentist today (12Apr2021) because of a toothache. He received the 1st dose of covid-19 vaccine last 23Mar2021. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt devel 11x5 cm redness, warm to touch, tender to direct palpation.
Bilateral burning pins; needles pain in hands and feet after the 2nd dose; This is a spontaneous report from a contactable Physician. A 36-Year-old female Physician reported for herself. A 36-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EL1284) via an unspecified route of administration in arm left on 06Jan2021 07:00 as dose 2, single (age at vaccination: 36 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EJ1685) via an unspecified route of administration on 18Dec2020 07:00 AM as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks, no other medications in two weeks. No covid prior vaccination and did not tested covid post vaccination. No known allergies. On 08Jan2021, bilateral burning pins and needles pain in hands and feet after the 2nd dose on 06Jan2021. No treatment was received. The adverse resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was resolving.  Follow-up attempts completed. No further information expected.
3-12-09. Mom called re: 4 bumps to left thigh with redness. 3-13-09 mom brought child to MD with increased redness and selling. 3-14-09 ED visit, labs drawn sent home. 3-15-09- ED visit with increased temperature, N?V, sent home.
have never received a 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a dose of Shingrix almost 5 years ago).   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: have never received a 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 2-Oct-2023 The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to  incomplete course of vaccination.
This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA ORAL (numbness in tongue,numbness in lips), ORAL DISCOMFORT (tickling) and IMMUNISATION REACTION (unspecified mild reaction to Moderna regular booster) 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 16-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2022, the patient experienced IMMUNISATION REACTION (unspecified mild reaction to Moderna regular booster). On 17-Sep-2022, the patient experienced HYPOAESTHESIA ORAL (numbness in tongue,numbness in lips) and ORAL DISCOMFORT (tickling). At the time of the report, HYPOAESTHESIA ORAL (numbness in tongue,numbness in lips) and ORAL DISCOMFORT (tickling) had not resolved and IMMUNISATION REACTION (unspecified mild reaction to Moderna regular booster) outcome was unknown.            No concomitant medications were reported. Patient received latest booster of Moderna COVID-19 Vaccine on 16-Jul-2022 and experienced a mild reaction (not specified what kind of reaction).  On 17-Sep-2022 patient reported numbness in tongue and lips and tickling which was still ongoing Caller visited cardiologists and neurologists and they could not find another cause for these symptoms, other than the vaccine. Reports did not specify date of 1st and 2nd dose of vaccine. It was reported that treatment received was unknown.
On 7/28/06 7-8am infant was noticed to have fever about 101 and rash. He also had decreased appetite and was somewhat irritable. On Exam 7/31/06 he had generalized erythematous maculopapular rashes.
12/01/21: Mother brought child to pharmacy to receive flu shot, paperwork was processed for flu shot, but child received Pfizer Covid-19 pediatric vaccine.    Child's physician was contacted.  Dr. recorded error in patient's chart and recommended that patient receive second pediatric covid shot in 21 days.
30AUG96 @AM awoke from sound sleep c/o itchiness hives to chest & back;no resp distress;no c/o diff swallowing;mom called nurse advised DPH;30AUG96 3AM still c/o itching took 2 DPH;930AM still itchy;poss allerg rxn;pt also tired;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 29Apr2021 as dose 2, single (Lot number: FF8841), in left arm, on 05Nov2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Negative; (Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Redness and swelling of left upper arm noticed 2 days after immunizations. No pain, no fever.
(L) arm, below deltoid with 10cm area of erythema slight warm and edematous, not particularly tender.
Pt. stated he had some itching & soreness 48 hrs post vaccine - then had gradual redness/soreness at site. Swelling occur up until visit 12/26/12. Cellulitis entire (L) upper/lower arm below injection site.
Vomiting the afternoon of 5/4/05.  Diarrhea on 5/5/05.  Diarrhea and projectle vomiting 5/5/05 evening.  Doctor thought this was due to a viral illness.
10/26 left arm swelling, 10/27 head pain & pressure & felt ill 10/28 left side numbness & tingling.
We gave a 2nd bivalent shot when patient was not eligible for it. Patient did not have an adverse reaction to it.
20 minutes after shot. Sharp pain in arm. Daughter said it feels like the needle was left in her arm.   Feels dizzy and out of it.  25 minutes after shot having trouble swallowing. No difficulty breathing. Very thirsty.  40 minutes after shot legs feel very heavy. Daughter was sliding them across floor instead of walking regular. She said it was like her legs forgot how to walk.   She was very irritable.  Two hours after shot she said she was feeling  better except for sore arm. Still felt somewhat sick.  Next day she said feels like she had the flu but was feeling much better except for sore arm.
Blood in the baby's stool, fever, severe stomach pain, baby has acted weak and was very irritable.
Stiff neck, face 4/9 Tingly scalp, face 4/9 Chest tightness 4/9 Face burning 4/9 Sound sensitivity 4/10 Back pain 4/13 Dizziness/ brain fog 4/14 Ears plugged 4/14 Face twitching 4/16 Headache 4/16  Muscle spasms 4/16  Swollen lymph nodes 4/16  Eye floaters 4/19 Face swelling 4/24 Buzzing in calves 4/29 Buzzing in calves, feet, right hand 4/30 Hand and foot cramping 5/17
Sore and arm is red and it is about 2 inches circular.   Fever, 101 for 3 hrs., only .Bad headache, body aches, and chills  are still going on , n addition to the redness and sore arm.   It is now 10:40pm.   No treatment was taken.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
flow seems to be getting heavier/around 04Nov and have been bleeding ever since; bloating; very painful cramping; abbreviated 2 day period in mid Sep/In mid Oct, I had a phantom period/around 04Nov and have been bleeding ever since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 (Lot number: FC3182) at the age of 42 years as dose 1, single and administered in arm left, administration date 16Sep2021 (Lot number: FF2588) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MIRENA, start date: 2017. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Sep2021, outcome "not recovered", described as "abbreviated 2 day period in mid Sep/In mid Oct, I had a phantom period/around 04Nov and have been bleeding ever since"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset Nov2021, outcome "not recovered", described as "flow seems to be getting heavier/around 04Nov and have been bleeding ever since"; ABDOMINAL DISTENSION (non-serious) with onset Oct2021, outcome "not recovered", described as "bloating"; DYSMENORRHOEA (non-serious) with onset Oct2021, outcome "not recovered", described as "very painful cramping". Therapeutic measures were not taken as a result of menstrual disorder, heavy menstrual bleeding, abdominal distension, dysmenorrhoea.  Additional information: The most recent COVID-19 vaccine was administered in facility at Pharmacy or Drug Store. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The other medications the patient received took within 2 weeks of vaccination was Mirena which was implanted in 2017. Clinical course: The adverse event start date was provided as 15Sep2021. Patient stated that she had regular 28-day cycles even on Mirena (5-7 days). She had an abbreviated 2-day period in mid sept. In mid Oct, she had a phantom period, with all the signs bloating, very painful cramping but no bleeding (She never had cramps with Mirena). After 2 weeks of this uncomfortable phantom period, she started a spotty period, around 04Nov and have been bleeding ever since. As this month progresses, flow seems to be getting heavier. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Pt vaccinated with Recombivax developed headache, chills, fever, neck & shoulder discomfort, stomach distress & nausea.
This spontaneous report was received from an office manager and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates reported as "over the past 3 months", the patients were orally vaccinated with improperly stored doses of ROTATEQ lot # M032636 with an expiration date: 06-APR-2018, M035456 with an expiration date: 01-MAY-2018 and M032643 with an expiration date: 04-MAR-2018 (dose was not reported). No adverse experience was reported. Administered doses of vaccines experienced the temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 21 hours cumulatively over "3 months," on unspecified dates. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA014473: US-009507513-1703USA014472: US-009507513-1703USA014470: US-009507513-1703USA014469: US-009507513-1703USA007914:
Pt reported bacterial infection at injection site. Being treated with BACTRIM DS & BACTROBAN by Dr from Urgent Care.
The incorrect bivalent vaccine dose was inadvertently ordered. The 6 month to 4 year old bivalent vaccine dose was ordered as the third dose and administered to the patient who is 5 years and 0 months old. There were no adverse events. The family was notified of the error by phone the same day one the error was noted.
After receiving the vaccine, felt dizzy for 10-15min. Vital signs stable 115/80, pulse 79, O2sat 99%  repeat 10mins later vital signs 115/76 pulse 84  O2 sat 99%. Fluid Hydration and monitored under observation. 911 dispatched, EMS arrived  to the scene @17:30 Monitor showed NSR.. He declined to go to a  hospital ,signed a written waiver against medical advice and left facility.
Large burning rash, somewhat itchy, but mostly painful like shingles pain.  Swollen lymph node under arm.  Swollen arm from shoulder to elbow
Severe head congestion settling in right ear.  Hearing loss found during visit to Ear, Nose and Throat dr.  Some tinnitus.
a few hours after vaccination my upper left arm swelled up at the injection site.  upper left arm pain, cannot lift my arm above shoulder height.  the area where my collarbone meets with my neck on the left side also swelled  up the next day.  reaction still the same 48 hours later.  Also had a slight headache and tiredness that day and the next, took Advil for the headache and rested.
Sore arm (at the injection site); Been feeling fatigued/tired; Having lightheadedness; Achy joints; Bouts of nausea; This case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in June 2021 in left deltoid, refer case US2021183421).   On 18th August 2021, the patient received the 2nd dose of Shingrix. On 18th August 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue, light headedness, joint pain and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the fatigue, light headedness, joint pain and nausea were not recovered/not resolved.   The reporter considered the injection site pain to be related to Shingrix. The reporter considered the fatigue, light headedness, joint pain and nausea to be unrelated to Shingrix.  Additional details were provided are as follows: The patient received a dose of Shingrix in left deltoid and she had a sore arm (at the injection site) in the afternoon and in evening of the vaccination day and the following day, since then she had been feeling fatigued/tired, having lightheadedness, achy joints and bouts of nausea.   The patient did not know if the shots were given intramuscularly. The patient said that doctor's office did not think her symptoms were due to Shingrix. The patient did not have information about lot number and expiration date. The patient did not receive any paperwork from pharmacy. The patient stated that she went to the doctor and the doctor ruled out (said she did not have) flu or Covid.  The patient said that doctor's office did not think her symptoms were due to Shingrix. The patient did not want to provide her doctor of medicine (MD) contact information. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021183421:Same reporter.
This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2022 at 10:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Feb-2022 at 10:00 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered past its 30-days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that, vaccine was administered on 15-Feb-2022 at 10:00:10. Dose number reported was booster. No treatment details were reported. This case was linked to MOD-2022-542869 (Patient Link).
10 days after receiving vaccinations (VARIVAX) - was diagnosed with shingles just distal to injection site. MD gave antivirals (VALTREX).
Second dose administered fewer than 24 days (Moderna) after the first dose (i.e., administered earlier than the 4-day grace period)
Pt woke up hurting all over. Diarrhea, weak. In next AM after receiving both H1N1, and Seasonal Flu Shot. Wife reported so sick couldn't move. Instructions given take him to Dr or ER, or call 911.
Left under arm swollen painful lymph nodes, high fever of 102 and 103 appearing 8 hours after injection; hives on chest below breasts and in between breasts appearing early morning of 11/29/21.
pt woke @ approx 2AM screaming w/T102 R;MOC called MD & was told to removed pt's clothes & APAP given; pt cried for >2hrs; in AM T103 R; mom took pt to ER pt given 1/2dropper Motrin;pt slept 3-4 hrs & upon awakening was afeb