chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After taking it I started getting a metallic taste in my mouth. It then started to lessen but within 20 mins of next dose it is strong again.; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (After taking it I started getting a metallic taste in my mouth. It then started to lessen but within 20 mins of next dose it is strong again.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 029A21A) for COVID-19 vaccination.    Co-suspect products included non-company products NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 vaccination and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Allergy to nuts, Fruit allergy (coconut) and Hashimoto's thyroiditis. Concomitant products included ONDANSETRON from 18-May-2022 to an unknown date and OXYCODONE from 18-May-2022 to an unknown date for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022 at 3:00 PM, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 25-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 25-May-2022 at 6:00 PM, the patient experienced DYSGEUSIA (After taking it I started getting a metallic taste in my mouth. It then started to lessen but within 20 mins of next dose it is strong again.). At the time of the report, DYSGEUSIA (After taking it I started getting a metallic taste in my mouth. It then started to lessen but within 20 mins of next dose it is strong again.) outcome was unknown.            No concomitant medications were provided by the reporter.  It was reported the device date was 26May2022.  No treatment medications were provided by the reporter.
Red rash below the injection site. Notice about 7-8 days after the first dose.
Dizziness following HPV injection, clamy, pale blood pressure went from 110/68 decreased to 80/52
Adverse event was the administration of an incomplete dose of Heb B vaccine. Patient was given a pediatric dose, (0.5ml) and was not given the adult dose of Hep B vaccine, (1.ml). Adverse event was not detected while the patient was in the clinic. Treatment is to re-call the patient back to clinic to administer the correct adult dose of Hep B vaccine.  There were no symptoms reported with the event.
Numbness in 3 finger tips on right hand , beginning day after 2nd shot continuing today, 10 days later.
This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5ml dose of GARDASIL. Subsequently, the patient fainted and felt fatigue. Unspecified medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information is not expected.
pain & swelling 6hr p/vax;no fever;area around inj site red & hot to touch;pt felt lightheaded, disoriented;MD dx cellulitis/allergic rxn;tx w/cefuroxime;better p/ATB;
Shot 9/28 12:00. Erythema evening. 9/29 Cellulitis like reaction. 9/30 12 x 18 cm red, tense, swollen. But child playing, started OMNICEF. 10/1/09 Definitely better.
PER PT, AS SOON AS SHOT GIVEN, FELT SHARP PAIN AND BURNING AT SITE. ARM FELT SORE AND HEAVY THAT NIGHT. HAVE NOT MOVED OR USED IT AT ALL BECAUSE SORE. ON 5/18/2012 WOKE UP AND ARM AND HAND FELT NUMB. AT THIS TIME PT HAS FULL RANGE OF MOTION OF LEFT ARM AND HAND WITH COMPLETE SENSATION.
A report has been received from a Health Professional concerning an 8 years 45 weeks 1 day old female patient. The patient received expired FLUMIST QUADRIVALENT (Intranasal). 0.2 millitres, once/single administration on 08-Jan-2016. The vaccine had expired on 30-Dec-2015. The patient also had product quality issue. FLUMIST QUADRIVALENT (Intranasal) was discontinued on 08-Jan-2016. The patient recovered from the event of expired FLUMIST on 08-Jan-2016 and the outcome of the event product quality issue is unknown. The report was considered to be non-serious.
Right lateral thigh erythematous and mildly edematous.  Slim papule radule surrounding injection site.  Erythematous area measured 4cm x 4 1/2cm.  Full ROM to leg-appears in no discomfort-walks well.
Patient developed headache, nausea, dizziness, and weakness hours after receiving Moderna vaccine (dose number unknown). Seen at Medical Center in the ER; determined to be vasovagal syncope. Location of vaccine administration unknown.
My COVID-19 infection symptoms stated on 03/06/2023 in the evening. I had respiratory issues, headaches, fatigue, fever, and body aches. On 03/08/2023 I went to the urgent care where they tested me for COVID-19, which was positive. They prescribe me TESSALON PERLES for 5 days. As of now I still have fatigue but other symptoms are gone.
Fully vaccinated breakthrough case that ended up hospitalized and requiring treatment due to severity of symptoms.   Receive Pfizer Vaccine 2/16 & 3/8 - couldn't remember exactly where but thinks it was at Hospital  (the information can be accessed  if needed)  Case was hospitalized at  Medical Center from 9/22 to 9/24 and was given the monoclonal antibody treatment as a responsive treatment due to the severity of her symptoms. The  at the hospital can be called for further information regarding her symptoms.  Additional Contact Information:  MEDICAL CENTER -  Cases's emergency contact -- no phone # provided
Pt developed red rash to face, neck, abdomen, hands, feet and on the back. Pt was very irritable and was crying a lot. No respiratory distress noted.
16 cm x 13.5 cm cellulitis reaction to right thigh. Area red, warm to touch with central induration.
This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 10Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter inquired what pain medications the patient could take as the patient had experienced soreness after the first dose in Mar 2021. The clinical outcome of soreness was unknown. Follow-up attempts are completed. No further information is expected; information about the lot number cannot be obtained.
Patient reports feeling like her heart was racing, no other symptoms reported. Patient reports symptoms improved. Patient was seen and cleared by EMS BP: 160/92, pulse: 96, Spo2 100%
has been in bed incapacitated since 2 am this morning.; This is a spontaneous report from a contactable consumer. A patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant mediations were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. This patient had been in bed incapacitated since 2 am this morning. The consumer reported several of her husband's co-workers had received their second dose of the COVID vaccine have experienced some side effects including extreme fatigue, nausea and fever. The outcome of event was not provided.   Information on the Lot/batch number has been requested.
Immediately after giving the vaccine, the patient started sweating profusely and stated he had trouble breathing. He proceeded to pass out.  The patient woke up within 30 seconds without the administration of an Epipen and was fairly alert. He continued to sweat and when EMS arrived he was reported to have a pulse of 54. BP was not reported
Headache started around 9am the morning following vaccine.  Nausea started around 4:30pm that same day and continued until next morning.. Ran a slight fever of 100.1 around 5am two days following the vaccine and it lasted approx. 2 hours.  Headache remaining to current time.  Taking Tylenol for pain
Sore Arm; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (ongoing), notes: several different pills in the morning; "Compromised immune system" (ongoing). The patient took concomitant medications. Vaccination history included: Moderna (Dose Number Unknown, Single), for COVID-19 IMMUNISATION, reaction(s): "tired", "got sore arm from all the other covid shot". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "Sore Arm"; FATIGUE (non-serious) with onset 2023, outcome "unknown", described as "tired".  Additional Information: Reporter did not had a compromised immune system but her husband does, he had ulcerative colitis (Intent: Medical History) and he never got affected by the shot other than a sore arm so this was what she found so absurd. Just a sore arm. He had gotten on the Friday before at 9:30 in the morning. He was 5, she did not know if he was 5'10 or 5'11 and he was probably like 200 pounds. He got sore arm from all the other covid shot so it was not anything really different and he was tired. His was all Moderna also with myself. This was the only Pfizer shot he got.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300333443 same reporter/drug, different AE/patient;US-PFIZER INC-202300334050 same reporter/drug, different AE/patient;
Fever of 102°F or greater began on the night of vaccination. Temperatures normalized after giving Tylenol dosed based on weight. Fever free for 15 hours then recurred. Persistent fevers for 6 days and ongoing. Fevers spacing out more since day 5. Slowly becoming low grade fevers. Child has been irritable during fever, but active otherwise. Decreased appetite in first 4 days after vaccination. Highest temperature recorded was 104.9°F.
Very sore arm, muscles are very sore, bad headache. Flu like symptoms. Don't want to do anything.
Anaphylaxis (difficulty swallowing, tingling tongue and throat, difficulty breathing, rash, increased heart rate) - transported to ER at  Medical Center, treated with IV steroids/antihistamines, sent home with scripts for continued steroids/antihistamines
Possibility of blood clot; Swelling at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE THROMBOSIS (Possibility of blood clot) and VACCINATION SITE SWELLING (Swelling at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Mar-2021, the patient experienced VACCINATION SITE THROMBOSIS (Possibility of blood clot) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE THROMBOSIS (Possibility of blood clot) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-123 is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: NNI On 07-May-2021: NNI
Patient developed a pruritic full body erythematous maculopapular rash the day after Hep A #2. Rash persisted for 5 days before I treated it with prednisone. Not otherwise ill.
COVID Arm: Redness, hardness, swelling, warm to touch, and sore at injection site the following day. Lasted several days. The redness decreased and size with ice/cold packs and Ibuprofen. Then it went away. Body and muscle aches the 2nd day following vaccination and restlessness. It last a couple of days and then went away. Took OTC Ibuporofen and rested.  The following week a rash and lumps under skin appeared on the right forearm extending to the top of the hand. Small papules with some itchiness. Took OTC allergy meds and used topical steroid. Rash cleared some, but still not completely gone yet.
Information has been received from a physician concerning her father, an 82 year old male who on 26-JAN-2000 was vaccinated with VAQTA vaccine inactivated. Concommitant medication included a daily vitamin. On 27-JAN-2000 the patient experienced cardiac arrest. He was 'brought back to life, a code was performed, and he was rushed to the nearest hospital". He remained hospitalized at the time of the report and was stable. Cardiac arrest was considered life-threatening. No further information is available.
This case was reported by a pharmacist and described the occurrence of injection site pain in a 46 year old female patient who received hepatitis B vaccine recombinant (Engerix-B).  The patient did not receive any concurrent medications.  On 01/23/2004, the patient received the sixth dose and final dose of an Engerix-B series in the arm.  The expiration date for this lot of Engerix-B is 12/04/2002.  At an unspecified time following administration of Engerix-B, on 01/23/2004, the patient experienced prolonged injection site pain.  The event resolved on 01/27/2004.  The reporter stated that the event could possibly have been related to erroneous administration, but noted that 2 additional patients had experienced similar events on the same date.
after the injection she complained of an itching sensation at the injection site. By the evening around 7 pm a rash began to form and reddness. she used topical Benadryl to the site. according to the patien the area was warm to touch. by the morning she complained of chills, and hardness to the injection site.c/o body aches and temp 100.2. she rested and took in fluids. noted today the red area to l arm is fading and no fever to site. She denies any discomfort at this time.
side effects that has been bothering for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects that has been bothering for 4 days) 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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ADVERSE EVENT (side effects that has been bothering for 4 days). At the time of the report, ADVERSE EVENT (side effects that has been bothering for 4 days) outcome was unknown. 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.
Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 10:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On 27-Oct-2021 at 10:04 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 59.01  Concomitant products were not provided.  On 27-Oct-2021 vials were moved to clinic. On 29-Sep-2021 and 05-Oct-2021 the vaccines were moved to fridge. On 27-Oct-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 29 and at 10 AM temperature was 32.  The vaccine beyond use date was reported as 29-Oct-2021 and 04-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Breakthrough case admission after three vaccines Pfizer 4/14/21 Lot# EW0158;  Pfizer 5/5/21 Lot# EW0172;  Pfizer 10/26/21 Lo0t# 30145BA
a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes; a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE PRURITUS (a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced RASH ERYTHEMATOUS (a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes) and VACCINATION SITE PRURITUS (a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes). On 30-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, RASH ERYTHEMATOUS (a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes) was resolving and VACCINATION SITE PRURITUS (a bad itching, and a huge red oblong circle, pretty large, like 3x4inches. Now the redness is almost gone but the itching persists sometimes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    This case was linked to MOD-2021-028823 (Patient Link).
Pt had Moderna Vaccine.  Pt verbalized lip tingling sensation, followed by throat swelling and fainting and grunting with inspiration.  Was not able to obtain BP at the time.  Epinephrine 0.1 mcg x 2 was given 3-5 minutes apart.  Pt responded well.  Was alert, and verbally responsive. Pt also received Benadryl 50 mg IM, Famotidine 20 mg, and Solumedrol 40 mg.  Pt was taken by Paramedics to Emergency department for continued management.  Pt was advised to not take second dose of Moderna Vaccine.
o 2 hours after her arm swelled and e=she couldn't move her arm o Headache o Nausea o Some redness o It itched a lot o She felt light headed o Couldn't sleep  she soaked in epsom salt and the hives went away
Stuck up sinus; Coughing; Chest congestion; Mucus in nose and throat; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Stuck up sinus), COUGH (Coughing), CHEST DISCOMFORT (Chest congestion), SECRETION DISCHARGE (Mucus in nose and throat) and HEADACHE (Headaches) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced SINUS CONGESTION (Stuck up sinus), COUGH (Coughing), CHEST DISCOMFORT (Chest congestion), SECRETION DISCHARGE (Mucus in nose and throat) and HEADACHE (Headaches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, SINUS CONGESTION (Stuck up sinus), COUGH (Coughing), CHEST DISCOMFORT (Chest congestion), SECRETION DISCHARGE (Mucus in nose and throat) and HEADACHE (Headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-192952, MOD-2021-193494 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: TCR report received: Updated event outcome for all reported events. Patient had denied further follow-up
COVID arm - lump, 1 & 1/2 -2 inch itchy rash on arm, pain. Instructed patient to use Ibuprofen or Acetaminophen and cold compresses as needed for pain and itchiness.
Patient stated they felt nausea and lightheaded after administration of shot. Patient informed they were highly anxious in receiving the shot. No swelling of lips, mouth or tongue, no hives or rashes noted. Patient remained conscious. Patient was given water and stayed for 20 minutes for observation and experience residual vertigo that faded in observation time. Patient was able to walk and turn prior to leaving without any dizziness. Nausea had subsided.
10 Year old male inadvertently administer adult 12+ dose of pfizer  Booster instead of correct pfizer 5-11  year old Booster.