chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was fully vaccinated and got a positive covid test; Was fully vaccinated and got a positive covid test; This is a spontaneous report from a contactable consumer or other non hcp. A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727, Expiry date: unknown), dose 1 intramuscular, administered in Arm Left on 24Mar2021 15:00 as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Left at hospital on 2021 (Batch/Lot Number: ER8731) as dose 2, single for covid-19 immunization. Medical history included colon cancer and diabetes mellitus. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included allopurinol (ALLOPURINOL), metformin (METFORMIN), lisinopril (LISINOPRIL), acetylsalicylic acid (BABY ASPIRIN) and atorvastatin (ATORVASTATIN) (patient received within 2 weeks of vaccination). The patient underwent lab tests and procedures which included sars-cov-2 test showed positive on 07Aug2021. The patient experienced was fully vaccinated and got a positive covid test (medically significant) on 10Aug2021 08:00. The clinical outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.  Follow-Up (16Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected."; Sender's Comments: Based on plausible dose-event temporal relationship the causal role of  bnt162b2 vaccine cannot be excluded for reported events of lack of efficacy.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
5 days post-vaccination, temperature ranging from 99.0-99.6F.; 4 days post-vaccination noticed lymphadenopathy behind right ear.; Mild swelling; sensitive to touch; This is a spontaneous report from a contactable nurse (patient). A 22-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), intramuscular in arm left on 17Dec2020 17:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included none.  No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient experienced 4 days post-vaccination (21Dec2020) noticed lymphadenopathy behind right ear. Mild swelling, sensitive to touch. 5 days post-vaccination (22Dec2020), temperature ranging from 99.0-99.6F. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. The case was non-serious. The outcome of events was recovering.  Information on the Lot/batch number has been requested.
Immediately p/inject recvd in lt thigh pt c/o discomfort & was limping p/left the clinic;  also exp soreness, swelling around inject site & nodule @ the inject site;
Fatigue, mild fever,  general body aches, pain at injection site and opposite arm (oddly), mild chills, headache, nausea
hives on her face; This case was reported by a consumer via call center representative and described the occurrence of hives in a 36-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Flulaval tetra with an associated reaction of urticaria (received Flulaval tetra 2018-2019, for 1st dose refer case US2021AMR073680).   On an unknown date, the patient received the 2nd dose of FluLaval Tetra 2019-2020 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, 3 days after receiving FluLaval Tetra 2019-2020 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced hives. Rechallenge with FluLaval Tetra 2019-2020 season was positive. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to FluLaval Tetra 2019-2020 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not reported but patient could be 35 or 36 years old at time of vaccination. The patient reported that she experienced the hives on face, 3 days following the vaccination. The hives came and went for a total of three days and then resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073680:same reporter
after the injection she had abdominal pain she was diagnose with cervical cancer stage v and to present date is getting worse now it been present in the brain
Missed 2nd dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose of Moderna vaccine) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.No treatment information was provided.
Two seperate swollen, red, hot lumps in upper right arm.  One directly where vaccine was injected, other slightly below injection site. Treating with cool compresses and ibuprofen 400mg every 8 hours.  Still experiencing symptoms 3 days later.
Information has been received from a pharmacist concerning a 38 year old patient who in February 2006 finished the Varivax series. Subsequently the patient had a titer value of 0.68. It was reported that a value of less than 0.91 is considered negative. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
11/18/2021, at 1:17 pm: Received Pfizer (1st dose). 11/18/2021, at 1:25 pm: She had trouble breathing. Assisted to a nearby chair closer to the treatment room, then directly assisted to a treatment room a few feet away. Blood pressure being taken when she became limp. Immediately assisted to the floor. 911 called. B/P 184/71-97- 98 percent O2 SAT. She had 4 seizures before ambulance service arrived. 11/18/2021, at 1:32 pm ambulance arrived. VS taken: B/P 145/78-113-O2 SAT 98 %. She is conscious, brought pocketbook to her. Family notified by phone. Patient on stretcher and transferred to ED.
Pt had an occipital stroke on the 13th of March. She lost half of her vision in both eyes. We went to the hospital after the eye doctor told her she had had a stroke. Eventually, after 4 trips to the hospital, 2 trips to rehab, we discovered the strokes apparently triggered non-convulsive seizures which they could never end up getting under control. She passed away on 31 May 2021.
After immunization, patient presented with "egg-sized" bump on arm. No other S/S of allergy. Site: (L) Deltoid - PNEUMOVAX site.
Had first Covid vaccination and within 5 minutes my throat tightened up causing my voice to become raspy and horse sounding. Was director to EMT who checked my vitals and monitored me for an hour. My BP was 158/95 which after the hour went down to 148/84. My chest was tight but my lungs were clear. I experienced some burred vision as well as a headache. After being released I returned home and took a Benadryl as directed by EMT and went to bed. I slept for 14 hours and upon awaking, my headache remained, the injection site was sore and my voice was a bit horse.
Patient developed a fever on April 1st that lasted thur April 4th or 5th, she also developed a rash on her stomach and chest area - that cleared up a few days later.
Fever of 103, localized redness and induration at injection site, generalized papular rash over face, trunk, extremities, palms of hands and soles of feet.
Large local reaction - pustule on left arm site with lesions left leg.  Local ice, Keflex PO.
Narrative: Patient passed away due to COVID-19. He was fully vaccinated at the time of death.
The Pfizer monovalent was mistakenly given instead of the bivalent. There was no adverse reaction.
Numbness to left arm, swelling and redness to site, muscle shakey, tight and weak.
I am having swelling in my foot, legs, and hands. It swells up 2 to 3 times its size. I also fever, body ache, and headache that only lasted for a day or two. The swelling in my extremities is still ongoing. I have an appointment on Feb 21st to see my doctor about this.
Pt's mom called 2/7/00 at 3:00pm. States that pt started running a fever of 103.8 (ax) on 2/4/00 post/vax. No other signs of infection. Was told to go to ER for workup. Child had been given tub bath & Tylenol but mom had not re-taken temp.
On November 2nd, patient received Pneumococcal vaccine. She reported on 11/03/01 that she had a temperature of 101.4, arm swollen elbow to shoulder. States feverish for several days. Patient reported this information to treatment center on 11/30/01.
Initial information received on 04-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 17 years old female patient who experienced mononucleosis, while she received 0.5 ml once dose of vaccines HEPATITIS B VACCIN, HPV VACCINE, MMR and IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect HEPATITIS B VACCIN not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MMR not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect HPV VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect IPV (VERO) lot N1K931M via unknown route in unknown administration site. The patient developed a non-serious mononucleosis (infectious mononucleosis) following the administration of IPV (VERO), following the administration of MMR, following the administration of HPV VACCINE and following the administration of HEPATITIS B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was mononucleosis. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for mononucleosis.
On Monday, February 20, 2023, upon administration of a subcutaneous MMR vaccine in the right arm of 11 year old pt., the patient experienced an adverse reaction. Immediately after injection, a small raised bump resembling a hive appeared. The bump was about 1 mm raised above the surface of the skin, and about 1 cm in diameter. It was pink in color, and the surrounding area of the arm was pink and blotchy. Two more vaccines (Menquadfi & Tdap) were given in the left arm. And one vaccine (IPV) was given in the right arm immediately prior to the MMR. Then the patient was advised to wait in the office for 15 minutes following the administration of the vaccine. An ice pack was applied to the area. After 15 minutes, the bump had almost disappeared and the arm was no longer red. The patient never experienced any itching or other signs of an allergic reaction.  Instructions were given verbally to the mother to call the pediatrician if symptoms continued or to call EMS if patient developed any signs/symptoms of anaphylaxis. The mother verbalized understanding. The patient was then cleared to leave with his mother at 11:45 AM. A VAERS report was submitted on 2/22/2023.
SORE THROAT; LEFT SIDE OF NECK PAIN; PAINFUL SWALLOWING; LOT OF PHLEGM; This spontaneous report received from a patient concerned an 89 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, gout in left foot, split nails issue, seasonal allergies, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included biotin for split nails issue. On 18-MAR-2021, the subject experienced sore throat. On 18-MAR-2021, the subject experienced left side of neck pain. On 18-MAR-2021, the subject experienced painful swallowing. On 18-MAR-2021, the subject experienced lot of phlegm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, left side of neck pain, painful swallowing, and lot of phlegm. This report was non-serious.
second dose on 6/3/21 and third on 7/8/21; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 10-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap IPV HepB with an associated reaction of no adverse event (first dose received on unknown date unknown batch number). Concomitant products included PEDIARIX.   On 8th July 2021, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 8th July 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device and an unknown time after receiving PEDIARIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Registered Nurse reported that, a patient received 1st dose of series as non-pediarix (Dtap-IPV-HepB). Then the patient got second dose with Pediarix and the third dose was given too early, which led to shortening of vaccination schedule. The reporter inquired about Pediarix as how to proceed with series, could pediarix, be a booster every 4 weeks as a catch up or would they do third dose over.  The reporter did not consent to follow up.
Administered GSK to < 18 yr old c/o stomach upset, vomiting 7 hours after vaccine no fever.
arm swelled & sore;rx Allegra x 10 days;MD felt shot given too low;
Patient received first dose Moderna on 3/19, when patient returned for second dose Moderna, a Pfizer vaccine was administered in error.
Five plus months later I had a terrible cold and thought it was bronchitis after my vaccine, 10-02-2022. I went to the clinic on 10-02-2022, a COVID-19 test was performed, examined my lungs as well. I was prescribed Paxlovid.  I had a few reactions to the Paxlovid, disgusting taste of metal in my mouth for some days afterwards.  I have to say COVID-19 also gave me anxiety and needed to take Lexapro for a while, I had situational anxiety due to COVID-19.   I have recovered from my symptoms, still feel little tired but overall doing well.
Patient presented to the emergency room with 5hrs of speech difficulty and right arm weakness ( contralateral to IM injection that occured two days prior to symptom onset). Currently being admitted for stroke workup.
unspecified injury; This case was reported by a lawyer and described the occurrence of injury in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injury. On an unknown date, the outcome of the injury was unknown.   It was unknown if the reporter considered the injury to be related to Shingrix.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (No complications, live full time birth) on 15-Feb-2016, Pregnancy (No complications, live full time birth) on 07-Apr-2018 and Alcohol use (social). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Oct-2020 and the estimated date of delivery was 26-Jul-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Ultrasound foetal: normal (normal) all were normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Prenatal care has been established.
After receiving a shot the day before, woke up with excessively painful arm to the point where using it was really hard. Took about 2-8 hours on both days after getting the injections that I started feeling sick. First day after the first shot I got a headache, felt fatigue and nauseas, chills and body ache all over, and fever. Fever and chills went away 6 hours after being treated and resting.  The day after I got the second injection, the symptoms seemed worse. Not sure if it was what I ate but it started with diarrhea and a bad headache. After, I was having difficulty breathing and felt nauseous and fatigue. 8 hours after the symptoms started I started getting body aches and a fever. All symptoms for both injections ended at the end of the 2nd day after receiving the vaccine.
Systemic: Confusion-Mild, Systemic: Headache-Medium, Additional Details: Patient complained of mood changes and depression and headache for 4 days.
a pt came in for imms and they received a vaccine that was meant for a 4 year old instead of the vaccines being given separately
Headache, Myalgia, Arthralgia, chills Narrative:  The morning after receiving the vaccine, the patient reported experiencing chills, generalized body aches, and a headache. She took acetaminophen 500mg every 4 hours to alleviate the symptoms.  Other Relevant History:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown), on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 24Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Anti viral details: Paxlovid, treatment start date is 08Jul2022, treatment stop date is 12Jul2022, other medication in 2 weeks product is Armour. Were you or Was the patient taking any other medications or products within 2 weeks of starting COVID-19 treatment was Yes. Did you the patient previously receive a COVID-19 Vaccine was Yes. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt exp large local rxn the size of a grapefruit (by pt description);MD treated w/ a steroid;recv an allergy shot as well;26AUG98 pt confused, high BP, throat swelling all w/in 10-15min per pt flu sx;pt had dyspnea for few days & fatigue;
Injection site was aching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site was aching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site was aching). At the time of the report, VACCINATION SITE PAIN (Injection site was aching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Per patient: "Unfortunately, I was impacted adversely  for days. My eyes and nostrils were flooded. My face and eyes were badly swollen and the rims of my eye lids were burning as if they were coated with Betadine. The burning could not be stopped and led to non-stop watering and tearing.  That was a major inflammatory reaction.   I had taken the Covid and flu shots together last year with no reaction, but this year was a serious adverse impact on my eyes especially and I could not see for two days. It wasn't until the third day that vision finally returned to the right eye.    Every three months, I receive Eyelea injections in both eyes from the Retina Clinic and the impact on my vision was dramatic.     I believe it's important that you know about this reaction and believe it should be reported to the official data base. It may have been a rare reaction, but this should be documented so macular patients in particular can be aware of this potential serious adverse impact. II think I am all right now but it left me very uneasy. "