chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle pain; Joint pain; Chills; Tiredness; Rapid pulse; Feeling unwell; Fever; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 21Apr2021 at 13:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included prior stroke, complex post-traumatic stress disorder (PTSD) and degenerative disc disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received other medications within two weeks of the COVID-19 vaccine, names were unspecified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 31Mar2021 at 13:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient previously took azithromycin (MANUFACTURER UNKNOWN), amoxicillin; clavulanate potassium (AUGMENTIN), guaifenesin (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication and experienced drug allergy. On 22Apr2021 at 01:00, the patient experienced muscle pain, joint pain, chills, tiredness, rapid pulse; Ave. 112 bpm, feeling unwell, fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. On 22Apr2021, the patient underwent heart rate and the result was 112 bpm. The clinical outcome of the events muscle pain, joint pain, chills, tiredness, rapid pulse; Ave. 112 bpm, feeling unwell, fever was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, MOD-2022-662875, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016, US-MODERNATX, INC.-MOD-2022-663014, US-MODERNATX, INC.-MOD-2022-662866, US-MODERNATX, INC.-MOD-2022-662861, US-MODERNATX, INC.-MOD-2022-662875 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871:Patient 15 US-MODERNATX, INC.-MOD-2022-662860: MOD-2022-662875: US-MODERNATX, INC.-MOD-2022-663016:Patient 15 US-MODERNATX, INC.-MOD-2022-662881:Patient 15 US-MODERNATX, INC.-MOD-2022-663014: US-MODERNATX, INC.-MOD-2022-662866:Patient 15 US-MODERNATX, INC.-MOD-2022-662861: US-MODERNATX, INC.-MOD-2022-662875:Patient 15 US-MODERNATX, INC.-MOD-2022-662995:Patient 15
patient received covid vaccine on 2/18 (second dose).  Patient states anxious about receiving vaccine and anxious about snowstorm.  Patient presented to ED on 2/19 with c/o Shortness of breath and chest tightness.  Patient has h/o HTN, HL, CAD.  ED prescriber began full cardiac workup and wanted to transfer patient to another facility for cardiology consult and further workup.  patient refused and left the ED AMA as she believed it was just a reaction to the vaccine.
Pt recieved Zostavax in the right arm and 4-5 days later developed a red rash below her right breast, pt states the rash is only painful while wearing a bra, but it had not cleared up 2 weeks later. Counseled pt to seek medical attention as it may be a shingles outbreak.
GOT COVID; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On NOV-2021, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report is associated with Product quality complaint: 90000206642.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with a dose of (Merck) VARIVAX (lot number, dose and route not reported) and with a dose of MMR II (lot #, dose and route not reported) 21 days apart, "a few years ago" on an unspecified date. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
I received my Moderna booster for COVID-19 on 11/8/2021. On the evening of 7/16/2022, I started to have a little bit of a sore throat and some body aches. They started at about 9 PM and I felt like I was coming down with something. I then went to bed. On the morning of 7/17/2022, I went for a bike ride with my family. I began to feel a bit weaker and achier. I went home later on that day and took a home COVID-19 test at about noon and got a positive result. I also had another brand of test, which I decided to try out, and it also yielded a positive result. I went to an urgent care clinic later the same day and got a PAXLOVID prescription. I started taking the PAXLOVID at about 3 PM or so that day. I felt pretty tired and had body aches and a little bit of a headache. I didn't have much of an appetite. I took some TYLENOL for the headache, which helped. I didn't take my temperature that day, but I did take it on 7/18/2022, and I had a low-grade fever of 100.4. I continued taking the PAXLOVID twice a day until the supply ran out. By the time 7/20/2022 rolled around, most of my symptoms had subsided. On 7/21/2022, I felt 100% better. On 7/20/2022, I took a PCR test at a local pharmacy and got a positive result. I took another home test on 7/29/2022 and got a positive result. I finally got a negative result for the first time when I took another test on 8/1/2022.
Had no symptoms with #1 (EP7534) on 4/14/21;  #2 (ER8735) on 5/4/21 resulted in chills, fever, aches started 12 hrs. after injection.  Booster #3  given at Pharmacy (FJ8757) reaction was worse than #2 injection.   Fever with shaking chills (too sick to take temp),  took temp in the morning and it was 101.7.   Could barely walk - every muscle and joint in my body hurt and had strange, sharp pains in top of feet, wrists and sides.    Fever resolved later in the day on 12/14/2021.
Spouse reported the night of the 3rd vaccine, the patient experienced a "seizure." He was rigid and unresponsive for a minute or so then was disoriented for an hour.  Called the MD but has not had a return call.
4-5 cm red center approx 7-8 cm total swelling area felt warm to touch and pain said it hurt (? Shingle-like reaction)
Vaccine given after 30-day BUD; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given after 30-day BUD) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given after 30-day BUD). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given after 30-day BUD) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.
Patient here for evaluation of hypoxia.  Patient tested positive for COVID-19 on 12/7.  Patient has symptoms of shortness of breath and cough.  Oxygen sats were 86-88% on room air.  PCP sent the patient to the hospital for an ID consult and Remdesivir infusion.
For 8 days following the injection I had a sore arm, on the 9th day the area became bright red about the size of a drinking glass lid, was warm to the touch, hurt and itched. and was hard  maybe slightly swollen..  It remains that way.
Mother states child began with fever 10:21;09. States that injection site was red and swollen and getting bigger.  Baby crying when touching injection site.  Dry cough noted on ER visit
Awoke 11:00 pm with high fever and body aches. Did not feel good enough to take temp until 5:00 am. Temp 100.8. At 6:00 am temp down to 100.0. Had low grade fever and minor body aches until around 12/18/05 12:00 noon. Treatment : 3 doses of 1000 mg tylenol 12/17/05.
Treatment of COVID-19; Treatment of 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 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: 9261), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN62012116), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: 30135B4), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE oral, start date: 17Nov2021; FAMOTIDINE, start date: 17Nov2021; TYMLOS, start date: 12Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 (PAXLOVID).
had shingles vacanation and months later shingles/suspected vaccination failure; shingles on head; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 18 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient had shingles vaccination and about 18 months later had shingles on the top of his/her head. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The case had been linked with US2021AMR176042 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176042:same reporter
Freezing feeling throughout body. Whole body aches.  No energy. Dizzy    Really bad headache.   Arm hurts for couple days .  Breathing was hard to do
Upper arm redness, swelling & discomf. Ibuprofen & BENADRYL topical admin.
AFTER 2 HOURS OF ADMINISTRATION PATIENT CALLED WITH COMPLAINTS OF PAIN TO THE INJECTION SITE AND ASKED IF SHE COULD TAKE TYLENOL OR ALEVE OTC TO HELP RELIEVE THE PAIN. RPH AVISED PT THAT TYLENOL CAN BE TAKEN AND ALSO COLD PACK TO THE ARM. AROUND 4:15PM (5 HOURS POST VACCINATION) PATIENT CALLED WITH FURTHER COMPLAINTS ABOUT VERY SORE ARM AND PAIN NEAR INJECT SITE AND CAN'T LIFT ARM. SHE STATES HER FINGERS AND ARMS ARE COLD AND TINGLY. WHEN ASKED IF SHE IS HAVING ANY FEVER OR CHILLS, SHE STATES SHE'S UNSURE IF IT'S CHILLS OR IF IT'S BECAUSE HER ARM IS IN SO MUCH PAIN. PT REQUESTED THIS BE REPORTED. PATIENT WAS THEN ADVISED TO CONTINUE TO MONITOR HER ARM AND CALL HER MD FOR FURTHER RECOMMENDATIONS. SHE WAS ADVISED TO SEEM EMERGENCY CARE IF THE PAIN IS INTOLERABLE. RPH PROVIDED VIS FORM AT INFORMED PATIENT ABOUT POTENTIAL SIDE EFFECTS AFTER VACCINATION WHICH INCLUDED PAIN AT THE INJECT SITE THAT COULD POTENTIALLY SPREAD FURTHER DOWN THE ARM, REDNESS, SORENESS, FEVER, CHILLS.
Vaccine was given too early. No adverse event has happened at this time. So far patient has been tolerating well.
chest pain & diff breathing 15-20min p/vax;on physical exam pt had nasal congestion w/rhinorrhea, diffuse wheezing both lungs w/tachypnea;recv epi & aerosol DPH;
Information has been received from a consumer and follow up information from someone at a physician's office concerning a 5 year old pt with sinusitis at the time of vaccination no other medical history and no allergies. It was reported that there were no adverse events following prior vaccinations. On 22May2003 at 3:15PM the pt was vaccinated SC in the right arm with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant therapy included vaccination IM in the left arm on 22May03 with a dose of diphtheria toxoid (+) hepatitis B vaccine recombinant (yeast) (+)  pertussis vaccine (+) Poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX). It was initially reported by the consumer that three to four days following vaccination, the pt developed a swelling on the back of her hands, just below the wrist and the swelling was reported to be the size of a silver dollar. The swelling went up and down, but had not gone away. The pt saw the doctor about this, but it was reported that the doctor did not seem to know what it was. Follow up information reported that on 10Jun03 at 4:45PM the pt developed swelling of the wrist with required a doctor's visit. Laboratory testing was done-see lab data. The outcome was reported as unknown. Follow up information also noted that vaccination with a first dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (manufacturer UNK) was received on 06Aug1998. It was not clearly reported if it was the pt or a sibling who received the vaccine and no adverse events were reported in relation to that vaccine. Additional information has been requested.
3-31-04- 2:30 pm- Rash on face and upper chest. Complains of itching everywhere- feet, chest. Complains of shivering. Complains of "little bit of fever."
Information has been received from a 21 year old female who received two dose of GARDASIL. She was supposed to get the third dose on 06-OCT-2008, she did not have insurance to pay for it so she did not get it. She started experiencing depression, dizziness and headache "around 19-OCT-2008". The patient mentioned that she had been sad previously after she gave birth to her child (14 months old); however, she was fine for a while and now the depression was back and it was much stronger. She felt angry and sad and wanted to be alone. The patient had the baby before starting the GARDASIL. At the time of reporting the patient was not recovered. No further information is available.
Red raised rash to right and left forearms (right greater than left) with associated itching.  Employee encouraged to take benadryl unless otherwise contraindicated.  No allergy to eggs.  No reaction to previous influenza vaccines.
Unable to hold up head, sit up, or stand. The patient was diagnosed with acute cerebellar ataxia likely related to her varicella vaccination. There has been literature to support a reaction seen typically 10-13 days after vaccination; hers were only two days. She was admitted 2/10/2010 and both CT and MRI of head and neck. She had near resolution of her symptoms of ataxia by discharge on 2/11/2010.
1st dose 16Nov2018, 2nd not yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 92-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th November 2018 with batch number ey93j).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The health care professional asked that the patient could get 2nd shot or need to restart the series. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd shot of Shingrix, which led to incomplete course of vaccination.
I went to my gynecologist's office the morning of 1/10/18 for an annual check up and was given the GARDASIL vaccine. Within 10 minutes I experienced an episode of syncope and rapid heart beat and I went to the ED department to sit with the Triage nurse. Soon thereafter I experienced numbness and tingling in my arms which has not dissipated. I also experienced extreme pain at the back of my neck that lasted for about 24 hours. I am currently struggling with what feels like arthritis in my hands. All of this happened the day the GARDASIL vaccine was given to me.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. On an unknown date a patient was vaccinated with M-M-R II (route, dosage, dose number and lot number unknown). The nurse reported that doses of M-M-R II, which were exposed to temperatures outside of the recommended storage range, have been administered to unspecified patients on unspecified dates since 05-FEB-2015. No adverse experience has been reported. Additional information has been requested.
administered the full dose of the Moderna vaccine as her second booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (administered the full dose of the Moderna vaccine as her second booster) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In April 2022, the patient experienced ACCIDENTAL OVERDOSE (administered the full dose of the Moderna vaccine as her second booster). At the time of the report, ACCIDENTAL OVERDOSE (administered the full dose of the Moderna vaccine as her second booster) outcome was unknown.            Patient was over 50 years old and had their 4th Moderna this morning. It was reported that patient was administered the full dose of the Moderna vaccine as her second booster. No concomitant medication information provided. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow-up received contained no new information.
Itching on the left side of her neck; Swelling; Hives spread to her shoulder, tricep and chest; Tenderness; About two to three inches below the injection site developed some hives; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Hives spread to her shoulder, tricep and chest), TENDERNESS (Tenderness), PRURITUS (Itching on the left side of her neck), SWELLING (Swelling) and VACCINATION SITE URTICARIA (About two to three inches below the injection site developed some hives) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (About two to three inches below the injection site developed some hives). On 14-Jan-2021, the patient experienced URTICARIA (Hives spread to her shoulder, tricep and chest) and TENDERNESS (Tenderness). On an unknown date, the patient experienced PRURITUS (Itching on the left side of her neck) and SWELLING (Swelling). At the time of the report, URTICARIA (Hives spread to her shoulder, tricep and chest), TENDERNESS (Tenderness) and VACCINATION SITE URTICARIA (About two to three inches below the injection site developed some hives) was resolving and PRURITUS (Itching on the left side of her neck) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
One generalized clonic seizure lasting about 5 minutes. 24 hours after receiving 4 month immunizations. Information received from discharge summary states hyperventilation. msv