chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 12Apr2021 at 10:00(at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient did not have a medical history. The patient was not allergic to food, medication or other product. Concomitant medications included ferrous sulfate/folic acid/zinc (PRENATAL) and fish oil/rosmarinus officinalis/tocopherol (ULTIMATE OMEGA) both are started from an unknown date and unknown if ongoing for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 14:00 the patient experienced diarrhoea. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event diarrhoea was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Diluent for Pfizer BioNTech Covid 19 vaccine EUA was less than recommended amount of 1.8ml resulting in higher than authorized dose. Patient was notified and educated on possible side effects. Patient will return for second dose at appointed time.
Myalgia, Fever, UrticariaPruritus, Anorexia, SOA, rhinorrhea, chills, Narrative: Self treated with Benadryl and motrin
pt recv vax 23DEC97 & 17JAN98 exp clay colored stools, severe pruritus, chills, fever, dark urine, severe arthritis, elevated enzymes (liver);dx cholestatic jaundice secondary to augmentin;
Administered Rt arm sq. Grew from 12:20 -> 12:40 1.5" > 1 inch section "puffy. looks like swelling grew from bumps to (inside) a larger reddish (blister round bumps - clusters. Advised 12:55 -> pt to f/u after phone cl MD appt. No pain No breathing problems.
pt recv vax 2MAY97 & 5MAY97 pt had trouble breathing & exp was felt to be poss resp syncytial virus (RSV);tx proventil, prelone & cefzil;pt was also cranky, crying, fatigued & had no appetite;
SICK ON 11-14-2021 WITH FEVER, BODY ACHES, POST NASEL DRIP, RUNNY NOSE, SORE THROAT, COUGH, SOB, LEFT SIDE CHEST PAIN, VOMITING, DIARRHEA TESTED + FOR COVID-19 11-17-2021,   ADMITTED 11-17-2021, DISMISSED 12-01-2021
Patient received doses affected by a temperature excursion as their freezer went out of range; Patient received doses affected by a temperature excursion as their freezer went out of range; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received doses affected by a temperature excursion as their freezer went out of range) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses affected by a temperature excursion as their freezer went out of range) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049l21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-2022 at 11:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2022 at 11:50 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received doses affected by a temperature excursion as their freezer went out of range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses affected by a temperature excursion as their freezer went out of range). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received doses affected by a temperature excursion as their freezer went out of range) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses affected by a temperature excursion as their freezer went out of range) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient received half dose. It was reported that no adverse event occurred at time of administration or were reported thereafter. Treatment medications were not reported.
Developed hives with some itching localized to site of vaccination.  Area was oval shaped with a radius of approximately two inches.
Bedridden/experienced BED BOUND; Oral intake reduced/COULD NOT EAT; Fluid intake reduced/COULD NOT DRINK; Fatigue extreme/EXTREMELY FATIGUED; This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (Bedridden/experienced BED BOUND), HYPOPHAGIA (Oral intake reduced/COULD NOT EAT), FLUID INTAKE REDUCED (Fluid intake reduced/COULD NOT DRINK) and FATIGUE (Fatigue extreme/EXTREMELY FATIGUED) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Previously administered products included for Product used for unknown indication: Humira (Patient was once on Humira few years ago and but stopped because it was not working as good). Past adverse reactions to the above products included No adverse event with Humira.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In May 2021, the patient experienced BEDRIDDEN (Bedridden/experienced BED BOUND), HYPOPHAGIA (Oral intake reduced/COULD NOT EAT), FLUID INTAKE REDUCED (Fluid intake reduced/COULD NOT DRINK) and FATIGUE (Fatigue extreme/EXTREMELY FATIGUED). At the time of the report, BEDRIDDEN (Bedridden/experienced BED BOUND), HYPOPHAGIA (Oral intake reduced/COULD NOT EAT), FLUID INTAKE REDUCED (Fluid intake reduced/COULD NOT DRINK) and FATIGUE (Fatigue extreme/EXTREMELY FATIGUED) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The causality of co suspect SKYRIZI for the event(s) of BED BOUND, COULD NOT EAT OR DRINK onset in May 2021, COULD NOT EAT OR DRINK onset in May 2021 and EXTREMELY FATIGUED was not provided. No treatment medications were reported.
The day after the vaccine,  itching started  on the arm that received the injection.   By Monday,  red itchy patches spread down the arm, to the other arm, across my back and abdomen.     By Tuesday, 04/27, the red patches spread down my thighs to my feet, and were spreading in my hair.    I contacted my primary care physician,  for an appointment that day.    The physicians assistant prescribed 20, 10 mg prednisone tablets taken over 8 days.    Took 4 tabs the first day, the rash cleared up almost completely within 24 hours.
This patient was home with her family who called 911 for her respiratory distress.  Ambulance crew arrived and found her to be in extremis.  She suffered a bradycardic PEA cardiac arrest after arrival of Ambulance.  Crew was able to obtain sustained (20 consecutive minutes) ROSC.  Patient was transported to ED.  Family related to crew that patient had been short of breath, and lethargic complaining of chest pain for past 2 or 3 days.  Family also related that the patient had recovered from CoVId months ago and that patient had received a CoVId vaccine two days earlier.
4.5 cm x 6cm on R upper arm pain rated at 7-8 on 1-10 scale. Applied warm compress for about 15min.
Td given 5/13/03. Seen on 5/16/03 after 2 days fever 103, achy, headache and confluent red rash covering 1/2 upper arm.
Arm was sore first day and then soreness went away. Two weeks later noticed pain in upper left arm near injection site that radiated down but not as far as elbow. Painful to raise arm and to remove clothing by pulling off over head.
Received 2nd booster at 34 years of age. No documentation of immunosuppression
After shot I became very weak. All my joints hurt, even the joints in my fingers. I had a fever of 101 for 2 days. As those symptoms reduced,  I came down with walking pneumonia &a rash has broken out on my stomach (rash is still active 2 weeks after shot)
i GAVE PATIENT VEXELIS, AND AN EXTRA DOSE OF HEP B. THERE WAS NO ADVERSE EVENTS OTHER THAN THE DOSE GIVEN TWICE. MOP STATED DAUGHTHER IS DOING WELL THERES NO REDNESS ON THE AREA AND BABY IS WELL. I DID REACH OUT TO MANUFACTUR, AND VAERS TO REPORT THE INCIDENT, AS WELL AS TO ASK IF THERE WAS HARM, OR WHAT TO LOOK OUT FOR. PARENT WAS NOTIFIED AS WELL
Hearing is not very good; This is a spontaneous report from a contactable male consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) in 27Jan2021 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, patient experienced "Hearing is not very good". Consumer stated that patient had received the first dose of the Pfizer Covid 19 vaccine on the 27Jan2021. For personal reasons was not able to receive second dose within the 42 days and at the time of report he was wondering if it was possible for him to receive the second dose. He was wondering what was the contraindication to receive the second dose after so much time passed from 27Jan. He was also wondering what was the efficacy or potency of having just received one shot of the vaccine. And he was wondering how long that potency lasts having received just one injection. While in conversation with Consumer stated that his hearing was not very good. The outcome for the event Hearing is not very good was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (26Apr2021): This is a follow up spontaneous report from a contactable consumer. This consumer (patient) suspect onset date and event were updated.  No follow up attempts are needed. No further information is expected.
I contracted COVID. I started with a dry throat, then the following day it turned into a scratchy throat, then the following day a bad sore throat and head congestion. I tested for COVID and was positive, so I called the number that it states to call when you are positive to get Paxlovid. I took it for 3 days and stopped. My sore throat and congestion went away, but I was left with a runny nose, and a cough.
Based on additional information received on 30 November 2015, this case becomes medically confirmed. Initial unsolicited report received from a consumer (patient's mother) on 16 October 2015. This case involves a 09-months-old male patient who was vaccinated with first dose of FLUZONE (batch number was unknown, expiry date, dose were not reported) intramuscularly in thigh on 12 October 2015. The patient's illness at time of vaccination reported as unknown, pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as no known allergy (NKA). Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 13 October 2015, one day following the vaccination, the patient had developed a rash on leg around injection site which then spread to back, shoulder, neck and arms. It was reported that the doctor saw it on 14 and 15 October 2015. The patient required ER/doctor visit. Relevant diagnostic tests/laboratory data and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none. Follow-up information was received from a physician on 30 November 2015. The patient was vaccinated with a first dose of 0.25 ml FLUZONE QIV (batch number: 45304FA, expiration date, route of administration were not reported) In the left thigh on 12 October 2015. Illness at time of vaccination was none and the patient had no Pre-existing physician diagnosed allergies, birth defects, medical conditions and no known drug allergies. It was reported that patient visited office for rash on 14 October and 15 October, non-allergic rash. Patient developed flesh colored papules on the right arm, shoulder, back and left leg. There are no records of an ER visit. On an unspecified date patient was recovered.
Patient fainted on her way to the car. She was dizzy, pale, and sweating.  This happened around 10 minutes after she received both shots. Mother was recommended to stay for 15 minutes, but her daughter never had adverse reaction in the past and both left right after.
Shortness of breath; Full body aches; Cannot recovery any energy; Extreme exhaustion; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN (Full body aches), ASTHENIA (Cannot recovery any energy), FATIGUE (Extreme exhaustion) and NAUSEA (Nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Headache. Concomitant products included TOPIRAMATE (TOPAMAX) and SUMATRIPTAN SUCCINATE (IMITREX DF) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), PAIN (Full body aches), ASTHENIA (Cannot recovery any energy), FATIGUE (Extreme exhaustion) and NAUSEA (Nausea). At the time of the report, DYSPNOEA (Shortness of breath), PAIN (Full body aches), ASTHENIA (Cannot recovery any energy), FATIGUE (Extreme exhaustion) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.   This case was linked to MOD-2021-223730 (Patient Link).
A report has been received from a physician via medical representative concerning a 40 year old male patient. No information regarding relevant history, concomitant disease, and concomitant medications was provided. Patient had received nasal FLUMIST (intranasal) on 01-Oct-2012. The physician reported that the day of FLUMIST administration he had a severe runny nose after dosing. He also experienced the inability to perceive odor, anosmia and loss of taste beginning one-two weeks after the vaccine. He also had a nasal CT on 24-Jan-2013 that revealed right side nasal polyps. The patient was prescribed AUGMENTIN for two weeks and was switched to clindamycin for two weeks. He still was having problems, so a sinus endoscopy was performed. The turbinates were shaved and triple antibiotic ointment and packing applied. After the surgery, he saw an allergist who diagnosed him with allergies to dust mites, grass, dogs, cats, and trees. He was started on allergy shots. In May-2013, a repeat scan showed sinus disease also in the left sinus. He was prescribed LEVAQUIN for three weeks. On 18-Jun-2013, the surgeon removed the remaining packing. Action taken with the FLUMIST was not applicable. The outcome of the event of anosmia, loss of taste, runny nose, nasal polyp, sinus disease and allergies was unknown. The reporter considered the events of anosmia, runny nose, loss of taste to be serious with seriousness criteria of important medical event and events of sinus disease, nasal polyp and allergies to be non-serious. Follow-up information received by AstraZeneca/MedImmune on 12-Aug-2013 from Physician originating from spontaneous source upgraded this case to expeditable: Due to patient having surgery, seriousness for the events of anosmia, runny nose was updated to serious from non serious. New serious event of loss of taste and non serious events of sinus disease and allergies were added. Corrected report 19-Aug-2013: Action taken was corrected to not applicable from unknown. Reporters were renumbered. Confidential was ticked for primary reporter.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-APR-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. On 22-APR-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
3JUL91 sore arm; 4JUL91 severe h/a, unrelieved by APAP or fiorinol; 5JUL91 h/a somewhat improved;
Information has been received from a licensed practical nurse concerning an 8 year old female who on 23-FEB-1999 was vaccinated IM with a 0.5 mL dose of Varivax (lot # 629140/1835H). It was reported that the patient developed a rash a few days prior to being seen in the office on 17-OCT-2006 with breakthrough chickenpox. On exam the patient's lesions were drying. The patient returned to school. There was no product quality complaint involved. Additional information has been requested.
Gradual onset of LE, UE paresthesias, fasciculations, as well as decreased deep tendon reflexes, weakness and malaise, onset towards end of July. Referred to Neurology.
Fever; Body aches; Very bad headaches in the back of her head; This is a spontaneous report from a contactable consumer, reported for a female patient (mom) that. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the reporter called and reported on behalf their mother who had Covid 19 vaccine the before day. She was having side effects which were expected like fever, body aches but especially very bad headaches in the back of her head. As Tylenol was advised to take for the symptoms, Is it okay to take Aspirin or is Aspirin not recommended reporter questioned. No other medical information was provided. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Pt was vaccinated at 2:12pm with Pzifer COVID vaccine. Pt went to observation room. at 2:15, pt alerted RN that she was feeling itchiness and that her "throat was closing". RN took vitals at 2:17, BP was 138/69 HR 66 spO2 97%. Additional RN present as a witness. Pt then became anxious and stated that she has hx of allergic reactions and that she needs to go to hospital now.  RN told pt that she cannot leave without further eval and stabilization. RN opened the ER box to grab the Epipen and pt started to walk out. RN stopped pt and told her she needed to stay and given her reported sx, would need to have Epipen or Benadryl. Pt states she does not want Epipen or Benadryl, only wanting Morphine or Prednisone.  BP reassessed and 169/71, spO2 98% at 2:20pm.  RN alerted lead RN and Dr was brought with to assess. Dr assessed pt, still c/o of itchiness and throat closing. Pt denies: nausea, vomiting, inability to complete sentences, wheezing. Dr went over risks of not medicating and pt was agreeable to Benadryl 50mg IM one dose. BP taken again, 161/87 HR 68. Benadryl given. Dr told pt that she should take ambulance to nearest hospital. Dr thoroughly went over risks.  RNs there as witnesses. Pt walked away and left AMA.
pt recvd vax 12AUG94 & approx 36hrs later devel sl fever & 4-5 large, irregular-shaped hives in shoulder area;not seen by MD tx w/DPH;
Pt received first dose of vaccine. He waited his 15 minute observation perioid and upon checking out he felt dizzy and started to wobble. The paramedic was standing next to him and guided him gently to the floor. He did not pass out, but was diaphoretic, pale and his pulse and BP were low. He was transported to nearby hospital.
rt thigh, red-raised rash; area is tender to touch; muscle is sore;
Patient received Pediarix instead of Kinrix; Patient had had 3 HepB doses before this Pediarix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) 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 Hepatitis b vaccine (birth dose of hepatitis B vaccine and two other doses (undetermined brand)).   On 29th July 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 29th July 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022115411   Additional Information: GSK Receipt Date: 04-AUG-2022.  Reporter's Comments: The nurse reported a 4 years patient received a dose of Pediarix instead of a Kinrix.  This patient had a birth dose of hepatitis B vaccine and two other doses (undetermined brand) before this Pediarix. The consent to follow up was granted. Additional Supportive Information: As patient received a dose of Pediarix instead of a Kinrix, which led to wrong vaccine administered. As per schedule patient already had 3 doses of hepatitis B vaccine and patient received Pediarix having antigen as hepatitis B, which led to extra dose administered.
The day after I received my vaccination I started experiencing sharp, shooting, burning pain that shoots down my arm to my middle finger tip and tip of thump and up my next to the base of my skull as if an electrical current was running through my arms. Nothing seems to stop the pain.
On morning of 23 March upon rising from bed at 645 AM, I experienced vertigo, lasting around one hour. On morning of 24 March I again experienced vertigo upon rising from bed  at 545AM, lasting around 2 hours.
I have had neurological symptoms where I lost coordination, tripped, fell, dropped things.  Incredible pain in both legs.  Shooting pain throughout my body.  Extreme fatigue for past 6 weeks,  Tachycardia. Numbness in feet and toes, My whole body has been affected.  My sister in law got her shot at the same time, same lot number, and has almost an identical illness as has her friend, another nurse at The Hospital. She and I were treated similarly.  Steroids and Gabapentin.  I have a diary of all my symptoms that I have documented for about the past 6 weeks.  I went from being a fit, healthy person to a frail woman who can barely walk.
Very sore and swollen lymphnodes at the base of neck on my front left side . I also had bodyaches and a terrible headache, fever,  and a sore arm, but I expected that
patient hospitalized 10/22-11/2/2021 with SAH (stroke)