chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus; Super sick; Moderna Side effects; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Super sick), IMMUNISATION REACTION (Moderna Side effects) and TINNITUS (Tinnitus) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Product used for unknown indication: Flu shot (Patient get a flu shot every year when they're available). Past adverse reactions to the above products included No adverse event with Flu shot.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Super sick), IMMUNISATION REACTION (Moderna Side effects) and TINNITUS (Tinnitus). At the time of the report, ILLNESS (Super sick) and IMMUNISATION REACTION (Moderna Side effects) had resolved and TINNITUS (Tinnitus) had not resolved.            No concomitant medication details was reported.  Patient got 2 moderna vaccines and 2 moderna boosters. Patient experienced tinnitus within 8 hours and tinnitus could last 6 months, a year or forever.  No treatment medication details was reported.
experience left arm pain radiating from my shoulder down to my fingers; experience left arm pain radiating from my shoulder down to my fingers; left arm weakness; This is a spontaneous report from a contactable physician (patient). A 65-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJUe85; expiration date: unknown) at vaccination age of 65-year-old intramuscularly in the left arm on 20Jan2021 10:30 at a single dose for covid-19 immunization. The patient's medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJUe85) at vaccination age of 65-year-old intramuscularly in the left arm on 30Dec2020 at a single dose for covid-19 immunization. The patient received the most recent COVID-19 vaccine in a hospital. On 21Jan2021 after the second Pfizer dose (24 hours after the injection), she began to experience left arm pain radiating from her shoulder down to her fingers. The pain was sharp, constant and associated with left arm weakness. This has persisted for 10 days with no relief and she was still experiencing this pain now. The events were considered as non-serious and did not require treatment. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 23-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
I experienced chills, fever, nausea, congestion, cough, muscle aches, and pain in  my groin area.
When they gave me the vaccine ten minutes later I felt chest pain, but I tried to stay calm and I thought it was due to a state of anxiety, but I think that the asthma was triggered by the vaccine, since I had several months without presenting relapses.
PT EXPERIENCING SORENESS AND REDNESS IN HER ARM OVER TWO WEEK POST VACCINATION
Pain at injection site first night of shot.  Nothing further until 1/10/21  when i woke with rash and heat and itching. Today 1/11/21 rash is larger and I am feeling flu like.  Nothing incapacitating but just  strange.
RAISED SWOLLEN AREA AT SITE OF INJECTION THAT HAS PERSISTED FOR 10 DAYS
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent via social media via a company representative concerned a female of unspecified age. 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 (dose number in series-1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient got sick, and covid (suspected covid-19 infection, suspected clinical vaccination failure). The reporter stated, "I believe that vaccine affected my daughter, she's sick alot since, and got covid anyhow".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000208729.; Sender's Comments: V0- 20211256165-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from two nurses concerning a 19 year old female who was vaccinated with the first dose of Gardasil (lot# not reported), 0.5mL injection. After receiving Gardasil, the patient experienced syncope and fell and hit her head. The patient was taken to the emergency room because she hit her head, but it was unknown if she was admitted (also reported as hospitalized because she hit her head). During the week of 12-NOV-2007 the patient reported that she had a bump on her head and a bruise on her bottom from the fall, but that she was now doing fine. The patient recovered, date not reported. Followup information received from the nurse, via the company representative, confirmed that it was unknown if the patient was hopitalised for any of the events. Additional information received from a healthcare professional (HCP), provided the lot # for the dose of Gardisil (lot # 658563/1063U), and confirmed that the patient was seen in the emergency room (ER), but was not hospitalized for any of the events. She added that the patient had recovered as previously reported, and was still doing well. Additional information is not expected. Follow up information received from a physician's assistant, confirmed that the patient was caucasian with no known drug allergies and no illness at the time of vaccination, and on 31-OCT-2007 at 11:30 am, was vaccinated in the left deltoid with the first dose of GARDASIL (lot# 658563/1063U). She confirmed that immediately after the vaccination, at 11:30 am, the patient had a vasovagal episode and hit her head on a metal door frame. She had no lacerations, no bleeding and no hematoma, though she did complain of a headache. She was taken to the ER via an ambulance. The patient's exam was normal, an electrocardiogram (EKG) was normal, and her vital signs were normal. No additional labs or studies were obtained. Additional information is not expected.
Myalgia; flu like symptoms; This case was reported by a physician via sales rep and described the occurrence of myalgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (received 1st dose on an unknown date and experianced flu like symptoms. For the tolerance of 1st dose, refer linked case US2020AMR171971).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the myalgia and influenza-like symptoms were unknown.   It was unknown if the reporter considered the myalgia and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experianced myalgia and influenza-like symptoms. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR172064:same reporter US-GLAXOSMITHKLINE-US2020AMR171971:1st Dose, same patient
in the hospital with the flu; Initial information received on 19-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health-care professional  This case involves an unknown age male patient who experienced in the hospital with the flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation ,strength, dose, route and  lot number: not reported) in unknown administration site as prophylactic vaccination,.  On an unknown date,  it was reported We got our flu shots but the patient was the hospital with the flu(influenza)(latency: unknown).  It is unknown if there were lab data/results available.   Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the event (in the hospital with the flu).  Outcome: unknown  Seriousness criteria: hospitalization for the event; Sender's Comments: Sanofi company comment dated 23-Dec-2022: This case involves an unknown age male patient who was vaccinated with Influenza vaccine (produced  by unknown manufacturer) and got flu and subsequently hospitalized . The time to onset is not reported with the role of the vaccine. The clinical course was not provided. Furthermore, additional information regarding condition at the time of vaccination, diagnostic workup, s would be needed for a complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Shortness of Breath, Runny nose and Cough, Received Monoclonal antibodies, COVID pneumonia with acute respiratory failure with hypoxia. Hospitalized and then discharged to inpatient rehab facility.
Recipients received underdose of 0.25 Moderna Bivalent Booster/patient were given a lower than authorized dose of the Moderna bivalent; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Recipients received underdose of 0.25 Moderna Bivalent Booster/patient were given a lower than authorized dose of the Moderna bivalent) 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)) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, 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. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Recipients received underdose of 0.25 Moderna Bivalent Booster/patient were given a lower than authorized dose of the Moderna bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Recipients received underdose of 0.25 Moderna Bivalent Booster/patient were given a lower than authorized dose of the Moderna bivalent) 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 related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Recipients received underdose of 0.25 Moderna Bivalent Booster/patient were given a lower than authorized dose of the Moderna bivalent). No concomitant product reported by reporter. It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.
Severe lasting insomnia. Started within days of first vaccine. Persisted for 3 months post vaccine, then suddenly resolved.  Also had  ~ 3 months of tachycardia following first vaccine. Tried Moderna, for booster, and severe insomnia started  day after booster, and continue to experience severe insomnia.  Cannot sleep without Ambien every night, and even then sleep is very limited.  (Had some menopause related insomnia ~5 yrs ago, successfully treated with Vistaril.)This  post vaccine insomnia is  completely different. Sometimes can only sleep for 2 hours after Ambien.
pt states that the next day after her vax she had weakness, chills, fatigue and she still has these symptoms.  Pt states that the injection site hurt for just a few days.  Pt contacted her PCP regarding her symptoms and was told not worry about them at this time but has an appt next week for an annual check up and will FU w/ her about this at that time.
Patient received H1N1 injectable IM (L) deltoid in AM - Staff member developed total body itching, progressed to tachycardia, HTN and SOB. Appt. with doctor 430PM - B/P 176/88 P - 134 O2 sat 100% - BP 154/93 HR 103 O2 sat 100%. Rx MEDROL dose pk - BENADRYL - Upon completion of 5 day MEDROL dose pk symptoms returned - went to ER.
Fever up to 104.3'F 24-hours after vaccination. Fever lasted for 12 hours
Pt recv vax on 1/25/99; on 2/2/99 pt exp swollen neck gland, fever (100); tx=warm compress & Tylenol
This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th August 2018, less than a day after receiving SHINGRIX, the patient experienced headache, difficulty sleeping, tiredness, pain and injection site pain. On 6th January 2019, the outcome of the headache, difficulty sleeping, tiredness and pain were recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the headache, difficulty sleeping, tiredness, pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she experienced side effects to the SHINGRIX after each injection. The patient reported that she received 1st dose of Shingrix and experienced severe headache, difficulty sleeping, tiredness and pain, and the issues lasted for two days. The reporter gave consent to follow up.For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK008002.
A 58 year old female nurse was inadvertently exposed to Oncotice, while reconstituting a vial for administration to a pt, with fluid being spilled on her face, neck, and her upper chest. Reportedly no fluid entered her eyes or mouth.
Fever up to 101F for one day Severe headache, chest pain , neck and upper back pain, loss of appetite, tired
Stayed in bed all day; Fever and stayed in bad all day; Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), BEDRIDDEN (Stayed in bed all day) and PYREXIA (Fever and stayed in bad all day) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021 and Pacemaker insertion (cardiac) since an unknown date. Concurrent medical conditions included Stroke. Concomitant products included METOPROLOL and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced COUGH (Cough) and PYREXIA (Fever and stayed in bad all day). On an unknown date, the patient experienced BEDRIDDEN (Stayed in bed all day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), BEDRIDDEN (Stayed in bed all day) and PYREXIA (Fever and stayed in bad all day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recv vax 17MAY96 & 18APR97 pt devel chickenpox;
Information has been received from a physician concerning an adult female who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck).  Three weeks after vaccination the patient developed a rash on both forearms, the injection site had redness and tenderness.  It was unknown if the patient had a fever.  Unspecified medical attention was sought.  The physician stated that he does not believe the rash was related to Zostavax (Oka/Merck).  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
On 3/25/21 at 1220 Pt received her first Pfzier vaccine to the left deltoid and was sitting in the post vaccine observation site under 15 min observation.  Pt was witnessed slumping down in chair by nurse at 1225 and then became unconscious with eyes gazed and to the right with snoring respirations. Pt was assisted to the floor by two nurses without any trauma lying supine and legs elevated.  VS were taken 122/60,59,20 and SPO2 87%. Pt woke while BP was being taken and started talking and was A&OX4. Pt was placed on oxygen at 10LPM with NRB mask.  SPO2 increased to 99%, pt's skins were W/D with good color.  Pt denied any SOB, itchy throat or difficulty swallowing, rash or hives. Pt was feeling a bit better and oxygen was taken off.  Pt was then sat up with legs straight while on the floor to repeat VS at 1231  Pt's BP was 70 systolic, pluse of 58, SPO2 dropped again to 87% and pt became vere dizzy and vision blackening and was layed back down immediately with legs elevated and NRB mask at 10 LPM was placed back on with increased SPO2 of 99%.  Pt had positive orthostates. Pt also c/o tingling hands.  911 was contacted at 1234.  VS at 1241 were 106/60, 62, 20 and SPO2 of 100%.  Pt's husband was at her side.  1247 engine co 54 arrived onscene and report was given to paramedic.  AMR unit 460 arrived approx 2 min later.  Pt was assessed and transported to closest ER.
sore arm; fever; muscle pain; chills; vomiting; nausea; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (fever), MYALGIA (muscle pain), CHILLS (chills) and VOMITING (vomiting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever), MYALGIA (muscle pain), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN MELT) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (fever), MYALGIA (muscle pain), CHILLS (chills), VOMITING (vomiting), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment  includes Tylenol, Motrin, Zofran.  No relevant concomitant medications reported.   Reporter did not allow further contact
Received the vaccine shot in the morning of March 24th, as the day wore on the vision in my right eye changed, becoming cloudy and somewhat obscured, it felt like i had some pressure or the right eyeball was swollen a bit,  I had difficulty focusing  close up, difficulty reading. When looking at distant objects, such as a street light, the light source looked like a spiky ring of light.  The vision in the left eye was a bit cloudy but that was gone by the morning of the 25th.  The vision issues in the right eye continued through most of the 25th though the feeling of pressure diminished and the  vision issues also lessened.  The eye/vision is still not completely back to normal on the 26th but is much better.
2/26/21 History & Physical- History of present illness: "Pleasant 79 years old female who started to develop recurrent episodes of nausea and vomiting of nonbilious none bloody material 1 week ago then started to have frequent watery bowel movements with the last bowel movement was associated with rectal bleeding, she started to develop generalized weakness and fatigue, she had 3 falls in the last week without hitting her head, she did not have loss of consciousness, over the last 2 days she has been complaining of numbness and tingling to the hands and feet, she was not able to walk due to generalized weakness.  She denied fever or chills she had no chest pain or shortness of breath.  2 weeks ago she got her second dose of COVID-19 vaccine. There was no change to her medications according to her, she denies sick contacts." Intubated and ICU transfer 2/28/21 for "Possible Guillain-Barré syndrome and impending respiratory failure" extubated 3/10/21.
Patient called on 9/24/20 and stated the injection site reaction was still present. The site was red, itchy, & is size of dollar coin.
I developed a rash in my torso, back, elbows.  It itches very much.  Seven days after the application of the vaccine, the itch, or rash, is still active.
local reaction w/each inject characterized by redness, pain, swelling, warmth & itching;