chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient indicated that after being fully vaccination she had a break through case of COVID on 08/29/2021. Sent home to isolate and quarantine. Can back from travel, hospitalization for three days was not able to eat or drink for three days . Came home for two days and was re- hospitalized for inflammation in kidney and gallbladder. Lupus was being impacted by the COVID.  New med. On antibiotic Augmentin 875-125mg twice a day and on last  09/20/2021.
Uncontrollable right thumb twitching (rhythmic contractions of thumb muscle pulling thumb towards palm of hand). Comes and goes but was not present prior to injection (this has never happened to me before).
Hospitalization for COVID19, hypoxia/COPD. Treated with  baricitinib, Remdesivir, dexamethasone, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
I just felt offload and knocked out,I felt that way knocked out; still having a reaction; woke up in the middle of the night; I didn't feel well; felt kind of flu-ish; pressure in my chest and pain in my chest, that pressure and it kind of came and went; I don't feel acid just pressure and pain but it lasted on and gone; I was stress and in pain all night; I got very very sleep; some aches and pain; feel very very exhausted, extremely exhausted; very tired; Nausea; pressure in my chest and pain in my chest, that pressure and it kind of came and went; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (I just felt offload and knocked out,I felt that way knocked out) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (I just felt offload and knocked out,I felt that way knocked out) (seriousness criterion medically significant), VACCINATION COMPLICATION (still having a reaction), SLEEP DISORDER (woke up in the middle of the night), MALAISE (I didn't feel well), INFLUENZA (felt kind of flu-ish), CHEST DISCOMFORT (pressure in my chest and pain in my chest,that pressure and it kind of came and went), FEELING ABNORMAL (I don't feel acid just pressure and pain but it lasted on and gone), MALAISE (I do not felt well), STRESS (I was stress and in pain all night), SOMNOLENCE (I got very very sleep), MYALGIA (some aches and pain), FATIGUE (feel very very exhausted, extremely exhausted), FATIGUE (very tired) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (I just felt offload and knocked out,I felt that way knocked out), VACCINATION COMPLICATION (still having a reaction), SLEEP DISORDER (woke up in the middle of the night), MALAISE (I didn't feel well), INFLUENZA (felt kind of flu-ish), CHEST DISCOMFORT (pressure in my chest and pain in my chest,that pressure and it kind of came and went), FEELING ABNORMAL (I don't feel acid just pressure and pain but it lasted on and gone), MALAISE (I do not felt well), STRESS (I was stress and in pain all night), SOMNOLENCE (I got very very sleep), MYALGIA (some aches and pain), FATIGUE (feel very very exhausted, extremely exhausted), FATIGUE (very tired) and NAUSEA (Nausea) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.
Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: fainted in the morning following vaccination
Pt had 3 febrile seizures between noon on 8/7/01 and 07:00 on 8/8/01. Admitted for observation/evaluation.
A non-serious spontaneous report of administration of expired product and administration of FLUMIST was received from a clinic administrator concerning a 24-month-old male subsequent to the administration of FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. On 22-Feb-2010, the patient was administered FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 13-May-2010 and incorporated into the narrative: information on late occurring adverse events.
I got the pneumovax 23 vaccine from my healthcare provider and within 10 hours started fevering just below 102. My fever hasn't broken at all and I'm going on 5 days. I also have a hardened lump in my arm of 4.5 x 5 inches raised by 1/2 inch.
Employer sent me to Health Dept for Hepatitis shot but Health Dept gave me a Flu shot, instead. I got very ill and had to spend 7 days in the hospital. The doctor's dx is Guillain-Barre' Syndrome (GBS). I have not recovered; lung and breathing problems.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concomitant medications or drug reactions/allergies. On an unknown date, the patient was inadvertently vaccinated with an improperly stored dose of VARIVAX lot number R008394 and expiration date on 20-MAR-2020, for prophylaxis (dose, route, and anatomical location were not provided). The lot of VARIVAX was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number and expiration date were not reported). The administered dose of the vaccine experienced a temperature of -1.9 degrees Celsius (°C) during a time frame of 2 hours and 30 minutes as recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved.
Reports that 2 days after vaccination developed a pruritic rash in the antecubital area, thighs, under breast, and on back. Takes Zyrtec routinely. Has taken Benadryl since rash developed. Had chills one day but no other symptoms. Was looked at by medical director and given directions for treatment.
Headache, redness, swelling, pain, fever, fatigue, swollen lymph nodes
Respiratory distress, throat swelling. BPs 186/97 (121), 150/104 (pulse 115), O2 sat 100%. Skipped lisinopril.
started with High Fever, Chills, headaches, slept for 3 straight days, then high fever again, kidney's hurt, went to Urgent care they said I had a kidney infection, gave me an antibiotic shot, fever stayed up, got a bladder infection, drank Cranberry juice, fever still up so went to ER, major headache, chills, checked my kidney's and they were fine, gave me a migraine medicine shot (never had a migraine before but they said it would be helpful) sent me home and I was fine the next day.
Patient states that he woke up at 0200 the morning  following  his first dose of the Pfizer BioNTech vaccine with a sore throat and feeling of fullness in his throat. At this time patient denied trouble breathing or swallowing. Patient arrived to ED via private car around 0330 complaining  of difficulty breathing.
mom calls states pt collapsed has greenish color; advised to watch closely & see pvt MD; on 22FEB93 phone call to mom states pt slept for 2 hrs &tiwtched & jerked while asleep; fever 100 oral;
Patient states that 3 days after receiving second dose of Covid-19 vaccine, she had redness up both arms.
Up to date with vaccination patient admitted to hopsital with breakthrough COVID infection PCR positive and admitted 4/19/22
Loss of consciousness; Hyperhidrosis; Panic attack; Nausea; Vomiting; This case was received via FDA VAERS (Reference number: 1005525) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), HYPERHIDROSIS (Hyperhidrosis), PANIC ATTACK (Panic attack), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), HYPERHIDROSIS (Hyperhidrosis), PANIC ATTACK (Panic attack), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.          Concomitant product use was not provided by the reporter. Treatment information was not provided  It was reported that the patient became nauseous and started vomiting approximately 20 minutes after the vaccine. She initially refused to go to the emergency room by ambulance. The vomiting continued and she then passed out and became diaphoretic. 911 was called and she was transported to the emergency room and tests were being ran. She said they did not feel it was vaccine related.  Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although the events are likely related to the act of being injected rather than the vaccine itself
mom reported to clinic 27JAN97 that pt exp sz activity approx 27 hr p/vax;pt w/blank stare & totally unresponsive for approx 20 seconds;denies fever or other adverse reactions p/vax;pt under the care of neuro for previous sz activity;
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/6/2021 and 3/10/2021. Presented to ED 12/29/2021 with complaints of nasal congestion and increasing weakness. Admitted for COVID-19 infection, GI bleed, complicated UTI. Initially no shortness of breath and did not require any oxygen. Subsequently O2 demands increased to high-flow nasal cannula. Treated w/Decadron and remdesivir. STEMI on 01/05/22. Troponins were markedly elevated. Patient is DNR/DNI. Expired 1/10/22.
Hospitalized 11/8/2021; COVID-19 positive 11/6/2021; fully vaccinated  ASSESSMENT / PLAN: Patient is a 80 y.o. F with PMH of afthritis, HLD, and cervical disc disease s/p fusion, who presents to this facility with 5 days of worsening shortness of breath, fever, and fatigue, admitted on 11/8/21 after failed outpatient management of COVID pneumonia now requiring supplemental O2. #Acute hypoxic respiratory failure with COVID pneumonia Patient presents with.... after testing positive for COVID on 11/6/21, CXR 11/8/21 demonstrating interval worsening of bilateral patchy opacities. Patient and daughter requesting monoclonal antibody therapy, but agreeable to Remdesivir if unable to give monoclonal antibodies. Plan: -Supplemental O2 with continuous pulse oximetry, incentive spirometry, and wean O2 as able -Started on Decadron and Remdesivir  -Tylenol prn -Not currently a candidate for monoclonal antibodies in the setting of supplemental O2 requirements, continue to further evaluate  -EKG pending -Consider CTA if patient clinically worsen  11/12/2021 note:  # Acute Hypoxic Respiratory Failure Secondary to Covid Positive Covid test on 11/06/2021, with symptom onset 11/04. Fully vaccinated for Covid with recent booster. Was hospitalized on 11/08 for hypoxia. Had increasing oxygen requirements and was transferred to the ICU. Subsequently intubated on 11/10.  CXR 11/11: Persistent diffuse airspace opacities, mildly worse in the left lung base. Plan: - Protective vent settings - Continue ceftriaxone for CAP coverage for possible superimposed PNA - Continue Dexamethasone 6mg daily - Started on Remdesivir 11/9. Will hold given AKI. - Trial proning 16:8 as tolerated   # Fever Noted to be febrile during hospital course. Started on antibiotics.  BCx 11/9 NG  MRSA PCR neg Plan: - Follow up blood and sputum cultures - Continue ceftriaxone - Monitor fever curve, Tylenol as needed 11/15/2021 note: # Acute Hypoxic Respiratory Failure Secondary to Covid Positive Covid test on 11/06/2021, with symptom onset 11/04. Fully vaccinated for Covid with recent booster. Was hospitalized on 11/08 for hypoxia. Had increasing oxygen requirements and was transferred to the ICU. Subsequently intubated on 11/10.  CXR 11/11: Persistent diffuse airspace opacities, mildly worse in the left lung base. 11/14: ABG's showing improvement, patient having clinical improvement with CXR showing slight improvements from prior studies. Will titrate vent settings with ABG's and clinical data. Plan: - Protective vent settings              - 4ml/kg-8ml/kg, plateau pressure less than 30, driving pressure less than 15              - adjust FiO2 and PEEP to keep low vent settings as tolerated              - Currently on Propofol, fentanyl. Vecuronium PRN if patient becomes asynchronous with vent.              - wean sedation as tolerated - Patient is s/p CAP coverage 11/12 for suspected superimposed pneumonia.  - Continue Dexamethasone 6mg daily (end date 11/17) - Started on Remdesivir 11/9. Held due to AKI (last dose 11/11) - continue to keep patient supine - Chest Physiotherapy as needed for thick copious secretions.  - Lasix 60 this morning - Negative LE dopplers
After receiving the vaccine I had some chills, fever, and achiness. I also had severe joint pain with muscle spasms to the point to where I just couldn't  sleep. It felt like a major fibromyalgia flare up. It was very painful. That started to go away on May 29, 2022. On May 30th it got better. On the back of my left thigh under my buttocks I felt a little itch. On May 31st the muscle spasms went away at that time, but again the back of my left thigh kept itching. On June 1st the spot behind my left thigh began alternating from a burning and tingling sensation. I tried looking at it, and though it looked like shingles. I went to the doctor, and they looked at it. They said that it does appear to be a mild case of shingles. I am not working today or tomorrow. They put me on Valtrex 1 gram once every 8 hours to not allow it to get too severe. It's strictly on my left thigh below the buttocks. My immune system reacts extremely sensitive to covid vaccines. The doctor recommended gabapentin. I also had severe uncontrollable diarrhea after the vaccine. It's still a little bad but I'm almost over that. I didn't have any vomiting just headaches, chills, and a light fever. My blood type is A-. I found out that my family with an A- blood type gets shingles.
Headache, Myalgia, Arthralgia & Diarrhea Narrative:
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received Shingrix for prophylaxis. On 9th October 2018, the patient received the 1st dose of Shingrix. On 9th October 2018, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site lump and injection site induration. On 11th October 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site lump and injection site induration were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site lump and injection site induration to be related to Shingrix. Additional details were reported as follows: After vaccination, the patient developed two lumps at the injection site which was hard and swollen.
Male patient was tested and found to have no hepatitis B antibodies, despite having a full vaccination series of Hepatitis B as a child; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a male patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hib UNK (Hib vaccine) for prophylaxis and Hib UNK (Hib vaccine) for prophylaxis.   The patient's past medical history included crohn's disease.   On 8th May 2002, the patient received the 1st dose of Hepatitis B vaccine. On 30th July 2002, the patient received the 2nd dose of Hepatitis B vaccine. On 27th September 2002, the patient received the 3rd dose of Hepatitis B vaccine. On 22nd May 2003, the patient received the 4th dose of Hepatitis B vaccine. On an unknown date, the patient received Hib vaccine at an unknown dose and Hib vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hib vaccine and Hib vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hib vaccine and Hib vaccine.      Lab Comments: lab test done on an unknown date
This spontaneous report was received from a consumer (patient's mother), refers to a 17 year old female patient with none pertinent medical history or drug reaction allergies. On 01-AUG-2013, the patient was vaccinated with the first dose of GARDASIL (Lot # H018755, exp date 21-MAR-2015) (1 shot, intramuscular route). Concomitant therapy was not reported. On 03-AUG-2013, the patient developed a bad headache followed by body aches and a fever that had remained between 100 and 102 degrees Fahrenheit. The patient still had the fever, which began about a week ago. The patient had also been having bad stomachaches, such that the stomach hurt sometimes when she ate. The patient experienced vomiting and last night (08-AUG-2013) the patient woke in the middle of the night with hives. The patient was reported to had developed a yeast infection at an unspecified time around the administration date of GARDASIL. The patient sought medical attention with the physician, and began therapy of DIFLUCAN for the yeast infection on an unspecified date, a day or so after 03-AUG-2013. She was administered BENADRYL as treatment for the hives. The reporter requested a lot check on the GARDASIL. Laboratory diagnostic studies were not performed. At the time of the report, the patient's outcome was not recovered. Additional information has been requested.
she became dizzy after witnessing her brother " pass" out after his shot . She layed on the ground and urinated on herself
Patient to clinic 07/29/21 to receive first dose Pfizer vaccine. Later c/o tingling of tongue and headache.  No c/o swelling or indication of anaphylaxis. Airway unobstructed. No apparent swelling of tongue. Vital signs: BP 186/98 HR 99 RR 20 Temp 99 O2 s sat 98%.  Onsite paramedic offered ibuprofen for headache, patient received 400mg of ibuprofen at 5:09 P.M..  Patient advised to seek emergency care due to elevated BP. Patient refused.
On 04/17/2002 Hep B given. at 8:30pm fever 102.8 deg. F and 400mg Advil given. At 10:30pm adult Tylenol given. On 04/18/2002 7:45am temp went down to 99 deg. F. Advil given.
VOMITING, FEVER, HEADACHE. FEVER ON THE DAY OF THE VACCINE & HEADACHES THE DAY AFTER THE VACCINE.
Patient presented to Emergency Department 7/23/2021, 5 days after receiving second dose of Pfizer/BioNtech SARS-CoV-2 vaccination. Primary complaint constant, sharp chest pain worsening with exertion. Bruised/heartburn type pain per patient began 2 days prior to admission. Cardiology consulted and diagnosed patient with myopericarditis attributed to recent vaccination.
Patient received full 0.5 ml dose for booster in series after Janssen vaccine where 00.25ml half dose was indicated.  No adverse event reported.
sore throat as the initial symptom then progressed to difficulty swallowing and shortness of breath that lasted about 2 weeks. Also had body ache and chills. Pt did not seek medical care and symptoms improved overtime. Still with intermittent shortness of breath.
Seriousness Criteria: Other-Medically Significant. Initial report received from a health care professional on 29 October 2008. A 41-year-old female patient had received a left deltoid intramuscular injection of FLUZONE SV 2008-2009 (lot number U2752AA) and on her way back to work, she blacked out for a few seconds. This caused the patient to have a minor car accident, in which she was not injured. The patient recovered and denied any further symptoms. No additional details were provided. Documents held by sender: None
Nausea, Overall body unwell, now a week later, a sore lump in armpit on vaccination arm.
Loss of smell and taste next day after dose number 2. Reports exacerbation of right leg sciatica after both injections, and hip "spasms" not previously experienced with sciatica symptoms.
The next day he noticed itchy bumps of dry skin on his face; Itchy rash/The next day he noticed itchy bumps of dry skin on his face; having an allergic reaction on his face and other parts of his body; This is a spontaneous report from a contactable consumer (patient). A 22-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EP6955, expiration date was not reported) via an unspecified route of administration, in left arm, on 24Mar2021 14:00 (at the age of 22-years-old), at dose 1, single for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient previously took augmentin [amoxicillin;clavulanate potassium] and Omnesa (as reported) and had similar allergic reactions. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. There was no history of previous immunization with the bnt162b2 vaccine, and no additional vaccines administered on same date of vaccination. On 25Mar2021, the patient experienced itchy rash on his face; the patient thought of having an allergic reaction on his face and other parts of his body and the next day (26Mar2021), he noticed itchy bumps of dry skin on his face; he thought it was shaving irritation, but it continued to spread and getting worse. There was no investigation assessment. The outcome of itchy rash was not recovered, and outcome of other events was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.
This case is 1 of a cluster of 3 patients' who experienced similar adverse events following vaccination with ADACEL. The events for the other patient's were captured in case number 2010-02613 and 2010-02614. Initial report received from a health care professional on 05 May 2010. A patient, with an unknown medical history, had received an injection of ADACEL, Sanofi Pasteur Ltd number C3311 and Sanofi Pasteur Inc. Lot number U3052AA, and developed pain in the left arm and neck after vaccination. Other vaccinations within 4 weeks were reported as unknown. The outcome for the events was reported as unknown.
Developed hives, pain in injection site, swelling at site. Treated with MEDROL dose pack, ice pack.
Throwing up every 20-30 min for five hours, nausea, diarrhea multiple events thru the event, not able to keep liquids down, shortness of breath, racing heart, dizzy, did not pass out but multiple times felt like I was going to do.
I had a really bad cough, fever, sore throat, no respiratory symptoms. I called my doctor, made an appointment with my doctor who tested me for influenza A and B, it came back negative. My doctor told me to go home and test for COVID-19. I used a home COVID-19 test that came back positive. I called the doctor to let her know that my test did come back positive, she prescribed the PAXLOVID. It helped with the fever; I still have the cough. I think I felt good for maybe a day. The doctor told me I have rebound COVID-19 and eventually I would get better.