chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Facial paralysis beginning 6/1/22.   Seen for same, stroke ruled out.   Pt was then seen by neurologist who diagnosed Bell's Palsy that was brought on by recent Moderna COVID vaccine.     prescribed antiviral, steroid taper, Vitamin B12,  pantoprazole.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 25th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: This case reported by the patient's wife. The patient received a dose of SHINGRIX on the left arm. The event was lasted for 2 days. This case has been linked with case US2018185583 and US2018GSK187827, reported by the same reporter.
possible Guillain-Barre syndrome / to Shingrix; possible allergic reaction to Shingrix; This case was reported by a physician and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of guillain-barre syndrome (the patient received 1st dose on an unknown date and experienced Guillain-Barre syndrome refer case US2021AMR079956).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and allergic reaction. On an unknown date, the outcome of the guillain barre syndrome and allergic reaction were unknown.   It was unknown if the reporter considered the guillain barre syndrome and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's colleague. The patient was also a healthcare professional. The age at vaccination was not reported. The physician reported a possible Guillain-Barre syndrome or possible allergic reaction to Shingrix for his colleague. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR079956:Same reporter
I had 103 fever nausea vomiting fatigue weakness and couldn't get out of bed for 3 days.
Pulmonary embolism with acute Cor Pulmonale/hypoxia  I had shortness of breath, dizziness, coughing.  I had Covid test on 3/12/21 that was negative.  Went to Urgent Care on 3/12/21.  Gave me an albuterol inhaler which was not effective in relieving symptoms.  I wasn't improving, so went to emergency room at the hospital on 03/18/2021.  I was admitted to hospital and placed on oxygen and kept overnight.  I was also given Xarelto.  I am at home and on Xarelto.
Child experienced hyper activity early in the morning until PM with stuffy nose, runny nose and cough in the afternoon.   The child experienced hyper activity the after the first shot (11/6/09); however, no cold symptoms.
GAGGING, FOLLOWED BY 1 MINUTE OF FLOPPINESS AND UNRESPONSIVENESS , THEN CRANKINESS.  TAKEN TO E.R. WHERE NO INTERVENTION OR WORKUP DONE, EXCEPT GIVEN ZOFRAN.  NEXT DAY CONTINUED "NOT HIMSELF" FOR HALF A DAY, THEN WENT BACK TO NORMAL, ACTIVE SELF BY THE AFTERNOON.
Sore throat, and chest feels heavy. Hurts to swallow.  No treatment. I am currently monitoring my issue. If symptoms worsen I will go to ER
pt recv vax JUN97 & 2wk later pt exp a full body rash that was itchy;pt felt that the full body rash was r/t therapy w/vax;
pt recv vax 25JUN96 & LMC was expected on 12JUN96 but did not occur;a urine early pregnancy test (EPT) on 27JUN96 was positive;subsequently, an abortion was performed between 27JUN96 and 02JUL96;f/u pregnancy blood test on 2JUL96 was neg;
Anthrax vaccine has swelling and redness extending 5cm to 10cm past elbow. Painful with full extension/pronation. No systemic symptoms.
+ edema, no pitting, mild erythema, mild TTP, no warmth.
Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. From 08-AUG-2017 to 22-AUG-2017, the patients were vaccinated with improperly stored VAQTA (lot # N008823 with expiration date 26-MAY-2018; dose and route were unknown, for prophylaxis) which were  exposed to temperature excursion of 9 to 25 degrees Celsius for 1 hours 34 minutes. There were no previous temperature excursions. Data logger was involved. No adverse reactions were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010405: US-009507513-1708USA010242: US-009507513-1708USA010408: US-009507513-1708USA010406: US-009507513-1708USA010407:
getting worse [taste and smell]; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (getting worse [taste and smell]) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Everything he eats tastes like dirt or garbage.  He also had altered smell.) in October 2020.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (getting worse [taste and smell]). At the time of the report, CONDITION AGGRAVATED (getting worse [taste and smell]) outcome was unknown.            Concomitant medications were not provided.  The patient received  his first dose (lot #017B21A) of Moderna COVID19 Vaccine 05Apr2021 and second dose (lot #036B21A) on 03May2021.  Everything he eats tastes like dirt or garbage, which started 4 or 5 months ago. He also had altered smell. He thinks it has been getting worse in the last few weeks, but he doesn't think it is from the vaccine.  No treatment information was provided.
Patient is a 75 y.o. male patient of personal MD with history of ESRD, CHF, Chronic resp failure, COPD, DM II, CAD, HTN, PE, PAD s/p b/l bka on Eliquis, CVA presented to local Hospital with sob and edema after missing HD.   Acute pulm edema ESRD Chronic heart failure with preserved ejection fraction Hypertension Missed 2 sessions of HD PTA On HD MWF Nephro consulted, patient dialyzed on 12/20,12/21, 12/23 continue with dialysis and fluid removal. S/p HD 12/26   Acute on chronic hypoxic respiratory failure Covid-19 Virus Infection COPD Date of onset of symptoms: ~12/12 Symptoms present on admission: weakness Date of covid positive test: 12/19 at hospital Vaccination status: vaccinated Imaging: Pulm edema Oxygen requirements on admission: 4L Oxygen requirement at baseline: 3 L Current oxygen requirements: 3L Medical therapy: Currently on Decadron?12/23 discontinued as patient stable on home 3L. Received 5 days of decadron during hospitalization Consultants following:  None Anticipated special isolation end date: 12/30   Pancytopenia WBC 4.4; Hb 10.8 Plt 32 Platelets of 32 on presentation, now back to normal Unclear if this was lab error Hematology consulted, likely all lab error Eliquis resumed Hemoglobin 11.2 with platelets 135 on 12/26  DM II; controlled Hemoglobin A1c 8.1 Diet controlled at home Currently on SSI, Lantus increased to 15 units nightly due to hyperglycemia Controlled Discharge on Lantus 10 units with further adjustments per PCP   PAD History of bilateral BKA Cont home Trental Eliquis resumed   Patient seen and examined on day of discharge patient was in the mid 90s on his home 3 L.  Denied any shortness of breath or chest pain.  Admits to bowel movement this morning.  Was amendable to Senokot-S on discharge for bowel regularity.  Denied any other complaints.  I did discuss with case management who confirmed that with outpatient HD that he can return to normal center at regular scheduled time. Family has private transport home set up for 12/27.
Pt admitted on 8/13/2021 with weakness. Pt is an Oncology for non-small cell lung cancer. She began having COVID symptoms on July 27th and was admitted to Hospital from July 29th through August 6th. During that time, she received a full course of IV remdesivir as well as steroids and broad-spectrum antibiotics.  She was discharged from hospital on prednisone.   Pt has been sleeping most of the time, lethargic and coughing per husband. Pt is still an inpatient at this time.
Optic Neuritis  Right eye Blurry vision starting around 7/2/2020 worsened & seen by Ophthalmologist on 7/16/20 & noted to have optic disc edema  Hospitalized & tx with iv solumedrol x3 dys
Pain at injection site, chills, fever, headache, body ache, irritability, and nausea.
Patient given a pediatric dose of Hepatitis B (0.5mL). Patient will need to be revaccinated with adult dose. Patient is aware, had no adverse reactions.
Adjuvant was administered / without being reconstituted; Adjuvant was administered; This case was reported by a other health professional via patient support programs and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 7th November 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that, only adjuvant was administered to the patient without being reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
This is a spontaneous report from a contactable nurse through a Pfizer Sales Representative. The nurse reported similar events for six patients, who experienced the same issues over the past 3 months before this report. This is the 6th of 6 reports. An elderly patient of an unspecified ethnicity and gender received on unknown date a single dose of PREVANR 13 (Expiry date and NDC # Unknown) subcutaneous in arm (unknown of which one). Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced local site reaction which produced cellulitis. The area became hot, hard, and red; generally a large portion of the arm, not localized to injection site, a more perfused area. The outcome of the events was unknown. Laboratory tests performed were unknown. The patient was treated with antibiotics for cellulitis.
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, pain at injection site, nausea Narrative:  Other Relevant History:
Fever, Chills, body aches & skin sensitivity starting 22 hours post second dose of Pfizer's Covid-19 vaccine. Symptoms resolved in 5 hours with continued use of Tylenol. Sore arm persists 3 days later.
pt says she developed a migraine headache and low grade temp.  By 5/17/21 she was not able to work for 3 days.  She had extreme exhaustion.  On 5/19/21 she was still exhausted feeling and had 27 episodes of diarhea.  On 5/20/21 she was not able to eat w/out having diarhea and still very tired.  By 5/22/21 she was feeling so bad she felt like she needed to go to the emergency room.  She decided to take her dicyclomine medicine instead.   This seemed to helped some but is waiting on her PCP to give her a CB.
severe reaction to Keflex; I had a severe rash on my feet and my palm; headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, NDC number, UPC number, expiry date was reported as unknown) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for covid-19 immunization and cefalexin (KEFLEX [CEFALEXIN] NDC number, UPC number, expiry date was reported as unknown), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included autoimmune disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After receiving second vaccine on Saturday, the patient experienced severe rash on feet and palm, two hours later. The patient seek medical attention because of that. The patient had headache and severe reaction to Keflex and had same reaction with the Keflex that the patient had with the vaccine and the patient didn't knew if the two have any similarity. The patient thought it would be important for information because the peoples who were not included in clinical going on and there were different people who react to vaccine and if there would be similarity then the people should be cautious because they probably would grow rash. The patient knew the clinical trials did not include autoimmune people and it was important to feed information regarding the patient. Consumer was informed about Pfizer medical information department and was provided with the number. the outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
FEVER; NAUSEA; Dizziness; WEAKNESS; Disoriented; FEEL LIKE HIGH; COULD NOT FOUCS ON TASK; VERY EMOTIONAL; FEEL LIKE CRYING; HEART PALPITATION; CHILLS; This spontaneous report received from a patient 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, intramuscular, and batch number: 1805022 expiry: UNKNOWN) 0.5 ml, administered on 07-MAR-2021 02:45 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021 11:35, the patient experienced chills. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.1 F, and EKG (NR: not provided) Normal. On 08-MAR-2021 02:30, the patientt experienced heart palpitation. On an unspecified date, the patientt experienced fever, nausea, dizziness, weakness, disoriented, feel like high, could not foucs on task, very emotional, and feel like crying. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitation, and the outcome of chills, fever, nausea, dizziness, weakness, disoriented, feel like high, could not foucs on task, very emotional and feel like crying was not reported. This report was non-serious.
Pt received a yearly influenza vaccination. Pt received this years flu shot at the pharmacy. Pt was taken to ER by ambulance. Death certificate states "anaphylaxis, respiratory and cardiac arrest, influenza vaccination." Body released to funeral home no autopsy.
Quite tender swollen right armpit. Uncomfortable to have clothing against it, hurt to touch. Hurt even when not touched. Took aspirin for pain relief.
This spontaneous report received from a doctor of pharmacy refers to 3 patients of unknown age. The patient were vaccinated subcutaneously with a dose of ZOSTAVAX (lot  # and dose not reported) on unspecified dates. No other co-suspects were reported. No concomitant medications were reported. It was reported that the 3 patients were vaccinated with ZOSTAVAX and after 3-4 days of the administration of the drug, all 3 patients came down with herpes zoster (date unspecified). No treatment information was reported. The outcome of came down with herpes zoster was unknown. The relatedness for the event was not provided for ZOSTAVAX. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report additional information will be provided if available.
headache; sore throat; red bumps on the upper roof of my mouth; problems with swallowing; my glands were also swollen; scratchy throat; problems with swallowing (hurt); This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 07:00 (Batch/Lot Number: EN6203) as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took codeine and experienced drug hypersensitivity. No other vaccine in four weeks was given to patient. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 25Mar2021, the patient started with a headache, in which she took tylenol then shortly thereafter she had a scratchy throat, sore throat and problems with swallowing (hurt), this continued throughout the day and into the evening. The next day same thing but she also noticed red bumps on the upper roof of my mouth, and noticed her glands were also swollen. Therapeutic measures were taken as a result of headache (headache). The outcome of the events was reported as not recovered. Information on lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Shots administered 4/28/03, redness, swelling, warmth of left deltoid approx. 2" diameter started 4/29/03. Phone call about symptoms 5/1/03 - symp tx - cool compress, Motrin to be done.
This spontaneous report was received from a licensed Practical Nurse concerned to a 14 years old patient of unknown gender. Nurse reported that the patient received an unintended 0.5 ml dose intramuscular of PNEUMOVAX 23 (lot not reported). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
BODY ACHES, HEADACHE, NAUSEA, VOMITING, FEVER.
Initial consumer report received on 03 May 2010: This polymedicated patient with medical history of hypertension was vaccinated with pandemic influenza virus vaccine and seasonal influenza virus vaccine (manufacturer and batch number unknown) on 30 Apr 2010. The patient presented with high blood pressure of 22/9 and headache on 01 may 2010. The patient experienced shortness of breath, pain in the chest and allergy in the chest (described as redness) on 03 May2010. Same day, the patient was admitted to the emergency room where the physician prescribed HIXIZINE (25 mg once daily). Outcome for headache, shortness of breath, pain in the chest and allergy in the chest was reported as complete recovery. No outcome was provided for high blood pressure.
This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 24-JAN-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F.  On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 04-DEC-2014 the patient was vaccinated with MMR II dose, expiry in April 2013 (lot #, route not reported). On 04-DEC-2014 the patient was administered an expired dose of MMR II. No adverse effect was reported. Additional information has been requested.
Information has been received from a county health registered nurse concerning a 6 year old patient who on 27-APR-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 23-MAR-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Severe rash after a week of vaccination. Appear on the back, arms, elbows, knee and neck. The rash would come and go.
Increased nausea and vomitting in the days following vaccine, also experienced lethargy, inability to concentrate or follow a conversation. I requested IV fluids and lab draw from oncologist, hgb and plt were critically low requiring admission to the hospital for 5 days and 2 units on blood and 1 unit of platelets.
Rash at injection site, tingling in both arms, hands, and feet. Diarrhea, dizziness, fatigue, muscle weakness, heavy menstrual bleeding earlier than usual with the largest clots I have ever seen (8/25/2021). Currently experiencing breakthrough spotting and mild bleeding 1 week early.
fever; headache; shivers; coughing; sinus draining; product storage error; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th July 2019, less than a day after receiving Shingrix, the patient experienced fever, headache, shivers, cough, nasal sinus drainage and incorrect storage of drug. On 25th July 2019, the outcome of the fever, headache, shivers, cough and nasal sinus drainage were recovered/resolved. On an unknown date, the outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the fever, headache, shivers, cough and nasal sinus drainage to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine stored at temperatures outside storage recommendations, which led to incorrect storage of vaccine. That he would need to be vaccinated again.  The patient had fever, shivers, headache, coughing, and sinus draining that lasted throughout the night and resolved around 4:30 am of next day of vaccination. The reporter consented to follow up.  Consumer did not have vaccine information for this adverse event.