chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 3/21/21 experienced Increased coughing, shortness of breath, rapid heart beat even when resting, fatigue, high blood pressure, difficulty sleeping, increased asthma, chest pain Went to on 3/24/21 Primary Care Dr. who prescribed using Advair 250/50, Albuterol Sulfate, and Ipratropium bromide Inhaler four times per day. she ordered blood work and COVID testing 3/26/21 Went to ER with severe chest pain and difficulty breathing and was treated by both the ER Dr. and Cardiologist Doctor . The EKG did not show a heart attack. They applied oxygen and Suggested I see a pulmonologist and follow up with Cardiology. Passed a kidney stone on 3/31/21 and brought it in for analysis on 4/6/21 4/6/21 met with APRN in Cardiology to review symptoms, she ordered a limited Echo.  Subsequently she ordered a Zio Patch Heart study to collect data over a 2 week period 4/22/21 met with Pulmonologist Dr. she suggested that I needed to meet with ENT to rule out allergies and she increased the Advair to 500/50 and she ordered blood work which was done on 4/26/21 4/29/21 met with APRN in ENT Dr. office for a scope to determine if allergies, Acid Reflux, or sinus issues existed.  The scope showed only a bit of scare tissue may be pressing against the voice box which might cause a cough so she ordered a CT scan of the neck (scar tissue from previous intubation 15 years ago) 5/18/21 ZioXT Patch installed 5/18/21 at 1:50 to be worn for 2 weeks to record unusual events with the heart 5/19/21 Revisited Dr. who summarized that blood work was normal. 5/21/21 had Limited Echo Cardiogram which showed no significant difference from previous echo done one year prior. 5/25/21 follow scheduled with primary care Dr.  6/17/21 follow up scheduled with Dr. in ENT to do a further study of the scare tissue found below voice box 7/9/21 flow up schedule with Dr.  7/19/21 Follow up scheduled with Dr. Patient (me) is feeling better, still experiencing cough and heart chest pain and breathing issues but not as difficult as before.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Shingrix for prophylaxis. On 25th May 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th July 2018, 51 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The patient broke out with shingles. At the reporting time, the patient's pharmacy had her 2nd dose in stock and she was questioning if she could get the 2nd dose during an outbreak of shingles. The patient did not provide name of her doctor as she was given the vaccination at the urgent care. She said she could find out whom so the follow up letter might be sent to her.
An 87 year old male pt was being treated with Oncotice since 2004 for bladder cancer. He presented with blotches of hives and itchiness, which are sometimes painful. The hives were not all over his body, they appeared in 10 blotches in the back, 6 blotches on the chest and 4 blotches on his arms. Some of the blotches were scaly due to that the pt was scratching it too much. Pt consults an allergist and skin physician, who prescribed him ointment and advised to continue with Benadryl cream. Both physician did not know the cause of the hives. On 6/29/05 his last cycle of Oncotice was completed. The events were ongoing. Urticaria.
No Additional AE/PQC; tient was administered GARDASIL 9 ( not supported ) After TE.; This spontaneous report was received from a nurse prescriber regarding a patient of unspecified age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.  On 28-JUN-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5ml as prophylaxis (lot number (w015188) and expiration date (06-JAN-2025) both confirmed as valid (no more vaccination details provided) after a temperature excursion (TE) (temperature: 0.0 Fahrenheit (F), time frame: 0 hours 20 minutes 0 seconds) (product storage error). No additional adverse event (AE) happened (no adverse event).
itchiness around her whole body especially her back; feeling a lot of nausea; she feels like she wants to throw up; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 02Jun2021 (Lot Number: EW0217) at 48-year-old as single dose for COVID-19 immunization. Medical history was none. Investigation Assessment was none. This report wasn't related to a study or programme. There was none vaccine administered on same date with the Pfizer vaccine. There was none other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient was staying with family then she will move on. Concomitant medication included vitamins nos and it was ongoing. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 12May2021 (Batch/Lot number: EW0105) at the age of 48-year-old as single dose for COVID-19 immunization and experienced nausea and couldn't stand up because she threw up everything she had eaten. The patient states she received both doses of the Pfizer Covid-19 vaccine, and 2 weeks after receiving the first and second dose, she was feeling a lot of nausea and feels like she wants to throw up. Itchiness around her whole body especially her back. The nausea for the past 2 or 3 days and the day before the currently day it was very strong. The patient hadn't thrown up but she had taken Pepto Bismol on 15Jun2021. The patient had avoided all tests and medications except for the Pepto Bismol. The patient wants to know if she could take Pepto Bismol for nausea after the vaccine. The patient also asked if after two weeks was it possible to still had side effects, and asked if she could started taken her vitamins and drunk alcohol again. And the patient also asked if this was related to the COVID-19 vaccine. The events were not required emergency room and physician office. The events were not following prior vaccinations. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
CELLULITIS; HEART BURN; SORE THROAT; SENSITIVITY IN UPPER RIGHT QUADRANT OF STOMACH; PETECHIA; BODY ACHES/ ACHING BODY; ACHING TONSILS; This spontaneous report received from a consumer concerned multiple patients of unspecified age, race and ethnic origin. The patients height and weight were not reported. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced heart burn, sore throat, sensitivity in upper right quadrant of stomach, petechia, body aches/ aching body, severe red rash, aching tonsils, severe pain in the right leg, and fever. It was reported that the skin was on fire hot to touch and red and a large, very red spot across the skin was found which later was diagnosed as cellulitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cellulitis, body aches/ aching body, heart burn, sensitivity in upper right quadrant of stomach, petechia, sore throat and aching tonsils was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210958657.; Sender's Comments: V0: 20210960441-Covid-19 vaccine ad26.cov2.s- cellulitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I received the shot on the 9th of August, had 2-3 days of the initial arm site swelling and pain. Then It went away and I was fine. Then the morning of the 17th of August I woke up in pain in my arm and a pins and needles sensation in my arm. I looked at it and it looked like hives, it was hot to touch and was a big, hard, red area. That lasted the 17th/18th/19th and on the 20th when I woke up and was supposed to go to the Dr., it was pretty much gone. Oh, and you know else, my menstrual cycle is very regular, and it should've come right after my shot, and it didn't come then when it did come it was only two days which is very weird for me since I am never irregular like that. So, on the 20th of August I had went to the Dr., but he said it was "normal" as a reaction after the vaccine and he recommended getting the shot in the other arm for the vaccine. So, for my next vaccine, I have a Dr. appointment 3 days after my vaccine just in case. At home I had treated with Benadryl.
pt recvd vax 440PM then pt turned pale, weak & blurred vision aobut 3 mins p/2nd shot; BP was 80 systolically & unmeasurable disystolically; pt given Adrenalin; poss anaphylactic shot;
4 days of fever & feeding immed following immun; also had arching of back per mom;
Frozen Shoulder on left side was diagnosed by Physician Assistant, office on June 27, 2017. I had previously communicated this problem with my left shoulder with Dr. her website. I tried treating the problem with heat, ice, TYLENOL, and stop pain ointment to no avail. PA recommended physical therapy.  I had an x-ray taken on June 29, 2017. I began physical therapy on July 10, 2017 at clinic.  After twenty sessions of physical therapy which ended on Oct. 19, 2017, I was told that my insurance would not cover anymore therapy. I am now able to reach up high and up my back, but reaching our to the side continues to be problematic.
Pt recvd vax & 3JUL92 h ad weakness; pt indicated had not eaten; reporter indicated pt was asked to rest & eat & that pt felt better;
This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Aug2022, outcome "unknown" and all described as "COVID". Clinical information: Reporter was a physician. Have 10-year-old twin boys who are ex-31-week preemies her husband and her have vaccinated our family as soon as was available. We developed COVID for first time 15Aug2022 and now twins tested positive 17Aug2022. Was there any trial to allow them to t as me antiviral? The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.,Linked Report(s) : PFIZER INC-202201070692 same reporter/vaccine/AE, different patient; PFIZER INC-202201070693 same reporter/vaccine/AE, different patient; PFIZER INC-202201070694 same reporter/vaccine/AE, different patient;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot # M018593, expiration date 28-JUN-2017 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 6 to 14 degrees Fahrenheit for 45 minutes. Digital data logger was used. There was no previous excursions. No adverse effect was reported. Additional information has been requested.
Lump on left side of neck, superclavicular. Appeared 2 days post injection
3 days after Imm developed large local reddened lump on right arm (SubQ) gradually subsided site of ProQuad.
Swollen arm very very painful to move hot to the touch,  rash. Fever,  nauseous, headache, body ache, dizzy, light headed,  fuzzy and faint, loss of appetite very tired. Symptoms started within a few minutes and got worse over time. The Er put me on steroids for 10 day's, antihistamines, and pepsid for 30 days.
Patient given 5-11 years old dosage, instead of 12 years and up dosage.
No adverse Reactions Reported. In November 2022 our Immunization program did our every-other-year audits in Both our offices. It was discovered at that time, that some covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the state.)
itches; burns; painful; This case was reported by a consumer via interactive digital media and described the occurrence of itching in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced itching, burning sensation and pain. On an unknown date, the outcome of the itching, burning sensation and pain were not recovered/not resolved.   It was unknown if the reporter considered the itching, burning sensation and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 03-JUN-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient have had the shot and had been suffering for 3 weeks now. Itches, burns and was painful. Additional supportive information: No follow-up was possible as no contact details were available.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 30-OCT-2018, the pharmacist inadvertently administered to the patient a dose of M-M-R II intramuscularly rather than subcutaneously, for prophylaxis (strength, lot 3 and expiration date were not reported). No adverse effects were reported.
This case was reported by a physician via call center representative and described the occurrence of intramuscular formulation administered by other route in a 5-year-old male patient who received KINRIX (batch number 3425B, expiry date 17th April 2018). On 29th March 2017, the patient received KINRIX (subcutaneous). On 29th march 2017, unknown after receiving KINRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were reported as follows: A dose of KINRIX was inadvertently administered subcutaneously, which led to Incorrect route of drug administration. No further information was available or reported regarding the event. Follow up information was received from the physician via call center representative on 9th May 2017: The patient demographics were updated. It was reported that the patient received KINRIX as 5th DTaP and 4th IPV. It was reported that the vaccine documented was given as intramuscular to right deltoid. The patient returned two days later with localized injection site reaction with no permanent harm along posterior right humeral region and looks to had been given subcutaneous rather than intramuscular. The symptoms included localized redness, warmth, mild itching and some tenderness. No systemic symptoms were reported. The VAERS details were updated.
brain freeze/shooting pain headache similar to brain freeze after you get ice cream; to help her sleep she took a sleeping pill; This spontaneous case was reported by a consumer and describes the occurrence of COLD-STIMULUS HEADACHE (brain freeze/shooting pain headache similar to brain freeze after you get ice cream) and INSOMNIA (to help her sleep she took a sleeping pill) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced COLD-STIMULUS HEADACHE (brain freeze/shooting pain headache similar to brain freeze after you get ice cream) and INSOMNIA (to help her sleep she took a sleeping pill). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Brain freeze, at an unspecified dose and frequency. At the time of the report, COLD-STIMULUS HEADACHE (brain freeze/shooting pain headache similar to brain freeze after you get ice cream) had not resolved and INSOMNIA (to help her sleep she took a sleeping pill) outcome was unknown.            Patient reported that she took a sleeping pill to help her sleep. In concomitant medications blood pressure medication was reported. Patient reported that she received second shot of Moderna and did not have any reaction. Patient reported that the shooting pain headache made her think as if she was having a stroke.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Follow-up information received on 17 APR 2021 contains Added historical condition, concomitant medications and treatment . Updated patient demographics, re-challenge date and event outcome. On 11-Jun-2021: No new information was updated.
Magnet stick to my erect penis but not when it's flaccid after my second injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Magnet stick to my erect penis but not when it's flaccid after my second injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 VACCINATION COMPLICATION (Magnet stick to my erect penis but not when it's flaccid after my second injection). At the time of the report, VACCINATION COMPLICATION (Magnet stick to my erect penis but not when it's flaccid after my second injection) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
pt developed rash all over her body and went to the ER for treatment.  The rash lasted several weeks and she was advised by her provider to not get the second dose of Moderna to complete her series but to get JOhnson and Johnson after 6 months.
Received injection 10/24/2002 without incident.  Became ill on 10/25/2002 with severe diarrhea - denied fever, body aches or other symptoms.  Because is diabetic and has hx of CHF, was admitted to the hospital for hydration and monitoring of glucose and electrolytes.  D/C on 10/27/2002, but remains on bland diet as diarrhea returns otherwise.  Stool cultures completed did not isolate other bacteria or causative agents.  Pt saw PMD 10/30/2002 who, according to the patient, advised him to avoid flu shots in the future. Nurse follow up on 06/28/04 states: "ADD: Nausea, Dehydration, Gastroenteritis."
Felt flush and had hives to arms and chest.  Hypertensive at 220/132.  Denies any difficulty breathing.  Negative edema to mouth, face or throat.  IV established and 50mg Benadryl given through IV.  Transported to hospital.
Narrative:  On 12/26/21 60y.o. MALE with a h/o Hypertension, DMII, HLD, CAD s/p AICD (2005) (last EF 25-30% 05/2021), paroxysmal AF and BPH who presents with 3 days of back pain and shortness of breath. Pt states these started 3 days ago with no specific trigger and have progressively gotten worse. He went to OSH for his back pain primarily and was sent home, unknown workup per pt. He also states he had mechanical fall there, slipped and hit R knee on floor. No prodromal sx, no head trauma or LOC. He now c/o R leg pain and weakness, had to come to ED today in wheelchair. He states he came in on 12/26/21 because his breathing and pain were worse. Pt with NSTEMI, POA, Acute on chronic HFrEF exacerbation, POA, Acute kidney injury without CDK, POA, Hyperkalemia, POA, Transaminitis, POA, Leukocytosis, POA, Low back pain, POA, Paroxysmal A fib, POA, HTN, HDL DMII & BPH (all POA). Plan was to admit patient to cardiology, however pt coded in the ER. Pt suffered a massive GI bleed & hypotension, loss of pulse. Resuscitation efforts performed by medical staff, but pt died on 12/27/2021 @ 02:04am. Death was caused by: Hemorrhagic shock. Pt had received covid vaccines on 3/18/21 & 4/15/21. This death is not related to covid vaccines.
5min p/vax fell to the floor, became very pale, lost consciousness w/eyes rolling back;had jerky movement (head hyperextended) & became bladder incontinent;had grand mal sz;disoriented, anorexic,unable to sleep;unable to get up;
Pt came in for a Well Child Check up, determined to be healthy with no medical issues.  Ordered by provider for a COVID booster and it was administered.  Pt had a COVID booster on 1/24/22, so was not due for a COVID Booster at the time.
Swollen lymph gland in neck, possibly under arm (pit) Sore deltoid, tender arm pit. Pain/tender lymph node in neck. also visibly red
Patient reported that she felt light headed immediately following administration (2 to 5 minutes) and asked if we could get her some apple juice. She then bent over in her chair to get bloodflow back into her head, and reported that she felt as though she passed out during that time and requested to lay down on the floor. Once on the floor she said that she was beginning to feel better, but vomited a little when she was sitting back upright. Because she lives over an hour away, I stated I wanted to call EMS to get her checked out. EMS reported to the scene and evaluated her. She said she was feeling better, declined to go to the hospital, and walked around the store before leaving.
Fever CHILLS, PAIN, BODY ACHES, NAUSEA SORE ARM Narrative:  NO ADVERSE EFFECTS AFTER 1ST VACCINE  Other Relevant History:
At next visit to clinic mother states rash appeared "all over" boy approximately 24 hours after vaccines were given on 4/29/13.
Patient experienced itchiness with hives, tingling around face and ears, post-Moderna #2. Physical exam notes redness behind ears, bilateral lungs clear.  Redness to the nose, mild airway involvement.  Pt scratching scalp, neck, nose and lower back.  States that she cannot stop itching.  EMS assessment at 1100: initial BP 146/104, HR 92, BP 143/73, HR 90.  Given Benadryl 25 mg tab @ 10:10 am, Benadryl 25 mg IM @ 10:25 am.  Ice pack applied.  Fire department was called.  Pt states that after Benadryl IM, itchiness stopped and she felt better.  Physical exam shows redness to lower back and nose is decreasing.  EMS obtained AMA.  Husband came to pick up wife.
He got his vaccine, he had a burning sensation and tingling sensation and broke out really bad on his arms, and the back of his neck and his back.  He went to the doctor who send him to the drug store and was given OTC topicals to help with the rash.  These medications are helping but it is still not clearing up.   He is being sent to the dermatologist for this rash.