chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breath with wheezing and cough lasting approx. 2 hrs followed by fever, chills and slightly rapid heart beat for several hrs.
Pain started on the lower left ventricle area of the heart as a dull pain and would last for a few minutes, pain was about a 2-4. Then it grew more intolerable as the days passed. Pain would be at a 9/10 for 40-50 mins at a time. It felt like vise grips on the bottom side of the heart. It felt like its couldn't pump.  I would be laying on the floor or on the bed not able to do anything except lay there. If I was doing something I would have to completely stop. It was terrifying.
pt developed hives / to shingrix; pt developed /swelling to shingrix; This case was reported by a physician via call center representative and described the occurrence of hives in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2021, the patient received Shingrix. In March 2021, less than a month after receiving Shingrix, the patient experienced hives and swelling. On an unknown date, the outcome of the hives and swelling were unknown.   It was unknown if the reporter considered the hives and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced hives and swelling. The reporter asked if it was safe to take covid 19 shot. No other details of Shingrix were available. The reporter consented to follow up.
I have had trouble breathing,  wheezing,  headaches, nausea, muscle aches.  None of which I had the day before.  I have had to go on an inhaler the last week as I am not improving.  My breathing was fine prior to the shot and I am getting worse.
Headache, dizziness, swelling and numbness to face and tongue, neck stiffness, neck pain, inflamed joints, body aches, feeling short of breath  Took 50mg benadryl and 800 ibuprofen initially Took 25mg Benadryl, 650mg tylenol, and 10mg flexeril 6 hours later  Numbness, swelling, and shortness of breath resolved
Pharmacy intern went to administer the vaccine and the patient moved her arm. Intern did not notice the syringe had punctured her glove and finger until after the patient's vaccination was completed. The intern removed her glove and realized there was blood and a puncture from the syringe in her finger. The pharmacists on duty as well as the owner of the pharmacy contacted the patient's mother. The intern was sent for blood work.
arm swollen from elbow down to wrist(started 09/11/2021 and still present til present 09/16/2021).  itching was present for couple of days (from 09/11/2021) but subsided.  the swelling has gone down a bit; but from wrist to elbow on left arm swelling still present.  pt advised to speak to pcp about any potential necessary treatment.
Body ache; Chills; Headache; This is a spontaneous report from a contactable consumer via Pfizer sales Representative. The consumer reported on three patients. This is the third of three reports. A patient of an unspecified age and gender received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, on the second dose of vaccination the patient experienced body ache, chills and headache. The patient was treated for body ache, chills and headache with ibuprofen and the symptoms went away in one day. The clinical outcome of the events was recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021117236 same reporter/product/event, different patient;US-PFIZER INC-2021117244 same reporter/product/event, different patient
Initial information received on 18-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional (office person medical assistant). This case involves a child patient (age and gender not reported) who was vaccinated with dtap-ipv component without reconstituting the PENTACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate reconstitution technique. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
23Apr90 pt vax;  next day devel lymphadenopathy, high fever, stiff neck, & swelling & discoloration at inject site.  Hosp & tx w/ meds.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Patient fainted, unfortunately did fall, however despite some bruises was ok. Waited for family to come to get him and was able to leave under his own power. Ambulance was called and he was checked, no issues found and did not leave with ambulance.
Wife present with pt and she stated before he received his vaccine that he has been known to pass out during a vaccine or after getting a vaccine. Pt's wife came and got me from exam room around 2:50p (about 10 mins after receiving vaccine and while pt was sitting in waiting room) stating that he didn't feel well. Pt's face was pale and skin was cool and clammy but alert when I asked him if he'd like to return to an exam room to lay down. He stated that he wanted to stay in waiting room sitting with his wife. I gave pt 2 small bottles of water but he declined them at that time. I started to check his BP and he became unreponsive but eyes still open. This episode last approximately 20-30 seconds and then color return to pt's face and he became responsive and answer questions appropriately. I asked pt again if he wanted to come into an exam room and lay down but he decline again. I advised pt and wife to stay in waiting room and asked his wife to watch for any other symptoms and advised them to stay an additional 15-20 mins. Both verbalized agreement and understanding. Pt's wife said he was feeling better at 3:15pm and after drinking the water I gave him and they left. Pt was alert and ambulatory upon leaving, steady gait.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. THE HCF is working with the local health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Dizziness, feeling faint, fever, aching joints throughout body, nausea (retching).
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. The patients' current conditions and medical history were not provided. On an unknown date during 2015, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# K001196 exp. 22-OCT-2015) (1 dose) and (lot# K0011948 exp. 07-JUN-2016) (5 doses) (dose was not reported) by oral route. There was no concomitant medication described. No adverse symptoms were reported. It was unknown if the patients sought medical attention. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Extreme joint pain all over body - specifically arm and legs, also including testes. Sought treatment - follow up study scheduled for possible auto immune disorder.
Narrative:  64 yo male with a h/o liposarcoma of liver(dx'd 12/28/20) and associated ascites, ESRD on HD died at Hospital due to SEPTIC SHOCK AND RESP FAILURE. Pt had received covid vaccinations on 4/14/2021 & on 5/5/2021.Further history from PCP note when pt establishing care on 6/25/21: "Liposarcoma of liver per wife pt received his 1st round of CTX 1/2021 and 2nd round 2/2021. On the last day of the second round of chemotherapy, he developed slurring of speech, and was sent for an MRI of the brain. Wife states he went into a coma on 2/6/21, and was declared brain dead. However, 2 days later, he regained consciousness, but developed significant physical disability. During hospitalization on 2/17/21 he was started on hemodialysis. Wife states he did not have a diagnosis of renal failure prior to that time. He was discharged from hospital on 3/10/21 to rehabilitation and skilled nursing where he stayed until 6/14/21. He has been home since then. Patient has also had ascites since the liver cancer was diagnosed, and undergoes paracentesis monthly. He is not being treated for his liver cancer at this time, and had been told by his oncologist that he may seek care at a center where clinical trials are being performed. However, pt decided to establish at the clinic in order to be seen by clinic oncology. He also had a colonoscopy in the summer of 2020 through Dr., at which time multiple polyps were found per wife, but not all of them were removed, and he was to be scheduled for a f/u C scope, which they are requesting through the clinic. Wife also states that he was admitted in November 2020 for shortness of breath 2/2 Covid." No further information regarding pt's death available. Not clear if pt's death is related to covid vaccinations, likely not related given patient's medical history & given that vaccinations were > 60 days since pt had received them.
heart pain; Shoulder pain; Neck ache; Stiff neck; severe chest pain; This is a spontaneous report from a contactable consumer (patient). This 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 23Feb2021 15:15 (batch/lot number: EN6198) as a single dose for COVID-19 immunization. Medical history included heart attack approximately 20 years ago). Family history included heart problems. Patient received unspecified concomitant medications. No additional vaccines administered on the same date of the Pfizer suspect. Patient experienced some side effects after receiving the first dose of the Pfizer-BioNtech Covid-19 vaccine. About 3-4 hour after she received the vaccine, on 03Feb2021 19:00, she had heart pain for around 5 hours, she also experienced shoulder and neck ache. These symptoms have resolved. She would like to know if she should receive the second dose of the vaccine, if these symptoms would be worse. Treatment for side effects: she put Spikenard, an oil, on the chest for the heart. At 15:10, she was fine, went home, had dinner, and then she first got shoulder pain/shoulder blade pain and then a stiff neck. Then she thought, she will go to bed and then had severe chest pain most of the night. Patient has never had flu or any vaccines. AEs did not require a visit to emergency room/physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event shoulder pain was recovering, of the event neck pain was recovered in 2021, and of the events heart pain, stiff neck, and chest pain was recovered on 23Feb2021.
Well localized area of erythema to injection site. Child otherwise well. Recommend icing the area with cool compresses and massage. Marked area of erythema with surgical pen and discussed with mother to return to care with any increase of redness outside marked area.
zoster related hearing loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 14-AUG-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for zoster related hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event zoster related hearing loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, zoster related hearing loss was determined to be medically significant.
tachycardia; inflammation in her body; could not get up from the floor; muscle pain /could not get up; shortness of breath; no muscle strength / in legs; congestive heart failure; hospitalized for decomposition of muscles; This case was reported by a consumer via call center representative and described the occurrence of muscle degeneration in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included congestive heart failure. Previously administered products included Shingrix (received 1st dose in July 2022). Concurrent medical conditions included autoimmune disorder.   In October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a month after receiving Shingrix, the patient experienced muscle degeneration (serious criteria hospitalization), muscle pain (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), muscle weakness (serious criteria hospitalization), inflammation (serious criteria hospitalization) and mobility decreased (serious criteria hospitalization). On 28th October 2022, the patient experienced tachycardia (serious criteria hospitalization). On an unknown date, the patient experienced congestive heart failure (serious criteria hospitalization and GSK medically significant). The patient was treated with milrinone. On an unknown date, the outcome of the muscle degeneration, shortness of breath, muscle weakness, inflammation, mobility decreased and congestive heart failure were unknown and the outcome of the muscle pain and tachycardia were not recovered/not resolved.   It was unknown if the reporter considered the muscle degeneration, muscle pain, shortness of breath, muscle weakness, tachycardia, inflammation, mobility decreased and congestive heart failure to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR192857   Additional Information: GSK Receipt Date: 23 DEC 2022 Reporter's comment: The patient reported that got Shingrix vaccine in July 2022 and October of 2022.  The patient reported had muscle pain, shortness of breath, and no muscle strength right after getting the second Shingrix shot, further described her muscle pain by saying said she could not get up from the floor and had no strength in her legs.  The patient said was hospitalized from 28th October 2022 to 31st October 2022  for decomposition of muscles. Patient said had tachycardia since her 28th October 2022 hospitalization. The patient reported said her doctor said there was inflammation in body based off her labs from the 28th October 2022 hospital visit. The patient also reported that was hospitalized from 9th December 2022 to 17th December 2022 for congestive heart failure and tachycardia. During that hospital stay she tried Milrinone intravenous that made her tachycardia worse. Patient reported that had congestive heart failure before getting Shingrix.; Sender's Comments:  US-GSK-US2022AMR192857:same reporter
No adverse event; First dose on 30-Jan-21 and second dose on 20-Feb-21; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Jan-21 and second dose on 20-Feb-21) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Jan-21 and second dose on 20-Feb-21). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Jan-21 and second dose on 20-Feb-21) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Jan-21 and second dose on 20-Feb-21).    Concomitant medication information was not provided by the reporter.  The reporter informed that, no adverse events was known.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-608998, MOD-2022-620515 (Patient Link).
This spontaneous report as received from a pharmacist refers to a female patient. The patient was vaccinated intramuscularly or subcutaneously with a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported) about a month ago in October 2012. In October 2012, 2 days after receiving PNEUMOVAX 23, the patient developed swelling, pain and redness in her injection site arm. Patient went to a clinic and saw a doctor who said that the symptoms on the arm looked like cellulitis, but was not. Patient's arm was swabbed, but no result was reported. Patient received pain reliever for treatment, but no antibiotics. At the time of this report patient had recovered. Additional information is not expected.
Localized swelling of right deltoid region with mild erythema. Apply ice to area for 10-15 minutes two to three times a day.
some bloody discharge like menstruation; very light menstruation outside of regular menstruation period; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Apr2021 at 13:45 at the age of 28-year-old as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included LOESTRIN for birth control from an unknown date and unknown if ongoing, VITAMIN D from unknown date for unknown indication and unknown if ongoing and ASHWAGANDHA from unknown date for unknown indication and unknown if ongoing. On 24Apr2021 at 16:00, the patient experienced very light menstruation outside of regular menstruation period. The patient had her regular menstruation a week before receiving the second vaccine dose, and then after receiving the second dose, she had some bloody discharge like menstruation. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very light menstruation outside of regular menstruation period and some bloody discharge like menstruation was resolving at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
shortness of breath; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced shortness of breath with her second dose and had to go to the hospital for a week. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Information has been received from a registered nurse concerning a 51 year old sister who on approx 10/15/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. The RN reported that on approximately 10/15/05, immediately after being vaccinated, her sister developed edema like a softball and redness at the injection site. Unspecified medical attention was sought. At the time of this report, the pts edema and redness at the injection site persisted. The follow up it was reported that the reaction to the Pneumococcal 23v polysaccharide vaccine happened to a relative and the details of the facility, physician and vaccine were unknown. No further information is available.
Patient describes hives at site of injection aprorx 2-3" in diameter- onset day of vaccine also describes "tightness in throat" sensation no trouble breathing.  No treatment needed or done.
Injection site soreness and tenderness within 5 hours that had completely resolved within 56 hours.; This is a spontaneous report from a contactable consumer (Patient). This 42yearold male consumer reported that he received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, Lot number: EL3247, Expiration date: UNKNOWN) via unspecified route of administration in Left arm on 12Feb2021 12:00 (at the age of 42-years-old) as a single dose for covid-19 immunization. Historical vaccine received dose 1, BNT162B2 (Pfizer-Biontech Covid-19 Vaccine batch number EL3247) on 22Jan2021 dose 1, single for covid-19 immunization. The medical history was not reported and no known allergies. The concomitant medication included Doxycycline for an unspecified indication start and stop date were not reported. The patient had not received other vaccine in four weeks. On 12Feb2021 05:00, the patient experienced injection site soreness and tenderness within 5 hours that had completely resolved within 56 hours. The patient was not Covid prior vaccination and no tested Covid post vaccination. The patient was not received the treatment. Outcome of event was reported as recovered on an unspecified date in 2021.   Follow-up attempts completed. No further information expected.