chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer who reported for herself, a 65-year-old female patient who received PREVNAR 13, (lot number and expiration date unknown) at the left arm, via an unspecified route of administration on 06Nov2018 at 11:00 at a single dose for immunisation. The patient stated that she got it because about 2 years ago, she got the PNEUMOVAX for immunization. Medical history included diabetes mellitus (reported as diabetic) from 2017 and ongoing, irritable bowel syndrome, acupuncture, and histamine reaction. The patient was told that she was diabetic and she wanted it to be less than 7 as it was way up before that. She took supplements to manage her glucose. The patient stated that in her records, it was documented that she has irritable bowel syndrome. She states that she has thrown up since and has gut pain. The patient got acupuncture below the curve of her left arm for irritable bowel syndrome and that one vein bubbled up 3/4 of inch. The patient stated that she was told that she had a histamine reaction, and she was bruised up from the reaction until 2 days ago. Concomitant medication included ANTRONEX tablet ongoing since Oct2018; the patient's nutritionist told her that whenever she got cold symptoms/sneezing or coughing to take this. The patient also took other unspecified whole food supplements and vitamins. On 06Nov2018, the patient got panic attacks at the site of a needle and she experienced sweats and chills. The patient stated that she was fatigued on an unspecified date in 2018 after pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was administered and that she slept for the whole day. She had another appointment that she was supposed to go to that day and did not attend it. The patient stated that on 07Nov2018, she was disoriented and had pain in her left shoulder. On 07Nov2018, she stated that all over her shoulder was a big red rash that lasted for 10 days, and she had nausea. She states that on 12Nov2018, she was throwing up and had diarrhea. The patient tried to resolve the disorientation when she went to her last appointment on 19No2018. She stated that the left shoulder pain resulted in red rash. They did not give her an antihistamine or anything for it. The patient had doctor's appointment for acupuncture and she mentioned the adverse events but she stated that they were not listening. The patient had constipation on an unspecified date. The patient underwent lab tests and procedures on 06Nov2018 which included HgBa1c: 7.8, Liver panel: Normal, Chem 7: Normal, Iron: abnormal low, Vitamin D: 17.9, abnormal. She stated that the doctor told her that she needs a daily iron supplement. She states that the doctor told her that her vitamin D range is supposed to be 30-100. Pain in left shoulder recovered on an unspecified date. Outcome of big red rash, panic attacks and chills was recovering; while outcome of sweats, nausea, vomiting, diarrhea and constipation was not recovered. The outcome of the other events was unknown. Information on the lot/batch number has been requested.
had the vaccine for shingles and got the 2nd worse case/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-June-2022 Reporter's comment: This case was reported by a patient's friend via interactive digital media. The patient had the vaccine for shingles and got the 2nd worse case her doctor had ever seen. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not provided.
After the flu shot patient stated feeling a little dizzy and wants to stay on the chair. Was talking to her dad for a little and then passed out and started to have a seizure; also lost bladder control. A few minutes later patient was wake, alert and coherent.
glove neuropathy; tingling in my left arm,felt like pins and needles; pinched nerve; numbness, spread to my left leg and soon spread to the entire left side of my body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 12:00 (Lot number: EV5318) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergic to shrimp" (unspecified if ongoing); "Allergic to Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (brand=Pfizer, Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 06Feb2021, when the patient was 56 years old, for Covid-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 01Mar2021, outcome "recovering", described as "glove neuropathy"; PARAESTHESIA (non-serious) with onset 01Mar2021, outcome "recovering", described as "tingling in my left arm,felt like pins and needles"; NERVE COMPRESSION (non-serious) with onset 01Mar2021, outcome "recovering", described as "pinched nerve"; HYPOAESTHESIA (non-serious) with onset 01Mar2021, outcome "recovering", described as "numbness, spread to my left leg and soon spread to the entire left side of my body". The events "glove neuropathy", "tingling in my left arm,felt like pins and needles", "pinched nerve" and "numbness, spread to my left leg and soon spread to the entire left side of my body" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown result; electromyogram: unknown result; magnetic resonance imaging: unknown result; magnetic resonance imaging head: unknown result. Therapeutic measures were not taken as a result of neuropathy peripheral, paraesthesia, nerve compression, hypoaesthesia. Additional information: No other vaccine in four weeks. No covid prior vaccination, covid tested post vaccination: No. Adverse event: Soon after my 2nd dose of the COVID-19 Vaccine I had tingling in my left arm that felt like pins and needles. It continued for like that for a couple of months.I could shake my arm and it would stop, but the tingling always came back. I thought that I had a pinched nerve. In May the tingling, and then numbness, spread to my left leg and soon spread to the entire left side of my body....from the top of my head to the bottom of my foot. My doctor sent me for a brain MRI, spinal code MRI, numerous blood tests, and two EMG's. At it's worst, it spread to my right side and I had severe stocking and glove neuropathy. It was hard to type as the day would go on, as my hands were effected and it would feel like I was wearing ski boots. The effects slowly diminished and now just my left foot remains numb. My doctor was sure that this was a side effect of the vaccine.
Down for 3 days; Could not drink water or eat anything; Felt nauseous if had a sip of water; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Down for 3 days), FEEDING DISORDER (Could not drink water or eat anything) and NAUSEA (Felt nauseous if had a sip of water) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced FEELING ABNORMAL (Down for 3 days), FEEDING DISORDER (Could not drink water or eat anything) and NAUSEA (Felt nauseous if had a sip of water). On 26-Mar-2021, FEELING ABNORMAL (Down for 3 days), FEEDING DISORDER (Could not drink water or eat anything) and NAUSEA (Felt nauseous if had a sip of water) had resolved.            No concomitant product use was provided by the reporter. No treatment medication was provided.
This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced skin been crazy. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin been crazy. This report was non-serious.
Nurse spoke to dad 9-14-11 at 7:20 PM, child given first dose of Omnicef at 3:10p. Vomiting & loose stool began at 5:30pm and another episode at 7p. Was advised to withhold dose until next day. Nurse spoke to mom at ~1:00pm on 9-15-11 who reported that he had a large episode of diarrhea shortly after Omnicef dose given, no diarrhea, and now experiencing nausea. He had Omnicef in the past, the last time having GI symptoms at the end of the course of treatment, she did not report the symptoms. She requested a new antibiotic. Zithromax was called to the pharmacy. Patient seen on 9-17-11 with dad, who reported that both parents started noticing tics the evening of 9-14-11 that coninue at 9-17 visit.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient noted an anaphylactic response to hepatitis b as a baby. Was counseled to wait 30 minutes in pharmacy to be monitored after receiving a vaccine. Around 25 minutes later patient approached pharmacist stating felt tongue tingling. Patient drank some water stated she felt better but in next two minutes noted her throat felt obstructed. Technician called 911. Paramedics arrived within 3 minutes. No epipen was given. Paramedics and immunizing pharmacist both mentioned possible anxiety attack
I had the Moderna vaccination on Feb 25 and on March 4 (day 10) my eyes and cheeks were swollen like a chipmunk. I?ve had no dermal fillers. My eyes and face are still swollen so I went to my Dr today. He has me on Benedryl and Prednisone.
No additional AE reported.; expired dose of VAQTA was administered to the patient; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 14-OCT-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml, lot #U004366, expiration date: 01-OCT-2022 (strength, vaccination schedule, site and route of administration were not provided) for prophylaxis (Expired product administered). The reporter stated the vaccine did not experience a temperature excursion. No additional adverse event was reported.
The morning after I received the vaccine I noticed my baby wasn't moving. I drove straight to the hospital where it was administered for and ultrasound where my doctor confirmed he had no heartbeat.
A few hours after vaccination, I felt some kind of strange feeling in my heart/chest area. An uncomfortable sensation that lasted 10-15 minutes then it went away. No trouble breathing. I did not have any more adverse events after this one. I had the same exact feeling with my 1st Moderna vaccine as well. I have fully recovered and did not go see a doctor.
No Adverse event; given vaccine which was beyond the 30 day use by date; Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022; given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No Adverse event) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022). On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022).    Concomitant medication not reported.  Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: fridge. Vial size: 5.5ml Maximum or minimum temperatures reached, as applicable (specify temp is in C or F): 0.29C (cold excursion) Excursion duration: 32hours and 30 min Date vial(s) moved from freezer to refrigerator, if applicable:15-Aug-2022. Where are they stored now: Returned to the freezer/refrigerator or maintained at room temperature - disposed as it was expired. Treatment medication not reported.
Pt complained of pain in muscle around site of injection within days of receiving vaccine.  The pain has radiated up and down arm, has affected sleep and range of motion.  Has been under physician care for this problem.
This case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, less than a week after receiving dTpa vaccine, the patient experienced generalized urticaria. The patient was treated with prednisone. On an unknown date, the outcome of the generalized urticaria was recovering/resolving. It was unknown if the reporter considered the generalized urticaria to be related to dTpa vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The patient was given TDAP about 7 weeks before the reporting date in 2017 and within 2 days she experienced hives all over the body. The patient tried to get rid of it herself and then she went to her doctor and got prednisone. After that the hives came back. They are somewhat better now. The side effects made it very miserable for her to take. The patient provided name of her physician's office. The patient was looking forward to hear from GlaxoSmithKline.
Headache; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 30th April 2020) for prophylaxis.   On 21st April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st April 2019, less than a day after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovering/resolving.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the right deltoid. The reporter was unsure whether the patient had attempted to treat the headache with anything.
This spontaneous report has been received from a registered nurse referring to a 12 month old male patient. The patient did not have medical history or drug reaction or allergies. Information regarding the patient's concurrent conditions were not reported. Historical drug included 3 doses of RECOMBIVAX HB on unknown dates. Concomitant therapies included M-M-R II and VARIVAX. On 05-SEP-2017, the patient was inadvertently vaccinated with a 4th dose of RECOMBIVAX HB lot # M042322, expiration date 21-FEB-2019, by intramuscular route in the right arm for prophylaxis.  Other suspect therapies included VAQTA. It was reported that the nurse who administered RECOMBIVAX HB "thought she grabbed VAQTA and it was not until after the dose of RECOMBIVAX HB was administered she realized she grabbed the wrong vial". On an unknown date the patient's mother was contacted, but she did not provide any information regarding adverse events. None laboratory studies were performed.
10/1/10 - redness, warmth, edema and arm hardness approx. 50 ml around injection site. Also feels "sick", fatigue, sinus drainage, cough. Rxn: right posterior arm.
This case was reported by a physician via call center representative and described the occurrence of pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 28th July 2018, the patient received SHINGRIX and SHINGRIX. On 28th July 2018, less than a day after receiving SHINGRIX and SHINGRIX, the patient experienced pain, injection site bruising, injection site erythema, injection site tenderness, inadvertent exposure to vaccine, exposure via skin contact and accidental underdose. On an unknown date, the outcome of the pain, injection site bruising, injection site erythema and injection site tenderness were not recovered/not resolved and the outcome of the inadvertent exposure to vaccine, exposure via skin contact and accidental underdose were unknown. It was unknown if the reporter considered the pain and injection site bruising to be related to SHINGRIX. It was unknown if the reporter considered the pain, injection site erythema and injection site tenderness to be related to SHINGRIX. Additional details reported as follows: The retired physician received an injection in her right arm and said that most of it ran down her arm at the time of injection, which led to inadvertent exposure to vaccine, exposure via skin contact and accidental underdose. The pharmacist injected a second dose into the left arm without incident. She had experienced aches and pains and left arm had some redness and was sore and was tender at the injection site on the left arm. The right arm only had a little bruising at the injection site.
bilateral sensorineural hearing loss and bilateral tinnitus.; bilateral sensorineural hearing loss and bilateral tinnitus.; Information has been received on from a lawyer and the patient (pt), regarding a case in litigation referring a female pt of unknown age. Medical history, concurrent conditions and concomitant medications were not reported.  In or around 29-APR-2017, the pt was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (route, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the pt suffered bilateral hearing loss with ringing tinnitus and was diagnosed with bilateral sensorineural hearing loss and bilateral tinnitus. As a direct and proximate result of defective Zoster Vaccine Live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using Zoster Vaccine Live (ZOSTAVAX). She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. She sustained severe and permanent personal injuries; serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The reporters considered bilateral sensorineural hearing loss and bilateral tinnitus to be disabling. Upon internal review bilateral sensorineural hearing loss was considered as medical significant.
COVID Breakthrough Case Pfizer Dose 1 3/13/21 (EN6204) Pfizer Dose 2 4/3/21 (ER8729) COVID Positive 9/17/21  9/16/21: patient is a 54 year old female who presented to ED with complaints of shortness of breath. Patient has a past medical history of multiple sclerosis, hyperlipidemia, hypothyroidism, uncontrolled type 2 diabetes mellitus and anxiety/depression. She began feeling ill two weeks ago. She developed nasal congestion, right ear pain and diarrhea. She was seen at urgent care on Sept 12th and started on Augmentin. Her symptoms have progressively worsened. She has become severely short of breath, especially with exertion. No chest pain. Decreased appetite and oral intake. Reports ongoing nausea and vomiting, with persistent diarrhea. She developed a fever yesterday and dry cough. She went back to urgent care today and her pulse ox was in the 80s, she was referred to ED for further evaluation and treatment. She has been fully Covid-19 vaccinated.  On arrival to ED patient was febrile 101.6, tachycardic 117 and hypoxic on room air at 86%. 5 L nasal cannula was applied with improvement oxygenation saturation to 94%. Laboratory findings were significant for CO2 14, pH 7.31, pCO2 37 hyperglycemia 339. ProBNP 359.Rapid COVID positive. IV Levaquin initiated in ED.  IV fluid resuscitation given with LR 5 L bolus.  Decadron and DuoNebs initiated in ED. chest x-ray showed bilateral pneumonia.  10/1/21: 54-year-old lady presented to the emergency room with worsening shortness of breath.  The patient was noted to be hypoxic and admitted for COVID-19 pneumonia.  She was intubated 3 days later and put on the vent for severe hypoxic respiratory failure.  The patient received standard treatment for COVID-19 infection that improved on remdesivir, dexamethasone, empiric antibiotic therapy.  The patient received a standard treatment for COVID-19 infection.  She was eventually extubated.  She is doing much better.  She is only on 2 L of oxygen via nasal cannula at rest and with activity.  The patient is recuperating well with physical therapy.