chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE reported; temperature excursion; This spontaneous report has been received from an unspecified source referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1637648 and lot # S010729 (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. The vaccine was exposed to a temperature range between 32.9 F and 34 °F, during a time frame of 16 hours which was called by a data logger (product storage error). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient has been complaining of generalized fatigue, productive cough, chest pain and shortness of breath but denies any headache, dizziness, sore throat, abdominal pain, nausea, vomiting, diarrhea or blood in stool or urine. Chest x-ray showed emphysema.  CTA of the chest showed no evidence of pulmonary embolism except for severe emphysema and multiple enlarged mediastinal and hilar lymph nodes   COVID-19 was positive Decadron and Remdesivir started.  He was treated with Respiratory protocol in setting of Covid with acute on chronic respiratory failure, with chronic bronchitis with 3 days antibiotics, mucolytics and bronchodilators.  Pulmonary and RT consulted.  He made daily improvement and was discharged to home on 4L O2 via nasal cannula noting baseline use is 3L w/prn use up to 5 L.
Pt showed a slight swollen red patch at the site of injection indicating that there was a reaction to the vaccine. She mentioned it was also itchy. No other symptoms or sob.
Subconjunctival hemorrhage of both eyes triggered a visit tot he ER,  CT scan, determination of something on the scan sent me to ICU, diagnosed with Acute cerebellar hemorrhage.
Patient reported a hypopigmented indentation in the skin overlying her deltoid started after her COVID-19 booster vaccination. Unclear on exact timeframe. She also stated she received a general "allergy shot" in primary care clinic around the same time. I am unable to verify documentation of this but if it was a steroid injection, could explain the observed skin atrophy.
I started feeling very tired and achy on Wednesday morning (2/3/21) and developed a headache that afternoon.  On 2/4/21, I ached less, but still had a headache.  In the late morning, I developed nausea, frequent bowel movements with soft stool (not actually diarrhea) and the shakes (no fever).  I ate some crackers and took two Tylenol Arthritis tablets.  I felt better, but by 7 PM, my upper arm near the injection site itched fiercely and had a large red patch.  Today I feel fine except that my upper arm still itches.  It is hot to the touch and also aches/hurts, but that is the only area that aches.  The rash is also slightly less red today.  I did advise my GP online (and sent a picture of my rash) this morning, but since I have read online this is known reaction, I was not concerned enough to make an appointment.  My GP did not recommend I make an appointment, either, but provided the web address to report the reaction.
Started feeling drug out a few days after, figured it was just " side effects". Tired, no energy ( not like me) Them a sharp pain started happening on the left side of my chest. Figured it was nothing. When all the symptoms  persisted, I made an appointment with my Dr.
The evening after I received the shot, I had extreme fatigue and a severe headache. The headache was very different and more severe than any headache or migraine that I have ever had. I also had weakness in my extremities. I laid down to rest for the evening and while trying to sleep, the headache continued to get worse and I also became very warm and had a fever. While laying down and trying to sleep I felt as if I was paralyzed and had difficulty opening my eyes and controlling muscle movements. I also was incontinent and urinated the bed that night which I have never in my adult life ever done. The headache, weakness and fatigue continued for approximately 3 days and then slightly improved. During that time my arm was sore but was a minor concern given my other symptoms. I continued to have a headache which then triggered a severe migraine about a week after the shot. During this entire time, I was unable to work or perform my normal duties as I normally would. It impacted my daily activities significantly. About a week and a half after the shot, I did not have the severe headache and migraine but still had lingering headaches and was fatigued. Then approximately 3 weeks after the shot I contracted COVID and was extremely ill for about 1 month and went to Urgent Care since I was still not feeling well from side effects from the shot and now felt worse with COVID exacerbating the side effects. Finally, now, almost 2 months after the shot and one month after COVID, I finally am feeling somewhat back to normal, although I still have general fatigue and weakness and am unable to perform my normal fitness and exercise routine without becoming short of breath and lightheaded (I generally am very active prior to this, a runner, and workout regularly).
Body ache was the worst. Headache pounding anytime I moved, chills, lethargy, got hot after 24 hours from vaccine, no fever.
Information has been received from a nurse concerning a female who on 06-OCT-2008 was vaccinated with the first dose GARDASIL in her arm, and immediately post vaccination she had redness and swelling at the injection site. The patient was treated with ice and medication, unknown name of medication and unspecified if medication was oral or topical. The patient was recovering. The patient sought medical attention at the office. Additional information has been requested.
Info has been received from an NP concerning a 6 year old male who on 9/28/1999 was vaccinated with a dose of varicella virus vaccine live (lot 631071/1002J). On 8/29/05, the pt experienced breakthrough chickenpox, less than 50 lesions. Unspecified medical attention was sought. It was reported that the pt recovered from the breakthrough chickenpox. No product quality complaint was involved. The NP also reported that the pt's brother also experienced breakthrough chickenpox after being vaccinated with varicella vaccine live. Additional info has been requested.
Extreme dizziness the morning after receiving the vaccine. As soon as I would try to stand or sit up, I would feel like I was going to pass out and had to immediately lay back down. I had to have assistance getting to the bathroom and was unable to walk to the kitchen or to sit up in a chair except for a recliner.  I also had orthostatic hypotension associated with standing. It was severe for 2 full days and gradually got better over the next 5 days.  It was my 3rd Pfizer dose. I opted for a Moderna booster 6 months later and had no side effects from that.
This spontaneous report was received from a a Licensed Practical Nurse (LPN) referring to an unspecified number of patients of unknown age and gender.  The patient's concurrent conditions, medical history drug reactions, allergies and concomitant medications were not reported. It was reported that the patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # L036301, expiration date 20-DEC-2017) administered on 08-DEC-2016, and GARDASIL 9 (lot # L040054, expiration date 26-DEC-2018) administered on  09-dec-2016 (strength, dose and route of administration were not reported) for prophylaxis. It was reported that the temperature excursion was for 30 minutes at 8.4°degrees C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA008769.
Pt recvd 2 doses of Engerix-B & 2nd dose given MAR91 then 2 days post vax pt exp allergic rxn of rash & felt tightening in throat;
dysuria, vulvar pruritus, vulvar discharge, and labial swelling; dysuria, vulvar pruritus, vulvar discharge, and labial swelling; dysuria, vulvar pruritus, vulvar discharge, and labial swelling; dysuria, vulvar pruritus, vulvar discharge, and labial swelling; dysuria, vulvar pruritus, vulvar discharge, and labial swelling; This is a literature report.  A 16-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: VULVAL ULCERATION (medically significant), DYSURIA (medically significant), VULVOVAGINAL PRURITUS (medically significant), VAGINAL DISCHARGE (medically significant), VULVOVAGINAL SWELLING (medically significant), all with latency 4 days after the suspect product(s) administration, outcome "recovered" and all described as "dysuria, vulvar pruritus, vulvar discharge, and labial swelling". The events "dysuria, vulvar pruritus, vulvar discharge, and labial swelling" required emergency room visit. The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: Negative; Epstein-Barr virus test: Negative; HSV1/2: Negative; Mycoplasma test: Negative. Therapeutic measures were taken as a result of vulval ulceration, dysuria, vulvovaginal pruritus, vaginal discharge, vulvovaginal swelling.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Vulval ulceration, dysuria, vulvar pruritus, vulvar discharge, and labial swelling and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
c/o 10cm local rxn, c/o kernel under arm pit; 4MAY92 @ 915;
improperly stored and administered; No additional AE reported; This spontaneous report has been received from a physician referring to an unspecified number of patients of unknown age with prophylaxis. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621931 expiration date not reported, but upon internal validation stablished as 26-JAN-2022 for prophylaxis and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot# R013434 expiration date not reported, but upon internal validation stablished as 21-MAR-2021   The vaccines were stored at a temperature range of 32.3 °F during a time frame of 5 hours.
I had no reaction immediately but two days ago started itching and warm and there is rash that is an oval around teh site about 3" long and 2" wide.
Large red warm induration measuring about 2.5 inches across and long w/ slight elevation.
sick; She has a split entry house and when going up and down stairs, breathing is harder; she tires out faster, but it goes away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Lot number: ER8727) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She is allergic to Sulfa" (unspecified if ongoing), notes: She is allergic to Sulfa.; "She later stated she had a bladder infection in the 1980's", start date: 1980 (unspecified if ongoing), notes: She later stated she had a bladder infection in the 1980's.; "she was hot and face was red and flushed" (unspecified if ongoing), notes: she was hot and face was red and flushed.; "she was hot and face was red and flushed" (unspecified if ongoing), notes: she was hot and face was red and flushed; "she was hot and face was red and flushed" (unspecified if ongoing), notes: she was hot and face was red and flushed; "She had a Hysterectomy when she was 18" (unspecified if ongoing), notes: She had a Hysterectomy when she was 18.; "She found out she was born with 2 uteruses and 1 kidney" (unspecified if ongoing), notes: She found out she was born with 2 uteruses and 1 kidney. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6202, Anatomical location: Injected in left arm.), administration date: 24Feb2021, when the patient was 65-year-old, for Covid-19 immunization, reaction (s): "headache", "chills", "dizziness", "fever", "leg cramps", "body aches and Joint aches", "body aches and Joint aches". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; DYSPNOEA EXERTIONAL (non-serious), outcome "recovering", described as "She has a split entry house and when going up and down stairs, breathing is harder"; FATIGUE (non-serious), outcome "recovering", described as "she tires out faster, but it goes away".  Follow-up (12Oct2022): The initial case was missing the following minimum criteria: ICH-Unspecified. AE. Upon receipt of follow-up information on (12Oct2022), this case now contains all required information to be considered valid. Additional information: Reporter's information, patient's details, product details and medical history added. Historical vaccine added. Suspect product coding updated. New event and concomitant therapy added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224579 Same reporter/ Patient and different dose and event;
Dizziness, Headache, Anaphylaxis, Fever, Palpitations, HYPERtension, Angina, Tachycardia, ,  began developing difficulty breathing and "heavy chest". Patient became unresponsive soon after. She was placed on 4L nasal cannula and responded to sternal rub. Medical emergency were notified immediately and arrived soon after. V/S were taken; 158/10 began developing difficulty breathing and "heavy chest". became unresponsive soon after. She was placed on 4L nasal cannula and responded to sternal rub. Medical emergency were notified immediately arrived soon after. V/S were taken; 158/108 HR 169 100% 4L resp 22. 09:25 BP 164/94 HR 126, 100% 4L. 09:26 155/101, HR 109, 100% 2L. 09:27 157/95 HR 93 100% 2L. EKG showed ST and BS was 81. Medic was notified and arrived at 09:04. was transferred to hospital. Trip, CXR was nml, mild low potassium. H/O mild elevated BP not treated.
back pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), PYREXIA (fever) and CHILLS (chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced BACK PAIN (back pain), PYREXIA (fever) and CHILLS (chills). At the time of the report, BACK PAIN (back pain), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Concomitant medication also include unspecified Blood pressure medication. Treatment medication was not reported.
1 day p/vax pt devel angioedema & flu-like sx;addtl info recv 3DEC96, indicated that pt recovered;
When giving the vaccine in the right forearm, a wheal did not form. Administered second dose in lower right forearm and wheal formed. No adverse reaction from second dose.
Fatigue; Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Fatigue) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, IBUPROFEN, AZITHROMYCIN and AMOXICILLIN for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). On 09-Apr-2021, the patient experienced FATIGUE (Fatigue). On 10-Apr-2021, FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No lab data has been provided by the reporter.   This case was linked to MOD-2021-147931 (Patient Link).
Pharmacy technician went to draw up vaccine and instead of using open diluted vial, she popped the top off the unopened vial, did not dilute, and administered to patient
very mild COVID Disease; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (very mild COVID Disease) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (very mild COVID Disease). In 2022, COVID-19 (very mild COVID Disease) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient received 4 Moderna COVID-19 vaccine so far. The last Moderna COVID-19 shot was administered on 07Apr2022. Patient only had a little cough and patient was fine after a few days. Patient was confused about Monovalent and Bivalent. Patient will go on a cruise on 04FEB2023 and require up to date vaccination records.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706633 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706633:Wife case
Suspect transient. No spinal tap done. S mptoms (24 hours after prevnar and fluad injectio n/same da  per pt right arm=prevnar; left arm=fluad) nausea, fever, intense neck pain, generali ed arthralgia/m algia. Self-limiting (resolved  ithin  48 hrs). Self-treatment=fluids, t lenol. No medical attentio n until toda  (10 da s later).
I woke up feeling ill with chills and slight fever. Overall tired and a bit nauseous. Body feels heavy.
Decedent received first Covid-19 vaccination on 03/16/2021, has not been feeling well the past week. This past week the decedent stated she had been more tired and was experiencing shortness of breath.
This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 41-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 24-NOV-2016 to 24-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular, Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 24-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Left arm redness, warmth, swelling, localized, and fever. Drugs: Benadryl, Keflex.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre Syndrome in a patient who received Influenza vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced Guillain Barre Syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre Syndrome was unknown. It was unknown if the reporter considered the Guillain Barre Syndrome to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient told to the pharmacist, they had a Guillain Barre Syndrome after an unknown influenza immunization in the past. The reporter inquired about that, if there would be a problem after receiving SHINGRIX.
Swollen, painful lymph nodes noted in left armpit and left neck approximately 2 hours after vaccination administered.
Left deltoid red and warm two days after flu shot. Arm examined 12/11/03 and no longer red. Pt says redness lasted only 2-3 days and is fine now.