chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admiistered after temperature excursion; This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2023, the patient received the 2nd dose of Shingrix. On 7th January 2023, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 25-Jan-2023 Reporter's comment: Consumer stated that the pharmacy contacted her about the second dose of Shingrix she had received.  Pharmacy reported to her that the dose she received had been stored outside of the recommended temperature range and that she needed to contact GSK.  Additional supportive information: the patient received Shingrix which was stored outside of the recommended temperature range, which led to Incorrect storage of drug.
This spontaneous report as received from a physician via the field representative refers to a 71 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unspecified date in August 2012 (reported as two years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On an unspecified date (reported as recently), the patient came to the office and had developed a mild case of the "shingles". No further symptoms were provided. The patient sought medical attention via office visit. The outcome of the event was reported as recovering. The relationship between the event and ZOSTAVAX was unknown. Additional information is not expected because physician cannot be contacted.
Menstrual cramps lasting three days and menstrual spotting and period lasting 8 days
Felt heaviness in chest and bp and pulse slightly elevated Pulse ox 100% no SOB
pt recvd vax; exp hives following 3rd dose; pt has hives for 2 wks; md prescribed seldane;
Moderna, Dose: 4; Pfizer, Dose: 1-3; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EH9899), on 10Jan2021 as dose 2, single (Lot number: EL1284) and on 29Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 45 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "hx VSD repair in 1979", start date: 1979 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Oct2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna, Dose: 4; Pfizer, Dose: 1-3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 18Oct2023 to 22Oct2023.; Sender's Comments: Considering interchange of vaccine, the contributory role of company suspect drug to all the reported events DRUG INEFFECTIVE,  COVID-19 cannot be excluded completely.
After 24 hours of taking the second shoot, the arm where I was given the vaccine was a severe pain, body aches and headache, 48 hours after the vaccine, I feel better.
A 66 year old patient experienced inadequate antibody levels after prophylactic treatment with RabAvert. The patient received RabAvert on 10/03/02, 10/10/02, followed by a third injection 2 to 3 weeks later. On 05/01/04, enzyme-linked immunosorbent assay (ELISA) testing was performed and showed inadequate antibody levels. On 06/15/04 repaid fluorescent focus inhibition test (RFFIT) was performed and showed below acceptable levels. A Booster shot was suggested due to the low post vaccination titers. The reporter stated that a booster would be obtained and follow up titers reported. Follow up information received on 07/22/04: The correct lot number for the RabAvert is #309011, expiration date 10/2005. The RFFIT result for this patient was 0.2IU/ml. Follow up information received 08/04/04: the RFFIT test result was converted to dilution to compare to the recommendation of adequate rabies virus neutralizing antibody titer (greater or equal to a serum dilution of 1:5 resulting in complete neutralization of rabies virus in RFFIT). The first RFFIT neutralizing antibody dilution results were less than or equal to 1:11. The sample was retested to refine the values at the lower cut off. On 07/06/04 the results of the RFFIT retesting was reported as 0.1 IU/ml or 1:9 dilution. According to recommendations, the patient did not need a booster dose of vaccine.
T = 107 degrees; Exergen thermometer; verified axillary = 105 x 5 days.
This spontaneous report was received from a certificate medical assistant referring to an unspecified number of patients of unknown age and gender. Medical history, concomitant medications and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX (dose and route of administration were nor provided; lot number M018645 expiration date 31-MAY-2018). No adverse effects were reported. The administered vaccines experienced a temperature excursion of 15 degrees C for 9 hours on an unspecified date. Data logger was not involved. Previous temperature excursion was 0 degrees C for 24 hours on an unspecified date. A product quality complain was not involved. This is one of three reports from the same source. Additional information has been requested.
Sore; Swollen lymph under left arm; Back pain; Fatigue; Booster; No appetite at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 18:30 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number: 2, lot unknown reason=Misplaced/discarded, administration time: 09:45 AM, Vaccine location: Left arm.), administration date: 25Apr2021, when the patient was 51 years old, for COVID-19 immunization; Covid-19 vaccine (dose number: 1, dose lot unknown reason=Misplaced/discarded, administration time: 09:45 AM, Vaccine location: Left arm.), administration date: 04Apr2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 18:30, outcome "unknown", described as "Booster"; DECREASED APPETITE (non-serious) with onset 2021, outcome "not recovered", described as "No appetite at all"; PAIN (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "Sore"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "Swollen lymph under left arm"; BACK PAIN (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "Back pain"; FATIGUE (non-serious) with onset 23Nov2021 21:00, outcome "recovering", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of decreased appetite, pain, lymphadenopathy, back pain, fatigue.  Additional information: First week: sore. Swollen lymph under left arm. Back pain. Fatigue. Down and out. Second week: Fatigue. No appetite at all. Day 15: finally feel closer to normal, still fatigued at end of day and low appetite. Facility type vaccine was pharmacy or drug store, no other vaccine in four weeks, no other mediation in two weeks and no known allergies. Lot for third dose was unknown reason and reason was provided as misplaced/discarded.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pharmacist administered second dose of pfizer Covid-19 vaccine according to company and regulatory policies.  Patient sat at in the pharmacy waiting area for 15 minutes.  Patient reported feeling well as she left the pharmacy.  Patient returned to the pharmacy approximately 5 to 10 minutes later reporting tingling in her legs.  Pharmacist gave the patient a bottle of water and continued to monitor the patient as she sat in the pharmacy waiting area.  Patient then reported tightness in her chest.  Pharmacist called 911 emergency services, who recommended a 1 time dose of aspirin 325mg chewed.  Pharmacist sat with patient until ambulance arrived.  Patient was awake, alert and oriented as she left with the ambulance to the hospital for further evaluation.
Client verbalized feeling anxious after receiving the vaccine.  Client was evaluated by onsite Paramedics.  Client was evaluated for additional 15 mins.  Per Paramedics, client symptoms resolved and released to go home at 9:02 am.
Urticarial-like rash beginning day after shots and worse at night 3d later, no resp. difficulty. Lesions did not wax/wane. Most rash is on legs/abdomen; also on arms and torso.  2/22/07 T/C to reporter & call returned.  States patient seen x 2 since report submitted.  Yearly labs done 2/8 were WNL.  seen 2/19 & had continued rash.  Continued treatment w/Benadryl.  Seen on 2/21 for continued mild scattered rash now diagnosed as mild eczema & left occiput adenopathy.  Afebrile & developmentally on target.  No other symptoms.
Starting about 18 hours after my shot, nightly hives around my elbows, forearms, and thighs. This is the third night in a row they have occurred. When I wake up in the morning they are gone, but reappear at night.
Received Pfizer dose 2 on 29 Mar. Lot # ER8733 left arm. Did have slight localized soreness initially. But nothing too bad. Then 4 to 5 days later around 02-03 Apr he developed severe left should pain. Pain is constant and rated at # 9. Able to move arm. No hx of injury. Did have surgery on that shoulder in May 2020 but has been doing well. He went to his ortho and he did an xray which was normal. He was told that his exam was normal with good movement. Recommended continued use of his lidocaine patch. Has MRI scheduled for next week. Pt stated he knows the vaccine caused his pain and wants it reported. He had read on the internet about shoulder injury after vaccination and believes that is what he has.
Achy, nauseous, vomiting, chills, arm very sore, intestinal discomfort. Couldn't eat. Started mid afternoon, continued through the night. Very tired next day, stomach still little upset. Third day much better.
Pt developed fever within 24 hours after vaccine administrations. Temp 101 rectal at 10:00 at daycare 3/14/06. Temp 102.7 at 2:18. 1.2 ml Tylenol 3:30 temp decrease 100 rectal
pt recv vax 20SEP96 & 1wk later pt was seen by MD who dx polymyalgia rheumatica;
Patient came to pharmacy on 09/30/21 and stated that since she had her second dose of the vaccine she has been experiencing pain at the injection site that radiates up her shoulder. It is not relieved by OTC pain medications and the pain occurs at rest as well. Patient was informed that she needs to contact her doctor and if she does not have one, she needs to see a doctor to be evaluated. She was also given a pamphlet on V-SAFE.
THE MORNING AFTER VACCINATION PT STATES SHE WOKE UP WITH A HEADACHE, NAUSEA, STOMACH ACHE, AND INJECTION SITE SORENESS. STATES SYMPTOMS RESOLVED BEFORE BEDTIME THAT EVENING.
Unstable lightheaded/ severe Lightheadedness; Dizzy/ Woozy feeling; Little shortness of breath; Tingling sensation in my lip; Funny taste in my mouth; Cant drive the car; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 10Jan2022 (Lot number: FJ6369) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Autoimmune disease" (unspecified if ongoing), notes: I have an autoimmune disease. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "light headedness"; Covid-19 vaccine (Dose: 1,MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "pain"; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "light headedness", "pain". The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "Cant drive the car"; DIZZINESS (non-serious) with onset 10Jan2022, outcome "not recovered", described as "Unstable lightheaded/ severe Lightheadedness"; DIZZINESS (non-serious) with onset Jan2022, outcome "unknown", described as "Dizzy/ Woozy feeling"; DYSPNOEA (non-serious) with onset Jan2022, outcome "unknown", described as "Little shortness of breath"; PARAESTHESIA ORAL (non-serious) with onset Jan2022, outcome "unknown", described as "Tingling sensation in my lip"; DYSGEUSIA (non-serious) with onset Jan2022, outcome "unknown", described as "Funny taste in my mouth".  Additional information: The prior 2 shots patient felt some light headedness the 1st day or so, but had more pain.
administration of an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-month-old male patient who received HAV (Havrix 720) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comments: The medical assistance reported the administration of an expired dose of Havrix to a patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received expired Havrix 720, which led to expired vaccine used.
Left deltoid, red itchy, warm to touch and swollen. Distance line of where redness and edema stop. Used ice to site. Also stated had nausea/aching that lasted approx 12 hours.
had it 4 times, Had all the shots/suspected vaccination failure; had it 4 times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received all the doses of Shingles vaccine and had it fourth times. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
No adverse event; HCP pharmacy administered vaccine vial from lot number that expired on 4-Jan-23 and vaccine was given on 4-Mar-23; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP pharmacy administered vaccine vial from lot number that expired on 4-Jan-23 and vaccine was given on 4-Mar-23) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP pharmacy administered vaccine vial from lot number that expired on 4-Jan-23 and vaccine was given on 4-Mar-23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP pharmacy administered vaccine vial from lot number that expired on 4-Jan-23 and vaccine was given on 4-Mar-23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP pharmacy administered vaccine vial from lot number that expired on 4-Jan-23 and vaccine was given on 4-Mar-23).    No concomitant information was reported. No treatment information was provided.
Headache, light-headed and swollen tongue were first symptoms almost immediately (3:17pm), followed by swollen lips & itchy throat at about 15 mins after the injection (~3:30pm), watery eyes and eye pain around 20 mins (~3:35pm), itchy tongue and lip numbness around 40 mins after the injection (~3:55pm). This is when I requested a Benadryl & was directed that I had to purchase my own in order to take. One dose of Benadryl was taken at 45 mins (~4:02pm), with symptoms slowly subsiding by 30 mins (~4:30pm) after taking Benadryl. I waited an additional 10 mins as symptoms continued to subside (~4:40pm). At 2 hrs & 45 mins after injection (~6pm),I still have some slight symptoms but they appear to be under control by Benadryl.
EXACERBATION OF MULTIPLE SCLEROSIS; NAUSEA; COULD NOT SLEEP; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, alcohol consumption, multiple sclerosis, and non smoker, and other pre-existing medical conditions included the patient is on keto diet. the patients found hard to drink alcohol with the diet and works 6 days per week. The patient is treated with naltrexone for multiple sclerosis. The patient took off-label low dose of naltrexone.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 205A21A expiry: 23-JUN-2021) .5 ml, frequency 1, total, administered on 24-MAY-2021 on left arm around 11:00 am for prophylactic vaccination. Concomitant medications included ibuprofen for drug used for unknown indication.  On 24-May-2021, around 8:30 pm and before bed, he had chills and could not get warm. He also could not sleep. He drank tons of water because he heard he should drink plenty of water with vaccinations. At 1 am on 25-May-2021, he woke up to urinate because of drinking tons of water and he had the worst MS exacerbation that he has ever experienced and it was long-lasting; he had zero balance, no leg strength, vertigo, and nausea, and he missed this day of work. He took two Advil 200 mg tablets at 1 am, 1 more at 2:30 am, and 1 about one hour before providing this report (2:00 pm). His daughter checked in on him but he was okay. As of 25-May-2021, his motor function is coming back, but his stamina is bad, he has weakness when trying to get around which is accompanied with more nausea. Otherwise, the nausea and vertigo, which occur simultaneously are better, loss of leg strength is better, and the loss of stamina and weakness persist The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 25-MAY-2021, was recovering from exacerbation of multiple sclerosis and nausea and the outcome of could not sleep was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210549148-covid-19 vaccine ad26.cov2.s-Exacerbation of multiple sclerosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Thursday afternoon at 11:16 I received the Janssen vaccine and started feeling jaw pain, neck pain, chest pressure shortness of breath and extreme nausea at around 7am on Saturday.
pt recv vax & pt exp a stiff neck, a sick feeling, a fever, dark urine & light stool;
Family was told that Patient expired in his sleep during the early morning hours of 1/15. I spoke with him the evening before (on 1/14), which was a day after he had received the Covid vaccine. He was not having any symptoms of allergy or reaction then. He did say that he felt tired, but he often complained of feeling tired over time.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: at 2:09 pt complained of lightheadedness, tingling in hands, and profuse sweating, advised to raise legs and took bp1: at2:14pm was 94/62/pulse 74, bp2: 2:23pm was 100/70 pulse 80, bp3: at 3:30pm 102/69 pulse 69, pt felt better and left 2:32pm with issues resolved
significant swelling at and around the site of injection, along with significant pain shortly after time of injection.  Subsequent bruising.  Bruising continues and has been increasing to this date (4.9.21) and the bicep and shoulder have a generalized swelling.
When patient received the first HPV shot she fainted and the doctor said she was just dehydrated. Patient hasn't been the same ever since she has had both shots... the second shot was 04-22-2013. Patient ended up having allergic reactions to all foods, and environmental.
Mom states, child had a knot in injection site day after injection. Next day, rash started. Red rash around injection with warmth to skin. Not tender. Measures 15 cm by 10 cm around right thigh. Warm to touch. No blistering noted.