chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient reported "significant" pain, swelling, redness, and itching around the injection site.; The patient reported "significant" pain, swelling, redness, and itching around the injection site.; The patient reported "significant" pain, swelling, redness, and itching around the injection site.; The patient reported "significant" pain, swelling, redness, and itching around the injection site.; This spontaneous report was received from a pharmacist and refers to a 75-year-old male patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 29-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml injection (lot#, expiration date, route and site of administration were not provided) for prophylaxis.  On 30-JUL-2020 (reported as "the next day"), he experienced "significant" pain, swelling, redness, and itching around the injection site. He reported the swelling was significant enough that it could be seen. The outcome of the aforementioned events was unknown.  The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; 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 suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2008USA001082: US-009507513-2008USA001325:
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar events for two patients. This is 2nd of two reports. An 8-decade-old (seventies) female patient started to receive PREVNAR 13 (lot number and expiration date not provided), via an unspecified route of administration from an unspecified date a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe rash and irritation at injection site. Outcome of the events were unknown. Information on batch number has been requested. Sender's Comments: Linked Report(s): PFIZER INC-2018223185 Same reporter/product/event, different patient.
Per pt two months after the first pfizer vaccine he started to develop tingling in the arm. It would come and go throughout the year. Sometimes it would feel like the arm has fallen asleep and he feels pins and needles. Also, he has trouble raising his arm above his shoulder. Per pt he wants to wait another month or two to see if it will get better and he will reach out to his pcp
The patient received the first dosage of the Moderna CoVid 19 vaccine today. The patient was informed that this will typically cause a sore arm and may cause symptoms of a upper respiratory type with some headache or achiness or even very minimal fever for the next 24 hours or so. Instructions were given to call me if symptoms become severe. Other instructions included taking Tylenol 325 mg 1 tablet 3 times per day as needed for aches and pains. It was reiterated that it is important to be sure to come back for the second dosage in 4 weeks and to continue to practice social distancing and wearing a mask and washing your hands frequently. Special mention was made to help the patient understand that maximal immunity to CoVid 19 infection does not occur until 2 weeks after the second dosage. Vaccine was administered in the deltoid of the left upper arm without incident. Waiting 30 minutes after the injection for evaluation and side effects was unremarkable except for the fact that the patient states that she had some slight blurriness in the left eye about 10-15 minutes after her injection but it went away after 1 or 2 minutes. She had no side effects from the injection at the time of her leaving.
Symptom onset 12/12/22. Treatment includes Paxlovid, admission, and assessment.
1MAR94 devel fever; 2MAR94 t103.7 MD notified no other unusual-s/s tired appetite okay; 2MAR94 t104.5 R unusual cry (not high pitched);
Temperature excursion. Doses of improperly stored VARIVAX were administered to patients; No additional adverse events were reported; This spontaneous report was received from other non HCP reporter referring to a patient of unknown age, race and gender.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot #W039294, expiration date: 11-DEC-2024, administered as prophylaxis (dose, vaccination scheme frequency, route and anatomical site of administration were not provided), which had a temperature excursion by being improperly stored (Product storage error ) (temperature was 17.4 F in a time frame of 2 hours 0 minutes and 0 seconds). No previous temperature excursion and additional side effects were reported.
Information has been received from a Healthcare Worker concerning a 44 year old female patient with diabetes, hypothyroidism, hypertension, mitral regurgitation, asthma, chronic renal failure, migraine, high cholesterol, depression and a possible allergy to latex and a history of a drug reaction with ULTRAM and codeine, who on 18-MAR-2004 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 and on 20-JAN-2010 was vaccinated with the second dose of PNEUMOVAX 23 (lot number 665270/1398Y). Concomitant therapy included insulin, LIPITOR, aspirin, NOVOLIN, NORVASC, PLAVIX, SYNTHROID, PERCOCET, ZYRTEC, FLOVENT and albuterol. The patient developed a large red area "this size of an orange" and soreness at the injection site in the right arm, after the second dose of PNEUMOVAX 23. There were no problems after the first dose.  No treatment was recommended. At the time of the report the patient had not recovered. The patient sought medical attention (office visit). No laboratory diagnostics studies were performed. Follow up information has been received from the physician concerning the patient who after received the second dose of PNEUMOVAX 23 (lot number 665270/1398Y) in the right deltoid on 20-JAN-2010, her arm swelled (the whole arm) with in hours of injection. On an unspecified date the patient recovered from the arm swell. The physician disregarded the bottle. This is one of two reports received form the same source. Additional information is not expected.
VARIVAX Temperature Excursion. Improperly stored VARIVAX was administered; Pharmacist confirms no symptomatic events or side effects reported. No additional AE/No PQC. / No adverse event known; This spontaneous report was received from a pharmacist concerning a 27-year-old female.  The patient's concurrent conditions and concomitant therapies were not reported. Pre-existing physician-diagnosed allergies, birth defects or medical conditions were none known. Historical vaccines administered on 02-JUN-2023 included Measles, Mumps, and Rubella Virus Vaccine, Live (MMR), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), and hepatitis b vaccine rhbsag (yeast) (HEPLISAV B).  On 26-JUN-2023, the patient received the second dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) with lot #W012165 and expiration date on 12-APR-2024, administered subcutaneously (SC) in the right arm for prophylaxis. The vaccine was administered by the healthcare professional at a pharmacy, and it was purchased with private funds. It was unknown if there was illness at the time of vaccination.  On unspecified dates, three separate temperature excursions occurred: one up to 12.092 degrees Fahrenheit (F) for 6 hours and 15 minutes, the second up to 13.6 F for 2 hours and 30 minutes, and the third up to 12.1 F for 1 hour, 45 minutes and 5 seconds. The temperature excursions occurred as a result of a reading from a Digital Data logger.    No adverse events were known.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA011965: US-009507513-2307USA011964: US-009507513-2307USA011966:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 24-SEP-2014, the patient was vaccinated with ROTATEQ vial lot # J001254, expiry date: 19-SEP-2014 oral. Concomitant medication was not reported. The reporting nurse stated that an expired dose of ROTATEQ was administered to the patient. No adverse effects reported. Additional information has been requested.
6/15/2021 17 y/o with past medical history of cardiac murmur who presents with itching, redness and hives to the left arm post vaccination. Patient states that this is the second dose in the two-dose series. Patient denies previous reaction to first vaccination. Patient states that vaccination was placed to the left arm. Patient denies sore throat, difficulty swallowing, difficulty breathing or chest pain. NP and Paramedics at patient side. Patient left posterior upper arm above the elbow with macular blanching erythema present and three dime sized hive-like rash present, patient with some itching. Patient given 25 mg Benadryl PO x1 and a bottle of water provided. Patient vitals with elevated BP noted (159/81). All other vitals obtained and within normal limits (134-148/72-87 BP, 100% RA, 68-73 HR). Patient observed for 40 minutes with resolution of symptoms. Macular erythema and itch resolved. Mother and patient aware of worsening and concerning symptoms that may present as time passes and advised Benadryl PRN. Patient and mother verbalized understanding and patient discharged in stable condition.
Pt called call center on 4/23/21.  Pt c/o fever 37.5C two days ago, also feeling tired, runny nose and slight exhausted, stated possible d/t s/e from ist dose covid vacine Pfizer he got on 04/18/2021. Fever resolved two days ago after he took OTC naproxen but still feeling tired. Pt stated he is feeling better today than before only concern for tiredness. Denies any emergency sx. Speech clear. This writer recommended pt to monitor his sx, drink enough fluids, have proper rest and food, other pt education also given, pt assure understanding of given instructions. Notified pt to call ED/go to ED if any emergency sx arises. Pt stated he will also consult with his PCP for his sx.
Muscle pain and ache; Fever; Bad chills; Injection site pain; Fatigue all throughout that led her to sleep a lot; Fatigue all throughout that led her to sleep a lot; Pain all over her body and ribcage; Pain all over her body and ribcage; Headache including the muscles on it (the one that connects to the bone).; This is a spontaneous report received from a non-contactable consumer (Patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 19Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. On an unspecified date in Aug2021, the patient experienced muscle pain and ache, fever, bad chills, injection site pain, fatigue all throughout that led her to sleep a lot, pain all over her body and ribcage, pain all over her body and ribcage and headache including the muscles on it. Patient got both doses of the COMIRNATY vaccine and had her 2nd dose 19Aug2021 (Thursday). Post vaccination up until today (5 days to date), she reported experiencing muscle pain and ache. Patient had alongside muscle ache, she also experienced fever and bad chills, injection site pain, fatigue all throughout that led her to sleep a lot, pain all over her body and ribcage, headache including the muscles on it (the one that connects to the bone). She generally reported being down all weekend that led her not to be able to come to work. Additionally, she reported she called urgent care to check if someone has reported to come in with the same AEs that she had. She was also concerned that AEs were because the dose she got was contaminated. The outcome of event was unknown   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 23-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U010395 had been verified to be a valid number; expiration date 01-APR-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144:
Her 15 year old son experienced a really bad headache and soreness in his arm; Her 15 year old son experienced a really bad headache and soreness in his arm; This is a spontaneous report from a contactable consumer (patient mother). A 15-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ENO179, Expiration Date: Unknown), via an unspecified route of administration, administered in Arm Left on 07Jun2021 (Monday) (at the age of 15-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Jun2021 (on Tuesday), patient experianced a really bad headache and soreness in his left arm and that lasted a short period. Reporter stated her son didn't really have a problem and fine already. Patient received Advil on 08Jun2021 for arm was sore. Reporter inquired the chances of the same side effects with the second Pfizer Covid 19 Vaccine. The outcome of events was recovered on Jun2021.  Additional information has been requested.
Covid test/ Result: positive for Covid; Covid test/ Result: positive for Covid; 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 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Guillain Barre syndrome" (unspecified if ongoing); "Myasthenia gravis" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing); "over weight" (unspecified if ongoing); "Covid", start date: Mar2020 (unspecified if ongoing), notes: first symptoms of Covid Mar2020. having a Myasthenia flare up and also getting Guillain-Barre symptoms with it. Concomitant medication(s) included: METHYLPREDNISOLONE taken for guillain-barre syndrome, myasthenia gravis.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 09Dec2022, outcome "unknown", COVID-19 (medically significant) with onset 09Dec2022, outcome "unknown" and all described as "Covid test/ Result: positive for Covid". The patient underwent the following laboratory tests and procedures: Full blood count: (unspecified date) good, notes: everything was good; Flu test: (09Dec2022) Positive, notes: positive for Flu B; Unit: Not Provided; Metabolic function test: (unspecified date) good, notes: everything was good; SARS-CoV-2 test: (09Dec2022) Positive, notes: Result: positive for Covid; Unit: Not Provided.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/6/2022 UPPER GI HEMORRHAGE  ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 12/17/2022 UPPER GI HEMORRHAGE  ACUTE DVT, UNSPECIFIED VEIN 12/14/2022 UPPER GI HEMORRHAGE HYPOTENSION 11/30/2022 UPPER GI HEMORRHAGE  ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/6/2022 MELENA  ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 12/17/2022 MELENA  ACUTE DVT, UNSPECIFIED VEIN 12/14/2022 MELENA  HYPOTENSION 11/30/2022 MELENA  ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/6/2022 CKD STAGE 3A (GFR 45-59)  ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 12/17/2022 CKD STAGE 3A (GFR 45-59)  ACUTE DVT, UNSPECIFIED VEIN 12/14/2022 CKD STAGE 3A (GFR 45-59)  HYPOTENSION 11/30/2022 CKD STAGE 3A (GFR 45-59)  ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 12/6/2022 ADENOCARCINOMA, RIGHT LUNG UPPER LOBE  ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 12/17/2022 ADENOCARCINOMA, RIGHT LUNG UPPER LOBE  ACUTE DVT, UNSPECIFIED VEIN 12/14/2022 ADENOCARCINOMA, RIGHT LUNG UPPER LOBE  HYPOTENSION 11/30/2022 ADENOCARCINOMA, RIGHT LUNG UPPER LOBE
This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a adult patient who received SHINGRIX for prophylaxis. On 30th May 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, 17 days after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The health care professional reported that the patient experienced large itchy rash after 2.5 weeks. The rash had lasted 2 weeks and continues to spread and which was worsening. The rash was located on his arms and left back area. The patient wanted to remain anonymous and had not followed up with his family doctor at this time. As per case description the latency was reported 2 nad half weeks but as per event onset date (18th June 2018), the latency was 19 days. Clarification has been raised.
8 consecutive months of normal bp readings prior to vaccination. after vaccination 2 consecutive months of high bp resulting in daily medication to control bp
Started w/ chills, fever (104.2 F), generalized body aches,  headache,  extreme fatigue, weakness , fainting. All symptoms subsided after 3 days.
The pt experienced a chronically sore arm, pain in the left eye, pain in the left knee, pain in teeth on left side. The pt had a root canal, physical therapy, eye drops and a bunch of tests.
Fever 100.8 dg F, aching joints, swelling at injection site (right arm, dorsal), pox right arm ventral.
pt appeared real apprehensive p/gave inj; c/o numbness in arm, sat down for 5 mins then stood up & said everything was blurry & hit the floor; 911 called & elevated feet; BP 106/64, P106; EMT advised to rest-color returned & felt better;
Warm, red, puffy rash, about 3 inch diameter.  Reported as itchy as well. no systemic effects.
Information has been received from a physician concerning an adult female patient for GARDASIL, a Pregnancy Registry product. It was reported that the patient, on an unknown dates, received the first and the second dose of GARDASIL (dose and lot # not reported). It was reported that the patient was pregnant (dates of last menstrual period and estimated date of delivery unknown) and the physician was asking if the third dose of GARDASIL could be given in pregnancy. The patient will turn 26 before the pregnancy is completed. Additional information has been requested.
Graves disease; This is a literature report. The full publication has been requested.   A 30-year-old male 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 immunization. The following information was reported: BASEDOW'S DISEASE (medically significant), 28 days after the suspect product(s) administration, outcome "recovered", described as "Graves disease". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: 15 IU/ml; Blood thyroid stimulating hormone: Less than 0.005, notes: Low; normalized, notes: after 6 weeks; Thyroid function test: Low TSH (Less than 0.005 uIU/mL), elevated T3, notes: (161 pmol/L) and FT4 (22.9 pmol/L); Thyroid stimulating immunoglobulin: 0.95 IU/l; Thyroxine: 22.9 pmol/L, notes: elevated; normalized, notes: after 6 weeks; Tri-iodothyronine: 161 pmol/L, notes: Elevated; Weight: Loss. Therapeutic measures were taken as a result of basedow's disease. The patient was treated with Methimazole and atenolol.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Basedow's disease" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
After vaccine - Extreme POTS symptoms and Vitamin D level dropped - on 50,000 IU Vitamin D/week ever since vaccine; was taking 2,000 IU/day prior to testing; recently put on Metoprolol due to ongoing orthostatic tachycardia.  Symptoms since April include extreme weakness, fatigue, orthostatic tachycardia up to 140s/150s when standing, unable to stand for extended periods of time, some days unable to stand for more than thirty seconds, slow healing bruises, etc.
PT. BECAME COVID POSITIVE 14 DAYS POST 2ND PFIXER VACCINE. EE TESTED (+) ON 5/3/21