chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 15 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported.  On 23-NOV-2016, the patient was vaccinated with a dose of improperly stored MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168:Original Case : 1701USA004150; US-009507513-1701USA007912:Original Case : 1701USA007906; US-009507513-1701USA007881:Original Case : 1701USA007910; US-009507513-1701USA007913:Original Case : 1701USA007910; US-009507513-1701USA007882:Original Case : 1701USA007910; US-009507513-1701USA004150:Original Case : 1701USA007916; US-009507513-1701USA007958:Original Case : 1701USA007916; US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX 0.65mL (strength and route of administration were not reported). It was reported that on an unknown date the pharmacist did not get the full 0.65ml when reconstituting ZOSTAVAX. He got approximately 0.5mL. Pharmacist stated he was withdrawing all the contents from one sterile water diluent into the syringe for reconstitution, but it came up short. So pharmacist then opens another sterile water diluent and uses more sterile water to equal the 0.65 ml. Additional information has been requested.
1/10/22 Patient here for a barky cough and congestion for about 1 week. She states that she has a history of having pneumonia in the past and bronchitis. Denies any fevers. She does have a strong cough, she does have some mild shortness of breath at that time. Patient states her mother is also sick at home. Patient is vaccinated. No known exposure she is aware of. She has taken no medication for symptoms. 1/17/22- ED visit- 52 yr/o female who presents with worsening cough, wheezing, difficulty breathing, pleuritic right upper back pain. She was diagnosed with COVID-19 approximately a week ago and has been sick for about 10 days.  1/17/22  ED visit: She states she is feeling worse over the past few days. She was prescribed an inhaler, steroids, and benzonatate prior to arrival without improvement. No anterior chest pain. REVIEW OF SYSTEMS: As per HPI, otherwise no vomiting or diarrhea, rash, swollen glands, numbness tingling weakness. All other systems negative.
MADE ME FEEL BAD OVERNIGHT; SWEATS; CHILLS; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) 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 made me feel bad overnight, sweats, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the made me feel bad overnight, sweats and chills was not reported. This report was non-serious. This case, involving the same patient is linked to 20211232327.
Patient developed sternal rash that rapidly extended to itching then itchy throat.MD called to  assess and at that time rash extended to both arms. MD decided to transport to ED for evaluation
she is shaking so bad; Was very hard to get up and shower today; shivering,chills; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (she is shaking so bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Was very hard to get up and shower today), CHILLS (shivering,chills), HEADACHE (headache) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced TREMOR (she is shaking so bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Was very hard to get up and shower today), CHILLS (shivering,chills), HEADACHE (headache) and PYREXIA (fever). The patient was treated with IBUPROFEN on 01-Feb-2021 for Prophylaxis NOS, at a dose of UNK dosage form. At the time of the report, TREMOR (she is shaking so bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Was very hard to get up and shower today), CHILLS (shivering,chills), HEADACHE (headache) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Blood pressure measurement: 102/63 (Inconclusive) 102/63. On 02-Feb-2021, Body temperature: 100.5 (High) 100.5. On an unknown date, Blood pressure measurement: 130/80 (normal) normal blood pressure.         Concomitant was not reported.
I started feeling depressed and anxious after my vaccination; it lasted a little over a week and I started getting frantic. I contacted my doctor and went in for an appointment. We assumed it was my general prescription so we changed my prescription Paxil to a different brand. However, after receiving my Moderna booster shot on 11/11/2021, I began having the same depression and anxiety effects again and we learned it wasn't my medication causing my mental woes, it was the vaccine. No changes were made to my prescription other than to see if it'll settle on its own, and eventually it did after a week.
patient reports Vomitting and Shortness of Breath 2 hours after recieving the vaccine . patient was advised to go to the ER for examination. ER report states patient was seen for chest pain but nothing about the vommiting
Right arm soreness (to touch as well as to use my arm)  Almost immediately Difficulty raising my eyes to read something above my head (11:30PM 03/08/2021) 7:30 AM 03/09/2021 (I woke up with the following): Fever 101°F Chills (stopped sometime after 3:00 PM 03/09/2021) Weakness of limbs Muscle and bone aches and pains (for the next 20 hours) Felt like I had been hit in my chest and abdomen by a truck SEVERE headaches (on top of my normal persistent headaches NDPH) Abdominal cramps (grew severe 10:00 PM and that lasted about 2 hours)  I stayed in bed all day, tried to drink plenty of fluids, slept off and on.  I took Acetaminophen every 8 hours through to 8:00 AM March 10.  I was too weak to prepare meals and I live alone so I ate only 8 or 10 cookies throughout the day as they were easy to grab and get back to bed.  Had moderate sweating episodes throughout the day and through the night of March 9/10.    Still felt sore when I woke up at 8:00 AM on March 10, 2021.  Took about 2 hours for me to get myself comfortable being upright and able to dress and move about.  Waited for Acetaminophen to work.
24 hours after vaccination began to notice swelling, induration, increased temp. in right upper arm, turned red and purple. Swelling extended to right elbow and right axilla. Painful to the touch. Total increase in girth of arm measured at mid-biceps was +5cm. This lasted until approx. 48 hours after vaccine was given. We went to a clinic where he was examined and given an RX for Triamcinalone ointment and Keflex tid x 7days. Advised to keep him out of the sun and apply cold compress.
2nd dose ofo Recombivax HB given 7MAY92 & on 8MAY92 awakened w/h/a & loss of appetite or 9MAY92 vertigo & dec appetite;
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (Strength, dose, frequency, route, anatomical location and expiration date were not reported) of lot # M042496, for prophylaxis. Concomitant therapies included sterile diluent. The nurse confirmed that the sterile diluent used to reconstitute the VARIVAX was properly stored. No adverse effect reported. The vaccines were exposed to multiple defrost cycles with respect to temperature for an unknown timeframe. There was no temperature excursion. There was no digital data logger involved. There was no product quality complaint involved.; Sender's Comments:  US-009507513-1708USA008906: US-009507513-1708USA008368: US-009507513-1708USA008907: US-009507513-1708USA008904:
I started having abdominal pressure/pain and the urgency to pee and urinating more often than usual. Vaginal burning as well. My right foot started aching. Urinary test strip at home tested positive. I then went to ER and it came back negative.
mom presented to clinic w/3rd dose of vax; devel abscess @ the site of inject;
Patient began having swelling of left arm & underarm on Monday AM. She also has a rash on her arm (warm to the touch). Patient has also had a headache since Monday AM (9-20-10).
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 18-year-old male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site pain, injection site warmth and injection site redness. On an unknown date, the outcome of the injection site pain, injection site warmth ad injection site redness were recovered/resolved. The reporter considered the injection site pain, injection site warmth and injection site redness to be related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The field representative reported that the doctor's patient experienced injection site arm soreness, redness and warmth lasting for 24 to 48 hours after 1st vaccination of BEXSERO. The vaccination date was reported as May 2016, but it was not clear if it belong to 1st or 2nd dose of vaccine. For tolerance to 2nd dose, refer case US2016GSK159486.
10/4/02 dT was ordered-0.5ml drawn up and given transdem to L forearm (was given on error had thought of Tb skin test). Left forearm erythema?, induration, swelling reported by pt 3 d. later relieved with "raking" induration ~ 1cm on 11/8/02 when seen pt was offered to f/u for problems at time of vaccine but chose not to. Old 11/8/02 to use warm moist heat and massage Ok if chooses to help with lymph drainage.
11/3/08--fever 101.5 degrees, chills, edema and erythema and pain to left arm.  suymptoms continued to 11/5/08.  Patient seem by PMD.  Treated with Rocephin 1 gram and Lortab for pain.  11/10/08--selling in the arm is resolved, she is afebrile.  Slight soreness in arm.  She is currently on Augmentin 500 mg po and pain tabs.
Limp with decreased responsiveness for 20-30 seconds about 2-3 hours after DTaP was administered.  Pt recovered completely within minutes, no treatment.
had high temp 100.4, mostly 102.8, 103.4 for 6 consecutive days
Pt received varicella vaccine SQ in Rt arm (back) 5-7-14 #1. 5-9-14 pt came to clinic due to a red raised 1.5 x 1.5 inch circle. Warm to touch. Patient says not as bad as earlier this AM. FNP-BC checked site and recomm. cool compresses. Inst. if site worsens to go to ED this weekend. Patient agreed.
22FEB95 mom reports welts @ inj site-no fever present & as evening progresses welts devel on rt arm; 23FEB95 welts all over body-very itchy, no dyspnea; pt dosed w/DPH; hives resolved;
SICK; STILL HAS A KNOT; WARM TO TOUCH; This spontaneous report received from a consumer on 25-JUN-2021 and concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was reported and has been requested. Concomitant medications included tofacitinib citrate for drug used for unknown indication. On an unspecified date, the subject experienced sick, still has a knot, and warm to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick, still has a knot and warm to touch was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: PATIENT REPORTS ITCHY RASH THAT IS WARM TO TOUCH; SAYS TEMPERATURE INCREASED 1 DEGREE
Aggressive take with surrounding erythema approx 10 cm. Dozen + papules/pustules to chest/neck.  Fever to 103.1. Myalgias.
severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (severe headache). At the time of the report, HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No.  Information on the Lot/Batch number has been requested.
pt recv vax 16DEC98 & that evening had a localized reaction of pain, redness, swelling, also abd distress nausea & diarrhea;
No additional AEs; Caller reported VARIVAX was administered after temperature excursion.; This spontaneous report was received from a physician via office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 25-JUL-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5ml subcutaneously, lot # U026207, expiration date 24-AUG-2023, for prophylaxis. The vaccine had been improperly stored in the temperature of 41.5 Fahrenheit degrees (F) for 2 hours and 45 minutes with no previous temperature excursion. It was unknown if digital data logger was involved. No adverse events were reported.
Started with very bad cramps which lead to diarrhea, that lasted about 1 hour. Then my SI joint started hurting so bad I couldn't stand it and went to ER. They gave me a shot of Torridol and a prescription for Naproxen. I was also nauseous, lethargic, chills, ringing in my ears, headache . I believe my SI joint started hurting due to having arthritis in the joint. The Naproxen escalated all the above. My arm also very sore, but that I could deal with.  Feeling a bet better by 12/28/2020. Going to try and get into doctors on 12/.
Redness and irritation near injection site on left thigh. Vaccines given on left thigh were DTaP -IPV and Var. on 1/11/16 at 4:43.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. The patient was vaccinated with GARDASIL (unknown strength and lot #) intramuscular in 2008 and later on 03-NOV-2014 and 06-AUG-2015 (Inappropriate schedule of drug administration). Concomitant medications were not reported. There were no known adverse effects. There was no product quality complaint involved. Additional information has been requested.
pt recv varivax 1/26/96 & in 4/98 pt devel varicella, approx 50 chickenpox w/low grade temp & cold sx.
Within 5 minutes after receiving vaccine chest started to feel warm. As time went on I started to wheeze and cough. 4 hours later I felt extreme pressure on chest and shortness of breath. My doctor called in prescription of prednisone and after taking the prednisone I was able to take a full breath again.  I stayed on prednisone for two days and wheezing and cough went away fully after two days on prednisone.
Fever on 8.10.07 x 1 day Vomited x 1 8.17.07 Rash started on 8.12.07
Fever; Blisters; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced fever and blister. On an unknown date, the outcome of the fever and blister were unknown.   It was unknown if the reporter considered the fever and blister to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine and developed a fever and blister. The reporter was unable to provide any additional details. This case linked with US2019160421, reported by same reporter.
Begin with abdominal pain on December 30 when she woke up, continued with nausea, then headaches, loss of appetite and by Sunday  January  3, 2021 swollen lymph node in left arm pit.  Was seen on January 4, 2021, told to call or return if it gets worse.  As of today she still has a swollen lymph node and swelling and redness around her injection site.
Left arm numbness followed by entire left sided hemiparesis and numbness/tingling. CVA confirmed via MRI showing multifocal acute ischemic infarct in the right frontal and parietal lobes. Cryptogenic Stroke diagnosed after PFO grade 5 discovered but cause of clots unknown with no cardiac abnormalities or family history.
Mom called our office on 5-21-09 to report that child received typhoid vaccine at health department 1-2 minutes after vaccine given child fainted. Became "stiff as a board" and  "arms and legs began shaking, revived fairly quickly but was out of it for 1 hour after." Mom attempted to get lot # from health dept. but was unsuccessful also unable to get information from health department it was reported, stated it was an unreportable offense.
Redness, swelling and warmth at site (L). Site 6 1/2" x 51/2" leg circumference 14" (R) L circum, 12 1/2". Treatment-BACTRIM.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication taken in 2 weeks. Patient received paxlovid treatment start date: 02Oct2022 and stop date: 06Oct2022 for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse effect; patient received an expired dose of PROQUAD; This spontaneous report was received from a medical assistant refers to a patient of unknown demographics. Patient's pertinent medical history, concurrent conditions and drug allergies or reactions and concomitant medication were not reported. On 25-APR-2019 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dosage schedule not reported, lot # N029156, route: subcutaneous, expiry date: 16-APR-2019) for prophylaxis. On 25-APR-2019, the patient received an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (expired product administered). No adverse event was reported.