chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 06 November 2014 from a consumer who is also the patient's parent. An infant had received via the transplacental route sometime in October 2010 an Influenza vaccine (manufacturer, lot number, mother's route and site of administration and a specific date not reported) and within 10 months after birth developed an egg allergy with symptoms of hives, swelling and vomiting. The patient also developed multiple food allergies and has asthma. The reporter stated there was no family history of food allergies or asthma. The reporter believed that her son's allergies and asthma are reactions to her having received the flu vaccine during her pregnancy. The reporter stated she later had another child, daughter, and did not have the flu vaccine during that pregnancy and her daughter has none of the allergies or asthma like her first son. The reporter declined to provide name and contact information for either her OB/GYN provider or her child's pediatrician. Outcome was unknown. Documents held by sender: none.
Covid19 breakthrough.  1st vaccine received on 12/29/2020.  76 y/o with PMHx of GERD, Prostate CA, DM, HTN, CAD s/p stents, Myasthenia gravis presents to ED with c/o Generalized weakness, body aches, fever, chills, dizziness, Loss of taste.  Pt states originally tested positive for Covid on 2/3/2022 but symptoms have progressively worsened to the point of having a difficult time caring for himself.   Pt febrile, Room air sat 94% and CXR shows mild Left sided PNA.  Pt treated with IV and po antibiotics.
On 7/21/00, the pt went to the ER with excruciating pain in the left knee. Could not walk was given crutches. The pt states (This is when I realize my pain was from Lymerix). 60 day follow up states patient has slurred speech, memory lapses, mood swings, and difficulty going up and down stairs.
20% hearing loss; Ringing in the ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (20% hearing loss) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A. and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced DEAFNESS (20% hearing loss) (seriousness criterion medically significant) and TINNITUS (Ringing in the ear). At the time of the report, DEAFNESS (20% hearing loss) and TINNITUS (Ringing in the ear) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Prednisone.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Systemic: Lymph Node Swelling-Mild, Additional Details: she felt like her one lymphnode was a bit swollen about 15 min after vaccine. Other patient came in and interrupted and she left.
When administering the vaccine, the needle was not fully screwed into the syringes (must have come loose while removing the protective sheath. As I was administering the vaccine, some of the vaccine spilled out of the needle/syringe junction, resulting in the pt getting an incomplete dose.
Blurred vision that was mild in nature (but noticeable, nonetheless). Began 15 minutes after vaccine received. Lasted 10 minutes. Resolved on its own. NOT accompanied by any other effect (i.e. nausea, vertigo, lightheadedness); This is a spontaneous report from a contactable nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL0140), via an unspecified route of administration on the right arm on 23Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) on an unspecified date and Ductal carcinoma in situ (DCIS) on the left breast in 2008. Concomitant medications included omeprazole and cetirizine (CETIRIZINE). On 23Dec2020 at 10:30, the patient had a blurred vision that was mild in nature (but noticeable, nonetheless). It began 15 minutes after vaccine received and lasted for 10 minutes. It resolved on its own and not accompanied by any other effect (i.e. nausea, vertigo, lightheadedness). No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovered on 23Dec2020 at 10:40.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sore arm, red approx 3" around site, warm to touch, slightly swollen, general malaise.
Guillian Barre reaction (difficulty walking, difficultyusing hands- small motor skills; difficulty speaking;  began on 2/7/21 and continued to worsen until hospitalization on 2/24/21 and 5 plasmapheresis treatments.   While hospitalized patient has developed double vision.
I'm currently being treated for COVID pneumonia and have been symptomatic for about 2 weeks now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 PNEUMONIA (medically significant), outcome "unknown", described as "I'm currently being treated for COVID pneumonia and have been symptomatic for about 2 weeks now".  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates the patients were vaccinated with improperly stored PROQUAD (Merck) (Lot # K018144 with expiration date 10-APR-2016, Lot # L026728 with expiration date 15-JAN-2017, dose and route not reported). Information regarding concomitant  medications was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a health professional concerning a 9 year old female pt who on 18-MAR-1996 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approximately 14-APR-2004, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that "there was no single report of adverse reaction following varicella vaccination". The reporter indicated that 49 other patients developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599,  WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, and WAES0405USA00619). No additional information is expected.
Information has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On 20-DEC-2016, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, strength, dose and frequency were not reported) intramuscularly rather than subcutaneously for prophylaxis. No adverse effects were reported by the patient. Additional information has been requested.
Redness, swelling, hot to touch, localized reaction 8 x 7 cm.
Patient went with her sister today and got a first dose Pfizer vaccine. She wasn't aware that she got the first dose of Moderna yesterday at store pharmacy.
Cardiac issues.   I have been consistently having severe palpitations. PVC's in clusters on cardiac monitors at hospital. Shortness of breath. Daily since 2 days after 2nd dose of Pfizer.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild
constant pain in the arm of the injection / pain as severe / sharp sticking pain; cannot raise her arm; at night, it wakes her up; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in March 2020 on unknown date suffered no adverse reactions).   In June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm, injected limb mobility decreased and nocturnal awakening. Shingrix was continued with no change. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased and nocturnal awakening were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased and nocturnal awakening to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with 2nd dose of Shingrix in beginning of June. After vaccination patient experienced constant pain in the arm of the injection which continues till the time of reporting. The patient described the pain as severe, calling it a sharp sticking pain.  She cannot raise her arm and at night, it waked her up should she roll over onto her arm. The patient had a virtual doctor visit due to Covid 19 and also had an x-ray which showed nothing in the bone.  The reporter consent to follow up.
Menveo given to 63 year old; Menveo, 2 doses 1 week apart; Menveo given to 63 year old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 63-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMV576A, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA576A, expiry date 31st July 2022) for prophylaxis.   On 15th December 2021, the patient received the 2nd dose of Menveo. On 9th December 2021, the patient received the 1st dose of Menveo. On 9th December 2021, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On 15th December 2021, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, extra dose administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient received 2 doses of Menveo 1 week apart at the age of 63 years old, which led to inappropriate age at vaccine administration and extra dose administered. The reporter consented to follow up.
pt recvd vax & w/in 10 dsy exhibited a poss false-pos monoucleosis test; also had a sore throat & pos strep throat test; Md office visit was require to treat strep throat;
The next day after receiving the vaccine, I felt nauseated. Then I started throwing up. I called my doctor and he prescribed me with medications for my nausea. I had pain around the site injection site as well. I was dizzy. I was also very tired, and that lasted for 4 days. I also have some autoimmune diseases that may of have caused some of my symptoms so I cant say that the vaccine exactly caused it. I also was having a harder time breathing. I was sent to a heart doctor. The doctor said that my heart was fine, but I have high blood pressure. I am recovered from the nauseas, but I'm still having issues with breathing.
Focal seizures X 2 approximately 12 hours after DTaP each lasting only a few seconds.  No previous history.  No family history.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low -28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling and redness at injection site size of golf ball. Took Tylenol and used ice 1x onset 1 day after injection.
The reporter for this case is the same as case number: 2012-03809 and 2012-03811. Initial report was received on 10 April 2012 from a health care professional, at which time this case was assessed as non-serious listed. Based upon follow-up information received on 25 May 2012 from a health care professional, it was determined that this case now meets seriousness criteria (OTHER - MEDICALLY SIGNIFICANT) and this case has been upgraded from non-serious to serious. This narrative included information reported on both dates. A 46-year-old female patient had received a dose one intramuscular injection in the left deltoid of ADACEL, lot number C4051AA, on 05 April 2012. The patient presented to the emergency room (ER) on 08 April 2012 and was experiencing redness, warmth and swelling at the injection site. The diagnosis was cellulitis. The patient was treated with KEFLEX 500 mg four times a day for 10 days starting on 08 April 2012 and ending on 18 April 2012 and SEPTRA 800/160mg two tablets by mouth two times daily for 10 days beginning on 08 April 2012 and ending of 18 April 2012. The patient was seen again at a physician's office on 10 April 2012 with the diagnosis continued cellulitis and treated with clindamycin 150mg 2 capsules by mouth 3 times daily for 10 days beginning on 10 April 2012 and ending on 20 April 2012. Concomitant medications included simvastatin, metoprolol and chlothalidone. The patient's past medical history was reported as hypertension, hyperlipidemia and allergy to penicillin. Illness at time of vaccination and other vaccinations within four weeks prior to vaccination date were reported as none. The patient's outcome was not recovered. Documents held by sender: None.
Back spasm found Blood Clots in lungs sudden on set 10 days after 2nd dose.
Weak and tight muscles in the legs, arms and butt area.  Have received both COVID19 vaccine shots, but not sure if these shots are the cause of these symptoms.  Doctor  advised that I report this to you, but is also restricting some of my other medications to rule out the medications causing my problems.
got really sick; thinks she might have had the flu as well.; she did not take her second dose; She threw up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick), INFLUENZA (thinks she might have had the flu as well), VOMITING (She threw up) and PRODUCT DOSE OMISSION ISSUE (she did not take her second dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PIROXICAM (PAXIL [PIROXICAM]), BUPROPION, GABAPENTIN, OXYBUTYNIN, BACLOFEN, TIZANIDINE and MIDODRINE for an unknown indication.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick), INFLUENZA (thinks she might have had the flu as well), VOMITING (She threw up) and PRODUCT DOSE OMISSION ISSUE (she did not take her second dose). At the time of the report, ILLNESS (got really sick) and INFLUENZA (thinks she might have had the flu as well) outcome was unknown and VOMITING (She threw up) and PRODUCT DOSE OMISSION ISSUE (she did not take her second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient got her first dose 3 or 4 months ago from the reporting date. No treatment information was provided. The patient weight provided as 111 without units.
Flulaval makes kids sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in an unspecified number of patients who received Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. 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: 18-SEP-2022 Reporter's comment: The reporter stated that the FluLaval Quadrivalent shots made kids sick. The reporter stated that GlaxoSmithKline need not to sold that product because it made kids sick. No additional details were provided. Additional Supportive Information: This case had been linked with case US2022134414, reported by the same reporter.; Sender's Comments:  US-GSK-US2022134414:Same reporter.
ITP  (PLT was 8,000 only in early morning of May 19, after treatment raised Up to normal,  then dropped monthly, present is about 40,000 only Current Doctor is M.D.   shingles appeared on May 22, recovered after about 50 days.
Mother called Health Dept @ 3:45pm reporting that child's lips were turning blue and swelling, she also reported child to E.R. because they were still in car in route near hospital. Child was seen in E.R. @ approx 3:50pm. He was given Benadryl and released home. At 4:30pm father reported child up and playing as normal. 7/17/09
chills; swollen arm; feeling cold day and night; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8727), dose 1 via an unspecified route of administration, administered in left arm on 20mar2021 at 16:26 as single dose for COVID-19 immunisation. The patient did not had medical history. The patient's concomitant medications were not reported. The patient did not receive any vaccines within 4 weeks prior to COVID-19 vaccine. The patient did not receive any additional vaccines on same date of the Pfizer suspect. On 20Mar2021, the patient had a swollen arm. She knew this was normal. She had no rash, but the swelling lasted quite a few days. That evening, she had night chills. She was feeling cold day and night. No matter how much or what she was wearing she was constantly cold. Eventually her arm swelling went down after 5 days. She iced, massaged and used the arm as advised, but it was the chills that were unbelievable. Therapeutic measures were taken as a result of swollen arm. On 26Mar2021, the outcome of the event swollen arm was recovered and on 09Apr2021, the rest of the events recovered.  No follow-up attempts are needed. No further information is expected.
His arm was sore; Nausea; Headache; Fatigue; This is different feeling than what he normally feels; This is a spontaneous report from a contactable consumer (patient's wife). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264, Expiration Date: 31May2021) via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. Medical history included diabetes mellitus. On 04Feb2021 the patient experienced his arm was sore, nausea, headache, fatigue. On an unspecified date Feb 2021, the patient experienced this is different feeling than what he normally feels. The reporter stated, Yes, he takes a lot, I would rather not because its lot he is diabetic and he takes blood thinner and statin and its very long list, but these are different so those, the reason I called because this is different feeling than what he normally feels when he gets ups in the morning, and that's why I thought maybe it because of Covid. The patient underwent lab tests and procedures which included glycosylated hemoglobin, diabetes, I do I have to look up the result and the date, the date was 30Jan and it was blood draw for his A1C. The outcome of event different feeling than what he normally feels was unknown and other outcome of the events was not recovered.
Extreme arm soreness which is getting progressively worse; making it difficult to lift or move the arm entirely; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 29Jan2021 10:30 (at the age of 26-years-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. It was unknown if patient had any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included gabapentin (MANUFACTUTERE UNKNOWN), fish oil (MANUFACTUTERE UNKNOWN), ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 13:00, the patient experienced extreme arm soreness which is getting progressively worse and making it difficult to lift or move the arm entirely. Seriousness criteria was considered as non-serious. The patient did not receive any treatment for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.