chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Four days after vaccine administration, Pt became unable to walk. Was evaluated by neurologist who advised pt to never again take the GARDASIL vaccine. 3/13/09 Received Neuro medical records of 9/24/08. FINAL DX:generalized weakness, fatigue, N/V s/p HPV vaccine Records reveal patient experienced weakness.  States patient developed weakness, N/V/D, fatigue, HA, abdominal pain, flushing, diaphoresis within 2 days of HPV #1.  Seen in ER & referred to Neuro.  Examination WNL & referred back to PCP.  3/16/09 Received ER medical records of 9/24/2008. FINAL DX: medication reaction; r/o GBS Records reveal patient experienced weakness, N/V/D, difficulty walking.
Received unauthorized high dose Moderna bivalent booster vaccine on 01/25/2023.  Had completed primary series with Pfizer vaccines dates 07/06/2022 and 08/01/2022
9:20A Pt came back to office c/o SOB, chest pain and lower back pain, administered O2 2Lpn, Benadryl 50mg PO EKG, P118, BP 142/90. 9:30A BP 140/90, P120. 9:40A BP 120/80, P84. 10:00A BP 124/80, P80. Dic O2. Dx: Tachypenia, tachycardia. Pt states "same reaction to ASA, Flexsit and Alleve.
Left thigh with pain/fever/redness. 5.5cm by 3.75 cm induration with erythema. within 24 hours, IM Comvax and Varicella. Follow-up 2 days later, no erythema 1 inch induration.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 26-JAN-2017 at 16:35, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457: US-009507513-1704USA000458.
adverse reaction: none; date of vaccination : 2018, 2019; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet, from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2101USA011905), refers to an approximately 69 years old female patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. She was administered unspecified flu vaccine, annually, since as long she could remember till present. On an unknown date in 2015, she received vaccination with zoster vaccine live (ZOSTAVAX).  On an unspecified date in 2018 and subsequently in 2019, the patient was vaccinated with unspecified pneumonia vaccine (manufacturer unknown) (dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis. The patient experienced inappropriate schedule of vaccine administration. The patient had none of adverse reaction or side effects experienced.  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2101USA011905:
Generalized immune response fever/soreness/muscle and body aches/increased neuropathy and neurology problems from underlying GBS. Continued 6 weeks. Had two 7 day courses of meloxicam, ending with the second round.
Started with stinging and then itching in her arm on 1/31/21. Deep red rash noted to area on this day as well, very itchy if she touches this at all. Arm was so sore after injection she could barely move her arm. She was also extremely tired for two days after getting the vaccine.
Pharmacies gives the 3rd dose to not immunocompromised people; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Pharmacies gives the 3rd dose to not immunocompromised people) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Pharmacies gives the 3rd dose to not immunocompromised people). At the time of the report, OFF LABEL USE (Pharmacies gives the 3rd dose to not immunocompromised people) had resolved.            No concomitant product information was provided. No treatment information was provided.
2nd shot of Pfizer 10/18/21, on 11/3/21 I went to the ER with blood blisters in my mouth, after bloodwork, they determined my platelets were at zero and began IVIG and steroid treatment for a brand new ITP diagnosis.
Information has been received from a pharmacist concerning a 76 year old female who on 07-AUG-2007 was vaccinated with Zostavax (Oka/Merck) (Lot #658086/0761U).  On 09-AUG-2007 the patient experienced a break out of zoster in her facial area.  The break out was on the right side of her face and mouth area.  The pharmacist administered the vaccination and the patient did go to her physician and she also saw a dentist.  As of 17-AUG-2007, the patient was recovering.  Additional information has been requested.
Information has been received from a registered nurse concerning a female who on 20-MAY-2008 was vaccinated with a 0.5 ml dose of GARDASIL vaccine (yeast) IM into the deltoid (lot number not reported). Concomitant therapy included DEPO-PROVERA. Subsequently the patient experienced pain and discomfort of the vaccinated arm. The patient was seen in the physician's office. The patient's pain and discomfort of the vaccinated arm persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2008. Information has been received from a registered nurse concerning a female who on 20-MAY-2008 was vaccinated with a 0.5 ml dose of GARDASIL IM into the deltoid (lot number not reported). Concomitant therapy included DEPO-PROVERA. Subsequently the patient experienced pain and discomfort of the vaccinated arm. The patient was seen in the physician's office. The patient's pain and discomfortof the vaccinated arm persisted. Additional information has been requested.
swelling w/some tenderness @ inj site;swelling in lt axilla, approx 20mm tender to touch;
This is a 58-year-old male with a past medical history of chronic obstructive pulmonary disease and recent CVA this past November, that presents to the emergency room by way of EMS with complaints of cough and shortness of breath.  The patient states that symptoms started yesterday.  He describes his cough as being productive.  The patient is legally blind and cannot describe to sputum.  He states that shortness of breath usually occurs with exertional activity including wall walking around.  The patient denies any chest pain, abdominal discomfort, nausea, vomiting, diarrhea or urinary symptoms such as dysuria, hematuria or increased/decreased urinary frequency.  He denies any dizziness or lightheadedness.  Again the patient is legally blind and has visual disturbance including blurry vision secondary to this.  He states that this does not feel like his normal chronic obstructive pulmonary disease exacerbation.  The patient's family has tested positive for COVID within the last 90 days, but he himself has had no known exposure as family members did self isolate during the normal quarantine time.  He is vaccinated against COVID-19.  Ultimately, the patient comes to the emergency department for evaluation and care.  Patient is a 58 year old male with a history of left sided multifocal ischemic stroke at the end of November and returned home on December 10, COPD, legally blind, congenital glaucoma, hypothyroid, hypertension, and a lung mass suspected to be cancer who presented to the ER with complaints of worsening shortness of breath and cough over the last 24 hours. He denied fever, chills, loss of taste or smell, nausea, vomiting, diarrhea, headaches, body aches, or falls. While in the ER he was put on 2 liters of oxygen and he maintained oxygen saturations in the mid 90s.  Lab work showed an elevated WBC at 18.72, elevated blood glucose at 129, and the patient tested Covid positive. His chest xray confirmed COPD, a nodular opacity near the right costophrenic angle as per previous CT, and parenchymal scarring, though no acute disease. The patient was transferred and admitted observation in hospital with COPD exacerbation, hypoxia and Covid for further monitoring and treatment. He was weaned to room air on arrival to the inpatient; the monoclonal antibody team was contacted as he is a potential candidate for therapy.   The patient received one dose of remdesivir and then qualified for monoclonal antibodies which was given on 12/30. He did not require supplemental oxygen while inpatient though he did have episodes of shortness of breath that resolved with time or inhalers. The patient states he has a nebulizer and duoneb solution at home that he normally uses 4 times per day.  He also has a walker.  He understands that he is to be following up with oncology regarding the CT results from his previous admission.  A walking oxygen saturation test was completed and he did not need supplemental oxygen. The patient is being discharged in stable condition on room air to complete a course of azithromycin and steroid taper for COPD exacerbation.    Active Issues Requiring Follow-up 12/10/21 CT that identified new lung mass
Febrile seizure (20 minutes) Temp 104 30 hours after immunization. ED visit 8/4/06, MD office visit 8/8/06, 8/9/06. Fever 8/4//06 to 8/9/06, macular rash appeared 8/8/06 until 8/11/06.
cellulitis; incorrect route of vaccine administration; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant) and intramuscular formulation administered by other route. On an unknown date, the outcome of the cellulitis was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the cellulitis to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The patient stated that she had a side effect of cellulitis. The patient did not consent to follow-up.
Within 48 hours of administration of VZV #2 (booster), pt erupted with both vesicles and hives, along with mild malaise.  Vesicles continued to erupt over next 48 hours with older lesions leaving crater.  Many lesions in scalp, axillary groin & intertrigenous areas.  Dx varicella.
About one week after my first vaccination I had raised red spots on my arm about the size of a quarter. Over the course of the week they continued to grow until the redness covered my entire upper arm. It was very swollen and warm to the touch. I had no fever but went to an urgent care. They prescribed antibiotics for me as they determined it was cellulitis and after the course of antibiotics it went away. After my second covid vaccine the next morning I woke up and had the same type of spots on my arm. My doctor prescribed the same antibiotic again but it did not work. I had to have a stronger antibiotic to take care of of the cellulitis the second time.
Headache; Will that cause your eye, your eyes could turn color, it's sort of red, it's reddish/ My eyes are all of sudden red; This is a spontaneous report from a contactable consumer (patient). An 85-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 20Feb2021 (Batch/Lot Number: EL9261) as dose 2, single (at the age of 85-years-old) for Covid-19 immunisation. Medical history included blood pressure abnormal. Concomitant medication included blood pressure pills. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration in Jan2021 (Batch/Lot Number: unknown) as dose 1, single for Covid-19 immunisation. The patient had his second shot on last Saturday (20Feb2021), and the only effect he was feeling was headache on an unspecified date, which he knew he was going to get. The patient then asked if the vaccine would cause the eye to turn color, it was sort of red, it was reddish, and asked if that would be a side effect. The patient had the first dose three weeks prior (Jan2021). Regarding the treatment in response to the event, the patient stated no, he wears glasses but (incomplete sentence). The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Area little colder like a lack of circulation; Swelling presented in the area under arm lower than the armpit area and midway between that area and right breast; Tenderness presented in the area under arm lower than the armpit area and midway between that area and right breast; Feel like nerve pain; Muscle aches; Low grade fever; Chills; Heat; Redness at the injection site; Swelling at the injection site; Tenderness at the injection site; This case was reported by a nurse via call center representative and described the occurrence of myalgia in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced localized feeling of warmth, injection site erythema, injection site swelling and injection site tenderness. On 16th October 2019, the patient experienced myalgia, fever and chills. On 18th October 2019, the patient experienced local swelling, tenderness and nerve pain. On 21st October 2019, the patient experienced coldness of skin. On an unknown date, the outcome of the myalgia, fever, chills and localized feeling of warmth were recovered/resolved and the outcome of the local swelling, tenderness, nerve pain and coldness of skin were not recovered/not resolved and the outcome of the injection site erythema, injection site swelling and injection site tenderness were unknown.   It was unknown if the reporter considered the myalgia, fever, chills, local swelling, tenderness, localized feeling of warmth, nerve pain, coldness of skin, injection site erythema, injection site swelling and injection site tenderness to be related to Shingrix.  Additional information received were as follows: The reporting nurse was the concerned patient. The patient received Shingrix on the right arm. The patient experienced redness, swelling and tenderness at the injection site. She was not sure if it presented the night of vaccination or the next morning following the vaccination.  One day after vaccination, she woke up on Wednesday morning with a low grade fever of 99.6 degree F, muscle aches and chills. The symptoms lasted through the day and night and seemed to resolve. Thursday morning and then later in the day, they presented again and resolved by Friday morning.  Three days after vaccination, on Friday morning, a new event of swelling and tenderness presented in the area under her arm lower than the armpit area and midway between that area and her right breast.  The tenderness and swelling had improved but it now felt more like nerve pain in that area and it also feels a little colder like a lack of circulation.  The patient reported the tenderness in the area turned into nerve pain after her son hugged her and squeezed that area. The reporter consented to follow up. The outcome of events reported in the Argus was not recovered while in structured field it was reported as recovering.
3NOV95 about 1 1/2hrs p/vax mom of pt called & reported some rash on the pt's behing legs;some coughing episdoe;MD's office contacted;rash/hives appeared per mom;
He got the vaccine and the first two days he had very little reaction, had a small swelling, then it went away.  Yesterday, 3/11/21 the injection site area went to itching, and then he noticed a pretty good swelling in that area, and now the swelling is fairly deep, 3/4" high and about 3" across, about as big as 1/2 the size around as a baseball and sticks up about an inch.  It's red to touch.  His son is a nurse and told him some remedies for the symptoms.   He has taken some ibuprofen for it as well, which did not do anything for the swelling.
Asthma exacerbation about 24 hours after receiving vaccine. Sore arm for over 2 weeks. Required use of extra nebulizer treatments.
Flu-like symptoms; Low grade fever; Body aches; Night sweats; Shaking involuntary; Malaise; Could not sleep well those two nights; it still hurt when she touched it; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Feb2021 (Lot Number: EL8982) at the age of 70-year-old as singe dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included levothyroxine sodium. The patient previously took the dose 1 of bnt162b2 on 14Jan2021 for COVID-19 immunization and experienced pain on her arm on 15Jan2021, rash on 15Jan2021, red spot where she had the vaccine and it was itchy on 15Jan2021, a little bit of a bump and it still hurts and when she touch it. In 2021, the patient experienced flu-like symptoms, low grade fever, body aches, night sweats, shaking involuntary, malaise, could not sleep well those two nights, it still hurt when she touched it. Therapeutic measures were taken as a result of it still hurt when she touched it. Outcome of events was unknown.
his armsand face were red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (his armsand face were red) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 101M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced ERYTHEMA (his armsand face were red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (his armsand face were red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.; 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.
Swelling left shoulder 9cm x 9 cm not warm, not red, not very tender.
Initial report received on 28 November 2012 from the Investigator participating in post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL; lot number C3746AA received on 12 October 2010, lot number C3793AA received on 10 December 2010, lot number C3800AA received on 04 February 2011 and lot number C4083AA received on 01 December 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 18 May 2012, approximately five months after the last dose. On 18 May 2012, the subject developed a cough and paroxysmal cough on 19 May 2012 without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 25 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 18 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
allergic reaction; Initial information received on 19-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced allergic reaction while receiving vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received INFLUENZA VACCINE produced by unknown manufacturer at an unknown dose (lot number, expiry date, strength, form, frequency not reported) via unknown route in unknown administration site for Flu. On an unknown date the patient developed a non-serious event "allergic reaction" (drug hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I will never get one again. I had an allergic reaction."  There were no lab data/results available.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (allergic reaction).  At time of reporting, the outcome was Unknown for the event allergic reaction.