chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-JAN-2016, the patient was vaccinated with a dose of improperly stored of unspecified HPV vaccine (unknown if it was GARDASIL or GARDASIL 9) "SDV; 10 pack" and lot number K010215 with expiration date of 05-MAY-2017 (dose, route of administration and anatomical location were unknown), which was stored at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 72 hours. The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
I received a flu vaccination in my left shoulder and it caused severe aching and throbbing pain throughout my entire arm that lasted for over 3 weeks.
Information has been received from a pharmacist concerning a female in her "early 20s" who on an unspecified date was vaccinated with third dose of GARDASIL (dose, route and lot number not reported). The pharmacist reported that after vaccination, the patient's eyes started to flutter and the patient passed out for four to five minutes. The pharmacist called the emergency medical services, but before they came, the patient had recovered consciousness. The patient was taken to a minor emergency clinic to get checked out. The pharmacist later that same day called to check on the patient and was fine. The patient received the first and second doses of GARDASIL and was fine. The patient recovered from the events on the same day she received the third dose (unspecified date). Additional information has been requested.
Hospitalization for Sepsis due to pneumonia/COVID-19 on dates 1/24/2023- 2/1/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Hallucination; Feeling sick; High blood pressure; Oxygen was low; Covid-19; Fever; A spontaneous report  was received from a consumer regarding a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced malaise, having fever, high blood pressure, abnormal, hallucination, oxygen being low/ oxygen saturation decreased, and COVID-19.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 05 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On an unspecified date after the mRNA-1273 vaccine was given, the patient experienced being sick, having fever, high blood pressure, hallucination, and oxygen being low.  On 13 Jan 2021, the patient tested positive for COVID-19.  Treatment included azithromycin.   Action taken with mRNA-1273 was not reported.  The outcome of the events, being sick, having fever, high blood pressure, hallucination, and oxygen being low, was not reported.; Reporter's Comments: Fever is consistent with the known safety profile of the product and temporarily associated with the administration. Hence, a causal association cannot be excluded.  Based on the known etiology for COVID-19 the other events are including COVID-19 are considered unlikely associated with product use and can be attributed to COVID-19 infection.
Hospitalization for COVID-19 on dates 9/12/22-9/22/22. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Patient presented with a warm, slightly raised, red area starting from the injection area and radiating down arm.
Patient presented to clinic wanting covid vaccine. Data showed 1 Pfizer vaccine in patient's history. Patient was given a primary dose of Spikevax/Moderna. Patient did not have vaccine card with her. Through an interpreter patient was called and now states she may have had 2 Pfizer's, unclear/poor historian with language barrier.
Eyes, throat, and tongue swelling. Itching, lips turned blue. Treatment: Epipen, ambulance (more epi), ER, (for at least 4 hours) steroids/benedryl/pepcid plus Zofran. Home steroids and benedryl. Prescription for Epipen. Recovered at home.
She was sitting and got a slight HA, light headed a little bit also per report. She stated she knew her b/p was high because this is how she always feels every time hr b/p is high. she states she struggle with high and low b/p so she didn't take any of her meds today. Pt took a prn clonidine that was in her purse for b/p 200/100 hr-120 @ 1415. 1445 b/p 180/98, hr-99 pt report HA and dizziness is resolved. Pt instructed to stand up and see how she feels. States she feels fine and is ready to go home. Pt escorted to car with her daughter. Instructed to follow up with MD as needed.
Woke up 4/19 with edema under both eyes.  No swelling anywhere else (rings on fingers were easily removed, no gain in weight, eyelids and eyes were unchanged).  Under eye edema felt "bruised" and appeared reddish/purple in color.  Today, 4/20, woke up with slightly less edema, slightly less pain, still purple
Patient presented to ED with shortness of breath. Per EMS the patient was placed on 3 L O2 by nasal cannula and given a breathing treatment. She has complaints of cough and wheezing for approximately one week prior to evaluation. Patient grew increasingly hypoxic and had to be transitioned to BiPAP. Patient has been admitted to the hospital. She is receiving dexamethasone and tocilizumab. The patient is also receiving broad spectrum antibiotics.
Severe itching all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Severe itching all over the body) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PRURITUS (Severe itching all over the body). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PRURITUS (Severe itching all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Doctor gave patient a steroid shot and put her on Steroid pack.
On 03/24/2021 around 10PM my left arm started to ache, was itching & stinging. On inspection, a red tender slightly swollen area where I had the injection. Also had more body aches than usual.  On 03/25/2021 upper left arm showed more redness & swelling. Also had nasal congestion & an episode of diarrhea in the PM.
By June 25th I had two pimples on my tongue, I had them for three days and also every night for those three days my left arm hurt really bad.  By June 28th, in the morning the pimples disappeared and by 2:00 pm half of my tounge was tasting salty and the other half sweet. June 29, my left eye was red, inflamed, and wasn't responding. June 30th my left side of the mouth was not responding either.
Patient developed a localized 3 inch diameter red, itchy, swollen area at the site of the injection that was warm to the touch.
Rhabdomyolysis, Chest pain. 21Jul04-Received immunizations- 4 shots in each arm. Had been training that morning. Did not work out at the gym that evening or do PT during that day. Denies significant local reaction at vaccination sites or systemic symptoms. 22Jul04- Awoke feeling hot. Took shower to cool off. Also c/o chest pain. Had not experienced similar chest pain in the past. Describes as like something sticking me in the middle of the chest through to my back. Rates pain as level 9 of 10 on pain scale. Pain would come and go throughout the day, with most episodes only lasting 15 min. Also reports both arms were sore. Usual tenderness over vaccine sites, but rest of arm was sore and had difficulty flexing elbows. Did not self medicate. No unusual exertion that AM. Sat in auditorium all afternoon. Went to gym to work the soreness out that evening. 23Jul04-Reports night sweats through the night. Awoke with increased soreness and difficulty bending elbows. Also c/o weakness of arms. Continued to experience episodes of chest pain, which now radiated to shoulders, neck and back of head. had to bend head over his plate to reach food because it was too painful to bring his hand up to his mouth. Attempted to participate in training but was told to go to clinic. Went to have his PPD read (reports +test-15mm); arms were extremely painful. No shortness of breath, or cough. No change in chest pain with deep breaths or position changes (except increased chest pain with movement of arms). Some question as to whether chest pain was exertional. Transferred to Hospital, first to ER and then admitted. Diagnosed with rhabdomyolysis, weakness, chest pain and renal insufficiency. On 7/25/04, he was transferred to Heart and Lung Center for further cardiac evaluation. Lost total of 19 pounds while hospitalized. Discharged on 3Aug to barracks. Experienced several days of anorexia and vomiting. Continued to experienced weakness, especially lower extremities. Unable to ambulate independently or to carry out ADL's. Had someone assist him to the bathroom or used friend's crutches. Follow up visit at medical clinic after discharge. BP elevated. Recommendation for MRI to look at renal vasculature and kidney size, 2 weeks convalescent leave. with repeat UA after returning. Discharge Summary received on 15/15/2004: Hospital d/c summary reviewed. Pt experienced the following symptoms of nausea, palpitations, and myalgia.
itchy rash (Left arm); raised rash (Left arm); red rash (Left arm); Hot rash,warm rash (Left arm); giant rash,,2 inch by 4 inch rash (Left arm); This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash (Left arm)), RASH PAPULAR (raised rash (Left arm)), RASH ERYTHEMATOUS (red rash (Left arm)), SKIN WARM (Hot rash,warm rash (Left arm)) and RASH (giant rash,,2 inch by 4 inch rash (Left arm)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced RASH PRURITIC (itchy rash (Left arm)), RASH PAPULAR (raised rash (Left arm)), RASH ERYTHEMATOUS (red rash (Left arm)), SKIN WARM (Hot rash,warm rash (Left arm)) and RASH (giant rash,,2 inch by 4 inch rash (Left arm)). At the time of the report, RASH PRURITIC (itchy rash (Left arm)), RASH PAPULAR (raised rash (Left arm)), RASH ERYTHEMATOUS (red rash (Left arm)), SKIN WARM (Hot rash,warm rash (Left arm)) and RASH (giant rash,,2 inch by 4 inch rash (Left arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-270439 (Patient Link).
Information has been received from a physician assistant concerning a female, a patient's friend, who was vaccinated with GARDASIL in a different office and suffered blindness.  She recovered a little but still had the symptom.  Upon internal review the blindness was considered to be an other important medical event.  Additional information has been requested.
Pt. received 1st MCV4 on 10/18/14 - left upper arm. Became tender and red by 24 hours.
Menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA763A, expiry date 20th November 2023) for prophylaxis.   On 29th August 2022, the patient received Menveo. On 29th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.     Additional Information: GSK receipt date: 15-Sept-2022 Reporter's comment: Both of them received same Menveo lot number. The reporter consented to follow-up via email. This case is for 2 of 2 linked patients. Additional supportive information: The medical assistant reported that the patient received a Menveo vaccine (powder) reconstituted with sterile water, which led to wrong solution used in drug reconstitution.; Sender's Comments:  US-GSK-US2022133240:Same reporter
Initial report received from the scientific literature on 17 January 2012. This reporter also reported another adverse event, which was captured in case number 2012-00729 and 2012-00738. Verbatim from article: "Patient A was a 2-year-old boy without asthma. At age 1 year, he experienced facial swelling after eating scrambled egg. During an egg oral food challenge at age 5 years, he experienced hives, cough, and rhinorrhea and received epinephrine and antihistamine. Before influenza vaccination, his egg and influenza skin prick test (SPT) responses were both positive (10-mm wheal with a 20-mm flare and 4-mm wheal with a 5-mm flare, respectively). He had an eczema flare and hives on his wrists after 0.05 mL of vaccination. He received oral antihistamine and did not receive the remainder of the vaccine". The outcome was not reported. Follow-up information was received from a health care professional on 28 March 2012. The patient received the dose one intramuscular injection of FLUZONE, lot number U2463AA, on 11 December 2007 at 11:35. The patient's outcome was recovered. Documents held by sender: None.
Thursday, March 18, 2021 8pm: fatigue 9pm: chills 10:20 pm: severe chills, shaking, mild nausea, 99.3 degrees 11:05 pm: extreme shaking, severe chills, moderate headache, moderate nausea, extreme fatigue, took 2 ibuprofen, 99.9 degrees 12:24 pm: all of the above, 100.5 degrees  Friday, March 19, 2021 no fever, hot flashes, mild dehydration, moderate headache, fatigue, body aches  Saturday, March 20, 2021 fatigue, mild headache  Sunday, March 21, 2021 symptom free
I gave vaccine that was indicated for 2-49 years of age. The client was a 55 year old healthcare worker working in our jail. Client will inform us about possible adverse events.
5 minutes after vaccines given, patient started sneezing and clearing throat.  No wheeze or stridor on exam. Pulse Ox 99%. At 12:52 Zyrtec 7.5 mg given by mouth and within a few minutes sneezing and clearing throat resolved. Then developed abdominal pain, loose stool x 2. At 13:25 Tylenol 320 mg given by mouth. Pain resolved over the next 20 minutes. He was observed for 1 hour after the Zyrtec was given. At that time point he developed a bright red rash on face, trunk and extremeties with itching. No definite urticaria or petechiae. No pain and acting normal. At 13:57 Prednisolone 37.5 mg given. At this point, outpatient observation is warranted. Anticipate observation at least overnight.  More aggressive treatment for anaphylaxis if symptoms progress or worsen.
This case was reported by a healthcare professional (pharmacy student) and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included human immunodeficiency virus. On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown details). On an unknown date, at an unspecified time after vaccination with ENGERIX B series, the subject experienced not responding to therapy. The pharmacy student stated that the subject "failed" the series. A second ENGERIX B series was administered. Per the pharmacy student, the subject was "low responder HIV patient' and "had low titers post 2 sets of series with ENGERIX B" and "failed both times". Since the pharmacist student was reporting based on a "question from an infectious disease physician," the reporter did not have any subject specified details. Follow up was received from Merck on 30 August 2013. The reporter, documented as a pharmacist, contacted Merck and provided that the HIV positive subject was an adult who "was vaccinated with 6 doses of ENGERIX and failed to seroconvert". Per the report from Merck, hepatitis B "antibody testing was negative." No additional details were available.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 07-DEC-2015 at time- 03:34, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.8 and 1.6 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter.
Patient was given Moderna 3rd dose (booster) on 10/29/21 and we found out she had received COVID antibody infusion on 9/22/21.
1 day, post vax, very weak and unable to get out of bed for 3 days. No appetite to eat or drink. Felt "dreadful" but able to get up off and on. Saw MD on Wednesday. Went to hospital. BP 80/50 for 2 days. Went home after rehydration. Home overnight and then to ER. She was admitted to hospital for 4 days, for tests. She was dx'd with Guillain-Barre Syndrome and discharged. She had no further progression of the neuropathy.
horrible headache; sore throat; congestion; tons of phlegm; sinus pressure; very sensitive to touch; eyes are burning and red; pain back of the eyes; sore throat can barely swallow; eyes are burning and red; This is a spontaneous report from a contactable consumer via Medical Information Team. This consumer reported for a 16-year-old male patient (son) that the 16 year old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for Injection) intramuscularly as a single dose for COVID-19 immunization. The patient previously had COVID only 2 days of congestion. The patients concomitant medications were not reported. The reporter mentioned that the patient woke up with a horrible headache, sore throat can barely swallow has a lot of congestion and tons of phlegm. Also felt like sinus pressure and the inner lining of the nose is like a scar very sensitive to touch, eyes were burning and red and complaining about pain back of the eyes. The patient took Motrin, oxygen level and temperature are fine. The patient was supposed to drive to meet family group members who are vaccinated. The reporter wanted to know whether he could be contagious and wanted to know whether to keep him in quarantine and be concerned about protecting. The reporter wanted to know whether the patient could take any medications and what point the patient should be taken to the ER.The patient also previously had COVID only 2 days of congestion. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reported erythema, and edema of left arm traveling towards her left hand. Treatment by PCP with clindamycin 3x/day for 5 days.
No adverse effects; patient was administered the 1st dose of MMR II on 07-NOV-2019 and the 2nd MMR II dose was administered on 13-NOV-2019; This spontaneous report was received from a nurse referring to a 5-year-old, unspecified gender patient. Patient's pertinent historical and concurrent conditions, historical and concomitant medications, drug reactions and allergies were not provided.   On 07-NOV-2019, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).  On 13-NOV-2019, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number S004118 has been verified to be a valid lot number, expiration date established as 11-FEB-2021) (inappropriate schedule of product administration). In addition, the patient did not experience any adverse effects.
a 4-years-old developed calf pain, and a fever of 104.5 degree F two days after the second dose of the Pfizer vaccine, leading to hospitalization; a 4-years-old developed calf pain, and a fever of 104.5 degree F two days after the second dose of the Pfizer vaccine, leading to hospitalization; a limp; a rash on his/her face, chest, and upper back.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 4-year-old 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), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (hospitalization), PYREXIA (hospitalization), outcome "recovered" and all described as "a 4-years-old developed calf pain, and a fever of 104.5 degree F two days after the second dose of the Pfizer vaccine, leading to hospitalization"; GAIT DISTURBANCE (non-serious), outcome "recovered", described as "a limp"; RASH (non-serious), outcome "recovered", described as "a rash on his/her face, chest, and upper back.". Clinical course: A 4-years-old developed calf pain, and a fever of 104.5 degree F two days after the second dose of the Pfizer vaccine, leading to hospitalization, a limp, and a rash on his/her face, chest, and upper back. All symptoms resolved by 10th days.  Follow-up attempts are completed. No further information is expected.
GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight and height were not reported. No medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were not reported, batch number: unknown) dose, unspecified anatomical location, and start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced Guillain-Barre syndrome (GBS). The patient was diagnosed with GBS and was hospitalized for a short period of time on an unspecified date.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This spontaneous report received from a consumer via company representative concerns a patient of unspecified age, gender, and ethnicity who was reported with Guillain Barre syndrome (GBS) after an unspecified duration from receiving the Janssen Covid-19 vaccine.  The patient was unspecified on an unspecified date.  No other pertinent information reported.  Information regarding other potential etiologies was insufficient, and the occurrence could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.