chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 39 year old female with a history of Papanicolaou (PAP) smear abnormal with high risk HPV and genital warts in 2008 and no known drug allergies who on 17-JUN-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# 0294Y). There was no concomitant medication. On approximately 24-JUN-2009 the patient experienced a non-pruritic erythematous rash all over her body after administration of her first dose of GARDASIL. The patient had been examined by a dermatologist (name not provided) and treated with steroids. No lab diagnostics study was performed. At the time of the report, the patient had not recovered. The patient sought medical attention via an office visit. Follow up information has been received from a medical assistant concerning a 39 year old female with a history of cochleitis, droperidol allergy and no illness at the time of vaccination who on 17-JUN-2009, at 11:40 am, was vaccinated IM in right deltoid with the first 0.5ml dose of GARDASIL (lot# 0294Y). It was reported that firm red papules generalized; some had faded to light brown scars, rash at oral mucosae cleared more than 2 months. A skin, lower abdomen punch biopsy was performed on 02-SEP-2009. The sections showed a punch type biopsy of skin with a wedge-shaped moderately dense to dense perivascular lymphocytic infiltrate involving the superficial and deep vessels. There was a rare eosinophil present. The infiltrate also involved the dermal-epidermal junction where there was hydropic change and scattered necrotic keratinocytes. The overlying epidermis showed hyperkeratosis with neutrophils in the stratum corneum. The features were consistent with an early stage of pityriasis lichenoides. A drug reaction would also have to be considered in the differential. Additional information is not expected.
About 1 week after receiving Flu vaccine, pt started developing weakness in her feet which progressed in an ascending fashion to involvement of bilateral upper extremities. Pt has lumbar puncture which showed albuminocytolocic dissociation, and an EMG that was consistent with GUILLAIN BARRE syndrome with motor and sensory axonal neuropathy. Pt was endotracheally intubated due to impending respiratory failure and initially had signs of autonomic instability with labile blood pressure, which eventually stabilized. Pt received IVIG daily for 5 days. Pt was discharged to a rehabilitation center requiring PEG placement for tube feedings. Pt was normally healthy, walked daily prior to events above. 02/09/07-records received and reviewed from Harborview Medical Center for DOS 11/28-12/17/06-DC DX: GUILLIAN-BARRE syndrome (acute motor and sensory axonal neuropathy). Non-ST elevated myocardial infarction. Postmenopausal bleed. Type 2 diabetes 9new diagnosis), Hypertension, Urinary tract infection, Anemia or chronic disease, Dysphagia. Percutancious endoscopic GT inserted. CT Chest:partial collapse of lower lobes. HX present illness: Six days prior to admission noted weakness in feet progressed in an ascending fashion and at time of presentation involved bilateral upper extremities. Symptoms of tingling and numbness began about the same time and progressed in similar distribution. Seen in ER and admitted to SNF where she was diagnosed with type 2 diabetes.  PMH:new diagnosis of type 2 diabetes, hypertension. PE: bilateral ptosis, variable facial sensory exam, bilateral facial motor weakness, especially with puffing out her cheeks. Weak gag reflex, trapezius symmetrically strong but somewhat weak. Decreased light touch pinprick and temperature sensation throughout especially below her clavicles bilaterally. Stocking pattern in feet. Respiratory failure on admission required intubation and subsequently extubated.   RX with 5 days of IVIG. Per annual follow up: As of 12/17/2006 pt was discharged to skilled nursing facility with significant improvement of weakness but has not been seen at our hospital since that time. Pt still had dysphagia and required P.E.G. placement for tube feeding.
Sack of liquid under left arm in armpit area/noticeable swelling. Sore left arm and headache.
History of Present Illness: strangulated ileostomy, abd pain increasing since 5 am, irreducible edematous venous congestion tender abdomen, HX of pouch with pouch failure and subsequent permant ileos formation also has desmoid tumors          PT REMAINS INPATIENT AT THIS TIME.
Patient is having muscular and nerve pain and never had this before the shot and continue to have it. Also had significant cellulitis and went to see her PCP. He advised her to get the 2nd dose.
lost appetite; at times I have to vomit; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost appetite), VOMITING (at times I have to vomit) and NAUSEA (nausea) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (lost appetite), VOMITING (at times I have to vomit) and NAUSEA (nausea). The patient was treated with ONDANSETRON ongoing since an unknown date for Nausea, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (lost appetite), VOMITING (at times I have to vomit) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.
She got a flu vaccine and pneumonia shot ( does not know the name of the vaccines ) but two months ago got pneumonia and an week ago got a flu; She got a flu vaccine and pneumonia shot ( does not know the name of the vaccines ) but two months ago got pneumonia and an week ago got a flu; flu; The initial case was missing the following minimum criteria: Invalid for Other-Non-Pfizer product. Upon receipt of follow-up information on 28Mar2019, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacture unknown) at single dose for pneumonia shot, influenza vaccine (FLU VACCINE VII) at unknown dose for flu shot, both via an unspecified routes of administration on an unspecified date. The patient's medical history and concomitant medications were not reported. The reporter stated in the early part of the winter she got the flu shot and the pneumonia shot. Two months later she got pneumonia and then last week in Mar2019 she got the flu. She stated she thought if she got the shots, she should not have gotten pneumonia or the flu. She stated she did not know the names of the products and did not even know if Pfizer made them. She stated she didn't know any better and got them at the same time, but people have since told her she should not have gotten them at the same time. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein)in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Redness, swelling, hot to touch, itching and sore, tender to touch, approximately 115 mm in length of area redness. put on Keflex 500 mg BID x 10 days
24 hours after 2nd shot: Nausea, vomiting, headache, fever, chills, skin pain all over, muscle pain, soreness at injection site.  12 hours later, I was completely better.
Was given Pfizer COVID Vaccine for 6 months and up on 4/6/2023 and was given Moderna Bivalent COVID Vaccine for 6 months and up 22 days later on 4/28/23.  Incorrect manufacturer product given at incorrect spacing interval.
Pt had near syncopal episode. Pt became pale, diaphoretic, dizzy, nauseous.
Sore arm; Itching; Rash at the injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRURITUS (Itching), VACCINATION SITE RASH (Rash at the injection site) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PRURITUS (Itching), VACCINATION SITE RASH (Rash at the injection site) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arm), PRURITUS (Itching), VACCINATION SITE RASH (Rash at the injection site) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included, Steroids. List of concomitant medication were not given.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: TCR: nonsafety info
face swelling noted 40 minutes after vaccine given. patient took two tylenol and it went away. patient left ~ 1 hour after
Patient fainted after getting her vaccine. EMS (was present on-site) observed patient for 30 minutes; she felt better after 15 minutes. Patient denied any additional medical attention and she felt okay afterwards. Later patient said that she has needle phobia. Patient has no symptoms or any additional issues as of 4/13/2021, when followed up with patient.
On 3/7/05, 4 days after injection it all began. Shakiness (akin to Parkinsons or MS). Bad Headaches. Loss of motor skills. In a constant fog, very limited ability to think. Onset of ADD, very limited ability to focus. Weakened immune system. Loss of balance. No treatment so far other than CT Scan, MRI, and EEG to tell me there is nothing wrong with me.
Patient was brought into the ER with weakness, confusion and decreased appetite for days after testing positive for COVID19 on 2/6.  Patient's wife had a fall on 2/2, patient helped his wife and again had recurrent fall and finally took to hospital on 2/5 where she was tested positive for COVID 19 and passed away on 2/5. Patient received his first dose of COVID-19 vaccine on 1/29/2021. Patient's daughter was concerned about patient's confusion, breathing and decreased energy levels and recommended to come to hospital for evaluation. Daughter report that she noticed mild fever, cough and some diarrhea on 2/6 when she came to check on him after her mother tested positive on 2/5. She thinks he might have symptoms 1-2
This spontaneous report as received from a Registered Nurse, via a company representative, refers to a currently 17 years old male patient. The patient's medical history and concurrent conditions were not reported. Approximately in 2014, reported as "around one year ago", the patient was vaccinated with his second dose of GARDASIL (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. According to the reporting nurse, after vaccine administration the patient experienced a syncope while driving his vehicle and struck another vehicle (road traffic accident). The patient sustained minimal injury. Whether the patient was observed for 15 minutes after vaccination, was not known. The reporting nurse stated that the patient sought unspecified medical attention. The outcome of road traffic accident, syncope and injury was reported as recovered on an unknown date. The reporter did not provide a causality assessment for the events. Additional information has been requested.
pt recvd vax & 17MAR94 pt had pos Hep B surface antigen confirmed by neutralization; 31MAR94 re-testing showed that the pt's Hep B surface antigen was neg;
about 45 minutes after the vaccine, my tongue started to feel strange and my mouth and tongue started to swell. I became dizzy and light headed.  It took me about 15 minutes to realize it might be an allergic reaction so I looked at the CDC website and decided to take Benadryl and also called my doctor.
Bad headache; Dizzy; bone pain; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP) from the Medical Information Team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as DOSE 1, SINGLE (lot number: EL3246) at the age of 74 years old, administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Knows that she has a lot of sensitivities to medications" (unspecified if ongoing); "Has a lot of allergic reactions" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 21Jan2021, outcome "recovered" (22Jan2021), described as "Bad headache"; DIZZINESS (non-serious) with onset 21Jan2021, outcome "recovered" (22Jan2021), described as "Dizzy"; BONE PAIN (non-serious) with onset 21Jan2021, outcome "recovered" (22Jan2021). Therapeutic measures were taken as a result of headache, dizziness, bone pain.  Additional information: Regarding Covid vaccines, caller states she feels very protected. Knows that she has a lot of sensitivities to mediations. Was pretty worried there would be some reaction. It was pretty strong so, she just blocked out a couple of days each time to get over it. Caller was very pleased with the vaccine. Knew there was going to be side effects. She is so sensitive to medications. Has a lot of allergic reactions, blocks out a couple of days each time for it. Patient had the very first vaccine 21Jan2021. That reaction was a really bad headache and, felt like her head was going to implode. It ached terribly, felt like her bones were breaking. She remembers talking to her husband and crying because one of her really good friend had just died from Covid. All she could think of was, is this what it felt like for her for those 2 weeks, this pain. She took Tylenol. Her daughter is a nurse, told her to take Tylenol and go to sleep. Woke up, still had headache and ached all over but, not as bad. Took more Tylenol and think, the next day, in the afternoon, it just sort of magically went away. The bad headache, being dizzy, the tremendous bone pain, was gone. Clarified that by the next day, 22Jan2021, those symptoms were gone. That next day, she was still going down and out and had kind of a headache but by the end of the day, it all went away. Patient had no prior vaccinations (within 4 weeks). Patient takes medication for diabetes and blood pressure. Sender's Comments: Linked Report(s): US-PFIZER INC-202300077975 same patient and product, different vaccine doses and events;US-PFIZER INC-202300077978 same patient and product, different vaccine doses and events;US-PFIZER INC-202300077976 same patient and product, different vaccine doses and events;US-PFIZER INC-202300077977 same patient and product, different vaccine doses and events;
Information has been received from a physician concerning a 10 year old female patient with no past medical history who on 3/19/04 was vaccinated with a dose of varicella virus vaccine live (lot # 644788/0328N). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. There was no concomitant therapy. On approximately 3/27/04, the patient was exposed to chicken pox. On 3/30/04, the patient developed a vesicular rash all over her body including on the face, trunk and a few on the extremities. There was also associated itching. There was no fever and no other symptoms. Unspecified medical attention was sought. Treatment for the rash was topical. The patient received calamine lotion and hydroxyzine hydrochloride. Laboratory tests were not performed. On 4/5/04, the patient's experience resolved with no complications. A product quality complaint was not involved. Additional information is not expected.
Patient received vaccination around 10:30 am in her right deltoid. Around 10:35 am, the patient complained about local reaction/swelling at the site of injection. Upon physical examination, the patient right deltoid had some swelling and was hard upon touch. Patient stated similar reaction when she received the tetanus vaccine. When asked about taking benadryl, she stated that her doctor told her not to take benadryl but didn't state the reason so benadryl was not given to her. Patient was then escorted to the emergency department.
Information has been received from a nurse practitioner concerning a 27 year old female who on 25-AUG-2006 was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast), lot#653650/0702F.  During the administration of the vaccine, part of the fluid went into the patient's arm, the patient's arm, the patient pulled away and the remainder went on the skin (no adverse reaction noted).  The patient complained of burning during administration.  Medical attention was sought.  The patient received a repeat dose with no burning noted.  Patient's status was reported as recovered.  Additional information has been requested.
48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
headache, sore throat , body aches, loss of taste, loss of smell, sinus congestion, nasal congestion, post nasal drainage.  starting 11/7/21
Nausea; Fatigue; feels like she has some type of cold; bloated; tired; foggy; lots of sweating; Dizziness; sweating a lot; she doesn't feel 100%; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 21 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: EW0150, Expiration Date: 31Jul2021) at the age of 21 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Nausea"; DIZZINESS (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Dizziness"; FATIGUE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Fatigue"; HYPERHIDROSIS (non-serious) with onset 06Apr2021, outcome "not recovered", described as "lots of sweating"; NASOPHARYNGITIS (non-serious) with onset 07Apr2021, outcome "unknown", described as "feels like she has some type of cold"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "unknown", described as "she doesn't feel 100%"; FEELING ABNORMAL (non-serious) with onset 06Apr2021, outcome "unknown", described as "foggy"; HYPERHIDROSIS (non-serious) with onset Apr2021, outcome "unknown", described as "sweating a lot"; ABDOMINAL DISTENSION (non-serious) with onset 07Apr2021, outcome "unknown", described as "bloated"; FATIGUE (non-serious) with onset 06Apr2021, outcome "unknown", described as "tired".  Additional information:Patient had a question about symptoms of the first dose. she has heard after the second dose the symptoms are pretty severe but mine are bad with the first dose. Is it normal? Her first dose was on Monday the 5 th and yesterday she was pretty standard foggy and tired. Today she has intense nausea, bloated and I feel like I have a cold and foggy head. The caller is calling about the Pfizer covid vaccine. The caller is curious because she has been talking to other people and they said the second dose had the worse side effects and no effects on the first dose. The caller has experienced symptoms after the first dose and didn't know if this could happen. The caller has had lots of nausea, dizziness, fatigue, lots of sweating, feels like she has some type of cold, and she doesn't feel 100%. The symptoms are moderate, it's nothing super super bad. The caller has been doing a lot of physical activity and she has been sweating more than usual during it and at night time. Patient had a scheduled appointment for a second dose due on 26Apr2021. Asked if the second dose has the worst side effects.Did reporter consent to further follow-up: unknown.Did the patient/consumer/ caregiver provide consent to contact the prescribing HCP: Unknown.  No follow-up attempts are possible. No further information is expected.
runny nose, t104, pneumonia; oral med  & IM inject 14MAR92;
Patient's left ankle starting swelling; Patient's left leg starting swelling; A spontaneous report  was received from a physician concerning a 38 years old male patient who experienced patient's left ankle starting swelling (joint swelling) and patient's left leg starting swelling (peripheral oedema).  The patient's medical history was not reported by the reporter. Concomitant medications were not provided.  On 11 Jan 2021, seven days prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 in the left arm for prophylaxis of Covid-19 infection.  On 18 Jan 2021, the patient's left ankle and leg started swelling. Healthcare professional performed an X ray and other analysis on the patient but didn't find anything. The patient  was treated with prednisone and the symptoms went away but when they stopped treating with prednisone the symptoms came back. Patient's symptoms were ongoing.  Healthcare professional showed his concern as he doesn't know what was happening to the patient. The patient was advised by his physician not to received the second dose.  Treatment for the events inluded predisone and Ibuprofen.  The second dose of mRNA-1273 was discontinued in response to the events.   The events, patient's left ankle and leg starting swelling, were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
My son was given an inoculation called Prevnar. Two weeks later, he began experiencing symptoms of pneumonia and was later dx'd as such by his physician on 4/16/01. He has had a fever of 103F-104F for the past 6 days. As a result, I have been out of work for the same amount of time and am considering legal advice on this matter as I am sure that the shot was the cause of his suffering.