chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large welts; drained pus. I got the first dose of the GARDASIL shot the week before school started back in August. It had a decent sized welt but I was told it was normal even after the three month period in which I was supposed to get the second shot. The nurse noticed the welt but proceeded with the second dosage. The month after the second shot, both of my arms had a giant bruise. A week ago my arm started draining a yellow pus. It greatly decreased in size. The other arm has not drained yet and is extremely sore still. They both however, still have a knot that seems to be here to stay.
cried for 5min or more p/shot;cried 1/2 p/shot;sore leg & temp over 101;
2 mins. after vaccines given Pt's legs becamer erythematous. No swelling or warmth. Pt. was given Benadryl. Redness diminished. After 1/2 hr.
This spontaneous report as received from a pharmacist via a company representative refers to a 79 year old female patient. On 27-OCT-2013 (reported as 37 day ago) the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On 29-OCT-2013 (reported as two days later) the patient returned to the pharmacy with severe swelling in her arm the size of a grapefruit (which arm not designated). Patient did not seek medical attention and no treatment was given to patient. The outcome of severe swelling in her arm the size of a grapefruit was reported as recovered/resolved on an unknown date. Additional information has been requested.
CG recieved vaccine on 3/19. CG called 4/13 to report the follow: On the evening of 3/19, CG experienced nausea, body aches, and chills. Next day on 3/20--  CG describes feeling lousy and experienced body aches. On 3/21, CG states feelings of a bad hangover (nausea, headache, chills, fatigue). After 3/23,  CG experienced moderate to severe headaches every other day. Severe headache continues to persist. Today (4/13), CG called to report severe headaches. History of migraines. CG will visit PCP tomorrow
COVID+ 11/17/2022.  Vaccination Status - Pfizer x3 + Pfizer BIVALENT BRIEF OVERVIEW: Admission Date: 11/21/2022 Discharge Date: Nov 23, 2022   Active Hospital Problems   Diagnosis Date Noted POA ? Pneumonia due to COVID-19 virus 11/21/2022 Yes ? Pulmonary hypertension 01/23/2020 Yes ? ILD (interstitial lung disease) 01/23/2014 Yes ? Stage 3a chronic kidney disease 06/30/2022 Yes ? PFO (patent foramen ovale) 09/02/2015 Yes ? Obesity 04/27/2015 Yes ? MCTD (mixed connective tissue disease)   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus   HOSPITAL COURSE: This patient was admitted on 11/21 with continued symptoms of acute COVID infection starting 11 days prior to admission.  Symptoms included fatigue, weakness, diarrhea, nausea, worsening hypoxia.  Patient tested positive for COVID 11/17.  Patient had had her initial COVID series of vaccinations but had not yet received a booster.  CT angiogram showed no evidence of PE and evidence of chronic interstitial lung disease with superimposed airspace opacities consistent with COVID.  She was treated with Decadron.  Pulmonary was consulted.  They recommended discontinuation of the patient's CellCept which has been prescribed for management of her interstitial lung disease.  There was the concern that that might be interfering with resolution of her COVID infection.  Additional is recommended that based on the patient's weight her Decadron dose be increased from the standard dose of 6 mg daily to 10 mg daily.  The patient demonstrates substantial improvement and was discharged in improving condition on 11/23.  She will take a 10 day course of Decadron 10 mg a day.  She will stay off CellCept for 4 weeks or restart after 7 days of baseline lung function.  She will see her pulmonologist in 2-3 weeks for follow-up to coordinate transition from treatment of acute COVID to ongoing management of her interstitial lung disease.. CONSULTS / RECOMMENDATION: pulmonary
If he scratches, the area becomes red; If he scratches, the area becomes raised; Rash left arm  (not injection site); Palms of his hands started itching/ Itching moves around from behind ear, to Calf, to Feet/ itching is in random body parts.; Sleep it off; Achy; Fatigue /Tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (If he scratches, the area becomes red), RASH PAPULAR (If he scratches, the area becomes raised), PRURITUS (Palms of his hands started itching/ Itching moves around from behind ear, to Calf, to Feet/ itching is in random body parts.), SOMNOLENCE (Sleep it off) and PAIN (Achy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A, 040A21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced SOMNOLENCE (Sleep it off), PAIN (Achy) and FATIGUE (Fatigue /Tired). On 22-Dec-2021, the patient experienced PRURITUS (Palms of his hands started itching/ Itching moves around from behind ear, to Calf, to Feet/ itching is in random body parts.). On 25-Dec-2021, the patient experienced RASH (Rash left arm  (not injection site)). On an unknown date, the patient experienced ERYTHEMA (If he scratches, the area becomes red) and RASH PAPULAR (If he scratches, the area becomes raised). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (If he scratches, the area becomes red), RASH PAPULAR (If he scratches, the area becomes raised) and RASH (Rash left arm  (not injection site)) had not resolved and PRURITUS (Palms of his hands started itching/ Itching moves around from behind ear, to Calf, to Feet/ itching is in random body parts.), SOMNOLENCE (Sleep it off), PAIN (Achy) and FATIGUE (Fatigue /Tired) outcome was unknown.            No Concomitant Drug details were reported.  As a treatment patient took antihistamine.   This case was linked to MOD-2022-437642 (Patient Link).
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) GARDASIL injection (lot # L014415, exp. date: 25-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pentacel and Menveo vaccines were right next to each other when Medical Assistant Grabbed Menveo instead of Pentacel which Pentacel is is needed when patient are getting  four month shots instead of Menveo.
adult dose of Engerix-B to a female 4 month patient; adult dose of Engerix-B to a female 4 month patient; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-month-old female patient who received HBV (Engerix B adult) (batch number 2224M, expiry date 1st March 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th April 2021, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 8th April 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that 4 months old child received an adult dose of Engerix-B, which led to overdose and adult product administered to child. No further events were reported.
After 2nd dose, the pain is worse; I had a baby via c-section in March 2020, I am still lactating; I had a baby via c-section in March 2020, I am still lactating; cramping in my lower abdomen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 10:00 (Lot number: er8731) as dose 2, single and administered in arm left, administration date 24Mar2021 09:30 (Lot number: er8727) as dose 1, single for covid-19 immunisation. Relevant medical history included: "c-section", start date: Mar2020 (unspecified if ongoing), notes: I had a baby via c-section in March, 2020. The patient took concomitant medications. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 24Mar2021 10:00, outcome "recovered", described as "cramping in my lower abdomen"; CONDITION AGGRAVATED (non-serious), outcome "recovered", described as "After 2nd dose, the pain is worse"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious), outcome "recovered" and all described as "I had a baby via c-section in March 2020, I am still lactating". Therapeutic measures were taken as a result of abdominal pain, condition aggravated.  Additional Information: Other medications in two weeks: Soloxine 0.1 once daily. After each shot, within 8-10 minutes she had cramping in her lower abdomen, as if she were getting her period. It wasn't as painful as her period, but enough to remember and send you all a note. It happened each time. After the first vaccine, the pain lasted only about an hour, and it was not as painful as after the second vaccine. After the second vaccine, the pain was worse, almost like period cramping. It lasted all day. She took Advil and it went way at night. Other medical history: She had a baby via c-section in March 2020. She was still lactating. Her periods have come back, but are not horrible.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021473742 same report/drug, mother/child case
Information has been received from a licensed practical nurse concerning an 84 year old white retired female with no known drug allergies who on 06AUG2003 at 10:45 AM was vaccinated with SC in the upper left arm with a first dose of pneumococcal vaccine 23 polyvalent. At the time of vaccination , the pt had black stools and was experiencing fatigue. Within 24 hours of vaccination, the pt developed urticaria. The pt also developed vesicles around the injection site. The pt was seen over about a three week pd. The rxn was not severe but appeared to be a type three allergic reaction. Unspecified medical attention was sought and no treatment was required. There was no product quality complaint involved. Follow up information indicated that the pt recovered with a steroid injection. Additional follow up information indicated that on 06AUG2003, the pt developed a large red swollen area on her left upper arm that was warm to touch and had water blisters. She presented to the office on 07AUG2003. The reporter indicated that the pt recovered. The physician also reported that two other patients had similar experiences following exposure to pneumococcal vaccine 23 polyvalent.
Patient seated on a chair in exam room one with mother and younger brother present. Patient given HPV, Tdap, and Menactra vaccines at 4 pm by RNs. Patient chatted following the vaccine, said her arms really hurt, and was encouraged to move her arms using a small stacking toy, which she did. I discussed with patient's mom the vaccines and providing Tylenol/Advil to patient as needed. Toy suddenly fell onto the floor; patient's head leaned back against the wall, and patient's eyes rolled back into her head. Patient's mother shook her and spoke her name loudly several times with no response. Patient's color was becoming pale and slightly green. Patient's right hand briefly clenched into a fist and flexed at the wrist. I asked support staff to call 911 and ambulance was requested. Patient's mother and I lowered patient to floor and placed head onto floor and elevated legs onto chair. Patient opened eyes and eyes focused on us. Pulse and BP taken by RN and results were normal. RN made ready and available anaphylactic reaction medical protocol supplies. Patient covered with blanket and cool compress applied to forehead. Supervisor RN observed patient and noted that patient was now responding verbally and respirations were normal; ambulance request cancelled. Patient stated she was cold. Patient said she had not eaten much for lunch. Patient's coloring returned to normal. Patient's pulse continued to be normal. Patient assisted to a sitting position on the floor, given sweatshirt to wear, and drank 8 oz water. Patient assisted to standing position at 4:45 pm. Mother instructed to monitor patient's breathing and to take patient to ER immediately if breathing problems developed. Patient said she felt well enough to walk. Patient left to return home with mother and brother.
has a fever; This is a spontaneous report from a contactable consumer (parent) reporting for her daughter (patient).  A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 23Apr2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in 2021, patient experienced fever. Patient was scheduled for second dose on 14May2021, and her parent (reporter) wanted to know if she could postpone the appointment. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
About 9:30 am the day of the vaccine, my right pinky felt tingly and started to go numb, in addition, I had the shingles two years ago and felt the nerve in my chest where my shingles first started. The following day June 23, 2021 my right under arm (armpit) became sore.  The above items were not listed as adverse side effects. In addition, I was very tired the day of and day after the vaccine, had a headache, and my arm is still sore and swollen.
A day after injection pt has dark red/purple not elevated linear rash going down his right forearm about 5 inches in length two in parallel to it, with some manifestation in the left shoulder. Pt state rash is not bothering him in any way and has had similar 1cm circular rashes but none this big.
This spontaneous report as received from a physician refers to two patients of unknown age and gender. Medical history was not reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) (first dose, dose, route of administration, anatomical location, lot number was not reported). No concomitant medications were reported. On an unknown date both patients developed a reaction the first time they had VARIVAX (Merck) - both experienced rash bigger than a quarter and maybe some chicken pox lesions. Action taken and outcome was not reported. The relatedness between both events and VARIVAX (Merck) was not reported. The outcome of the events was unknown. Additional information has been requested.
2/18/2021 Patient received her 2nd dose of Moderna vaccine at 1230pm in the medical clinic examination room.  At 1245pm, patient complained of dizziness 15 minutes after her injection.  I advised her to sit and continue observation for another 15 minutes. At the same time, VS was taken in the examination room.  She walked with steady gaits, conversing with me, and denied shortness of breath.   After taking her VS, she was directed back to sit in the medical clinic for further observation.  Patient was talking and drank some water from the water bottle.  After 10 minutes, patient stated that she felt better and ready to go back to work.  When she was about to leave the medical clinic area around 1255pm, she developed a nosebleed on her right nostril.  I assisted patient in the bathroom to apply pressure on the right side of the nostril to stop the bleeding.  Patient and I stayed in the clinic for approximately another 15 minutes to stop the nosebleed.  Her nose bleed subsided, and she was ready to return to work.  I explained to patient that she may feel sore and body ache after her 2nd dose of the vaccine.  Patient had no further questions and left the medical clinic area around 115pm.  2/19/2021 Patient came to work this morning and mentioned to (name) who was in line for screening that she woke up with pain and swollen of her left side of her face.  (name)  reported patient complaint to (name) , Director of Nursing.  (name)  advised (name)  to report the issue to the GMO on call.  Doctor directed patient to seek medical attention from her primary care doctor.   (name)  notified patient and her supervisor - (name) .   Patient came up to the administration area and she told (name)  and (name)  that she wanted her brother to take her to the hospital.   She left the Hospital and went to UMC accompanied by her brother around 930am.   UMC called (name)  at the request of patient that she is in the emergency room and getting a full workup.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 37-month-old male. Neither the patient's medical history nor the concomitant medications were reported. The reporter spoke to patient's mother on 28-Feb-2012, mother did not report any adverse events. She did not want to bring her son in for additional dose of FLUMIST as the expired FLUMIST was his second dose. The product expired on 12-Feb-2012. On 23-Feb-2012, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 27-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Very sore arm that kept me awake during the night. Headache, flu-like lethargy. 24 hours later, it's still hard to get out of bed.
Swelling and edema of right upper arm from vaccine site in the deltoid to the elbow.  Per patient wife arm is also warm to the touch and patient began sweating today (10/27/2019)
Pt developed 3.5 x 3.5 cm wheal at site of injection. When observed on 8/29/11.
Information has been received from a physician assistant concerning a female with no pertinent medical history was vaccinated with the second oral dose of Rotateq (human-bovine) (lot # not provided). There was no concomitant medication. Subsequently, the patient experienced blood in her stool after receiving the second dose. The patient sought unspecified medical treatment. There was no product quality complaint involved. Upon internal review, blood in her stool considered to be an other important medical event. Additional information has been requested.
02/22/12: Site of injection hot, red, swollen, hard, and itchy. Symptoms occurring in site. ZOSTAVAX was injected.
Vomit x6 -24 hours Drowsiness - 3+ days Fatigue 3+ days Nausea 3+ days Loss of appetite 3+ days  Hi amounts of localized pain in injection site, causing loss of motor function in right arm because of high pain 24hours Headache  6 hours Constipation  3+ days  Struggling urinating  3+days
Initial information received on 07-Jun-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 12 years old female patient who experienced faint rash under both eyes and swollen eye, while she received vaccines HIB vaccine and MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a first dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine lot U5848AA in unknown administration site. On an unknown date, the patient received a dose of suspect HIB vaccine not produced by Sanofi Pasteur lot number not reported in unknown administration site. The patient developed a non-serious faint rash under both eyes (eyelid rash) Unknown latency following the administration of Meningococcal A-C-Y-W135 (D CONJ) vaccine and Unknown latency following the administration of HIB vaccine. The patient developed a non-serious swollen eye (eye swelling) Unknown latency following the administration of Meningococcal A-C-Y-W135 (D CONJ) vaccine and Unknown latency following the administration of HIB vaccine. (Other relevant tests included No lab test.) Final diagnosis was swollen eye and faint rash under both eyes. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for faint rash under both eyes and as Unknown for swollen eye. List of documents held by sender: none.
Sick with covid; Sick with covid; Sick with Covid; extreme chills; no taste; sore; can't really move; GI issues; headache; slight cough; This is a spontaneous report from a non-contactable consumer (patient). This is the first of two reports with events experienced under the first dose. A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 04May2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 06Aug2021 patient experienced sick with covid, extreme chills, no taste, sore, can't really move, Gastrointestinal (GI) issues, headache and slight cough. It was reported that on 06Aug2021 patient was sick with Covid and following symptoms: No fever but extreme chills, no taste, sore, can't really move, GI issues, headache, and slight cough. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101265501 Same patient and drug, different event and dose