chrisvoncsefalvay/vaers-outcomes huggingface dataset:
choking on phlegm; phlegm; Coughing; Serious sinus drainage; Fatigue; could not hold food down; This is a spontaneous report from a contactable consumer. This 21-year-old female consumer (patient) reported for herself:  Product detail: product=COVID 19, brand=Phizer Start Date/Time: [Phizer] 2Jun2021 03:30 PM Lot number=Bw0182 Lot unknown=False Dose number=1, Vaccine location=Left arm Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No  Reported Event: Serious sinus drainage, coughing, fatigue (if I do fall asleep I will wake up choking on flem) can't hold food down  Prior to vaccination  Since the vaccination, has the patient been tested for COVID-19?:No Device Date : 05Jun2021 If patient recovered: Not recovered If treatment AE: No If covid prior vaccination: Unknown If covid tested post vaccination: No  No follow-up attempts are needed. No further information is expected.
it was rpt fr MD concerning pt who was vax & approx 7 days later pt devel measles w/high fever & non pruritic rash consisting of red dots.
Event occurred at approx. 4:00 pm. Patient received the above vaccines and upon leaving clinic room just complained of a sore arm. Mother ran back to clinic from the outside motioning for help. A bystander witnessed pt. stiffen up and collapse to the ground. She had a bump on her forehead and lip was bleeding. Pt. was transported to hospital for evaluation. Ice pack was applied to head.
Lots of tightness in the chest.; Terrible migraine; Extreme chills; Low fever; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151) via an unspecified route of administration in the right arm on 11Apr2021 at 09:45 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease. Concomitant medication included loratadine (CLARITIN) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 21:30, roughly 12 hours after the injection the patient experienced terrible migraine, extreme chills and low fever. Additionally, on 12Apr2021, around 14:00 the following day she started experiencing lots of tightness in the chest. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events terrible migraine, extreme chills, low fever and lots of tightness in the chest were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
9/2 - 6 PM - Redness - swelling and painful. 9/3 - Was seen in ED. Started on abx. and admitted for presumed cellulitis, LA. 9/5 - Discharged on Augmentin. 9/8 - F/U with me - normal PE.
Headache; Fever; Nausea; Vomiting; Body ache; chills; No appetite; Thirst; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 5P2P7PV) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA798) for prophylaxis.   On 15-MAR-2023, the patient received the 1st dose of Bexsero (left deltoid) and the 2nd dose of Menveo (right deltoid). On 15-MAR-2023, less than a day after receiving Bexsero and Menveo, the patient experienced headache (Verbatim: Headache), fever (Verbatim: Fever), nausea (Verbatim: Nausea), vomiting (Verbatim: Vomiting), general body pain (Verbatim: Body ache), chills (Verbatim: chills), appetite absent (Verbatim: No appetite) and thirst (Verbatim: Thirst). The outcome of the headache, fever, nausea, vomiting, general body pain, chills, appetite absent and thirst were not reported.   It was unknown if the reporter considered the headache, fever, nausea, vomiting, general body pain, chills, appetite absent and thirst to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.     It was unknown if the company considered the headache, fever, nausea, vomiting, general body pain, chills, appetite absent and thirst to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-JUN-2023 The reporter stated on 15th March 2023 patient administered both Bexsero and Menveo in same visit in different arm. On same night of vaccine administration symptoms began. They performed the Covid-19 test which was negative. The reporter agrees to follow up from GlaxoSmithKline. Note: Both the vaccines were considered as suspect because both were administered on same time and all the reporter symptoms occurred on the same night after administration of both vaccines. Since on same night (15TH March 2023) symptoms started full event onset date was captured. As per SD the given lot number was conservatively captured even if it was mentioned as last digit was not able to read
Explosive watery diarrhea for 6-8 weeks starting  about 5-7 days after vaccine.
Patient received Pfizer COVID-19 vaccine and 7 months later hospitalized with COVID-19 pneumonia with cough, chest pain, and acute on chronic hypoxic respiratory failure. Received dexamethasone 6mg daily for 5 additional days. Discharged to home medically stable.
Pt did not have any adverse reaction pt was given a second flu shot; first one was received on 9/26/11.
Patient called into pharmacy to report that after receiving her flu and COVID-19 shot yesterday, her hand and lower arm on the side of the injection began swelling. Patient was advised to contact MD for a prednisone taper or antihistamine.
Day 5 - developed rash over entire body  Extreme  arm pain at site of injection returned Nasal pain (experienced during covid) and headache
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
Started with slight tingling in left breast and continued to build at first off and on then felt it consistently and then noticed that left breast filled out bra more, then started feeling the swelling in arm pit could swelling in arm pit and then tingly down arm and hand, msg PCP and they referred to health care provider that was about end of January, she msg me made appt for mammogram and then the mammogram was towards the first week of Feb. and when I went in and did mammogram it showed no problems she sent me right over for U/S and they did find anything either, around 2 weeks after that it was all gone.
Pt recvd vax 4OCT93 & c/o numbness in feet; 29OCT93 had inc numbness & tingling in both feet, numbness was moving up both legs; dx polyneuropathy to r/o GBS;
Team member presented to clinic c L arm discomfort s/p J&J vaccine. TM states the site is itchy and pain felt 5/10(1-10 numeric pain scale). Area is red and hot to touch. Redness noted on injection site and on the right lateral side of the arm. RN.
Fever up to 102, severe chills, arm pain, muscle aches for 24 hours after vaccine. All resolved, with only acetaminophen for treatment. However, now I have numbness mostly in my fingertips, but also some numbness in hand on the right side. I do have arthritis, so it might be related to arthritis in the wrist and not the vaccine.  I know I got a quadrivalent flu shot, but do not know the manufacturer and just picked the first one. I did not receive any paperwork in hand from store, I registered to receive the shot online.  I have never had a reaction to a flu shot previously. I have received them each year since 1990 and never had more than a little sore arm and maybe felt a little bit bad for a day. This shot kicked me to the curb!
This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A female patient of an unspecified age, race and ethnicity received PREVNAR 13 at 0.5 ml, single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, one month after the vaccination, in 2017, the patient experienced sinus issue. The patient recovered from the adverse event on an unspecified date.
Apparent vaccine administration error. According to vaccination registry, this patient received a complete 2 dose Pfizer series  on 1/13/2021 and 2/03/2021, respectively.  This was done at a different long term care facility by  Department of Health did verify that records indicate vaccine doses were administered. Current facility and patient's wife indicated to us that no previous covid doses given and he was in need of the series.  Error in the registry? Possible same name and date of birth but 2 different people?  Wife a poor health historian?   Regardless, another series was completed on 6/17/2021 and 07/16/2021.  4 doses. Patient experienced no known adverse effects.
Myalgia, Arthralgia, Fever & CoughWheeze Narrative: day 1-7-chills, muscle ache; ha; fever; sweats; fatigue; sore throat; cough
Site: Pain at Injection Site-Mild, Systemic: urologic symptoms-kidney pain, urinary pain, repetitive urination-Medium
Refrigerator expiration date: 6/25/2022 (removed from freezer on 5/26/22), Administered to patient: 6/27/22; Vaccine that was administered after the refrigerator expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that was administered after the refrigerator expiration date) and PRODUCT STORAGE ERROR (Refrigerator expiration date: 6/25/2022 (removed from freezer on 5/26/22), Administered to patient: 6/27/22) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that was administered after the refrigerator expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Refrigerator expiration date: 6/25/2022 (removed from freezer on 5/26/22), Administered to patient: 6/27/22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that was administered after the refrigerator expiration date) and PRODUCT STORAGE ERROR (Refrigerator expiration date: 6/25/2022 (removed from freezer on 5/26/22), Administered to patient: 6/27/22) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Vaccine was administered after the refrigerator expiration date.    Refrigerator expiration date: 25-Jun-2022 (removed from freezer on 26-May-2022).  Treatment information was not provided.
Abdominal pain, severe, Emergency Department visit X3 with negative work up including CT.Symptoms began 24 to 48 hours after oral typoid and were mild after first dose and severe after the third.  Described as crampy with crescendo/decrescendo pattern.
Swelling of lower lip on left side, cough, body aches, sore left arm (vaccinated in left arm).
Client felt light headed and diaphoretic within 15 minutes of vaccination. Was transported to Hospital.
extreme dizziness a couple hours following the vaccine, headache for around 36 hours, weakness for 36 hours,
Severe asthma attack "worse one ever"; received relief w/ albuterol inhaler; body aches; general malaise; N/V 30 min. post asthma attack; headache; tender abdomen; lingering nausea w/o vomiting. Day 2 post reaction: Small amount of IBS lingering.
Information has been received from a consumer concerning her son who on unspecified date, was vaccinated with the first dose of VARIVAX (Merck) (lot # not reported). The consumer reported that her son was diagnosed with autism at three years of age after receiving VARIVAX (Merck) as an "infant". The consumer stated that her son was showing verbal improvement, and she was unwilling to have her son to received the second dose of VARIVAX (Merck). At the time of reporting, the patient's autism persisted. On unspecified date the patient sought medical attention via multiple office visits. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested.
Both injections were given in the same arm, an inch a part. Patient reported arm was sore the following day, two days later patient came into our store reporting arm was red, swollen and painful. With advice, she went to the urgent care clinic. Cellulitis was the diagnosis. She was given an antibiotic and a steroid. On follow up, she is responding to the medications and arm was no longer red and swollen.
From initial information received on 12/28/04 and 12/30/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 20 year old female patient received a 0.1cc dose of TD ADS ADULT, lot number U1356AA, administered ID in the left forearm in error instead of TUBERCULIN PPD on 12/28/04 at 10:00 AM. 140 minutes later, at 12:20 PM, the patient developed itching at the site of injection. At the time of this report, the patient had not recovered from this event.
Still have a hard, warm, red, swollen ring around injection sight. Cold chills and hot flashes for one day. I had diarrhea for about 4 hours. Nauseous for a day. Extreme fatigue for over 24 hours. I am still having fatigue.
PATIENT COMPLAINED OF UNCONTROLLABLE SHIVERING, SWEATING, BODY ACHE AND JOINT PAIN THE NIGHT OF THE IMMUNIZATION THAT CONTINUED TILL THE MORNING.
No other adverse events/effects reported; that improperly stored ROT ATEQ and PEDV AX HIB was administered yesterday; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-MAR-2021, the patient was vaccinated with doses of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, orally, lot # 1691303, expiration date 21-DEC-2021 (strength and dose were not reported) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter, intramuscular, lot # T020616, expiration date 16-MAR-2023 (strength and dose were not reported), both for prophylaxis.  On an unknown date, the doses of the vaccines were exposed to temperature excursion at 47.1 Fahrenheit degrees (F) for 10 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
compression fracture; Patient fainted; This case was reported by a nurse via sales rep and described the occurrence of faint in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and Flu vaccine at an unknown dose. On 4th February 2020, unknown after receiving Shingrix and Flu vaccine, the patient experienced faint (serious criteria GSK medically significant) and compression fracture (serious criteria hospitalization). On an unknown date, the outcome of the faint and compression fracture were unknown.   It was unknown if the reporter considered the faint and compression fracture to be related to Shingrix and Flu vaccine.  Additional details were provided as follows The age at vaccination not provided. The patient experienced fainted and subsequently hospitalized with a compression fracture. The reporter gave consent for follow up.
Pt got sweaty and lightheaded approx 5 min after shot was given. had Dry heaves. was given water and and ice pack, refused ambulance and said felt about 99 % better about 3-5 minutes after, held for 25min total  for observation
She reports that on 01/17/2021 she developed hives at the injection site and itching.  The hives has not spread but she then developed a different looking red rash on both hands that is itchy, started on 01/19/2021.
Information has been received from a lawyer regarding a case in litigation concerning an unspecified patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 06-NOV-2015, the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot#, expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On 12-AUG-2016, the patient was treated by the physician for a vesicular outbreaks, which were diagnosed as herpes zoster and was prescribed acyclovir for management of his painful symptoms and chronic pain (onset dates were not reported). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were reported as related to the therapy with ZOSTAVAX.
Swollen, red, hot area, 4 inch in diameter persisting for 2 or more days.
Redness, tender, swelling at L thigh noted 5/15/01. 8x8cm anterior patch + erythema, possible cellulitis, possible local reaction.
Ecchymosis 11.5x10 cm at injection site and 2 1cm areas dorsal forearm LUE.
A developed shingles like rash in left T8-9 dermatoma, 2 days after receiving the vaccine.
Dose administered 24 hours post puncture; Dose administered 24 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered 24 hours post puncture) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2022 at 11:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered 24 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered 24 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered with Booster Dose. The vial was initially stored in the refrigerator on 20-Feb-2022 Date and time vial was first punctured was on 21-Feb-2022 at 11:01 AM The vial stored post puncture was at Room Temperature The vial did not undergo any temperature excursions Total amount of time the vial was exposed to room temperature range was (8 Degree to 25 Degree celsius that equals 46 Degree Fahrenheit  to 77 Degree Fahrenheit )-24 hours and 29 Minutes.  No concomitant medication details was provided. No treatment medication details was provided.
Clients aunt called 30 minutes after vaccine was given stating the client had stiffening in the hands, nausea, clammy ,heart racing and tremors in muscles. Client stated they went to Urgent Care to be seen .  He said he was given two medications Methylprednisolone and Banocin.
MENACTRA place on rt arm on 7/20/11. On 7/22/11 Rt arm has redness circumferential with minimal raised.
Headache 8pm Body aches 830pm Fever/chills/lethargy 9pm  Symptoms lasted about 15hrs
initially arm was sore for several days.  Then 1 week later progressed to swollen area about 2" in diameter that felt like a knot under the skin.  The area was warm to touch, white or non-pigmented, and surrounded by hives.  After 24 hours and several doses of amoxicillin, the area is improving but continues to be warm, surrounded by hives with pigmentation returning.  The knot does not feel as tight.
Fever at 102.5.  Muscle aches,  headache,  chills.
A literature report was received on 02Nov05 concerning a 79 yr old female vaccinee. The vaccinee had a history of abdominal swelling for several months, which was later diagnosed as ovarian carcinoma. No details were provided regarding the vaccinee's  concomitant medications. In Dec 2000, the vaccinee presented with a 2 wk history of purpuric eruption over her lower legs that started 2 weeks after receiving Fluvirin. Investigations revealed elevated ESR at 75mm in the first hr, proteinuria and haematurio on urinalysis. A skin biopsy showed a leucocytoclastic vasculitis which responded to treatment with clobetasol propionate ointment. Her vasculitis had almost fully recovered before anti cancer therapy was started. Her urinalysis returned to normal 2 wks after presentation. The discussion between the authors suggest a causative link could not be proven. Although it it likely that the vaccine has potential to provoke immunologically mediated problems. The mechanism by which influenza vaccine cause vessel damage is likely to be by abnormal immunological activation.
Pt was seen in MD's office 3 days post vax with cellulitis at injection site. Pt was treated with oral antibiotics.
cough, nasal congestion, runny nose, cold sweats, decreased taste, decreased smell, fatigue with COVID positive PCR on 08/03/2021
a few minutes following the injection patient reporting a feeling of heart racing and appeared to be sweaty.  Vitals showed that patient was tachycardic and hypotensive.  EMS was called.  2 doses of 0.5 mg EPI was given IM  5 minutes apart along with 100 MG of Benadryl.
At the time of the event, a red swollen area presented at the injection site. Since, it has become itchy and remained red and minimally swollen. Today (8 days from injection), the area of redness has expanded and appears as a bullseye.  Itchiness and swelling have decreased, but the redness has expanded.
Both of my vaccination, within 10 minutes, I felt like a wave came over me, flushed and palpitations. They monitored me for an hour.  I did get the rash on arm, was not as extensive as the first vaccine. I took antihistamines.  I was in bed for 1 day; fatigue. Next day I was fine. Telehealth with allergist and cardiologist; family hx of afib. Told me to take medication for palpitations but I chose not to because my BP tends to run low.