chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot feeling at the injection site; soreness at injection site; redness at injection site; stiff neck; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced injection site warmth, injection site pain, injection site erythema and stiff neck. On an unknown date, the outcome of the injection site warmth, injection site pain, injection site erythema and stiff neck were unknown.   It was unknown if the reporter considered the injection site warmth, injection site pain, injection site erythema and stiff neck to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had redness at the injection site, soreness at the injection site, a hot feeling at the injection site, and a stiff neck after receiving the vaccination. The reporter did not consent to follow up. The reporter would not give any additional information about the adverse effects reported because did not feel comfortable doing so since it was not concerning herself. The reporter did not give permission to follow up with HCP.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167494:same reporter US-GLAXOSMITHKLINE-US2020167493:same reporter US-GLAXOSMITHKLINE-US2020167490:same reporter
Friend who passed away after having the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Friend who passed away after having the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was performed, but no results were provided.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered DEATH (Friend who passed away after having the Moderna vaccine) to be related.    Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who died after receiving a dose of mRNA-1273.222 vaccine, latency is unknown. An autopsy was performed and it was reported that it may have been a result of the vaccine but no further information was provided. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who died after receiving a dose of mRNA-1273.222 vaccine, latency is unknown. An autopsy was performed and it was reported that it may have been a result of the vaccine but no further information was provided. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.; Reported Cause(s) of Death: may have been a result of the vaccine
Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: vasovagal syncope/fainting.  Patient was unconscious between 30 seconds to 1 minute.  Held seated patient to prevent injury from fall and choking.  After patient regained consciousness, had him lie down for >30 minutes and monitored his pulse/heart rate.  Was able to leave without assistance after about 45 minutes.
pt recv vax 10SEP97 & 11SEP97 pt devel cellulitis;pt exp marked erythema extending from the inj site, a distance of approx 10cm in both proximal directions;devel swelling @ inj site, chills, & fever of 102;pt hosp x 2d;treated for celluliti
Pain in arm at injection site; Swelling at injection site; Red face and chest upon waking day after; Dizziness upon waking; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration on an unknown date in Aug2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included only allergies and known allergies to medications, some foods, some trees, yeast and mold and bee venom. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included pseudoephedrine hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC) and ibuprofen (ADVIL); all for unknown indications from unknown dates and unknown if ongoing. On an unknown date in Aug2021, the patient experienced pain in arm at injection site, swelling at injection site, red face and chest upon waking day after but subsided within 2 hours and dizziness upon waking, subsided in a few hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red face and chest upon waking day after and dizziness upon waking was resolved on an unknown date in Aug2021. The clinical outcome of the events pain in arm at injection site and swelling at injection site was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pt reports redness, swelling, heat, & tenderness to left upper arm since last night (PNEUMOVAX given yesterday at 2pm). Pt has used ice & TYLENOL with some relief. Rx CIPRO for possible cellulitis.
Asthma kicked in,2 hours later and then 3 hours after that she had another attack; it's tough to make a fist; excruciating pain in shoulders, arms, and wrists; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma kicked in,2 hours later and then 3 hours after that she had another attack), HYPOKINESIA (it's tough to make a fist) and ARTHRALGIA (excruciating pain in shoulders, arms, and wrists) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Arthritis and Asthma. Concomitant products included VALSARTAN for Blood pressure management, ROSUVASTATIN for Cholesterol.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced ASTHMA (Asthma kicked in,2 hours later and then 3 hours after that she had another attack), HYPOKINESIA (it's tough to make a fist) and ARTHRALGIA (excruciating pain in shoulders, arms, and wrists). The patient was treated with PREDNISONE at a dose of UNK dosage form. At the time of the report, ASTHMA (Asthma kicked in,2 hours later and then 3 hours after that she had another attack), HYPOKINESIA (it's tough to make a fist) and ARTHRALGIA (excruciating pain in shoulders, arms, and wrists) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a medical assistant refers to a patient  of unknown age. On 08-APR-2015, the patient was vaccinated with an improperly stored GARDASIL lot # K004205, expiry date 12-JAN-2017. No adverse effects were reported. Additional information has been requested.
ash, swelling, itching; Mother states onset of symptoms started when she got home after observation period was completed. Pt was in clinic over an hour as she also had her dental appt in clinic following 2nd dose pfizer administration. When pt got home, mother states she developed pallor, mild tongue swelling with rashey spots to edge of tongue and darker tongue, itchy throat and pt stated her tongue felt weird, but not that it was swelling, mild chest tightness, extensive rash to chest. Bendadryl 50mg given and that helped.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015 , a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 10-AUG-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the zoster vaccine live (ZOSTAVAX) vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. Additional information has been requested.
Shingles virus first appears on body.  Received treatment with antiviral medication and pain patches.  Not sure if this is related to the Tdap vaccination, but thought I would still report it.
a 16 year old male received a dose of Ipol and Varicella by mistake that was due for another person, no AE; a patient accidentally received an extra dose of Ipol, no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a Physicians Assistant.  This case involves a 16 years old male patient who accidentally received an extra dose of IPV (VERO) [IPOL] by mistake that was due for another person.   The patient's medical history, medical treatments, vaccinations and family history were not provided.   Concomitant vaccinations included VARICELLA VACCINE.  On 24-Oct-2019, the patient received a sixth dose of suspect IPV (VERO) [lot P1F491M, expiry date: 30-NOV-2020] via intramuscular route in unknown administration site.   It was a case of actual medication error due to extra dose administered and wrong patient received product.  The PA reported that a 16 year old male received a dose of Ipol and Varicella by mistake that was due for another person due to the 16 year old having the same first name and the date of birth was not verified prior to administration. The 16 year old patient did need the Varicella but this would make the 6th IPOL vaccine. Patient was fine after the doses.  Outcome was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches and weakness that evening, took tylenol with relief. 1/8/21 patient woke up in the middle of the night with fever, blister on the inside of her lip, and her right cheek twitching. 1/8/21 patient went to PCP to be checked out. Discovered redness and bruising at the injection site. Patient has had relief with tylenol and zyrtec.
6x6 cm indurated red mass @ inject site; No other sx; treated w/Ibuporfen & ice; 3SEP93 f/u: given SC; recovered;
7 days post administration , puritic rash developed . Presented first on both ankles, progressed to lower leg , upper leg ,both arms and belly.
chills, fever, body aches and nausea all lasted 24 hours- tylenol and motrin to treat symptoms hives- lasted a few hours dizzy, headache and tired- lasted 48 hours tylenol and motrin to treat symptoms left arm soreness- lasted 5 days tylenol and motrin to treat symptoms enlarged lymph node left armpit- treated by dr...Doxycycline Hyclate 100 MG 2x a day for 7-10 days, warm compress and motrin to relieve pain. Day 3 of antibiotics starting to feel better.
Symptoms like after the flu vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 93 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Feb2021 (Lot number: EN5318, Expiration Date: May2021) at the age of 93 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart issues" (ongoing); "Heart stents placed" (unspecified if ongoing), notes: He had the stents first close to 20 years ago and then another one 10 years ago; "Pacemaker" (unspecified if ongoing), notes: It was put in about 2 years ago; "Sleep" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS (ongoing); FLOMAX RELIEF (ongoing); KLONOPIN (ongoing); LIPITOR ORIFARM (ongoing); TYLENOL; MELATONIN taken for sleep disorder; CANDESARTAN taken for blood pressure measurement (ongoing). Vaccination history included: Pneumonia shot (He gets his flu shot every year and pneumonia shot with no problem); Flu shot (He gets his flu shot every year and pneumonia shot with no problem). The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Symptoms like after the flu vaccine". Therapeutic measures were taken as a result of influenza like illness.  Additional information: The patient taking Eliquis for about 3 years, Flomax for probably 3 years, Klonopin for probably over 10 and Lipitor for might be 10 years. The patient did not visit emergency room or physician office for the event.  No follow-up attempts are possible. No further information is expected.
pt recv vax 22OCT97 12:99 & 23OCT pt had clonic tonic sz Dilantin level was subtherapeutic;
10 days after her vaccine, the patient observed a 3x5 inch rectangular rash on her arm at the injection site. She did not experience pain or itching. The rash resolved on day 13.
eyeballs were burning to the extent that she cannot open her eyes and that they were very painful; eyeballs were burning to the extent that she cannot open her eyes and that they were very painful; weakness; joint pain; fatigue; diarrhea; increased use of inhaler (she is asthmatic); low grade fever; headache; trembling/shakiness; neck pain; vomiting; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported) via an unspecified route of administration on 06Mar2021 as single dose for covid-19 immunization. Patient medical history included asthma from unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient got the first dose of the Pfizer COVID-19 vaccine on Saturday (06Mar2021). She wanted to know if having adverse events associated with the Pfizer COVID-19 vaccine even 5 days after is still normal. She said on the evening the day she got her vaccine (06Mar2021), she started vomiting on 06Mar2021. On Day 2 (07Mar2021), she started to have joint pain, fatigue, diarrhoea, increased use of inhaler (she is asthmatic), low grade fever, headache, trembling/shakiness, and neck pain. On Day 3 (08Mar2021), she continued to have her adverse events and had weakness. Yesterday (10Mar2021), her eyeballs were burning to the extent that she cannot open her eyes and that they were very painful. She said that she received the vaccine with her mom (76 years old) who did not have any adverse events with the vaccine. The outcome of the event eyeballs was burning to the extent that she cannot open her eyes and that they were very painful was unknown rest all were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever 101.8, weakness, ecchymosis, redness & warmth at injection site size of palm of hand, pain radiating into shoulder blade
pt given vax 8/9/99;positive preg test 8/24/99-gestation approx 6wk;
Dizziness, itchy, tightness to inj site on arm, tingles. Symptoms resolved about 15 after observation. Pt was released back to observation area and pt checked out. Pt received the Johnson and Johnson vaccine.
Nurse inadvertently administered proquad to 26 y/o pt instead of MMRII vaccine. Patient observed following incident. Patient did not display any side effects and was instructed to call PCP or report to ER if any concerns or reactions occur.
infection.  On an unknown date, the patient experienced the event(s) hypertension headache, headache in forehead.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hypertension headache, headache in forehead was unknown.
Myositis of right thigh with fever, leukocytosis, and transient inability to bear weight on right extremity without preceding symptoms consistent with an infection. Patient had a clinical and laboratory response to empiric antimicrobial therapy.
Patient tested + for covid on 8-7-22 and was admitted same day to hospital.  Had shortness of breath and fatigue.  dx of covid pneumonia, copd, cad and arthritis.  expired on 8-23-22 .
left-sided facial swelling, sent to ED, received steroid injection and liquid benadryl, symptoms resolved
day following vaccine had transient event where speech was garbled, unable to move any extremities, support head or body weight, lasted 5-6 minutes
Patient received vaccine then 5 minutes later developed shaking, anxiety and tongue swelling. Within 24 hours, the patient developed bells palsy.
Child received H1N1 vaccine @ mass vaccination clinic, sat in observation for 15 minutes, got up to leave, started experiencing tingling in tongue: facial swelling, EMS attended to child, vitals were stable, inj site WNL, parent wanted EMS transport.
No additional adverse effects reported; A patient was administered improperly stored VARIVAX; This spontaneous report has been received from a medical assistant concerning 15-month-old child of unknown gender.  Information regarding the patient's current conditions, medical history, concomitant therapies, drug allergies or reactions, and historical drugs were not provided.  On 16-JUN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number S010297 has been verified to be a valid lot number, expiration date reported and validated as 03-APR-2021) as prophylaxis (concentration, dose, dose description, frequency of vaccination scheme and anatomical location of vaccination were not reported).   The varicella virus vaccine live (Oka/Merck) (VARIVAX) underwent a temperature excursion in the rage of 15 to 46 degrees Fahrenheit (29.5 degrees Fahrenheit) for 67 hours, as recorded by the data logger (product storage error). The vaccine was reconstituted with a properly stored sterile diluent.  There were no previous temperature excursions.No adverse effects were reported for the patient.    This is one of several reports received from the same reporter.; Sender's Comments:  US-00950713-2007USA003075:
Pt began to itch approximately 2 hours post vax, and played ball that evening with onset of rash to her abdomen and increased itching. Rash spread to her legs and shoulder and neck region. No wheezing or shortness of breath. Her doctor prescribed Claritin and Caladryl on 2/9/00. On 2/10/00 rash is less but still continues.
1 day after FLUMIST, developed ear pain. 7 days after FLUMIST (R) ear red and swollen, lymph nodes swollen, ear painful - ear drum clear - not infected. 10 days after FLUMIST - Bell's Palsy on (R) side of face.
I woke up couldn't move, it felt like I had been hit by a truck. I had a fever of 103.0 and a severe headache. Dr put me on bed rest.
Patient was seen 2 weeks after his WWC visit on 8-17-18 for office visit 8-31-18 complaining of increased pain and redness at injection site. On exam he had 1 inch by 2 inch area of swelling, erythema, and tenderness at site. He was treated for cellulitis with cephalexin 500 mg tid x 10d.
Low grade temperature 24 hr x to shots on right arm. (DTaP and IPV) , MMR on left arm No previous reaction. Mom noticed swelling on 07/03/02. vomited x 1 on 07/02/2002, no diarrhea, Denied pain on 7/31/02 5 cm erythema, seen by MD on 7/3/02, Phone f/u 7/05/02 @ 3:00 . Per dad, no swelling, no pain or itching. "He is much better"
Knotted arm; Warm to Touch; Boil or swollen; Left leg muscle cramps; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Knotted arm), FEELING HOT (Warm to Touch), PERIPHERAL SWELLING (Boil or swollen) and MUSCLE SPASMS (Left leg muscle cramps) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NODULE (Knotted arm), FEELING HOT (Warm to Touch), PERIPHERAL SWELLING (Boil or swollen) and MUSCLE SPASMS (Left leg muscle cramps). At the time of the report, NODULE (Knotted arm), FEELING HOT (Warm to Touch), PERIPHERAL SWELLING (Boil or swollen) and MUSCLE SPASMS (Left leg muscle cramps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-108719 (Patient Link).
Pain in right shoulder and right forearm. Also an hematoma in right forearm with inflammation.  The same day that she got the flu shot, she automedicated herself with Acetaminophen and Lidocaine cream from store. Next day she went to an Emergency Room and the physician that attended her said that this was a vaccine adverse reaction.
PM Nov 13 onset shortness of breath; pulmonary hemorrhage; diagnosed Nov 18; intubated Nov 20; renal hemorrhage.
Next day after flu vaccine, noticed redness below injection site, no fever or other symptoms noted, ice pack applied to arm resolved within 2 days.
Pt states she recieved her first dose of the vaccine at 11:50 am.l Pt states after 40-50 minutes she started having tingling in her hands and face. Pt denies any rash, hives, or swelling. Crew determind the pt is having a panic attack and calmed her down. Pt's vitals are stable. Pt states she is feeling better and wants to leave. Pt didnt require transport to hospital.