chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some soreness in his arm; myalgia; fatigue; fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (Injection site pain after receiving 1st dose on February 2019, see case US2019AMR123448).   On 7th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 8th July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, myalgia, fatigue, fever and shivering. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the myalgia, fatigue, fever and shivering were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, myalgia, fatigue, fever and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose in left deltoid.  The patient had some soreness in his arm when he went to bed last night.  This morning he woke up with myalgia throughout his whole body, fatigue, fever and shivering.
On the morning of this event i printed out the list of patient we would be seeing for the day. It tell me which vaccines the patient has or hasn't had yet. At the time of pt's appt, I misread the form and thought he was due for a flu shot. I was not aware until later that day that the flu shot I gave was expired and had been sitting out of the refridgerator for almost 24 hours. When I gave the shot to patient there was no immediate reaction.
Patient admitted 9/13/2022 at medical center for complaints of shortness of breath and weakness.
Extreme congestion (runny nose, etc) starting about a week after birth/vaccination and up until his death on 10/28/17.
Body aches; Fever of 102.2 (degrees Fahrenheit); This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and PYREXIA (Fever of 102.2 (degrees Fahrenheit)) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced MYALGIA (Body aches) and PYREXIA (Fever of 102.2 (degrees Fahrenheit)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 UNK. At the time of the report, MYALGIA (Body aches) was resolving and PYREXIA (Fever of 102.2 (degrees Fahrenheit)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: 102.2 (High) Fever of 102.2 degrees Fahrenheit.         No concomitant medications were provided by the reporter.
Immediate burn with injection and painful after.  Went to shoulder specialist on 9/14/2021 and diagnosed with SIRVA.  Range of motion decreased more than 20% in all directions on left arm/ shoulder, pain when lifting arm, pushing arm, or reaching across body.  Starting diclofenac for 4 weeks then will assess.  If not any better in 2 weeks, will consider cortisone injection and MRI for treatment .
Extreme pain across  right shoulder, under shoulder blade and weakness- right arm and hand.  Symptoms increased until diagnosed and given Neurontin for nerve pain. Over 2. months, pain decreased and weakness resolved in 4 months.
This spontaneous report was received from a nurse regarding multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L037554, expiry date 25-DEC-2016) (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of -0.17 degrees Celsius for 1 hour 15 minutes. There was no adverse effect reported. Data logger was involved. There were no previous excursions reported. This report is one of several reports received from the same reporter. Additional information has been requested.
Shortness of breath, rapid heart rate, lymph nodes pain, muscle aches, headaches, dizziness, finger numbness and toe numbness (all on left side).  Rash on the arm at injection site that didn't develop until all the other symptoms. Some symptoms have gone away,, some have subsided.  And some are still here 3 months later
Pt recvd 3 doses of Engerix-B vax; 25FEB92 no antibody level to Hep B surface antigen were detected;
Patient received HPV9 on 8/28/15. Went to urgent care on 8/29/15 to obtain x-ray to check progress of her scoliosis and it was there before the procedure was done that she passed out and was sent to the ER.
Her arm feels heavy; COVID arm; red; There were hives, and they got bigger and bigger; arm started feeling hot; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm started feeling hot), PRURITUS (itching), LIMB DISCOMFORT (Her arm feels heavy), VACCINATION COMPLICATION (COVID arm) and VACCINATION SITE URTICARIA (There were hives, and they got bigger and bigger) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (arm started feeling hot), PRURITUS (itching) and VACCINATION SITE URTICARIA (There were hives, and they got bigger and bigger). On an unknown date, the patient experienced LIMB DISCOMFORT (Her arm feels heavy), VACCINATION COMPLICATION (COVID arm) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (arm started feeling hot), PRURITUS (itching), LIMB DISCOMFORT (Her arm feels heavy), VACCINATION COMPLICATION (COVID arm), VACCINATION SITE URTICARIA (There were hives, and they got bigger and bigger) and VACCINATION SITE ERYTHEMA (red) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Consumer informed that the Adverse Events are now resolved and declined further Follow Up.
pt developed local reaction to vaccine. pt had warmth & erythema at vaccine site measuring 12x7cm. no pain/ fever.
COVID-19; Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028LL208) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced COUGH (Cough). On 03-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COUGH (Cough) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitant medication were provided.
pt seen in office on 8/23/07. had varivax 2 days prior and presented with l arm red and swollen. md noted an 8 cm erythematous and indurated confluent area on l arm. pt was given benadryl 25mg po and discharged home. mom was told to call back if no improvement, any changes or questions.
9/21 - extreme fatigue, chills, headache, sore and red arm; 9/22 - extreme fatigue, sore and red arm; 9/23 - sore and red arm; 9/24 - sore arm; 9/25 - sore arm.
pneumonia; sick; Initial information regarding an unsolicited valid serious social media case was received from a non-healthcare professional (patient) via social media on 07-Dec-2020.  This case involves a patient of an unknown age and gender who experienced pneumonia and was sick (Illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (batch number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that the patient was so sick (Illness) and had pneumonia and was placed on antibiotics (Z-pack) cough syrups. Doctor of the patient almost put the patient in the hospital, but the patient preserved and after a week, was way better. The patient was now afraid to take a coronavirus infectious disease (COVID-19) immunization because of fear that the patient could die. So the patient would take the chances and would take lots of vitamins, eat healthy and wear a mask and hope for the best.  No relevant laboratory details were provided.  The event of pneumonia was assessed as medically significant as per the important medical events list and the event of illness was assessed as non-serious.  Outcome of both the events was resolving at the time of report.  Information on the batch number was requested for this case.; Sender's Comments: This case involves a patient of an unknown age and gender who presented with pneumonia after receiving  INFLUENZA VACCINE from unknown manufacturer. Time to onset is unknown. Although, medical history, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
After spending time out in direct sunlight I breakout into hundreds of small hives. It only happens when in direct sun. Sunscreen does not prevent this issue.
involuntary movement disorder; tremors; balance problems; memory loss; This spontaneous report was received from a lawyer and concers a case in litigation and refers to a female patient (pt) of unknown age. There was no information about pt's concurrent conditions, concomitant therapies or medical history provided. On 24-JUL-2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Approximately ten days after receiving zoster vaccine live (ZOSTAVAX), pt suffered debilitating neurological injuries including severe involuntary movement disorders, tremors, balance problems and memory loss which have continued until today. These injuries have resulted in substantial medical treatment and have prevented pt from working. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and caused by zoster vaccine live (ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and disfiguring personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), pt suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment oflife, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of severe involuntary movement disorders, tremors, balance problems and memory loss were considered disabling.
Pt received shot at 1626. At 1637, pt reported that her lower lip felt itchy, cheeks were red. Pt has hx anaphylaxis to multiple food allergies and carries epi pen with her. At 1638, VS: BP 168/112, P 86, O2 100% RA.Lungs clear bilaterally. Pt then reported that her tongue felt ?numb? and ?pins and needles? sensations. Recheck BP is 200/130 at 1644. Pt is awake, alert, oriented. She states that when she has anaphylaxis in the past, this is how it initially presents. Dr. called at 1645 and notified of pt condition and advises to give epi and benadryl and call ems. EMS called at 1650 by RN. Pt requested to wait until EMS is closer to take epi as she said that it can make her blood pressure raise. At 1653, pt willing to take epi. Pt?s seat reclined. Epi pen 0.3mg given at 1653, Benadryl 50mg liquid given at 1654 by RN. EMS on site to take over care at 1655. Pt remains A&OX4 at this time. No difficulty breathing at this time. Pt remains fully conscious. Pt transferred to hospital in EMS. Pt notified that due to her having anaphylactic reaction to vaccine, she will not be able to receive another vaccine. Pt advised to follow up with PCP. RN
hearing loss and other zoster related injuries; hearing loss and other zoster related injuries; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 76 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 04-NOV-2014, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster related conditions.  On an unspecified date, the patient was treated by a physician for the following injuries resulting from Plaintiff's zoster vaccine live (ZOSTAVAX) use: hearing loss and other zoster related injuries. The outcome of the events was not provided.   Upon internal review, hearing loss was determined to be medically significant.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Redness, warmth, tenderness to L upper arm. Raised area slightly bigger than a silver dollar.
Received inj. 5:35 PM on 11/2/2012 - within a few hours became very ill 3:05 AM 11/3/2012 on the floor unable to move paralyzed from the chest down ER visit admitted to hospital stayed in the hospital from 11-3 - 11-9. Transferred to Rehab nursing facility. Released on 11-28-2012.
Severe crushing chest pain substernal midchest > 5 minutes unrelieved until fell asleep.
Pt recvd 2nd dose of vax & shortly thereafter pt exp welts & itching localized to the arm where vax was given; MD felt that was having allergic reaction;
Could hardly raise her arm; stools; general malaise; flu; felt sick; chills; fever of 102F; muscle pain; joint pain; felt worn out; injection site was red; Injection site was swollen; Next day arm still sore; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could hardly raise her arm), PAIN IN EXTREMITY (Next day arm still sore), DIARRHOEA (stools), MALAISE (general malaise) and INFLUENZA (flu) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Next day arm still sore), VACCINATION SITE ERYTHEMA (injection site was red) and VACCINATION SITE SWELLING (Injection site was swollen). On 05-Mar-2021, the patient experienced DIARRHOEA (stools), MALAISE (general malaise), INFLUENZA (flu), ILLNESS (felt sick), CHILLS (chills), PYREXIA (fever of 102F), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (felt worn out). On an unknown date, the patient experienced MOBILITY DECREASED (Could hardly raise her arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Could hardly raise her arm), PAIN IN EXTREMITY (Next day arm still sore), DIARRHOEA (stools), MALAISE (general malaise), INFLUENZA (flu), ILLNESS (felt sick), VACCINATION SITE ERYTHEMA (injection site was red), VACCINATION SITE SWELLING (Injection site was swollen), CHILLS (chills), PYREXIA (fever of 102F), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (felt worn out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
On 8/21 pt had MMR II, DPT and Varicella vaccinations. DPT and Varicella were given in the right arm and MMR II in the left arm (per the nurses memory; not documented).On 8/22/08 the mother noted the right arm was swollen, red, hot and hard from the shoulder to the elbow. She took the pt to the ER. The hospital child was prescribed BENADRYL. On 8/23/08 the redness and swelling were past the elbow so the mother took the child to the pediatrician. The child was prescribed erythromycin for a possible cellulitis. Additionally the mother started applying cold compresses. Around noon on 8/24 the symptoms started to improve. At 1600 8/25/08 the pt was 90% better. Mother instructed to stop antibiotics. Symptoms completely resolved without further treatment. Symptoms: Erythema, Swelling, Pain.
2nd dose: 102 high Fever, difficulty breathing , palpitation on  02/06/2021,  slight fever the next day then 3rd day 02/08/2021 headache, dizziness, hallucination with fever. headache and body pain until  6th day. then it subsided. after 8th day. 1st dose(01/08/21):  delayed reaction 8 days after the vaccination chills, headache and body pain for 5 days.
Patient reports becoming very sore and bled with reported changes to band-aid after administration of flu shot to left arm. She reported to clinic located at work and spoke with RN who said site was "high". Patient also reported that a pharmacist told her it was "high". Patient complained of numbness to (L) arm.
Extreme body aches, fever, chills. Intense body aches and fatigue for approximately 16 hours.
Within 10 minutes of receiving flu shot, the pt experienced itching at the injection site and over abdomen. Approx. 2 hours later, the pt had a racing heart rate of 160 and hot flashes. Aid car was called and pt was transported to ER. He complained of pain and tingling on left side of head. Currently he is experiencing heart arrhythmia. He continued to experience cardiac arrhythmia.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
warm to touch; rash around injection site; itchiness on left shoulder; Pink reddish circle; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE RASH (rash around injection site), VACCINATION SITE PRURITUS (itchiness on left shoulder) and VACCINATION SITE ERYTHEMA (Pink reddish circle) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE RASH (rash around injection site), VACCINATION SITE PRURITUS (itchiness on left shoulder) and VACCINATION SITE ERYTHEMA (Pink reddish circle). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE RASH (rash around injection site), VACCINATION SITE PRURITUS (itchiness on left shoulder) and VACCINATION SITE ERYTHEMA (Pink reddish circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Approximately 20 minute after vaccine administration, returned to unit and became lightheaded and foggy.  Unable to fully concentrate on tasks.  Flushed in face and unsteady lasting approximately 1 hour.  Developed headache lasting remainder of shift.  Developed body aches/chills in evening
This case was reported by a consumer via other and described the occurrence of allergic reaction in a male patient who received SHINGRIX (batch number B327C, expiry date unknown). On 25th April 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced allergic reaction, pruritus, welts, vomiting and tachycardia. On an unknown date, the outcome of the allergic reaction, pruritus, welts, vomiting and tachycardia were unknown. It was unknown if the reporter considered the allergic reaction, pruritus, welts, vomiting and tachycardia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient allegedly had SHINGRIX vaccination on 25th April 2018 and had allergic reaction resulting in itching, welts, vomiting and tachycardia. The medical attention was being sought.
01/09/22 presents to EC ED for "acute onset dyspnea". PMHx of "asthma, diastolic heart failure and COPD"
On May 8, 2018 the patient came in to the pharmacy where he received his SHINGRIX shot and inquired if the rash he developed a few days before was shingles and he was referred to his primary care physician.