chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In September 2018, the patient received the 1st dose of Shingrix. In September 2018, 1 day after receiving Shingrix, the patient experienced muscle pain, loss of energy, injection site erythema and fever. On an unknown date, the outcome of the muscle pain, loss of energy, injection site erythema and fever were recovered/resolved. It was unknown if the reporter considered the muscle pain, loss of energy, injection site erythema and fever to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix sometime in September 2018 exact date was not known. He had muscle aches, fever and no energy. The symptoms began 1 day after the dose and lasted for 4 to 5 days. The patient had a big red spot on the injection site the resolved after 3 days. The patient had denied permission to contact their physician. This case has been linked with case US2018186350, reported for his wife.
Right arm swollen at site the size of an egg, red & hot to the touch. Gave store brand TYLENOL and did warm compress.
Positive pain with numbing/tingling sensation radiating to finger tips. Positive fever, positive nausea, positive HA, positive dizziness.
Approximately 3-5 minutes postvaccination pt was squatting down near parent when pt stated she was starting to feel light headed then fainted. Legs were elevated and vital signs taken. Pt. revived within 30 - 40 seconds. An ARNP examined pt. who was then able to sit without difficutlies. Neuro check wnl PERRLA. Cranberry juice provided to pt. who had stated she had very little to eat today. Approximately 5-8 minutes post fainting pt. was able to stand without c/o light headedness. Had pt and parent stay 20-25 minutes longer for observation.
On the seventh night after vaccination, somewhat suddenly, I could not move my left arm without pain, pain radiated to left  side of neck, two red  swollen splotches near injection site, which were hot to touch, appeared & I had some itchiness at the site . Pain & arm movement  fully resolved on its own within  about  10- 12 hours, With intermittent  ice  applications, swelling  resolved within  10 hours.  As of today, four days after the reaction started, I still have splotches, but they are a lighter color,  & a bit of soreness in  that area.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (possible that doses were given after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (possible that doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (possible that doses were given after expiration date) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. It was reported they have 20 vials of Moderna vaccine, Caller not know if they had a shelf life extension. They have quite a bit of it in the freezer. No treatment information was provided by the reporter.
slight pain at site from injection - hours later into the next day moderate pain at injection site.  Could not sleep on that shoulder as pressure then created more intense pain.  Continues into the second day
Laryngeal edema. hoarseness developed over about 30-60 min. to the point of barely being able to whisper. never developed shortness of breath. It started to subside without treatment within about 2 hours.  I was already at ED then because I didn't know if it would subside or get worse. I did get decadron 12mg and Benadryl 25 mg by mouth but the symptoms had already started improving before any treatment given.  no other symptoms. normal heart rate (60s), 100% O2 sat, BP elevated but returned to normal. no swelling of lips or face, no rash, no sweaty or clamminess or rapid breathing. Respiratory rate remained round 15/min. no feeling of impending doom.
In a few days had left severe shoulder, lost strength. Weakness persist to present. Pain with motion. Self PT.
Information has been received from a registered nurse concerning an adult female who on 12/28/01 was vaccinated with Varivax On 01/07/02, the patient developed 5-8 vesicular lesions and a low-grade fever. Unspecified medical attention was sought. Additional information has been requested.
achiness; tingling; Loss of appetite; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), PARAESTHESIA (tingling), DECREASED APPETITE (Loss of appetite), FATIGUE (fatigue) and PYREXIA (fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), PARAESTHESIA (tingling), DECREASED APPETITE (Loss of appetite), FATIGUE (fatigue) and PYREXIA (fever). The patient was treated with CALAMINE at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, PAIN (achiness), PARAESTHESIA (tingling), DECREASED APPETITE (Loss of appetite), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medication was reported.   This case was linked to MOD-2021-015832.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 90-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). Concomitant products included hydralazine and Levothyroxine. On 24th April 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 24th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 30th April 2018, the patient experienced stiff neck. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the stiff neck was unknown. It was unknown if the reporter considered the injection site pain and stiff neck to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The next day after receiving vaccine, the patient had excessive soreness at the injection site. On the day of reporting, 6 days after receiving SHINGRIX, the patient woke up with a stiff neck on the same side that she received SHINGRIX.
Patient called pharmacy to say he woke up day after administration on 3/31/13 with a itchy rash at siteof injection. He called pharmacy on 4/1/13, said it was less itchy today but wanted to report it.
Urticaria, Skin erythema- Information has been received from a physician concerning a 13 month old caucasian female, who on 22 Dec 2000, was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 635280/0579K in the left thigh. At the time of vaccination, the patient had benign neutropenia. Concomitant vaccination included poliovirus vaccine ipol and streptococcus pneumonia vaccine prevnar.
experiencing shortness of breath, fatigue, muscle pain, headache, fever, body aches, chills, fatigue, chest pain
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, swelling, pain and skin warm. On an unknown date, the outcome of the erythema, swelling, pain and skin warm were unknown. It was unknown if the reporter considered the erythema, swelling, pain and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist did not provide any more information at the time of reporting but stated that she would call back on Monday with more information about the patient. This case was linked with US2018130334, reported by the same reporter.
Redness, itching, and rash at injection site. Reported symptoms on 10/08/2014 @ 9:30 AM.
More than 24 hours after getting the vaccine I noticed warm spots on my arms and legs and noticed red raised blotchy spots where it was warm. At the injection site there is a very warm raised hard lump. I took Benadryl and it helped me sleep. It got more painful and warm and I was very uncomfortable.  Its not as bad 16 hours later, however the swelling is still pretty bad at the injection site
8cm area of induration on left upper arm developing approximately 36 hours after administration of varivax vaccine.
He got an upper respiratory infection (tested negative for Covid and flu on swab at pediatrician's office) and had croup for the first time in his life 10 days after the first dose. It seems possible to me that the vaccine may have caused slight inflammation that, in addition to the upper respiratory infection, triggered the croup. He received oral dexamethasone in the pediatrician's office the next day and did not experience any further croup symptoms. He did have sniffles and an occasional cough during the day. He still has a runny nose as of today.
Very Painful Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very Painful Sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Very Painful Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Painful arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Very Painful Sore arm) had not resolved. Patient reported her adverse event of very painful sore arm , after vaccination stopped and restarted on 15Feb2021      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date in February 2014 the patients were vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown) which had been improperly stored. No concomitant medications were reported. No adverse events were reported. The action taken with GARDASIL was unknown. No product quality issue was reported. This case is related to case 1403USA007409 and 1403USA008197 via same reporter link. Additional information has been requested.
At 0958 hrs, after vaccinating patient ( 54 Y/O female), with Hepatitis B and Influenza, patient slumped in chair but did not lose consciousness.  Patient reported feeling dizzy with headache 6/10; patient also reported history of headaches. LVN took VS at 100:00 am and were BP165/90, HR 79. Patient then reported she had been fasting since 2/27/2023. She was offered Emergency Medical Services but denied them. She denied previous vaccine reaction to vaccines and major health issues. At 10:05 am VS were BP 158/81, HR 79. Patient then stated headache pain level to be 4/10. PHN Supervisor was notified of the situation. 10:20 am VS were 161/77, HR 79. At this time, patient reported that the dizziness and headache diminished. Final VS 10:35 am were BP 124/76, HR 63. Patient remained alert and oriented through the entire event.  LVN advised patient to follow up with PCP and for husband to observe for any changes in condition. 10:50 AM pATIENT DEPARTED CLINIC WITH HUSBAN.
Fever (went up to 102), aches, sore arm, diarehea, throwing up, tired, headache, dizziness  (all lasted for several days).  Felt like a very bad case of the flu.  I also receive a flu shot each year and have  almost the same reactions.
Janssen COVID-19 Vaccine EUA: two weeks after vaccination patient reported to an urgent care with right leg swelling and headache. Two days later patient presented an emergency department, diagnosed with left lower extremity deep vein thrombosis (DVT) and bilateral pulmonary emboli (PE). Transferred to current hosptial for management including anticoagulation with a direct thrombin inhibitor, intravenous immune globulin (IVIG), and additional laboratory testing.
Did Xray found a big black spot on top of left side of stomach.  dr said it was blood clot from the vaccine.; Severe stomach pain; This is a spontaneous report received from a contactable consumer (patient). This 68-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as 2nd dose, single at the age of 68-year-old for covid-19 immunisation. The patient received the 1st dose of bnt162b2 on unknown date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe stomach pain. Did Xray found a big black spot on top of left side of stomach. Dr said it was blood clot from the vaccine. Happened week after taking shot. The product was used by the patient. The outcome of event was unknown. Information on the lot/batch number has been requested.
Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
(7/1/2021) Chronic Diahrrea, bloating, gas, first time having these issues, ongoing
Just shortly after the first set of shots he had a temperature and hives all over body and after second set of the same shots 2 months later it became worse resulting in an emergency trip to the hospital that week. He has severe allergies to animals and food. And asthma now. I seen it escalate after each set of shots he has had.
Cough with  phlegm; Covid pneumonia; tested positive for Covid 19; Loss of smell; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of smell,covid-19,covid pneumonia and cough with phlegm.  The patient's medical history was not reported. Concomitant medications was not reported.  On 03 Feb 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 09 Feb 2021,the patient experienced loss of smell.On 11 Feb 2021,she tested positive for covid pneumonia.On 16 Feb 2021,she had  covid pneumonia.On 26 FEB 2021 she has cough with phlegm and slight loss of smell. This case is considered as a serious case as the event covid-19 pneumonia is medically significant. Lab details were not provided.  Treatment for the events included Z pack,steroids and antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of the report,the events covid-19 pneumonia,anosmia,covid-19 and productive cough were unknown.; Reporter's Comments: Covid-19 pand Covid-19 pneumonia are unlikely to be related to Moderna Covid-19 vaccine. Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 16-year-old male patient who received MENVEO. Concomitant products included Influenza vaccine Quadrivalent. On 31st October 2017, the patient received MENVEO. On an unknown date, less than a week after receiving MENVEO, the patient experienced injection site erythema, injection site irritation and injection site wheal. The patient was treated with Steroids. On an unknown date, the outcome of the injection site erythema, injection site irritation and injection site wheal were recovering/resolving. The reporter considered the injection site erythema, injection site irritation and injection site wheal to be related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported. The patient received MENVEO coadministered with Influenza vaccine Quadrivalent on the left arm. Following administration, the patient experienced local irritation (redness). On 2nd November 2017, 2 days after vaccination, the patient reported knife like welt at the site where MENVEO was administered. The provider treated the patient with cool compress and steroid. The healthcare professional (HCP) followed up with the patient where, his mom reported he was doing fine now. The reporting HCP did not administer the vaccines, but felt MENVEO caused the adverse events (AE). The patient did not require any further care or treatment. The reporter gave consent to be followed up.
Pfizer-BioNTech COVID-19 Vaccine EUA I got the first dose on 1/20/2021, and the side effects occurred on 1/21/2021. My left arm was so painful that I couldn't raise it. I felt dizzy and got a fever in the afternoon. The temperature is around 101?. Then I took some Ibuprofen and I recovered the next day.
itching/Itching areas in a pattern on body; red/itching area; both of his hands were swollen, red and very itchy; This is a non-serious spontaneous report from a contactable consumer. This consumer reported for a 78-year-old male patient (Reporter's Husband). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL9246), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 14:30 (at the age of 78-years-old) as a single dose for covid-19 immunization. Medical history included blood cholesterol abnormal. Concomitant medication(s) included atorvastatin; paroxetine; omeprazole; tamsulosin; metoprolol. After the first dose, on 17Feb2021 later in the day he had onset of itching areas in a pattern on body. She called to ask if there are any recommendations regarding the second dose of the Pfizer COVID-19 Vaccine relative to this event. Second dose is scheduled for 08Mar2021. Itching areas in a pattern on body: On 20Feb2021 caller took the patient to the walk-in because this event was so bad that he would wake up during the night due to itching so bad. This event was not like a rash to her; she thought this event was strange because usually a rash is like on the chest and legs or whatever; but it was more of a pattern of a probably 6-8 inch circle on both thighs where the areas were raised and a little bit red; and then on each of his sides from under his armpits down to his waist he had a line of itching areas that were red; and an itching area on his lower back that was red; and then both of his hands were swollen, red and very itchy. At the walk-in the doctor gave him prescription fluocinonide cream which he started on 20Feb2021. After starting fluocinonide cream he slept all night and used it for about a week and the fluocinonide cream really worked; he recovered completely from the event by around 25Feb2021. Caller reported that there was nothing new around time of vaccine and event onset, regarding concomitant products and other medical conditions. Outcome of the event was recovered on 25Feb2021. No follow-up attempts are possible. No further information is expected.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a three years old female patient who received 0.25 ml dose of vaccine FLUZONE QUADRIVALENT inadvertently. The patient's past medical history was not reported. No other concomitant vaccine was administered. On 02-OCT-2018, the patient received a 0.25 ml dose of suspect Influenza Quadrival A-B Vaccine (lot number: UT6259KA and expiry date: 30-Jun-2019) via intramuscular route in the left leg. It was a case of actual medication error due to vaccine underdose. No adverse event was reported. 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. List of documents held by sender: none.
4 day history of numbness and tingling in left arm. Was gardening when symptoms started in left hand/thumb. Then progressed to wrist. Felt surface numbness on back of hand, then numbness/tingling progressed to left forearm and left biceps.   Feeling like today she is having left triceps and left-sided chest palpitations/tingling. Eventually developed dermatomal vesicular rash in area of numbness/tingling.
No additional AE reported; proquad was improperly stored and then administered; This spontaneous report was received from a physician refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 12-FEB-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # T023920, expiration date was reported and also validated as 09-JAN-2022 (dose was unknown; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The data logger registered, that the vaccine was stored at the temperature of 30 Fahrenheit degree (F) for 11 hours and 45 minutes. There was no previous temperature excursion detected. No additional adverse event (AE) was reported.