chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 05-Dec-2017 from a pharmacist, concerning a 29-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2017, the refrigerator in which vaccine was stored, reached a maximum temperature of 56 F and reporter was not sure of the time span of temperature excursion (reported as 17 hours). On 05-Dec-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179602P expiry date: 30-Apr-2018), which had undergone temperature excursion above 46 Fahrenheit. It was unknown, whether patient had any adverse event after the vaccination. The reporter assessed the case as non-serious. Non-significant follow up received on 05-Jan-2018: No new information received.
Covid vaccine drawn up in syringe was not wasted after 12 hours and was kept in the fridge for 24 hours and used. No patient complaint of adverse events.
Dizziness, Headache, Myalgia, fatigue and scratchy throat Narrative:
Fever, erythema, maculopapular rash face, trunk and extremities, mild conjunctival infection, runny nose - Measle-like syndrome.
His wife had a sore arm after the Comirnaty. It was sore in the arm and the armpit.; His wife had a sore arm after the Comirnaty. It was sore in the arm and the armpit.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shots (Caller and the patient both had their Flu shots), administration date: 21Oct2021, when the patient was 72 years old, for immunisation, reaction(s): "No reaction". The following information was reported: AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "His wife had a sore arm after the Comirnaty. It was sore in the arm and the armpit.". The event "his wife had a sore arm after the comirnaty. it was sore in the arm and the armpit." and "his wife had a sore arm after the comirnaty. it was sore in the arm and the armpit." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Redness; Bit of swelling since 9/7/18; No TX yet.
Patient received pfizer vaccine on 2/11/21, 3/11/21 and 11/17/21. Admitted on 5/26/22 for osteoarthritis of knee. Was to be transferred to another hospital and found to be COVID positive on 6/3/22.  From here, she was placed on isolation. Follow up chest x-ray showed right sided pneumonia. The hospitalist followed the patient for medical management and had her on Doxycycline and Rocephin. She was breathing okay and did not require increased respiratory support. She was eating and voiding without difficulty. She had an additional 5 day stay after her positive COVID confirmed test and was ultimately accepted to other facility swing bed for continued rehab on 6/9/22.  She was transferred in stable condition on 6/9/22
i was really tired and all my joints and ankles were really sore and swollen. My whole body achy
THROAT SWELLED UP; STOMACH AND ABDOMINAL AREA SWELLED; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included 3.4 to 4.4 aneurysm in the aorta, and aneurysm in the blood vessels in the left side of the brain, and concurrent conditions included allergic to citric acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: 05/APR/2021) dose was not reported, administered on 05-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Lab test (NR: not provided) negative (units unspecified). On 05-APR-2021, the subject experienced throat swelled up. On 05-APR-2021, the subject experienced stomach and abdominal area swelled. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, throat swelled up, and stomach and abdominal area swelled, and the outcome of nausea was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, not supported GARDASIL, (anatomical location, lot #, expiration date were not reported) 0.5 ml, was intramuscularly administered, post excursion of -2.3 Celsius degree for 10 hours. This is the one of several reports from the same reporter source. Additional information has been requested.
Patient described having a sore arm "feeling" where the shot was 6+ months post injection. Patient stated it caused functional limitations.
Patient called us a few days after the vaccine, he hadn't felt well for a few days afterward. He had stomach issues including diarrhea and his arm felt very sore. He couldn't work one day
Significant shoulder soreness: although started the day of the injection, got somewhat worse the next day. Took Aleve, may or may not have made much difference. General feverishness, body aches and low energy. Started to set in overnight after injection. Took Tylenol, helped quite a bit. All symptoms disappeared almost magically after 24 hours.
A spontaneous report (United States) was received from a physician concerning a 53-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed about 5 to 8 cm diameter pruritus around the injection site/vaccination site erythema/vaccination site swelling/vaccination site pruritus. The patient's medical history was not provided. No concomitant product use was reported. On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, post vaccination, the reporter stated the patient developed about 5 to 8 cm diameter pruritus around the injection site. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, about 5 to 8 cm diameter pruritus around the injection site/vaccination site erythema/vaccination site swelling/vaccination site pruritus, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Started with a headache, nausea, a fever 106.4, extreme fatigue, very tired,  no appetite, I am trying to keep fluids down. Swelling and soreness at the injection site. all muscles are stiff and sore especially my neck.
The injection site became swollen, red, itchy and tender. The affected area spread to a circumference of about 4 inches. A mild temperature of 99 degrees occurred on day 2.
Nause for 3 days, rapid heart first day, fever day one, dizzy confused 3 days, dizzyness keeps returning, swollen lymph nodes in neck and sore throat for over 2 weeks, headache several days.
Arm soreness and pain, blue blood spot size of nickel several inches below injection site/bruising, redness, swelling, lump several inches below vaccination site, itching at and around injection site, persisting ulnar nerve damage, headache, fever of 102+ degrees, chills, body aches, GI issues, fatigue, and occular migraines
"bilateral thumb joints became very painful, hot, inflamed and difficult to move.  Began taking NSAIDS with minimal pain relief," as reported by patient. Reported s&sx to Occupational Health via telephone on 10/26.  Updated facility on 11/12 via email.  Started using thumb immobilizer 11/13, more comfortable when using immobilizer but no improvement when not in use.  left thumb joint becoming aggravated from increase use.  As reported by patient on 11/17/10.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient. the pertinent medical history included hypertension. On 12-JUL-2014 the patient was vaccinated with OSTAVAX (lot # J016259, expiration date 27-FEB-2014, dose 1, route subcutaneous. The reporter stated that the patient was a case of ocular shingles 4 weeks back and on 18-JUL-2014, the patient was diagnosed with exacerbation of the ocular shingles is being treated with an unspecified antiviral medication by her unspecified ophthalmologist. The outcome of exacerbation of the ocular shingles  was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. Additional information his not expected as reporter refused additional contact.
Pt. states that after receiving the 3rd Booster of Phizer 09/30/2021, started experiencing symptoms of fever, chills, and pain in the arm. Still continuing to experience symptoms. No noted Primary visit.
Approx 7 days after the first dose, the injection site felt warm and firm, and was slightly reddened.  Very itchy.
I have never had a cold sore before. I believe I have 2 starting right now on the upper lip right side. I did have chicken pox when I was a child. This is the only thing I can think of that may have caused this. I was under some stress recently but not more than I have been in before.
Severe difficulty breathing lasting 24 nights (and 10 times during the daytime); This is a spontaneous report from a contactable consumer, the patient. An 80-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Mar2021 at 13:00 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Medical history included 2 stents placed on an unknown date in 2010. The patient had no known allergies. 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 vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Feb2021 at 15:00 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. On 19Mar2021 at 01:00, the patient experienced severe difficulty breathing lasting 24 nights (and 10 times during the daytime). The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, the patient underwent nasal swab test and the result was negative. No therapeutic measures were taken as a result of the events. The clinical outcome of the event severe difficulty breathing lasting 24 nights (and 10 times during the daytime) was recovered on an unspecified date in Apr2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # M042324/expiration date 10-JUN-2018, dose and route were not reported) for prophylaxis. The vaccine was exposed to temperature excursion between 0 degrees Celsius to 1 degrees Celsius for 2 hours and 41 minutes. There was no previous temperature excursion nor data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009093: US-009507513-1709USA003852: US-009507513-1709USA003854.
This spontaneous report as received from a pharmacist refers to a 66 year old female diabetic patient with asthma and no known drug reaction/allergies. On 25-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J003359, expiring 21-JUN-2014, 0.65 ml, subcutaneous. In approximately August 2013 the patient experienced headache, injection site reaction and large lump big as an egg, after she received ZOSTAVAX. There was no evidence of any rash. The patient call pharmacy for medical attention. The patient was instructed to use ibuprofen as a treatment for the events. The outcome of the events was unknown. The causal relationship was not reported. This is one of several reports from the same source. Additional information has been requested.
Fever over 101 for 24hrs Redness/inflammation at the injection site for several days Fussy for 2 days
Allergic reaction to a flu shot / Breaking out across the back of his neck; This spontaneous case was received on 15-Jun-2021 from Med Communications (reference number: SEQW21-01435), reported by other non-health professional and processed together with additional information received on 16-Jun-2021 from Med Communisation (SEQW21-01441), reported by other health professional and concerned a male adult patient. The patient was between 27-32 years old at the time of vaccination. At the time of this report, the patient was 42-year-old.   The patient was mentally handicapped. No other patient's medical history and concomitant medications were reported.  On an unknown date, 14-15 years ago as reported, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.    On an unknown date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient experienced an allergic reaction to a flu shot with breaking out across the back of his neck. It was not a drastic reaction. The care coordinator worked with the patient. The reporters would like to get information on the ingredients for the current vaccines and flu vaccine administered 14-15 years ago. The patient's mother and the patient were interested in getting the COVID shot.  On an unspecified date, the patient recovered from the event.  The reporter assessed the event as related to influenza virus vaccine polyvalent.  Company comment: The event of 'allergy to vaccine' is considered as related to influenza virus vaccine polyvalent.; Sender's Comments: The event of 'allergy to vaccine' is considered as related to influenza virus vaccine polyvalent.
Approx. 6 weeks after 2nd shot, experienced shortness of breath, fatigue, chest tightness, sinus/head pressure. Cannot exercise for more than 10 minutes without resting. Heart monitor and stress test results show no abnormalities.
COVID-19; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced HEADACHE (Headache). On 25-Dec-2020, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Very spiked blood pressure, nausea, flushed, dizziness, sore arm, ended up in ER.
On January 14th around noon, my vaccination site started itching pretty badly.  By later afternoon, I could feel a couple small bumps (like mosquito bites) under my skin at that site.  By evening, the area was red and quite itchy.  I put Cortisone-10 cream on it to help with the itching.  By the morning of January 15th, the area was raised and my upper arm seemed a bit swollen.  Itching continued as well as redness and the area was hot to the touch.  One large lump under the skin.  Redness was about 2.5 inches round.  I called my vaccination location and they were worried about cellulitis so advised me to be seen by a doctor.  Saw CNP at medical clinic.  She diagnosed me with cellulitis  and gave a prescription of Cephalexin 500mg, 1 capsule four times a day for five days.  I asked about getting the second shot in the series and she stated that I could just do it in the other arm.
TEMPERATURE "SPIKED", ACHINESS, STOMACH UPSET FOR A FEW DAYS.
This spontaneous report as received from a pharmacist referred to a 91 years old female patient with no Pertinent Medical History and no Drug Reactions/Allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot # reported as H018799, exp date 15-Jan-2014, subcutaneous, dose unspecified) on 21-DEC-2012. Concomitant medications included MEGACE, trimethoprim and levothyroxine sodium (manufacturer unspecified). On 31-DEC-2012 (today) the patient had a single fluid-filled pustule in middle of her back with a flat, two-inch-by-four-inch rash surrounding it. Patient had sought unspecified medical attention. No Lab Diagnostics Studies Performed. No treatment was given for the events. The outcome was reported as not recovered/not resolved. The causality between adverse event and ZOSTAVAX was unknown. Additional information has been requested.
SEVERE ALLERGIC REACTION; This spontaneous report received from a health care professional via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe allergic reaction was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Swelling of left ear for first 6 days, then swelling worked way down into neck, causing swollen lymph nodes and body aches and headaches.  Also suffer from RA and it seemed to have caused a painful flare up or swollen and stiffness in shoulders.
This is a spontaneous report from a contactable physician via a sales representative. A (Age: 50s-60s; Unit: Unknown) male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced soreness on an unspecified date. The outcome of the event was unknown.
2pm fatigue, soreness in arm 11pm nausea, vomiting, chills 12pm insomnia, fever, chills, body aches, joint pain 2am continued fever despite fever reducers 6am (day after) continued fatigue, arm soreness reduced 12pm continued low grade fever -99.6-100, fatigue 6pm continued low grade fever, fatigue 6am (2 days after) improvement in symptoms 12pm return of low grade fever, and fatigue. continued soreness in arm
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: pityriasis rosea (per MD diagnosis)-Mild, Additional Details: Patient saw prescriber and was told to report adverse reaction as pityriasis rosea to the pharmacy who administered.
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 54-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 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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) 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). 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) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given.
Headache and migraine, constant headaches, general brain fog. Migraine was sudden onset Saturday night at 9:00 pm. Tylenol lessens pain. Headaches and migraines are still ongoing.
2 1/2 hrs post vax pt devel t100.6, eyes sensitive to light, shooting pains in arms, nauseated off & on, h/a, extreme fatigue talked to MD told take extra strength APAP;
Pt described pale- reddened skin about 4 inches across at the injection site. She c/o shortness of breath cough & dizziness.
No adverse reaction reported. Pt was given booster dose post expiration time by 30 minutes.
Vaccine administrator did not properly dilute the Pfizer Vaccine. prior to injection  The full contents of the undiluted vial (6 Dose equivalent) was injected into the Patient  Patient was monitored and released after 15 minutes without incident or adverse event.  The patient was later contacted via telephone (Approximately 5:00 PM)  by the Facility Administrator.  The Administrator reported that at that time the patient was "Fine".  Note: The Administrator is assisting in translation.