chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a female healthcare worker of an unknown age reporting on herself. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the healthcare worker went to administrate GARDASIL strength reported as 120 Y (unspecified units), dose, frequency, product lot#, expiry date not reported to an unspecified patient. She reported that the needle came off the syringe when she went to administrate GARDASIL to unspecified patient and all the vaccine sprayed out into her face. She stated some of the GARDASIL vaccine went into her eyes and at the time she did not feel any type of burning or stinging so she went about her day and did not flush her eyes or take any steps to take care of her eyes. She was wearing her contact lenses and did not remove at this time. On an unknown date, reported as approximately three weeks to one month later, she noticed her eyes were gummy, sticky and irritated in the morning when she wakes up, and now she cannot tolerate wearing her contact lenses because she can't see out them. She felt like her contact lens were clouding up. On an unknown date, the patient sought medical attention by visiting an unspecified ophthalmologist who treated her with a combination eye drop that consist of tobramycin and another unknown medication (name and manufacturer unknown). The ophthalmologist mentioned she had little bumps under eyelids that are secreting mucus. There was no product quality complaint involved. The outcome of the events her eyes gummy, sticky and irritated in the morning, she cannot tolerate wearing her contact lens because she cannot see out of them, she had little bumps under her eyelids that are secreting mucus was reported as not recovered. The outcome of the events she felt like her contact lens are clouding up and all vaccine sprayed out into her face was unknown. The healthcare worker also reported that there was no issues with unspecified patient that the GARDASIL was intended for. This GARDASIL that was sprayed out of the syringe during preparation did not come into contact with the unspecified patient. The unspecified patient went to receive full dose of GARDASIL, because she drew up another dose of GARDASIL after the situation. The causality of the events her eyes gummy, sticky and irritated in the morning, she cannot tolerate wearing her contact lens because she cannot see out of them, she had little bumps under her eyelids that are secreting mucus was unknown. Additional information has been requested.
Cellulitis secondary to shots. Right arm 1 1/2" inch / left arm - 1 inch redness, warm, tender both arms at injection sites. Tx'd with BACTRIM DS 1/2 BID x 10 days.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with dose 1, dose 2 and dose 3 GARDASIL (lot # 673256/0629AE, exp date: 16-DEC-2014, reported by a healthcare worker) on 30-JAN-2012, 24-MAY-2012 and 20-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
BLOOD CLOTS IN LEGS; This spontaneous report received from a patient via social media via a company representative concerned a patient of an unspecified age, sex. 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 01 total administered 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 blood clots in legs. Patient reported as, "...same here blood clots in my legs". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230103610-blood clots in legs. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Seizure occurred on same day as immunizations. Lasted 2 min, temp 102.7. No prior history of seizures.
COVID 19 infection  SIRS criteria not met on admission. CXR was unremarkable. Patient without oxygen requirement. No indications for COVID-19 specific therapy.  Will continue supportive care for now Tylenol PRN fever
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported that she started to have tingling numbness in both legs below the knee (predominately calf muscle) within 30 minutes of vaccine. numbness lessened after walking around, but was still noticeable 2 hours after vaccine
Vaccine #1: Pain, swelling & numbness of right arm; unable to lift arm above my waist for 2 days. Tylenol did not help. Deep depression for 2 days-I just had to pray through it. Vaccine #2: minimal pain, numbness, and soreness at vaccination site
Two vaccine not a problem at all they are extremely painful; This case was reported by a consumer via media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the vaccine was received, not a problem at all but was extremely painful. For tolerances of 2nd dose, refer case US2021AMR130065.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR130065:Same reporter.
Complained of itching on friday (shots given thursday PM).  Mom noticed swelling about 20:00 friday night.  Took patient to ER friday PM.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 03-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (Incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Vaccine administered to pediatric patient; A spontaneous report was received from a nurse concerning a 16 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and vaccine was administered to a pediatric patient.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot #026L20A) on 31 Dec 2020, intramuscularly in the left arm, for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the Moderna vaccine was administered by error to a pediatric patient. The patient experiences no symptoms and was absolutely fine.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine was administered to a pediatric patient, resolved on 31 Dec 2020.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
I have now been bleeding extremely heavily for 9 days; I began my period a bit early. It was more heavy than usual, it went for 10 days very heavy, and abruptly stopped. Then 7 days later, it returned, and I have now been bleeding heavily for 9 days; I began my period a bit early. It was more heavy than usual, it went for 10 days very heavy, and abruptly stopped. Then 7 days later, it returned, and I have now been bleeding heavily for 9 days; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 20Feb2021 12:00 (age at the vaccination: 39-year-old) as dose number unknown, single for covid-19 immunisation in public health clinic/veterans administration facility. Medical history included fibromyalgia. Concomitant medication(s) included tramadol taken for an unspecified indication, start and stop date were not reported; norethindrone acetate taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took ibuprofen for drug hypersensitivity. On an unspecified date, the patient was bleeding extremely heavily for 9 days. On 23May2021, she began her period a bit early. it was more heavy than usual, it went for 10 days very heavy, and abruptly stopped. then 7 days later, it returned, and she have now been bleeding extremely heavily for 9 days. Patient stated that, she was out one evening and she bled through her ultra-tampon, maxi pad and jeans instantaneously. Instead of lasting the usual 5-7 days and tapering offset the end, it went for 10 days very heavy, and abruptly stopped. Then 7 days later, it returned, and she have now been bleeding extremely heavily for 9 days, but 16Jun2021 sought out and received medication to stop it. The events result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the events with norethidrone acetate. The outcome of the events was not recovered.  Follow-up actions are needed. Further information has been requested.
fever; chills; nausea; backache; arm soreness; numbness on left side of face; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of 0.5 ml of Shingrix in left arm intramuscularly in February 2022).   On 10th May 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 10th May 2022, 12 hrs after receiving Shingrix, the patient experienced fever, chills, nausea, back pain, pain in arm and numbness facial. On an unknown date, the outcome of the fever, chills, nausea and back pain were recovered/resolved and the outcome of the pain in arm and numbness facial were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, nausea, back pain, pain in arm and numbness facial to be related to Shingrix.     Additional Information: GSK receipt date: 11-May-2022 Reporter's comment: The patient self reported this case. The patient received a dose of Shignrix in left arm and about 12 hours after the vaccination, the patient developed fever, chills, nausea, backache, arm soreness, and numbness on the left side of her face. The patient still had at soreness and numbness in her face. The patient did not want to provide any more demographics and had to go before could inquire about lot/expiry date of the vaccine or whether she would like follow up with her health care professional.  No health care professional for the follow-up. Did not consent to follow-up.
Pfizer Dose 1 3/19/21 (ER8730) Pfizer Dose 2 4/9/21 (EW0153) COVID Positive 8/15/21  8/15/21: The patient presents with difficulty breathing and cough.  The onset was just prior to arrival.  The course/duration of symptoms is constant.  Degree at onset moderate.  Degree at present none.  The Exacerbating factors is none.  The Relieving factors is none.  Risk factors consist of none.  Prior episodes: none.  Therapy today: beta-agonist albuterol.  Associated symptoms: cough. Patient was tested positive for COVID on Thursday August 12th, 2021 and was given the news the next day.  Patient states that he has had problems with cough, congestion trouble breathing body aches and pains due to the COVID. Patient has had both shots and is diabetic and is currently on doxycycline.  Patient states his main concern is that he is having trouble breathing.  Patient takes an albuterol inhaler and states that did not help much.  8/17/21:Patient was admitted from the ER on August 15th, 2021 with bilateral pneumonia due to post COVID syndrome. Patient states that when he would walker try to do anything exertion he would cough become short of breath very easy. The chest x-ray showed a bilateral pneumonia patient states he feels much better with IV antibiotics and breathing treatments.  Patient did not require oxygen during his hospital stay and states that he was able to walking cooperate with his treatment feels comfortable going home at this time.
No adverse effects; the patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 24-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) vial (lot # S009562 and expiry date 26-JUL-2020 both verified to be valid) (strength, exact dose, route of administration were not reported) for prophylaxis.  The suspect vaccine was stored in a temperature of 58.3 Fahrenheit (F) for 3 hours and 15 minutes and in a temperature of 52.1 for 1 hour and 21 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effects were reported.
Intense and strong vomiting and mild diarrhea for 5 hours and unable to keep water down during that time.
Febrile seizures (he does have hx) fever x 2 days max 103.5 sz x 1 min.
rash on her lower arm, rash around her right ankle; Several red lines 3-4 on lower left leg going up towards towards knee; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot was not reported), via an unspecified route of administration, administered anatomical location not reported, on 24Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient stated she had her first dose but experienced an allergic reaction like rashes after the first dose. The patient stated she had a rash on her lower arm, several red lines, about 3-4, on her lower left leg going up towards her knee. The patient stated she had a bit of a rash around her right ankle. The patient stated she was unsure about her left ankle. The patient stated she was not sure when these symptoms began. The patient wanted to know if she should get her second shot because she heard that with the second shot the reactions might be worse. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My spouse received the Pfizer vaccine on the first dose and the second Moderna is there any reason for concern?; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My spouse received the Pfizer vaccine on the first dose and the second Moderna is there any reason for concern?) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My spouse received the Pfizer vaccine on the first dose and the second Moderna is there any reason for concern?). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My spouse received the Pfizer vaccine on the first dose and the second Moderna is there any reason for concern?) had resolved.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates since 03-AUG-2015 the patients had been administered doses of PROQUAD (lot # L009210 with expiration date of 17-SEP-2016, dose, strength and route unknown), which underwent a supported temperature excursion. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Chills, redness at site, 15 x 13cms redness around injection site, distal to site, erythema present, area hard & warm to touch.
Chilblainlike lesions on hands and sparse eczema- like rash on rest of body with onset 8 days from vaccination
This spontaneous report as received from a currently 67 years old female patient refers to herself. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot # and expiry date were not provided). The patient received a letter from her physician's office informing, that the PNEUMOVAX 23 she received, had been improperly stored and it might not be effective for her. No adverse experiences were reported. The outcome of vaccination failure and causality assessment were not provided.
w/in a wk of shot pt started c/o of pain in the lt heel w/in 3 wks had to see MD; now is in a wheelchair w/pain in both heels & dx of spondyloarthropathy;
Flu-like symptoms; Headache; Stomach irritation; Tiredness; Achy; preventing them from sleeping; being so uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 22nd June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd June 2020, 1 hr after receiving Shingrix, the patient experienced influenza-like symptoms, headache, gastric irritation, tiredness, pain, difficulty sleeping and discomfort. On an unknown date, the outcome of the influenza-like symptoms, headache, gastric irritation and tiredness were not recovered/not resolved and the outcome of the pain, difficulty sleeping and discomfort were unknown.   It was unknown if the reporter considered the influenza-like symptoms, headache, gastric irritation, tiredness, pain, difficulty sleeping and discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had flu-like symptoms and a headache. The caller stated that on the day of vaccination (less than a day after vaccination), the patient felt tired and achy going into the night and preventing them from sleeping due to being so uncomfortable.  The caller confirmed that all symptoms on day 2 after the injection are better but not fully gone.  No lot or expiry provided due to receiving at a pharmacy. The healthcare professional information was not obtained.
11 days post Moderna booster I began having intense itching on the palms of my hands and all over my scalp. The next day I woke up with slight hives on my arms and and a red rash on my neck and hands, along with the very intense itching. I took benadryl every 6 hours to control the itching. I went to sleep and woke up at 3:00am with extremely large hives on my trunk, neck, chest, in my armpits, and my hips/waist, along with relentless itching all over my body. I went to the ER where they gave me an epinephrine shot and steroids to calm the reaction (the nurse believed my tongue was swollen, and I had a slight lump in my throat). I followed up with a GP two days later, and he prescribed Prednisone, which I took for 12 days. The itch subsided with steroids, and some of the hive swelling improved over the next 8 days or so. The rash has now turned into dermatographia, my skin is extremely hypersensitive and I still have intense itching if I do not take a Zyrtec each day. I still have small hives if my skin is scratched or brushed against.
left anterior descending coronary artery thrombus requiring thrombectomy, presented as acute anterolateral STEMI
Information has been received from a licensed practical nurse concerning a 43-month old obese white male with allergies to penicillin and the pertussis vaccine (unspecified) which caused hives, asthma, esophagitis and a heart murmur who on 01-Jun-2001 was vaccinated SC in the right arm with the first dose of varicella virus vaccine live (lot #635461/1246K). Other concomitant vaccinations administered on that same day included a SC dose (1st) in the left arm of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #636400/1276K) and an IM dose (3rd) in the left thigh of Hib conj vaccine (Lot #628914/1618H), and an IM dose (2nd) in the left thight of pneumococcal 4 6B 9V 18C 19F 23 F conj vaccine (CRM197) (Lot #474-947). Illness at the time of vaccination included baby bottle caries and clear rhinorrhea. The LPN reported that on 29-Sep-2003, the patient was seen in the emergency room (ER) for cough. On 08-Oct-2003, the patient developed a fever and vomiting. On 09-Oct-2003, the patient developed a rash characterized by more than 100 lesions. It was noted that, three weeks prior, the patient was exposed to a cousin who had chickenpox despite being vaccinated with varicella virus vaccine live (WAES #0310USA01683). On 10-Oct-2003, the patient was seen by a physician and a diagnosis of lesions consistent with atypical varicella infection was made. It was noted that the patient's mother stated by the patient and his sister "broke out" in hives after getting pertussis vaccination, however the LPN reported that she found no documentation in the patient's chart that this was diagnosed by the physician. No laboratory/diagnostic tests were performed. On 20-Oct-2003, the patient recovered. Additional information is not expected.
no fever, 20-70 pox, no pruritus, irritability a/breakout;no treatment necessary, light case 10 day course from start to finish;
Patient came in for flu vaccine. While administering vaccine patients arm was relaxed and was still unable to administer vaccine due to faulty syringe. Needle was removed from patients arm and new flu vaccine was given in opposite arm with no problems. No signs or symptoms.
Vaccinated 9/7/2021, 3/27/2021, 3/6/2021. Admitted 2/17/22 with COVID.
Extreme pain in muscles and nerves.  Blood tests performed and put on prednisone in order to walk. At one time on 30 mg. Prednisone, after being referred to rhematologist currently trying to wean off prednisone and put on Meloxicam
PATIENT HAD VERY,  VERY  SORE ARM FROM ELBOW ON UP TO THE SHOULDER. PATIENT HAD LOSS OF USE OF THE ARM FOR 2 DAYS ACCORDING TO THE PATIENT