chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of inappropriate schedule of product administration (more than 35 days from 1st vaccination) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced inappropriate schedule of product administration (more than 35 days from 1st vaccination). At the time of the report, inappropriate schedule of product administration (more than 35 days from 1st vaccination) resolved. No concomitant medications, laboratory details or treatment information provided. The patient was actually scheduled for 2nd dose on Jun 1, 2021. Action taken with mRNA-1273 in response to the events:  not applicable.
This spontaneous report as received from a physician refers to his wife of unknown age. The physician reported that his wife had received a dose of ZOSTAVAX (lot# and expiration date not reported) "about 4 years ago". The physician stated the patient "had a spot near her eye, her eye was swollen, she had couple other spots on her head, and experienced pain {in an unspecified area of the body)" and diagnosed with herpes zoster "within the last year". The patient was treated with an unspecified antiviral medication. No additional information provided. Additional information has been requested.
Case number PHEH2014024314, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to 60-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 13 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose number unknown, single (Lot number: Fj4991) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from Apr2023 to 03May2023. .
Sore swollen arm, shivering for 24 hrs, body aches, headache
After dose 1 and about started 9 days on 01-13-2021 having PVC intermittently and this continued into my second dose. Also had dizziness and hypertension. I went to see doctor on 02-01-21. The PVC were continuing, they did blood pressure and it was very elevated and started medication and the PVC are continuing today. I have my blood pressure checked in the previous months and it has been normal but I still have the PVC.
Elevated liver functions after receiving vaccines diagnosed April 2021 after previously being normal Dec 2020 and Feb 2021.
Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Menopausal symptoms, PROPRANOLOL for Tremor.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm) (seriousness criterion medically significant). On 01-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Ultrasound scan: abnormal (abnormal) found a large benign mass (cyst) on left breast in the upper quadrant of the nipple approximately 5 cm. On 25-Apr-2021, X-ray: abnormal (abnormal) found a large benign mass (cyst) on left breast in the upper quadrant of the nipple approximately 5 cm.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included ibuprofen.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-127452 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Information has been received from the licensed practical nurse concerning a 68 year old white male with no known allergies who was vaccinated IM with a dose second dose of pneumococcal 23v polysaccharide vaccine (lot # 647039/0604N). It was noted that the patient received a first dose of pneumococcal 23v polysaccharide vaccine in 1997. The patient experienced a sore arm with swelling, redness, and tightness on or near the injection site. The reporter indicated swollen and sore he reported later on 11/4/03. It was noted that the patient never came to the office during the reaction. The patient was treated with ice and ibuprofen. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information is not expected. The reporter also indicated that two other patients experienced similar reactions after therapy with pneumococcal 23v polysaccharide vaccine.
This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a patient who received ROTARIX. On an unknown date, the patient received ROTARAIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to ROTARIX. Additional details were received as follows: The reporter reported that, the patient experienced an adverse event after administration of ROTARIX. The reporter did not have any information. The reporter would have a call back from a health care professional with additional information.
1wk /p inject had pain&redness @ site./P 4 days pain stopped-redness cont,moved down arm to elbow.@ end of Jan91 or early Feb91 pt noticed "Bld blister @ site".Saw MD-drained 12Feb.19Feb MD incised area&inserted drain /p removing fat tissue
problem with her shoulder; she couldn't lift her arm over her head; needle was probably injected too high on her arm; problem with her shoulder; she couldn't lift her arm over her head; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN6206) via an unspecified route of administration, administered in right arm on 09Mar2021 10:30 (age at vaccination 77 years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included mastectomy therefore she could not get the vaccine in her left arm. Concomitant medication was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that a few days afterward she started to have a problem with her shoulder; she could not lift her arm over her head on an unspecified date in Mar2021. She called the COVID hotline in and they advised the needle was probably injected too high on her arm. The patient called her physician, and she did go in to see the nurse practitioner who started her on physical therapy and gave her a prescription for Naproxen. The patient had to do ten sessions to get her shoulder back to where it was supposed to be. She thought that was a little better on the day of report. The patient scheduled for the second dose and she was scared to get it because she did not want to have another problem on an unspecified date in Mar2021. The patient was scheduled to receive the second dose on 29Mar2021 at 11:00. She was asking for recommendations about what to do in that situation. The patient was received Naproxen 500 mg and physical therapy for treatment of events. Outcome of event problem with her shoulder; she could not lift her arm over her head was not recovered.  No follow-up attempts are possible. No further information is expected.
He started feeling funny, his pulse starting racing, the vein in his right arm (the shot arm) started pulsing rapidly.  He then had chills, fever of 101.2.  His pulse stayed at 95-100 beats per minute for 2 hours.  I spoke to a nurse friend of mine who told me to give him Tylenol and Benadryl.  His pulse went down to 80 beats per minute.  His fever went higher during the night but eventually broke.  Next morning he was still running a low grade fever and took Tylenol the rest of day.  He also had diarrhea on 2nd day and exhaustion.  3rd day feeling better but still tired.  No fever or diarrhea today.
Phone call 7/31/02 - redness at injection site and hives up and down both legs. No fever, no illness. Itchy.
Discolored diarrhea  (yellow-orange) occurred the day after vaccination 5/28/2022 which has now subsided. Stiff neck and muscles around the neck occurred on Sunday 5/29/2022, and has not resolved up to date after interviewing patient on 6/4/2022. Patient has visited chiropractor 4 times since incident and marginal improvement has occurred; not significant enough to make patient feel better.
Intermittent Urticaria/rash throughout body that lasts for about 1-2 hours then subsides.  Taken 25mg Benadryl prn.
vomiting with in 24 hours; dose_received: 03; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 22 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 17:00 (Lot number: FL3197) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0178), administration date: 18May2021, when the patient was 21 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168), administration date: 09Jun2021, when the patient was 21 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 17:00, outcome "unknown", described as "dose_received: 03"; VOMITING (non-serious) with onset 06Jan2022 11:30, outcome "not recovered", described as "vomiting with in 24 hours". Therapeutic measures were not taken as a result of vomiting.  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
pt recv vax 17MAY96 & 31MAY96 pt devel a rash;pt was noted to be covered w/lesions;
Inadvertently administered 0.5ml dose of Moderna COVID vaccine to a 16 year old female; A spontaneous report was received from a pharmacist. This case concerns a 16 year old female patient who experienced inadvertently administered 0.5ml dose of Moderna COVID vaccine to a 16 year old female with the use of mRNA-1273.    There was no medical history provided. There were no concomitant medications provided.   On 16 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch # 026L20A), for prophylaxis of COVID-19 infection.   On 16 Jan 2021, it was inadvertently administered 0.5ml dose of Moderna COVID vaccine to a 16 year old female. It was noted the patient did not experience any adverse reactions during the 15 minute observation period. There was no treatment information provided.  Action taken with mRNA-1273 to the event of inadvertently administered 0.5ml dose of Moderna COVID vaccine to a 16 year old female was not provided.  The outcome for the event of inadvertently administered 0.5ml dose of Moderna COVID vaccine to a 16 year old female was resolved on 16 Jan 2021.; 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.
Hypertension (160); Intense migraine; hot arms; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 05May2021 at 17:45 at 44 years (Lot Number: EW0170), as single dose, for COVID-19 immunisation. The patient's medical history was not reported. Patient did not have known allergies, did not have COVID-19 prior to vaccination, was not pregnant and was not pregnant at time of vaccination. Concomitant medication included unspecified birth control. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 10Apr2021 at 14:45 at 44 years (lot# EP7533) in left arm. Patient did not receive other vaccines in four weeks. The patient experienced hypertension (160) (medically significant) on 06May2021 at 06:00 with outcome of not recovered, intense migraine (medically significant) on 06May2021 at 06:00 with outcome of not recovered, hot arms (medically significant) on 06May2021 at 06:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood pressure: hypertension (160) on 06May2021. Therapeutic measures were taken as a result of the events and included treatment with lisinopril 20 mg. Patient did not tested for COVID-19 post vaccination.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # K010216, expiry date 17-SEP-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Joint aches, stiffness in joints, severe pain in wrists, hands, shoulders, pelvic area.   Tired.
2/23/2021 - patient found in room w/ left groin pain & right sided numbness - upon admission to hospital he has no movement in right leg & minimal movement in right arm.
About 5 min after the pt received her shot she stated the did not feel well. Pt was very pale the pt did pass out for a second and came back around on her own. Took her pulse and we took her BP 113/67 76. She was taken down to the ED for monitoring  Dizziness, Headache, Lightheadedness, Loss of consciousness, Weakness, tachycardia   flushing, tachycardia. Lip swelling 4 hrs after second Moderna Covid vaccine
Face swelled up on right side.  Lips throat and checks.  I could hardly eat drink etc.  Throat was bad also had a rash on chest and on back around left arm
inability to function; blood pressure which is usually 130/80 spiked for several weeks at consistently 200; rash that moved all over my neck arms and legs which was extremely painful and I still have small rashes on arms 11 weeks later; Extremely fatigues; almost lost ability to walk; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15May2021 at 17:00 (at the age of 59-years-old) at dose number unknown, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were reported as none. Patient had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. On 19May2021 at 16:00, the patient had a rash that moved all over her neck, arms and legs which was extremely painful and she still had small rashes on arms 11 weeks later. Blood pressure which was usually 130/80 spiked for several weeks at consistently 200, since 19May2021 at 16:00. Patient had to be hospitalized in 2021 due to inability to function, on 19May2021 at 16:00. Extremely fatigues and almost lost ability to walk, on 19May2021 at 16:00. The events were reported as non-serious. The events resulted in emergency room/department or urgent care visit. A treatment was received in response to the events. The patient underwent lab tests and procedures, which included X-ray, EKG and bloodwork in 2021, all with unknown results. The patient had recovered from the events in 2021.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
13NOV95 pt devel 2" swelling in rt delt-IM w/in 1 min of vax;pt didn't know of having prev rxn to any components of vax;pt advised to put ice on it&go to ER if diff breathing;27NOV95 pt concerned w/yellow circle w/4 10" purple specks
THROBBING PAIN; THROWING UP; DIARRHEA; SORE ARM / SEVERE ARM PAIN; This spontaneous report received from a patient concerned a 55 year old female. 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 not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, the subject experienced sore arm / severe arm pain, throbbing pain, throwing up, and diarrhea.  Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm / severe arm pain, throbbing pain, throwing up and diarrhea was not reported. This report was non-serious.
pt stated he got vax he started having joint pain in the left knee.  On 3/23/2021 he is still having this pain and it has become severe.  He is taking Aleve and has not contacted his PCP at this time.
She has had a local reaction where the flu shot was  given: 10 cm diameter area of induration, heat, erythema, tenderness.
PT BECAME UNRESPONSIVE AFTER VACCINE GIVEN, EPIPEN ADMINISTERED, 911 CALLED, PT HOSPITALIZED
Client verbalized feeling dizzy and nauseous after receiving the vaccine.  Client was evaluated.  Client was hydrated and place in a cool environment until resolved.  Client was cleared at 2:57 pm.
Following morning after vaccination- Body aches, severe head ache, fever (from 99.9 at 8 am to 101.9 by 10 am), light cough and head congestion. All day with the same symptoms. Days 2-4 : night sweats, light cough, head pain  with each cough, head congestion, on Tylenol and Ibuprofen.
Swelling; Redness; Pain; This is a spontaneous report based on the information received by Pfizer . (LRN: LRN4318153)  A contactable healthcare professional reported that a 40-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphteria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization. Medical history included (lower) leg localized swelling, ongoing asthma with acute exacerbation (also reported as severe persistent asthma, uncomplicated), blurry vision, carbuncle chest wall, cervicalgia, depression, possible diffuse nontoxic goiter, esophageal reflux, hepatic disorder, allergic rhinitis, vaginal discharge, lumbar strain, menorrhagia, open wound of the hand, telangiectasia, hereditary hemorrhagic and "last blood transfus". Concomitant medications were not reported. On an unknown date, the patient experienced swelling, redness and pain. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 24 hrs of immuniza. with large local reaction: redness and swelling of entire deltoid. Then 24-48 hours generalized itchy rash. 5 days after immuniza, rash on deltoid and swelling from mid upper arm over the AC joint.
Initial: fever within first 24 hrs (100.2 F), muscle (head, shoulders and both arms) aches, soreness at injection site Day 3  after injection (11/5/2021): rash, redness and inflammation on inside left arm from mid-upper arm down to mid-lower arm. Rash expanded over approx 48 hrs, still present at  time of this reporting (11/9/2021); fever and body aches subsided after 24 hours.
Vax was inadvertently reconstituted /w sterile H2O instead of diluent provided, she was told to use aluminum hydroxide to dilute for fewer side effects. Pt had "a sore thigh" no sx of severe irritation, pt recovered
dermatitis skin lesions gen over entire body that devel rapidly over a 6hr period;rash is very pruritic & erythematous;DPH given;
Info. has been received from a health prof'l concerning a 37 y.o. female w/a codeine allergy who in the 80's and in the 90's was vax'd w/Hep B vax recombinant series. There was no concomitant therapy. It was reported that the PT's titer was taken in the 80's and in the 90's and was found to be negative both times. In May 02 the PT received Hep B vax recombinant. On 5/15/02 the PT experienced pain and swelling at the inject site (left deltoid), nausea, vomiting, diarrhea, headache and generalized achiness. It was reported that the pain at the inject site lasted for more than 2 days. Add'l info has been requested.
PT was diaphoretic and felt like passing out .PT had nausea and begin to vomit. PT was attended by EMS and cleared by NP once symptoms resolved.
Case previously recorded as MA2009-4854. Initial case report received from a physician on 20 NOV 2009. A 59-year-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. 1007396P) on 09 NOV 2009. On an unspecified date, he experienced muscle pain at injection site and injection site reaction (rash, erythema, nodular pustules). On 16 Nov 2009 the patient experienced subcutaneous painful nodules. On 17 Nov 2009, he developed vesicles and hyperthesia of the affected site. The physician reported that the patient had 4-5 lesions with neuropathic pain and neuritis. Further more the reporter stated that it looked like zoster. The outcome of patient was not reported.