chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 07-Nov-2017, was reported by a health professional and concerns a(n) 11-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received AFLURIA from 05-NOV-2016 to 05-NOV-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54507. No additional suspect drugs. Adverse reactions/events and outcomes: On 05-Nov-2016, the pharmacist was giving AFLURIA PFS. When she gave the shot, there was a hissing/gurgling sound. Some of the dose leaked out on the patient's arm (outcome: Unknown). Special circumstances: Accidental exposure. The patient did not receive the full dose of vaccine-No adverse reaction (outcome: Unknown). Special circumstances: Underdose. Reporter's comments: The reporter assessed the event as non-serious.
Patient insisted on getting a 2nd booster of Moderna (total of 4 vaccines), against the advice of the CDC and Safety Review Workgroup. Because a second booster is not adviced at this time, I felt it necessary to report the event in case there is an adverse outcome it will be documented
Patient notified the pharmacy that they had a knot in the back of the arm and a sore arm still on 4/1 not sure if it was from the vaccine or not but it started after the vaccine.
Patient was in the hospital suffering septic pneumonia, but was about to be discharged to skilled nursing facility for antibiotic treatment; he was completely aware, awake, etc. He was given the vaccine booster shot and found next day to have suffered Hemorrhagic stroke; never recovered, died Mar. 11, 2023 at nursing home of "late effect cerebrovascular accident"
Patient received bivalent vaccine for 12 years and older. Patient was 8 years at the time of vaccination.
Left deltoid with erythema, warmth, swelling c/o itching to site, pain to touch and on elevation and rotation of arm. Warm compress & Advil since 3/27/2012. Reported to OHS on 3/29/2012 erythema, induration 4" long x 3" wide, tender to touch. Still with discomfort on elevation and rotation. Tx with warm compresses & Advil, refused Benadryl 25 mg p.o. and topical cream.
Patient described swelling and redness in the arm. Also fever in the arm, but no systemic fever.
Patient claimed of heart palpitation 24 minutes after receiving the vaccine. When checking her blood pressure it was 170/105 with HR 129. 10 minutes later, it was 139/92 HR 110 respiratory rate 22. However, she said she feeling worse and requested for 911 to be call as she felt like the palpations were radiating from her heart to her throat. We eventually found out that she had a history of panic attacks but it did not feel like what she felt before. Paramedics took over and resolved the issue in the pharmacy. Customer left on her own without paramedics as her blood pressure eventually stabilized and decreased.
Right arm - circular swollen redness, 4 inches in diameter. Patient complains of entire body aches and soreness at injection site. Also stated that he sweated profusely.
suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient got the shot for shingles and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not given. No further information would be available.
Information has been received from a pharmacist via sales representative regarding a 68 year old female patient. The patient's medical history, drug reaction and allergies were not provided. On 22-OCT-2013, the patient was vaccinated with a subcutaneous dose of ZOSTAVAX, single stand dose, (dose and lot number were not provided). On 22-OCT-2013, the patient developed a blister at the injection site after received ZOSTAVAX accompanied by fever and chills. The patient sought medical attention, at office visit. At the time of the report, the patient had not recovered from the adverse event. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that since May 2014 (exact date unspecified) an unspecified number of patients received doses of vaccinated with VAQTA (dosage details, route, lot# and expiration date were not reported) that were exposed to temperatures outside of the proper storage range. No adverse effects reported. This is the one of several reports received from the same reporter. Additional information has been requested.
ADMINISTERED EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 57 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-OCT-2021, the patient experienced administered expired vaccine, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309987, 20220309972, 20220310631, 20220309858, 20220310306, 20220310363 and 20220310548.
Swollen lymph nodes in upper neck and breasts 15 hours after shot. Breasts nodes still swollen. Neck nodes go up and down. Menstrual cycle 10 days after shot. Prior to both doses, cycle was EXTREMELY irregular. Could go anywhere from 67-139 days between cycles. This was 32 days. Shortest cycle I?ve had.
This spontaneous report as received from a retired physician refers to herself, a 70 year old female patient with drug reaction/allergy to LEVAQUIN. In 2006 the patient was vaccinated with ZOSTAVAX. Dose number, lot number, expiry date, route of administration and anatomical location were not reported. On 19-JAN-2014 the patient developed an area of redness in the L1 distribution. The patient self-diagnosed this as shingles. This diagnosis was confirmed by her neurologist during a routine follow up visit on 20-JAN-2014. The patient was prescribed FAMVIR and Prednisone. The patient was recovering from the shingles at the time of reporting. No causality assessment was reported, the action taken was reported as not applicable. Additional information has been requested.
Rash which increased in size up to 1 x 6 in below the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash which increased in size up to 1 x 6 in below the injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L204) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash which increased in size up to 1 x 6 in below the injection site). The patient was treated with CEFALEXIN (CEPHALEXINE) for Vaccination site rash, at a dose of UNK dosage form. On 25-Feb-2021, VACCINATION SITE RASH (Rash which increased in size up to 1 x 6 in below the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.
Fever of 99.9 body chills, sweats, tired, arm extremely sore at injection site, loss of appetite
Itchiness; Hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and URTICARIA (Hives) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced PRURITUS (Itchiness) and URTICARIA (Hives). At the time of the report, PRURITUS (Itchiness) and URTICARIA (Hives) outcome was unknown.            Patient was not on any concomitant medication. Treatment included Antihistamines. Patient had no events with the second dose.   This case was linked to MOD-2021-424536 (Patient Link).
Shingles developed at 14 days after vaccine..I have never received shingles vaccine...burning sensation on 1/20/2021 follow by rash in next 24hrs. Confirmed by Doctor on 1/22. Started Valtrex 1/22.
Thirsty as a son of a gun; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Thirsty as a son of a gun) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced THIRST (Thirsty as a son of a gun). At the time of the report, THIRST (Thirsty as a son of a gun) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medicatation and treatment provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Approx. 10 minutes after receiving 2nd dose of vaccine, client stated she felt nauseous and light headed.  BP 142/98, P 100 at 10:16am.  Placed on floor with head down/feet elevated.  Ice packs applied to neck.  Given water to drink.  Monitored for 30 minutes with no improvement.  BP 112/80 P 80 @ 10:46am.  Squad called  to transport to ER.
Patient states that he has been having dizziness. States that symptoms are mild. Denies headache, nausea, vomiting, change in gait or balance. Does state he has had blurring of vision. Advised to immediately see his primary care provider or go to the emergency department if it is after hours.
Redness & swelling at site of injection- DTaP 3 cm X 8 cm long area of warmth, induration & erythema. No axillary - Keflex 250 mg 1 tsp TID X 10 days. Call if fever, arm pain, redness beyond inj. line.
stroke; I would be feel foggy headed; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 11:00 (Lot number: FF2588) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "MS", start date: 1992 (unspecified if ongoing); "Thyroid", start date: 1975 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number: EW0172, Expiration date: 30Nov2021, intramuscularly in left arm at 11:00 as dose 1, single), administration date: 03Sep2021, when the patient was 63 years old, for COVID-19 Immunisation, reaction(s): "could barely move / felt like I was paralyzed", "Very painful throughout of my body", "Aggravated my MS". The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 20Dec2021, outcome "not recovered", described as "stroke"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "I would be feel foggy headed". It was further reported that the patient has not experienced any effects from 2nd dose. The next few months after receiving the vaccine she would felt "foggy" headed, at times she would say to herself that she hope this was not stroke. It would subsided until December and it increased. On 20Dec2021, patient had stroke. It was reported that the patient has no history of high blood pressure and has no indication to have stroke. The event "stroke" was evaluated at the emergency room visit twice. The patient underwent the following laboratory tests and procedures: blood thyroid stimulating hormone (0.350-4.840): (22Dec2021) 1.300, notes: Normal; magnetic resonance imaging: (20Dec2021) unknown results; (22Dec2021) unknown results. Therapeutic measures were taken as a result of cerebrovascular accident.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200192886 same reporter, drug and patient; similar event, different dose
Swelling of left upper arm from shoulder joint to mid forearm and slight erythema and warmth, no fever. Tx Benadryl 1 t ,q 6hrs, warm compress.
chickenpox 23MAR98;brothers also had vax also same lot & also devel chickenpox;
itching on the hands; blister going in between the fingers; reaction had worsen; This is a spontaneous report from a contactable consumer or other non-health care professional. A 17-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, in right arm, on 11Apr2021 at 16:30 (at the age of 17 years), as single dose for COVID-19 immunization. The patient medical history included Strong Family History of Rheumatoid Arthritis, states her mother is crippled, immunodeficiency and borderline immunocompromised. Historical vaccine included cervical cancer vaccine. The patient didn't have any history of all previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines administered on Same Date of the Pfizer Suspect. The patient didn't receive any vaccines prior 4 weeks. The patient concomitant medications were not reported. The patient previously took cancer vaccines and experienced eczema, cancer vaccines and experienced pyrexia, lo loestrin fe for contraception and experienced heavy menstrual bleeding. She has not taken the second dose yet which is more than 21 days. On 1Jun2021, the patient had experienced Itching and blistering on her hands and between her fingers and it mostly started at the palm and she can't stop itching reported as worsened. Reporter wanted to know if anyone else had the same reaction. patient also started on birth control. She had prior reaction from cervical vaccine at 12 years of age, also had eczema at the top of feet and fever. Reporter wanted to know if her daughter can still take the second dose because her high school clinic has schedule for second doses on 24Jun2021. Reporter tried to ask if she could also take the second dose of the vaccine because she is "borderline immunocompromised", but she already had HCP appointments set for her and her daughter and decided shell ask the doctor as well. The events didn't lead to emergency room or physician office visit. No investigation assessment performed. Patient received treatment with Zyrtec, reporter states her daughter called from school and she forgot to take it today at school, it does help somewhat. UPC, Lot, Expiration Unknown. Caller states they tried an itching cream, but it was not the proper one, she thinks it did work but it had an extra ingredient for a feminine product. She wants to note her daughter started on Birth Control, Lo Lo Estrogen, Dosage unknown. Caller states it was strange because she had heavy periods and they are trying to find out if she has fibroids or endometriosis, and the doctor gave her a packet of birth control and when they tried to refill it 3 weeks ago, their insurance didn't cover it so it might be a combination of her stopping that. Caller states she thought maybe if someone else and reported it. Outcome of the events was reported as not recovered.  Communication: Caller provided with Report Reference. The caller was provided with the phone number, hours of operation 8am-8pm EST Mon-Fri and 9am-3pm Sat-Sun
Patient began experiencing hot flashes and nausea ~10 minutes after receiving the shot for ~5 minutes before experiencing severe dizziness for ~5-10 minutes including briefly collapsing/fainting (for ~1 second) while walking back to the store.  Dizziness rapidly subsided after the first 10 minutes, and had completely subsided ~30 minutes after the first symptom appeared.
He received the 1st dose of the Pfizer COVID vaccine on 4/22/21 and within 5 minutes, developed coughing, sneezing, and rhinorrhea. Within 2-3 hours, symptoms progressed into pt having swollen and red cheeks and red eyes.  Denies any sob, tongue or lip swelling, hives, abd pain, dizziness. His BP was his normal, O2 was normal and he was sent home. He did not take any Benadryl or use epinephrine. That night he had subjective fever and night sweats. The symptoms lasted for 2 days and pt used Tylenol for symptomatic relief. Sx resolved by the 3rd day
sore throat; swollen lymph nodes in neck ; swollen lymph node in injection arm that was injected; tingly cold sensation in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingly cold sensation in injection arm), OROPHARYNGEAL PAIN (sore throat) and LYMPHADENOPATHY (swollen lymph nodes in neck ; swollen lymph node in injection arm that was injected) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PARAESTHESIA (tingly cold sensation in injection arm). On 26-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and LYMPHADENOPATHY (swollen lymph nodes in neck ; swollen lymph node in injection arm that was injected). On 23-Jan-2021, PARAESTHESIA (tingly cold sensation in injection arm) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and LYMPHADENOPATHY (swollen lymph nodes in neck ; swollen lymph node in injection arm that was injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not provided by reporter.  No relevant concomitant medications were reported.
Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 2459T, expiry date 08-OCT-2023) for prophylaxis.   On 09-OCT-2023, the patient received Shingrix. On 09-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired dose given).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 9-Oct-2023 A registered nurse called in to request information about how to proceed after a patient received a dose of Shingrix.  The reporter provided partial information about the event, patient and vaccine. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. The patient received an expired dose of Shingrix, which led to expired vaccine used.
Right arm redness, heat and swelling that encompassed entire upper arm. Arm was painful to touch and to move. Visited Emergency Room, where labs and IV fluids were administered as well as IV Ceftriaxone and prescriptions for Septra and Keflex. Patient received 3 vaccinations that day, 2 in his right arm and 1 in his left. He received MMR, IPV and DTAP but it was not documented which vaccine he received in which arm.
runny nose, body aches/pain, low-grade fever, nasal congestion, sneezing, coughing, chills/hot flashes
2 hours after Fluzone was administered pt complained of tight chest, swollen glands, swollen tongue, difficulty breathing. Fever and chills. Patient took an antihistamine.
right cervical and axillary lymphadenopathy; This is a spontaneous report received from a contactable nurse (who is also the patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, expiry date: unknown), via an unspecified route of administration on the right arm, on 27Jan2021 13:15, at single dose, for COVID-19 immunization, at public health department. Medical history included hypertension (HTN), anxiety, depression, myalgia and penicillin allergy (PCN allergy). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medication included losartan; hydrochlorothiazide, triamterene (MAXZIDE); cetirizine; colecalciferol (VITAMIN D); escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccination. On 29Jan2021, the patient experienced right cervical and axillary lymphadenopathy. No treatment was given for the event. The patient was recovering from the event. The reporter assessed the event as non-serious.
Customer reports no other AE.; administration of an expired dose of GARDASIL 9 to a 24 year old female; This spontaneous report was received from a registered nurse, referring to a 24-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 10-AUG-2021, the patient was vaccinated with an expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliters (ml) one time as prophylaxis (lot number R026716 which has been verified to be valid, expiration date reported and validated as 30-MAY-2021) (route of administration and anatomical site of injection were not reported) (expired product administered). In addition, no other adverse events were reported in the patient.
Chills, muscle spasms, fever, high heart rate, sore arm, rash, headache, body aches.
About 4 hours after shot I felt nauseas and dizzy, had a low grade fever of 99.6.  Had the shot in my left arm, had sharp pain in my left upper back and left lower abdomen.   Arm was not sore until the middle of the night and next day - very sore to touch.   Next day, just tired and  a little feverish.
Fever, Sore Throat, Pain In Injection Area, Headache, and Weakness.