chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First two doses of the shot did not affect her, this one threw her for a loop; Was not aware it would affect her so badly; have no appetite; exhausted; headache; low grade fever; dizziness; inner ear violent dizziness where the room went up and down; she received her booster dose; I was wired; Drenched in sweat; couldn't move the next day; Sick ever since; Did not sleep that night; This is a spontaneous report from a contactable consumer or other non hcp.   An 84-years-old female patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 01Nov2021 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, The patient experienced sick ever since on 01Nov2021 with outcome of recovering , drenched in sweat on an unspecified date with outcome of not recovered , did not sleep that night on 01Nov2021 with outcome of recovering , couldn't move the next day on 02Nov2021 with outcome of recovering , first two doses of the shot did not affect her, this one threw her for a loop on an unspecified date with outcome of recovering , was not aware it would affect her so badly an unspecified date with outcome of recovering , have no appetite, exhausted, headache, low grade fever, dizziness, inner ear violent dizziness where the room went up and down, she received her booster dose, i was wired on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: unknown results on low grade fever.    Follow up (10Nov2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP telephonic follow up activity which included the information.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
insomnia; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "insomnia"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1 day post vax the child complained of uncontrollable spasm in right arm. Mother took child to the MD's office at the hospital. No treatment or diagnosis was given. The spasm stopped before leaving the ER. On 3/13 and 3/15 the spasms reoccurred for less duration and pain. Mother feels there is a pattern and it is related to physical activity. Mother was advised to have child evaluated by a neurologist.
ITP (idiopathic thrombocytopenic purpura) on 03/01/2002, platelet count 19k and resolved on 03/06/2002.
mom states c/o stomach pain & was lying in the floor;mom picked pt up & started having a sz was jerkings, not responding;
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Mild, Additional Details: Pt received Fluzone HD 2022-23 and Pneumovax 23 on 9/1/22 at 9am. Began experiencing fever-like symptoms (low grade fever, slight body aches) that night around 6-7pm. Woke up in morning on 9/2 and had bruising at injection site and redness/swelling on bicep/deltoid area. Area was hot to the touch, swollen and moderately painful. Adverse effects are resolving on 9/3/22, pt doesn't request follow up with MD.
Sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 2nd February 2019 and experienced pain in arm).   On 10th July 2019 02:00, the patient received the 2nd dose of Shingrix (intramuscular). On 10th July 2019 07:00, 5 hrs after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: On 10th July 2019, at 2:00 pm, the patient received vaccine and by 7:00 pm that evening noted that her left arm was sore. The patient did not consent to follow up. The reporter was unable to obtain additional information. For tolerance to the 1st dose of Shingrix, refer case US2019AMR130762   This case has been linked with cases US2019125903, US2019125907, US2019125912, reported by the same reporter.
pt recv vax & started exp episodes of n/v, gen weakness, anorexia, somnolence, fever to 102 & inc white count since 1/25/99 has missed 16 1/2 days of school & felt sick Monday addtl days;
The patient reported to a staff pharmacist here that she has been sleeping since noon today and is nauseous. She has diarrhea, said "I need an IV" and can't eat.
adverse experience; revaccinated; Temperature excursion involving VAQTA; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 18-month-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 27-DEC-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # U024504, expiration date: 15-OCT-2022, which have been verified to be valid lot numbers for hepatitis a vaccine, inactivated (strength, exact dose and route of administration were not provided) in left thigh for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination (inappropriate schedule of vaccine administered). The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582:
Rash/hives 5 days after 1st and 2nd hep shot.
Given the wrong vaccine. Went in for my bivalent Covid booster, was given the shingles shot. I did not sign off on a shingles vaccine nor was I given paperwork, informed of side effects. Just an ?oops I gave you the wrong one? and then was given my Covid booster instead.
Fever chills fatigue and ongoing hot flashes and cold spells where I cannot get warm. Temperature swings are terrible for over 3 weeks since the second vaccine
Information as received from a certified medical assistant (C.M.A.) refers to a 13-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On 28-JAN-2017, 29-JAN-2017 and 30-JAN-2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M027882 with expiry date of 14-APR-2019, lot # M001814 with expiry date of 15-OCT-2018, lot # M036056 with expiry date of 18-MAY-2019 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of below 32 degrees Fahrenheit (with minimum temperature of 25 degrees Fahrenheit) for 14 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006371: US-009507513-1702USA006372: US-009507513-1702USA006370.
No adverse event.  Mis administration of TDAP.  Pt is 9 yrs old - should of been TD.
Severe headache, much congestion, cough, loss of appetite.  Was prescribed Paxlovid. Felt pretty bad for five days.
Headache, low-grade fever,  overall muscle aches, stiff neck that started about 8-9  hours after reciving the vaccine.
Headache, dizziness, muscle pain in both arms and legs, with the most severe pain in left arm where the vaccine was administered.  Time of symptoms is 2+ days
States woke up with sore hand and noted swelling in the arm, around her eyes and knees. She came to work the next day and was helped in getting ring off her finger that was swollen and someone gave her a Benadryl. She states swelling was gone within 3 hours of the Benadryl.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 04-FEB-2008, the patient was vaccinated with dose 1 of LIQUID PEDVAXHIB (lot #, dose and route not reported). On 11-APR-2008, the patient was vaccinated with dose 2 of LIQUID PEDVAXHIB (lot #, dose and route not reported). On 04-JUN-2008, the patient was vaccinated with dose 3 of LIQUID PEDVAXHIB (lot #, dose and route not reported. No adverse event was reported. Additional information is not expected.
Sudden onset of high fever 103.2 degrees Fahrenheit muscle cramps- continued fever no other symptoms besides severe chills not relieved by Advil.
SIRVA-partial  rotator cuff tear and frozen shoulder. Pain when doing daily activities such as dressing and driving.  Physical Therapy  sessions to attempt to regain mobility.  Using prescription diclofenac sodium topical gel.
A few days after the shot, I had some pain in my left leg (calf), and noticed a lump about 1" or so in size, with internal swelling in an area of about 2 to 3".  This was strange because I have never had something like this before, and I have not played sports or had any real opportunity to hurt my leg physically, nor have I engaged in any activity that could have physically impacted the area. I noticed this a few days after the shot, but I suspect it started earlier and I had not noticed until a few days later when it hurt. I have monitored the site and it reached its peak about one week after the vaccine and then stayed that way for a few days, then gradually subsided. I still have the lump, but it is much reduced and does not hurt any more. I hesitated to take the second dose appointment worried that it could be related to the vaccine dose, and if it is, I am worried if this kind of swelling (or maybe it is an internal clot) or whatever it was, could turn up in  a more vital area of my body, such as my brain, where it could be dangerous.
(I have 3 shot of your vaccine). /I get Covid 19 and my primary doctor prescribe me Paxlovid; (I have 3 shot of your vaccine). /I get Covid 19 and my primary doctor prescribe me Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and legal division. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "(I have 3 shot of your vaccine). /I get Covid 19 and my primary doctor prescribe me Paxlovid". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: I get Covid 19 and my primary doctor prescribe me Paxlovid 2x150mg 100mg (EUA) QTY: 30 (LOT:FX4465) EXP 31Jan2023. On 3rd day I have to stop take the pills because I fell like poison on my body, I felt intoxicated), and my eyes like fire l and too much bitter on my mouth and vomiting. I call your facilities on (withheld) and talk with Nurse of Medical Department and explain the situation. I try to make a claim  but I can't communicate with that Department. (I have 3 shot of your vaccine).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
vaccine given 2/2, the following day noted to have 10 x 10 cm red, indurated area around injection site.  Seen in ER treated, complain itching with Keflex
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date the patient experienced underwent a temperature excursion and no adverse effect reported. The outcome of underwent a temperature excursion and no adverse effect reported is unknown. The reporter considered underwent a temperature excursion and no adverse effect reported to be not related to GARDASIL. {Additional information has been requested./ Additional information is not expected.}
Patient with Onset of bloating and nausea.  Diagnosed with metastatic pancreatic CANCER
pt had pain in arms & muscle weakness in arms & legs. 4Jan91 hospitalized to R/O GBS. Neuro consult revealed pt did not have GBS & was D/C 7Jan91.  MD felt sxs d/t vaccination w/ MMR.
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 12 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
101-102.3 temp for over 12 hours; severe muscle aches; headache; fatigue; Vertigo sti ll ongoing; This is a spontaneous report from a contactable consumer.   Female consumer (patient) reported for herself. A 50-year-old female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: unknown), via an unspecified route of administration on 17Jun2021 as a single dose for COVID-19 immunisation. The patient received first dose on 27May2021 as a single dose for COVID-19 immunisation. Medical history included Hashimoto Thyroiditis, Interstitial Cystitis, Migraines and History of Vertigo. The patient's concomitant medications included Levothyroxine on 01Jan2018 for Hypothyroidism (ongoing), Amitriptyline, Topiramate on 01Jan2016 for Migraine (Ongoing), Aimovig on 1Jan2019 for Migraine (ongoing). On 18Jun2021, the patient had 101-102.3 temperature for over 12 hours, severe muscle aches, headache, fatigue and vertigo. The patient experienced the same events on the first and second vaccine doses. The outcome of the events was resolved  Information on the lot/batch, further information has been requested.
Severe back of neck pain and head locked up (couldn't move it up/down/right or left without more extreme pain). This started a few hours after the shot on Sunday a.m. and lasted in great pain till Wed evening.  Today, Thursday, I can move my head/neck almost back to normal with out too much pain, but not completely gone yet. I took Acetaminophen and Ibuprofen for pain, which only took a bit of the edge off, but never took it away.
Extreme pain, redness, swelling of right arm and fingers not only at the injection site but entire arm. Headache like I have never experienced, sore muscles and joints, fever 101.9 for 24 hours, nausea, swelling of face and hands, rash on right ear external, extreme fatigue, chills, could not sleep due to pain in my right arm. Also, when given the injection, the LPN rubbed my arm very hard immediately following the injection. It was very painful!
Dizziness, muscle pain, fever 102.7, nausea symptoms began with an hour of vaccine administration.
pt recv vax 31DEC96 & 16JAN98 pt devel chickenpox;
Patient called and said has had sore throat and fatigue since immunization. Left arm has been very sore and could barely lift it. Patient complains of 5-6 nickel sized bumps around injection site of left arm.
Upon leaving clinic pt could not raise or move her R arm. Red, warm swollen, stiff TYLENOL taken with zero relief pt states plus reaction from flu years ago.
Late very light period, very abnormal. Negative pregnancy test. No treatment as of yet. Doctors appointment scheduled.
Swelling of ankles, joint pain and a rash developed. The rash spread each day for another two weeks. Joint pain and swelling went away after 2-3 days. Mild stomach discomfort that lasted a couple of weeks.
Redness, swelling at injection site, injection 6/19/14, patient recommended to use BENADRYL, ice, ibuprofen by physician. Scheduled Dr. visit for 7/1/13 same day pharmacy notified.
Expired medication given on July 2, 2018. Expiration date 6/29/2018. Lot Number: M046008 Expiration Date: 6/29/2018 Manufacturer and NDC: Merck & Co Inc and 0006-4047-41 Brand Name of Product:  ROTATEQ Rotavirus pentavalent.
This spontaneous report as received from a registered nurse refers to a 41 years old female patient with none pertinent medical history. The patient was vaccinated with RECOMBIVAX HB (Intramuscularly in the left arm) (lot #1111AA, exp date 06-JUN-2014) on 03-JUL-2012. No concomitant medications were reported. On 03-JUL-2012 the patient had an allergic reaction to the RECOMBIVAX HB one hour after vaccination. The patient received adult RECOMBIVAX HB on 03-JUL-2012 and about an hour later developed an itchy scalp, hives on the under arm of the injection site arm and hives at the injection site, itchiness and swelling of the throat and some swelling of the tongue, but no problem breathing. The patient reported that a little while later (time frame unspecified) she developed itching in the stomach, ribs and on the other arm (right arm). The patient informed the office that they took BENADRYL (time frame unspecified) and she felt a little bit better. The patient called the office on 05-JUL-2012 and reported itching and some throat swelling, but the hives were gone. The patient was given prednisone and CLARITIN as treatment on 05-JUL-2012. The patient was referred to an allergist. The allergist called the office (date unspecified) and stated that he felt the patient had an allergic reaction to the RECOMBIVAX HB. The office did not plan on completing the vaccination series. The outcome of the adverse event was recovered/resolved. Additional information has been requested.
Pt.'s Wife states that after receiving the 3rd dose of Moderna 02/11/2022, started experiencing symptoms 02/13/2022 of Bilateral Stroke(Mid-Interial), CT Scan preformed (Normal) MRI (appearance of Blood Clot traveling to the brain). Emergency Room transported. Admitted to hospital (ongoing admission).
Information has been received from a nurse practitioner concerning a 9 month old child who on 07-FEB-2011, was vaccinated orally with the first 2 ml dose of ROTATEQ (lot # not provided) and the third dose at the age of 9 months (on approximately 03-SEP-2011). No adverse effect was known. The patient did not seek medical attention. Follow up information was received from an advanced practice nurse (APN) concerning a 9 month old male patient with no pre-existing allergies, birth defects or medical conditions who on 16-SEP-2011 (previously reported as at the age of 9 months), was vaccinated orally with the third dose of ROTATEQ (lot # 110078AA was not valid for ROTATEQ. The nurse reported that this mistake was realized after the patient had left the clinic. No adverse event was reported. The patient had been seen 3 times since the event. No further information is available.
Vial already reconstituted, LPN administering vaccine drew dose from vial, then diluted further using 1.8ml of Normal Saline.  Injected entire syringe into arm of patient.
Fever started within 6 hours of receiving the second dose of the vaccination. Within the first 4 days post vaccination I had body aches, headache, fatigue, 1 day of vomiting and diarrhea. All other symptoms besides the fever and fatigue where gone by day 5 but fever persisted for 2 weeks and 5 days. On day 19 I had bloody urine that showed high white count, blood and traces of protein on the urinalysis.
Started on evening of day vaccine given arm swollen, erythematous, indurated upper arm (same arm vaccine given in). Treated with Tylenol, compress and Benadryl.
patient instructed to wait 15 minutes. she was checked on at that time (after 15 minutes) and she stated through an interpreter (her daughter) that she felt light headed.  B/p 122/ 84 HR 66 Pulse Ox 97%.  Further questioning revealed that she had not had breakfast this morning, snack given and laid flat.  She felt better in 10 minutes, and left with children.
pt recv vax 14APR97 & 12hr post vax pt devel a fever of 101.5, h/a & body aches;approx 24 hr post vax pt recovered;