chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother returned to the clinic with 15 year old son on 1/10/00 AM with complaint of left arm redness and swelling from elbow down. Mother was advised to seek medical attention for son. Unknown whether medical attention was sought.
Information has been received from a physician concerning an approximately 8 weeks female with milk allergy and gas who "at the two month visit", on approximately 19-MAR-2010 was vaccinated with the first dose of ROTATEQ, oral (lot number not reported). Concomitant therapy included the first dose of PENTACEL, first dose of PREVNAR, the second dose of RECOMBIVAX HB and ENFAMIL NUTRAMIGEN "at the two month visit" on approximately 19-MAR-2010. "At the patient's two months visit", in approximately 19-MAR-2010, the patient was very gassy and was diagnosed with a milk allergy, and was put on ENFAMIL NUTRAMIGEN (manufacturer unspecified). "About three weeks" after receiving ROTATEQ, in approximately April 2010, the patient developed 10 to 12 diarrhea stools which had blood in them. The physician reported that the patient then saw a gastroenteritic physician and an allergist and they could not tolerate ENFAMIL NUTRAMIGEN (manufacturer unspecified). The physician reported that the patient then came back at her four month visit and received all the four month vaccines except ROTATEQ. Subsequently, the patient recovered. Upon internal review, 10 to 12 diarrhea stools which had blood in them was considered to be an other important medical event. Additional information has been requested.
Received Pfizer vaccines on 12/28/20; 1/19/21. Tested positive for COVID by PCR on 6/14/21. Tested d/t symptoms of anosmia, dysguesia.
Pt conveyed they are experiencing itching over entire body and internally, Sx onset of 2/13 with progression through today 2/15.
Patient reports that he started experiencing itching all over his body around two weeks after the vaccine and it progressively got worse until he felt that he needed to be seen by his medical provider. He was then diagnosed with shingles by Dr. on 06/10/2019.
Experienced shortness of breath and bloating. Went to hospital first on 6/10/22 and tests were inconclusive. Reentered hospital on 6/16/22 and determined that I was suffering from severe congestive heart failure[ heart operating only at 10-15%].  Started on a blood pressure and cholesterol medications to hopefully get my heart working better. The doctors thought my case was very unusual because of age and lifestyle.
feeling unwell; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a 99-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller was calling regarding her sister who was due for her 2nd Pfizer shot at the date of reporting, received 1st Pfizer shot on 24Mar2021. Caller did not elaborate but sister was feeling unwell (onset date not specified) at the date of reporting and would like to reschedule 2nd dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 52-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 29Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 21Oct2021 as dose 3 (booster), single (Lot number: FF2P88) and on 07Apr2022 as dose 4 (booster), single (Lot number: F54989) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine and codeine derivatives, reaction(s): "known allergies: Codeine and codeine derivatives", notes: known allergies: Codeine and codeine derivatives. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive, notes: I tested positive for Covid at noon on 25Jul2022; (01Aug2022) Positive, notes: I tested during the morning of 01Aug2022, prior to going to work, and I had a positive result. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient tested positive for Covid at noon on 25Jul2022; the test was the result of a recent exposure. He began feeling tired and achy around 3pm on 25Jul2022. He began Paxlovid around 6pm on 25Jul2022. He awoke on 26Jul2022 with no symptoms. He tested during the morning of 01Aug2022, prior to going to work, and he had a positive result. He felt well until late afternoon on 01Aug2022, which is when more significant symptoms began to occur. As of 03Aug2022, he had significant fatigue and aches, a headache, significant sinus inflammation, and a scratchy throat. He was experiencing Paxlovid rebound with worse symptoms. He was questioning if the rebound is due to both my body not mounting a significant enough defense and the Paxlovid dose being insufficient to drop the viral load below its pathogenic level. The patient did not receive any other medication within 2 weeks prior to Covid vaccination.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Chills, fever and head ache onset 4 hours after vaccine. Treated with acetaminophen and  All adverse events were resolved next day (8th april) evening 7 pm.
Injection was on a Saturday. Within 24 hours, I noticed swelling and tenderness in lymph nodes on/above right collar bone, with swelling and pressure from that point up to the right ear. This got worse with sharp shooting pains from the collar bone/clavical area making it hard to sleep. The swelling finally started to dissipate by the next Saturday/Sunday.  However it is not 100% gone. There is some swelling still in the lymph node up to the ear, you can feel the physical difference when touching, and it's still more sensitive to the touch. The right ear still feels some pressure also like I have water in it but I've not been swimming at all. Now, on Sunday, 1 week after the injection, I have a terrible red itchy rash from shoulders to arms to back of the hands. It's very uniform on both arms and hands, almost solid red in some places My Mom has had contact dermatitis before so I know what that looks like, splotchy and uneven where the irritant touched it. This is not that.
saddle pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "saddle pulmonary embolism". Clinical Course: Reporter's father had saddle pulmonary embolism that occurred within days of receiving his "safe and effective" COVID booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Severe oral pain after receiving second VARIVAX on 12/11/2020; shingles; my arm completly broke out where i I had the vaccine. It was red and real painful; my arm completly broke out where i I had the vaccine. It was red and real painful; my arm completly broke out where i I had the vaccine. It was red and real painful; This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient was allergic to gatifloxacin (TEQUIN) and levofloxacin (LEVAQUIN). Historical drugs included gatifloxacin (TEQUIN) and levofloxacin (LEVAQUIN). Concomitant therapies included: levothyroxine (SYNTHROID) and fluticasone (FLONASE).   On 28-AUG-2020, the patient wac vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 ml, subcutaneously for prevention of chickenpox (lot # and expiration date were no provided). On 11-DEC-2020, patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 ml, subcutaneously for prevention of chickenpox (lot # and expiration date were no provided). She reported having no type of reaction after first dose of varicella virus vaccine live (oka/merck)(VARIVAX), but after second dose on 11-DEC-2020, she stated that her arm completely broke out where she had the vaccine. It was red and real painful. She had oral pain that developed on 02-JAN-2021 and got much worse on 03-JAN-2021. She called her dentist on 04-JAN-2021 and was seen on 05-JAN-2021. The patient went to urgent care on 06-JAN-2021 due to the pain and was prescribed Augmentin 87 5mg , twice a day (bid). She then saw an endodontist on 07-JAN-2021 and an ear, nose, throat (ENT) physician on 08-JAN-2021. ENT felt it was shingles that attacked her trigeminal nerve. ENT physician started her on Acyclovir 1 g, three times a day (tid), prednisone 20mg and gabapentin 300mg, tid. The patient ended up in the emergency room due to severe oral pain on 09-JAN-2021. The physician at emergency room switched caller from gabapentin to carbamazepine 100mg, tid. On 11-JAN-2021, she saw another endodontist, who stated it may be shingles induced by the varicella virus vaccine live (oka/merck)(VARIVAX), that attacked her trigeminal nerve. The outcome of adverse events was reported as recovering.  The reporter considered herpes zoster to be related to varicella virus vaccine live (Oka/Merck)(VARIVAX). The causal relationship between oral pain, pain in extremity, injection site pain and injection site redness was not provided.  Upon internal review, the events of herpes zoster and oral pain were considered to be medically significant.
On 10/8/21 patient presented to clinic with mother to receive first dose of Menactra and Tdap booster because she missed those when they were due for her age. School is requiring documentation of their administration. Patient received Menactra U6921AA exp 4/17/22 in left deltoid and Tdap Boostrix 57GJ2 exp 5/29/23 in right deltoid at 4:33pm. Patient was advised to wait in waiting area for 15min. About 4:46pm pt started to feel unwell. Mother approved provider with pt?s symptoms of pallor, sweating, unease, and pt was brought into exam room to lay down with feet up. Cold compress placed on pt?s forehead. Provider explained to patient and mother about vasovagal response and that it was a response many people had two vaccines, and there was no issue with the vaccines themselves. Pt was told to lay down until feeling better and mother stayed at pt?s side. Around 5:00pm pt was able to walk out of clinic with mom feeling better with no more pallor or sweating.
pt recvd vax;devel a sterile abscess at inject site; was tx w/ incision & drainage of the abscess in Nov93; cont to have pain at the abscess site;
Received vaccine on 3-11-11. Arm very sore, swelling could not move without severe pain. Called clinic was told it is normal. Called again after 10 days. Went back to clinic was put on Nanaproxen & FLEXERIL. As of 3-1-11 arm still in pain.
Swollen leg after PREVNAR 13 vaccine given in right thigh gave 2 ml of BENADRYL after 15 min, reaction cleared.
Extreme blood loss during menstrual cycle resulting in two hospitalizations and two separate blood transfusions. Two bags of blood needed both visits within 60 days of each other. 1st cycle bled for 30 days before being hospitalized the 2nd cycle bled so much I nearly passed out.  I had never had menstrual cycles this bad until after the vaccine. Infact I have little to very infrequent periods. Symptoms were extreme fatigue lightheadedness chest pain/pressure difficulty breathing and headache and pressure that lasted for dead. Bleeding through a maxi pad every 2 hrs for 7 days.  1st hospital stay was regional hospital, 2nd was at a different hospital
8 Days after receipt of Smallpox Vaccination, patient developed multiple discrete erythematous papules on chest, abdomen, and back.  Describes as non-pruritic, non-tender.  Diagnosed with non-viral pustulosis.  Recommended symptomatic relief with Ibuprofen and Allegra prn.  Lesions resolved within 4 days without use of meds.
Flu like symptom, LE weakness, numbness, tingling. Left facial weakness, sensory loss to bilateral lower extremities. IVIG was given. 10/28/09:  Hospital Records received for dates of service 10/1/09 to 10/9/09.  Final Dx:  GBS Assessment:  Had viral prodromal after flu shot.  Woke unable to ambulate. Significant leg weakness and general weakness.  Bilateral foot and leg pain.  Low back pain. Areflexia. Drooping of R eyelid with poor eye closing.  Slightly slurred speech. Trace edema in extremities.  MRI of Head and Spine-Negative.  EMG consistent with GBS.  LP with markedly elevated protein. IVIG.  Abdominal distension; decompressed via NG tube.  Possible ileus or possible Ogilvie Syndrome.  Urinary retention requiring foley catheter. Thrombocytopenia.  Mild protein malnutrition.  Anemic.  Glucose intolerance.  HTN.  Low Vitmin D.   Admitted for rehab. on 10/15/09.    10/29/09:  Neurology consult received for 10/10/09:  Dx:  Guillain Barre Syndrome. Assessment:  Presented with LE weakness, no numbness. Impression-weakness and sensory loss following flu vaccination, pattern of weakness suggests peripheral etiology and abnormalities on the spinal tap are consistent with acute demylenating polyneuropathy.  Need NCS and EMG for formal diagnosis.  Administer additional dose of IVIG.    ICD 9 Codes:  357.0, E858.8, 784.51, 564.00, 401.9, 496  12/3/09 Hospital records received. 10/9/09 to 10/19/09. Additional information abstracted.  Assessment: Ischemic Colitis. Colitis at the right colon from the hepatic flexure to part of the transverse colon.
Mother, reported that pt has a severe headache the following morning after receiving her H1N1 vaccine on 11/10/9 at 6:00pm. Her symptoms began suddenly on 11/11/02 ~8:00Am. Her symptoms were headache halo vision & fatigue. She had some localized tenderness at the injection sight, no swelling. Her mother gave her MOTRIN & by 4:00 pm that day she was feeling better. No prolonged symptoms. No temperature. No vomiting.
p/vax pt exp breakthrough chickenpox mostly on scalp, face & neck, vesiculated & crusting lesions;pt treated w/zovirax;
At 18 hours, aches and listlessness. At 22 hours, fever 101.0.
Patient requested Covid Booster - Chart had all previous 4 vaccines listed as Pfizer, none were entered as Bivalent. After administration of Pfizer Bivalent patient found card for me to update. Patient had 2 cards, the second card that patient had a date of PFizer Bivalent listed as 11/16/22. Provider was notified. - This was a duplicate vaccine.
flublok was administered to 9 pediatric patients with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA420021(CLUSTER), 2022SA419213(CLUSTER), 2022SA420025(CLUSTER) and 2022SA420094(CLUSTER).  This case involves a 7 years old male patient who was administered flublok, with no reported adverse event, after receiving vaccine influenza quadrivalent recombinant vaccine [Flublok qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2022, the patient received a dose of suspect influenza quadrivalent recombinant vaccine (form: unknown, strength: standard) (lot QFAA223 and expiration date: 30-Jun-2023) at a dose of 0.5ml once via intramuscular route in the left deltoid for immunization.  On 10-Oct-2022 (latency: same day), the patient was administered flublok with no reported adverse event (product administered to patient of inappropriate age) following the administration of vaccine.   No lab data reported.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
localized erythema and swelling 4.5 x 4 cm, on right thigh.
ABDOMINAL PAIN; LEG PAIN; TIREDNESS AND FATIGUED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced tiredness and fatigued. On 11-APR-2021, the subject experienced abdominal pain. On 11-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness and fatigued on 27-MAR-2021, and had not recovered from abdominal pain, and leg pain. This report was non-serious.
Patient began having a Twitching to her Left eye within 24 hours after vaccination. Patient then began having a severe headache and pain that comes and goes  in the back of her Left ear approximately 72 hours after injection. On 05/01/2021 Patient had numbness and paralysis on her left side of her face and assymetrical smile. Patient went to the Emergency Department and was diagnosed with Bells Palsy
Chills, Muscle aches throughout my body, Elevated Heartrate (~115bpm while laying down trying to sleep-recorded on fitbit), could not sleep due to symptoms persisting through the night. Took tylenol in the morning and symptoms faded soon after. Took another dose of tylenol in the afternoon when symptoms seemed to be returning. Symptoms did not return afterwards
1 trip to physician office due to unmanageable migraine and leg cramping pain on 9/9/21.  After doctor visit, doctor called that evening saying that my D-Dimer was too high and to immediately go to the ED.  Went to ED that evening.  Low fever, sweating, excruciating headache and leg cramping for 3 days.  They did ultrasound on legs and chest x-ray for blood clots.  Performed a COVID test, more blood work, and administered pain meds through IV.  All tests were negative.  The excruciating migraine and leg cramping continued for 3 more days.  On Sunday, went back to the ED.  They did 2 cat scans (1 with contrast), MRI of head, more blood work, another IV, etc.  They administered more pain meds and a steroid.  Discharged with allergenic reaction to vaccine as the most likely cause.
On 11/23/22 I was feeling ill, I took a home COVID-19 test that came negative. I started to feel better by 11/25/22, then on 11/27/22 I started to feel bad again. I had a runny nose, foggy brain, little to no cough. I took a home COVID-19 test that came back positive. I called the nurse line from my insurance and had a telehealth visit and was prescribed PAXLOVID. I was able to start that immediately. I was testing negative by 12/02/22. It felt like I had a mild cold.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a medical student regarding a 3month old male patient who experienced cardiac arrest. The patient received a dose on an unspecified date in 2004. The reporter indicated nothing significant regarding the patient's medical history. Indication for Prevnar was immunization. Product was administered on an unspecified date in 2004. Dose regimen was 1 dose. Concomitant medications were not reported. On an unspecified date in 2004, one day post-immunization, a 3 month old male patient (now 5 months of age) experienced cardiac arrest. The reporter stated that the patient is still alive and has been hospitalized intermittently. As of 7/20/04, the patient had not recovered and was in the ICU. No additional information was available at the time of this report.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, unspecified patients were vaccination with doses of VARIVAX (Merck) (dose, dose number, route and lot number were not reported) that were stored improperly. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information is not expected because there is no permission to contact.
Patient complains of left shoulder pain times 2 days after receiving flu shot at Pharmacy and denies any trauma or injury and no reactions to previous vaccines. Inability of ROM outward, forward, backward without severe pain. Patient applied dry heat and took ibuprofen on October 15th 2019 without relief of symptoms.  Patient was referred to PT and RX oxycodone.
SHINGRIX. History: I had chicken pox as a chid, shingles in my thirties, shingles in 2017. The reaction to the shot was a couple of hours after the shot. Pain in the shot area and flu like symptoms, aches, fever, shivers. These went away the following morning.
rash took place after use of vaccine that covered patient bicep; This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This Pharmacist reported similar events for 2 patients. This is second of 2 reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash that took place after use of vaccine  and covered patient bicep on an unspecified date. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020399735 same reporter/drug, similar event, different patient.
I had a little bit of nausea, headache, rapid heart rate the whole time and a sore arm.  My estimated date of delivery is 04/25/2021. I am 23 weeks gestation.
Pt presented to office after vaccines administered, left thigh has reddened, firm oval shade approximately 2 cm 2 X 1.5 " raised, not tender to touch, warm to touch, Treated for Cellulitis- EX Motrin for discomfort given. Duricef susp 300 MGM  every 12 hours X 7 days.
This RN had been preparing vaccines for adults, and she forgot to take the pre filled Hepatitis A vaccine syringe from the child health clinic supply. Patient received 1 cc Hepatitis A vaccine rather than the pediatric dose - 0.5cc.