chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Saturday, May 15, while sitting with his wife, "froze" for a short period of time, approximately 1-2 minutes. His wife did not know what was wrong and urged him to go to the hospital. His son brought him to the hospital, he presented with elevated blood pressure, a slightly asymmetric smile, and black tongue. He was admitted to the hospital and multiple tests (brain scans, electrocardiogram, etc.) were run to try to diagnose what had occurred. On the afternoon of Sunday, May 16, in the midst of being discharged from the hospital, pt had another "episode" which was later categorized by physicians as being a partial complex seizure, where he "froze" and became unresponsive for approximately 1 minute. During the event, he was wearing a heart monitor, which showed no unusual heart activity, but his blood oxygen level dropped during the event. On Sunday, May 16, pt had a second partial complex seizure (third seizure over the 2-day period). This seizure was timed at being approximately one minute in duration. Following the seizures on 5/16, patient was given Ativan and also a 1500mg loading dose of Keppra. On Monday, May 17, patient had a EEG administered, which indicated that there was no unusual activity occurring in the brain during the test. He was advised to continuing taking Keppra at 750mg/day. Pt does not have a family history of epilepsy, never played contact sports, and has not suffered brain injuries such as a concussion.
Initial health care professional report was received on 25 Jan 2010: This patient (15 months old) was inadvertently administered with 0.5 ml FLUVIRIN (batch number 102123P1A) on 25 Jan 2010, intramuscularly. No adverse events were reported on vaccination. The seriousness criteria of the events was not reported.
Throat had a "thick" feeling and a sharp pinching feeling towards the front within 10 minutes of injection. The airway was clear and there were no signs of anaphylaxis. Continued to be monitored for one hour.
Severe headache, body aches, low grade temperature (99.4F), lack of energy, malaise for 12-14 hours, with body aches and malaise lingering with periodic headache for the next 24 hours
Case number PHEH2015US020014, is an initial spontaneous report from a pharmacist received on 05 Oct 2015. This report refers to a 30-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. It was reported that when the pharmacist was preparing the RABAVERT (batch number: 556011A, expiration date: 28 Feb 2018) the pharmacist poked herself with the vaccine needle on 05 Oct 2015. Final outcome of the event was unknown. Seriousness and causality were not reported.
Severe joint pain numbness, headache and fever, hyperglycemia, fatigue all within the first 48 hours. Then mental changes and forgetfulness, expressive dysphagia, tremors, numbness, and loss of feeling in extremities. Complete saturating night sweats and dizziness.
This is a spontaneous report received from a contactable reporter(s) (Physician). A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), on 20Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 22Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: Clindamycin"; Diclofenac sodium, reaction(s): "Known allergies: Diclofenac sodium". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received treatment for covid-19 as Paxlovid from 25Aug2022 to 29Aug2022, administrator through oral. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the available information in the case, the causal association between the event Vaccination failure, COVID-19, disease recurrence and the suspect drug BNT162B2 cannot be excluded.
pfizer vaccine was in fridge beyond 30 days at time of administration. pharmacist did not know of this until after administration. discussed with pt. pt stated no adverse reactions to vaccination. advised pt to repeat dosage.
left arm was numb all the way down to hand was not working; left arm was numb all the way down to hand was not working; Nervous; This is a spontaneous report received from a contactable consumer(patient). A 63-year-old female patient (weight: probably 160 pound) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207) at single dose via an unknown route in left arm on 21Mar2021 for Covid-19 immunization. Medical history was not provided. Concomitant drugs included on occasion melatonin, ascorbic acid (VITAMIN C), and vitamin D. Patient went to doctor every year having basic lab work done but none other than that. Her left arm was numb all the way down to hand was not working and it made her nervous.  It started with her first vaccine dose. She was always been very healthy and this all started pretty much when got vaccination.  Treatment taken in response to adverse events included paracetamol (TYLENOL). Outcome of the events was unknown.  Follow up needed, further information has been requested.
Cold Sweats; Fever; This spontaneous case was reported by a nurse and describes the occurrence of COLD SWEAT (Cold Sweats) and PYREXIA (Fever) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced COLD SWEAT (Cold Sweats) and PYREXIA (Fever). On 06-Feb-2021, COLD SWEAT (Cold Sweats) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
This is a spontaneous report from a non-contactable consumer. A patient (student at university) of unknown age, gender and ethnicity received TRUMENBA or BEXSERO at single dose on unknown date. The student passed out after receiving the vaccine and went to the hospital. The outcome was unknown. Pfizer is Marketing Authorization Holder of meningococcal group b rlp2086 in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of meningococcal group b rlp2086 has submitted the same report to the regulatory authorities. No follow up attempts possible. No further information expected.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-NOV-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 120, and 144 hours, with the lowest recorded temperature of 34, and 33 degrees Fahrenheit (1.11, and 0.55 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a medical assistant concerning a 38 year old male patient with cardiac disease (right sided), mild intermittent asthma, drug reaction to hydrocodone and morphine (caused nausea and vomiting) and a history of hernia surgery who on 24-NOV-2009 was vaccinated SQ in the left deltoid with a 0.5 ml first dose of PNEUMOVAX 23 (Lot number 664653/1337Y). Concomitant therapy included VALTREX and PROVENTIL HFA. On 25-NOV-2009 the patient experienced pain at the site of the shot radiating elbow to neck and had difficulty turning his neck. The patient had no rash and no shortness of breath. Subsequently on 30-NOV-2009 the patient recovered from pain at the site of the shot radiating elbow to neck and difficulty turning his neck. The patient sought medical attention by a phone call. Follow up information has been received from the physician's assistant certified concerning the 38 year old patient also with bipolar disorder, common migraine, but no illness at time of vaccination and no adverse events following prior vaccination, who on 24-NOV-2009 was vaccinated SQ in the left deltoid with a first dose of PNEUMOVAX 23 (Lot number 664653/1337Y). Concomitant therapy also included EXCEDRIN. On 25-NOV-2009, the following day to vaccination, the patient experienced pain at the injection site radiating to elbow and neck and had difficulty turning his neck. The physician assistant stated the there was no rash and no Shortness of Breath. No relevant diagnostic test and laboratory data was reported. On 28-NOV-2009 the patient recovered. No further information is available.
felt ill; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The reporter reported that, his eye doctor had mentioned, his wife was feeling ill after receiving the dose of Shingrix. No further information related to the event was available with the reporter. The reporter did not consent follow up. The case is linked with the case- US2020200799, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020200799:same reporter
soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes.   On 29th May 2019, the patient received the 1st dose of Shingrix. On 30th May 2019, 1 days after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The patient after vaccination experienced soreness at the injection site. The patient planned to follow up with the physician. The patient consented to follow up. For tolerance to 2nd dose, refer case US2020005551.
After the 1st dose by 8pm I was exhausted, my arm was a little sore. Night sweats .One week later, I noticed that it was itchy and started to turn red. Through the weekend, it was getting redder and was spreading and getting hot. I used topical cortisone but it didn't do anything. Saw the doctor and he said that it related to the vaccine and called it covid arm, went off wed or Thursday. On 3rd dose of the moderna on 11Nov2021 it happened again on 13 Nov same symptoms. Night sweats for a week.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On or about 19-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date was not provided). On or about 19-SEP-2013, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as shingles. The patient was prescribed VAL ACYCLOVIR and PERCOCET for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
FLU-LIKE EFFECTS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included kidney stones. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, frequency 1 total, administered  on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced flu-like effects. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu-like effects. This report was non-serious. This case, from the same reporter is linked to 20210341909.
Primary vaccine.  Examined by MD on 03/19/2003.  2in redness, induration at vaccination site.  Patient reports .5 cup of drainage from site on 03/14/2003-Drainage less not but redness up.  Transient roseola-like rash on chest, neck and trunk.  Throat culture taken 03/19/2003.  Complained of sore throat.  Left cervical hymphadeosopathy.  Headache low grade fever.
No additional AE details; Customer calling for TE evaluation of VARIVAX. Customer states she called yesterday 5/24/2022 to report a TE but they just found out they had another TE 1 week ago and they need to report that at this time. VARIVAX has been administered to one patien; This spontaneous report was received from a customer referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 25-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number U028164, expiration date 09-SEP-2023 (dose and route of administration not provided) for prophylaxis and that was reconstituted with a sterile diluent (product storage error). No adverse event was reported.  the excursion was between -14 degrees Celsius (°C) to 10 °C for 2 hours and 5 minutes and between -10°C to 8°C with an average of -0.4°C for 1 hour and 25 minutes. A previous temperature excursion was deteceted and was between -14°C to -10°C with an average of -12°C for 50 minutes.
Site redness, warm to touch, and swelling noted the size of two silver dollars on 9/16/08 - Parent advised to give patient Motrin, apply ice or warm washcloth to site and call MD's office in morning if continues with symptoms or worsens. Patient seen in MD office 9/17/08 with fever, swelling size of baseball, and blisters noted at site of injection given.
her arm was sore and red; her arm was sore and red; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were none. The patient experienced that her arm was sore and red on an unspecified date. Clinical outcome of the event was unknown.  No follow up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
1-2 hours after vaccine, complaints of flushing, being hot, weakness through day 4. 10/12/03 shortness of breath, chest tightness. Rx Benadryl, Epi and Solucatf IV. Discharged home. Returned to clinic 10/12; admitted with shortness of breath, "my throat is swelling", Epi, Benadryl. Solumedrol and hospitalized.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 14-DEC-2015, the patient was administered ZOSTAVAX, (lot# and route unknown), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered permanent and debilitating injuries to her eyes, including vision loss and was diagnosed with optic neuritis and optic neuropathy. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of ZOSTAVAX the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. As a direct and proximate consequence the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. Upon internal review optic neuritis and optic neuropathy were considered medically significant events. Optic neuritis and optic neuropathy were reported to be disabling. Additional information has been requested.
Case number PHEH2013US014616 is an initial spontaneous report from the physician received on 05 Jul 2013. This report refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: M12125) via intramuscular route on 01 Jul 2013. On 02 Jul 2013, his injection site was warm to touch and swollen. His MD (reporter) saw the patient and treated him with an antibiotic. The outcome of the events was reported as decreased, but not completely resolved at the time of reporting. The seriousness and causality of the events were not reported.
Left arm soreness - swollen left deltoid, red patch in left axilla with left axillary lymph nodes swollen.  Generalized achiness and some nausea.
ITCHING TO INJECTION SITE, VERY HOT TO TOUCH, PAIN 2HOURS AFTER ADMINISTRATION. REDNESS PROGRESSED TO 8" x5". KEPT AREA ELEVATED, ICE PACK APPLIED.
Started by feeling aches and low energy around 8:00 p.m., by 9:30 p.m. bad chills and increased aching all over body including ears, neck, head, chest, back, limbs, and high and low stomach. Fever of 100.6 around 11:00 p.m. Around 3:00 am extreme stomach nausea and pain and need to vomit, though unable to vomit. Also unable to sleep throughout evening. Stomach and chills better around 12p. Attempted to eat something easy, stomach pain increased again. Aching has not stopped. Feeling extremely drained and weak.
Vaccine administered as part of routine PEx 2/18/2009. Pt seen on 2/23/2009 with pain and redness in the vaccination site and neck soreness. She was treated with Bactrim DS BID and Zyrtec 10mg daily as well as OTC Ibuprofen PRN. On 3/7/2009 she presented to ER with burning pain in band like distribution in the upper abdomen and tingling in the lower extremities. Pt. was d/c'd home and returned the next day with HA, increased tingling and difficulty with ambulation. She was found to have decreased sensation below the umbilicus and R > L lower extemity weakness. Pt was treated with IV steroids and had clniical improvement and was d/c'd from hospital when she was able to ambulate w/o assistance on oral prednisone. Further follow up is pending.  4/2/09 Received hospital medical records of 3/8-3/11/2009. FINAL DX: myelitis, etiology undetermined Records reveal patient experienced 3-4 days of burning sensation in band like distribution around upper abdomen, back pain, numbness/tingling of LEs, difficulty walking, throbbing frontal HA, N/V.  Seen in ER on 3/7 & d/c.  Returned because of increased s/s.  Neuro consult done.   Tx w/IV steroids.  Strength improved & d/c to home on tapering steroids x 2 more wks w/neuro f/u. Follow-up: Patient has had 90-95% recovery of her initial symptoms (numbness and weakness) as well as marked improvement by MRI in spinal cord lesion. Pt is now diagnosed with Multiple Sclerosis and on treatment doing well thus far. Unclear whether the onset of MS was related to vaccination or not but certainly timing of events was very suspicious.
Flu shot was more sore than usual immediately following, with sharp shooting pains with certain shoulder movements e.g. Taking off a hoodie. It's been 3 weeks now and my arm is still hurting if not worse, with increased stiffness despite stretches/exercises. Hurts worst upon waking up. My shoulders usually pop almost daily. Now the left shoulder crunches occasionally.  Also am having muscle stiffness to right arm/shoulder (opposite side). Do not know if this is related or just stress and being tight. Right knee is also swollen, palpable swelling in popliteal area. Never had this before? Not painful just tight.
no adverse event; Caller is a medical assistant who reports that PROQUAD and VARIVAX were inadvertently administered to a patient concomitantly today; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JUL-2022, the patient was inadvertently vaccinated varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 mL once, lot #U033046, expiration date: 21-OCT-2023) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(recombinant human albumin (rHA))  (PROQUAD) (0.5 mL, lot #U016976, expiration date: 24-NOV-2022) administered for prophylaxis (strength, anatomical location and route of administration were not provided) (accidental overdose) with sterile diluent (MERCK STERILE DILUENT). The patient had no adverse effects or symptoms from receiving these doses (no adverse event).
Patient called and stated she had cellulitis at the injection site. She was in that afternoon and given an antibiotic after being examined by PAC.
Headache, chills took TYLENOL and was better 4-5 hrs. later.