chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a 70 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 18-SEP-2015, the patient was vaccinated with a dose of (Merck) VARIVAX lot # L013068, expiration date 14-APR-2017 (strength, dose and route of administration were not provided). The patient should have received ZOSTAVAX. No adverse effect was reported. Additional information has been requested.
At approximate 1435- this RN at patient?s side.  Speaking with patient, patient c/o feeling hot.  Patient verbalizing, state not feeling well.  RN  called to bedside for assistance.  Pulse ox 96% HR 46.  Patient attempting to drink some water, states not feeling well.  Patient noted to be slightly pale. ? Adm team notified-  RN (Lead RN in post recovery) and site lead ? Adm team at bed-  and RN  ? Patient became pale, states feeling funny, assisting to lie down, syncope episode for approximately 10 seconds noted ? Patient laid down on floor with assistance by RN  and RN ? no trauma ? Legs elevated ? 1435 Hr 46, B24 BP 139/90, pulse ox 96% ? 1436-Legs remain elevated, patient verbalizing giving history ? 1437- patient denies allergies, states has never received any type of vaccine before ? 1438- patients states prior history of MI in Dec/2019.  On medications- Benazepril, Asa, Lipitor ? Patient denies pain, states feeling better, refusing 911 ? 1443 BP 160/100, P63, R-20 Pulse ox 94%.  Patient states feeling better refusing 911.  Skin color improving, remains verbalizing ? 1450- patient refusing 911, requesting husband  ? 1451- skin color improved, perfused, assistance to chair, calling husband ? 1453- husband at bedside ? 1454 patient remains awake, alert, oriented x4.  Skin color perfused, warm and dry to touch.  Husband remains at bedside, patient states ?feels fine? states at baseline. ? 1458 vital signs updated- BP 130/90, Hr 61, R 16 pulse ox 96 percent.  Patient laughing, states feel fine, RN  remains at bedside, speaking and educating patient. ? 1459 Patient signing for refusal of transport.  Patient educated by this RN and RN  any changes in status to call 911. Patient and husband stated understanding. ? Patient signed for refusal of further observation and refusal of transport.  Patient ambulatory on leaving with strong, steady gait.
Blood pressure elevated, 200/120, starting at 6 pm,  chest pain,  chest pain running down my arm.
Clarified that he is referring to the booster for the Pfizer Covid-19 vaccine.; sore arm; redness on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation; Bnt162b2 (dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Clarified that he is referring to the booster for the Pfizer Covid-19 vaccine."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness on the injection site". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Smallpox vaccine given 03/16/2011. pt started experiencing sypmtoms approx 2 weeks later. small fluid filled, itchy painful, blisters all over body.  Pt was given steroids and antihistamines at civilian hospital.  Helped for a little while but condition did not resolve.  Was seen by provider 04 Apr given triamcinilone cream.  Pt was seen again 07 Apr Rx Motrin 800mg, Percocet-325mg, clindamycin, bactroban, and Atarax.  Pt was also but on 2 weeks for convalescent leave.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In or about 2012, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). In or about 2015, the patient was treated by a physician at an office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
2 weeks after Menactra developed Guillian Barre syndrome. DC DX: acute inflammatory demyelinating polyneuropathy.  Presented with numbness in the soles of feet that began 4 days prior to admission that was associated with muscle tightness of his thigh. Following day experienced a headache that was around his forehead and goes to back of his head. Right side of face drooping and felt unsteady.
During first dose, my left arm was swollen, very warm to the touch, with itching and a red line running down my arm.  This occurred about 5 days after the shot.
Information has been received from a healthcare worker concerning a 9 week old female with a history of "reflux" who on 08-JAN-2009 was vaccinated with the first oral dose of ROTATEQ (Lot# : 662802/1172X). Vaccinations received the same day included PREVNAR and PENTACEL. On 08-JAN-2009, the patient "vomited up" her first dose of ROTATEQ during administration of the vaccine. The patient was hospitalized for vomiting and "not eating". A stool culture on the patient was positive for rotavirus. At the time of this report, the patient was not recovered. Phone call had been made for medical attention. Additional information has been requested.
Pain mid back area 10/28/09. Visit to clinic 10/29/09 Diagnosed with Shingles. Rx - VALTREX x 7d.
eyes felt tired and hurt; eyes felt tired and hurt; difficulty swallowing; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 50 year-old patient received bnt162b2 (BNT162B2) (Lot number: EW0169) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing); "Hx thyroid " (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ASTHENOPIA (non-serious), EYE PAIN (non-serious), outcome "unknown" and all described as "eyes felt tired and hurt"; DYSPHAGIA (non-serious), outcome "unknown", described as "difficulty swallowing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Time of Vaccine: 5:30. Time of Reaction: 5:50. Prescriptions, OTC meds, supplements: Thyroid meds, Allergy meds. Allergies(food/drugs/etc.): Denies. Daughter taking mother to the hospital for AMA form signed.  No follow-up attempts are possible. No further information is expected.
patient developed raised itchy red rash on neck right below hairline.  Patient had not seen a physician yet for symptoms when reported.  She had seen the dermatologist earlier in the week for other skin related issue.
Chest pressure, shortness of breath, pain in between shoulder blades, tight chest, heart flutter for over a week after booster. I was feeling 100% fine prior to booster
Rash on upper left temple and swollen lymph nodes around left ear started on Friday. Headaches resembling a tension headache radiated up the left side of the face and skin is sensitive to the touch through the weekend. Diagnosed at shingles and antiviral medication prescribed on Monday. Visiting Opthalmologist as rash is near eye.
large rash around injection site 1/9/21 (day 10 post injection). The rash is an oval/football shape and is about 4.5 in across and 2.5 in high. There is a distinct red ring around the edge. It?s itchy, slightly warm to the touch, and there is still a lump in the center.
Dyspnea, chills, cough   Tx: Remdesivir IV started 8/9 for 5 days course Dexamethasone 6 mg daily started 8/9 for 10 days
Arthritis in shoulder; This non-serious case was reported by a consumer and described the occurrence of shoulder arthritis in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shoulder arthritis (Verbatim: Arthritis in shoulder).The outcome of the shoulder arthritis was not reported.   The reporter considered the shoulder arthritis to be related to Shingles vaccine.  The company considered the shoulder arthritis to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-SEP-2023 The patient self-reported this case. The patient experienced arthritis in shoulder caused by Shingles vaccine. The consent to follow up granted.
This spontaneous report was received from a registered nurse refers to unspecified patients of unknown ages and genders. Concurrent condition and medical history were not reported. On an unknown date, the patients were vaccinated with 3 doses improperly stored GARDASIL 9 injection, 0.5 ml, lot # L011846, expiration date on 16-JUN-2017 (strength, dose #, route of administration and anatomical location were not reported. There was no product quality complaint (PQC) involved. No adverse effects was reported. Additional information has been requested.
Grandmother called this evening saying patient was having a headache and she had not experienced that after the 1st vaccine
This prospective pregnancy case was reported by a consumer and described the occurrence of sore arm in a 41-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) while pregnant. A physician or other health care professional has not verified this report. There were no concurrent medications. On 27 April 2011 the subject received unspecified dose of BOOSTRIX in the left arm. The subject just found out that she was pregnant following vaccination. The subject experienced vaccine exposure during pregnancy. Her date of last menstrual period and estimated date of delivery were not reported. At an unspecified time following vaccination with BOOSTRIX, the subject developed a sore arm. At the time of reporting the outcome of the events was unspecified. The pregnancy was ongoing.
Severe joint pain in both hands & wrists w/inflammation & stiffness; Progressively worsened both shoulders, hips & knees; tx w/Pred; Also had numbness & tingling in both hands & fingers;
consumer reports daughter exp swelling, aching, redness, warmth from shoulder to elbow of immunized arm; blisters formed; now brown discoloration (approx 3" diameter reamins; treatment w/ice pack; DPH, APAP prescrived cortisone cream;
17JUN93 redness @ the vax site almost 2/3 of the arm (maculo-papular rash); no fever; no pain; no treatment;
Shortness of breathe, chest pain, numbness which resulted in pulmonary embolism
This spontaneous report as received from a nurse refers to a 63 year old male patient. On 29-MAY-2014 the patient was vaccinated with VARIVAX (dose, route of administration, LOT# and expiration date were not reported). The nurse stated that she wanted to administer ZOSTAVAX to the patient but she inadvertently administered VARIVAX. No adverse effect was reported. Additional information has been requested.
The pt was diagnosed with acute cerebella ataxia. The pt woke with legs shaking, unable to move or walk and crying. The pt started vomiting but had dry heaves. The pt experienced a fever, sinus drainage, sinus infection, raspy voice, congestion for three days.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 20-MAY-2013 the patient possibly may have received an expired dose of PNEUMOVAX23 (lot # 671405/1420AA; expired date 11-APR-2013) (dose, route, strength and indication were not reported). No symptoms reported. The action taken and outcome were not reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
I had minor headaches 5 out of 8 days. At first I thought it was just a headache but after repeat headaches , which would be  unusual for me, I realized it was probably the shot. Not major pounding headaches, more like eye strain annoying type headaches.  Aspirin didn?t provide much relief. Motrin was better.
@ time of vax pt was approx 2wk pregnant; On 6FEB91 had an abrupt abortion & hemoglobin dropped to 6 w/in 3hrs; D&E was performed, & the pathology report showed normal fetal tissue;
Extremely sore arm for 2 days after shot then it just went away. On April 6th I got Shingles.
Headache, Myalgia, Diarrhea & NauseaVomiting  Narrative:
Pt became dizzy within seconds, lost consciousness briefly and felt weak for a couple of hours, post vax.
DTaP Right arm deltoid lower, red/ swollen 16 x 9cm. Tx Benadryl/Tylenol.
vertigo; dizziness; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: En6199), administered in the left arm, on 03Mar2021 at 12:00 PM (at the age of 39-years-old) at 1st dose, single dose for COVID-19 immunisation. The patient was not pregnant. Medical history was reported as none; patient had not known allergies. Patient had not COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications were not reported. No other vaccine received in four weeks and no other medications received in two weeks. The patient experienced, after 10 days of taking first dose, on 10Mar2021 at 19:00 (as reported), vertigo and dizziness. No treatment was administered for the events. The patient had not recovered from the events.  No follow-up attempts are possible. No further information is expected.
Patient received Pfizer vaccine but during waiting/monitoring period, patient reported tongue swelling, new onset itchiness, and tightness in her throat.  She was transported to the emergency department.  During her ED visit, she was treated with benadryl IV push one time.  No other treatment necessary.  Provider unable to determine if response was true allergy to vaccine or anxiety.
Upon giving the HPV vaccination, patient had syncope event after HPV vaccination. She was placed from sitting to supine position on exam table; other staff assistance provided. Cold cloth and ammonia inhalant administered. Patient lost consciousness for approximately one minute followed by pupil dilation, staring into space, and involuntary limb movements, left eye deviation. No loss of bladder or bowel control, no tongue biting, no convulsions noted. EMS arrived at 11:30 am. At that time Patient was responsive and crying. Full exam completed by EMS ; patient was stable. EMS and mother discussed plant to go home due to being stable and following up with pcp.  No sports physical completed.
Upset stomach, dizziness, chills, headache. 4:45pm 11/22/2021 until 5am 11/23/2021.  Arm pain with golf ball sized lump 11/23/2021- current 11/24/2021- pain is spreading to armpit lymph nodes.
This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (Case Number: 00398291). A contactable pharmacist reported that a female patient of an unknown age and race received PREVNAR 13 at single dose on unknown date for immunization via an unspecified route of administration. Concomitant medications were not reported. The patient developed pneumonia on an unknown date, three months after administration of vaccine. Pharmacist reported the pneumonia was caused by complications of a heart attack; however, pharmacist was uncertain whether patient experienced the heart attack prior to or after administration of PREVNAR 13. The outcome of the event was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Fever; arm red; arm red; required antibiotics; This case was reported by a consumer via other manufacturer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, injection site erythema, erythema of extremities and infection. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the fever, injection site erythema, erythema of extremities and infection were unknown.   It was unknown if the reporter considered the fever, injection site erythema, erythema of extremities and infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was calling on behalf of someone else. The person received Shingrix in left arm. The reporter stated that, it was told on the news that if a person had an adverse event to other vaccines, that person should not receive Covid vaccine.  The reporter was calling for information as to whether this person should receive the Covid vaccine. The reporter wanted to know how she would know if the ingredients in Covid-19 vaccine and Shingrix vaccine were similar. The reporter was inquiring if it was accurate that someone who had an adverse event to any other vaccine should not take the Shingrix vaccine. The reporter mentioned a reaction to a previous Shingrix vaccine, on 1st occasion experienced redness on injection site and experienced fever and required antibiotics. The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2020AMR249487.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249487:2nd shot
Left arm and severe  shoulder and neck pain a few days after Moderna Vaccine taking pain medicine and receiving therapy from June 2021 to present.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with an improperly stored PEDVAXHIB (lot # M047666, expiration date: 24-OCT-2019) for prophylaxis (dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Digital Data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.
Heavy menstrual  bleeding and cramping that has been going on since the night of vaccination (for last two weeks and still occurring) that was separate from menses which had ended the week before. I also had flu like symptoms for two days and continue to have slight brain fog
Information has been received from a health professional concerning an 8 year old female patient who on 04/30/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Subsequently, on approximately 04/09/2004, the patient developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that there was not a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other patients developed breakthrough cases of chickenpox.  No additional information is expected.
Info has been received from a health professional concerning an 8 year old female with no known medical history or allergies who on 11/2/98 was vaccinated, SC, in the left arm with a 1st 0.5 ml dose of varicella virus vaccine live (lot 62775/1245H). There was no concomitant medications or illness at the time of vaccination. On 11/25/05, the pt started to experience lesions. On 11/29/05, she was seen in the office with some lesions scabbed over. She also developed 2 new lesions on her back for a total of about 30 lesions. No treatment was required. At the time of the report, the pt was recovering. There was no product quality complaint involved. Follow-up info indicated that on 11/27/05 (previously reported as 11/25/05), the pt experienced scabs, blisters and dried lesions on her face, scalp and trunk, more than 30 were noted. Subsequently, the pt recovered. No further info is expected.
Dizziness, NauseaVomiting, body aches, warmth and ringing to left ear. Narrative:
Pounding heart rate, it is faster than normal; can hear her heartbeat in her ears; Felt like she had fever and felt like kind of warmish; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0140), via an unspecified route of administration, on 30Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included seasonal allergy, brain aneurysm, psoriasis, diabetic, blood pressure, immunosuppressant, cholesterol, and stent in brain. The patient's concomitant medications included metformin, semaglutide (RYBELSUS), valsartan for blood pressure, acetylsalicylic acid (ASPIRIN), ustekinumab (STELARA) as immunosuppressant for psoriasis, and an unspecified statin for cholesterol. The patient took the COVID vaccine yesterday morning (30Dec2020) at the hospital and she had like a pounding heart rate, it is faster than normal, but it is pounding. The patient can hear her heartbeat in her ears. The patient took her blood pressure and it is normal at 123/78 something like that. Heart rate is an over - little 72, 75, little bit fast but not tachycardia. The patient felt like she had fever and felt like kind of warmish, but her temperature is 98.2. As treatment, the patient took an over-the-counter medication, paracetamol (TYLENOL). The outcome of the events was unknown.
I always had issue with my scalp, but after getting the vaccines I noticed my scalp getting worse and worse, After the 5th dose on about 10/04/2022 it was completely worse. It is red rash with little bumps on it. I went to the doctor for a checkup and told my doctor about the itchy rash. It was in my hair on my scalp. I broke it was very noticeable. I went to skin specialist with an itchy red rash. He gave me for medicines for the scalp, fluocinolone; acetonide topical solution; calcipotriene topical solution, clobetasol propionate topical solution. Clotrimazole betamethasone cream. I had seen now three doctors for my scalp. They itch really bad, and I put on the creams.
Every muscle aches, low grade fever (100.7), chills, no appetite, fatigue, necessary to stay in bed for two days now.