chrisvoncsefalvay/vaers-outcomes huggingface dataset:
elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse.  A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine.  Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy.  The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. 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.
arm became red; arm became itchy; arm became swollen; Hurting injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to the company on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm became red), VACCINATION SITE PRURITUS (arm became itchy), VACCINATION SITE SWELLING (arm became swollen) and VACCINATION SITE PAIN (Hurting injection site) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042Z20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included HCTZ and LOSARTAN for Blood pressure.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm became red), VACCINATION SITE PRURITUS (arm became itchy), VACCINATION SITE SWELLING (arm became swollen) and VACCINATION SITE PAIN (Hurting injection site). At the time of the report, VACCINATION SITE ERYTHEMA (arm became red), VACCINATION SITE PRURITUS (arm became itchy), VACCINATION SITE SWELLING (arm became swollen) and VACCINATION SITE PAIN (Hurting injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included hydrocortisone cream and cefalexin as well, for a toe infection.
Red raised hives all over body that would creep and move around my legs neck arms and torso.
This is a spontaneous report from a contactable consumer or other non HCP reporting for herself. A 85-year-old female patient received PREVNAR 13 via an unspecified route of administration at single dose on 27Dec2017 for immunisation trying to prevent having pneumonia, administered by a pharmacist. Medical history was none (no cold or allergy). The patient's concomitant medications were not reported. The patient have had the side effects that just running her nuts: she experienced redness in her arm, red from her elbow to her shoulder on 28Dec2017 with outcome of recovered, swelling on 28Dec2017 with outcome of recovered, pain/started soreness was really bad, pretty quickly after on 28Dec2017 with outcome of unknown, itching on an unspecified date reported as worsened, she has been clawing herself all over here and there on an unspecified date with outcome of unknown, cholesterol is a little over 200 on an unspecified date with outcome of unknown. Swelling, redness and pain lasted about 6 weeks. The redness finally mostly went away (later confirmed that consumer recovered completely from redness), it took 6 weeks for the redness to get a lot better and came to normal. The itching had just gotten worse and worse. She has been clawing herself all over here and there and she has been to her family doctor and to two dermatologist and something was going to be done she was just desperate to know what to do next and how to get rid of it. The swelling got completely recovered in a week or two. The pain in that arm was okay. She was still experiencing the Itching, she has tried so many home remedies and has tried dermatologist family medicine man, nobody has been able to help her. She received treatment taken for itching, redness, swelling and pain: they have given her prescription medication and some over the counter (unspecified medications) to get all that and nothing has helped. She started out with Hydrocortisone and now she was using Nystatin cream and also something like Gold Bond cream, Cetaphil Moisturizing Cream. Also she has used this because it had some ZEASORB-AF, it was actually for athlete's foot but it soothed all over but nothing is lasting. Lab Work: she just had a regular checking cholesterol, every six months. Everything was fine there wasn't a thing that was out of line, except cholesterol which was a little over 200 but still the doctor said that it was good so don't worry about it. A Product Complaint was filed.
Small portion of blood and vaccine solution poured out from injection site immediately after needle removed from muscle, and induration suddenly built up at IM site. Cold compression applied to IM site.
Patient developed erythema at injections site about a week after receiving shingrix and prevnar in the same arm.
Site right arm is red 5cmx6cm; no induration. Seen in office 4/21/03.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and still got shingles. The patient would not say that the vaccine prevents anyone from getting shingles but it could make the outbreak more tolerable if anyone gets them. The patient was speaking from self experience. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
pt recv vax 18MAR97 & later exp chills, fever, body aches;A generalized rash & bright red cheeks were noted 18hr p/vax;the initial sx resolved & the rash & facial redness, tx w/DPh are improving;
CALLED INSISTENT THAT WE REPORT HIS NEUROPATHY AND ISSUES DUE TO THE VACCINE. Has a history of shingles 2x in the past; has had 1 shingles vaccination. He claims he has had an Herpes virus in his back for 2 years.  In May he developed a severe case of shingles that has caused such severe neuropathy, he can't work. Claims it is a result of the COVID vaccination he got in Jan/Feb 2021. Claims he knows this is an issue with others and asking for it to be reported.
2-3 hours after receiving vaccine, I noticed an itchy throat and slight arm pain; on 02-27-2021, I woke up with a headache and severe arm pain, couldn't lift it without extreme discomfort;  at 1700-1800, I drove myself to get something to eat and after returning home I took two Tylenol for pain; after about 20-30 minutes of taking the Tylenol, I felt short of breath, my chest was tight, my heart was racing, and there was a burning sensation near the bottom portion of my heart, and I felt doomed so I drove myself to the ER because I did not want my children to witness me in distress; I was discharged o n 02-28-2021 with prescription for allergy medication and told to follow up with my HCP & cardiologist; on 03-01-2021 at 1444 a rash started on my left  extending towards the injection site and my chest started to get tight, I  left work and took a Benadryl and went to sleep; on 03-15-2021, the rash on my left arm reappeared but extended to the left neck and chest area and my chest started to get tight, so I took 2 Benadryl  called my HCP for an appointment went to sleep; seen by HCP  on 03-16-2021 who witnessed rash and was prescribed prednisone and referred to allergist for follow-up; symptoms were reported using  V-safe
has sporadic a-fib (at baseline); She stated she was in real bad stroke territory; she felt like she was going to faint; Her blood pressure was 220/97; tingling in her hands and feet; felt like brain sizzling like it was frying/going to faint; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, first dose) solution for injection intramuscular in the left arm on 06Feb2021 at 09:30 (at the age of 79-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing sporadic A fib (atrial fibrillation) for 6 years know about; allergy to polyethylene glycol in 1985 (she had difficulty taking birth, control pills and they found out it was the coating PEG in); cerebrovascular accident prophylaxis; in 1985 She had difficulty taking birth control pills and they found out it was the coating PEG in it. She had an allergy to this where she broke out in bumps on her fingers and mouth and had itchy eyes, a full blown allergy; and when she was 45 going through menopause. Concomitant medication included apixaban (ELIQUIS) for A fib and cerebrovascular accident prophylaxis. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021, the patient had sporadic a-fib (at baseline) then put in a medical van requiring emergency room visit. The patient stated, She stated she was in real bad stroke territory, felt like she was going to faint (6 minutes after vaccination), blood pressure was 220/97, tingling in her hands (6 minutes after vaccination) and feet and felt like brain sizzling like it was frying/going to faint (6 minutes after vaccination) on 06Feb2021. Lab tests included blood pressure on an unknown date high 150s and never lower than 187, then on 06Feb2021 was 220/97, on 09Feb2021 was systolic blood pressure 180, then on 10Feb2021 had gone down. The outcome of the events atrial fibrillation and feeling unwell was recovered on 06Feb2021, after 3 hours. The outcome of the events stroke, faint and tingling of extremity was unknown. The outcome of the event blood pressure was 220/97 was recovered on 10Feb2021.
THE PATIENT HAD SEVERE MUSCLE TENDERNESS AND SENSITIVTY AT INJECTION SITE.  THE PAIN WORSENED AFTER THE SHOT HAD BEEN GIVEN DAILY.  11-19-2013 SHE SAID IT FEELS AS THOUGH THERE IS A BALL IN HER MUSCLE WHEN SHE TOUCHES HER DELTOID.  SYMPTOMS NOT GETTING BETTER 11-17-2013.
* On 4/2/21 - Fever 103.2, Fatigue, No appetite, Dizziness. * On 4/5/21 - Severe chest pain.  Went to ER.  Transferred to clinic in.  Admitted to clinic on 4/5/21:     - Test:  Ultrasound, Xray, Lab Tests, Electrocardiogram     - Outcome:  Pericardial enhancement adjacent to the left ventricle with no effusion     - Treatment:  Motrin 400 mg/4 times a day, Protonix 40mg/day to protect stomach
Patient given a second dose of PNEUMOVAX 23 instead of PREVNAR 13 booster.
Patient was administered a second dose of the COVID vaccine even though the first dose was administered on 11/29. At the time, patient stated that it was their first dose. This was an at-school vaccination event, and the student had come with permission from their parents to get vaccinated. The parents had the child vaccinated on 11/29, but the information was not conveyed until after the fact. No AEs.
long lasting goose bumps, bruise like rash on legs and soles of feet, pain in feet,
itching in their right upper deltoid; it was really red, kind of swelling, a little bit hot to the touch; down the arm, around their wrist area, hurt to turn; Now the arm is only a bit red as large as an orange; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (itching in their right upper deltoid), SWELLING (it was really red, kind of swelling, a little bit hot to the touch), PAIN (down the arm, around their wrist area, hurt to turn) and ERYTHEMA (Now the arm is only a bit red as large as an orange) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historic conditions.) and Mastectomy (27 years ago patient had left mastectomy).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PRURITUS (itching in their right upper deltoid), SWELLING (it was really red, kind of swelling, a little bit hot to the touch), PAIN (down the arm, around their wrist area, hurt to turn) and ERYTHEMA (Now the arm is only a bit red as large as an orange). At the time of the report, PRURITUS (itching in their right upper deltoid), SWELLING (it was really red, kind of swelling, a little bit hot to the touch), PAIN (down the arm, around their wrist area, hurt to turn) and ERYTHEMA (Now the arm is only a bit red as large as an orange) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.
patient stated she is still dizzy following the vaccination on 12/2/21. She felt dizzy following the immunization and still has the problem
Vomiting; A spontaneous report was received from a nurse on 18OCT2023 regarding a female patient of unknown age who had "vomiting" (PT: Vomiting) following the administration of Vivotif (typhoid vaccine live oral Ty21A; lot number: 3003850) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 14OCT2023, the patient took the first dose of Vivotif followed by the second dose on 16OCT2023. Reportedly, the patient did not have any side effects with either of the first two doses. However, on 18OCT2023, the morning when the patient woke up, she had an episode of vomiting and later she felt better. A while later, on the same date, the patient took the third dose of Vivotif and after 45 minutes she again had an episode of vomiting. The patient did not see the capsule and did not look for it either as there was a 45-minute interval between her taking the capsule and the episode of vomiting. Further, the patient was advised to take the fourth capsule on 20OCT2023.  The outcome of the reported event was unknown, at the time of this report.  No action was taken with Vivotif with respect to the reported event.  No additional information was reported.  Company comment: It was reported that a patient took a second dose of Vivotif on 16OCT2023 and had vomiting on the morning of 18OCT2023 when the patient woke up. Further on 18OCT2023, the patient again had an episode of vomiting after 45 minutes of taking the third dose of Vivotif. Considering a temporal association (between the onset of the event and Vivotif intake) and a known potential of Vivotif to cause vomiting, the causality for the above event is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a patient took a second dose of Vivotif on 16OCT2023 and had vomiting on the morning of 18OCT2023 when the patient woke up. Further on 18OCT2023, the patient again had an episode of vomiting after 45 minutes of taking the third dose of Vivotif. Considering a temporal association (between the onset of the event and Vivotif intake) and a known potential of Vivotif to cause vomiting, the causality for the above event is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.
Pt was observed for 15 min and during the 15 min observation she reported being nauseous. While speaking to her she started looking pale and staring into space. She startd to faint but we caught her before she fell to the ground avoiding head injury. She reported lack of vision for 1 minute but recovered. EMT was called and they advised pt to go to ER with them b/c pt's hypotension. BP at first check was 78/62. Second check 103/70.
COVID-19; COVID-19; Feeling unwell; Pain; This is a solicited report from a Non-interventional Study based on information by Pfizer from the Regulatory Authority, Manufacturer control number: 21K-163-4086850-00.  A currently 76-year-old male patient received bnt162b2 (BNT162B2), intramuscular on 21Jan2021 (at the age of 75-years-old) (Batch/Lot number was not reported) as dose 1, single, then intramuscular on 11Feb2021 (at the age of 75-years-old) (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at an unknown dose and frequency (Citrate free) for moderate to severe ulcerative colitis. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced COVID-19, feeling unwell and pain. The patient had underwent lab tests and procedures which included Covid positive on an unspecified date. The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown.   Solicited report from the Regulatory Authority by a consumer of an elderly male with events of non-serious not feeling well, COVID 19 and pain with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced not feeling well, COVID 19 and pain. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a covid 19 vaccine trial. On 21Jan2021, he received 1st dose covid 19 vaccine manufactured by Pfizer, biontech. On 11Feb2021, he received 2nd dose covid 19 vaccine manufactured by Pfizer, biontech.  The reporter's causality for adalimumab for the events of not feeling well and pain was not provided. The reporter's causality for the event COVID-19 with adalimumab was no reasonable possibility. The reporter's causality for BNT162B2 for the events malaise, pain and COVID-19 was possible.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  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
23OCT97 devel numbness of tongue & perioral area;numbness proceeded to arms, legs;tx w/human immunoglobulin, APAP;2DEC97 f/u still weak, back to work 1/2day today;dx w/GBS;
how do I get the Comirnaty vaccine out of my body. She expressed she had beyond anxiety and PTSD from the first dose and will not get the second dose; PTSD; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: ANXIETY (non-serious), outcome "unknown", described as "how do I get the Comirnaty vaccine out of my body. She expressed she had beyond anxiety and PTSD from the first dose and will not get the second dose"; POST-TRAUMATIC STRESS DISORDER (non-serious), outcome "unknown", described as "PTSD".  Additional Information:Question: Caller declined to provide her name and callback number. She asked: how do I get the Comirnaty vaccine out of my body. She expressed she had beyond anxiety and PTSD from the first dose and will not get the second dose.Caller declined warm-transferred offered. She disconnected before I was able to ask for her age, to offer closing statement and survey reminder. E-transmitting AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 21-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # K008884, expiration date 20-SEP-2015. The patient was again vaccinated on 21-SEP-2015, with another dose of ZOSTAVAX lot # L011535, expiration date 03-JUL-2016, as well (extra dose administered) (vaccine administration routes and dosage regimens were not provided). No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.