chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Tiredness; bad stomach ache; nausea; Vomited; really bad diarrhea; flu like; Insomnia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 03Sep2021 (Lot number: FC3184) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 06Sep2021, outcome "recovered" (06Sep2021), described as "Vomited"; DIARRHOEA (non-serious) with onset 06Sep2021, outcome "not recovered", described as "really bad diarrhea"; INFLUENZA LIKE ILLNESS (non-serious) with onset 06Sep2021, outcome "not recovered", described as "flu like"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; FATIGUE (non-serious), outcome "recovered", described as "Tiredness"; INSOMNIA (non-serious) with onset 03Sep2021, outcome "recovered" (2021), described as "Insomnia"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "bad stomach ache"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Therapeutic measures were taken as a result of insomnia.  Additional information: . Caller reported that her side effects started yesterday. Caller stated she vomited and had really bad diarrhea describing the diarrhea as yellow and flu like. Caller reported that she had headache and tiredness. Caller stated she did not see sore throat as a side effect to the vaccine . No Other Products. No Investigation Assessment.Her and her son had the COVID vaccine on Friday. 3 days after the COVID vaccine side effects started . Caller says that all of her side effects began yesterday, confirmed to 06Sep2021. She then clarifies and says that she felt the tiredness and the headache days before but they were not severe and even yesterday they were not severe, but she had the bad stomach ache and the diarrhea and then vomiting, she only threw up once. She says that she was not having the headache and the tiredness today and when inquired when it ended she states that she still doesn't feel top notch. She was still having the diarrhea and the headache has gone away and the nausea was not as bad today but the stomach ache was still there a little bit. The vomited ended yesterday, she only threw up once. Insomnia was began on 03Sep2021. She took this thing that she has called sleep sense and it has melatonin in it. Pretty much she slept all day yesterday. She didn't move much from either the bed or the toilet.She was feeling fine before the COVID vaccine. She has O+ blood type and she knows that you can have no symptoms at all and be carrying it, she doesn't know if that's true or if it's just rumors going around.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-JUL-2016, the patient was vaccinated with a dose of properly stored expired dose of PNEUMOVAX 23 (lot # L002310, expiration date: 08-JUL-2016). No adverse reactions was reported. Additional information has been requested.
pt recv vax 17JUN98 AM & by evening devel fever (max 103);by early morning of 18JUN98 a maculopapular rash devel on upper arms, forearm & anterior arm;
This spontaneous report was received from a nurse and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with improperly stored VARIVAX subcutaneously (dose unknown) from lot # M015735 with an expiry date of 30-MAR-2018. No adverse effects were reported. Therapy with VARIVAX was continued. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Welt-like rash on torso, legs and feet. No itching, no pain, no fever. Patient had questionable vaccine reaction after receiving MMR at 15 months. Rash and fever 13 days following vaccine administration in 2009.
This spontaneous report as received from a physician via a company representative refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an extra dose of GARDASIL 9 (dose, lot#, expiration and route of administration were not reported). The patient did not experience an adverse event. Product quality complaint (PQC) was not involved. Additional information is not expected as no contact details were provided.
Pt felt body aches/chills/headache and then after a few days started to get significant neck pain that he cannot relate to anything else. He is attributing it to the vaccine.  He has a hard time turning his head to the side.
ErythemaMultiform, UrticariaPruritus & ERYTHEMA; PRURITUS
After receiving the vaccine my arm felt extremely heavy, swelling and hot.  I was not able to elevate my arm above my shoulder level. I started developing chills, body aches and severe fatigue.  Then, I started developing a severe headache, fever of 102.5, heart rate of 115, chest palpitations and shortness of breath.  I started taking 650mg of Tylenol every 6hrs to control the fever, but it persisted for more than 24hrs.  Albuterol Sulfate HFA inhalation 90mcg every 4-6hrs, 1-2 puffs, I drank about 5 liters of pedialyte in 48hrs and regular water to keep hydrated. I applied cold compressions to my left shoulder.  I will continue to monitor these severe symptoms with the possibility to go to the hospital emergency room if they do not improve within the next 48hrs.
Symptoms appeared on face 11/30/06. 12/01/06 spread to trunk and all extremities.
shingles; This is a spontaneous report from contactable other Hcp (Pharmacist) from a Pfizer sponsored program . A 25-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on May2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not took other products. On unspecified date, the patient experienced shingles. She is on an oral antiviral treatment for shingles. She mentioned that the shingles was already on the peak when the patient consulted with the doctor and was only prescribed the regimen recently. She is asking for how long should they wait before giving the COVID vaccine. Reporter wants to knew when would be a good time for the patient to receive her second dose because the patient is on oral antiviral treatment for shingles due to being on antiviral for another 4 days. Reporter stated that the shingles infection happened between the first dose and the second dose and he couldn't confirm when the patient received the first dose and when the shingles exactly happened. The reporter mentioned that the patient was already taking those oral antivirals at the peak of the infection because the infection was already going on before she consulted with her doctor and was prescribed with the oral antiviral treatment. Reporter stated that what she does know is that the patient was further along in the virus, it was not the beginning of the shingles. Reporter unsure of when patient received the first dose, stating it was sometime in the beginning of May2021 she would think and states she was scheduled for the second dose on 24May2021. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Severe, Additional Details: pt did not feel well immediately following the administration of the vaccine. patient felt dizzy and sat on floor. pt remained AO X3
Nausea; Vomiting; Chills; Shaking; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 16:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included zolpidem (MANUFACTURER UNKNOWN) and hydroxyzine (MANUFACTURER UNKNOWN); for unknown indication from an unknown date and unknown if ongoing. On 26Apr2021, the patient experienced, nausea, vomiting, chills and shaking. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, chills and shaking was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Have received continual hives all over body since first Moderna shot in April 2021 and it persisted the same with 2nd Moderna shot but worsened. Hives lasted for over 2 months by reappearing daily throughout body from April-June. Decided to do Pfizer booster instead with the hope of a less reaction. Day 2 of the Pfizer booster and the same hives from the first 2 shots have reappeared all over my body again. Since the 1st shot in April I went to urgent care, emergency room, minute clinic, allergist, and PCP but none could emphatically  link it to the vaccine because it didn?t match the suggested symptoms agency listed for covid. I have pictures that document the hives after each shot. To add, after the 2nd Moderna shot, I received flu-like symptoms as listed by agency as well as chest pain that was very intense which led me to go to urgent care back in May. During each outbreak and symptom there was nothing that precipitated those reactions except for the shot. I was healthy and well prior. Since receiving the booster, I?m now 100% certain the shot caused my reaction as once again I was well until getting it.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient received the first dose of GARDASIL (Lot#, dose and route not reported) 2 years ago, in November 2010. The patient was in the office today, on 20-NOV-2012, to receive the second dose. No adverse effect reported. It was not known if the patient sought for medical attention. Additional information has been requested.
Within 3 minutes of receiving vaccine, had extreme nausea, dizziness, diaphoresis, and motion sickness. Had vomiting 30 minutes after vaccine. Within 3 hours injection site had swelling the size of a baseball with purple/blue discoloration and tenderness around the site.
I tested positive for COVID 40 days after my 2nd booster. My Dr. has given me a prescription for Paxlovid.
Fever - Temperature of 100.0F; Headache; Redness - Near Injection Site; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever - Temperature of 100.0F), HEADACHE (Headache), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SUMATRIPTAN for Migraine headache.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever - Temperature of 100.0F), HEADACHE (Headache), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever - Temperature of 100.0F), HEADACHE (Headache), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
I developed allodynia  on the right side of my trunk from the axillae to the umbilicus front and back.  Symptoms did not cross the midline.  I self medicated with NSAIDs, no better.  I saw my internist on 8/29/19 and had labs, started prednisone 60 mg tapering by 10 mg over 6 days.  Symptoms much improved on steroids but not resolved.  As of today I am 5 days off steroids and my symptoms continue to improve gradually.
7 hr after receiving 2nd Moderna vaccine, developed pain in shoulder without redness or swelling.  Eval by physician 3/11/2021 and prescribed  Diclofenac gel 1% appy to affected area 3 times/day.   He has used it for 5 days with no improvement.   He is contacting his physician for f/u today.
HYPOXIA 4/1/2023 PROSTATE CANCER HYPOXIA 4/1/2023 BACTEREMIA
Pt came in 10/30 for imz listed above - administered around 130pm by relief pharmacist - both in same arm - RPh did tell me they are given at least 1in apart but not noted exactly in consent form - pt said her arm started hurting that night and when she woke in the morning she had to stay in bed and miss work the next two days because she was feeling so badly. She did not call the pharmacy with this concern until Friday, Nov 2 then came in on Saturday, Nov 3 to show the pharmacist working her very red arm. Pt was instructed by RPh to use ice packs to help with site swelling, ibuprofen for discomfort and inflammation and also possibly BENADRYL. As the pharmacy manager today, Monday, Nov 5, I called to follow up with pt to see how she was doing. She did not see her Dr regarding the concern but had two family members that were nurses and they looked at it and said it was a result of both vaccines being given in the same arm.
Tired; Passed out, was semi-unresponsive; Vein was hit on vaccination; Arm blew up after the shot (swelled); Arm was still back and blue; Extreme weakness; Wanted to sleep/slept for 24 hours/slept the rest of the day; A spontaneous report was received from a consumer, concerning herself, a 71-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and was passed out, was semi-unresponsive; vein was hit on vaccination; arm blew up after the shot (swelled); arm was still back and blue; extreme weakness; wanted to sleep/slept for 24 hours/slept the rest of the day and tired.~  The patient's medical history includes leukemia ongoing since on an unspecified date and was not being treated. Concomitant medications were not reported.  On 23-Feb-2021, prior to onset of events, the patient received their second of two planned doses of mRNA-1273 injection, (Lot/Batch number: 001A21A) intramuscularly in their left arm for prophylaxis of COVID-19 infection.   On 23-Feb-2021, after the second dose of vaccine, the patient's arm blew up (swelled) and passed out, duration unknown, followed by less responsive with extreme weakness and sleepiness. Patient was sent to the ER (Emergency Room) where she was administered with fluids and anti-nausea medication and was released. Patient also informed that her vein was hit during the vaccination. Patient slept for 24 hours. On 24-Feb-2021, she was only awake for five hours. She again slept the rest of the day. At the time of this report, patient's arm was still back and blue, and was still tired but she was also much improved and is staying hydrated.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome for the event, arm was still back, and blue was considered not resolved at the time of this report. The outcome for event tired was resolving at the time of this report. The outcome for events, passed out, was semi-unresponsive; vein was hit on vaccination; arm blew up after the shot (swelled); extreme weakness; wanted to sleep/slept for 24 hours/slept the rest of the day were resolved on 23-Feb-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Aproximately 7 minutes after receiving vaccine patient began experiencing right arm pain that travelled to her forearm. She described it  as dull and 2/10.
24 hours after vaccine, extreme body aches began and mild headache.  72 hours after vaccine body aches subsided and severe sore throat, fever and chills began.  96 hours after vaccine, still sore throat and fever and chills... no sense of smell or taste, congestion began.  120 hours post vaccine, sore throat, fever and chills gone, still have no sense of smell or taste and congestion and cough began.  Days 5-14 post vaccine symptoms are: no sense of smell or taste, congestion, cough, headache, very tired and weak.
shingles; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  In 2016, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and/or zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the events. The patient received the treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Paresthesias - numbness, tingling involving both upper and lower extremities - Sx come and go but started on day of vaccine. Then more sx 2 wks later then again 2 wks later. Episodes last upwards of 1 hr - no known HA at time of attacks.
Anaphylactic Reaction; Significant angioedema; Severe allergic reaction; A spontaneous report was received from a nurse, who was also a 28-year old, female patient who received Moderna's COVID-19 vaccine and experienced an anaphylactic reaction, a severe allergic reaction, and significant angioedema.   The patient's medical history, as provided by the reporter, included Hashimoto's disease and thyroid disease. No relevant concomitant medications were reported.   On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced an anaphylactic reaction, significant angioedema and a severe allergic reaction. Treatment for the events included epinephrine, unspecified antihistamines and unspecified intravenous fluids.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was considered not resolved.; Reporter's Comments: This case concerns a 28 year old, female patient with medical history of autoimmune disorders including Hashimotos disease and thyroid disease, who experienced a serious unexpected event of anaphylactic reaction, angioedema and hypersensitivity reaction. The event occurred on an unspecified date after first dose mRNA-1273 ((Lot# 039K20-2A) administration. The subject's concomitant medication was not provided. The event was treated with epinephrine, iv fluids and anti-histamines. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Moderna COVID 19 Vaccine EUA  Developed a large, very red rash type area on the arm which was vaccinated about 9 days earlier.  It started as a very itchy area about the size of a half dollar coin then by the second day it had grown into a rectangular area about the size of 1/2 a dollar bill.  I went to Urgent Care and was advised to take Benedryl.  I took Benedryl for two days and the area has cleared up.  No more itching and the hot hard red area is gone.
Pain in right deltoid, decreased mobility of right shoulder, nausea, chills and fatigue all on 10/31/03 Above symptoms continued and redness approx 8 inches surrounding injection site noted on 11/01/03 Treatment: Ice to injection site and tylenol for the pain
About one hour after the injection, child began to experience increasing periorbital swelling, followed by increasing swelling of her lips.  No rashes. No trouble breathing.  No wheezing on exam.  No fever.  No emesis.  No mental status changes.  Seen in the Emergency Department that same evening (Feb 23 PM), within hours of reaction onset,  treated with diphenhydramine, dexamethasone, and famotidine, then discharged home with Epi-Pen.  Telephone follow-up care by me the next day (Feb 24 PM), when mother reported less swelling around the eyes, no breathing concerns, and almost complete resolution of lip swelling.  Advised to continue anti-histamine treatment (with OTC non-sedating, long-acting loratadine or cetirizine at 10mg daily) until complete resolution of swelling.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent and unknown gender. On 03-SEP-2014 the patient was vaccinated with an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Actually fewer side effects (no headache, no fatigue) than with dose 1 for first 30 hours. Allergeric reaction including hives 30 hours after vaccine. I had eaten shrimp about 7p on 2/5 (day after vaccine), became itching, then broke out in hives on face, chest, neck and back. Took 50 mg Benadryl and went to ER as I had Covid vaccine the previous day.  Monitored in ER, given 60 mg Prednisone in ER, observed for 3 hours, then released with rx of 40 mg prednisone daily for 4 days. I have had 2 other severe allergeric reactions including hives, and once anaphyaxis over the past 30 years, with the common denominator of having eaten shrimp.  I feel it may be possible that the Covid vaccine had my immune system on high alert and even a slight intolerance to shrimp caused the allergeric reaction. I regularly eat shrimp with no adverse effects.  I felt it important to report this reaction although it may not be a direct side effect of the Covid vaccine.  Again, first dose side effects were mild with a low grade headache and fatigue.
Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of abdominal discomfort (for tolerance of 1st dose refer case US2019AMR233004).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced upset stomach. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the upset stomach was recovered/resolved.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced upset stomach after receiving 2nd dose of Shingrix. The reporter believes this may be due to his mass since he was taller and reportedly weighs 100 pounds more. No more information provided. This case has been linked to the case US2019232431, reported by the same reporter.