chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to a male patient of unknown age. The patient has no drug reactions or allergies. The patient's medical history included six hernia surgeries. On 06-FEB-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, dose number and route were not provided) lot # G013023. Concomitant therapies included LOVASTATIN and HYDROCHLORTHIAZIDE. In the beginning of June the patient experienced a "tingling sensation on his lower abdomen". The caller stated that tingling sensation is similar to the tingling sensation he felt when had a previous case of shingles. The patient did not seek medical attention and no treatment was given. The outcome of tingling sensation on lower abdomen was reported as not recovered/not resolved. No reporter causality provided. Additional information has been requested.
Tired had to go to bed for 2 days. Site area swollen red and bruised. No energy or appetite.
This is a spontaneous report from a non-contactable consumer (mother) reporting for a patient (son). A 12-months-old male patient of an unspecified ethnicity received PREVNAR 13 at single dose, MMR, HEPA-B and INFLUENZA, all via an unspecified route of administration on 24Oct2016 for immunization. The patient medical history and concomitant medications were not reported. The patient had an allergic reaction, the boy's face got red and his eyes got swollen on an unspecified date. The mother mentioned the boy had had a peanut butter sandwich and wasn't sure if it was an allergic reaction to the food. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
she felt very cold for 10 days; was scheduled to get her second dose on May 11 but she was very sick and missed the appointment.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (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: FEELING COLD (non-serious) with onset 2021, outcome "recovered" (2021), described as "she felt very cold for 10 days"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "was scheduled to get her second dose on May 11 but she was very sick and missed the appointment.". The events "she felt very cold for 10 days" and "was scheduled to get her second dose on may 11 but she was very sick and missed the appointment." were evaluated at the physician office visit. Therapeutic measures were taken as a result of feeling cold, illness.  Additional information: She felt very cold for 10 days. She had seen her doctor and was prescribed an antibiotic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: was fainting,,, the nurse practioner came and took his blood pressure,, we gave him some water,, after about 40minutes his mother came and took him home,, the nurse practioner thought he was anxious about the shot and needle,, checked air way,, he laid on the floor for 30 minutes
more than half the dose didn't make it into the arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (more than half the dose didn't make it into the arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (more than half the dose didn't make it into the arm). At the time of the report, INCORRECT DOSE ADMINISTERED (more than half the dose didn't make it into the arm) outcome was unknown. Not Provided      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.   No concomitant information provided.  No treatment information provided.
Severe headaches and rapidly worsening sore throat and severely swollen tonsils, especially on right side. Visited Clinic on 3/30/2022 due to pain severity increasing dramatically over the course of the week. Became unable to swallow. Having difficulty  talking and even breathing.
Day after vaccination --brain fog, Dizzy. Friday 1/15/2021 6:30 head spinning, nausea; symptoms have not subsided
Red arm, swollen, warm covered entire arm from shoulder to elbow itching and pain went away in about 4 days
Pt describes: "the site was very tender, hot and painful with a big bump for 2-3 days after the injection.  It has been pretty much since the injection.  It is warm and no longer raised." as of conversation on 08/25/2020 with pt. Treatment: Cold compresses to the site of injection and observe for any changes.
This case was reported by a consumer via call center representative and described the occurrence of eye swelling in a adult female patient who received Shingrix for prophylaxis. In September 2018, the patient received the 1st dose of Shingrix (intramuscular). In September 2018, 1 day after receiving Shingrix, the patient experienced eye swelling. On an unknown date, the outcome of the eye swelling was recovered/resolved. It was unknown if the reporter considered the eye swelling to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. Approximately 6 weeks ago from the date of reporting, the patient received Shingrix. The day after receiving Shingrix, the patient had swelling around her right eye which resolved in approximately 3 days. The patient reported the event to her doctor via email. The reporter had denied permission to contact their physician.
Per parents a rash started to break out on 08/10/2018 and the parents called the on-call doctor for the Health Department. Since the doctor could not physically see child, doctor sent to the parents/client to the nearest hospital ER. At the hospital, the client was prescribed Steroids and Benadryl. Today, the client was seen in the health center (08/13/2018), what appears to be hives per photos from parents, the client is recovering from the hives and no current hives seen on body. Last dose of Benadryl was given to client at 8:00pm on 08/13/2018.
Within 20 minutes of shot, muscles in neck and shoulder began to spasm painfully. Spasms ceased after approximately 2 hours, but extremely limited range of motion and severe pain persisted for two weeks. Patient was instructed to take ibuprofen and not "baby" the shoulder. Five weeks after initial shot, range of motion is still not back to normal, and shoulder joint is still painful.
Patient's left deltoid, axillae and left chest wall, swollen, red and inflamed. Painful and impedes use of left arm. Symptoms developed 3 days after receiving pneumococcal vaccine in left deltoid. Seen by MD and dx'd with infection and started on antibiotics.
STABLE ANGINA 12/21/2022 -- RECURRENCE OF SAME SYMPTOMS
The morning of  August 2, 2021 I went to the urgent care and they did a Strep throat test and it came back positive. An then by Wednesday August 4, 2021 I couldn't smell or taste anything. I went to be and I was sick for about two weeks. I had no energy and I was very weak and couldn't do anything. I believe that I had come down with COVID-19. But I didn't have a fever at all. Urgent care prescribe me, Amoxicillin for 10 days. As of today Sept. 07, 2021 I still can't taste or smell.
Chief complaints: Right sided arm pain and not feeling well. Onset: Quickly after Tdap vaccine on 2-21-17 Duration: 1.5 days Severity: Patient has left work early for 2 days in a row. Pain in arm is severe. Reports being unable to have full ROM with right arm.  Characteristics: Patient reports that whole right arm is more swollen then left and there is redness at site of TDaP injection. Reports that when shirt rubs against arm that he is in a lot of pain. Patient also reports experiencing whole body aches and a super bad headache. Reports that he has taken Meloxicam but it "just makes everything worse". Feels like neck is in a lot of pain as well.
Case number PHEH2014US02551116, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 89-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Next day soreness continued getting worse for several weeks until entire arm hurt from neck to wrist.  This lasted several weeks until I went to the doctor. The doctor prescribed 2 weeks of round the clock 600 mg motrin. This helped for a few weeks but the pain returned but more mild and only in the shoulder area. It still hurts to move arm to certain positions
Patient c/o lump in throat, sinuses started running, eyes became red, within 1 1/2 hours of vaccination. During hospitalization had decreased BP, elevated temperature.
pt recv vax & exp severe redness, soreness & swelling in the arm & joint;
Pt has been experiencing left arm numbness, chest pain and heart racing from the evening of vaccination until now.
red hot blotch on his arm; bloated, extended stomach and gas; Gas after 2nd dose; stomach hurt; couldn't eat; couldn't get out of bed because he didn't have any muscle/muscle pain; fatigue; joint pain/pains in wrists, shoulder; chills; vomiting; fever; sweating; shaking; Pains in neck; pains in lower back; lost 15 pounds; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt) and FEEDING DISORDER (couldn't eat) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt), FEEDING DISORDER (couldn't eat), MYALGIA (couldn't get out of bed because he didn't have any muscle/muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain/pains in wrists, shoulder), CHILLS (chills), VOMITING (vomiting), PYREXIA (fever), HYPERHIDROSIS (sweating), TREMOR (shaking), NECK PAIN (Pains in neck), BACK PAIN (pains in lower back) and WEIGHT DECREASED (lost 15 pounds). At the time of the report, ERYTHEMA (red hot blotch on his arm), ABDOMINAL DISTENSION (bloated, extended stomach and gas), FLATULENCE (Gas after 2nd dose), ABDOMINAL PAIN UPPER (stomach hurt), FEEDING DISORDER (couldn't eat), MYALGIA (couldn't get out of bed because he didn't have any muscle/muscle pain), FATIGUE (fatigue), ARTHRALGIA (joint pain/pains in wrists, shoulder), CHILLS (chills), VOMITING (vomiting), PYREXIA (fever), HYPERHIDROSIS (sweating), TREMOR (shaking), NECK PAIN (Pains in neck), BACK PAIN (pains in lower back) and WEIGHT DECREASED (lost 15 pounds) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
she had an outbreak of shingles; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) 1st dose, single for COVID-19 immunisation. Medical history included cancer before and there is a "weak spot" in the past radiation site. The patient's concomitant medications were not reported. The patient had an outbreak of shingles on an unspecified date with outcome of unknown. The event was assessed as non-serious.  Information on lot/batch number has been requested.
Hives and facial swelling approximately 30 minutes after vaccine; went to urgent care; doctor administered epinephrine and steroid; started series of benedryl and Pepcid for 48 hours; swelling and hives went away
4 hours post injection, experienced cough, wheezing, throat felt tight. Immediately took Benadryl 25 mg which improved respiratory states within 1 hour, 8 hours post, injection developed fever 103.8 with shaking chills. Lasted 6 hours. Took Tylenol PM. No further sx except fatigue!
Pfizer vaccine was administered outside of Facility- reported by patient  R09.02 HYPOXEMIA 12/14/2021 CANCER METASTATIC TO INTRAABDOMINAL LN R09.02 HYPOXEMIA 12/14/2021 ASTHMA, UNSPECIFIED
One week after my initial vaccination (1/15), I had several mosquito size red welts on my right upper arm that itched.  The next morning (1/16) it had turned into one large red area on my upper arm that was still itching.  By 1/17 the red area was a bit larger and still itched.  On  1/18 the area was a little bit larger but the redness was going away.
Information has been received fro physician concerning a female patient between 14 and 16 year old who on 15-AUG-2008 was vaccinated with the first dose of GARDASIL. After receiving the vaccine, the patient fainted and experienced twitching. The patient recovered. Medical attention was sought. This is one of two reports received from the same source. Additional information has been requested.
Swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lips) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (Swollen lips). On 18-Jan-2021, LIP SWELLING (Swollen lips) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  No treatment medication was reported for this event.   This case was linked to US-MODERNATX, INC.-MOD-2021-074846 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074846:Second dose case
My doctor think I have Pleurisy. .  I have shortness of breath, hard to couch or take a deep breath.  Spasms in my right side,
Temp. started climbing about 6pm. 10/07.  Extreme sweating.  Shivering so bad, I could barely walk to the bathroom at 1-2am By 1-2am 10/8 temp went above 100.  Took aspirin (325mg enteric coated.  Extremely tired. No appetite.  Slept until 4pm 10/8.  Ate some soup.  Back to bed 10pm.  Woke 10/9 feeling better, still weak.  When I took a shower, I noticed tenderness under my left arm.   About 4pm 10/9, fever returned.  When it reached 99.8, took Tylenol 625mg 8hr.    This temp. pattern is the same I had when I had covid in 2020, and after each vaccine.  My first three vaccines were Moderna.  The side effects were worse and got worse with each shot.  So, I decided to try Pfizer.  The only difference is I don't have the dull pain in my bones I had with my last Moderna vaccine. I have not seen a doctor, nor talked to my pharmacy.  I am monitoring  myself.
21FEB92 past 2-3 days looks like has measles, today looks like Rubella-red blotchy very bright; does not have thermometer; eyes watery @ first; wants to be held, grumpy; 1st smaller pin-point spots started on tummy by diaper; diarrhea;
Pt exp 5hrs solid screaming  w/no pause, rt thigh swollen twice normal size;
Severe skin itching all over, burning and tingling in arms, hands, legs and feet after the second dose.
Within hours of the vaccination, debilitating pain in shoulder joint was experienced.  No fever, swelling or redness.  Was not taking normal arthritis medication for the prior two months.  Not sure if pain is an arthritis flare.
Patient received dose 1 of the Pfizer COVID vaccine (lot EW0175, exp 8/2021) at approximately 1710. At 1717, patient requested that Paramedic take her blood pressure because she felt anxious. Vital signs: blood pressure 152/88, O2 99%, pulse 104, respirations 16. PHN approached to assess the patient who reported feeling hot and nervous. Patient reported experiencing similar symptoms when she felt anxious. Patient denied allergies, reported medical condition to include anxiety, and takes anxiety medication not specifying what medication. PHN gave patient water to drink and encouraged patient to remain for 30min monitoring, to follow up with provider, and when to call 911. PHN offered patient Benadryl but patient declined. Patient drank water and reported "I want to leave," stood up, and paced back and forth in the observation area. At 1725, patient requested her vitals be taken again and sat down. Vital signs: respirations 18, blood pressure 152/92. Patient reported "I feel fine I'm leaving." Patient left walking with steady gait at 1728.
I21.4 ACUTE NON ST ELEVATION MI 3/10/2023 DM 2 W HYPERLIPIDEMIA
Given tylenol for slight fever L leg swollen with red spot,irritable in afternoon, fever went to 103.6F down to 102.9 and back to 103F, down to 100F today. Stopped walking on Thursday L leg bruise, hard swollen to size of silver dollar.
Patient immediately started experiencing a "fullness" in back of throat. No breathing difficulty. Adenoid was very swollen.
Nausea and vomiting that began less than 12 hours after the vaccine was administered and continue until 36 hours after vaccine administration time.  Facial redness and itchiness.
numbness of face; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; swelling and itching of tongue and lips; menstral cycle thrown off by 10 days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: not available/provided to reporter at the time of report completion), intramuscular, Left arm on 06Jan2021 13:45 at single dose for covid-19 immunization. Age at vaccination was 43 years. Patient was not pregnant at the time of vaccination. Medical history included Hoshimotos and Acid reflux. Allergies to medications, food, or other products included sulfa allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included omeprazole 40mg, paroxetine 20mg. On 06Jan2021 14:00, the patient experienced swelling and itching of tongue and lips within 15 min, numbness of face the next day (on 07Jan2021) continuing for several weeks. Menstral cycle thrown off by 10 days. The events resulted in emergency room/department or urgent care. Recovered with lasting effects. Benadryl, pepcid and prednisone treatment was received for the events. Events outcome was recovered with sequelae.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relationship, the association between the vaccine and the events swollen tongue, lip swelling, tongue pruritus, lip pruritus, hypoaesthesia cannot be completely excluded. Delayed menstruation is probably an intercurrent condition for which the patient's age is also a contributing factor.  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.
Medical assistant states they did not have concerns about the pre-filled gardasil syringe upon attaching safety-glide needle to prepared for administration. Upon medical assistant putting the needle into the patient's L deltoid, as she began attempting to push on the syringe to inject the glass vaccine syringe malfunctioned and the glass broke. The medical assistant was then unable to push the vaccine into the patient's deltoid, and the syringe separated completely from the needle, leaving the safety-glide needle alone in the patient's arm. The medical assistant carefully took the needle out of the patient's deltoid and immediately discarded this needle into the sharps container. There was no immediate adverse effect for this patient (aside from needing to receive a second "injection" with a needle), and this patient then was then administered a subsequently prepared different dose of HPV vaccine without issue during the same visit.  The medical assistant involved immediately reported this to their supervisor.
4cm diameter raised erythematous plaque around site/of inj, maculo-erythematous rash & over trunk & around lesion described above on site of inj;
Fever; Chills; Migraine; Tinnitus; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19.  On 23Apr2021, the patient experienced fever, chills, migraine and tinnitus. The events did not result in doctor or other health care professional office/clinic visit, and 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 fever, chills, migraine and tinnitus was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reports itchiness, warmth, swelling and redness that is present from Left deltoid (injection site) to left elbow.
Patient awakened on 04/25/2003 with erythema, swelling, pain of right arm from shoulder to elbow.  Skin felt hot-to-touch.  Treatment :  Benadryl, Elixen ice to area.  Had received immunizations the previous day.  Unable to reach patient by phone to follow up and see how his doing.
Injection given at 0915 and at 0918 employee had complaint of vision disturbance and light headedness. Employee laid down on bed and stated symptoms subsiding at 0920. At 0930 employee states "itchy/tingling/pin prick sensation all over body"
Abdominal rash within 3 weeks after 1st varicella vaccine.  Went to primary care provider who cultured the rash and determined it was varicella.
raised erythema, inflammation, pain to touch, warm to touch at injection site, started after injection, still continued 2 days later, patient has not yet followed up with physician at this time; cold compress & nsaid for treatment- will f/u with md if no resolution of symptoms in a few days