chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker (also reported as nurse) refers to a 18 months old male patient. The patient had a previous febrile seizure on 27-JUN-2012. On 26-JUL-2012 the patient was vaccinated with VAQTA (25/0.5 U/ml) (lot # reported as H01043, expiration date 28-FEB-2015). Concomitant medications were reported as none. On 07-AUG-2012, "the day prior to 08-AUG-2012" the patient developed a high fever and on 08-AUG-2012 the patient had a seizure (described only as a febrile seizure). The patient sought for medical attention by contacting the office. The patient was recovered by 10-AUG-2012. It was also reported that the patient's father had a history of febrile seizures as a child (dates unspecified). And the family of the patient believed the child received GARDASIL rather than VAQTA due to an office follow-up scheduling error and the patient had a seizure. And on 11-SEP-2012 the nurse (local reference # US12-043716) reported that the "family happened to get a callback after that appt (in error) for get the next dose of GARDASIL". The nurse indicated that vaccine was given in "area where patient up to age 4 are seen" and "the nurse who gave it in unfamiliar with GARDASIL admin". It was reported by the nurse that lot number in file was "a hep A vaccine lot number" and it was "very unlikely that GARDASIL was the vaccine administered". And there was "no record of child receiving GARDASIL". Upon internal review, febrile seizure is considered to be medically significant. Additional information is not expected.
next 2 days pain at injection site.  As that faded, started to have muscle soreness, tingling and pain in right side shoulder, arm pit, especially painful in shoulder blade.  Continued feeling this and overall sensitivity to the touch on right side.  This continued until Apr 5, a rash developed eventually running from spine on back, shoulder, continuing under the arm, around to the front, across the breast to sternum.  This torso rash is at more or less the same "latitude" as the injection sight on the arm.  Diagnosis: shingles.  Extreme pain and fatigue for the next 10 days.  Starting to feel more tolerable pain starting on Apr 14.
Patient wasn't feeling well directly after injection, then passed out for several minutes, and was non-verbal for at least 15 minutes till started feeling better.
Information has been received from a physician concerning a 10 yr old female who on 06Nov97 was vaccinated SC once with the first 0.5ml dose of varicella virus vaccine live. On 16Jun05 the pt had body aches and a fever. She was seen in the physician's office on 17Jun05, she had about 15-20 varicella lesions on her back and trunk. The pt was given diphenhydramine hydrochloride (Benadryl) for the itching. No outcome was indicated at the time of this report. No product quality complaint was involved. Additional information has been requested.
Received 2nd dose of Moderna Covid vaccination 9/21 and on Oct 12,2022 I started my menstrual cycle for the first time in a year. Then over the next month I noticed extreme lethargy, palpitations and chest pains. I endured this until April when I was admitted to the ER with abnormal EKG. In addition to tachycardia & bradycardia I've also subsequently been diagnosed with edema, gastroparesis, dysautonomia, and hypothyroidism
Patient stated that on 10/25/2022 at 1:30am he noticed that half of his tongue was swollen. It was on the same side as injection site. He stated that it was uncomfortable and he was concerned so he took 2 benadryl tablets. The swelling subsided completely by 9am on the same day.
I contracted COVID. I had a slight sore throat, runny nose, sneezing, lot of fatigue. The fatigue was the worse. All the symptoms lasted for 3 or 4 days, but the fatigue remained. I then began to feel dizzy, and that lasted around 2 days. I originally tested negative one day then positive the next. I called the urgent care and was given PAXLOVID. About day 7 with COVID I tested and tested positive, but I was feeling a lot better. Then by day 10 I was negative, and the vertigo dizziness went away. My strength seems back to normal day by day, I am limited in my steps, but overall I seem to be back and nothing lingering.
pt recv vax 16AUG98 & devel nausea, chills, T101;Monday loose BM;18AUG98 same nausea, chills, T102.8;
received a dose of expired Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) (expiry date 30-JUL-2023) for prophylaxis.   On 23-AUG-2023, the patient received Shingrix. On 23-AUG-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: received a dose of expired Shingrix).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-AUG-2023 The pharmacist reported that a patient received a dose of Shingrix on August 23th 2023 expired in July 2023 which led to expired vaccine used. The vaccine administration facility is the same as primary reporter. The healthcare professional mentioned that patient was on her 60s, did not have the exact age or date of birth. No lot number provided. The reporter consented to follow up.
Patient received dose 1 or Shingrix on 01/23/2020. Patient is now requesting second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: The patient was now requesting for second dose. The consent to follow-up was granted. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case has been linked to the case US2020049336 reported by the same reporter.; Sender's Comments:  US-GSK-US2020049336:Same reporter
Started with pimples and then open areas on anterior neck by 3/25-26. new lesion on right eyelid and 3/27 on upper chest. 3/28 in office with eroded quality to neck lesions, crusted pustule on right eyelid; small pustule on: left upper chest, left axilla, right chest-lateral and small papules/early pustules on upper inner arms and on chest wall. Patient is not scratching. Mupirocin for eroded lesions. Home care and contageon prevention counseling to father who brought son in.
Information has been received from a registered nurse (R.N.) concerning a male child ranging in age from 6 to 12, who in the past 2 weeks was vaccinated subcutaneously with a second dose of Varivax. Following vaccination the child experienced a hard nodule from his elbow to his upper arm, as well as redness and warmth around the injection site. Medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
1 yr ago had Hep A, B influenza, tetanus. Patient reported she had vomiting/fever/swelling at site with last series a 1yr ago. Contacted doctor to discuss. It was agreed to give only Hep and Hep B today. 15 min after administration patient stated she felt shaky-trembling noted. BP 140/100, P 88, R18. Had her lie down, co-worker of patient gave her Benadryl 125mg po 0920 0930 and tremors, rash appearing on back , and around ears. Taken to hospital by friend.
itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (160849). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching". Therapeutic measures were taken as a result of pruritus.  Additional information: It was also reported that there was a inbound call from patient stating, since receiving the Pfizer covid 19 vaccine he had been experiencing itching but this medication (Eucrisa) was very useful.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed fatigue on evening of 6/9/17. During the day on 6/10/17 had myalgias, fatigue, nausea and difficulty sleeping on the night of 6/10. Called on call physician 6/11 instructed to hydrate, limit exercised. Had headache 6/11. Symptoms improved.
10:15 am - Received flu shot in left arm. No pain. 12:00pm pain in forearm. Needed to rub, = 12:30pm pain in left hand between 3 middle fingers. Couldn't sleep, throbbing pain in fingers. Took Naprosyn no relief. 11/1/07 - Took Tylenol, no relief. Throbbing pain continues in middle 3 fingers.
Moderna COVID-19 Vaccine EUA  Fatigue, body aches, chills, headache, mild nausea, low grade fever with Tmax of 100.4  for 2 days so far. Symptoms relieved with acetaminophen and ibuprofen so far
Chest and back pain 5/10, VSS, sent out to ER at 1400. No other symptoms but lethargy.
My son says he began to feel wierd. His legs, arms, and his head felt funny. When he arrived home at 210 PM his walk was wierd. He walked on the tips of his toes and stumbled. He could not really move his arms. He looked sick. I asked him what was wrong and he said his arms and legs were numb and that they hurt. So he laid in my bed for the rest of the day. I called his Dr. and described what was going on and they stated it wasnt vaccine related, they had me check his grip and his right side grip was weaker. They told me to give him ibuprofen. I kept checking him for fevers and asking him how he felt the rest of the day. By Sat morning all symptoms had gone away slowly.
Subsequent to receiving vax, the pt developed cysts on the left side of her body.: one 1/4 inch cyst on the temple; one cyst on the ankle and one cyst on the wrist. The temple and wrist cysts resolved in 2-3 days. The ankle cyst has not resolved. No treatment was given. Subsequently, she received her second and third doses of hepatitis B vaccine. No additional cysts developed following the second and third doses. As of 07/27/2000, the outcome of the event is ongoing.
Shortly after admin of ZOSTAVAX pt noted asymmetric, tenderness over (L) scalp/neck. When seen 7/7/09 Red rash (not vesicular noted) posterior scalp red raised lesion (L) neck.
8/13/2021- Date of 1st vaccination patient was already on menstrual cycle-no abnormal issues (heavy bleeding) during the 1st dose. Issues (heavy bleeding) noticed on or during 2nd dose, during menstrual.  9/3/2021- Date of 2nd vaccination; patient had her menstrual starting the 1st week of September; which was abnormal, o include heavy bleeding. After abnormal heavy bleeding cycle, patients menstrual cycle would stop for 2-3 days and start back heavy again after the 2-3 days. At this point; patient noticed extreme heavy bleeding. Patient being a teenager dealt with it thinking it was just a change that would go away; until she started having headaches, shortness of breath, tiredness, dizziness, and chest pains as well as the heavy menstrual cycle. Patient notified parents when dizziness and chest pains worsened. Parents scheduled medical appoint on 8 October 2021, and found out that day from the doctor that her hemoglobin (blood) levels were extremely low; causing for her to have a same day blood transfusion. Hospitalized 8 October 2021 @ 1pm for a blood transfusion, and released at 11:30 pm.  Patient received 2 units of blood while hospitalized; as well as, ferrous sulfate 325 (65 FE) MG tablet, and norgestimate-ethinyl estradiol 0.25-35 MG-MCG tablet.
Patient received the H1N1 live virus through the nose. She is 65 year of age with a long term health problem.
Sore arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) and NAUSEA (Nausea) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm) and NAUSEA (Nausea). At the time of the report, MYALGIA (Sore arm) and NAUSEA (Nausea) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-295365 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-295365:same reporter, same event and different patient
Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles. At the time of the report the patient's status was unknown. Additional information has been requested. This is one of several reports from the same source.
Myalgia & Arthralgia Narrative:   dose 1-day 1-5-sore at inj site; day 1-2-fatigue, lower back , hip and leg spasms/cramps, chills
presented with AMS, cough/SOB x3 days from oncologist office; +covid in ED; CXR: Covid 19 PNA; D-dimer 16.02; CRP  12.8; Ferritin 2036.3 Tx:  Initially on 6 LPM O2; up to High flow O2 60/50:  Rec'd Remdesivir, Vanc, Unasyn, Maxipime,  Decadron, Lovenox, 1/25 palliative care consult; DNR but continue aggressive measures; 1/27 comfort care1/28 inpatient hospice- died shortly after
Chills-overnight, pain and redness (3 inches) presently continues, headache-2 days, dizziness-2 days.
No adverse event; Patient administered with the Moderna vaccine which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine which were beyond the 30day beyond use date.).    Concomitant drugs were not reported. It was reported that more or less 192 patients had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date. Beyond use date for the monovalent vaccine with Lot number 939902 was reported as 02-Sep-2021. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
10 days after vaccine administered patient developed redness, warmth, and itching at injection site of left arm. No pain or swelling. On exam, 6 cm x 4.5 cm area of mild erythema, and warmth. No induration or drainage. Blanchable to the touch. This could be possible allergic reaction or developing cellulitis. Patient was placed on TRIAMCINOLONE cream to help with itching. Cephalexin BID x 7 days to cover for bacterial in reaction with this. OTC ZYRTEC once daily as well.
Redness and pain at the site of injection, followed by rash the following day that spread across her back to the other side of her body. The rash seems to have red patches with raised bumps. No systemic signs of anaphylaxis.
Started with muscle pain in left arm., from shoulder to elbow.  , Then headache started. Took 1 Advil Liqui-gels 200 mg. Headache stooped and arm pain eased up. Then nausea almost vomited dinner about 5:30.. I felt cold outside even though temp was in 80's/. Went to bed about 9:30 and I was freezing, shirving. Was under 2 quilts and still shivering. Could not sleep and headache was back. About 11:30 I took another Advil and fell asleep Woke up at 7:30 am with no symptoms. .
This case was reported by a consumer and described the occurrence of pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, headache and debility. On an unknown date, the outcome of the pain, headache and debility were recovered/resolved. It was unknown if the reporter considered the pain, headache and debility to be related to SHINGRIX. Additional details were reported as follows: The reporter stated that her husband had severe aches and pains, headache and debilitation for 3 days after vaccination with SHINGRIX. The patient laid out for 3-4 days with symptoms similar to previous cases of the flu. This case was link with case US2018GSK156342, reported by the same reporter for the same patient (case for 2nd dose).
Dizzy chest contracted stopped breathing. Family called ambulance and EKG showed heart activity to the point they wanted medflight to hospital. Took by ambulance ( my usual heart doctor) kept over night. Told reaction to COVID shot
Headache, Arthralgia, Fever, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, NIGHT SWEATS Narrative:
Chills, fatigue, aches, headache for 2 days Sore, reddened and swollen injection site for three plus days
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: soreness-Severe, Additional Details: patient went to doctor and dr said the shot went over vein and had huge bruise and bleeding inside. called patient and said he was sore and when he went to dr yesterday the dr reported to pharmacy . at present he just had blod clot which the dr said will go away after a week or so. the patient is on blood thinner also hence it happened a severe clot
Severe diarrhea and abdominal pain starting on day after vaccine. I have loose bowel movements and intermittent cramping for years secondary to illegal resection and Somatuline, but this was much worse than usual. It persisted and increased so I saw the doctor on March 4/21. He did labs and a CT of the abdomen that day. CT showed severe pancolitis. I was started on Flagyl orally that day. On March 7/21 steroids orally was added because of lack of improvement. Within a couple days I was improving and back to normal within about a week.
Shot for Flu, right Arm....high up on arm...stay tender longer than before.....pneumonia shot...injection in shoulder - high up right arm,  arm started throbbing, became hard to move, pain moved to entire arm, upper right shoulder, in my up right side of the back, continued to my neck then behind my right ear...arm felt as if my bones had twisted around,..couldn't hold arm up, held down and pain was consistent. Numbness set in...went to emergency.....gave pain pill, didn't stop pain...home, took TYLENOL for 4 day, pain remains but not,. still hurting very bad, in muscles, around shoulder where bone connects......went to my primary doctor.....arm to be put in sling...continue rotations of arm shoulder, taking pain pills.....pain remains..uncomfortable, unable to do normal funtions at this time.
Red, warm to touch from right shoulder to elbow. Denies discomfort. T 98.5. ENC to use cold packs and children Tylenol. ENC to see a physician.
Fever, chills, dizziness, weakness, fatigue. Onset roughly 6hrs after 2nd dose of vaccine. Duration: 30 hours.  2 weeks after 2nd dose of vaccine- full body hives, itching, constricted airway following exposure to cat. This was an unprecedented reaction.
Light headedness; Swelling raised site; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 14:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included COPD, CHF, CAD, diabetes, hypertension, stroke, stent stenosis (Heart stent), and clot blood (blood clots). The patient received unspecified medication within two weeks of vaccination. The patient was allergic to unspecified medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Mar2021 at 15:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. On 06Apr2021 at 16:45, the patient experienced light headedness, swelling raised site and difficulty breathing. Therapeutic measures were taken as a result of events and included treatment with BENADRYL and pro air inhaler. The clinical outcome of the events light headedness, swelling raised site and difficulty breathing were recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. known_allergies Yes added as Relevant Med History.
Patient went to her physician because she had pain in her right arm. She showed me her arm and she presented a red spot near her axilla. Prescriber gave her a prescription of DURICEF 500mg every 12 hours for 7 days.
04/16/2022 I started to feel a sore throat in the evening. The next day I continued to have the sore throat and I was getting very fatigued throughout the day. Then I began to start to get runny noses, congestion about 4 days after. I tested positive the Friday after, about one week from feeling symptoms. I only had cold symptoms and fatigue for a few more days and then it started to go away. the following week, 2 weeks post initial symptoms, I only had fatigue as a continuing symptom. A new symptom came on being dizziness and it has lasted up until now As of now symptoms are all gone except for light amount of dizziness still continuing. My heart rate was also in the 40's during this time. I did have an EKG and also went in for dizziness. My heart rate is now in the 50s and I am going to be seeing a cardiologist again.