chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin reaction; itching; general discomfort; Inability to sleep; welts; This case was reported by a pharmacist via call center representative and described the occurrence of skin reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2021, the patient received the 1st dose of Shingrix. On 6th May 2021, 10 days after receiving Shingrix, the patient experienced skin reaction, pruritus, discomfort, sleeplessness and welts. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the skin reaction, pruritus, discomfort, sleeplessness and welts were recovering/resolving.   It was unknown if the reporter considered the skin reaction, pruritus, discomfort, sleeplessness and welts to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Reported stated patient received first dose of Shingrix and experienced an all over skin reaction. Reported stated patient experienced itching, welts, general discomfort, and inability to sleep associated with the all over skin reaction. Reported stated patient has attempted to treat the skin reaction with Benadryl and prednisone. Reporter stated they would ask patient to call in to provide information and additional details. Reporter did not consent to follow-up.
Patients father stated the patient had a severe rash on her stomach the evening she received the vaccine.
sore arm; day 4-5, I have this interesting muscle strain in my upper left flank under my shoulder blade; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MUSCLE STRAIN (day 4-5, I have this interesting muscle strain in my upper left flank under my shoulder blade) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), VITAMIN D3 and VITAMIN B6 for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and MUSCLE STRAIN (day 4-5, I have this interesting muscle strain in my upper left flank under my shoulder blade). At the time of the report, PAIN IN EXTREMITY (sore arm) and MUSCLE STRAIN (day 4-5, I have this interesting muscle strain in my upper left flank under my shoulder blade) outcome was unknown. Not Related      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.   Treatment information not provided.
Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL concerning a 19 year old female patient with hypertension, asthma and obesity, no drug reactions/allergies, who on 23-JUL-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included lisinopril (manufacturer unknown) and montelukast sodium. On 16-OCT-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 660620/0571X) and was pregnant. The patient was due for the third dose on 21-JAN-2009 but did not receive it due to her pregnancy. The patient had a prenatal panel (normal). The patient came in for an OB visit. Her LMP was on 30-SEP-2008 and her EDD was 07-JUL-2009. Follow-up information was received from a staff person at nurse practitioner's office. It was reported that the patient was induced secondary to developing hypertension, and she had a vaginal birth on 24-JUN-2009 at term. The patient was seen in the office on 02-JUL-2009 for evaluation of her blood pressure and was treated with medication (unspecified) for hypertension by one of the physicians at that visit. The patient returned for further evaluation on 07-JUL-2009 and it was noted in the chart that both the mother and her baby were both doing well. The patient was last seen on 10-AUG-2009 by another physician in the practice for her postpartum visit and there was no indication of any problems for mother or baby. Follow up information has been received from the nurse practitioner that reported that the 19 year old female patient with chronic hypertension and with superimposed pre-eclampsia in her pregnancy was induced. On 24-JUN-2009, the patient was admitted to the hospital and was induced; the patient had a vaginal delivery of a healthy baby. There were no adverse events for the baby. On 28-JUN-2009 the patient and her baby were discharged to home. It was noted that on 09-JUL-2010 chart note, the baby was nursing well and that the baby was doing well. The nurse practitioner stated that "everything looked fine". Additional information is not expected.
Breakthrough case admission after three vaccines Pfizer 1/14/21 Lot# EL0142;  Pfizer 2/4/21 Lot# Em9810;  Pfizer 10/28/21 Lot# Ew0164
Chills - 8 hours Muscle aches - 12 hours  Fever  - 4 hours  Sweating - 5 days on and off Headache - 10 days Swollen lymph nodes - 7 days Joint pain -  3 days
This case was reported by a healthcare professional and described the occurrence of arm pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness, arm swelling and vomiting. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752230A, A0752231A, A0752232A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
I woke up the morning after the vaccine with a sore arm. It also felt warm to the touch and was swollen. I had a low grade fever. I slept most of the day and felt as thought I was coming down with a cold. My chest also felt tight and I had a headache most of the day. They next day, I felt slightly better and my fever went down. I was still fatigued. About 3 days later I woke up so short of breath I could not breathe. I went to sit in my recliner and called my doctors office. I saw my doctors PA and she did some tests including an EKG and blood work.  She wants to see me back next week. Nothing has been conclusive. However, whatever she prescribed me has helped me breathe better. The PA also wants me to follow up with my cardiologist.
Last shot given was DTaP. Soon after that, baby had like syncopy, cold hands and feet, pale and crying weakly but was alert; normal breathing. Heart rate around 100. Received 0.2 adrenaline and oxygen. After 15 minutes was acting good, good color. BP in leg 90/50; temp was 97.5.
Seen at this office for consult 1/6/2012.  Documented significant subcutaneous atrophy L upper arm, possible triceps muscle.  3x5 cm area, picture taken and on file.
where people are getting blood clots and mentioned she have had them all; now I feel so bad; 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 female patient received BNT162b2 (BNT162B2), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 3 (Booster), booster shot by Jun), administration date: Jun2021, for Covid-19 Immunization; Bnt162b2 (Dose 2), administration date: Feb2021, for Covid-19 Immunization; Bnt162b2 (Dose 1), administration date: Jan2021, for Covid-19 Immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "where people are getting blood clots and mentioned she have had them all"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "now I feel so bad".  Clinical course: Patient stated that she was "very concern with the four pages article about the new study and confidential Pfizer COVID vaccine where people are getting blood clots" and mentioned she have had them all and she have had her neighbors all get them and now she feel so bad." Patient confirmed that she had her Pfizer covid vaccine "last year Jan, Feb, booster shot by Jun, and another one this year." Caller mentioned that the article says infectious particles can be seared through respiratory and nasal fluids, the virus rules the whole mechanism to immunity maybe manifest it to aerosol transfer to antibodies between immune and unimmune host. She don't know what was this all about. They say it's just a scam that made millionaires out of these guys that came up with it. "Patient stated that the article was from "22Jul" which says that the vaccine was "giving people blood clot", "killing people" and was "dangerous".  Patient also added that her "husband has a heart condition working with asbestos and died 17Feb and maybe it was her fault because she got the vaccine. As per caller, the article if from a magazine by "(name Withheld) " which makes report on damaging products that kills people. After providing the response caller stated that "I don't get sick from them but it scared me.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Urticaria, generalized, without angioedema, lasting 1 hr responded to diphenhydramine.
Right outer aspect of arm extending light redness 100mm radiating from injection site with darker redness extending 50mm from injection site radially. Denies itchyness but complains of slight pain.
due to personal issues she could not get the 2nd dose within the dosing window; Metallic taste of vaccine; Metallic smell of vaccine; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Metallic taste of vaccine), PAROSMIA (Metallic smell of vaccine) and PRODUCT DOSE OMISSION ISSUE (due to personal issues she could not get the 2nd dose within the dosing window) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Mar-2021, the patient experienced DYSGEUSIA (Metallic taste of vaccine) and PAROSMIA (Metallic smell of vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (due to personal issues she could not get the 2nd dose within the dosing window). At the time of the report, DYSGEUSIA (Metallic taste of vaccine), PAROSMIA (Metallic smell of vaccine) and PRODUCT DOSE OMISSION ISSUE (due to personal issues she could not get the 2nd dose within the dosing window) 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.
15 hours after the booster I woke up and was nauseous and light headed. I passed out and had a seizure for 10-15 seconds. When I came to I threw up. Now I am achy and sore and have a headache.
started getting extreme itching of the back of my scalp and then the lymph nodes in the back of my neck started to swell and more going up the back of my head. Was put on several different medications and ointments over the course of 2 months, special shampoo to use, after 2.5 to 3 months it all went away
Patient noticed an area of redness that spanned from the injection site (left deltoid) down to the area below her elbow.
Clammy, chills, nausea, lymph node in left armpit enlarged to size of a line
Moderna COVID-19 Vaccine   Injection site: Pain and tenderness.  Also, pain and tenderness of lymph nodes in the arm pit area.  These side effects started within 3 hours of injection and lasted about a week.  General side effects: Headache, fatigue, body aches, slight fever 100.4 F, nausea, and vomiting.  These side effects started about 12 hours after injection and lasted about 24 to 36 hours.  Additional side effects: Hives on upper body (chest, neck, and back areas).  This side effect started after 36 to 48 hours and last about 3 days.
Pt had nausea, vomiting and diarhea that started shortly after recieveing her first vaccine.
Patient received wrong dosage of vaccine. Patient received .25 Milliliters of vaccine versus .5 Milliliters of vaccine. We were able to find the patient and give them additional .25 Milliliters of vaccine.
This is day 3 of moderate to severe persistent headache. He had been alternating Motrin and Tylenol throughout the day for the last 2 days with no significant improvement. Denies hx of migraine headache. Ordered Maxalt as abortive therapy- outcome pending.
Information has been received from a healthcare worker concerning unknown number of patients, who, on unspecified dates, may have received M-M-R II (dose, route and lot # not reported) exposed to unknown temperatures for 2 months, which subsequently were found to be unsupported by in-house stability data. No adverse symptoms reported. This is one of several reports from the same source. Attempts are being made to obtain identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
After administration of Yellow Fever Vaccine, patient became very fushed, weak, and nausiated. BP was taken at 122/86.  Appeared to be more related to s/s of hypoglycemia.  Pt hadn't eaten today.  Pt and mother had denied any adverse reactions to shots in the past.
Pt received Johnson & Johnson COVID vaccine last week 4/05/2021. The following day she started with chest pain/pressure, palpitations and left neck pain. These pains come and go. Left arm with episodes of feeling hot and numb. Vaccine was given in R arm. Reports left arm hot and numb, feels weak. 3-4 episodes daily. Duration of several minutes. Starts randomly. Improves spontaneously. Denies weakness, color change. Affecting entire L arm but mostly bicep region.   Neck pain has since improved. Continues with episodes of L arm numbness, and chest pressure and palpitations
I started having a really strange headache on one side of my head. I called the doctor, and they told me to check my blood pressure and by the next morning it was back to normal. I developed head pressure and when I went to the doctor, they gave me an EKG and sent me to the hospital because there was a concern about my heart rate. After all the testing, they told me everything was fine. No medication was prescribed. I was going back and forth to the doctor. In February I had a panic attack, I didn't know what I was feeling so I went to the emergency room. They completed the same test and said everything was normal. They advised me to take ibuprofen but did not prescribe anything. I went to my primary doctor who told me I was suffering from anxiety. He also referred me to a cardiologist. I went to the cardiologist who did a stress test and confirmed everything was normal. I went to another doctor who did the same test and confirmed all was normal but he began to treat me for anxiety with the medication fluoxetine. I was good until last Monday when I had another panic attack. I returned to my doctor who repeated the battery of test. The EKG showed slightly elevated on October 24. I now have to have a sonogram next week. I still feel like my body is heavy from side effects.
sore; swelling; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (sore) and VACCINATION SITE SWELLING (swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 28L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced NECK PAIN (sore) and VACCINATION SITE SWELLING (swelling). At the time of the report, NECK PAIN (sore) and VACCINATION SITE SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Mild- moderate tenderness in left deltoid; This is a spontaneous report from a contactable physician.  A 61-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number=EK 9231, via an unspecified route of administration, in left arm, on 30Dec2020 at 13:45 (at the age of 61 years-old for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included allergic rhinitis, a distant history of thyroid cancer and an allergy to iodine. Concomitant medication included biotin (BIOTIN), cetirizine (CETIRIZINE), fish oil (FISH OIL), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levothyroxine sodium (SYNTHROID).  . The patient has not had any vaccinations in 4 weeks. The patient has taken other medications (concomitant medications) within 2 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 31Dec2020 at 0700 the patient experienced mild- moderate tenderness in left deltoid. The patient was not hospitalized for the event nor received any treatment. The clinical outcome of the mild- moderate tenderness in left deltoid was recovering. Since the vaccination, the patient had not been tested for COVID-19.
I had about four weeks of fatigue (upon exerting myself) after the second vaccine, that passed and at the five week mark, had symptoms of a herpes outbreak (Iwas diagnosed with herpes thirty years ago) that is, genital blistering,, redness, and swelling. Also, blistering and itch on a couple fingers.
This is a spontaneous report from a contactable healthcare professional (patient). A 46-year- old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 16 Jan 2021 at 12:45 PM at a single dose for COVID-19 immunization in a hospital.  Medical history included high cholesterol, GERD, Barrets esophagus, IBS-C, brain aneurysms, and known allergies to penicillin. The patient also received first dose of other vaccine in left (arm).  Concomitant medications included clopidogrel bisulfate (PLAVIX), pravastatin, amitriptyline, famotidine, and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS).  The patient has known allergies to Topamax. The patient experienced burning feeling from chest down to feet, tachycardia, high blood pressure, and chest pain on 16 Jan 2021 at 12:45 PM. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. No treatment received for the events.  The patient is recovering from the events. Information on the batch/lot number has been requested.
Shingles developed on back and arms. Painful, raised rash causing stinging and discomfort,  Anti viral meds prescribed as well as pain medication
Cold; External ear pain; Facial paresthesia; Arm discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), EXTERNAL EAR PAIN (External ear pain), PARAESTHESIA (Facial paresthesia) and LIMB DISCOMFORT (Arm discomfort) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 30-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous). In November 2021, the patient experienced EXTERNAL EAR PAIN (External ear pain), PARAESTHESIA (Facial paresthesia) and LIMB DISCOMFORT (Arm discomfort). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) had not resolved and EXTERNAL EAR PAIN (External ear pain), PARAESTHESIA (Facial paresthesia) and LIMB DISCOMFORT (Arm discomfort) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. There was no reported medical history.  No treatment and concomitant medication provided.
Systemic: Lightheadness for 30 mins felt better after resting-Medium; symptoms lasted 0 days
On second day developed marked headache and nausea,  very mild disorientation  I went to office to try and sleep it off. Headache got worse so went home to bed.  5 hours later I am feeling much better
This case was reported by a nurse via call center representative and described the occurrence of tiredness in a 63-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received on an unknown date). In August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness and muscle pain. On an unknown date, the outcome of the tiredness and muscle pain were recovered/resolved. It was unknown if the reporter considered the tiredness and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife and also a registered nurse. The patient received SHINGRIX in the arm and within 24 hours the patient felt very tired and developed severe muscle pain. These symptoms lasted for approximately 6 weeks before going away. The reporter did not consent to follow-up.
Pt. states that after receiving the 2nd dose of Moderna 05/28/2021, started experiencing symptoms 06/11/2021 readings of HBP (prescribed HBP medication), diagnosed with *Tachycardia, Previous Covid + to vaccination, experienced similar symptoms. Primary visit current 07/29/2021 still continuing.
It was reported that an 18 year old female pt received a Menomune vaccination administered on 06/17/2002. Immediately she experienced seizure activity for 20 minutes with jerking movements of extremities. Pt was unresponsive for 30 seconds. Observed for 20 minutes with no further seizure activity completely resolved. She has no prior history of seizure activity.
Patient had initiial pain and then it went away almost immediately.  She went home and cut up strawberries and felt sweaty with GI upset.  She had this intense pain for about 15 hours.  Patient couldn't move her arm, so she tried Tylenol, but it didn't touch the pain. Patient iced injection site and started taking Motrin. Patient did not sleep all night due to the pain. Patient stated the pain was worse than giving birth (and she has done that 3 times).
Employee contact Employee Health on 10/14 stating her Left should has been hurting ever since her vaccine especially when moving it. Employee was referred to  Clinic for evaluation.
45 minutes after shot heart start to race and atrial fibrillation took place for the next five hours