chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complained of redness swelling on Left arm after PNEUMOVAX vaccine was administered. Patient seen 2 days later on 11/29/2017, L upper arm with redness and warmth and tenderness extending from several cm below shoulder to nearly anticubital fossa. Also extends several cm onto upper anterior chest and covers entire circumference of arm. Patient was treated with SULFAMETHOXAZOLE-TRIMETHOPRIM 800-160 MG ORAL TABLET (SULFAMETHOXAZOLE-TRIMETHOPRIM) 1 orally twice a day #10 Tablet Tab x 0.
Weird feeling in feet/lower legs.  Pain/aching, feels as if wearing socks.  Have appt with neurologist in October
Inadvertent administration of Vaxelis after temperature excursion; This spontaneous safety report, with reference number 02430531 (Interaction Number), was received by a partner on 19-JUL-2023 and forwarded to agency on 19-JUL-2023 and 20-JUL-2023, from a healthcare professional on behalf of a physician.  A ten-month-old neonate experienced an inadvertent administration of Vaxelis after a temperature excursion. No symptoms were reported.   Excursion details were reported as 65.2 F for 9 hours 45 minutes, 32.4 F for 42 hours 45 minutes. Batch number: U7217AA with expiration date:12-NOV-2024.  The causal relationship between Vaxelis and the reported event "Inadvertent administration of Vaxelis after temperature excursion)" was assessed as not applicable due to the nature of the event.  Companion Case: MCM-005056  Further information is expected.  Significant follow-up information was received by agency on 03-AUG-2023, from a HCP. The case is maintained as non-serious  The causal relationship between Vaxelis and the reported event "Inadvertent administration of Vaxelis after temperature excursion" was assessed as not applicable due to the nature of the event.  No further information is expected.
Developed Guillain-Barre; This serious case was reported by a physician via call center representative and described the occurrence of guillain barre syndrome in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   In FEB-2021, the patient received the 1st dose of Shingrix and COVID VACCINE. On an unknown date, 1 week after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Developed Guillain-Barre) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUN-2023 The reporter was a Doctor of Osteopathy. Approximately in February 2021, the patient received a COVID shot and a Shingrix vaccine a week apart. About a week later after vaccination, the patient developed Guillain-Barre. Healthcare professional did not have the patient's initials nor the expiration or lot number. It was unknown if the reporter considered the guillain barre syndrome to be related to Covid vaccine.     The reporter consented to follow up via email.
began having symptoms of shingles 12 hours after second shot; severe pain; This is a spontaneous report from a contactable consumer.  A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 18Mar2021 12:00 (Batch/Lot Number: EP754) at single dose (at the age of 48 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had no allergies.  The patient previously took BNT162B2, dose 1, (lot number: EN6198) on 25Feb2021 1:30 AM, vaccine location on the left arm. The patient began having symptoms of shingles 12 hours after second shot on 18Mar2021. Urgent Care visit 3 days later and now severe pain because of the shingles. No covid prior vaccination and not tested for covid post vaccination. The patient was hospitalized due to the events. The outcome of the events was not recovered.
Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong muscle and joint aches/pain; fever; White bump near injection site.; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9262 and expiry date: 31May2021) via Intramuscularly to left arm on 22Jan2021 10:30 at single dose for COVID-19 immunization. Patient medical history included bladder infection, blood pressure, she has some old age stuff like blood pressure, and she had Thyroid removed and takes a thyroid pill every day and she tends toward GERD. Concomitant medications included she does take other medications, but they are not relevant. Patient previously took Shingles shot for Shingles (Had the first of the Shingles shot but it was before that. She is due for the second one but she is putting it off for the COVID second dose). Patient reported that she got the COVID vaccine and was really excited because seemingly, she had no side effects. The shot did not hurt. Ten days after she go the shot, she got really hot at night and really strong muscle and joint aches on 31Jan2021. She was up almost all night. It just kept waking her up. So, she took something, an Ibuprofen thing to reduce fever and pain. The next night she took one proactively and did not have pain. The third night, she had it again but it was a headache all night and she was hot on 02Feb2021. It only seemed to happen at night. She felt like it was from the vaccine. She was not worried she had COVID. She had no breathing problems and did not feel like she was going to pass out. They said she should wait 48 hours and take a test to see if she had COVID. She did and it was negative. She does not feel any negativity toward the vaccine. She went in for a bladder infection and it was from a doctor's appointment that she got information and they told her she could go ahead and get it. Since she got the vaccine, she got white bump in the vicinity of the vaccine like a while mole, and another in the vicinity of the area as well. It does not itch or hurt. She noticed it about a week after the shot. She does not know the date. She was still on medication for a bladder infection but it would not have done anything. When she had reaction to the vaccine, it was already 10 days after she got the shot. She had asked them at Kaiser, and they think it was unrelated to any other medication. Outcome of event fever was recovered on 01Feb2021, for white bump near injection site was not recovered and recovering for all other events.
Patient was given 0.25 ml of H1N1 and should have received 0.50 ml due to her age.
Tinnitus occurred at 0400 the day after administration. Tinnitus not accompanied by any other complaints or symptoms. No deafness. Tinnitus intermittent in nature.
I gagve outdated KINRIX. Exp. date was 11-23-14 I told father and he will bring child back in 1 month to repeat dose.
hypopigmentation and lymphadenopathy  Narrative: Experienced lymphadenopathy on injection side after first dose - which he reports lasted ~1x wk prior to spontaneously resolving. No other associated sx other than notes developing odd hypopigmented/ yellowish area on medial side of left forearm. Described as ovoid in shape and about 3 inches long, 1 inch wide. No associated pruritus, sloughing, hives, swelling, warmth, or tenderness. Denies bruising/injury to area or history of contact dermatitis. He is not sure when it started and did not notice for a week after injection, lasted 2-3x days and self resolved without intervention.
Once vaccine was administered I felt short of breath but didn?t pay any mind. I thought it was my anxiety. About 6 I started to feel tired with a headache. About 8 pm my throat started to feel itchy. Next day I woke up with my chest feeling tight with a cough and phlegm. I thought it was just a side affect of vaccine and took my inhaler. On Saturday I woke up with a bad migraine and my chest still hurting. I knew something was wrong. I went to urgent care. I had ekg and X-ray and Covid test done. The ekg numbers came back low so dr requested a CT. My results came back as me having Covid in my left lung. Covid testing came back positive the next day. Prior to vaccine I did not feel sick or have any symptoms of being sick.
Pt received the Pfizer vaccine (Pfizer Lot#:EN6200, 1st dose) at 1232 on left arm. Pt reported to lead RN that she got up and felt dizzy. Pt reported not being able to see anything for approximately 5 seconds. Pt stated that she immediately sat down. Pt stated that she has suffered from hypoglycemia in the past. Lead RN gave pt water. Pt was given a piece of candy by one of her friends in the observation area. No vital signs were taken. Pt was kept an extra 15 minutes for observation. Pt immediately started feeling better after eating candy. Lead RN reassessed pt and educated pt on s/sx that would warrant a trip to the ED. Pt stated that she was feeling a lot better. Pt left building after being observed for 30 minutes. Pt walked out of building with a steady gait.
Mom calling and states that she is currently with child at clinic as child has been having hallucinations since last HPV on 1/15/2015. Child has had 2 prior doses of HPV up to this date. States that started about 3-4 days after last vaccinations. She sees figures hanging from ceiling, or dark shadowing figures. At home and at school. Child with severe anxiety now due to this.
C/O  chest tightness, throat tightness and tongue swelling while driving her car home - went straight to ER at Memorial Hospital, saw doctor.
SORENESS AND ACHINESS; HIGH FEVER; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced soreness and achiness. On 25-AUG-2021, the patient experienced high fever. On 25-AUG-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, soreness and achiness and headaches was not reported. This report was non-serious.
Vaccine given on 9/26/13. ON 9/30/13 patient showed me the injection site. Red, hard, not/warm to touch, itchy and site of injection was very visible.
9-1-09 4 P fever 101.7 temp.  TYLENOL alt. after Ibuprofen per Dr.  9-2-09 no fever.
burning sensation down arm to middle finger lt arm;shooting pain into shoulder area;no redness or swelling noted;burning & pain inc in intensity w/time;
onset of inconsolable crying x 45min 5hr p/vax given;APAP helped;swelling/?pain site of vax;10hr p/vax onset of projective vomiting x 7 became limp & pale, sl fever;
Immediate burning of face, ears, body within 10 minutes of shot Within 15 minutes of shot tachycardia of 115-140  Hypertension within 15 minutes of shot   Hives along torso present 2 hours after shot  Day 8 after vaccine a large 8 cm node appeared in Left Axilla ( same arm as shot was administered )  Still experiencing some significant tachycardia that was not present prior to vaccine ( resting heart rate 112-126)
I experienced nausea and diarrhea, along with headache, fatigue and low appetite. My symptoms started 12/16/2021 in the evening and lasted through 12/21/2021. My symptoms forced me to stay home from work on 12/17 and 12/20/2021. On 12/20 I went to urgent care. My temperature was slightly high and they tested me for Covid and the flu. Both  tests came back negative and they determined I had a stomach virus. I was prescribed with Zofran and also was told to buy Imodium. The medications helped with my symptoms.
Patient had syncope and nausea, BP 124/84, HR93, RR16, given apple juice and graham crackers, discharged in stable condition after 1 hour.
Arthralgia, Fever, Diarrhea, NauseaVomiting, low grade temp 99.8 knee pain flushing Narrative:   Other Relevant History:
This spontaneous report as received from a pharmacist student refers to a patient of unknown age and gender. On 04-APR-2014, the patient was inadvertently administered with a dose of VARIVAX (Merck), lot # 671029/1065AA, expiration date 05-JUL-2013, 0.5 ml, subcutaneous that had expired in July 2013. No adverse effects were reported. Additional information has been requested.
Patients hand became red and felt a burning sensation that still continues to this day. Onset occurred after first dose of Moderna in March 2021. Condition worsened after the 2nd dose of the vaccine.
A report has been received from a physician a 17 year old, female subject, who had been receiving FLUMIST (Intranasal). The patient's concurrent disease(s) included spinal muscular atrophy four. FLUMIST (Intranasal) started on an unknown date. The patient experienced pneumonia. The outcome of the event of pneumonia is unknown. The report was considered to be non-serious by the reporter.
soreness, fatigue, congestion, night sweats, itchy, rash, difficulty breathing
mom reported 26MAR98 small flesh colored raised areas started on neck on 23MAR, still spreading into hair, chest, legs;no other s/s has appt w/PMD tomorrow;
Two small bumps/pimple like, slight redness. Treated with ZYRTEC Children Allergy.
Patient had a 1/2-3/4 inch lump with 2 inch circumference at the injection site. The area was raised. It was not red. The lump lasted approximately 48 hours. We were notified by family 11/14/18.
When I woke up at 5:30 AM (day after shot), I was overwhelmed with nausea and dizziness, started sweating and then saw a picture of a white roundish figure with lime green dots on it for about 10 seconds and then all of a sudden I had ringing in my ears - hissing like the sound of a TV when stations have gone off the air....I had to lay back down in bed. The ringing lasted a couple minutes - went away....the picture of the white roundish figure with lime green dots came back again, then the hissing noise came back again - while I was lying down in bed....a few minutes past and it went away. I laid down till about 7:30 AM - fell back to sleep. Woke up without the nausea or sweating or hissing in my ears. Thought you should know about this.
Measles like rash 8 days following vaccine administration. See below - pt also treated with Amoxicillin for (L) OM. Also - questionable 5th Disease.
Injection site arm soreness; Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnancy) and INJECTION SITE PAIN (Injection site arm soreness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 18-Aug-2020 and the estimated date of delivery was 25-May-2021. On 18-Aug-2020, the patient experienced PREGNANCY (Pregnancy). On 04-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site arm soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy. The delivery occurred  on 25-May-2021, which was reported as Unknown.  At the time of the report, PREGNANCY (Pregnancy) and INJECTION SITE PAIN (Injection site arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2020, Pregnancy test: positive.
Stomach upset; Hot flashes; Headache; Muscle pain/Hurt/achy all over; Chills; Felt like they had COVID-19 all over again; Swollen joints; They could hardly walk; Got hot; Bouts of diarrhea; Shortness of breath; Dizziness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt like they had COVID-19 all over again), JOINT SWELLING (Swollen joints), GAIT DISTURBANCE (They could hardly walk), FEELING HOT (Got hot) and DIARRHOEA (Bouts of diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Drug allergy (Trimpex, Macrodantin) and Perfume sensitivity (Strong smells like perfume). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, HYDROXYZINE for Anxiety, VITAMIN D3 for Vitamin D, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION COMPLICATION (Felt like they had COVID-19 all over again), JOINT SWELLING (Swollen joints), GAIT DISTURBANCE (They could hardly walk), FEELING HOT (Got hot), DIARRHOEA (Bouts of diarrhea), DYSPNOEA (Shortness of breath), DIZZINESS (Dizziness), FATIGUE (Fatigue), MYALGIA (Muscle pain/Hurt/achy all over) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (Headache), ABDOMINAL DISCOMFORT (Stomach upset) and HOT FLUSH (Hot flashes). At the time of the report, VACCINATION COMPLICATION (Felt like they had COVID-19 all over again), JOINT SWELLING (Swollen joints), GAIT DISTURBANCE (They could hardly walk), FEELING HOT (Got hot), DIARRHOEA (Bouts of diarrhea), DYSPNOEA (Shortness of breath), DIZZINESS (Dizziness), FATIGUE (Fatigue), MYALGIA (Muscle pain/Hurt/achy all over) and CHILLS (Chills) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-130754 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: ADR Form
have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also/TSH level is markedly increased; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID: (004756).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; levothyroxine sodium (SYNTHROID), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BLOOD THYROID STIMULATING HORMONE INCREASED (non-serious), outcome "unknown", described as "have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also/TSH level is markedly increased". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for levothyroxine sodium was unknown.  Additional information: Caller wanted to know about reports of elevated TSH levels after covid vaccine. How long it takes to resolve, was there any inflammation going on. She has seen this with herself and with other members of her family, her Sister, daughter and brother- in-law, they all take Synthroid and have elevated TSH levels in the more recent labs, they all have gotten the Pfizer covid vaccine also. She stated other people were also experiencing it post covid injection they are having thyroid problems. Members were not having any symptoms, but their TSH level were very elevated, her was 57 and she was in the hospital due to it. Her doctors were also not aware of this side effect.  Her brother- in law stated that this could be reaction from covid vaccine /reagents as he does the research internationally. Their doctor thinks that they were not taking Synthroid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1/13/2021 first dose of Moderna, 2/10/2021 2nd dose of Moderna and booster of Moderna 10/22/2021 on 10/24/2021 she stated she developed red circles silver dollar size on both legs, by 11/20/2021 she developed "boils" "pimply" looking red rash on both forearms "felt like skin was on fire",  then by January 1, 2022 she developed a rash on her face, puffiness, and that's still there and developed "ocular migraine-kaleidoscope of colors" which that only lasted about 10 minutes on that date, she reported.
Patient reported to pharmacy to receive the influenza vaccine. she filled out all paperwork for the flu vaccine. Pharmacy administered the Pfizer vaccine dose # 2 instead of the influenza vaccine. Patients first Pfizer vaccine was on 8/29/2021. Patient wanted to report the event in case she had negative effects. At this time, the patient does not have any side effects.
Left arm where Varivax was administered became swollen and temp of 100F. The next morning lymph nodes under both arms and in neck were swollen and very painful to the extent that he didn't want to put his arms down. This lasted for about 3 days. 5 days after this he was diagnosed with strep.
Pt recvd 2 doses of Engerix-B on 14FEB92 & 18MAR92; 24MAR92 devel nausea & flu-like sx; sx resolved as of 10APR92 w/o treatment;
No additional AE reported; An expired dose of VARIVAX was administered to a patient on April 13, 2022.; This spontaneous report was received from a registered nurse referring to an unspecified age and gender patient whose medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters (ml), once, for prophylaxis, lot number T012552, was determined to be a valid lot number, and the expiration date was reported and upon internal verification established as 10-APR-2022 (expired vaccine used) (route of administration, anatomical location, and vaccine scheme were not reported).   No additional adverse events were reported.
ANGINA, UNSPECIFIED ACUTE NON ST ELEVATION MI HYPOTENSION  1/29/2022,  1/30/2022,  2/4/2022,  5/13/2022,   5/17/2022 --  RECURRENCE OF SAME SYMPTOMS
From 12 Jan to the current date of Jan 25 I have had an intense headache.  The headache varies from severe to bearable, but has not cleared up.