chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on injection arm/ huge rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 22Mar2021 09:02 (Lot number: EN6206) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Shingrix, start date: 2017, reaction(s): "Rash", notes: Caller states she had previous reactions to Shingrix like a rash from this one. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 24Mar2021, outcome "recovered" (27Mar2021), described as "Rash on injection arm/ huge rash". Therapeutic measures were taken as a result of vaccination site rash.  Additional information: Vaccination facility type was noted as pharmacy or drug store. Family medical history relevant to adverse events noted as none. 4 years ago, patient had a severe reaction to part 1 of the Shingrex shot. Reporter stated she had a huge rash 2 weeks after the injection, 4 times the size of what she got with the Pfizer which covered her entire arm. Patient received a topical steroid cream. Reporter stated the rash was lumpy, hot and red and all over her arm from the injection site to her elbow. Reporter stated after her first vaccination on 22Mar2021, she had a huge rash as well that happened pretty quickly and lasted a couple of days. Reporter stated with all 3 vaccines she got a rash on the arm. Caller stated she went to her dermatologist in Apr2021 for her rash and her told her to take Zyrtec 10mg twice a day for 2 weeks which was inconvenient because she was too tired, but it did not help.   Follow-up attempts are completed. No further information is expected.
pt got 2 vaccines - flu and 2nd covid vaccine   , pt fainted - gave water and put ice pack on back , pt was very anxious
Moderate diarrhea on Day 2 and gastrointestinal sensitivity (day 3).
First injection - only a sore right deltoid (injection site).  Fairly intense but only lasted 24 hours and easily alleviated by Tylenol. Second injection - Ringing in my ears - noticeable starting about 9pm the day of the second injection (3/11/21) and it's still going strong.  Intensity of ringing has remained constant to date unfortunately.  Headache was minor and on & off starting the night of the injection date and appear to still encounter them but intensity has been low.  Taken Tylenol to alleviate symptom with success.  Soreness at injection site - less intense on second shot than first but it lasted about 48 hours.  The Tylenol I took for the headache seemed to help with the arm pain.  On the day after the injection, my right latissimus dorsi (same side as shot) became sore but only for about 24 hours. Tiredness - didn't feel the exhaustion until about 9pm on the day of the injection.  Exhaustion/tiredness set in more than expected so very low activity the day after and went to bed several hours earlier than normal.  Still feeling tired but emerging from that as i'm starting to feel more energy come back.
This spontaneous non-valid report was received from a nurse concerning a patients of an unknown age and gender. Information regarding the patients' concurrent conditions, medical history, drug reactions and allergies and concomitant medication was not reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II, lot # R027063, expiration date 20-SEP-2020, GARDASIL 9, lot # R020200, 1586749, expiration dates 05-MAY-2021, 13-FEB-2021 respectively, PNEUMOVAX 23 lot # R033079, batch # R027063, expiration dates 06-JUN-2020, 06-JUN-2020 respectively, and ROTATEQ, orally, lot # R013861, expiration date 04-DEC-2019, (strength, dosage schedule and route of administration were not reported) all for prophylaxis. The vaccines were stored at a temperature of 10.5 C (Celsius degrees) for the time frame of 2 hours. The vaccines previously temperature excursion was at 23.37 C for 3 hours and 40 minutes. The call was because of data logger. No adverse effects reported (no adverse event).
client received covid vaccine approx 5-10 min later c/o feeling sick to stomach and light headed. client vomited moderate amount of brown liquid. client was pale and clammy. client was checked by ems.
redness; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and erythema. On an unknown date, the outcome of the injection site pain and erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination with Shingrix, the patient experienced  pain at injection site and large bright red spot 2 inches wide and 2 and half inches long. The injection site pain was lasted for 4 days and erythema was lasted for more than a week. The patient did not consent to follow up. No further details were provided.
High fever (103.3). I am usually low grade (approx 96.5). I also had a weird (metallic?) taste in my mouth beginning this morning, which is 2 days post vaccination. I have chest heaviness and last night I had some labored breathing.
the evening after the vaccine, I had difficulty breathing and headache.  Took me 5 minutes of trying to breath to get enough air and did not lay back in bed, I sat up and didn't have any other issues.  the headache is out of the ordinary for me as well
patient reports fever, chills, diarrhea that started yesterday. states was vaccinated yesterday J&J vaccine. was called today by someone stating was in contact with someone that tested positive.
WEAKNESS; HEADACHE; Flu like symptoms; FEVER; SEVERE BACK PAIN; RUNNY NOSE; BODY ACHES; DIZZINESS; INSOMNIA; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 06-MAR-2021 16:50 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced pain at the injection site and insomnia. On 07-MAR-2021, the patient experienced flu-like symptoms, fever  99.0 in am and 102.5 (units unspecified), severe back pain, runny nose, body aches, dizziness, headache. On an unspecified date, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at the injection site, fever, insomnia, severe back pain, runny nose, body aches, dizziness, weakness, headache, and flu like symptoms. This report was non-serious.
Headache, Chills,  fever 101.1 , body aches   Sleep / Rest
Vomiting, cough, diarrhea No treatment. Improving from earlier in the day.
Patient presented to the pharmacy on Saturday, October 12 with a 5-6 inch bruise on the inside muscle on his arm. He had a spot on his bicep which is not where his shot was given. I told him to place a cold washcloth on his arm and take an anti-inflammatory and benadryl. He purchased the benadryl and told him we would call him Monday to see if it is any better.
Pfizer BioNTech COVID-19 Vaccine EUA: Hospitalization Patient received Pfizer Vaccines on 9/8/2021 and 9/30/2021. Presented to ED on 9/30/2021 with severe crampy abdominal pain, diarrhea, nausea after receiving her second COVID-19 vaccine earlier in the day. On arrival the patient was tachycardic up to 120s (states tachycardic at baseline). Covid test was negative. UA negative. CMP and CBC WNL. US of pelvis and CT A/P were negative. Patient was treated with zofran, morphine x1, LR and atarax. Abdominal pain resolved by the morning of 10/1/2021 and patient was discharged.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter knew the 3 people who got shingles days after getting the vaccine. This case was considered as suspected vaccination failure as time to onset for the event, details regarding vaccination schedule was unknown. This case has been linked to the case US2019AMR070828 and US2019AMR070829, reported by same reporter.
12/29/2022 started around 4:00 a.m. with coughing, aches,fatigue, no fever. Covid Tested negative. 12/30/2022 still coughing, aches, fatigue, no fever. Tested positive. Redid test, tested positive again.
This spontaneous report as received from a physician via a Company representative refers to an 83 year old female patient. The patient had a history of breast cancer, current conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, lot number and expiration date not reported). On an unknown date, the physician reported that the patient was diagnosed with shingles in the eye area after receiving ZOSTAVAX. The patient sought for medical attention on an unspecified date. Outcome of shingles in the eye area was unknown at the time of the report. Additional information is not expected since no consent was given to perform follow up.
Dizziness; Weakness; Tongue felt fuzzy and prickly; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and PARAESTHESIA ORAL (Tongue felt fuzzy and prickly) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness) and PARAESTHESIA ORAL (Tongue felt fuzzy and prickly). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and ASTHENIA (Weakness) was resolving and PARAESTHESIA ORAL (Tongue felt fuzzy and prickly) had not resolved.        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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Dizziness, Myalgia, NauseaVomiting, fatigue, shaky, face flushed Narrative:  Felt okay the day of vaccination and day after, then Sunday, felt tired, then today began to have waves of nausea, began to vomit and experience dizziness, feeling flushed and warm but temp is 97.6 F- afebrile, sent home from work. States she was foggy and fatigued after the 1st dose right after but the following day felt "totally fine".
puss at injection site; hot to touch at injection site; swelling at injection site; itchiness at injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PUSTULE (puss at injection site), VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included SIMVASTATIN (ZOCOR), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), APIXABAN (ELIQUIS), METFORMIN, ACETYLSALICYLIC ACID, ATORVASTATIN CALCIUM, RAMIPRIL (AVOPRIL AS), IRON, CALCIUM and VITAMIN D3 for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PUSTULE (puss at injection site), VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site). At the time of the report, VACCINATION SITE PUSTULE (puss at injection site), VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itchiness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported.
Heart attack,  On June 5th I started having chest pains and thought it was heartburn. On June 8th I went to the emergency room and was transferred  to cardiac care hospital immediately had a cardiac catheter was diagnosed  with MI. Spent 24 hours in the ICU and then was transferred to another floor for 2 days. I'm being treated with meds.
Thrombocytopenia and Petechia. Resolved 4/4/06.
Patient had an allergic reaction after received the shot. Onsite EMS was called vitals were taken BP 112/74  98% O2 room air  HR 78.  Patient refused evaluation/care. Left aginst medical advice.
1-2 hrs after vaccine, pain and swelling in left arm.  4 hrs after, headache. Next day, shoulder is swollen and red, warm to touch and painful.  24 hrs after vaccination, rash all around the injection site. 30hrs after, rash gone. Shoulder still swollen, red, warm and painful.
Information has been received concerning a 14 year old female with unspecified allergies who on 28-Sep-2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast).  Concomitant therapy included loratadine (Claritin).  Subsequently on 01-Oct-2007 the patient came into the office and reported that she was experiencing hypersensitivity to her tongue, in terms of feeling of tongue.  Her taste buds were enlarged and she also said she was feeling tired.  The physician also reported that the patient has other allergies and the physician does not know if that was the reason why she was experiencing hypersensitivity to her tongue.  At the time of the report the patient's outcome was unknown.  Additional information has been requested. Information has been received from a physician concerning a 14 year old female with seasonal allergies who on 28-SEP-2007 was vaccinated with a first dose of HPV (Lot # 657617/0384U) intramuscularly in the left arr. On 01-OCT-2007 the patient came into the office and the physician reported that on 30-SEP-2007 the patient experienced a "fuzzy" feeling of tongue with bumps on her tongue. The patient also complained of feeling very tired and stated food tasted poorly. The patient also repoeted that she experienced hypersensitivity to her tongue, in terms of feeling of tongue. The physician reported that the patient's tasted buds were enlarged. The physician also reported that the patient has other allergies and the physician does not know if that was the reason why she was experiencing hypersensitivity to her tongue. Symptoms were resolved by 07-OCT-2007. Repeat HPV vaccination was given 01-DEC-2007. No reactions.
Erythema, swelling, itching, at injection site (size - about 2x a silver dollar) length greater than width.
Experienced fever and chills since 11 PM.  Is taking Tylenol currently.  As of 1233 on 1/8/21, still febrile.   Arm is sore.  He is aching all over (general malaise).   Feels like he is fighting the Covid infection again.
Slight feeling of swelling within the mouth; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm, on 01Feb2021 at 11:00 (at the age of 78-years-old) at a single dose for COVID-19 immunisation. Medical history included high blood pressure, indolent follicular lymphoma (not under treatment, but being watched), and allergy to cat dander. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 11Jan2021 (at the age of 78-years-old), in the right arm, for COVID-19 immunisation and erythromycin estolate (ILOSONE) as an antibiotic and experienced allergy. The patient experienced slight feeling of swelling within the mouth on 01Feb2021 at 11:30. The event was reported as non-serious. It was reported that the patient felt the swelling in the mouth after the 15 minute wait. The patient did not receive treatment for the event. The clinical outcome of slight feeling of swelling within the mouth was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
sweating Narrative: Patient is a 72 yo MALE with PMHx significant for T2DM,HLD,HTN,BPH, chronic pain, obesity, and schizophrenia. Patient received COVID-19 vaccine (Moderna dose #1) on 2/13/21; 5 minutes s/p vaccine dose administration, is noted to be sweaty. Patient's wife reports that he becomes sweaty when his sugars run high (T2DM on glipizide); Fingerstick glucose = 330, reports baseline blood glucose of ~ 200s and that he had a grilled cheese sandwich one hour prior to vaccine appointment. Patient seen by vaccine clinic provider; BP = 122/73mmHg, HR = 81bpm, O2sat = 86%, RRR with few irregular beats. EKG done which reveals LBBB w/o acute changes (compared to prior EKG). Patient's symptoms resolved in ~ 10 minutes w/o treatment. Per provider's assessment, low likelihood of cardiac in nature, no infectious sx to explain hyperglycemia, spontaneous resolution of sx makes anaphylaxis or allergic reaction unlikely, and does not believe sweating was related to vaccine. Clinic provider reviewed criteria for 911 and shared telephone care number with patient and wife.
administered expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Date the vial was initially stored in the refrigerator reported as unknown and the vial did not undergo any temperature excursions. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Non Significant  - Reporter address updated
Patient had his first covid vaccine at 1340 and within 10 minutes the patient's neck began to swell, turn red and he felt like he was having trouble breathing.  Rapid response called in building, Epi pen administered, Benadryl 50mg IM administered and pt sent to hospital via 911 ambulance at 1418
Uncontrollable vomiting, body aches, nausea,  extreme headache, and extreme fatigue.
A non-serious, spontaneous report of anemia has been received from a physician concerning a 28-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST, on an unknown date. On an unknown date, the patient experienced "anemia following FLUMIST in a female in good health". The outcome of the event, anemia, was unknown.
Patient experienced pain on the right side of her face and teeth, sinus  headache the next day after the second dose of the vaccine and the symptoms have not been subsided since 06/10/2021. Her current pain level is on scale of 5/10 at the moment. Sinus Headache is the symptoms that causes her the most discomfort
While I did experience most of the common side effects - headache, chills, muscle aches, joint aches, short fever - I wanted to report a side effect that surprised me.  My eyelids became puffy and the area around my eyes was swollen and ached. My eyes were also very sensitive to light. This started on the morning of day 2 and is still lingering, but better, by day 4.
Swelling of lymph nodes in size of injection; Swelling of lymph nodes in size ofinjection- painful shoulder nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 30-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  as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  On 16Apr2021, the patient experienced swelling of lymph nodes in size of injection along with painful shoulder nodes. No therapeutic measures were taken as a result of these events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event swelling of lymph nodes in size of injection along with painful shoulder nodes was recovering at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Symptoms lasted from 2100 on 5/14/21 2000 on 5/15/21 Fever between 100-102 degrees Fahrenheit Body Aches Chills Vomiting Extreme Fatigue Throbbing Headache
Received the vaccine, no reactions at all, went shopping all afternoon, and went to bed, woke up at 4:00 AM with a super bad headache and a fever.  Laid back down in bed, worse headache she has ever had and does get migraines.   She did have the size of about an egg with a rash on the arm itself.  She was disoriented, had chills and clammy, felt like she wanted to throw up but did not, fatigue.  The intense headache lasted until this morning 3/18/21.   She took 600 mg of Ibuprofen initially and then 500 mg every 4-6 hours of Tylenol, which helped.  The headache is pretty much gone, small fever, able to walk better this afternoon.