chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site was tender to touch; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site was tender to touch) and VACCINATION SITE PAIN (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site was tender to touch) and VACCINATION SITE PAIN (Sore arm). On 20-Mar-2021, VACCINATION SITE PAIN (Injection site was tender to touch) and VACCINATION SITE PAIN (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient usually takes a cocktail / glass of wine at night and also takes medical cannabis , especially CBD and some THC, at every night. Patient wants to know regarding whether alcohol, cannabis, NSAID or Tylenol will affect the immune response, either before or after his second shot.   Patient is scheduled for his second shot on 14Apr2021. Concomitant medications and treatment information was not provided.
Rash on left and right side of upper chest, middle lower back, between chest and abdomen, start coming on the side of the ribs; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old-male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8732) via unspecified route of administration on 26Mar2021, (at the age of 53 years old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6205), via an unspecified route of administration in the right arm on 05Mar2021 at 09:15, (at the age of 53 years old) as a single dose for COVID-19 immunisation. On 12Mar2021, the patient experienced rash on left and right side of upper chest, middle lower back, and between chest and abdomen, start coming on the side of the ribs. No therapeutic measures were taken as a result of reported event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of rash on left and right side of upper chest, middle lower back and between chest and abdomen, start coming on the side of the ribs was not recovered.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported: updated Age at Vaccination as 53 years
fever, bodyaches, insomnia and slight headache for 24 hours. Temperature remained above 100 with the use of ibuprofen or acetaminophen. Bodyaches, fatigue and slight headache continued till 48 hours post vaccine. Day 3 after vaccine fatigue and mental fog.
DIZZINESS; DIARRHEA; LOSS OF APPETITE; VOMITING; HEADACHE; NAUSEA; CHEST PAIN; DRY MOUTH; STOMACH PAIN; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced dry mouth. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced stomach pain. On 07-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced diarrhea. On 12-APR-2021, the subject experienced loss of appetite. On 12-APR-2021, the subject experienced vomiting. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, and dry mouth, and had not recovered from nausea, headache, vomiting, diarrhea, stomach pain, chest pain, and loss of appetite. This report was non-serious.
Heart Palpitations, light headedness, red/dry eyes, pressure in head.  These symptoms persisted for 3 weeks, with increasing exhaustion. When palpitations did not resolve, PCP advised to go to ER.  ER visited on 10/18, with follow up to Cardiologist on 10/20.  Cardiologist continuing to assess to r/o underlying condition.
Started with fever, 9 days after shot then next day about 4PM started with being very limp, would not wake up to stimulation. both sites. /// went to ER X2. Gave IV, antibiotic, blood work and a spinal tap. Got much better approx. 24 hours after start of symptoms.
Developed large amount of swelling, itchiness, redness, and erythema Kw/in 5 minutes of injection. 2 1/2 hours stated she felt short of breath and lightheaded, even after she took 2 tabs of BENADRYL 15 min. after her injection when she felt her arm swell. (Swelling had decreased). Went to E.D.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 20-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case: 1808USA001261; US-009507513-1808USA004382: Original Case: 1808USA001261; US-009507513-1808USA004383: Original Case: 1808USA001261; US-009507513-1808USA004384: Original Case: 1808USA001261; US-009507513-1808USA004385: Original Case: 1808USA001261; US-009507513-1808USA004380: Original Case: 1808USA001261; US-009507513-1808USA004379: Original Case: 1808USA001261; US-009507513-1808USA004376: Original Case: 1808USA001261; US-009507513-1808USA004377: Original Case: 1808USA001261; US-009507513-1808USA004378: Original Case: 1808USA001261; US-009507513-1808USA004386: Original Case: 1808USA001261; US-009507513-1808USA004387: Original Case: 1808USA001261; US-009507513-1808USA004362: Original Case: 1808USA001261; US-009507513-1808USA004363: Original Case: 1808USA001261; US-009507513-1808USA004364: Original Case: 1808USA001261; US-009507513-1808USA004389: Original Case: 1808USA001261; US-009507513-1808USA004390: Original Case: 1808USA001261; US-009507513-1808USA004391: Original Case: 1808USA001261; US-009507513-1808USA004392: Original Case: 1808USA001261; US-009507513-1808USA004393: Original Case: 1808USA001261; US-009507513-1808USA004394: Original Case: 1808USA001261; US-009507513-1808USA004395: Original Case: 1808USA001261; US-009507513-1808USA004396: Original Case: 1808USA001261; US-009507513-1808USA004365: Original Case: 1808USA001261; US-009507513-1808USA004366: Original Case: 1808USA001261; US-009507513-1808USA004367: Original Case: 1808USA001261; US-009507513-1808USA004397: Original Case: 1808USA001261; US-009507513-1808USA004398: Original Case: 1808USA001261; US-009507513-1808USA004399: Original Case: 1808USA001261; US-009507513-1808USA004368: Original Case: 1808USA001261; US-009507513-1808USA004369: Original Case: 1808USA001261; US-009507513-1808USA004400: Original Case: 1808USA001261; US-009507513-1808USA004401: Original Case: 1808USA001261; US-009507513-1808USA004370: Original Case: 1808USA00126.
PATIENT GOT ADVERSE REACTIONS 10 MINUTES AFTER SHOT. SHE FEEL FACE FLUSHING. PULSE RATE 88 PER MINUTES. BLOOD PRESSURE 189/89. SHE STATES SHE DOES NOT HAVE ANY HYPERTENSION.
Left arm red swollen from shoulder to elbow. Area had multiple scattered raised papular rash. Low grade fever.
"lump" under the skin/marble ball under the skin"; chills; temperature was 99.8 degrees Fahrenheit.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION ("lump" under the skin/marble ball under the skin"), CHILLS (chills) and PYREXIA (temperature was 99.8 degrees Fahrenheit.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 041L208) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE INDURATION ("lump" under the skin/marble ball under the skin"), CHILLS (chills) and PYREXIA (temperature was 99.8 degrees Fahrenheit.). At the time of the report, VACCINATION SITE INDURATION ("lump" under the skin/marble ball under the skin"), CHILLS (chills) and PYREXIA (temperature was 99.8 degrees Fahrenheit.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99.8 f (Inconclusive) 99.8 F.         No concomitant medications was reported. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
fever at 24 hours post vaccination with headache and bodyaches.  Back to baseline 1/24/202
Since receiving Tdap pt. had fever, vomiting and body aches for 3 days.
Information has been received from a Clinical Medical Assistant (C.M.A.) concerning unspecified patients of unknown demographics. The patients' medical history and drug reactions/allergies were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, route, lot number and expiration date were unspecified). On 15-JUN-2015, the C.M.A reported that multiple different unspecified patients were administered (Oka/Merck) VARIVAX that were again stored improperly on unspecified date. No adverse effects reported. Additional information has been requested.
On 05-22-2021, participant's mother states her daughter pain started at about 1:00AM. I took her to Urgent care because she was having chest pain, nausea and headaches. She also had 99.2F of fever but no congestion or cough.  At the ER an EKG was done and it was a bit off, lab work was also performed, x-ray of the chest was also done and they gave her an Albuterol treatment. She was given IV fluids and steroids and a CT scan of the chest was also performed. After 9 hours, she was discharged home and could not find anything wrong. On 05-25-2021 I took her to her pediatrician who pushed on her chest and it hurt her when he did this, her pain level was between 5 and 8 out of 10 on VAS scale. EKG's were performed as well as lab work, x-ray of the chest at the pediatrician office. Her daughter also said her chest hurt her to exhale and inhale.  The pediatrician said that her rib cage and breast bone where inflamed upon pressing on her daughter's chest and that she has s costochondritis. As of today my daughter still has nausea that comes and goes and also continues with the headaches and takes Ibuprofen as pain medication.
high fever of 102-103 x 24 hrs; severe local react x 3 days;
Severe HA, Vertigo, Nausea, Fatigue, Mild Pharyngitis
Patient believes the Shingrix vaccine has caused her to not be able to raise her arm above her right shoulder.
Pt is a 39 year old female who was deployed on 19 Mar 03. On 25 Mar 03 she received anthrax # 1. Stated her arm was a little sore and within 48 hours she felt that she developed cold symptoms. She noticed that her head was congested, had nasal congestion, sore throat, and green sputum production. She denied fever. No other people in her unit had similar symptoms. No symptoms prior to receipt of anthrax. She went to the doctor 5 days later on 03 Apr 03 because she was not getting any better and thought that it was partly due to the fact that she was working constantly. She was prescribed antibiotics and after taking began to feel better. She finished her antibiotics and on 16 Apr 03 she received AVA # 2.  Patient reports that 48 hrs later she developed same symptoms as with AVA # 1 but this time the symptoms were worse. Stated she was waking up at night coughing. Went to the MD instead of waiting like before and was given different antibiotics, an expectorant, and 2 days of quarters. Did not require hospitalization. Symptoms resolved in mid May. She stated that everyone in her work group arrived at the same time and received anthrax.  She reported that 4 out of 5 in her work group developed similar symptoms.  States she has returned to normal and never had symptoms similar to this since May. When questioned about past or current episodes of shortness of breath or cough she reports that she has always had an occasional cough approximately a couple of times per week. States it does not wake her up at night. No PND. She experiences shortness of breath about 2 times a week and wheezes 5-6 times a month in which she rarely uses her inhaler. Stated she was diagnosed with asthma in 2002. In reference to exercise tolerance she states that she looses her breath at about 1¾ mile walking about 4-4.3 mph.
Pt recvd vax 22APR92 6MAY92 rt eye red & watery, rt side of lips not feeling nl, congestion, sore throat, rash; 7MAY92 total rt side of face unresponsive, no taste; dx Bell's palsy, swelling of neck glands, fluid in rt ear;
fever of 38 degrees Celsius; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever of 38 degrees Celsius) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). On 22-Apr-2021, the patient experienced PYREXIA (fever of 38 degrees Celsius). On 22-Apr-2021, NAUSEA (nausea) had resolved. At the time of the report, HEADACHE (headache) and PYREXIA (fever of 38 degrees Celsius) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non significant follow up received on 24-MAY-2021, no new information
I felt tired the evening of the shot.  The next morning I had fever and chills, body aches everywhere, severe headache, extreme fatigue, and very upset stomach. By the second day following the vaccination I have a very bloated stomach and extreme pain.  These symptoms continued with the stomach and headache becoming worse. Entered the Emergency Room the evening of May 7th and admitted into the Hospital.
Daughter called to report that the patient died on 02/15/2021.  No report of symptoms from the vaccine on 02/13/2021
Client went to see physician this AM.  when he started having symptoms of ringing in ears and dry mouth, and feeling achy early this AM.  At that time his left arm and axillary area started swelling and became hot to touch. He received Toredol IM for pain and was sent home with an RX for Toredol.
chills; her hands and feet were cold; her body felt hot; felt like she had fever; she did not and she could barely do anything; 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 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; PERIPHERAL COLDNESS (non-serious), PERIPHERAL COLDNESS (non-serious), outcome "unknown" and all described as "her hands and feet were cold"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "her body felt hot"; PYREXIA (non-serious), outcome "unknown", described as "felt like she had fever"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "she did not and she could barely do anything".  Additional Information: Patient that she spoke to a nurse and doctor before about side effects she experienced after receiving the first dose of the Pfizer COVID-19 vaccine. Stated that she had a severe reaction for 3 or 4 days. She had chills, her hands and feet were cold, her body felt hot and felt like she had fever, but she did not, and she could barely do anything. She would like to know if this has been reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Unsteady gait. Numbness in feet, legs. Falling. Shaking.
pain at the injections site; redness at the injections site; swelling at the injections site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 90-year-old female patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 1st July 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date). Concurrent medical conditions included stroke.   On 26th July 2022, the patient received the 2nd dose of Shingrix. On 26th July 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site redness and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site redness and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain, injection site redness and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's comment: The registered pharmacist called and reported that the patient had experienced swelling, redness and pain at the injections site.  The adverse event was filed.  The registered pharmacist gave medical disclaimer. The patient was referred to health care professional.  The patient spoke personal information and content.  The consent to follow up was given.  The vaccine administration facility was the same as primary reporter.
About 30 min after receiving shot, she called and reported symptoms of bilateral facial tingling, numbness in upper teeth and lip, and metallic taste in her mouth. I asked her to report back to my office and she was there almost immediately. As I was questioning her, the symptoms persisted and as I was about to check vitals, she stated she felt like she was "going to pass out." She sat for another minute or two and was able to walk assisted by me to the ER. Once in the ER vitals were stable and symptoms of facial tingling, and numbness in teeth and upper lip persisted, and she developed an headache. An IV was started and she was then given IV steroid, The Dr. verbalized was not concerned about analphylactic reaction. She was monitored and then released to home after a few hours of monitoring. The next day she reported new symptoms of delayed speech, which was evident when I saw her in person. She came to work and I took her to the ED to be evaluated once again. She had CT scan and was tested for Lyme Disease. CT was negative and Lyme test was unequivocal. She followed up with provider the next day (10/3). Symptoms of delayed speech persisted, and she was referred to neuro. 10/4 she had MRI and neurologist stated this was all due to Lyme and not related to Flu shot. Follow-up with PCP the following week it was revealed to patient she did not have Lyme, and symptoms were due to flu shot. It remains under investigation by Agency to determine if this was caused by flu shot or reaction to something else.
Severe joint pain (wrists, elbows, shoulders, ribs, hands), shooting pain down legs, arms ribs, pelvis, Muscles seizing up, chills (2 weeks after 2nd vaccine), dizziness, exhaustion I've been taking tylenol and Advil
All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.
Head was killing me/ Headache; wasn't feeling that great on that night; It hurts all day since 2 weeks especially my eyes; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (wasn't feeling that great on that night), EYE PAIN (It hurts all day since 2 weeks especially my eyes) and HEADACHE (Head was killing me/ Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In February 2021, the patient experienced EYE PAIN (It hurts all day since 2 weeks especially my eyes). On 22-Feb-2021, the patient experienced FEELING ABNORMAL (wasn't feeling that great on that night). On 23-Feb-2021, the patient experienced HEADACHE (Head was killing me/ Headache). At the time of the report, FEELING ABNORMAL (wasn't feeling that great on that night) outcome was unknown, EYE PAIN (It hurts all day since 2 weeks especially my eyes) had not resolved and HEADACHE (Head was killing me/ Headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.