chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Side effects; This case was reported by a consumer and described the occurrence of adverse drug reaction in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. After receiving the Shingles vaccine, the patient experienced all side effects and they were nasty. The reporter reported that why was the Shingles vaccine not given by sex and weight as her husband had no side effects.
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history and concomitant medications reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
diarrhea, joint pain, body aches, chills, vomiting, headache, fever
8 day's after the shot my left are is swollen, hot, red and the pain is not just like when I get the flu shot. When I move my arm it hurts and I can't sleep on the side. When I had the small Pox shot my are went numb that was well over 40 years. Put this one hurts. I have not contacted my FNP-C as I have checked on-line and found out what it is.
pt recvd vax;1 hr p/ vax began w/ a cry,more forceful,higher pitched & louder than usual;unconsolable for 4 hrs;13dec94,16 hrs total;seen 14dec in f/u w/ an unremarkable exam,fontanell was soft;no recurrence to date
Patient reported feeling dizzy to his caregiver while seated during observation period and then completely passed out. By this time Pharmacist had requested the technician to call 911. Patient gained consciousness within seconds but reported dizziness and blurry vision. Patient stated being able to breath fine, but pharmacist noticed labored breathing, pharmacist checked pulse and breathing and pulse was 60 bpm. Police officer arrived on sight by 3:10pm, followed by EMT. Vitals were checked BP 104/64. Patient declined medical care and being taken to the hospital, stating feeling normal now. During 911 call, emergency agent informed pharmacy staff to inform patient to remove any tight clothing so patient willfully removed his T-shirt since he was sweating. Patient waited in the sitting area and left around 3:50pm
pt recvd vax & 24 hrs later devel generalized hives w/pruritus; pt seen by MD who treated w/Pred & Atarax; 2 wks later devel an upper resp infect & cough;
Pulse over 100 BPM for at least 6 hours, stabbing chest pains, fever, chills, severe joint pain.  I could feel my heart beat throughout entire body, I am extremely cardio fit and routinely get my pulse to 185+, but this felt very wrong at 100 BPM.  Very deep pounding.  Most symptoms resolved in 24 hr.  Pulse returned to normal, but did not feel right with exercise for about 6 weeks.
8 hours after vaccine HPV was given patient had swelling of eye and hives on face. Went to ER. Given EPIPEN and DECADRON.
I experienced nausea and vomiting with fatigue for two weeks after the vaccination. I lost 20 pounds in two weeks due to this.
Pt was 16 at the time of vaccination.  Pt reports no issues since being vaccinated.
Tightness of chest; Chills that come and go; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness of chest) and CHILLS (Chills that come and go) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced CHEST DISCOMFORT (Tightness of chest) and CHILLS (Chills that come and go). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Tightness of chest) outcome was unknown and CHILLS (Chills that come and go) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant medications include inhaler. Patient wants to know if she can use inhaler as she did not use it for a longer time.
Right side pain that began immediately after my second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Right side pain that began immediately after my second vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's medical history not reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Right side pain that began immediately after my second vaccination). At the time of the report, MYALGIA (Right side pain that began immediately after my second vaccination) outcome was unknown.            no concomitant medication reported.
Patient reported lip swelling at 11:30pm day of vaccine and resolved following  day 9:30am
pt recv 1st dose of varivax 4/21/98 immed following pt exp ``severe & intense crying for many hours w/inconsolable screaming''. also rpt pt arching & thrashing but was afebrile.
has a very bad migraine headache; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264), via an Intramuscular route of administration in left arm on 04Feb2021 at 09:30 (at 65-years age) as a 1st dose, single for COVID-19 immunization. Medical history included ongoing Blood pressure, ongoing Hypothyroid, ongoing Migraines. Concomitant medication(s) included metoprolol taken for blood pressure; Olmesartan taken for blood pressure; levothyroxine sodium (SYNTHROID) taken for hypothyroidism. Vaccination facility was in Health Clinic. Patient had a very bad migrane headache on Feb2021. Patient called because she had a terrible migraine after first vaccination. Patient needed to know if she could take Maxalt the day after. She did take it (Maxalt) because headache was bad. By the afternoon she was okay. Patient did not have a reaction on the 2nd vaccine. The outcome of the event was recovered in Feb2021.  Follow-up attempts are completed. No further information is expected.
Facial flushing, bilateral upper arm swelling and erythema.  Patient was treated with Claritin, Benadryl and Medrol.
pt recvd vax & c/o lt elbow aching & burning w/in a few hrs; had UE joint pain for 3 more dasy; denied fever, chills, or local react; no MD exam; cont to work;
This case was considered to be medically important based on follow up info received. Follow up info received provided an additional event of throat swelling and pt status of recovered. Info regarding Flumist was received from a healthcare professional regarding a 10 year old male pt who experienced hives, blotchy rash and "weird sensation" in throat. At 10 years of age, the pt received a dose on 12/16/03. On 12/16/03, the pt experienced hives (urticaria), blotchy rash (rash macular) and "weird sensation" in his throat (pharyngolaryngeal pain) and throat swelling on 12/16/03 twenty minutes following receipt of Flumist. The pt's symptoms improved when he was administered two teaspoons of Benadryl. He did not experience difficulty in breathing. Throat swelling was considered a medically important event (OMIC).
CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea and chills was not reported. This report was non-serious.
Patient came in for her 2nd Pfizer-COVID vaccine. Patient stated having dizziness after her first vaccine, so we had her stay longer than 15mins for observation. Vaccine given at 9:18am. At 9:33am I checked on patient, she reported dizziness. She was given a sack while waiting. At 9:48, checked on patient for a second time and she reported still having dizziness and now headaches. APRN notified and came to check on patient. She was then given water and tried talking with her. She began walking to the room so we can closely monitor her, while walking she began swaying as she walked. Once in the room the APRN had her lay down, from there the patient became unresponsive to verbal and physical prompting. I was in the room with APRN ready with an Epipen to administer to patient. Epi was administered at 9:54am. Placed SpO2 on patient index finger to monitor pulse and oxygen, also checked her blood pressure. Monitored vitals till First Responders and EMS came. EMS to transport to nearest ER for observation.
I have been waking up in the middle of the night regularly. I even wake up 2-3 times at night. I went the doctor, and they prescribed me trazodone. The medication works sometimes. The bottom number in my blood pressure actually went up. I went to the doctor and they put me on a different medication to get that lower number down.
Moderna Vaccine was administered after the beyond use date of 30 days at refrigerated temperature. Beyond use date 10/01/2021
1. My daughter started to have psychosis symptom such as hallucination, believing unreal thinking someone was visiting her at 4am so she went out side waiting on July 4th 2021 (1.5 month after the 1st shot). She was taken to Hospital for mental treatment. Her diagnosis at this time was Unknown Psychosis. 2. She had 2nd psychosis episode starting the last week of August 2021. She walked to Hospital for treatment. She was diagnosed with Cannabis Induced Pshocosis. 3. After the 2nd Moderna shot on Oct 30th, 2021, she said she had headaches and felt tired for about 3 days. She started not sleeping well from Nov 8 and having auditory hallucination.  The condition got worse day by day until Nov 15th when we contacted 911 to bring her to the hospital.  Starting Nov 14 afternoon thru Nov 15, she slept most of time but when she woke up, she wanted to run away from home and screamed. At second hospital, she was diagnosed COVID positive.
Inflammation localised; feeling miserable; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation localised), FEELING ABNORMAL (feeling miserable) and VACCINATION SITE PAIN (Vaccination site pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0298A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LOSARTAN, TRAZODONE and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 18-Mar-2021, the patient experienced INFLAMMATION (Inflammation localised) and FEELING ABNORMAL (feeling miserable). At the time of the report, INFLAMMATION (Inflammation localised), FEELING ABNORMAL (feeling miserable) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitant medication were provided.
a blood clot came out on his stoma; This is a spontaneous report from a contactable consumer (patient's wife) from Pfizer-sponsored program .  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller (Name) is calling on behalf of her Husband (Name). Her husband got the 1st dose on 14Apr2021 (caller not sure with the date) and after the vaccine he experienced a blood clot came out on his stoma in 2021. Caller asking if this is a reaction of the vaccine. Caller also asked if her husband can get the second dose even if he is a blood thinner. Caller also has a question for herself if she can take the 1st dose because she is allergic to Prednisone and Metformin and had a bad reaction with this medication. Therapeutic measures were taken as a result of event (blood thinner). The outcome of event was unknown.  Information on the lot/batch number has been requested.
Temperature began in the evening, post vax. Temperature was taken rectally and was up to 101F. Tylenol was given.
Induration at tetanus site of Right arm 5-10 mm. Resolved in 4 weeks.
January 28, 2021-blood pressure very high, 100.1 fever for 2 days after vaccination, headache, cardiologist gave more medication. March 1, 2021-loss of voice, high blood pressure, rash, sore arm, 100.1 fever for a week after vaccination, body aches.
Patient is a 53 y.o. male with a past medical history that includes NIDDM2, chronic lymphedema and LE wounds, HFpEF, HTN, CKD, and CAD.  He presented on 10/4/2022 with generalized weakness, unsteady gait, and worsening BLE edema. Home health had found him to be hypotensive and he was brought to the ED and admitted to the ICU requiring pressors and broad spectrum antibiotics for sepsis related to LE cellulitis. He underwent wound debridement with podiatry. He was transitioned to oral antibiotics and transferred out of the ICU 10/15, but found to be COVID-19 positive 10/15 leading to delay in disposition.
White tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOLOURATION (White tongue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TONGUE DISCOLOURATION (White tongue). At the time of the report, TONGUE DISCOLOURATION (White tongue) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-075727 (Patient Link).
On March 24 I began experiencing severe pain in my right arm. The er thought it might have been a pinched nerve or something along those line. March 28, noticed a lack of muscle control on the right side of my lips while drinking from a straw. This time I was admitted as a possible stroke. Two different MRI sessions revealed no stroke. They performed a lumbar puncture and discovered that I had extremely high protein levels. After having been admitted, for the next couple of days my face slowly lost the ability to close my eyes fully and a complete lack of control of my lips (total paralysis on my face). I also began to experience bouts of stabbing pain throughout my body and weakness in my limbs. After the after th
Rash - 10 days after MMR C/O itchiness, No fever.
redness to injection site, warmth to touch, sensitive to touch, 3cm x 3cm tissue induration. Reduced with Children's Benadryl.
p/vax pt exp shooting pains in the back of neck;outcome of pt unk;
TDAP given in (L) deltoid following site location and placement per protocol. No redness or swelling at site after placement. Pt discharged with no complaints related to injections.
MATERNAL EXPOSURE DURING PREGNANCY; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Nov-2020 and the estimated date of delivery was 07-Sep-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (MATERNAL EXPOSURE DURING PREGNANCY) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pregnancy test: positive (Positive) Positive.     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.   Treatment information was not provided.
The arm where the shot was administered, underneath the armpit area was swollen (Lymph Nodes) also had body aches, slight fever.
Sore arm; it was just some discomfort; Feeling like he is getting the flu; This is a spontaneous report from a contactable consumer.   A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, by injection, administered in left arm on 20Apr2021 14:15 (Batch/Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history were none. Concomitant medication(s) included atorvastatin (ATORVASTATIN) taking for several years at 20mg, once daily by mouth for blood cholesterol; lisinopril (LISINOPRIL), taking for a year; prior to that he took Atenolol, 50/25mg once daily; [withheld] vial at 5mg, one twice daily by mouth for blood pressure, all ongoing. Historical vaccine included first dose, BNT162B2 on 30Mar2021 between 14:15PM and 14:30PM in the left arm,Lot number EW0150 and experienced sore arm on 30Mar2021. The patient received the 2nd dose of the Pfizer covid vaccine yesterday, waken about 2am, feeling as if he has the flu, no fever, just blah feeling. Can he take Tylenol or Advil, just to feel a little better. He has some discomfort in the arm and is feeling like he has the flu but with no fever. The second shot he had a little soreness in the arm again but less than the first time. Adds that soreness is still there when he raises his arm and he can tell he had a needle in his arm. This morning when he awakened, about 16 hours after the shot, he felt like he was getting the flu, but it was just some discomfort. Adds he checked his temperature and he had no fever. No emergency room or physician office visit. Not vaccinated at   Facility. Feeling like he is getting the flu was on 21Mar2021. Outcome was not recovered for all events.  No follow-up attempts are needed. No further information is expected.
Patient was experiencing cold symptoms, with symptom onset about 10 days before he fell very ill, on 5-30-2021. His wife called EMS, and he was taken to the ER and then admitted to the Hospital on 5-30-2021 experiencing generalized weakness, confusion and having suffered a fall in his home. Upon admission, he was in respiratory distress. His medical records indicate Acute Hypoxemic Respiratory failure and COVID19 Pneumonia. He passed away on 06-01-2021.
hives; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient's sister). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown), via an unspecified route of administration on 03Feb2021 as dose 1 (at the age of 71 years), single for covid-19 immunization. Medical history included hard of hearing from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced hives, swollen lymph nodes and their physician told them that those were not side effects, those were severe allergic reactions. Reporter wanted to know the efficacy of the vaccine for single dose only. The outcome of the events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
After my first shot I had a strong burning, ripping sensation on my left side near my lung/diaphragm. This continued for three weeks after the first shot. After the second shot (October 14), two weeks to the day, my chest was tight and felt like a heavy object was on it,. I was short of breath. The symptoms continued to worsen and the pain around my left lung became unbearable, I was unable to fill my lungs and could not catch my breath so I went to the ER.
legs started itching; both legs, from the knee down to his ankles, had red spots all over them; looks like a poison ivy rash - It's itching really bad; slight sore arm from the injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (legs started itching), ERYTHEMA (both legs, from the knee down to his ankles, had red spots all over them), RASH (looks like a poison ivy rash - It's itching really bad) and INJECTION SITE PAIN (slight sore arm from the injection) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRURITUS (legs started itching), ERYTHEMA (both legs, from the knee down to his ankles, had red spots all over them), RASH (looks like a poison ivy rash - It's itching really bad) and INJECTION SITE PAIN (slight sore arm from the injection). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency and HYDROXYZINE at an unspecified dose and frequency. At the time of the report, PRURITUS (legs started itching), ERYTHEMA (both legs, from the knee down to his ankles, had red spots all over them), RASH (looks like a poison ivy rash - It's itching really bad) and INJECTION SITE PAIN (slight sore arm from the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported
Large local reaction with urticaria surrounding injection site. BENADRYL 12.5 mg PO and cold compress given. Pt observed for 30 minutes and normal vitals. Smaller urticarial rash after 20 minutes.