chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose not received for >35days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not received for >35days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not received for >35days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not received for >35days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided for mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not any causality assessment.
Information has been received from a healthcare worker concerning a female patient of unknown age. No relevant medical conditions and drug allergies were reported. On 10-AUG-2015, the patient was inadvertently administered an expired dose of GARDASIL intramuscularly (lot # H011350, expiration date 21-FEB-2015, strength and dose were unknown), this was her first dose in the series. No adverse effects were reported. Additional information has been requested.
Extreme upper right arm pain at site of injection and shoulder and lessened range of motion continuing currently. Treatment meds include Pennsaid & Flector Patch and Cortisone shot.
Pulmonary thrombus embolism in the left main pulmonary artery .  I am on blood thinner(xarelto). The dosage keeps being changed because the blood clots keep reoccurring.
Two days after the vaccine stated she got an intensive skin rash all over her body and then seven days later she started having pain in her join and stiffness pain was so horrible she couldn't lift her hand and the rash wouldn't go away the pain kept coming back even after she got a cortisone shot after the pain. Doctor gave her steroids to stop the pain and the pain went away little after the shot.
Red rash both arms and chest - patient has been taking BENADRYL OTC, she is seeing improvement. Advised to see primary Dr if no further improvement 2-3 days.
dry cough; low grade fever/he had a low grade temperature of 99.0 Fahrenheit last night and 101.0 Fahrenheit this morning; body pain; body weakness; This is a spontaneous report from a contactable Nurse  A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 16Dec2020 10:30 at single dose for covid-19 immunisation. Medical history was none (no relevant patient or family medical history). The patient's concomitant medications were not reported. On 17Dec2020 the patient experienced low grade fever, temperature of 99.0 F on 17Dec2020 and 101.0 F on 18Dec2020, body pain and weakness with outcome of not recovered. On unknown date the patient experienced also cough with unknown outcome. The event fever was considered serious as medically significant and was reported as worsened. The reporter wanted to know what to do. The caller read somewhere not to take Tylenol, though he did take one this morning. He was to increase fluid intake but what other treatment was recommended.   Information on Lot/Batch has been requested.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, fever, body pain, cough and weakness there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The patient received the vaccine and within a few minutes,  he got sweaty, pale, passed out for a short period and was unresponsive briefly but still breathing.  We took off his long sleeve shirt and put a cold compress on his head till EMS arrived.  They took is blood pressure and EKG.   He refused to get in ambulance.
This spontaneous report as received from a consumer refers to a 67 year old female patient. There were no drug reactions/allergies. On 19-JUL-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency and lot # unspecified) in the left arm. Other suspect therapies included prednisone (manufacturer unknown). Concomitant therapies included SYMBICORT. On 20-JUL-2014, about 24 hours after vaccination, the patient experienced hard, arm tender knot at the injection site. She stated that her arm was tender for about 2 weeks. On 28-JUL-2014, patient had to have a CAT scan. On approximately 25-JUL-2014 (also reported as 3 days prior to CAT scan), she had to take prednisone (manufacturer unknown. On 04-AUG-2014 the patient experienced rash developed at injection site and on the back of her legs. Rash was only on left side of her body. On an date in 2014, patient had back pain as well, the patient was concerned that prednisone (manufacturer unknown) could have caused this reaction, since she had to take this so shortly after ZOSTAVAX vaccination. No lab diagnostics were performed. The outcome of events was unknown. The patient did not receive any treatment for the events. The patient did not seek medical attention. Product quality complaint was not involved. The reporter considered hard, warm tender knot at the injection site, arm was tender, rash developed at injection site and on the back of her legs with ZOSTAVAX was unknown. Additional information has been requested.
Felt shaky after about 5 minutes , not right pain travel from shoulder up back of neck facial numbness almost half way across mouth up to eye area  on same side as injection
Covid-19 vaccine EUA: I took 10mg Zyrtec 2 hours prior to vaccine because of potential mast cell activation issues. Took another 10mg Zyrtec at 8pm and went to bed. Awoke 6:00 am, 18 hours after vaccination. Symptoms of stiff and painful neck and shoulders February 14 and 15, somewhat lessened February 16. Have taken Ibuprofen and Zyrtec since onset.
6/24/03: Cellulitis 3" diameter surrounding pustule. Red, hot and streaking (+) lymphad axilla. Rx's with Levaquin 800 mg po Qd #5. Symptoms resolved 6/27/03 on meds.
The next day after receiving the flu shot, her leg got hot to the touch, bruised, hard under the skin and was swollen near the injection site. These symptoms lasted about a week. However, she still has bruising around the injection site and it is almost two weeks and counting after she received her flu shot.
My right side felt heavy all time. It felt as if it going come again arm burn and heavy when infection come.
12:30am (11/15/17) woke to upset stomach, freezing, shaking, body aches, severe headache and  vomiting (6 times) until 5:30am. Headache lasted throughout the day (11/15/17) as well as weakness and body aches. Unable to leave the bed. Next day (Thursday 11/16/17) moves to the couch and was able to move around. Friday 11/17/17 was almost myself.
Received shot on 4/7. Felt fine three days after on 4/10 and went for a standard run. Morning of 4/11, woke up with three massive bruises on my knees. On left knee, bruises were located on the inside and outside of my knee. On the right knee, bruises were located on the inside of my knee. These bruises were at least 3-4 inches in diameter. News of blood clotting from J&J vaccine was released on 4/13. Days after 4/11, knees and ankles started to swell. By 4/14, the swelling in my knees and ankles continued and I became fearful of blood clots that would become life-threatening. Evening of 4/14, admitted myself to the ER.
Information has been received from a lawyer regarding a case in litigation concerning a female (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2016, the patient was treated at a medical facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Other symptoms with first injection were the same as well as severe headache, fatigue, rash on my feet.; Other symptoms with first injection were the same as well as severe headache, fatigue, rash on my feet.; Other symptoms with first injection were the same as well as severe headache, fatigue, rash on my feet.; heart racing/palpitation; Elbow Joint Pain on injection arm; Off label use (Pregnant at the time of vaccination); Drug use in unapproved population (Pregnant at the time of vaccination); This is a spontaneous report from a contactable consumer or other non health care professional (patient). This is a maternal report.    A 35-years-old female patient received  first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported: not reported, expiry date: not reported), via an unspecified route of administration, administered in arm right on 20Apr2021 15:00 (at age of 35-years-old) as dose 1, single for covid-19 immunization. Medical history included sulfa allergy, covid-19. Concomitant medication(s) included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken an unspecified indication start and stop date were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother reported she became pregnant while taking bnt162b2. The mother was 17 Weeks pregnant at the onset of the event. The patient experienced other symptoms with first injection were racing heart, heart palpitations, elbow joint pain, as well as severe headache, fatigue, rash on my feet in 2021. After both injections the patient had reactions similar to my symptoms while the patient had Covid. My most severe symptoms are racing heart, heart palpitations. Other symptoms are elbow joint pain on injection arm. Other symptoms with first injection were the same as well as severe headache, fatigue, rash on my feet. No treatment was received for the events.The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported: not reported, expiry date: not reported), via an unspecified route of administration, administered in arm right on 11May2021 14:00 (at age of 35-years-old) as dose 2, single for covid-19 immunization The outcome of the events was not recovered.    Follow-up attempts are completed. No further information is expected.
Initial Shot - Swelling in the sinus' and some dizziness, exhaustion and arm pain:  Lasted for day and a half  Second Shot - Exhaustion,  Swelling in the sinus' and dizziness, Arm Pain, Pain which appeared to be in lymph nodes (under arm and side of breast), Fever x3 days:  Lasted for about a week  Subsequent - I have had three periods since the vaccine.  I have been in menapause for 7ish years.  Periods started out minor for the first one limited bleeding and 2-3 days.  The second one, about a month later,  was a full week of heavy bleeding.  The third one came 4 days after the last one.  I am currently experiencing the third one.
Fever; Sore arm; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient) reported herself. A 53-years-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, lot number: EL3247), via an unknown route of administration in left arm on 04Mar2021 at 09:45 (at the age of 53-years-old) as single for COVID-19 immunisation. The patient's medical history was none. He had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 04Mar2021 at 23:00, the patient experienced fever, sore arm, chills and nausea. patient for this report and reporter became aware of the symptoms during the night following the vaccine administration, which occurred on 04Mar2021. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment received. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse practitioner concerning a 19 year old female with no pertinent medical history or a history of drug reactions or allergies who on 01-MAY-2007 was vaccinated with her first dose of Gardasil, 0.5 ml, IM, left deltoid.  There was no concomitant medication.  On 05-MAY-2007 the patient developed hives.  The patient was instructed to take diphenhydramine (BENADRYL).  No laboratory tests were done.  As of 08-MAY-2007, the patient was recovering.  Additional information has been requested.
Pulmonary embolism in his left lung; Chills; Hard to breathe; shaking a lot; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EW0164) via an unspecified route of administration on 19Apr2021 at 12:00 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unspecified date and ongoing and urinary tract infection (UTI) from an unspecified date and unspecified if ongoing. Concomitant medications were reported as none. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: first letter is either a G or O but he thought it was OE8732) via an unspecified route of administration on 29Mar2021 at 11:45 (at the age of 55-years-old) as a single dose in the left shoulder for COVID-19 immunisation. Illness at vaccination was UTI.  On 20Apr2021 the patient experienced pulmonary embolism in his left lung, chills, hard to breathe and shaking a lot. The patient was hospitalized for pulmonary embolism in his left lung (blood clot) from 20Apr2021 to 26Apr2021. The clinical course was reported as follows: The patient stated that he had the second Pfizer shot on 19Apr2021 and on the 20Apr2021 he had a really bad reaction to it. He had chills, it was hard to breath, he was shaking a lot and had a UTI and COPD and had to call an ambulance to come get him. When he went to the emergency room, they did a CT (computerized tomography) scan of his chest and found a pulmonary embolism in his left lung and he was put on a Heparin drip for 7 days and stayed in the hospital for 7 days. The event hard to breathe ended shortly after he got to the emergency room since he was on oxygen. The patient had a history of COPD, so sometimes he had trouble breathing, but right now he did not. The event shaking a lot ended a little after he got to the emergency room. The patient also stated that he had a history of UTI in the past and had a UTI during the vaccine but was not treated for the UTI until he was at the hospital. The clinical outcomes of the event pulmonary embolism in his left lung was unknown; chills, hard to breathe and shaking a lot were all recovered/resolved on 20Apr2021.
Patient was given adult dose of Hepatitis B vaccine(20mcg) instead of the pediatric dose(10 mcg), spoke to patients mom, states pt is feeling fine, and hasn't had any problems following the injection.
anaphylaxis; throat tightness; shortness of breath; lip swelling; throat swelling; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the first dose of bnt162b2 (lot number EN6199) via intramuscular on 04Mar2021 at 13:45 PM at single dose in left arm for COVID-19 immunisation. The patient had no COVID prior vaccination. The patient's medical history included ADHD, obesity, anxiety, history anaphylaxis to peanuts and allergies: peanuts. The patient's concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERRAL), diphenhydramine hydrochloride (BENADRYL). "5 min after injection", the patient developed throat tightness, shortness of breath, lip and throat swelling consistent with anaphylaxis. Events onset date reported as 04Mar2021 at 13:45 PM. Events resulted in emergency room/department or urgent care. The patient received epinephrine as treatment. The outcome of events was unknown. It is unknown if COVID tested post vaccination.; Sender's Comments: Based on temporal association  and known drug profile the reported  anaphylaxis with throat tightness, shortness of breath, lip and throat swelling are assessed as  due to  bnt162b2.  Case will be reassessed if additional information is  received.
Patient has arthritis; This spontaneous case was reported by a physician and describes the occurrence of ARTHRITIS (Patient has arthritis) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Patient has arthritis). At the time of the report, ARTHRITIS (Patient has arthritis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  A patient who was scheduled to get the second booster, received from another doctor an Intramuscular  injection of prednisone and would like to know if that can affect the immune response or if there are any studies about how much the immune response decrease when a shot of prednisone is given to a patient. Reporter mentioned that the patient has arthritis, agent was not able to clarify if the patient was diagnosed before or after receiving the Moderna vaccines. Treatment information was not provided.  Company comment:  This case concerns a female patient, of unknown age, with no reported medical history, who experienced, unexpected, non-serious, AESI of Arthritis, unspecified days after receiving a dose of mRNA-1273 vaccine.  Date of vaccination was unknown. Clinical course and treatment details are not available in this report. Reporter mentioned that the patient has arthritis, but it could not be clarified, if the patient was diagnosed with Arthritis, before or after receiving the Moderna vaccines. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient, of unknown age, with no reported medical history, who experienced, unexpected, non-serious, AESI of Arthritis, unspecified days after receiving a dose of mRNA-1273 vaccine.  Date of vaccination was unknown. Clinical course and treatment details are not available in this report. Reporter mentioned that the patient has arthritis, but it could not be clarified, if the patient was diagnosed with Arthritis, before or after receiving the Moderna vaccines. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I contracted Covid 19 and tested positive on 11/6/21. I had fever up to 100.9 and headache and congestion.
gout attack; have to get the next shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of gout attack in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced gout attack (Verbatim: gout attack) and incomplete course of vaccination (Verbatim: have to get the next shot).  The outcome of the gout attack was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the gout attack to be related to Shingles vaccine.     It was unknown if the company considered the gout attack to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media.  The patient reported that he/she got the first shot and got a small gout attack in April. He/She has to get the next shot thus he/she hoped it would not happen again. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Severe migraine and Meniere's flare with pain, photosensitivity, tinnitus, vertigo, and severe discomfort/pressure in right ear. This occurred about 3 weeks after a sinus infection, 5 days after adding a 10 day taper of prendisone, and 1 month following the Moderna booster.  After multiple doses of Zomig over 4 days, contacted ENT and primary care. Primary care doc prescribed Reglan and tylenol.  ENT follow up scheduled for Friday.
Giant patch redness and swelling from site of injection (Deltoid) down entire up arm, sl. blister 2 episodes of wheezing.
Information has been received from a physician concerning a 20 year old female with unknown medical history, who was vaccinated with the three dose regimen of GARDASIL (Lot # unknown). Subsequently, on an unknown date, the patient had an abnormal pap smear test, result in which she was positive for low-grade dysplasia and HPV. The patient sought unspecified medical attention. Outcome unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  Follow up information has been received from a certified medical assistant.  The medical assistant reports that "no AE, since they recently found out patient was sexually active and did not want her mom to know so she denied it previously (at time of vaccination).  Additional information has been requested.
Patient had raised welt (very large hive) and hot to touch. Ran a fever for 3-4 days. Cough (Pt. not sure if attributed to vaccine).