chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is an 85-year-old female with a history of hypothyroidism, hypertension, and osteoarthritis who presented from home complaining of 4 days left shoulder pain that radiates into her left pectoral area.  She states she was vaccinated with the Janssen Covid vaccine on 4/8/21 in her left shoulder and her pain started 4/23/21.  She is not sure if these were related.  It was initially intermittent, sharp, stabbing, however became fairly persistent.  She has noted her blood pressure being elevated.  On my evaluation her blood pressure is 185/64.  Patient states she was recently started on lisinopril for hypertension.  She has not taken her lisinopril yet today. Chest x-ray showed no obvious infiltrates.  Clear lung fields.  Normal cardiac dimensions. EKG shows sinus mechanism with normal axis, intervals, ST segments.  Otherwise normal EKG. D dimer was elevated, and VQ scan was negative for PE. Patient was evaluated by Cardiology who recommended outpatient stress test. Echo showed LVEF 60-65%. Trace aortic valve regurgitation. Mild mitral regurgitation. Mild mitral leaflet calcification is visualized. Trace tricuspid regurgitation. The right ventricular systolic pressure is calculated at 28mmHg. Patient was found to have hyperlipidemia and was started on statin. Her pain resolved on the day of discharge. Her blood pressure was controlled with lisinopril and coreg. She is to follow up with Cardiology and her PCP.
I experienced leg and knee pain and some cramping in legs after first shot, same after 2nd shot.  Symptoms lasted few weeks lessening each day.   After 3rd shot, I had extreme pain and cramping in left leg.  Additionally my left knee would buckle under my weight with no warning.  I scheduled an X-ray after the pain with the 1st shot.  No damage was seen in the left knee . However I had the pain for weeks.
This spontaneous report was received from a pharmacist referring to a male patient of unknown age who on an unspecified date, was vaccinated with a dose of ZOSTAVAX (lot # not reported), the patient was then administered a second dose of ZOSTAVAX (lot # not reported) on an unspecified date approximately 1 month after the first dose. No adverse effects reported. Additional information is not expected. No further information provided.
A little over a month after 4th dose vaccination, I started having increased nasal congestion, scratchy throat and fatigue. On 5-22-2022, I took a home test for Covid and it was positive. The following day, I called the doctors office and I went in to see them on 5-24 in which they did a rapid test that was positive as well as the PCR. They told me to manage my symptoms over the counter with Mucinex and Delsym and to boost my immune system with vit C, vit D and zinc. I am feeling about the same today. I am reporting a breakthrough case of Covid.
Itching at injection site that lasted for 2 to 3 days. Injection site sensitive to being touched (feels bruised) for several months afterward even up to present time 1/13/2012.
Started 6 days after 1st immunization: presented with nausea, low grade fever (100) , chills and hot flashes, headache, muscle aches and joint pain (severe), exhaustion. This lasted for 36 hours.  Now feel  fine.
patient had the vaccination and waited for 15 minutes, then when he was walking out the store then he felt dizzy and fainted for seconds, Dad was there to catch him when he was falling. he came back to conscious as I was there, we called 911 and paramedics came and checked on pt. then he went home with parents after he was done with the checkup with the paramedics.
After a few minutes after receiving vaccine, patient complained of dizziness, blurred vision and numbness on left arm. She was brought to a room and assessed, and vital signs were stable and right after she started having a seizure that lasted for less than a minute. She felt confused and all her left side felt weak, and she could not move limbs. EMS was called and she was transferred to the emergency room by paramedics.
Patient claims 2 days after immunizations she became nauseous, extremely dizzy, disoriented, headache 911 called, transported to hospital (ER) overnite.
as per patient -- Severe facial drooping on my right side of face.  Eyebrow was a little over a half inch lower and the corner of my mouth was lower than that ? a loop.
Woke up at 2am crying from whole body being in pain. Could not stop shivering even when covered in 4 blankets but also sweating. Managed to sleep for a few hours before waking up with the worst headache- it felt like someone had wrapped something around my head and was squeezing. Moving made it worse. Could barely stand and head was foggy.
patient was vaccinated with second covid vaccine on 2/12/21. Patient was admitted to the hospital on 03/04/2021 with fatigue and diagnosed with COVID 19 (positive lab test on 2/26/21 and 3/4/21). Case expired on 3/8/21.
Information has been received from a registered nurse concerning her son who is her 20's and who when he was a child on unknown dates, was vaccinated with the complete series of RECOMBIVAX HB (dose, route and lot number not reported). The nurse stated that her son recent had an hepatitis B antibody test that showed his level was less than 4 and he was required to receive additional hepatitis B vaccinations for school. The patient did not sought medical attention. At the time of the report the outcome of the patient was unknown. This is an amended report. The preferred term for the adverse event was changed from "Hepatitis B surface antibody negative" to "Hepatitis B antibody negative". Additional information has been requested.
PATIENT COMPLAINED OF SHORTNESS OF BREATH.   OXYGEN GIVE. CALL TO ED AND TRANSPORTED  TO HOSPITAL.
Bad allergic reaction through the Pfizer COVID-19 Vaccine; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization; acetylsalicylic acid (ASPIRIN (E.C.)), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included hypersensitivity- have allergies but haven't been tested in years. The patient's concomitant medications were not reported. The patient experienced bad allergic reaction through the pfizer covid-19 vaccine (hypersensitivity) on an unspecified date. She mentioned that she knows someone who have bad allergic reaction to Pfizer COVID-19 Vaccine. Limited information was available over the call. The action taken in response to the event(s) for acetylsalicylic acid was unknown. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
94yo patient that was given a vaccine on 4/8/22 from our store.  She is having significant pain/discomfort and swelling (no redness) in the shoulder and says the pharmacist gave her the shot very high in the shoulder joint starting day of and consistantly bad until she followed up with us 4/13/22.  She has been unable to rest comfortably (needs to remain seated upright), cannot raise her arm and even twitches at pressure applied to her shoulder. Likely SIRVA.
unable to use arm because it was painful; This is a spontaneous report from a contactable consumer, the patient. A 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: FM9209), via an unspecified route of administration, in the left arm on 09Feb2021 at 4:00 PM (at the age of 88-years-old) as single dose for protection from COVID/COVID-19 immunisation. The patient had no medical history. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient did not underwent any lab investigation. The patient did not administered any vaccines on same date of the suspect vaccine. Caller received the BNT162B2 vaccine on Tuesday afternoon on 09Feb2021. On 10Feb2021 the next morning he was unable to use his arm because it was painful. He was not able to put his coat on to go outside. Today when he woke it was 90% better and a little later it was 100% better like he had a new arm. He saw the list of reactions that painful muscles was listed. This was a lack of use of his arm because of the pain. The patient did not visit to physician office or emergency room. Outcome of the event was recovered on 11Feb2021.
Patient reported previous nausea after receiving vaccines in the past as well as fainting. Monitored the patient for 30 minutes after her vaccination, and she vomited within 30 minutes. The patient reported she felt well after vomiting and denied needing any further attention or assistance
Moderna Covid-19  1-3 days post vaccine warm, sore, large erythema (about 2x3 inch), went away after 3 days 1 week post injection, site became red and itchy again. Same size erythema.  Day 8 (current), still red, less itchy but there.
Cellulitis. Swelling of limb. Welts. From initial information received from a health care professional on 30/Jun/2003 regarding an adverse event occurring in the US, it was reported that an 18 month old female patient received a Daptacel vaccination, lot number C1383AA, administered intra-muscular in the left leg on 27/Jun/2003. The next day the patient developed swelling of the thigh, cellulites and welts on the thigh at the injection site. Patient was seen by a physician and treatment of Keflex was prescribed. The patient's recovery status is unknown.
Chest pain and difficulty breathing, feeling very similar to Anaphylaxis.  Treatment including 50mg of Diphenhydramine HCl, and 600mg of ibuprofen.
Began to have nerve pain behind right ear during the night of 10/07/2021. Continued to worsen through the next two days. On the third day, 10/10/2021, facial nerves began to shut down. Dr. diagnosed by phone conference with patient that she had Bell's Palsy. The diagnosis was confirmed the next day in an examination by the physician in an office visit. At this time the paralysis has not resolved completely but is improving slowly.
Pt recvd Engerix-B 27FEB92 & 27FEB92 c/o burning pain @ inject site;
I got the worst migraine. I could barely stand up, no matter what I took it didn't work. I should have gone in sooner to get a shot because my doctor could give me a shot try to stop it but I didn't. I let it go on too long before I finally went to the doctor. She gave me a prescription for steroids. I felt better after the shot but by the time I went in it was time for my next vaccination. I did do better with the next vaccination.
Ringing in ears, Tinnitus, noticed approximately 1 week after vaccination.  Has not subsided after first noticed.  Upon receiving 2nd vaccination, within 6 hours Tinnitus was worse (louder), and has remained constant as a high frequency pitch.  From time to time have ears feeling blocked.  Went to ENT, Audiologist.  Hearing is perfect, with a slight decrease most likely at the same frequency of the Tinnitus. Tinnitus is definitely worse after 2nd vaccine.  Most likely will reconsider any potential future boosters..as adverse reaction, I cant take a chance for it to worsen, as in sound getting louder.
Received the first dose oft he Pfizer Covid vaccine on 13 Apr 2021. He then tested positive for Covid-19; Received the first dose oft he Pfizer Covid vaccine on 13 Apr 2021. He then tested positive for Covid-19; This is a spontaneous report from a contactable pharmacist from a Pfizer sponsored program. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 13Apr2021 as dose 1,single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported as, patient who received the first dose of the Pfizer Covid vaccine on 13Apr2021. He then tested positive for Covid-19. Received 1st Pfizer Covid 19 vaccine on 13Apr and tested positive the end of Apr2021. Reporter would like to know when consumer can receive 2nd Pfizer Covid vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on an unspecified date on Apr2021. Outcome of the events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of COVID-19  and Drug ineffective and the suspect product BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Patient admitted as inpatient on 10/7 due to acute hypoxemic respiratory failure due to COVID-19. Patient was tested for COVID-19 and was positive on 10/7.  Patient required high-flow oxygen 25 L at 70%.
had inc temp palms hot, lt side where shot recvd ached for 2-3 days, had cold @ time of shot;
Extreme fatigue; Sore muscles all over body; Mild headache; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown) via an unspecified route of administration in the left arm on 11Mar2021 at 09:00, (at the age of 49 years old) as a single dose for COVID-19 immunisation. Medical history included Diabetes, hypo thyroiditis and overweight. Concomitant medication included metformin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURERUNKNOWN) for unknown indication from unknown date. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 20:00, patient experienced extreme fatigue, sore muscles all over body and mild headache. The patient did not receive treatment for the reported events. It was reported that adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the fatigue. muscle soreness and headache were recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 5 year old female who with no known drug reactions/allergies and no known medical history who on 08-SEP-2006 was vaccinated with VARIVAX (Merck). On 10-JUN-2010, the patient received another dose of VARIVAX (Merck). There was no concomitant medication. On 10-JUN-2010, after the vaccination, the patient developed a 2 1/2 inch red, warm, raised and swollen area on her left thigh at the injection site. No lab diagnostics studies were performed. At the time of reporting, the patient did not recover from the events. The patient sought medical attention through office visit. Additional information has been requested.
Information has been received from a 46 year old female patient with a mental (social) disability and no known drug allergies. On an unspecified date in May 2017, the patient started therapy with ZEPATIER (genotype, lot number, dosage, and frequency not reported) for hepatitis C virus. There was no concomitant medication. The patient started developing a rash and then acne breakouts on her face and arms after two days of starting the ZEPATIER. The ZEPATIER was successful in curing her hepatitis C, but the patient stated she was still having acne breakouts on her arms and face. The patient stated it disappears and then reappears in the same areas. The patient sought medical attention and reported unspecified treatment. It also reappeared after receiving an "unspecified Hep B vaccine" (thimerosal content, lot number, dosage, and route of administration unknown) in approximately January 2018 (reported as three months ago). The patient never had acne and breakouts prior to receiving ZEPATIER therapy. No further symptoms were reported. Therapy with ZEPATIER was continued. The outcome of the rash is unknown. Additional information has been requested.
Pt c/o severe headache within an hour after receiving her vaccines, the headache lasted approximately 3 days. Pt had no appetite and was taking Tylenol extra strength, but not routinely. We did home treatment over the phone. We suggested Ibuprofen 600mg with food every 4-6 hours and suggested she stay hydrated. Pt was feeling better with first dose of Ibuprofen.
facial swelling, facial numbness on left side, lip swelling and numbness, airway issues, coughing, wheezing, SOA, unable to speak more than a few words at a time, hives, skin burning, vomiting, dizziness, severe vaginal pain, blurry vision
About 20 minutes after immunizations given and topical fluoride applied to teeth, patient developed erythematous rash around eyes, mouth and arm; as well as swelling of his eyes. Benadryl with given, with resolution of swelling and near resolution of rash over course of 45 minutes. No stridor, no vomiting, no change in mental status.
on 9/13/19, I was administered a flu shot That night I came down with very severe flu symptoms. Fever, sweats, strong nausea, loss of energy and severe vertigo This lasted through the night and periodically through the weekend.  It was so serious that I considered going to the ER.  I reported this to the clinic was told that this was normal and that it is impossible for live viruses to remain  in the serum.  I have has many flu shots and am not allergic ---- this was very unusual and frightening.  I can't help but surmise that there was either live viruses remaining or that there were QC issues associated with the formulation.  Can you please investigate.
Information has been received from a licensed practical nurse concerning a 13 year old female who on 30-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) IM. On 31-JUL-2008 the patient received the second dose of GARDASIL vaccine (yeast) IM and 5-10 minutes after injection was given, she felt dizzy and fell on ground. She could only see black, but was talking to nurse the entire time. Oxygen was given and patient rested. She was discharged home with her mother. On 31-JUL-2008, the patient recovered. Additional information has been requested.
20 min after receiving vaccinations child developed rash over face and neck and had an episode of diarrhea. No other symptoms. Child was monitored for an additional 40 min (a total of 1 hr. after receiving vaccines) and did not develop any further sx.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756510A, A0756512A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in  Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Patient is a 72-year-old male who has been having cough and shortness of breath for the last 2 weeks.  He was treated as an outpatient for possible pneumonia.  He has been vaccinated with the Johnson Johnson COVID vaccine.  Tested positive for COVID-19 yesterday.  He was having some loss of taste or smell.  Denies any diarrhea.  Denies any current cough or congestion.  Denies any current fevers or chills.  Denies any nausea vomiting.  Denies any burning, pain, increased frequency urination.  He is a nonsmoker.  He is not on any home oxygen.  No other active complaints at this time.
Ten days after the second dose of the vaccine I had a panic attack and my doctor needed to prescribe additional medication. I was feeling very anxious for about 48 hours, and it was not like anything I had before. My menstrual cycle was very unusual for about 3 months. I was having spotting before my period and then it would last longer than normal. Then I would get another period before it was due.
Extreme pain in left breast and left arm; I had inflammation.; Extreme pain in left breast and left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2021 as dose 2, single (Lot number: EW0167) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Vaccine lot number: EW0170, Vaccine location: Left arm), administration date: 20Apr2021, when the patient was 44-year-old, for COVID-19 Immunization. The following information was reported: BREAST PAIN (disability, medically significant), PAIN IN EXTREMITY (disability, medically significant) all with onset 22May2021, outcome "not recovered" and all described as "Extreme pain in left breast and left arm"; INFLAMMATION (disability, medically significant) with onset 22May2021, outcome "not recovered", described as "I had inflammation.". The events "extreme pain in left breast and left arm" and "i had inflammation." required physician office visit. Therapeutic measures were taken as a result of breast pain, inflammation, pain in extremity. Clinical course: Other medication in 2weeks: No. Extreme pain in left breast and left arm. Went to Dr. and they confirmed Inflammation. Treatment mediation included steroid shot. No known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375113 Same reporter/patient, same drug/different dose, same AEs;
6/1/05 at 9:46 am:  After receiving Td and Varicella vaccines the client fainted.  BP=100/80; Pulse=88.  Patient monitored with BP and pulse assessment every 15 minutes - within normal limits. Patient vomited x3 during stay in clinic.  BP and pulse remained stable.  Notified patient's private MD and sent of office with mother at 11:30 am. MD visit:  assessment as pale white female teen who had only eaten a banana the night before as her evening meal.  On the morning of immunizations, did not eat breakfast.  States has a fear of shots.  Nausea persisted in MD's office.  Rested in office approx. 30 minutes and left with mother.  Color significantly improved.  Fluids and small meals encouraged.