chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The patient had no drug reactions/allergies. There was  no information about patient's concomitant medications and pertinent medical history reported. On 08-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX23, injection, lot # L029113, expiry date: March 2017, intramuscularly (dose was not reported). Since having the vaccination on 08-DEC-2015, the patient experienced "constant pain at the injection site". There  was no treatment given for the event. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention by calling the pharmacist. The relatedness between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
2/3 vaccination 2/4 4 am woke up. I had a really really bad HA / couldn't lift head, my legs ached / joints all over, my L arm was so fiery red and swollen.  Did not eat for 48 hours. I tried to go to work but I had to leave. Symptoms lasted till that Sunday.   *COVID + 01/2021
Tested positive for COVID-19 on 8/14/21 via PCR;  Admitted to hospital on 8/16/21;
Patient appeared to be pale and started sweating with complaint of nausea and expressed to use bathroom to vomit. Patient was escorted to the bathroom where he vomited a multiple times. Water was provided to the patient, and blood pressure was measured after 10 minutes. Blood pressure measure was 175/115; however, patient stated that it is always high, and he is feeling much better.  Patient was monitored for 30 minutes, and he confirmed to feel safe to leave. Patient also reported his symptoms to V-Safe. He does not have an established PCP to follow up. Pharmacy information was provided to report any additional symptoms or complaints.
vision loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration unknown) for the long-term prevention of shingles and/or zoster-related conditions at the medical office. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, in 2010, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a physician for vision loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of vision loss was determined to be medically significant.
This spontaneous report was received from a pharmacist referring to a multiple unspecified patients. No concurrent or historical conditions were reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA, (Lot # L004734, expiration date 01-JUN-2017) doses, routes, anatomical locations were not reported. No concomitant medications were reported. No adverse effects were reported. No further information was provided. No product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
At 6pm covid like symptoms hit like a brick wall, exhausted, heated chills , headache, injection site pain heat and swelling. Today is 6 days post injection and I still have extreme exhaustion and migaines
suspected vaccination failure; shingles/Got the shot and still got shingle; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he/she had the shingles shot experienced shingles few years later. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Swelling, itching, redness (4"X4") square, occasion pain, soreness - near and around the injection site.   The injection site was getting better and around day 10 everything got worse and size of the redness and swelling got worse
Realized after giving the shot that it had only been 20 days since his first dose of Moderna. No adverse events to report at this time.
Headache; Chills; Fever; No appetite; Tired; This is a spontaneous report from a non-contactable consumer.  A 31-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0187) via an unspecified route of administration, administered in left arm on 28May2021 at 17:30 (at the age of 31-years-old) as a single dose for COVID-19 immunization.  dose 1 via an unspecified route of administration, administered in left arm on 07May2021 at 17:30 (Batch/Lot Number: EW0165) as 1st single dose for COVID-19 immunization. Patients past medical history included severe headache from 07May2021 after first dose and sore arm from 08May2021 (second day). The patient's concomitant medications were not reported. The patient previously took norco. The patient was not pregnant at the time of vaccination. The patient had not been tested for COVID-19 nor before neither since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Facility where the most recent COVID-19 vaccine was administered was at the Pharmacy or Drug Store. On an unknown date, the patient experienced, headache the next day, chills, fever, no appetite for the entire day and tired. The clinical outcome for the events was recovered.   Follow-up attempts needed. Information on the lot/batch number has been requested.
Pt. with headache and dizziness day after administration. Symptomatic care advised with TYLENOL or Ibuprofen and increased fluids.
Pain in upper L arm started within 24 hours of receiving DTAP/IPV. Ice applied with little relief. Patient was not able to attend school, due to is pain. Associated symptoms include redness and mild warmth at injection site. Denies fever, vomiting, diarrhea, poor UOP, sleep disturbance. Red, painful area on upper L arm approx 3.5in by 5in. Arm improved every day, and patient is back in school, as of 08/29/2106.
Trigemic Neuralgia in left side of face flared up. Treated with 10 days of prednisone and additional doses of gabapentin. Slight pain is still present.
Joint pain, general malaise, fatigue and increased susceptibility to infectious disease.  Follow up on 05/15/2000: "Patient partially recovered from adverse event.  Joint pain."
DIZZINESS STARTING 26 HOURS AFTER VACCINE, SEVERE DIZZINESS LEADING TO FAINTING, FOLLOWING BY SEVERE INFLAMMATION STARTING IN RIGHT HAND WHICH MOVED INTO CHEST AND TORSO AND EVENTUALLY BRONCHITIS. SEVERE DIARRHEA, MALAISE, NAUSEA. DIZZINESS LEADING TO FAINTING CAUSED HITTING OF HEAD.
pt received the johnson and johnson shot at 3:00pm. He began passsing out and myself and his girlfriend helped him to the floor. I administered an epipen 0.3mg. Pt became awake immediately. 911 was called. bp 150/80 when EMT arrived.
pt recv vax MAR96 & APR96 & sx of shoulder & neck pain w/weakness LUE;clinical atrophy of supraspinatus, scapular spine, upper lt arm muscle masses;EMG/NCV acute partial denervation C-6 myotome vs upper trunk brachial plexus;
Initial presentation was to the Hospital on 1/6/22 with right sided weakness and paresthesias, emergently transferred for specialized intervention to larger Health System - Hospital.  Patient had pulmonary embolism (left lower lobe segmental branch) and acute embolic stroke (mid distal left P2 segment) requiring mechanical thrombectomy and anticoagulation.  Later found to have patent foramen ovale, no evidence of deep venous thrombosis on lower extremity doppler ultrasound.  Has progressive strength and sensory recovery but still with deficit at time of discharge. Treated by interventional neurology, neurology critical care, and hematology.  Suspected etiology pro-thrombotic/provoked from oral contraceptive with embolism but did receive vaccine within 28 days of acute illness presentation.  Discharge planning to home with outpatient therapies and oral anticoagulation.
pt recv vax 5JUL96 the next day 6JUL pt exp pain in the rt arm;pain was described as extreme soreness extending from rt shoulder to fingers post 3rd dose;
Patient walked to exit door and stated to recovery nurse that she felt as if she were going throw up.  Patient seated in chair by nurse given a trash can. I was flagged over along with another recovery nurse.  Vital signs obtained  BP: 110/70 HR: 88 o2: 96 RR:20 .  Pt assessed and quick history obtained.  Daughter is present.  Pt states she ate breakfast and takes 9 pills but does not remember what they are for neither does the daughter. Daughter states mom is severe alcoholic and is unsure if mom really ate anything or took medicine today. Patient sipping water and states she feels better.  Second set of vitals obtained  BP: 108/64 HR:88 RR:18 o2:96 No further medical attention requested. Patient encouraged to eat after leaving clinic. Adverse event date 3/8/21   Vaccinated Time:  1502 Begin time: 1513  End time: 1525
3/11 Day 1-immediate and severe headache, 3/12-13 Day 2-3 body aches, flu like symptoms, headache,  tight chest, upset stomach 3/15-16 Day 5/6-severe headache, upset stomach, tight chest AND NOW on DAY 6 the injection site is red, warm to the touch, swollen and itchy-like an allergic reaction.  I have small hives/itches on other parts of my body.  Generally don't feel well
Adverse event: Patient developed a macular papular rash to the injection site (~8 cm area) and her upper back just along the line of the spine of bilateral scapula. Treatment included Diphenhydramine, Loratadine, Famotidine, & topical Calamine Zinc lotion Outcomes: Patient presented to the Clinic reporting the rash appeared after she received her COVID vaccine boost, about 1.5 weeks prior to arrival. Rash was present, but no infection, abrasions healing. Follow up visit pending.
We have been receiving all the Pfizer COVID vaccines /are still getting COVID; We have been receiving all the Pfizer COVID vaccines /are still getting COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: as a child. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "We have been receiving all the Pfizer COVID vaccines /are still getting COVID".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
penetrating headache; headache like that has been kind of growing in frequency and in extremity, getting worse/my headache I am really hurting right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (dose:1), for Covid-19 Immunization; Moderna (dose:2), for Covid-19 Immunization; J and J (dose:3), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 27Apr2022, outcome "not recovered", described as "penetrating headache; headache like that has been kind of growing in frequency and in extremity, getting worse/my headache I am really hurting right now". Therapeutic measures were taken as a result of headache.  Additional information: Reporter consent to contact given: No. Consumer stated, "I have the Pfizer as my final booster shot (clarified as Pfizer Covid-19 vaccine), my fourth shot and my only Pfizer, the other two were Moderna and the third was J and J and the reason I am calling is the side effect. Is there any record of there been like a penetrating headache. I had the shot last Wednesday and I had a headache like that has been kind of been growing in frequency and in extremity, getting worse. This is what, Sunday I am going to see my practitioner tomorrow regarding it because it is like going almost 24 hours. I have been able to kind of control it with some medication(Treatment)." Consumer was informed about the role of Pfizer Drug Safety and informed that is the concerned department to answer the question. In response to further probing: Consumer stated, "No I can not. I got to go deal with my headache I am really hurting right now." Reassurance: Consumer stated, "No, not right now, thank you, thanks for the phone number." Further probing could not be initiated as consumer declined to complete the report. Hence, product details (LOT, expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call. Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Induration greater than 120 mm in left arm, swelling and decreased feeling in left hand. Patient saw emergency room doctor (informally, since he works with Doctor) who thought the swelling might be putting pressure on the ulnar nerve.
The client received a 3rd dose of the COVID-19 vaccination. The 1st dose of Pzifer was given 1/2021 and the 2nd dose 2/2021.  The client did not have a reaction but the site will continue the client status.
She got her vaccines, got terrible back pains, and violent diarrhea.  Saturday and Sunday and yesterday when she went up to the store and walked she thought maybe she had a blood clot in her left leg.  The leg was painful like a blood clot in it.  The diarrhea is awful, and still continues.  She is taking Imodium but is afraid to each very much, she only weighs 104#, and does want to have anymore diarrhea.  She does not feel that she should have gotten the vaccine.  She is also having chest pains.  She has not called her doctor with regard to her symptoms.  She has an appointment to see him in a couple of weeks.  She tried to reach out to the pharmacy and was told not to bother them, they were too busy.    She is very sorry she got the vaccine, and to make sure that older people get recommendations from their doctor.  She did get her COVID shots, and did not want to get another.  She does not think that the RSV vaccine for older people is advisable.
Patient called this afternoon and reports that she just left the office of her neurologist and it was reported to her that her COVID vaccine caused her to have a stroke. Patient reports that she started to experience right sided vision changes shortly after receiving her second COVID vaccine.
Chills; Palpitations/her heart was racing; Blood pressure went up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: EN9581) 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"; PALPITATIONS (non-serious), outcome "unknown", described as "Palpitations/her heart was racing"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "Blood pressure went up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated she just wanted to know if she should take the second dose since she was fine now Patient stated in the beginning in the 15 minutes she was waiting her heart was racing and then it went down and was fine and then it started back again and also she had chills and her blood pressure went up. Patient stated within 3 weeks this happened maybe once or twice. Patient asked should she get the second dose.  No follow-up attempts are possible. No further information is expected.
Dizziness and weakness Swelling and pain of lymph nodes on the left arm and on the neck
I had a stroke on 9/30/22 four days after vaccine. But can not be sure of causation.
I had severe muscle cramping and pain within a couple hours of receiving my first Covid Vaccine, so bad I could barely walk up the stairs to my house. The pain decreased over the course of the following 2 weeks, but still had residual cramping/pain in my lower back. I received my 2nd dose on Jan. 28, 2021, and immediately started having debilitating headaches, pretty much everyday, had fatigue regularly after 2nd dose also. Then I noticed my allergies, generally not severe, got markedly more severe this year. About a month and a half ago, I started getting a facial parathesia on occasion. This includes a burning, painful, numb ears/face. The attacks of parathesia have increased in pain and numbness every time I get an onset, the last one happened 2 weeks ago. Also a couple weeks ago I started having a lot of issues breathing, so was seen by a doctor to get better inhalers/medicines. Last week I started having severe issues with breathing and over production of mucus. I also have an elevated D-Dimer, had to have a chest CT to make sure I did not have an pulmonary embolism. I still continue to have breathing issues and nobody can figure out exactly what is wrong with me. All reactions seem to be inflammatory in nature and all my issues started after the Moderna Covid Vaccine. I never had these issues prior and had no long term medical illnesses or underlying conditions.
Approximately 10:45 to 11:00 AM, beginning to feel tightness in throat and headache.  Symptoms progressed to throat closing and shortness of breath, confusion by 12:00PM. Primary Care physician contacted via phone at 12:00PM and instructed patient to take Benadryl 50mg PO.  Benadryl 50mg liquid PO was taken PO at 12:15PM (after being purchased) and continued Q6H around-the-clock until 11/30/2014. Patient also went to facility at 12:20 after Benadryl taken to discuss allergic/anaphylactic reaction with nurses who administered vaccine.
No additional AE reported.; HBP responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion.; This spontaneous report has been received from a healthcare business professional (HBP) regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 02-SEP-2022, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant Human albumin (rHA)) subcutaneous injection, lot #W017570, expiration date: 29-NOV-2023, administered for prophylaxis (strength, dose, route of administration and anatomical location were not provided) after temperature excursion of 5.7 Fahrenheit (F) for 30 minutes (product storage error). There was a previous temperature excursion of 6 F to 14 F (9.1 F) for 1 hour 6 minutes. There was no additional adverse event (AE) reported, and no additional information provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA003637:
Late Sat. night, vomiting - diarrhea. Stopped vomiting and diarrhea Sunday afternoon. Fever 101.8. TYLENOL given. Headache, nauseous and dizziness started. Fever stopped but now nausea and dizziness. Finally is able to eat today. Mother instructed to call MD. Mother thought maybe it was flu.
Exactly 7 days after receiving first Moderna vaccine the injection site is itchy (like a bug bite) and has a little round bump. (It is NOT a bug bite, just itches like a mosquito bite) It also feels a little warmer than the rest of my body.  It?s not awful just a little annoying right now but the article I came across describing ?Covid Arm? following Moderna suggested people send in an adverse reaction report. I would get the injection again and still plan to get the 2nd dose, unless I shouldn?t for some reason.
Vaccine interval less than recommended; Second dose administered fewer than 17 days (Pfizer-BioNTech)
felt like foggy / as soon as I took the shot I knew i got something; arm hurt immediately; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like foggy / as soon as I took the shot I knew i got something) and MYALGIA (arm hurt immediately) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt like foggy / as soon as I took the shot I knew i got something) and MYALGIA (arm hurt immediately). At the time of the report, FEELING ABNORMAL (felt like foggy / as soon as I took the shot I knew i got something) and MYALGIA (arm hurt immediately) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided No treatment medications were provided   This case was linked to MOD-2021-236437 (Patient Link).