chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UNDER AGE PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. 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, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced under age subject. On 06-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the under age patient and off label use was not reported. This report was non-serious.
I woke up with shooting pains/cramping running down the sides of my body/arms to the bottoms of my feet. It felt like a cramp but worse, kind of like nerve pain. I tried to walk it off but it persisted for about five to ten minutes. I had never felt that kind of pain before.
Patient received Pfizer 1st dose on May 28. 2021 at MassVax.  On June 12, 2021, her received a 2nd dose of Pfizer at MassVax.  The 2nd dose was given 6 days to early.
Dysphagia. Started having trouble swallowing around the end of October. No exact date. Got worse until around Nov. 23 when could hardly swallow solid food. Family Dr. sent me to Nose/Throat Dr who did scope down throat. Thought reflux. Prescribed Cooky Swallow Test. Diagnosed neurological. Sent to Neurologist who prescribed MRI of brain. No stroke. He sent me to another facility. Had a blood test which found no indications.
slight neuropathy in fingers; Very itchy - almost painful itchy zings in my elbow area, face and legs; Very itchy - almost painful itchy zings in my elbow area, face and legs; Very itchy - almost painful itchy zings in my elbow area, face and legs; Very itchy - almost painful itchy zings in my elbow area, face and legs; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Mar2021 11:15 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation at a Pharmacy or Drug Store. The patient has no medical history. The patient has no Covid prior to vaccination. The patient had other medications in two weeks but no other vaccine in four weeks. On 13Mar2021 11:30, the patient experienced very itchy, almost painful itchy zings in her elbow area, face, and legs. The patient also had some slight neuropathy in fingers. This has continued for three days and started immediately after receiving the vaccine. The patient was not tested for Covid post vaccination. The events were not treated. The outcome of the events was not recovered.
This spontaneous report as received from a Certified Medical Assistant refers to a currently 46 years old female patient with sulfamethoxazole, BACTRIM allergy and no pertinent medical history. On an unspecified date (sometime in the last 5 years), the patient received vaccinations (unspecified # of doses) with (Merck) VARIVAX, 0.5 ml, SQ (lots # were not provided). No concomitant medications were provided. These vaccinations were required because she was showing no titers for varicella and was working at different healthcare facilities. Medical Assistant noted that the patient stated after receiving these vaccinations with (Merck) VARIVAX that she did not show any titers for varicella 2 or 3 times when titers were drawn on an unspecified dates. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was not provided. This is one of the several reports of the same source. Additional information is not expected.
Vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
mom reports symptoms began 8/31/20 with Fever of 101.8 accompanied by runny nose, congestion and mild fussiness and tired. Brought pt in the next day at which time pt was placed on Amoxicillin for acute sinusitis. Pt ran fevers x 5 days and developed a rash that progressively worsened. MOm reports rash started out on torso then spread from head to toe and rash appears to have a welted appearance (similar, in places to hives. Pt brought back on 9/9 to see provider again at which time viral vs drug allergy rash was considered and Steroid creams prescribed and advised to follow up in 2 days if not resolving and provider would consult with pediatric derm. Pt continued with progressive fussiness and worsening rash
103 degree fever (same night as shot) - continued through the following night even with taking tylonel and Advil, headache, aches, covid arm within two days of shot (red, swollen, itchy, tender, warm to touch  red spot near injection site)
This spontaneous report received from healthcare worker refers to patients of unspecified demographics. On 05-MAY-2014, excursion occurred 14 of 33.8 Fahrenheit (F) (rounded to 34 F) for 8.31 minutes affecting PEDVAXHIB (lot number J014279, expiry date 16-SEP-2016). It was reported that the excursion products were supported. Approximately on an unknown date in May 2014, the patients were vaccinated with PEDVAXHIB (lot number J014279, expiry date 16-SEP-2016) (dose unspecified) for vaccination post excursion. Concomitant therapy was unspecified. No product quality complaint was involved. No adverse effects noted by any patient. The outcome of event was unknown. No additional information was available. This is one of the several reports from the same reporter. Additional information has been requested.
My pulse was aridic and having anxiety.  I was in the hospital for four days, and bp was up.
This is a spontaneous report received from a noncontactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed thrombosis/blood clots (medically significant), with outcome of unknown. Clinical course: She said she had family members who got the first and second dose of the Pfizer COVID-19 vaccine. One of them had blood clots. The other one had myocarditis and he's 24 years old. The reporter wanted to know if they can proceed with the booster dose. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
I received the first dose of the Moderna vaccine on 1/1/21.  Initially, I had a sore arm for 24 hours but otherwise no problems.  Then, on day 8, my left deltoid area started itching and there was a red, slightly raised area just larger than a golf ball. I called the  hotline at that time and took a Benadryl.  Then, 24 hrs later, the area had expanded to over 3 times the size and felt warm. I actually went and saw a friend who lived in my neighborhood who is a general surgeon and he thought I should get it checked out to make sure it wasn't an NSTI.  Being Saturday at 9pm, I went to the ER  where they started me on Keflex/Bactrim for a presumed cellulitis.  By the next morning, the redness and itching were gone and my arm felt totally back to normal the next day after that. Unfortunately, on day 3 of the antibiotics (Tuesday the 12th), I had symptoms of anaphylaxis (chest tightness, wheezing, throat clearing, lip swelling, hoarse voice, impending doom sensation).  I took Benadryl 50mg and got my epi pen ready but did not use it.  (I have a tree nut allergy).  The symptoms resolved completely about 1 hour later.
This case was reported by a healthcare professional and described the occurrence of a 3-year-old male subject not responding to therapy following vaccination with Engerix B for prophylaxis. Concurrent medical conditions included chronic otitis. On 25 April 2005, 21 September 2004 and 3 August 2004 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (0.5 ml, intramuscularly) to complete the 3 dose series. Lot numbers were provided as ENG550642, 558582 and AHBUA. On 24 July 2007, the subject was tested and found to have not responded to therapy. In the past few months, the subject was also diagnosed with an enlarged spleen. This case was assessed as medically serious. At the time of reporting the subject was not responding to therapy and the outcome of the enlarged spleen was not reported.
I had Hepatitis B shot, and after seven days, I discovered 3 bald spot on my head. It's pretty scary to see the hair loss.
tinnitus flare in left ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus flare in left ear) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Mar-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 TINNITUS (tinnitus flare in left ear). At the time of the report, TINNITUS (tinnitus flare in left ear) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.  Upon internal review on 04-AUG-2021, the age was corrected to 45 years.   This case was linked to MOD-2021-092027 (Patient Link).
PATIENT WAS ADMINISTERED 0.3ML OF UNDILUTED PFIZER VACCINE. PT WAS OFFERED AN MD EVALUATING TO INCLUDE AN EKG AND TROPONIN LEVEL. PT REPORTS PAIN AT SITE, SWELLING AT SITE, JOINT AND MUSCLE PAIN, AND HEADACHE. SHE IS TO BE SEEN BY MD  ON 12/17/21.
24 Hours post vaccination:  full body rash for 3 days.  Took Benadryl for two days it went away.  Both left and right hips hurt so I couldn't walk.  Took Tylenol and and aspirin for two days.  Pain went away. 8 Days later vomiting and diarrhea, Right and left hips hurt again.  Fainted.  Taking  fluids, Tylenol and aspirin.  Tired.
Patient received Pfizer Covid vaccine dose #1 at 4:07pm, 10 minutes later patient said that she was not feeling well. She felt her left arm was going numb, light headed, dizziness and chills. at 4:10 BP was 127/81 pulse 70.  At 4:25 bp was 136/82 pulse 83. She was still feeling light headed, cold, and shaking. Pt given orange juice.  At this point patient stated she has a hx of losing hearing and then a feeling of passing out. This has occurred more than one time. Pt also stated having lost feeling in both legs with no explanation as to why.  4:35pm bp 133/82 pulse 85, she was feeling cold and shaky. 4:42 pm patient stated she was getting colder and was still light headed. 4:56pm very cold, chills and dizziness. Pt  was given another blanket. Both pt and father were asked if emergency services should be called.  5pm  per parent;'s request  were ok to give 480mg of tylenol, she was very dizzy and cold bp 132/85 pulse 89. Father approved of us calling for emergency services. Pt symptoms not improving. Emergency services arrived pt was able to get onto her feet and walk to the stretcher. Pt stated she is still very dizzy.
Fever of up to 102, extreme chills and shakes, night sweats of large amounts, headache for 30 hours have now a lingering cough
she has lost 10 pounds in the last 2 months; Left arm pain at injection site; Headache; Nausea; Rapid Heart Beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid Heart Beat), WEIGHT DECREASED (she has lost 10 pounds in the last 2 months), NAUSEA (Nausea), VACCINATION SITE PAIN (Left arm pain at injection site) and HEADACHE (Headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Cardiomyopathy. Concurrent medical conditions included Penicillin allergy. Concomitant products included HYDROCODONE, METOPROLOL SUCCINATE (TOPROL), VITAMIN D [VITAMIN D NOS] and DIMENHYDRINATE (DRAMAMINE) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid Heart Beat) and NAUSEA (Nausea). On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Left arm pain at injection site) and HEADACHE (Headache). On an unknown date, the patient experienced WEIGHT DECREASED (she has lost 10 pounds in the last 2 months). On 03-Feb-2021, HEART RATE INCREASED (Rapid Heart Beat), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. On 04-Feb-2021, VACCINATION SITE PAIN (Left arm pain at injection site) had resolved. At the time of the report, WEIGHT DECREASED (she has lost 10 pounds in the last 2 months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also include hydrocodone, Toprol, Vitamin D, Dramamine. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Additional event added and patient was feeling better and also she denied further follow-up.
The vaccine was administered in left Arm. Swelling in left Arm , left leg and pain in left knee started after the second shot of vaccine was administered. The swelling in arm, leg and knee pain has not subsided at the time of filling this form ( 2 months post vaccination). It appears medical attention is required as the swelling appears to be gradually increasing. Considering medical/ER appointment.
01/07/2022, I got the vaccine in the morning and by the night, I had vomiting, diarrhea, fever, chills for 2 to 3 days.
Per Nurse Record: Nurse Stat called to front desk. When RN arrived, found pt flat on back on floor, verbal and responding to questions. Per other observers, pt was standing at the desk, her eyes rolled back, and she fell to the floor. This was about 5 minutes after receiving Gardasil injection at 330pm. Pt was immediately evaluated by MD and NP.  BS 150; O2sat98%; Oxygen face mask was applied.  RN called 911, but the pt declined these services and the call was not completed. MD advised pt that 911 should be called and she should be evaluated for r/o seizure and for the trauma to her head. She again declined 911 services and said her boyfriend would take her to the ER.   She states she got her gardasil shot, felt fine, walked out of the room, states she became dizzy/nausea/hot, then she fell, when she came to she said it "felt like she was in a dream", then "flashes of images" orthostatics: 112/80; 80 lying 110/80; 82 sitting 110/80; 88 standing  Now pt c/o pain to back of head, slightly nauseated. Pt's boyfriend arrived within 30 minutes and spoke to both NP and MD, who both advised that pt should be seen immediately in ED. Her boyfriend states he will take her now.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, he was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Flu shot given IM in left deltoid.  Proquad given SQ in posterior left arm.  Within 5 minutes of vaccine administration, hive noted next to Flu vaccine site.  Hive measured 3.5cm. x 2.5cm., flesh-colored to slightly pale, crescent shaped.  Dr. examined patient and ordered oral dose of Benadryl; given 15 minutes after vaccine administration.  No difficulty breathing noted.
atrial fibrillation; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included blood pressure high (back high blood pressure) and drug allergy (Tetracycline, sulfa allergy). Concomitant products included atenolol, atorvastatin, desmopressin, estradiol vaginal and rimegepant sulfate (Nurtec).   On 05-SEP-2023, the patient received Arexvy. On 12-SEP-2023, 7 days after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was resolved.   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-NOV-2023 The patient self-reported this case. The patient received Arexvy shot and with 7 days interval he/she watched him/her and had atrial fibrillation.  The patient watch continued to give him/her daily's.  The patient was on a vacation and went to him/her doctor when he/she got home on 13th September 2023. The patient had no prior vaccinations for this reported event. The patient did not have any current illness. The follow-up could not be possible as no contact details were available.
Left arm red, swollen, hot at site of DTAP injection silver 1/2 dollar.
PERICARDIAL EFFUSION Narrative: Patient with history of pleural effusions and recurrent pericardial effusions presented 9/11/20 to facility ~7 days following influenza vaccination for routine imaging and found to have abnormal chest CT with concern for pericardial effusion. Patient not admitted at the time, however presented to ED 9/25/20 with worsening shortness of breath and cough. Patient admitted for bacterial pneumonia with parapneumonic effusion. Discharged 10/10/20. At 10/16/20 PCP visit, patient reported he believed the event was triggered by influenza vaccine.
Temperature spiked to 102 degrees.  Fever, chills, bodyaches, sweats, fatigue.
I experienced numbness in the tip of my right pinky finger that I hadn?t noticed prior to the vaccine shot. I still have the numbness to this day. I don?t notice it unless I flick the right pinky fingertip with my right thumb. It seems to be the same amount of numbness during all these days, without change.
Headach, still neck and light sensitivity soon after injection. These symptoms lasted about 24 hours. After these abated then significant swelling of left arm pit and ringing in both ears for 10 days now.
70mm x 35mm reddened area that is wam, tender and  hard to touch.
Patient came to the ED with fever and weakness.  Patient also had diarrhea.  Patient admitted to the hospital with Covid and hyponatremia and treated with remdesivir.
A week after shot, developed a red, raised, indurated warmer 2 in x2 in area in the area of the injection
SEVERE SWEATING, SHORTNESS OF BREATH, DIARRHEA, VOMITING, HEADACHE. RECEIVED TREATMENT AT LOCAL HOSPITAL. PATIENT RECEIVED BENADRYL AND MEDICATION FOR NAUSEA.  PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION
Patient reports that within 2 hours of receiving Janssen vaccine, started with migraine-symptoms and dizziness; he had to stay out from work the next next day due to fatigue/dizziness/headaches/myalgias. Started with shortness of breath and asthma exacerbation symptoms on 4/1/21; saw PCP, on 4/2/21 for shortness of breath and asthma/allergy-like symptoms. He also reports that since the time of his vaccine his BP has been running slightly high around 140/85 and headaches have continued off and on. He was started on Budenoside inhaler by PCP and prednisone (patient does not recall dose). Came to see me at on-site clinic on 4/13/21 for continued headaches and concerns to blood pressure elevation persistence
Information has been received from a registered nurse concerning a 5 year old male who was vaccinated with the second dose of Varivax (Oka/Merck). Subsequently within days after being give the second dose the patient experienced injection site irritation including swelling, redness and warmth in a six inch area surrounding the injection site. Also, he had raised bumps at the injection site. Additional information has been requested.
Left glute injection site became inflamed with palm-sized area red, indurated, swollen, and exquisitely tender with pain to touch and with movement (painful to put weight on L foot, for example). margins initially clearly defined (pt outlined with sharpie), and redness extended past margins in multiple directions but margins became less clearly demarcated and redness decreased as area spread. Low grade fever (up to 100.3) along with fatigue, headache, myalgia persisted through Monday following vaccine on Thursday. Injection site Redness mostly resolved by Wednesday, but fatigue and induration remains and painful to touch directly.  Treatment included rest, acetaminophen, ibuprofen, and ice. Saw walk in provider at PCP clinic on Monday.  of note, l arm soreness was mild and resolved within 24 hrs of vaccine; r arm soreness moderate and resolved within 24-48 hrs.
pt to ER w/bright red spots, pruritus, itchy, resp rate 20; recvd flu vax 0700 that day; no unusual diet, chemical exposures; took usual dose of contraceptive in AM, ? single cold capsule; dx allerg rxn of ? etiol; ? flu vax relationship
Site isand swelled up; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site swelling (Verbatim: Site isand swelled up). The outcome of the injection site swelling was not reported.   It was unknown if the reporter considered the injection site swelling to be related to Arexvy    It was unknown if the company considered the injection site swelling to be related to Arexvy.   Additional Information: GSK Receipt Date: 23-OCT-2023 The case was received from the patient via (Open field AE monitoring) interactive digital media. The reporter stated that after the patient received a dose of Arexvy, the site was swelled up.
Fever (up to 102) so far, lower back pain, headache, nausea, shaking chills, achy joints, fatigue, swollen lymph node under injection site arm , dizziness