chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt did not have vaccine card with them for me to identify lot number. Reports left arm spots, plus pain that has last for several weeks. Reports the spots are across the entire arm. No excessive swelling is visible, redness is localized to spots, reports pain lessened over last week.
On 7-20-08 the day DTaP # 4 given, Grandmother, reports client had asthma and she watched client often. Client went to bed at 8 or 9 pm. Client slept with grandmother. Grandmother reports "in middle of night" she noticed client had shallow respirations while client slept. Reported that she patted him and talked to him as she usually does as he often had "bad dreams." Reports client eventually "calmed down" and resps returned to normal. Reports did not seek medical tx. Reports made PCP aware of routine visit for next week.
5/29/2021 superficial veins became dilated throughout chest. 6/05/21 began to notice memory fog/loss 6/11/2021-chest pains, heart palpitations that didn't stop. They would come every 15 seconds, irregular heart rate that went from below 50 up to 160 in seconds. Arm weakness began 6/13/2021.
This case was reported by a pharmacist via sales representative and described the occurrence of injection site blisters in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 11 November 2013 the subject received unspecified dose of FLULAVAL (unknown details). On 11 November 2013, immediately after vaccination with FLULAVAL, the subject experienced injection site blisters (described as "blistering"). At the time of reporting the outcome of the event was unknown. The pharmacist reported other cases with FLULAVAL. See cases A1052877A and A1052879A for details.
The shot was administered into the left shoulder (extremely high on the arm) and immediately felt pain. Severe pain all day, and by the end of the day, any movement with left arm caused extreme pain and was not able to sleep due to pain. The next day (6/14), I called the nurse to ask about pain and described my symptoms of feeling nauseous and not being able to move my arm. I was told nausea was possibly from the pain and to take TYLENOL and it should be better by the weekend and if not to call back. During the remainder of the week, I was in excruciating pain and could not move my arm, bear weight on it, or sleep well. Friday (6/16) I called back because I was still in pain and there was no sign of improvement. I was told to see an orthopedic. On 6/27 I was able to see the orthopedic and was given oral steroids to help with the inflammation and hopefully solve the issue. Pain had diminished some at this point, but I was not able to bear much weight, or move my left arm above my head or across my body. I was icing my shoulder and taking ALEVE for pain relief. I was told if the problem still persisted I would need an MRI. On 8/3, I had an MRI showing tendonitis and bursitis in the left shoulder. On 8/10 I received a Cortisone shot and was prescribed physical therapy. After completing physical therapy at the end of September, I regained movement and can now move my arm above my head and across my body. Certain movements with my arm/shoulder still cause some pain, carrying heavier items causes some pain, and most days there is still a dull persistent pain in my shoulder.
From initial information received on 13Sep04 from another manufacturer regarding an adverse event occurring. It was reported by a pharmacist that a 48 year old female pt received a dose of Typhim VI as well as a first dose of Havrix, admin in the right thigh on 18Aug04. The route and site of admin were not reported for the Typhim VI product. The lot numbers were not reported for either product. Approx two days later, on 20Aug04, the pt experienced a fever greater than 101 degrees F, nausea and vomited twice. On 26Aug04, the fever and vomiting resolved. On 27Aug04, the myalgias got worse. The pt was seen in the ER. A complete blood count revealed a white blood count of 4.6 and a lymphocyte count of 51%. The pt was told in the ER that the events were probably due to a viral infection. On  29Aug04, the pt experienced dizziness. She was seen by a neurologist. A CAT scan was normal. At the time of the initial reporting, the myalgia had worsened and the dizziness and nausea were ongoing. The reporting pharmacist considered the events to not be related to vaccination with Havrix. The pt's recovery status was unk at the time of this report.
Information has been received from a physician concerning a 19 year old female who was vaccinated with an IM, third dose with Gardasil. Subsequently the patient experienced numbness in legs. Subsequently, the patient recovered from numbness in legs. It was reported the patient had no problems following the first 2 doses. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a physician concerning a 19 year old female with asthma, morbid obesity and peanut allergy and a history of orthopedic injuries from previous falls who on 26-FEB-2007 was vaccinated in her left arm with a third dose of GARDASIL (lot# 655849/0263U) at 11:00. On 27-FEB-2007 at 10:00 the patient experienced light vaginal bleeding that was between her menstrual cycles and numbness in both legs. Subsequently, the patient in one week recovered from light vaginal bleeding and numbness in both legs after 7 days. The patient did not seek medical attention until several weeks after these symptoms. No further information is available.
very itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EN6207) at the age of 48 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma, Asthma is severe, that is why she got the shot; "Anxiety" (unspecified if ongoing); "Known allergies: Soy" (unspecified if ongoing); "Antihistamines" (unspecified if ongoing); "Birth control" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Reflux med" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR taken for asthma (ongoing); SYMBICORT taken for asthma (ongoing); ACIPHEX taken for gastrooesophageal reflux disease, asthma (ongoing); XYZAL taken for antiallergic therapy (ongoing); XOLAIR taken for food allergy (ongoing); ATROVENT taken for asthma; VENTOLIN [SALBUTAMOL] taken for asthma; LIPITOR taken for blood cholesterol (ongoing); NORETHISTERONE taken for contraception; EPIPEN; VENLAFAXINE taken for anxiety (ongoing). The following information was reported: PRURITUS (medically significant) with onset 21Mar2021, outcome "unknown", described as "very itchy". The event "very itchy" required emergency room visit. Therapeutic measures were taken as a result of pruritus.  Clinical course: Had the first shot 21Mar2021 and had the reaction within 25 minutes of the injection. Started getting very itchy and they kept her there for an hour and a half. Took Benadryl and they just monitored her.
Kinrix administered to a 7y/o; Kinrix administered as 1st and 2nd dose DTaP series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Kinrix, Kinrix Pre-Filled Syringe Device, the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The nurse reported that a 7 year old patient was administered Kinrix as the first and second dose in the DTaP series. At the time of reporting, the nurse did not have the patient details, date of administration, lot number/expiration date. The vaccine administration facility was the same as primary reporter.   The consent to follow up was granted. Additional Supportive information: The 7 year old patient was administered Kinrix as the first and second dose in the DTaP series which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.  This case was one of 10 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022136455:Same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136466:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136461:Same reporter
After 2nd  vaccination, experienced more of the flu-like symptoms that were minor and tolerable  About 10 days later notices some slight body type aches that were pronounced in any body position lasting more that 15-30 mins. As time went on, 8 wks post vaccination I noticed a left side clavicle edema and limited range of motion. Pain has been a 3-5 and on some day 6/7. This has continued regularly sine June 2022 and pain has disseminated  fully. Edema is noticeable to the blind eye In comparison with the right side clavicle. Overall there is a tighter, less range of motion type of body ache that takes over the entire body. In particular like a bone-ache flossing all over Likened to a tough workout. Even when there is limited additional exercise thrust upon the body. A constant full body sore that does not go away. Overall the the clavicle bone pain seems To be the worst of the ailments.
After 2nd immunization had redness at injection site, prolonged crying over 24 hrs. DTaP given 06/05/2002. The follow up received on 6/20/02 states, "crying started as soon as child was immunized and was ?"
Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Mild headache). At the time of the report, HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Treatment information was unknown.
SHARP PAIN IN LOWER LEFT GROIN; JAGGED RAINBOW COLORS IN RIGHT EYE IN RIGHT LATERAL VISION; BRAIN SPEECH WASN'T FIRING CORRECTLY; HEADACHE IN LEFT TEMPORAL LOBE; FATIGUE; NAUSEA; RING IN EARS; CHILLS; PRESSURE IN HEAD; DIZZINESS; DIARRHEA; FLUSHED FACE; RED FACE; FEELING HOT; JOINT PAIN; MUSCLE PAIN; SHAKING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered to left arm on 11-MAR-2021 17:26 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced feeling hot. On 15-MAR-2021, the subject experienced shaking. On 15-MAR-2021, the subject experienced joint pain. On 15-MAR-2021, the subject experienced muscle pain. On 15-MAR-2021 06:00, the subject experienced pressure in head. On 15-MAR-2021 06:00, the subject experienced dizziness. On 15-MAR-2021 06:00, the subject experienced diarrhea. On 15-MAR-2021 06:00, the subject experienced flushed face. On 15-MAR-2021 06:00, the subject experienced red face. On 15-MAR-2021 06:00, the subject experienced ring in ears. On 15-MAR-2021 06:00, the subject experienced chills. On 15-MAR-2021 06:00, the subject experienced headache in left temporal lobe. On 15-MAR-2021 06:00, the subject experienced fatigue. On 15-MAR-2021 06:00, the subject experienced nausea. On 17-MAR-2021, the subject experienced brain speech wasn't firing correctly. On 20-MAR-2021, the subject experienced jagged rainbow colors in right eye in right lateral vision. On 21-MAR-2021, the subject experienced sharp pain in lower left groin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 19-MAR-2021, and had not recovered from ring in ears, pressure in head, headache in left temporal lobe, fatigue, chills, dizziness, nausea, flushed face, red face, feeling hot, muscle pain, joint pain, jagged rainbow colors in right eye in right lateral vision, brain speech wasn't firing correctly, shaking, and sharp pain in lower left groin. This report was non-serious.
Patient is fully vaccinated.  40-year-old female who presents emergency center for evaluation of generalized myalgias including chest wall aching, upper extremity and lower extremity aching.  Patient states that she was diagnosed with COVID approximately 15 days prior.  Patient states that she was having chest pain and shortness of breath for 1 week after having diagnosis of COVID. Positive for cough and myalgias. BP (!) 200/88  | Pulse 83  | Temp 97.6 °F (36.4 °C) (Oral)  | Resp 18  | Ht 149.9 cm (4' 11")  | Wt 83.9 kg (185 lb)  | SpO2 95%  | BMI 37.37 kg/m² CXR: No acute cardiothoracic process. Toradol given with improvement. Discharged home.
took 1st capsule on 26JAN93 & 26 hrs later devel fever of 102 & vomiting; no diarrhea & no skin react;
Patient c/o mild dizziness, nausea 10 minutes after FluMist administration.  Patient had one episode of vomiting 40 minutes post FluMist Vaccination.  Patient indicated she had some initial transient itching on chest and arms which resolved within minutes.  Denied SOB, blackout, tight throat, chest pain, itching, rash, or any other symptoms.  Symptoms of dizziness and nausea resolved within the hour with bed rest.  Provider stated symptoms consistent with vasovagal phenomenon following vaccination with FluMist.
Chills started around 3am. Mild fever started around 8am and it lasted  all day. Joints, muscle aches and headache all day. Acetaminophen helped with all of these, but I was in bed all day.
Patient presented to ED 3/25/21 and 3/26/21 and was subsequently admitted on 3/26/21.
Report 20010099371 described rash with itch in a 35 year old male who received hep B vaccine(Engerix-B). Reportedly, the vaccinee had no known drug allergies or medical history. He took no concomitant medications. On 04/18/2001, the vaccinee received his first "adult" left deltoid dose of Engerix-B. 17 hours later, he experiened a red rash with welts on the waist and bilateral lower extremities which itched. A physician visit was required. As of 04/19/2001, the events had not resolved.
Patient complained for headache, stomach pain and nauseous. patient fainted. Patient had chills and had eyes hurting. We put ice pack and took BP, medical and allergy info till EMS arrived. Just to be on safe side they recommended patient to go on ER.
about 11AM on date of vax pt began high pitched inconsolabled crying & screaming which lasted for about 28-30 hrs; fever up to 100 R began about same time & lasted 2-3 days; one thigh (mo doesn;t remember which was red & swollen beginning ;
sz approx 30min in length;adm to hosp ER;spinal tap x 2 performed;CSF results suggested poss underlying aseptic meningitis;T max 101.4 day p/admission recv 7 days IV/IM ATB;
induration w/exfoliation lt deltoid area; following flu shot;induration  = 60mm x 40mm
Swelling  Intense pain Burning sensation Itching around  injection site Raised red patch directly around injection site Headache Joint pain Tendinitis in affected arm
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient had radiating pain at injection site that traveled to kidneys for 2 weeks
Feeling  little hot; Shoulder is  hurting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling  little hot) and ARTHRALGIA (Shoulder is  hurting) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Feeling  little hot) and ARTHRALGIA (Shoulder is  hurting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, FEELING HOT (Feeling  little hot) and ARTHRALGIA (Shoulder is  hurting) outcome was unknown.            No concomitant medications were  reported Patient also used Ice for treatment
1) 1 cm X 2 cm erythematous induration on lateral thigh at site of immunixation X 2 days,  2) irritability X 2 days (nonstop crying), no fever, no URI symptoms, no other symptoms
Numbness, Felt cold and getting sick, coughing, headache, ears hurt, throught
Pt to ED 11/6 for SOB. Pt COVID+ 11/6. 11/10 pt expressing she was having difficulty breathing. Upon entry, pt was flat on the bed and cyanotic. 11/12 Pt is alert and oriented x4; able for follow commands, on 2.5L NC; no respiratory difficulties. 11/14 Pt intubated, is weaning but had thick yellow secretions earlier. 11/15Suspect resp failure due to pulm vasc congestion, possible bacterial pneumonia.  11/17 Pt remains on ventilator, is alert and oriented. 11/20 Remains on vent. VSS throughout shift. 11/23 Pt is intubated, following commands, nodding/gesturing appropriately, NSR on the monitor, and saturating in the upper 90s on the ventilator, denies pain/discomfort. PT expired 11/27.
At 12:30pm (10/22) patient had nausea & vomiting (x1) and headache. Patient then took TYLENOL. Later on patient had dizziness and some shortness of breath. The paramedics were called at 5:40pm, but the patient did not need to be transported. Via telephone on 11/2 patient was doing fine.
pt recvd DTP/OPV 20APR92; 2-4 hrs p/vax exp an inject site reaction which included swelling, erythema, induration; seen in office 23APR92; swelling was oval in shape & extended from under shoulder to elbow; afebrile; unk if tx initiated;
Dyshidrotic eczema On left arm started on ring finger and progressively got worse and still have it. I?ve never had eczema and neither has my family.
Body Tremors/tremors get worse when I feel cold; dizziness; headaches; balance issue; tremors get worse when I feel cold; I blurt out words for no reason; Eyes can't focus, when trying to read the words seem to be shaking; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm right on 11Jan2021 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 21Dec2020 (lot number: EH9899) for covid-19 immunisation. The patient experienced body tremors, dizziness, headaches, balance issue, tremors get worse when she feel cold, she blurt out words for no reason, eyes can't focus, when trying to read the words seem to be shaking on 18Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Dec2020, sars-cov-2 test: negative on 27Feb2021. There were no treatment received for the events. The patient did not recover from the events.; Sender's Comments: Based on the available information, causality between reported events and BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.  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.
Received immunizations at site at clinic.  2-3 hours later had temp 106.  Gave Tylenol & sponge bath.  Temp did not return.  Was being treated for ear infection.
pt seen on floor in prone position per staff pt lost consciouness for 9 secs. staff who witness the accident said pt slid down on chair and fell face forward vitals: 86/60 p-60 R-16 o2 98% offered food and fluids denied nausea vs bp 106/65 P-75 R-18 o2 98% RA t-98.1 at 337 pt verbalized no dizziness no headache able to move all extremitites without discomfort no vleedign on gums/mouth no change loc 347 BP104/63 P77 o2 99% pt parents will accompany pt to visit primary doc. clininc for further eval.
Pt recvd vax & following vax pt exp pain in shoulder & arthralgia; pt was treated w/Cortisone in joint;
Info has been received from an RN concerning a pt between the age of 6 to 8 years, who at the time of the 1st birthday, was vaccinated with a dose of varicella virus vaccine live. Between 9/04 and 12/04, the pt developed mild breakthrough cases of varicella. Unspecified medical attention was sought. There was no product quality complaint involved. No further info is expected.
This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. On an unknown date in July 2016 (reported as "within the last month") had an unusually large injection site reaction with redness and significant swelling. On an unspecified date, the patient sought medication attention. The patient had to apply ice packs to keep the swelling down and recovered from the events on an unknown date. The reporter did not provide the relatedness of the event with PNEUMOVAX 23. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients. On unknown dates, the patients were vaccinated with a dose of M-M-R II (lot number and expiration were not provided), 0.5 ml, subcutaneous. Other suspect therapies included VARIVAX (Merck) (lot number, expiration date unspecified) (both dose and route were not provided). It was reported that the patients cried after receiving M-M-R II and VARIVAX (Merck) because the vaccines caused burning at the injection site. The outcome of events was unknown. This is one of several reports received from the same source.  Additional information is not expected.
Pt went to ER 10-27-07 c/o left arm redness; ER doctor states;"pt has some erythema surrounding this with a sharply demarcated border consistent with mild cellulitis approximately 10 cm in diameter, no significant lymphadenopathy in area but dose have an indurated area in left axilla.