chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the pain; she did get shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "got the pain"; HERPES ZOSTER (non-serious), outcome "unknown", described as "she did get shingles".  Additional information : When probed if the concern is with Pfizer COVID-19 2nd dose: Consumer stated that consumer actually talked to his/her friend whose daughter in law had Pfizer 1st and 2nd injections and she not only got the pain but she did get shingles (Further clarifications unknown) so may be those are two things that CDC or you who ever needs to know, because that was the only person consumer talked to was her and it's about her daughter in law so but they should probably know that is the real possibility of that like what people can experience. When probed if consumer has any details about the friend's daughter in law: Consumer stated could tell her to do that but consumer can tell her to report if you think if it is necessary.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician and refers to a 2-year-old male patient. No information about patient's concomitant medication, pertinent medical history, drug reactions or allergies was provided. On 13-JUL-2015, the patient indicated for a dose of hepatitis A vaccine, but inadvertently received a dose of GARDASIL intramuscularly (dose, lot# and expiration date not reported). No adverse experience was reported. Additional information has been requested.
c/o of red, swollen, eyes, stuffy nose; no resp distress; (mom called clinic & reported sx; uncertain whether sx are MMR-related; instructed mom to apply cool compresses every 2-3 hrs (to eyes) & give DPH;
POSITIVE COVID-19 RESULTING IN HOSPITALIZATION, SHORTNESS OF BREATH, HYPOXIA
sick; awful gastric stomach pain; loose bowels; very tired; sharp pain in eye/Eyes hurt to touch; developed a stye on her left eye/developed stye on my right eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (sharp pain in eye/Eyes hurt to touch), HORDEOLUM (developed a stye on her left eye/developed stye on my right eye), ILLNESS (sick), ABDOMINAL PAIN UPPER (awful gastric stomach pain) and DIARRHOEA (loose bowels) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer. Concomitant products included DICLOFENAC (VOLTAREN [DICLOFENAC]) for Arthritis, PARACETAMOL (TYLENOL) for an unknown indication.   On 26-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced EYE PAIN (sharp pain in eye/Eyes hurt to touch) and FATIGUE (very tired). 27-Mar-2021, the patient experienced HORDEOLUM (developed a stye on her left eye/developed stye on my right eye). On an unknown date, the patient experienced ILLNESS (sick), ABDOMINAL PAIN UPPER (awful gastric stomach pain) and DIARRHOEA (loose bowels). At the time of the report, EYE PAIN (sharp pain in eye/Eyes hurt to touch) had not resolved, HORDEOLUM (developed a stye on her left eye/developed stye on my right eye) and FATIGUE (very tired) had resolved and ILLNESS (sick), ABDOMINAL PAIN UPPER (awful gastric stomach pain) and DIARRHOEA (loose bowels) outcome was unknown.            No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-067715 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up received on 01-Jun-2021 content significant information. Dosage information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067715:Dose 1
patient has a history of minor allergic reactions.  She developed some difficulty swallowing and tightness in throat.  She was not in distress and requested oral benadryl as this has worked for her in the past.  Vitals monitored, benadry given 50MG PO.  Patient improved over 45 minutes.  Returned to work with instructions to report to ER if symptoms return.
Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.            .No concomitant medications were reported.  Treatment medications were not provided by the reporter.
patient received a dose of PNEUMOV AX 23 and developed "egg sized swelling" near the injection site.; This spontaneous report was received from a Registered Nurse concerning a 65 years old female patient. The patient had none pertinent medical history or concurrent conditions. Her drug reactions and allergies included azithromycin (ZITHROMAX) and sulfamethoxazole, trimethoprim (BACTRIM). The patient's concomitant therapies included albuterol, dupilumab (DUPIXENT), fluticasone propionate (FLONASE), fluticasone propionate, salmeterol xinafoate (ADVAIR), hydrochlorothiazide, lisinopril, omeprazole (PRILOSEC), tiotropium bromide (SPIRIVA) and zoledronic acid (RECLAST).  On 15-JUL-2019, the patient was vaccinated with one dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, for prophylaxis (Lot No. R031810 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date not reported, but upon internal validation established as 02-SEP-2020) On the same date, the patient developed "egg sized swelling" near the injection site. The patient didn't seek medical attention, received any treatment or laboratory diagnostics or studies were performed for the adverse event.  On 18-JUL-2019, the patient recovered from egg sized swelling near the injection site.  The causal relationship between the Injection site swelling and therapy with of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Patient has swelling of the left arm along with redness and tightness of the muscle. Also, a rash has developed on the side of the torso.  Symptoms and signs appeared within 24 hrs. of the vaccination.
Fever of 99.9 (for 2 days), flu-like symptoms, swollen red eyes and congestion. Broke-out in rash around neck, back, elbow creases, arms and chest.
Headache, extreme fatigue, nasal congestion, soreness at injection site, brain fog.
The report had been received from a consumer via Vaccine Adverse Event Reporting System (VAERS). The report concerns a 50 years old male patient. The patient's medical history included headache, lethargy and back pain. The patient's concurrent disease included anxiety. The patient's wife and son had 'stomach bug' (gas, bloating, diarrhea) in mid December. Concomitant medications included trazodone. On 29-Dec-2004, the patient received FLUMIST (intranasal). 29-Dec-2004, he developed leg pain, weakness and numbness starting 01-Jan-2005. He was evaluated in PMP on 06-Jan-2005 and admitted w suspected onset of GBS. Exam revealed decreased reflexes and increased CSF protein. Final diagnosis: Guillain-Barre syndrome and spinal headache. He was evaluated and treated by neurologist given 4 courses of plasmapheresis, symptoms improved and was discharged home 13-Jan-2005 with outpatient rehab and Neuro followup. At the time of reporting, the event of Guillain Barre synd and spinal headache was ongoing. The event of spinal headache had been identified from the source document and added as an adverse event by the company physician. The previous events of myalgia, myasthenia and paraesthesia were omitted, because they are symptoms of Guillain Barre syndrome. According to the reporter the event of Guillain Barre syndrome was considered as serious with the serious criteria of hospitalization and the company physician considered the event of spinal headache to serious with the serious criteria of hospitalization. Summary of follow-up information received by AstraZeneca/MedImmune on 25-Feb-2015 from consumer via VAERS: new event of spinal headache added, event of myalgia, myasthenia and paraesthesia were omitted, because they are symptoms of Guillain Barre syndrome, event of Guillain Barre syndrome outcome updated, concomitant disease and relevant history added, narrative updated. Corrected report: FLUMIST route and formulation added, action taken with FLUMIST added, administered by added, other reporter deleted, case unsuppressed, narrative updated.
IM given in left arm 3rd dose. (Booster).  Moderna COVID-19 Vaccine Lot 045C21A given was removed from freezer on 10/6/2021 @ 11:45AM.  Given on 11/5/2021, out of time range. Patient contacted that evening. Moderan manufacturer called. Patients called the following Monday letting them know that MODERNA was looking into this and would be getting back to us. Also let them know I would be following up on them once we heard back from them. Called patient today 11/17/2021 and let him know that Moderan let us know the vaccine was viable, no additional booster vaccine is required.
Her left upper arm swollen red/fever, arm double in size. Swelling starts from over top of shoulder to lower elbow. neck pain. Face a little swollen, head hurts, cold sweats, pain in arm, and some nausea. Some little bumps
Fatigue, malaise, and mild body aches from about 12 hours to 36 hours post vaccine. Then, starting about 4 days post vaccination, noted 2 enlarged (1-2cm) right axillary lymph nodes  and 1 tender 2-3cm enlarged supraclavixular lymph node.   These lymph nodes are on the same side and area that the vaccine was received.   It is 7 days post vaccine and the nodes persist but are less tender.
8/17/21: presents to the ED with complaints of COVID-19 symptoms. had persistent cough for the past  couple of weeks and she tested positive for coronavirus on Saturday (08/14). Her PCP prescribed her po steroids, azithromycin and benzonatate on the same day, she is complaint with medications. But her cough is not getting any better and she developed fever and SOB for the past 2 days, so she decided to go to ED for further treatment.  She received both doses of the Pfizer COVID-19 vaccine; First Dose: 01/29/21 Lot Number EL1283; Second Dose: 02/19/21 Lot Number EL9262 Diagnosed with: sepsis w/fever, tachycardia and COVID pneumonia, mild hypoxic resp failure 8/19/21: patient discharged
Information has been received from a consumer concerning her husband's uncle who was vaccinated with a dose of MMR II. The reporter stated that the patient "passed out and quit breathing" after getting MMR II. This is one of several reports received from the same source. Upon internal review "quit breathing" was determined to be an other important medical event. Additional information is not available.
July 24, 2001, Patient had a ?spell? where she felt sick, went to the restroom in case she threw up and was found out of it on the floor by her sister.  I, Mom, got to her shortly after and she was very disoriented and pale.  After approximately 30 minutes she returned to normal, but had no recollection of the event.  The second episode was in November while she was at work.  She went into the bathroom feeling sick again and her coworkers could not get her to respond while beating on the door.  She came ours approximately 40 minutes later with no memory of what happened.  The third episode was 12/21/21. She woke up at 9 am when her alarm went off and went to the bathroom, gelling sick once again.  Her roommate heard a thud and got to her to witness her convulsing on the bathroom floor.  She hit her head, and hip.  She lost control of her bladder and bit her tongue. She would not respond to he roommate. 911 was called and she was transported to the hospital.  Her first memory is being in the hospital.  They treated her for dehydration and sent her home.  The fourth episode was February 9, 2022.  Same scenario as in December, except it was at 2am. Woke up feeling sick, went to restroom, roommate heard her fall and found her on the floor.  She seized for several minutes and then went into a deep sleep.
Both ears started to bother me. When I woke up I had airplane ear and feeling and ringing in my ears. I went to the doctor and he said I had fluid in both of my ears. I had acute serous tinnitus in both ears without rupture. He said I can treat it with AFRIN nasal spray. It is getting a little better but not 100 percent. Yesterday I had aches and chills.
Covid positive test; Covid positive test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  Other medication was received in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had shortness of breath for almost a month afterwards; I had a lot of phlegm; I had a lot of redness; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 16Jun2021 12:00 (at the age of 34-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma. There were no concomitant medications. Patient did not receive any other vaccine in four weeks or other medication in two weeks. Patient had no known allergies. It was unknown if patient was pregnant at the time of vaccination. Patient reported that on 17Jun2021 at 01:00, I had shortness of breath for almost a month afterwards. I had a lot of phlegm. when I put a magnet against my arm it fights against the magnet, I had a lot of redness. The AE resulted in emergency room/department or urgent care. Patient received treatment of Inhaler and mucinex dm, and antibiotics. Patient did not had covid prior vaccination and not covid tested post vaccination. The outcome of the event was recovered with sequel on an unspecified date on 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
vaccine reaction.  Patient received 2nd COVID vaccine x 1 week ago. Reports chest tightness and SOB x 1 week and dry cough x 1 day. Reports intermittent body aches and nausea. Denies fever and known contacts. CC: malaise, chest tightness, dyspnea with pleurisy  HPI: 23yo F presenting to ED for evaluation of the above symptoms that have been constant since receiving her second COVID vaccine 7 days ago. The chest tightness has no palliating/provoking factors, no associated N/V or diaphoresis, no radiation of pain. She has no cough, no hemoptysis, no fever. There is no chest pain when supine. Pt states she has some chest discomfort with inspiration. She has no traditional risk factors for PE. She has no ACS risk factor
Information has been received from a physician concerning an 18 year old female with a history of severe scoliosis and histiocytosis x at age 1 who in September 2007, was vaccinated with the first dose of GARDASIL.  In March 2008, the patient was vaccinated with the third 0.5 ml dose of GARDASIL.  The patient experienced ataxia after receiving all three dose of GARDASIL, her speech was slurred and slowed and she was hyper reflexic with present Babinskis bilaterally.  The ataxia started and worsened about the time she started the GARDASIL.  Neurologist had no diagnosis.  At time of reporting patient outcome was not recovered.  Unspecified medical attention was sought.  Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2017, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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 is unknown. Additional information has been requested.
Patient received PREVNAR 13 vaccine Thurs 10/22/15. Developed baseball sized rash at injection site over weekend. Reported to pharmacy on 10/26/15. Advised to the diphenhydramine and contact MD. MD advised same treatment.
Hot, itchy, red rash on neck and chest started with small patch on neck at 10am then by 3pm whole chest and more of neck had rash  Took one benedryl (25mg) and used cortisone 10 topically on area
Extreme fatigue; Angioedema on soles of both feet; Itchiness; Rash on lower part of right wrist; Rash on the front part of the arm/anterior part of arm; Feet swelling; Fatigue; A spontaneous report was received from a consumer who is a 47-year-old, female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema, rash and pruritus.  The patient's medical history was not provided by the reporter. Concomitant medications reported included vitamins.   On 25-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27-Jan-2021, the patient reported having rash on lower part of right wrist and arm, fatigue, feet swelling, itchiness and angioedema itchy (angioedema).  On 22-Feb-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25-Feb-2021, the patient reported having rash on the front part of the arm/anterior part of arm, extreme fatigue, itchiness, burning rash (not hives).  No lab details were mentioned.  Treatment for the events included Benadryl as instructed by her health care professional.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, angioedema, rash and pruritus, were considered unknown or not reported.  The event angioedema was deemed medically significant.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. Patient presented severe pain at site of injection that limited movement as well as fever, malaise and fatigue.
Initial report received from a consumer on 30 November 2010. A male patient (age not reported) received in October 2010 a left arm injection (route not reported) of INFLUENZA VACCINE, lot number not reported. The patient's medical history was not provided. The patient received the injection in the left arm and the next day developed pain in the arm and shoulder of the right arm with muscle tingling. The pain continued for two weeks. The patient had seen a health care provider (HCP) and was diagnosed with Parsonage-Turner Syndrome. The patient's identifiers was declined to be given by reporter who also had no further information to report and did not want any future contact. The outcome was reported as unknown. Documents held by sender: None.
Took me days to learn how to walk; Fuzziness the spinning of my head; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Took me days to learn how to walk), DIZZINESS (Fuzziness the spinning of my head) and PYREXIA (Fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Took me days to learn how to walk), DIZZINESS (Fuzziness the spinning of my head) and PYREXIA (Fever). At the time of the report, GAIT DISTURBANCE (Took me days to learn how to walk), DIZZINESS (Fuzziness the spinning of my head) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104.         Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication information was provided No treatment medication information was provided   This case was linked to MOD-2021-137978 (Patient Link).