chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I tested positive for COVID-19 on 1/31/23. I had very mild symptoms. I had a headache, congestion, and some body aches. I contacted my doctor and was prescribed PAXLOVID. I felt better after taking PAXLOVID.
I received a call from the a representative at the Pharmacy stating that the had given an EXPIRED Vaccine to my daughter. He wanted us to come back into the store and get another shot. I was so unset. I need minute to get my self together. He went on to say that i could bring her back in 6/8/2021 the same day of the expired vaccine was given. However, he would recommend that I give it a day or two before  bringing her back in. Also, while on the call he did apologize and said that the best thing he could is offer me a GIFT CARD!!. I felt to say that to a parent who?s daughter was just given an expired vaccines was totally unprofessional and insulting.
Severe and worsening brain fog. Inability to think. Struggle with basic tasks. Short term memory completely gone. Trouble completing a conversation.
she hadn't had much of an appetite; was queasy; achy; a little down in the dumps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 34-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEPRESSED MOOD (non-serious) with onset 01Nov2023, outcome "unknown", described as "a little down in the dumps"; PAIN (non-serious) with onset 01Nov2023, outcome "unknown", described as "achy"; DECREASED APPETITE (non-serious) with onset 01Nov2023, outcome "unknown", described as "she hadn't had much of an appetite"; NAUSEA (non-serious) with onset 01Nov2023, outcome "unknown", described as "was queasy".  Additional information: Reporter's daughter had the vaccine yesterday (01Nov2023) and she hadn't had much of an appetite, was queasy, achy, a little down in the dumps.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Narrative:  The patient received the Pfizer COVID 19 Vaccine Jan/Feb 21. The patient tested positive for COVID 19 on 30 July 2021 and was hospitalized on 29 July 2021 with hypoxemia, weakness, and fever. The patient's condition did not improve and the patient died of COVID pneumonia on 5 August 2021. The EUA requires that any patients that tested positive for COVID 19 and required hospitalization after receiving the vaccine must be reported.
Difficulty breathing, sputum, cough, chest pain, tiredness initially. BP raised, HR raised. Later, only sputum and tiredness. (One-two weeks after).
73 yr old female tripped and fell onto right side. Client  was examined and declined ambulance.
Onset of palpitations within 2 hours of receiving second dose leading to a diagnosis and treatment of SVT with Adenosine that same day.
hospitalized and diagnosed with guillain barre syndrome; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a non-healthcare professional.  This case involves a 15-month-old female patient who was hospitalized and diagnosed with guillain barre syndrome after receiving vaccines PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Jan-2023, the patient received suspects DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, PREVNAR not produced by Sanofi Pasteur and PROQUAD not produced by Sanofi Pasteur (strength, formulation, route, dose, lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination (Immunisation).  On 20-Jan-2023, the patient developed a serious event of hospitalized and diagnosed with guillain barre syndrome (guillain-barre syndrome) same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, PROQUAD and PREVNAR. This event was assessed as medically significant, and patient was hospitalized due to this event.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) was not applicable.  It was not reported if the patient received a corrective treatment for the event (hospitalized and diagnosed with guillain barre syndrome).  At time of reporting, the outcome was Unknown for the event hospitalized and diagnosed with guillain barre syndrome.; Sender's Comments: Sanofi company comment dated 16-Feb-2023: This case involves a 15-month-old female patient who was hospitalized and diagnosed with guillain barre syndrome after receiving vaccines PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. Based upon the reported information, the role of vaccine cannot be assessed. Additional information regarding additional risk factor, medical treatment, underlying conditions and family history, concomitant medications excluding other predisposing etiologies would be needed for complete assessment of the case.
First / vaccine in / 6/26/2018 / Second dose / not yet received; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 26th June 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacy Intern reported that, till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to  incomplete course of vaccination. The lot number and expiration date were unknown for 1st dose. The reporter consented to follow up.
Persistent L upper arm pain since second dose Moderna on 3/5/21.  Initially pain 8/10, now 2/10 still having localized pain with touch and raising L arm over head.  No redness or warmth.  Patient believes the vaccine was given in too high in the arm and wasn't given correctly.  Physical findings seem to suggest that patient's second Moderna vaccine given on 3/5/21 was given in the L Subacromial bursa and not in the Deltoid muscle
within 15 minutes of vaccine being administered patient began complaining of tingling in hands and the feeling going up her arms bilaterally.  Patients hands and face were red and blotchy denied them feeling itchy.  BP was checked and reported to be elevated from patients normal.  Medic was on the floor and ran the situation, a blood sugar was obtained and BP continuously monitored.  After another 20 minutes patient was hesitant to go to ER, since symptoms were subside.  Within an additional 10 minutes patient requested to be taken to the ER via ambulance due to symptoms returning in addition to tingling in lips and BP spiking again.
At approximately 11:45 pm the same day I received my second Moderna injection for Covid, I woke up from sleep shivering uncontrollably. I felt like I was chilled to the bone and was shivering so hard my muscles all felt contracted. I did not have a fever at this time. I got extra blankets and tuned heat up and over next 45 minutes managed to decrease shivering. Around this time, I rechecked my temperature and had a fever of 101.7. I used tylenol and later motrin as the fever kept rising. I was in and out of sleep with severe body aches, arm pain at site of injection, and increasing fever even after taking ibuprofen an hour later. My temp eventually reached a max of 104.5 at which point I uncovered myself and got ice packs for my head and neck. I managed to get my fever down to about 102.6 and it stayed in that range until about 445am the next morning. I was finally able to get a little rest. When I woke at 815am, my fever was 100.5. From there, the more notable issues were the intense body and joint pains and skin sensitivity along with increasing arm pain at site of injection. My fever managed to stay low grade around 99.5 throughout the day but then started increasing again in the evening. At about 500pm, it was at 100.8. I took more medication to reduce it and was unable to sleep until about 2am still from the pain. I then slept for approx 6 hours into Sunday morning,  today, and have had no fever. I am improving with pains, but have noticed red blotchy areas near my injection site which still hurts immensely but is tolerable.
Got the shot....soon after I got shingles./Had the shot..a week later I had shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received Shingles vaccine and a week later experienced shingles. The follow up would not be possible as no contact details were available.
Hives and swelling to face and chest. Shot given 10/3/18. Called for seeking treatment on 10/5/18. Sent to work comp MD. Dx: urticaria OTC, BENADRYL. No follow up, released.
On 12/6/00, red, swollen and hot area, with temperature of 100.3F. Has nausea and feels bad. Treated with Keflex. On 12/13/00, pt doing well.
Developed one-sided facial palsy with a significant droop that affected the eye early in February of 2009.  Went to ER. Significant change in sensation on affected side also.  Treated with steroids and eye drops.  Affected eye was taped shut during the severe portion of illness.  As of 3-31-09, no further drooping but some sensation change persisting.
Immediately post vax, the pt reported developing joint and muscle pain. The pain went away after several days. Unspecified medical attention was sought.
A spontaneous report was received on 14-NOV-2014 from a female consumer (age not specified) concerning herself. On 08-NOV-2013, the patient received ZOSTAVAX (route not specified). She stated she has never had the chickenpox. Concomitant medications were not specified. Less than a week after she received the ZOSTAVAX, she developed red blotches on her upper body and she experienced burning and itching until January 2014. The patient reported she still has the itching and the burning mainly on her back but some of the red blotches have gone away. She sought medical attention and received unspecified treatment. Additional information has been requested.
felt so hot at the injection site; sore arm - left arm; Moderna arm - hives at the injection site; arm hurt so bad - left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (felt so hot at the injection site), PAIN IN EXTREMITY (sore arm - left arm), INJECTION SITE URTICARIA (Moderna arm - hives at the injection site) and INJECTION SITE PAIN (arm hurt so bad - left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L70A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Levaquin caused swollen lips), Allergy to antibiotic (Augmentin Levaquin caused swollen lips) and Hay fever. Concomitant products included LOSARTAN, METOPROLOL, ALENDRONATE SODIUM (ALENDRONATE), OXYBUTYNIN and BUPROPION for an unknown indication.   On 01-Feb-2021 at 11:45 AM, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Feb-2021, the patient experienced INJECTION SITE WARMTH (felt so hot at the injection site), PAIN IN EXTREMITY (sore arm - left arm), INJECTION SITE URTICARIA (Moderna arm - hives at the injection site) and INJECTION SITE PAIN (arm hurt so bad - left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Feb-2021, INJECTION SITE WARMTH (felt so hot at the injection site), PAIN IN EXTREMITY (sore arm - left arm), INJECTION SITE URTICARIA (Moderna arm - hives at the injection site) and INJECTION SITE PAIN (arm hurt so bad - left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Treatment medications included ice pack, itch cream on the hives when itched.   This case was linked to MOD-2021-023271 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Added relevant medical history, concomitant  and treatment medications and the events outcome changed from unknown to recovered with  added stop date.
Husband stated about 1 week after flu shots wife "lost interest in daily activities, didn't feel good-acted like she was overdoses.
Numbness of neck/shoulders, face, lips, hands and slightly at chest.  Also strange tingling sensation and slight itching in those areas. Numbness would come and go at different times from day to day. Symptoms seemed to peak after about 6-8 weeks and then lessened and lessened. Achy allover too.
8/30/21 6pm.  Cold chills, shivering, temp. 100, weakness, uneasy on feet. 9/1/21                  In bed all day, temp. 102, weak, uneasy on feet, lost taste, voice high pitched, hearing diminished, slept all day. 9/2/21                  Feeling better, temp. 100.4, walking better, voice cleared up, hearing better, still showing signs of weakness
had injection site soreness for a few days which resolve. 5 days after injection developed pain R upper arm and shoulder with limited R.O.M. Saw P.C.P today and he diagnosed employee with bicep tendonitis. Treated with ibuprofen.
Information has been received from an investigator regarding a 15 month old male who received his 1st dose of Prevnar as part of the part of a post marketing safety trial on 6/29/00. The next day, the pt was seen in the clinic for angioedema and urticaria. He recovered. Angioedema is considered "Medically Important". Both the investigator and medical monitor agree that these events are probably related to vaccine administration.
Varicella lesions (5-10) appeared on neck, back,R arm 8 days after vaccine.
Patient's daughter called today wanting to report an adverse event that she believed was related to mother's covid vaccine. Patient received first vaccine 3/27 and on 4/4 had to go to the ER with severe dizziness. This incident was not reported to the pharmcay until today. Patient received 2nd dose on 4/28. On 4/29, the ambulance was called by patient's husband because the patient had passed out. When she got to the ER, they determined that the patient had a seizure and she was admitted to the ICU. The patient does not have any history of seizures. She is still currently in the hospital but was moved to a regular room on 5/10 or 5/11 (daughter did not know the exact date). She is still having effects such as cannot feed herself and daughter said that communication is VERY limited.
The pt was vaccinated on 2/11/03 at 16:40. One hour, post vax, she stated she had an increase in heart rate (to about 100) and felt flush on her chest. She stated that she had this "funny" feeling for 2 minutes. She stated that since the initial episode, she has had chest pressure/heaviness across the top of her chest (not angina/pain). Over the last month the symptoms have increased and as of last week, it woke her out of a sleep. She had a visit to her PCP who did a CXR and EKG and both were normal. Last night, 3/27/03, she was awakened with this pressure and has made an additional appt. for her doctor.
had the flu shot and then got the flu; severe dehydration; Could not walk; been sick for 4 weeks; Initial information received  on 25-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case is linked to case 2022SA521395.  This case involves an unknown age Female patient who had the flu shot and then got the flu, severe dehydration, could not walk and been sick for 4 weeks while receiving vaccine Influenza Vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, expiry date, dose, strength, form was not reported) not reported via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a serious had the flu shot and then got the flu (influenza) (unknown latency) following the administration of Influenza Vaccine. The patient was hospitalized for this event. On an unknown date the patient developed a non-serious severe dehydration (dehydration), could not walk (gait inability) and been sick for 4 weeks (illness) (unknown latency) following the administration of Influenza Vaccine.  The lab data was not reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.   At time of reporting, the outcome was Recovered / Resolved on an unknown date for the events.; Sender's Comments: Sanofi company comment for information received on 27-Dec-2022: This case involves an unknown age Female patient who had the flu shot and then got the flu, severe dehydration, could not walk and been sick for 4 weeks while receiving vaccine Influenza Vaccine. Further information regarding medical history, concurrent condition during vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
This spontaneous report as received from a pharmacist refers to a 59 year old female patient. The patient had no medical history and no allergy history. On 18-OCT-2016 the patient was vaccinated with ZOSTAVAX (dose and frequency were not reported, lot # M001747, exp 07-APR-2016 subcutaneously). The pharmacist reports that while he was administering the vaccine, the unspecified patient reported "discomfort", and the pharmacist also noted that the injection site began to "bubble". The "bubble" around the injection as being "as big as a pinky finger nail". The pharmacist "put a bandaid on the area and instructed the unspecified patient to "ice the area". The "the bubble was diminishing by the time she left the Pharmacy", but the pharmacist did not know if the symptoms fully resolved. No lab diagnostics was given. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
IPOL vaccine was given to a child one day after expiration with no adverse event; Initial information was received on 09-Dec-2020 regarding an unsolicited valid non-serious case from a nurse via regulatory authority (Reference number- 00386646) via call center.  This case involves a 04-years-old male patient who was vaccinated with expired vaccine (expired vaccine used), IPV (VERO) [IPOL] on 08-Dec-2020 (lot number: P1F54 and expiry date: 07-Dec-2020) at 0.5 ml dose via intramuscular route in the left arm for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications were not reported.  This was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
No adverse events observed. But due to miscommunication patient was given FLUAD. He wanted to get pneumonia shot. Patient already had one flu shot for the season 2017/2018.
pt recv vax 22OCt97 3PM & 4PM had h/a, didn't feel good was very hot but did not take temp;had loss of appetite;body itched that evening next morning;noticed rash on stomach;next day rash on sides of neck;legs marbled looking but no rash
I woke up with lung pain when taking a deep breath, sharp pain in my chest and lungs. I got hold of my cardiologist and he said to take Ibuprofen 3-4 times a day. The Ibuprofen really helped right away and after the holiday weekend I did not have lung pain but I did have the chest pain. I then went to see my PCP after the holiday weekend, she told me to continue taking Ibuprofen, the suggestion was that I might of had pleurisy. I then began to take Ibuprofen when I started to feel chest pain, around my heart area and because of my pace maker. I felt lousy for the month of June. I also had few days of low grade fever which went away. On the first week of July, I feel like I am coming out of a fog and stopped taking Ibuprofen on 07-07-2021 and I have been fine ever since I had lab work, echocardiogram, EKG and all my tests show I was fighting off something.  I did not get tested for Covid. I felt like almost I had the flu, fever, body aches. Been to doctor but no diagnosis. I feel fine for over a week and a half now. All my symptoms happened 6 weeks post vaccination.
Pt had an 11cm X 11.5cm area of redness with inflammation. The area was hot to the touch, hard to the touch and she complained of pain with palpation and with rest. ROM without changes. Afebrile.
Patient received expired Pfizer Covid Vaccination 5 days after expiration date.  No Adverse Reactions reported.  No treatments given.