chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Excessive/prolonged Cough; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 13Sep2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team,. A 53-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 03Aug2022 as dose number unknown, 0.5 ml single (one time administration) (Lot number: FJ2607, Expiration Date: 31Aug2023) at the age of 53 years intramuscular (IM) for immunization (also reported as "patient reported cough"), Device Lot Number: FJ2607, Device Expiration Date: 31Aug2023. The patient's relevant medical history was not reported. The patient took concomitant medications (per patient take OTC drugs). The following information was reported: COUGH (non-serious) with onset 04Aug2022, outcome "not recovered", described as "Excessive/prolonged Cough". Therapeutic measures were not taken as a result of cough. Additional information:  A nurse reporting a temperature excursion with Prevnar 20 and wanted to get information about stability. Temperature excursion: The highest temperature was 8.7 Celsius for 15 minutes and the lowest temperature was 2 Celsius for one hour. The nurse wanted to know if the vaccine was still good to administer to patients. The lot numbers involved in the excursion were FJ2605, FJ2606, FJ2607. Prevnar 20 was administered to patients. Male and Female 40-70 years old. Administered to 21 patients in total. No complaints from any patients at this time. No side effects have been reported from the patients. Most of the patients received the Prevnar 20 after 13Jul2022. On 13Sep2022, the nurse reported that this patient experienced excessive cough. The patient only started prolonged cough after receiving vaccine. No rechallenge. There was no admission to hospital due to the event. No emergency room visit, no treatment received, no specific tests and no surgery required. The patient was not deceased. It was unknown if there was a reasonable possibility that the event was related to suspect product as assessed by the nurse; then later on the same follow-up, the same nurse reported that there is no reasonable possibility that the event is related to the suspect pro duct.  No follow-up attempts are needed. No further information is expected.  Follow-Up (19Sep2022): Follow-up attempts are completed. No further information is expected.
Pain in right arm, up shoulders and into neck at 7 PM 12/11/2001.
Shoulder, at site of injection, has been hurting to the point that it limits my daily activities.  The pain is chronic and usually about an 8 or 9 on the pain scale.
Several days after Varivax developed bumps that turned to blisters, then dried up. Continuous to get a new lesion almost daily on same area of left lower leg. Has been on antibiotic since 11/3/04 for BOM.
Received Pneumovax 23 vaccine in left shoulder (only vaccine given on that day). Approximately 4 hours after vaccination, shoulder was very swollen, hard and painful (joint and muscle pain), which limited movement of arm. Swelling decreased significantly on second day (arm still painful), but new symptom appeared overnight: a cellulitis-like reaction on front of upper arm (bicep area). Swelling of shoulder and redness and swelling of front of arm decreased on third day. Swelling of shoulder and redness and swelling of front of arm mostly resolved 4 days after injection, however, 4 weeks after injection, I am still experiencing some minor joint pain when moving arm across chest (no joint pain prior to injection).
Patient received a second Moderna Bivalent Booster. The first Moderna Bivalent booster was given on 10/18/22 at a local pharmacy, patient got a second Moderna Bivalent booster at an office visit on 12/7/2022.
In and out of consciousness, sweating, eye rolled back to head, feeling weak, double vision lasting about 10-15 minutes
Influenza vaccine was administered on 9/22/14. Patient began to experience increased pain with decreased ROM to left arm within 1 hour of administration. S/s have been getting worse.
No additional AE.; Improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a nurse referring a 44-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 21-SEP-2022, the patient was administered with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W002601 with expiration date 24-JAN-2024, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error), which had a temperature excursion of -11.8 celsius (C) for 1 hour 45 minutes 0 seconds; also, a previous temperature excursion happened. There was no additional adverse event reported.
Swelling, redness, itching,  warm to touch at injection site about 1 week after administration
Follow up info received from the physician provided vaccination date, lot number, admitting diagnosis, test results, and outcome. Info regarding Prevnar was received from an infectious disease physician regarding a 5 month old male who developed a respiratory syncytial virus infection and pneumococcal bacteremia. The infant received his first dose of Prevnar on 9/10/03, at 2 months of age. The infant was hospitalized on an unspecified date with a respiratory syncytial virus infection and then developed pneumococcal disease. Blood cultures performed on 12/7/03 and 12/9/03 were positive for Streptococcus pneumoniae serotype 19. The lab reported that they did not specifically test for serotype 19F. The physician indicated that a sample will be sent to CDC for serotyping. An immunologic workup was negative. The infant was admitted to the ICU and intubated. The physician reported the infant "survived and is doing well."
Systemic: Confusion-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Weakness-Mild. Additional Details: BP 110/62 Pulse Ox 90. Placed in rescue position and ambulance called. Patient is autistic and mother was with him. She stated he has anxiety.
By early summer 2021, pt reported having having SOB and decreased energy, difficulty with typical activities. Throughout the summer she reported progressive symptoms including lightheadedness, tightness in her chest with any actiity, generalized weakness and groggy, mild dull headaches.  She had syncopal episodes in September with 2 ER visits. Elevated D-dimer noted at that time. Sinus bradycardia/Ventricular standstill, complete AV block, Mod left ventricular hypertrophy were diagnosed; she underwent pacemaker placement on 09/21/23.  Following pacemaker placement, she continued to have spells , reporting being lightheaded or groggy, SOB, tightness in the chest. She had limited energy and minimal tolerance to activity.  Across continued visits and care with Cardiology and Pulmonology from fall 2021 to present the following additional diagnoses have been given: Chronic Diastolic right heart failure, Moderate persistent asthma, enlarged RV (mild), LA (mod) wall motion hypokinesia, moderate COPD. On ER visit in August 2022, CT revealed mild tortuous aorta, gallbladder lesion, renal cyst.  Treatment/Outcome no cardiac treatment or meds were provided. Pulmonologist prescribed nebulizer treatments, now pulmonary rehab. She continues to be limited in her activity with dyspnea on exertion and poor endurance.
Father noticed reaction one day after shots were given.  Area where shot was given is warm and red patient had no symptoms.
Large (2") red area around injection site, firm to the touch, not tender, arm muscle does ache, deeper red/purple color closer to site. Came to have it checked 10/01 in pharmacy.
This is in follow-up to report(s) previously submitted on 5/14/2007.  Information has been received from a registered nurse concerning a 26 year old female who on 27-JAN-2007 was vaccinated with Gardasil (lot number "0284U" also reported as 0284J.  invalid lot #). Concomitant therapy included SEASONIQUE. On 07-APR-2007 the patient experienced a 1 cm tender nodule at the injection site (deltoid muscle) after receiving her second dose of Gardasil.  IM in her left delotid on 03-APR-2007 (previously reported as 04-APR-2007). The patient's tender nodule persisted. The patient's outcome was unknown.  Additional information is not expected.
Per mom facial rash started 2 days after immunizations. Today 8/28/08, papular/macule rash to face, left forearm, palms itchy and rash on palms painful. Medication prescribed today diphenhydramine 12.5 mg = 5CC every 6 hours prn; hydrocortisone 2.5 % ointment TID follow-up in 1 week.
I had previously experienced  significant elevated blood pressure following the original Shingles (live) vaccine for about a week following the vaccine (180/103 and I am usually around 118/65). Doctor encouraged me to get the new Shingrix vaccines stating it was no longer a live virus and was much more effective so I did.  The week following the vaccine #1 I was at a dog show when I noticed I felt very groggy and had trouble thinking clearly. I put this off to not having eaten breakfast. Over the next few weeks I felt more tired than usual and was at work and stood up to help the Dr. (I am a dental assistant) and suddenly felt extremely dizzy, like I might pass out. This continued for the next 10-15 minutes and when we took my BP it was 185/108--highly unusual for me. I was taken to the ER where they ran several tests, bloodwork, EKG, etc. which all came back as normal and my BP gradually went back down to a more normal range. The elevated BP continued for 2-3 weeks (I was told to check it 2x/day). I also wore a monitor to record my heart rhythms for 2 wks to verify that I had no abnormal cardiac activity. I remembered having had elevated BP after receiving the original vaccine and while we can't be certain we are suspecting that this was again a longer, more drawn out reaction to the Shingrix vaccine. My MD has advised me not to get the 2nd dose due to the potential of this being a reaction to the vaccine.
2/14/07 Mother called in child has a reddened ring around the injection site approximately 1 inch in diameter. Child complain of itching of entire arm. Mother called doctor's office per RN request. Office recommended use of cortisone cream.
Bell?s palsy, systemic rash, allergic reaction. Patient woke up 02/27 with allergic reaction including copious mucus in nose and throat and coughing which lasted 1 hour +. When recovered somewhat patient?s left lower was swollen and it felt like she had received shot of Novocain. Symptoms resolved within about 2 hr after taking 25 mg Benadryl.  Sunday evening 2/28, patient noticed itchy rash over body (mostly torso and in ?hot spots?) and mild lip numbness also. She took more Benadryl thru the night (every 4hours) helped. Monday all were worse. So patient called her PCP  and they advised her to go to ER. She went to hospital. There she was diagnosed with post dose reaction to covid vaccine (Moderna) and given prednisone, albuturol inhaler and Pepcid prescriptions in addition to Benadryl around the clock.
on 12/17/19 I Obtained 2nd dose (shot) of Recombinant Zoster SHINGRIX at 0830 am at Dr. First dose there was only achy feel and sort arm where shot was administered. Began feeling "flu-like" at 5pm. At 8pm I felt flu like, feverish, achy, stomach ache and minor swollen lips ( not visible but felt it ) . I took 2 Benedryl and went to sleep .  At 0030 am on 12/18/19 I felt worse and had a solid (not dots) rash on Neck, Inside Elbows, inside forearm, Torso, armpits, thighs. At 0700am I felt worse and rash continued and slightly itchy but not enough to scratch. Took 2 tablets of Benedryl To date 12/19 the rash continues but flu like symptoms have subsided. On 12/19 I did notify my physician Dr I do get similar reactions to NSIADS, Zinc, Penecillin
Stuffy ears for 4  days so far which developed 2 days after 2nd dose of Maderna vaccine.  I feel like I have gone through a significant altitude change and there has been no way to "pop" my ears, through yawning, blowing out with nose plugged/mouth closed etc.  It's disorienting,  I had the typical fever/chills/general sick feeling for 2 days following vaccine. Not a huge deal in the scope of things but I figured I might as well report it.
Administered vaccine, Patient asked for some water, left to go get some, heard a noise, called patient's name and received no response, came back into room to patient going rigid and falling to floor hitting his head on the cabinet on the way down. I instructed my technician to dial 911 for medics. Patient was unconscious briefly and required medical assistance and brief hospitalization in E.D.
Within 15 minutes, both arms felt very heavy. I had a twitch in my left cheek. My eyelids were heavy. I felt extremely tired and I was afraid to go in the office conference room in case I fainted and no one would notice. I walked down the hall feeling as if I had a few alcoholic beverages, I was very nervous, I had no problem breathing. I was sorry that I had this flu injection. It was the first one that I had. I do not plan to have more. My symptoms lasted approximately one to one - and -  a half hours.
2/16/2022 patient presented to ER with SOB symptoms  for 4-5 days. Patient has a hx of COPD with a recent workup by pulmonology. Patient took a home Covid-19 test and tested positive on 2/14/2022 and tested positive again 2/16/2022 at Hospital.
Immediately after shot, strange head sensations--lightheaded, confused. A minute after that, a tight throat. After 30 minutes, I was released, though still had those symptoms the rest of that day. The EMT at the site thought I'd had a mild allergic response. 36 hours after the shot, I woke up itching a lot on my head, trunk, and arms. I saw no obvious rash (maybe a little mottling) or hives. I used a small dab of Benadryl cream on the itchiest spot. The symptoms disappeared  pretty soon.
headache, stuffy nose, fever 102 at home, nonproductive cough, chills. starting  11/20/21
Initial misuse report received on 11-Dec-2013 from a health care professional. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that a patient received underdose of PENTACEL vaccine. List of documents held by sender: none.
developed burning pain in the tips of the toes and the fingers; This is a spontaneous report from a contactable physician. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Mar2021(at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus (DMII), hypertension (HTN) and dyslipidemia (DLP), eggplant allergy, contrast allergy and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 04Mar2021, 12 hours after vaccination the patient developed burning pain in the tips of the toes and the fingers. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event burning pain in the tips of the toes and the fingers was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a female patient who on 23-MAR-2010 was vaccinated with the first 0.5mL dose of GARDASIL. On 24-MAR-2010 the patient woke up with a rash on her back. The patient had a doctor's appointment on 24-MAR-2010. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Pt reported to feel dizzy.  BP: 124/80, After 15min monitoring pt reports feeling better.  Pt left the facility, symptoms resolved.
About  4 hours after injection I started feeling pins and needles in my hands and then I started feeling it  all over. It would come and go.  A few days later it felt like burning, stinging and itchy.  I?m still getting it but not as frequently.  There?s no rash.   I?m concerned about getting a 2nd vaccine.   I know this could be related to the vaccine or anxiety.   I saw blogs that this happened to others after the Covid vaccine.
Lot # might also be GW0516, or FW0176 or FW0516, cannot tell from handwritten lot number from pharmacist). The first dose I did not have these issues, except I did have a burning sensation at the injection site about 30 minutes after injection. the burning sensation went away after 5 minutes and my arm was very sore for two days. After the second injection I did not have the burning sensation as with the first injection. Approximately 13 hours after the second shot I felt nausea starting and overall faintness. 12 hours after the injection I woke with a very bad headache, chills, every muscle in my body ached and  the headache was very bad. Temperature was 101. 24 hours after the injection temperature was down to 99. I drank lots of fluids, (juice and water, no caffeine), slept a lot. 48 hours after the injection temperature  was back to normal, most aches were only in my knee and elbow joints, muscles in my hands and feet
17 mo who developed fever, LAOM and acute tinnitus. Febrile seizure with onset of fever.
This is a spontaneous report from a contactable consumer (patient's friend) via Pfizer-sponsored program. A 42-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Aug 10, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The reporter called on behalf of her friend, who received the first dose on Aug 10, 2021 and experienced headache, dizziness, injection site pain, and nausea. The reporter stated patient was still dizzy with a slight headache and asked if we can recommend something like Dramamine for him to take. Reporter stated she already knew these are reported reactions from the papers they gave her for 1-3 days. The outcome of dizzy and slight headache events: not recovered; and the outcome of other events: unknown. Information on the lot/batch number requested.
syncope, dizzy, lightheaded, nausea, low grade fever, slight chills, shivering, slight headache
Redness, swelling, warmth skin condition, arm pain. TX: Methylprednisolone; Ranitidine.
One day, post vax, pt developed localized swelling of the leg around vaccine site. Swelling was 8cm in diameter and itchy. Treated with Benadryl.
Swelling of my taste buds and feeling of something constantly on my tongue.  Sometimes waking up with a "necrotic tongue"  Need to swish water in order to be able to move my tongue.  Loss of sensitivity in the AM.  Very irritating in the PM.  Feels like I keep getting pieces of dead skin in my mouth
RIGHT SIDED CHEST PAIN, NOT EXCRUCIATING, BUT LASTING 90-120 MINUTES; TENSION IN CHEST; CHILLS; FEVER; This spontaneous report received from a patient concerned a 21 year old male. 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced right sided chest pain, not excruciating, but lasting 90-120 minutes. On 07-APR-2021, the subject experienced tension in chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right sided chest pain, not excruciating, but lasting 90-120 minutes, fever, tension in chest, and chills. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
After the shot, my arm was hurting for a couple of days. It hurt the most of all my shots but nothing to really complain about. In July I contracted Covid. I have coughing, a severe headache, joint aching, chills, and runny nose. What got me to test was the headache because the headache was the thing that stood out the most. My doctor prescribed me Paxlovid and I am currently on day 2. My symptoms are going down a bit since the first day.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6207), on 02Apr2021 as dose 2, single (Lot number: ER8734), on 04Oct2021 as dose 3 (booster), single (Lot number: FF2587) and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing); "HIV+ 30 years" (unspecified if ongoing), notes: HIV+ 30 years. Concomitant medication(s) included: METOPROLOL; SYMTUZA; TIVICAY; VALTREX. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Oct2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: After Paxlovid done, tested neg for 5 days; (unspecified date) Positive, notes: Started testing pos 2 days after that; (05Oct2022) Positive, notes: Started Paxlovid on 1st day of symptoms/testing pos. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information:  Started Paxlovid on 1st day of symptoms/testing pos. Symptoms went away after 3 days. After Paxlovid done, tested neg for 5 days. Symptoms came back on 6th day. Started testing pos 2 days after that. On 5th day of symptoms- feeling sick. Congestion, headache, lots of sneezing and runny nose. Much worse than before the Paxlovid. Still in the thick of it - hopefully better soon.
Complained of headache and nausea about 10 minutes after vaccination.  BP in right arm 211/132, left arm 197/138.  She denied history of high blood pressure but did not know all her meds and is a poor historian.   BG- 344, had burrito earlier in day with meat and cheese.  Denies changes in vision. Outcome- sent out to local hospital for evaluation of hypertensive urgency