chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STAGE 3 KIDNEY DISEASE; This spontaneous report received from a patient concerned an 80 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included: abstains from alcohol, non smoker, lactose intolerance, penicillin allergy, and gallstones (awaiting for surgery). The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808982 and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 12-APR-2021 on left arm for prophylactic vaccination. Concomitant medications included gabapentin, levocetirizine, levothyroxine, Singulair (montelukast sodium), methocarbamol and rosuvastatin for drug used for unknown indication.  On 19-MAY-2021, following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1), the patient experienced stage 3 kidney disease (back pain on right side above hip and discomfort subsumed under stage 3 kidney disease). Patient also reported that 2 days prior to getting the booster, that "shet felt some discomfort and pain from the kidney disease when I bought a car from that lady". Laboratory data included: Estimated glomerular filtration rate (NR: not provided) 32 mL/min. On 20-OCT-2021, Laboratory data included: Estimated glomerular filtration rate (NR: not provided) 63 mL/min. She was glad that her kidney function has been improved from 32 to 63ml/min. On an unspecified date, Patient was frustrated that for 5 months from her first blood test she had been eating bananas, tomatoes, avocadoes, potatoes that would hurt her kidneys and her potassium levels were also quite high. Laboratory data (dates unspecified) included: Potassium level (NR: not provided) High. She did not receive any medications for her back pain or stage 3 kidney disease. Patient was also under the care of a kidney care nephrologist associate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported and batch number: 1808982) dose was not reported, 1 total, administered on 29-OCT-2021 in left arm and on same day received the flu shot into her right arm. It was unknown whether patient had any adverse events following vaccination with booster dose of covid-19 vaccine ad26.cov2.s. The outcome of stage 3 kidney disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220100154-covid-19 vaccine ad26.cov2.s-stage 3 kidney disease. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Redness, warmth, tenderness and swelling (L) upper arm. Temp: 99.7. 1/27/16: Seen by staff. Dx. cellulitis and treated with cephalexin. TYLENOL and Ibuprofen for discomfort. Mother here with daughter for re-eval,. from 1/27/16. Mother states, she still has swelling, and pain. But the warmth is going away. Pt. says, it doesn't hurt where the swelling is. Is also still finishing up her antibiotics. 4 yo F comes in with mom for the following: After receiving DTaP, IPV, MMRV on 1/25/16-> developed erythema, swelling, and pain in the (L) arm (deltoid area)-> the DTaP/IPV were given in the left deltoid. Seen in walk in on 1/27 and started on KEFLEX yesterday. Currently has much improvement in symptoms. Per mom, no hives or rash developed anywhere else and pain has subsided and pt using arm well. Per provider note, rash was seen "shoulder down to middle of humerus erythema and hot to touch with mild edema and some pain". Mom denies trouble breathing, swelling in lips, fever, or any other rash. Eating and drinking well.
Patient received her shot at 9:36am. She walked out to her car and got hot in the face and noticed it was red. She came back in. She stated her lips were tingling. Dr gave her 25mg of benadryl. She stated she had a past reaction of steroids with flushing/redness. Her blood pressure was 176/106 and a pulse of 91.  The patient stated after 15 minutes of the benadryl that she felt better. Her husband was going to drive her home since she took a benadryl, and she stated she was already getting sleepy.
J&J Jansen one shot dose lot 1805031.  By mid June started having trouble walking distance began labor breathing.  By July 4th legs were completely swollen difficulty breathing, sleeping alot made Dr appointment.  Went to primary diagnosed in office with congestive heart.  Took him off plavex put him on Eliquis 5mg and furosemide 40 mg. recommended to see heart doctor STAT. Next day 7/13/2021 went to heart doctor.
NauseaVomiting  Congestion, rhinitis  Narrative:  Saw Provider who dispensed  Claritin 10mg po once for symptoms.
Hospotalive March 6th 2021. Numbness, loss of use left foot, leg, L-ARM, HAND. DAZED, COULDN'T CONSINTRATE, FUNCTION. TAKE TO EMERGENCY ROOM at Piedmont Athens Reg Med Ctr and admitted. Had cat scans, MRI's, ultrisounds, EKG's. Blood clots ediologity unknown, caused by COVID 19 VACINES. PFIZER
Hives and blisters on multiple areas of the body. Since April 2021 until present
approximately 2 weeks after vaccine injection patient developed macular-papular, pruritic rash on feet. no other new medications taken by patient or allergens applied to area.
Fever; threw up a couple of times; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and VOMITING (threw up a couple of times) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0112L0A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PYREXIA (Fever). February 2021, the patient experienced VOMITING (threw up a couple of times). At the time of the report, PYREXIA (Fever) and VOMITING (threw up a couple of times) had resolved.            No concomitant medications were provided by the reporter.   Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-004683 (E2B Linked Report). This case was linked to MOD-2021-205686 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up information received on 3 JUN 2021 contain information include:New adverse event- Vomiting was added, the outcome of other events were updated and information about second dose of vaccine was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-004683:Crosslinked (MOD21-03428)
Dull Low back pain; sharp low back pain with long durations of lumbar extension. Symptoms subsided within 36 hours. Managed well with ibuprofen.
Information has been received from a physician concerning a 12 month old patient who on 05/27/2003 was vaccinated with a dose of varicella virus vaccine live.  On 06/19/2003 the patient experienced a case of breakthrough varicella.  It was noted that it was questionable if it was from the vaccination.  There were less than 50 lesions.  Unspecified medical attention was sought, but there was no treatment and no hospitalization.  The patient recovered.  No product quality complaint was involved.  The is one patient out of 40 reported.  Thirty nine other cases experienced breakthrough varicella after vaccination with varicella virus vaccine live.  Additional information is not expected.
Information has been received from a physician concerning an 18 year old female with no known medical history and drugs allergies, who on 24-APR-2009 was vaccinated with a 0.5 ml first dose of GARDASIL, intramuscularly. There was no concomitant medication. On 27-APR-2009 the patient discovery that she was pregnant. No adverse effects reported. The patient had a urine pregnancy test at office that was positive. The pregnancy was confirmed with a blood test. The patient LMP was on 01-APR-2009 and her estimated delivery date will be on 06-JAN-2010. The patient sought medical attention through an office visit. Follow up information received from a physician indicated that the patient was a female. On 09-MAY-2009 the patient had an elective termination of her pregnancy. It was unknown if the products of conception were examined or if the fetus was normal. The patient's outcome was unknown. Upon internal review elective termination was determined to be another important medical event. No further information is available.
Pt came to the hospital for blood streaked stool and dysuria and frequency. pt had uti and covid treated with cefepime and iv hydration. pt d/t
Pain @ inject site, p/4 hrs next day pt could not walk; On exam sl redness; no swelling; Normal neurological exam; fever 104, swelling of thigh & knee; Seen in ER; Effusing hip knee joint; xray done; dx rxn vs infect;
Same the Soreness and pain was manageable during the evening of the day of vaccination. But next day very early morning (around 4am onwards), situation became beyond manageable.  My BP went from regular level (123/82) to (136/110) with severe pain around the eye. Especially from the back of the eyeball. And intolerable headache from both sides and feeling that my eye balls would burst.   I noticed swelling around my shot area and also it was very painful to touch
she may have myocarditis; symptomatic ventricular ectopy; fatigue; headache; This is a spontaneous report received from a contactable consumer for a female patient (our young, female physician) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 1ST DOSE, SINGLE DOSE for covid-19 immunisation on unknown date. The patient's concomitant medications were not reported.  The patient who was with no major medical problems  developed symptomatic ventricular ectopy that she stated to begin 10 days after her second vaccine dose (Pfizer). She is currently under the care of a cardiologist who believed she might have myocarditis. She also experienced fatigue and headache with her second vaccine dose. She was started on ibuprofen and is feeling "a little better". She denied fever or other systemic manifestations. The outcome of the events was unknown.  Therapeutic measures were taken as a result of she may have myocarditis (myocarditis).  Information on the batch number has been requested.
Felt over heated/three to five minutes he felt a rush; Sweating through my clothes; Black vision; Very close to passing out/he felt like fainting; I couldn't form a sentence to come out of my mouth to ask for water from him; Very fatigued; Nausea; Headache/pressure at the crown of his head; Felt disoriented like super forgetful; Felt disoriented like super forgetful; His motor functions not on point like trying to operate electronics; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injcetion), administered in arm left, administration date 12Mar2021 13:30 (Lot number: EN6208) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Oral surgery" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Felt over heated/three to five minutes he felt a rush"; HYPERHIDROSIS (non-serious) with onset 12Mar2021, outcome "recovered" (14Mar2021), described as "Sweating through my clothes"; VISUAL IMPAIRMENT (non-serious) with onset 12Mar2021, outcome "unknown", described as "Black vision"; PRESYNCOPE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Very close to passing out/he felt like fainting"; SPEECH DISORDER (non-serious) with onset 12Mar2021, outcome "not recovered", described as "I couldn't form a sentence to come out of my mouth to ask for water from him"; FATIGUE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Very fatigued"; NAUSEA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Headache/pressure at the crown of his head"; MEMORY IMPAIRMENT (non-serious), DISORIENTATION (non-serious) all with onset 12Mar2021, outcome "not recovered" and all described as "Felt disoriented like super forgetful"; IMPAIRED DRIVING ABILITY (non-serious) with onset Mar2021, outcome "not recovered", described as "His motor functions not on point like trying to operate electronics". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The events did not require a visit to emergency room (ER) and physician. The patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Redness and pain of the arm.,  Shortness of breath, relieved with albuterol nebulizer at home.    Sensation of swelling in the throat, but normal examination.  Lungs were clear auscultation.   Pulse oximetry was normal.  Patient was prescribed an EpiPen, and instructed to go to the emergency room for any worsening of symptoms.  Steroids were not prescribed.
3/20/2021   Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, he experienced an adverse reaction with the following symptoms:  tighenting around face and mouth.   Assessment : Time of assessment 1702. Alert and oriented. Redness noted around mouth, no swelling noted,    Actions taken:  BP at 1702, BP- 149/94, P- 102, O2- 100 GIVEN WATER     Medications administered: FAMOTIDINE 20 MG PO X 1 BY NP, Benadryl 25 mg PO x 1 by NP   Disposition: Reports no further symptoms of adverse reaction after observation for , minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/20/2021  4:39 PM 0.3 mL 12/11/2020 Intramuscular
With 1st dose almost instantly I experienced numbness on my nose (my entire all the way to my face) and congestion and runny nose. The numbness never went away I still experience it until today 03/12/2021. With the second dose was completely different. I did not get a congestion or runny nose but the numbness is still present from the first dose but did not get worse. I also had a headache, bad body aches with the second dose. Like I had a case of really bad flu, after 2 days completely fine (except nasal numbness).
Patient came in for 2nd shot of covid19 vaccine. Stated she had minimal side effects from first (sore arm, redness, etc.). Went over what to expect with the 2nd shot (a more robust response), etc. She seemed nervous so that we let her sit in the  booth as we had no other patients immediately following. While she was waiting in the booth during the post admin time, she fell out of the chair and hit her head on the gray steel pole, and it seemed to stun her. I, along with another  pharmacy customer,  a nurse, picked her up and placed her in a chair. She stated her blood sugar was low. The nurse asked that I take her blood pressure first. Patient asked that I go ahead and check her blood sugar. She stated that it had been up since she had a steroid shot 2 weeks ago. This had not been listed as a "yes" on her intake form. She had listed NO on this question. We grabbed a monitor off the shelf and tested it as well. Her blood pressure was checked 3 times and it would not register. The blood sugar registered 78. She stated that it normally ran 120 to 150. We gave her some water and was in the process of getting her some crackers and peanut butter. She found a peppermint circle in her purse and wanted that instead. The nurse told her not to drive home and to call someone. Her son, I believe came in and picked her up at approximately 6.20pm . The shot was admin approximately at 5:45
After vaccine was administered throat and tongue started tingling and worsened as 10 mins later. I was administer Allegra. After Allegra, I started getting redness and blotchy in my neck, jawline and abdomen. After 1 hour the Allegra lessened the redness and throat and tongue tingling.  Next day 1/8/21 I had a fever, chills, nausea, headache and body aches. All reported to PCP.
This case was reported by a healthcare professional to a sales representative and describe the occurrence of the redness and swelling at the injection site in a 4-year-old subject (unknown gender) who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). On an unspecified date in either in March 2006 or April 2006, the subject received the 5th dose of Infanrix in an unspecified thigh (lot AC14B018AA0). On the same day, the patient received injections of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles mumps and rubella virus vaccine (M-M-R II, Merck). The injection sites for IPOL and MMR II were not provided. At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 11 April 2006, the subject experienced redness and swelling at the injection site of Infanrix. The subject was seen in the emergency room. The outcome of the events was not reported,. The nurse considered the events to probably be related to vaccination with Infanrix.
pt recv vax;devel sore arm,sore neck & swollen glands;swollen nodes;inc level of WBC, platelets,granulocytes;segmented neutrophils & atypical lymphocytes;low levels of monocytes, lymphocytes,bands &  eosinophils;ESR was elevated; low BUN
Patient's husband called and said patient had swelling in her left arm with red rash. He said the swelling was lower than the previous day after receiving the vaccination. Pt did not have any discharge in the arm.
High grade fever that lasted for 32 hours total and peaked at 103.5. Severe cold chills that led to involuntary convulsions. Body aches that last for three days. Extreme fatigue.
INCORRECT PRODUCT STORAGE; PUNCTURED VACCINE THAT WAS LEFT AT ROOM TEMPERATURE FOR 5 HOURS WAS ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced incorrect product storage, and punctured vaccine that was left at room temperature for 5 hours was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and punctured vaccine that was left at room temperature for 5 hours was administered was not reported. This report was non-serious.
BILATERAL PULMONARY EMBOLISM; UNSPECIFIED ISSUE WITH SPLEEN; DIZZINESS; HEADACHE; This spontaneous report received from a healthcare professional (nurse practitioner) via a company representative concerned a 54 year old female patient. The patient's height, weight were not reported and medical history was not known. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported,1 total administered (anatomical vaccination site unspecified) on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, "about one week prior to admission", the subject experienced headaches and dizziness. On 03-APR-2021, the patient was admitted to hospital for bilateral pulmonary embolism and something with her spleen. The reporter believed that the patient had tests done on spleen (not further specified). Initially it was reported that the patient was out of hospital now and doing much better, but later it was clarified that patient has not yet been discharged from hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bilateral pulmonary embolism, unspecified issue with spleen, headache and dizziness was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 54-year-old female patient experienced headache and dizziness unspecified days after receiving covid-19 vaccine ad26.cov2.s for prophylactic vaccination. The patient was hospitalized 1 week later for bilateral pulmonary embolism (PE) and unspecified issue with spleen.  Medical history and concomitant medications were reported. No other details of the events were reported. The patient had not yet been discharged from hospital. Based on a limited information, the events of bilateral PE, unspecified issue with spleen, headache and dizziness are assessed to have an indeterminate causal association to immunization, per the organization causality classification for adverse events following immunization.  Company causality is considered not related to covid-19 vaccine ad26.cov2.s. Additional information has been requested for further assessment.
1st week flu like sym; then bad muscle pain, even bladder problems. Slowly pain left most of body and stayed in my arms and shoulders. In Dec. bicep in left arm tore. In April bicep and tricep tore in left arm. It's now June still some pain in arms.
About 3-4 hours after receiving the vaccine my arm was red, hard , swollen , hot and painful at injection site. The area was about the size of a quarter. I took some ibuprofen to ease the pain and swelling as well as applied ice to the area.  The next morning 01/28/21 I woke up with the area being more swollen, larger in size as well as all the symptoms stated above but more pain. I have chills , body aches as well as a headache. I iced the area and have been doing Tylenol and ibuprofen to help ease symptoms. I circled the area in case of any changes. By around 2pm I call my doctors office as the pain was more and the area had swelled up to baseball size. Again I have all the same symptoms continuing but more intensified. I was advised to go to urgent care. I went to urgent care and the doctor stated she felt it was cellulitis. She started me on antibiotics and gave me instructions on what to do if it got any worse. By the time I got home from Urgent care and getting my meds my arm had swelled up more. I have started the antibiotics at 7:50pm (01/28/21)
Left side abdominal cramping / discomfort started 9/22. Been constant since. Sought medical attention beginning 10/12. Follow up labs and CT scan negative. Referred to gastroenterologist 11/11. Follow up labs negative. Began dicyclomine on 11/12. No noticeable difference in pain / discomfort levels so far.