chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 74 year old male patient with a history of herpes simplex and no drug reactions or allergies, who "the first week on June, 2009" (on approximately 01-JUN-2009) was vaccinated with a 0.65 ml single dose of ZOSTAVAX (Merck). Concomitant therapy included pravastatin Na, DICLOMINE, "isolbide", metoprolol and FLOMAX.  The consumer reported that "within a week of receiving ZOSTAVAX (Merck)" (on approximately 08-JUN-2009) he started to develop little white pimples that had a red mark around the pimple all across the forehead. The consumer reported that he had seen a couple physicians and no one can figure out what it was. Laboratory diagnostic studies were not performed. Then, recently, he asked his family and found out that he never had the chickenpox as a child. The consumer stated that he still had these little white pimples that have a red mark around the pimple. Follow-up information has been received from a physician who reported that vaccine was not given by him. Additional information has been requested.
Starting within 3 days I noticed a growing joint pain in all major joints.  Hips, shoulders, elbows, wrists, knees and many knuckles in both hands.  Also a heaviness generally, and relentless headache.  For at least 5 weeks this condition continued to get worse, until I was about to call my PCP to see if I had developed rheumatoid arthritis.  Just as I was ready to investigate what was going on I woke up one morning and, strangely!,  all the pain was gone.  Overnight the pain went from miserable to back to normal for me.   I have no arthritis normally, no joint pain.  I wasn't connecting my joint pain to the vaccine at first until I heard reports and talked to others who had also had similar reactions.  I feel better now, but I do wonder if the reaction I had could lead to future maladies and cause lasting arthritic conditions in the future.
16 year old received first shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received first shot) in a 16-year-old patient of an unknown gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received first shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received first shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.
Patient was seen 10/7/22 and requested Pfizer Bivalent booster. Patient was actually given another dose of Pfizer Monovalent Booster. Patient was notified. Patient will return for correct vaccine.   No symptoms or side effects.
no adverse effects; received one dose of GARDASIL 9 while pregnant; received one dose of GARDASIL 9 while pregnant; received one dose of GARDASIL 9 while pregnant; This spontaneous prospective pregnancy report was received from an office manager referring to a pregnant female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  The patient became pregnant with last menstrual period (LMP) of 28-NOV-2018.  On 15-MAY-2019, at a gestational period of 24 weeks, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage schedule, route and anatomical location were not reported), lot # R004689, with expiration date on 29-NOV-2020, for prophylaxis (maternal exposure during pregnancy) (vaccine exposure during pregnancy) (product use issue). On an unknown date an unspecified blood work was performed.  The pregnancy outcome was outcome pending and the fetal outcome was unknown. The estimated date of delivery (EDD) was calculated as 04-SEP-2019.
My little toe of the right feet developed something like frost bite, it is hyper-sensitive to touch, note this is my 3rd dose, also this dose I developed side effects 36h later, light headed, drunken like and fatigue on Fri afternoon and got worse on Sat, by late Sunday it is almost gone and fully recovered on Monday  Previously ~2 weeks after 2nd dose ( Lot ER8729), I developed similar issue on my big toe on the right feet as well, it was also excruciating and very very hypersensitive, only recovered 3 weeks later, in both cases, the toe issue developed > 2 weeks after vaccination.
Urticaria on 11/7/01 and 11/8/07 - periorbital, L cheek, lower abdomen.  No known allergies.  Treated with Zyrtec 1 1/2 tsp QD
Pt. states that after receiving the 2nd dose of Phizer 02/23/2021, started experiencing fluid in the ears (both), ENT visit prescribed steroids. (Previous condition "Holiday Heart") out of rhythm heart pain continues but reduced after steroid use. Hearing loss noted in both ears.
Excessive thirst; This is a spontaneous report from a non-contactable physician, the patient. A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733) via an unspecified route of administration on 24Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Mar2021, the patient experienced excessive thirst. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of excessive thirst was recovered on unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
within a minute of receiving the vaccine I started feeling dizzy and woozy and like I was floating. Then my blood pressure went up and my heart started beating faster. I had tightness in my chest and I got a tickle like feeling at the top of my chest. I got nauseous. BP was elevated (140/85) normal 107/65.  I stayed for an hour. I was very very sleepy the whole time.  3/5/21 I still have the tickle and tightness and pressure on my chest and I am having vertigo attacks. I got a headache and pain and stiffness in my neck where I have had nerve pain injections and ablations.
Late in the evening on 2/4/2023, patient presented to the emergency department via ambulance from the nursing home for evaluation of shortness of breath, hypoxia with oxygen saturations in the high 60s at the nursing home, and a positive COVID-19 test at the nursing home. In the emergency department on 2/5/2023 just after midnight, patient was given a COVID-19 NAA test which resulted positive; Her chest x-ray showed minimal bibasilar opacities consistent with COVID-19 infection; She had dyspnea with audible wheezing and coarse breath sounds. Patient was treated with supplemental oxygen, DuoNeb nebulizer, and steroids. She was diagnosed with acute respiratory failure with hypoxemia, COVID-19 virus infection, and COPD/asthma exacerbation. Patient was admitted to the hospital for further evaluation and treatment.    Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital:
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medications were not reported. It was reported that the vial did not undergo any temperature excursion, vial was placed in the refrigerator on 05-Nov-2021. Patient did not experience any adverse reaction.
Patient was due for second dose of COVID-19. The first dose was Moderna. Patient was given her second dose of COVID-19 using Pfizer. The mistake was not caught until the patient had waited the allotted time after vaccination. The patient  did not have any adverse reactions during the 15+ minutes they were there after vaccination. Patient was informed of the incident and voiced understanding to seek medical attention if needed and that a provider would be in contact with them.
NOT COUGHED AS HARSHLY AS BEFORE A MONTH AFTER RECEIVING VACCINE; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non smoker, asthmatic, and chronic cough, and other pre-existing medical conditions included: Patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced not coughed as harshly as before a month after receiving vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not coughed as harshly as before a month after receiving vaccine was not reported. This report was non-serious.
Pt tested positive for COVID on 1/25. Pt tested positive in Sept, negative in Oct and Dec. this is being treated as a re-infection.
Received vaccine afternoon of July 3rd. Morning of July 4th developed itchy rash to both arms, neck and right knee. Patient went to UC and was found to have macular papular rash on bilateral UE, upper back and neck.  Patient treated with prednisone and triamcinolone cream. Provider stated reaction related to COVID vaccination.
Information has been received from a pharmacist (reference # NK 5489) concerning a 61 years old female patient who on 23-OCT-2012, was given one injection of ZOSTAVAX (dose and route not reported) (lot # 670617/0618AA) which expired on 26-JUL-2012. The patient had no relevant medical history or relevant concomitant medications. The patient's relevant past drug history was unknown. It was unknown if there was any relevant laboratory data. As of 30-OCT-2012, the patient had not been revaccinated and the outcome of her getting the expired ZOSTAVAX was unknown. This is one of several reports received from the same source (related MARRS # 1211USA00230). Additional information has been requested.
She states she received her first dose approx. 19Aug2021 and reports having sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 19Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy to iodine" (unspecified if ongoing); "allergy to shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "She states she received her first dose approx. 19Aug2021 and reports having sore".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with improperly stored dose of PNEUMOVAX23 (lot# L003188 with expiration date 06-JUL-2016; lot# L003227 with expiration date 13-OCT-2016; lot# L024132 with expiration date 27-JAN-2017; dose, anatomical location and route of administration were not reported). The vaccines were exposed to 4 hours 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour 30 minutes at 51.3 F, 2 hours at 56.3 F on the sixth of May (year unspecified). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccine during my shift at the hospital; 12 hours after receiving the vaccine, when I woke up to go back to work, the site was pink, swollen, itchy and I felt ill: scratchy throat, headache, nausea, cold chills. No fever so I went to work. For the next 2 days, the site got redder, and larger and the skin felt hard and very hot. I took benedryl and slept with an ice pack on the site. Finally after about 4 days, the redness started to go away and I was feeling better. To note, the flu vaccine was given more towards the back of my arm in the fat and not in my deltoid muscle as it should have been.
Patient returned 5 days after vaccines were administered with very large local swelling to the deltoid area spreading towards the arm pit.
pt recvd vax;next day devel extensive erythema, pain & swelling in rt arm;tx w/ keflex for possible cellulitis;clavicular/intraclavicular red streaked;tx augmentin
UrticariaPruritus hardness/swelling Narrative:  Reactions occurred week after injection; resolved 2 days after appearing
I received he first vaccine and had no symptoms but the following day I had a scaley not itchy rash on face "like a fish".  the rash stayed for the 3 weeks. then i got the second maderna vaccine and the same day told to go into the hospital evaluation area but released same day. and i was okay the day of but the followin day i started feeling dizzy and could not walk and needed help from family.  I felt tired and worn out for three days. the rash appeared again the day after on my face and on my arms; it was dark red his time and started to peel off a week after.  i still have a rash but it is lighter in appearance.
Patient called 12/08 stating injection site was swollen and red when she woke up. She stated it was "like a bee sting" with a welp. Patient was going to go to the doctor to get it looked at. Patient came into pharmacy on 12/09 and added her under arm is swollen. Upon looking at patients arm, I can confirm patients arm has a 2in x 2 in welp, is red and swollen only in that area a little to the right, but still on the deltoid. Patient stated it has gotten bigger over the last day. Isn't very painful, just concerned about the redness/fever and swelling at injection site.   Assured patient it appears to be injection site reaction and to be sure to monitor it over the next couple of days. Also told patient to notify her Dr if pain and swelling gets worse.
16yo female pt had syncope episode approx 15 min after vaccination.  Parents said they had just come off of a long international flight and that pt was very tired and had not had anything to eat or drink.  After vaccination, the family walked around the store, and pt fainted on other side of store.  Emergency services were called.  Pt was helped to sitting upright in a chair, and had a scraped knee.
excursion was just found and happened about 2 weeks ago and was unsure whether or not were administered to patients but that some probably were; This non valid spontaneous report was received from a nurse referring to an unspecified number of patients of unknown ages or genders. The patients' concurrent conditions. Medical history or concomitant therapies were not reported.  On unknown dates, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T028929, expiration date reported as 08-MAR-2023; rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1707591, expiration date reported as 11-MAR-2022; measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) lot # T013725, expiration date reported on 21-APR-2022; hepatitis a vaccine, inactivated(VAQTA) lot # T035721, expiration date reported on 15-APR-2022; or hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # T028933, expiration date on 03-NOV-2022. The nurse reported a temperature excursion; temperature of 9.6 C, time frame of 1 hour and 25 minutes, with no previous temperature excursion, and a data logger was involved. The nurse stated that the excursion was just found and happened about 2 weeks ago and was unsure whether were administered to patients or not, but that some probably were. No product quality complaint reported.  This is a non valid report since no patient identifiers were reported.
04/02/2021 Office visit: Review of Systems: Integumentary: Pruritus and Rash.  Muscle and Skeletal: Joint swelling. Assessment/Plan: Redness and swelling of upper arm (M79.89):  Ice arm, please notify if no improvement or if redness is progressively worsening.  s/p covid vaccine, local erythema from injection site, will monitor. Other skin changes (R23.8):  Adverse effect of vaccine, initial encounter (T50.Z95A).  Redness and skin swelling after 2nd (covid) vaccine this past Tuesday (3/31).  Use cool compress to the area, please let us know if this redness and swelling is not improving.  04/09/2021 @ 4:28  I called patient for f/u of R arm injection site irritation (see 4/2 OV notes).  She said onset of sx's began that evening of the 2nd covid vaccine (3/31) w/ swelling, tenderness w/ redness of upper arm and across upper chest.  Otherwise she was fine, had full arm motion.  After being put on antibiotic for both the arm and UTI on 4/2, sx's resolved in 2 days.  Today, 4/9, No swelling, no redness, no tenderness.
A week after each dose I had a rash on my stomach come up. The first time it laster about a week and was about the size of a small glove. The second shot I got the rash again but it was worse. It was a larger area and was itching worse. So far I'm on week 3 and it is still there. I work in a doctor's office and asked the NP to look at it. Stated it looks like a shingles rash.
This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient. A 74 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 28Oct2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Open heart surgery" (unspecified if ongoing). Family history included: "Hypertension" (unspecified if ongoing), notes: mother. Concomitant medications included: Allopurinol; Nexium [Esomeprazole Magnesium]; Metoprolol; Valsartan; Atorvastatin; Folic Acid; Methotrexate; Baby Aspirin; Remicade. Past drug history included: Brimonidine. Vaccination history included: COVID-19 vaccine (Primary Immunization series unknown; unknown manufacturer), for COVID-19 Immunization. The following information was reported: OPTIC ISCHAEMIC NEUROPATHY (medically significant), outcome "unknown", described as "I had a micro stroke in my left eye and it is called NAION". Additional information: Consumer stated, "I am calling to report a possible side effect from, I guess it would be the booster, I have only had the third booster (Pfizer COVID-19 booster shot) not the fourth (further not clarified) but about 6 weeks ago (further not clarified) I had a micro stroke in my left eye and it is called NAION that is the name of the problem and my husband is just 'proof of it' (further not clarified), because my pulmonologist told me he knows of someone who after a booster went blind in her eye (further clarification unknown) and we googled it and there does seem to be a connection between the mRNA vaccines and after that problem (further clarification unknown)." Consumer stated, "The Lot# is it looks like PR the way they wrote it 2012  it looks like, I cannot tell it is FS or FP, 2588."(Further clarification unknown). Consumer was informed about the role of Pfizer Drug Safety department. Other medical condition: Consumer stated, "A lot of them. I just recently had open heart surgery (further clarification unknown), I have hypertension/blood pressure. I have psoriasis, I have 'Gals' (further not clarified), I have asthma, and there is a bunch". The patient had no lab test. The patient had no prior vaccination. The patient had family medical history (Blood pressure or hypertension) on her mother. Time of vaccination: around 10-10:30 (AM). The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a othemedical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 22-FEB-2018, the patient was vaccinated with M-M-R II lot # N020926, expiration date on 01-AUG-2019, for prophylaxis (strength, dose, and route of administration were not reported) which was reconstituted with an expired sterile diluent (MERCK STERILE DILUENT) lot #L012345, expiration date on 23-JAN-2018 (strength, dose, and route of administration were not reported). No adverse effects were reported.
Patient received first dose at age 17 on 3/15/21, completed series with second dose today.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 15-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Information has been received from a woman in a physician's office concerning a female pt with no allergies and no medical history who on 01Aug2002 was vaccinated with a dose of varicella virus vaccine live.  There was no concomitant medication. Subsequently, the pt developed a skin rash. Unspecified medical attention was sought and no treatment or prescription drug was required. It was reported that the condition had resolved. No product quality complaint was involved. Additional information has been requested.
Client stated he felt "flushed". Skin warm/dry/pink. Respirators even/unlabored. BP 162/86, HR -74, P 18. Client has history of HM on BP meds but no name of medication provided. Client may additional isminus. Denied feeling flushed, states he felt fine. Client was wishh to drive himself home.
Patient admitted on 1-27-07 with vomiting and diarrhea. 3/22/07 Received medical records from hospital which is only H&P.  Call to medical records dept to confirm.  Patient seen in ER late at night & kept there overnight for hydration & observation.  Admitted to peds floor next AM 1/28/07 & d/c to home same day. FINAL DX: Acute gastroenteritis & mild dehydration.