chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. An 81-year-old male patient received PREVNAR 13 (Lot # J90092, exp. Date 30May2016), via an unspecified route of administration at 0.5 ml, single in the left arm on 02Dec2014. Medical history included ongoing hypertension. Concomitant medication included VASOTEC 5 mg once a day for blood pressure. He received earlier inoculation for pneumonia at the age of 65 years. The patient experienced slight soreness at the site on 02Dec2014 with outcome of recovered, itchiness at the site on 07Dec2014 with outcome of recovered, redness at site on 08Dec2014 with outcome of recovering. Therapeutic measures were taken as a result of itchiness at the site. The patient described the events as follows: he experienced slight tenderness at the site of injection, which was his left deltoid on the day he received the vaccine that lasted about a day or 2. Also reports itchiness at the site 6 days after receiving it that cleared after taking an unknown name 1 percent anti itch medication. Then the site turned a significant reddened color that was about 3 x 3.5 inch in diameter with no discomfort, around the site. The redness was there a week and had lessened in color, but still there, color is more pinkish now. His primary physician gave him the ok to take the vaccine. Follow-up (25JAN2015): Follow-up attempts completed. No further information expected.
1st episode of localized bilateral elbow (R>L) and left knee pain onset within 3 days following receipt of AVA #3 in Jul 1999, given in the left arm; pain was described as "arthritic"; no  associated joint swelling, redness or warmth, paresthesias or paresis; unable to fully extend right elbow for several days due to stiffness; elbow pain lasted several months and gradually resolved; the left knee pain resolved within 5-7 days. No symptoms consistent with a large local reaction, or other significant systemic symptoms. 2nd episode evolved similarly following receipt of AVA #4 given with Hep B vaccine in Nov 2007, both in the left arm. He did maintain full range of motion of his right elbow, and the left knee pain resolved within 3 days. He noticed increased pain in his right elbow with right-hand shaking and internal rotation. He denied previous trauma involving his neck, shoulders, or upper extremities  he did have a left knee ACL repair in 1997, but his knee was rarely bothersome since then. He has been able to perform all duty functions, and pass AFPTs despite symptoms. No underlying history of rheumatoid or connective tissue disorders, or history of adverse reactions to other vaccines received in either childhood or adulthood. The remaining ROS was negative.
4/8/21 PT CALLED INTO OFFICE STATING SHE STARTED WITH A RASH FROM HEAD TO TOE DAY AFTER.- ADVISED TO TAKE ALLEGRA .  WENT TO HOSPITAL ED ON 4/10/21 WITH C/O SKIN IRRIATION AND REDNESS, MILD SOB AND SOME DIFFICULTY SWALLOWING.  SEEN AT URGENT CARE (? dos) WAS TREATED WITH 25MG IV BENADRYL.   ED GAVE HER BENADRYL, SOLUMEDROL AND PEPCID PLUS IV'S ECG SHOWED SINUS TACHYCARDIA INSTRUCTED TO TAKE 5 DAYS OF PEPCID BID; PREDNISONE 5 DAYS AND EPIPEN; BENADRYL 50MG EVERY 6 HOURS FOR 24 HOURS THEN PRN
Dysequilibrium 2.5.21 upon waking, worsened to incapacitate her so seen at Hospital ER 2.9.21.  Symptoms improving daily since.  Off work still.
Developed left axillary adenitis 3 days after receiving flue vaccine in left deltoid.
Very sore left arm, hurts when I move it.  Tender arm. Sore throat, migraine, chills, body aches.
Approx 15 outbreaks since 1st and second doses\ suspected Vaccination failure; Approximately 15 outbreaks; Rash is itchy\ rash along upper buttocks/lower back\ rash on left side; 1st dose August 2019  2nd on July 26 2020; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2020, the patient received the 2nd dose of Shingrix. In August 2019, the patient received the 1st dose of Shingrix. On 26th July 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The patient experienced approximately 15 outbreaks of Shingles since receiving first and second dose of Shingrix. For tolerance of 1st dose of Shingrix, refer case US2021AMR178368. The patient reported outbreak always occurs on the left side, on the upper buttocks or lower back where the waistband of the underwear lies.  The patient reported rash was itchy and has the appearance on mosquito or spider bites.  Less than 1 years after 1st dose of Shingrix, the patient experienced suspected vaccination failure, shingles and itchy rash. Less than 2 years after 2nd dose of Shingrix, the patient experienced vaccination failure, shingles and itchy rash. The patient reported not having an outbreak for the past 4 weeks. This case was considered as suspected vaccination failure as details time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The reporter consented to follow up.
02/05/2021 my upper left arm was itchy all day with mild swelling.  02/06/2021 when I awoke I noted a red circle in the same area, approximately 2-2 1/2" in diameter.  02/07/2021 the redness is still present but not as red as yesterday.  02/08/2021 the redness is fading each day but still present.
12-4-14 I received my flu shot from the ER charge nurse approx 830-845. About 1 hour later I began to feel dizzy and shaky. I noticed symptoms were increasing and I had chest tightness, heaviness, heart racing and pain. I went to the Emergency Room after my meeting at 1200 and my symptoms increased and I was admitted. Under observation from 12-4-14 to 12-6-14. I have continued to have high blood pressure and shakiness.
5 y.o., patient scheduled to receive 1st dose of Pediatric Pfizer vaccine on Tuesday, August 2 2022. Patients mother and father educated on preferred route for age group is deltoid. Per parents request, patient was to be given vaccine on vastus lateralis. At approx. 1305 nurse attempted to administer the vaccine as an intramuscular injection into the R vastus lateralis. Parent appeared to use appropriate comfort restraint method and control of the limb of the injection site. After the nurse injected the needle into the thigh but prior to the vaccine being administered with plunger into the leg, 5 y.o.patient made a sudden jerk movement and released the needle, the syringe was inspected and confirmed that the dose of 0.2ml vaccine remained in the syringe. The needle and syringe were discarded immediately into the sharps container. A bandaid was placed on the puncture site. Another vaccine syringe and needle were prepared for the child. After properly using a different comfort restraint method, the nurse was able to safely administer the vaccine on the R leg, vastus lateralis, without incident. Patient was observed for the required time and satisfactorily completed the appointment.
1st shot.  Shot site swelled up, became red, hot to the touch, itchy, pain, lasted 5 days.  Headache, very bad, lasted 5 days.  Nausea, still have it 7 days later, bot as bad as first 5 days.
pt recv vax 14NOV97 & mom reported pt had sz on 18NOV97;pt has hx of sz;
Pt recvd 2 hep B vax on SEP90 & OCT90 & exp arthritic pain for 3 days.
Flu symptoms; Cough; Runny nose; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "Flu symptoms"; COUGH (non-serious), outcome "unknown", described as "Cough"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose".  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (22Oct2021): 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.
Developed the first symptoms of pityriasis rosea less than one week after dose one of the vaccine. Was diagnosed with pityriasis rosea by his pediatrician 12 days after receiving his second dose of the vaccine.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 year old female. 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 not reported, batch number: 206AZ1A, expiry date: unknown) dose was not reported, dose number in series was 1, 01 total administered on 01-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that the patient was exposed to her boyfriend who showed first symptoms on 02-JAN-2022. On 04-JAN-2022, the patient felt sick with fever, diarrhea, and coughing (suspected covid-19 infection), on 07-JAN-2022 she tested positive for coronavirus disease-19 (COVID-19) with a home kit test and had suspected clinical vaccination failure (dose number in series was 1). Patient denied having a COVID-19 PCR (polymerase chain reaction) test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority; Sender's Comments: V0: 20220116981 -COVID-19 VACCINE AD26.COV2.S- suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
unusual headache; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 28Feb2021 at 13:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included papillary thyroid cancer. Concomitant medications included levothyroxine sodium (SYNTHROID) for unknown indication from an unknown date received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medication, food, or other products. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccination. On 28Feb2021 at 18:30, the patient experienced unusual headache started about 5-6 hours post injection and low-grade ache that came from the middle of the head and made her to reach in and rub it. Headache was not there for about 24 hours on 6Mar2021. No therapeutic measures were taken as a result of the event. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event headache was recovered on 10Mar2021.   No follow-up attempts are needed. No further information is expected.
Left lymph node within the armpit, extremely inflamed; Malaise; While I did not have a fever, chills and could not stay warm; Almost felt like a sinus infection; Whole body ached; Difficult breathing, like running in the winter, or hiking in higher elevations than accustomed to; "0" appetite; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration on 10Nov2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 12Mar2021 (at the age of 58-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CK8734) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunisation. The patient previously also received tetracycline (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 11Nov2021, the patient experienced extreme inflammation of left lymph node within the armpit and malaise, while she did not have a fever but chills and could not stay warm. The patient  almost felt like a sinus infection, whole body ached, "0" appetite, difficult breathing, like running in the winter or hiking in higher elevations than accustomed to. For first two doses, the patient not had one side effect, not even a sore arm. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events left lymph node within the armpit, extremely inflamed, malaise, while she did not have a fever, chills and could not stay warm, almost felt like a sinus infection, whole body ached, "0" appetite, difficult breathing, like running in the winter or hiking in higher elevations than accustomed to was resolving at the time of this report.
Caller is a medical assistant transferred from Specialist requesting information on expired dose of PNEUMOVAX 23 (pfs) that was administered to a patient. Product expired 10/20/2023 and was administered to the patient 11/6/2023. Product had not exper; Caller is a medical assistant transferred from Specialist requesting information on expired dose of PNEUMOVAX 23 (pfs) that was administered to a patient. Product expired 10/20/2023 and was administered to the patient 11/6/2023. Product had not exper; This spontaneous report was received from other health care professional and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 06-NOV-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 ml, (lot number W007035 has been confirmed to be valid for polyvalent (23-valent) (PNEUMOVAX23), expiration date reported as 20-OCT-2023) (strength, route of administration, and indication were not provided).  A specialist requesting information on expired dose of polyvalent (23-valent) (PNEUMOVAX23) that was administered to a patient the product expired on 20-OCT-2023 and was administered to the patient 06-NOV-2023. At the time of reporting, the outcome of the event was not unknown.
pain @ site LA progressing to weakness, numbness, tingling LA, edema all extremities;
Patient was given Pediatric vaccine instead of Adolescent/Adult  vaccine.  No adverse outcome
This spontaneous report was received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly stored PROQUAD subcutaneously, lot # M022400, expiration date: 01-NOV-2017 (strength and dose were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
I had a red raised hot area after the shot that itched. 10 days after I got the 1st dose, it spread throughout my arm. The small red, raised itchy spot had now increased in size and spread throughout my arm and up in my shoulder. My shoulder now hurts when I raise it up or try and pick anything up certain movements. My arm has a weird feeling in my shoulder all the way to my hand sometimes. It feels tingly at times but is not constant. My skin where the reaction happened is now different. It is rough and different to touch.
Patient called via telephone to report a large red rash around the injection site. No other symptoms, no trouble breathings, no hives. No treatment required.
Cold sweat, unresponsive for approximately 60 seconds.  Recovered after about 20 minutes.
Several hours after receiving Moderna COVID-19 vaccine she developed a headache which progressed through the afternoon into feeling weak and dizzy, increased fatigue.  Symptoms persisted through the night with addition of nausea, incontinence of urine, vomiting and sensation of fever.   Pt unable to keep food down.  Walk in clinic visit on 8/21/21 recorded temperature of 99 F and HR elevated to 92, pt was instructed to visit ED.  ED diagnosed pt with vaccine reaction including intractability of vomiting and hypokalemia.
5-6 paps vesic, fever one week ago of 103, Break through case of Varicella.
pt recvd vax & 1wk post vax exp non-itching hives which resolved in several days;
Itching occurred around the injection site at 6:15 P.M. and has continued until today (1/25/21.)  This has improved. Itching on back (rash formed) started Saturday (1/23/21) at 10:00 A.M. and continued until today. (1/25/21.).  Improving some now.
Redness, size (in diameter) about tennis ball and some swelling lasting about 1 week when reported.
Headache, low grade fever, runny/stuffy nose, sore/itchy throat.
I awakened with sever itch from head to toe. There was no rash, no hives, went on for hours. I the morning after shower my injection site which had not been any issue at all was bright red, hot and a little swollen. Perfect 4 in. diameter circle. Called the Pharmasist that gave injection and he said to take an antihistamin and "DO NOT GET THE 2nd DOSE because we still don't know enough about this vaccine." No further concerns at this time. Within 24 hr. the red circle had dissipated and within a couple of hours the itch was gone.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 01-MAR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018) orally for prophylaxis (Incorrect product storage). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958.
Client fainted during check out. Client was checked out by clinic nurses and found to have no injuries. Client left clinic ambulatory with mom.
No adverse event; LPN called to report that an adult dose of VAQTA was administered to a pediatric patient. Nurse refused to give any patient or HCP information but it did happen within her office and she mentioned she already made the providers in the office aware. R; This spontaneous report was received from a licensed Practical Nurse and refers to a 13-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-JAN-2023, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Adult product administered to child).
Pfizer COVID vaccine  first shot Jan. 16 2021   SECOND SHOT 2/6/21          first shot developed rash on left upper leg and blisters on lt foot. was almost gone then after second shot sunday morning woke up with rash both upper legs, bach and many blisters on feet, has been same but more rash on both legs and body , many blisters on both feet could  hardly walk sunday and monday after second shot