chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of infected cyst in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 4N2AB, expiry date 10th February 2023) for prophylaxis. The patient's past medical history included surgery (Patient underwent surgical incision and draining of cyst post infection). Previously administered products included Shingrix (1st dose received in 5th January 2021 with batch number 2A3ZA and expiry date 14th October 2022). On 30th July 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced infected cyst and drug dose administration interval too long. On an unknown date, the outcome of the infected cyst and drug dose administration interval too long were unknown. It was unknown if the reporter considered the infected cyst to be related to Shingrix. Additional details were reported as follows: This case was reported by the pharmacist. The pharmacist reported the patient developed an infection in a pre-existing cyst after receiving the second dose of Shingrix. The patient received first dose on 5th January 2021 and second dose on 30th July 2021, which led to drug dose administration interval too. The patient underwent surgical incision and drainage of cyst post infection. Upon escalation to 2nd line specialist, HCP stated cyst was removed 8 days later (after Shingrix administration). The reporter consented for follow-up.
batches of red skin on front of both upper legs Batches of read skin on entire abdomen rednes on both sides of upper back below shoulders Batches of red skin on both sides of lower back red skin on entire upper chest area going down to about 1/3 way down both breasts Red skin next to trunk going into both breasts red skin on both upper arms, towards the exterior side of each upper arm.
Temp 99.6 and congestion.; Temp 99.6 and congestion.; This is a spontaneous report from a non-contactable nurse. A 24-year-old female patient received first dose of BNT162B2, intramuscularly on 18Dec2020 08:00 at a single dose for COVID 19 immunization. The patient medical history was not reported. The patient is not a pregnant at the time of vaccination. Concomitant medication included sertraline hydrochloride (ZOLOFT), ethinylestradiol, ferrous fumarate, norethisterone acetate (TAYTULLA). The patient experienced temp 99.6 and congestion, both on 18Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. This is a non-serious report. The outcome of events was not recovered.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
hives all over; This is a spontaneous report received from a contactable consumer (patient's wife). A 38-year-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiration date: 30Jun2021) via an unspecified route of administration in the arm right on 05Apr2021 11:16 AM as a single dose for covid-19 immunisation. Medical history included ongoing asthma since he was born and eye surgery from 05Mar2021. Concomitant medications included prednisolone acetate from 05Mar2021 after eye surgery. The patient previously received (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202, expiration date: Jun2021) on 15Mar2021 11:16 AM at 38 years old for covid-19 immunisation. The patient received his second Covid 19 vaccine on 05Apr2021 and the hives started on 08Apr2021. The patient had hives all over. The hives did get worse overnight. The patient had gotten hives when he was younger but it was a reaction to a plant. The hives he had currently have not gone away even with a shower or taking Benadryl. He took 2 25mg tablets of Benadryl within an hour of each other yesterday, 08Apr2021. Then about 9 hours later he took 2 more 25mg tablets. He was going to sleep so he thought the Benadryl (lot number: SEF004, expiry date: Dec2021) would help with that. The patient had no questions except if her husband needed to go to the doctor. The AEs did not required a visit to Emergency Room, no physician office. The patient had no Prior Vaccinations (within 4 weeks). Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Patient noted that two days after the event there was a very small swelling, but went away. On Friday, May 7, 2021, the patient noticed a large swelling  immediately below the injection site. She applied ice packs and the swelling  went down but not away at the time of this writing. Patient also  noted some itching and redness with the swelling.  She felt the ice packs were working and I encouraged her to use Loratadine 10mg once daily for five to seven days. She was strongly encouraged to call the MD if she felt she needed medical intervention and to call the pharmacy in fourty-eight to seven-two hours after this write-up.
8/8/21: DRY COUGH AND HEADACHE STARTED 8/10/21: LOST TASTE AND SMELL
Moderna COVID-19 Vaccine EUA Lightheadedness, flushing, fever, nausea
Been vaccinated, have them/suspected vaccination failure; shingles 50 times, worst case; COVID-19; numb skin; burning; Itching; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, [the patient experienced vaccination failure (Verbatim: Been vaccinated, have them/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles 50 times, worst case), covid-19 (Verbatim: COVID-19), numbness (Verbatim: numb skin), burning sensation (Verbatim: burning) and pruritus (Verbatim: Itching). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the covid-19 and numbness were not reported and the outcome of the burning sensation and pruritus were recovered/resolved (duration 1 year).   It was unknown if the reporter considered the vaccination failure, shingles, covid-19, numbness, burning sensation and pruritus to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, covid-19, numbness, burning sensation and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that worse than anything he/she ever had.  The patient had shingles right now.  The patient had them over fifty times.  The first time lasted about ten months.  The patient's doctor said that he/she won the prize for the worst case of shingles he had ever seen.  The patient had been vaccinated with shingles.  The last vaccine really helped until he/she had covid.  The skin on her left leg was numb.  The patient just went through a year of burning and itching. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
12hr p/vax pt c/o numbness on lt side neck, arm, torso & leg;scalded rash appeared to mid calf bilat;treated w/DPH-resolved in 48hr;mom took pt to MD 3wk later titer drawn MD recommended no further hep B secondary hypersensitivity;
After given 2nd vaccine on this day, was hit with extreme vertigo and dizziness less than a minute later.
Achy, wheezy, projectile vomiting, water like stools. Feel very 'sick'. Two days later still the same.
Patient states they got their 1st Pfizer COVID vaccine on 4/19/2021. Patient got swollen tongue when at home the same day. Patient visited the urgent care regarding symptoms on the same day; was prescribed oral steroid medication, prednisone, and took for 7 days. After taking prednisone, swollen tongue has subsided partially.  Noted patient has no known allergies and is currently taking contraceptives orally. Patient scheduled urgent care visit 5/8/2021 for consultation for 2nd dose.
Large area of rash over arms, thighs, calves, and buttocks. Rash at its peak about 6 hours after it started, then reduced overnight with only some rashes remaining.
A few weeks after my first moderna vaccine I had blue toes, numb legs, weak legs, pins and needles throughout my body, fatigue, moments of leg paralysis, uncontrolled muscle twitch's , brain fog, pain in my legs, and bladder weakness . A few days after my second dose my symptoms worsened.
Immediate red rash on chest, resolved within minutes.  Within hours severe arm pain around injection site of Zostavax.  Body aches, fever, fatigue.  These symptoms resolved over a course of 6 days without treatment.
Information has been received from a health professional concerning a 53 day old male who, on 10/24/01, was vaccinated with a 1st dose of Haemophilus B conjugate vaccine, a 1st dose of DPT and Prevnar. On 10/30/01, the infant experienced emesis. On 11/27/01, when the infant was 2 months old, he received his 2nd injection of Hep-B and an injection of IPOL. Two days later, on 11/29/01, the infant again experienced emesis. He was seen in the physician's office and blood was drawn for unspecified lab analysis. The infant continued to experience intermittent emesis, with episodes occurring on 12/15/01 and 1/3/02. As of 1/7/02, the infant was being evaluated for possible malrotation or volvulus of the stomach. As of 1/11/02, the intermittent emesis was ongoing. The pt provider considered it to be moderate in intensity and possibly related to either Hep-B vaccine administration, malrotation or volvulus of the stomach. It was noted that the pt experienced fever following receipt of Hep-B. Emesis, possible malrotation of the stomach and possible volvulus of the stomach were considered to be "Other Important Medical Events". Additional information has been requested.
The day after the injection I had a sore arm, slight headache and slight nausea. Since that time I have had a slight "pressure" headache almost continuously.  Today is 2/24/21, more than 6 weeks after the first shot and the symptoms have only slightly subsided. I have decided to forego the second shot until the symptoms completely disappear. I have not sought any medical care because the symptoms are not severe enough and I am hoping they will subside by themselves. If they continue for a long period I will seek medical care but my guess is there will not be a lot that can be done.
runny nose; watering eyes; sneezing; This is a spontaneous report from a contactable consumer (patient).  A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 12:15 (Batch/Lot number was not reported), age at vaccination of 73-years-old, as single dose,for covid-19 immunisation.  Medical history included lung neoplasm malignant from an unknown date and unknown if ongoing, autoimmune thyroiditis from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing (shrimp). The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Left on 21Jan2021 12:00 (Batch/Lot number was not reported) for covid-19 immunisation. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported.  The patient had not received other vaccine in four weeks. The patient experienced runny nose, watering eyes, sneezing, all on 13Feb2021 1645. No treatment was administered for the events. The patient was not tested for covid prior vaccination nor post vaccination. The patient was considered to be recovering from the events.  Information on the lot/batch number has been requested.
Patient broke out all over body with water blisters and open sores. Patient had a fever of 99.2. More than 100 sores were present 48 hours after vaccine. Patient was taken to clinic 72 hours after vaccine because of the excrutiating pain. Doctor prescribed anti-viral medication, Acyclovir, to be taken for 5 days.
(bruise) noticeable puffy; soreness at the site of injection; purple bruise which is just above the wrist - left arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (purple bruise which is just above the wrist - left arm), SKIN SWELLING ((bruise) noticeable puffy) and INJECTION SITE PAIN (soreness at the site of injection) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE PAIN (soreness at the site of injection). In March 2021, the patient experienced CONTUSION (purple bruise which is just above the wrist - left arm). On an unknown date, the patient experienced SKIN SWELLING ((bruise) noticeable puffy). On 05-Mar-2021, INJECTION SITE PAIN (soreness at the site of injection) had resolved. At the time of the report, CONTUSION (purple bruise which is just above the wrist - left arm) and SKIN SWELLING ((bruise) noticeable puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
After receiving vaccine period symptoms magnified.  Highly unstable mental health. Unsure what would be happening during the time of period and having cramps/pains
Pt. relates awakening to 4 minutes of epistaxis for past two days after nasal vaccine 3 days ago. Exam notes superficial tissues at anterior nasi bialterally. PMHx of epistaxis but not lasting as long. No ASA containing products or OTC/Herbal product consumption.
2 month old was administered PNEUMOVAX 23 by accident; This spontaneous report was received from a consumer concerning their 2-month-old patient of unknown gender. Information regarding concomitant medications, pertinent medical history and drug reactions/allergies was not reported.     On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis by accident (dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported).
Client stated that approx 6 hrs after administration of vaccines she started feeling light-headed and dizzy. She stated she vomited several times during the night and into the next day. Presently has a "bad" headache, c/o lethargy and arm red with "non-raised" rash on her face. Client referred to the ER.
This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 16-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885  with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Patient had bleeding at the site of inyection that lasted a few hours with severe arm pain from the inyection. She has small arms and maybe the 3mL of vaccine could have been too much. Patient also had severe chest pain and shortness of breath after 1-2 hours after taking the vaccine, I almost took her to the emergency room at the hospital that evening but we don't have insurance and going to the hospital would put us at higher risk of contracting COVID-19. So I waited for her symptoms to wear down.  Patient felt moderate chest pain for 3-4 days after the vaccine and still experiences some shortness of breath  as of today, 08/10/2021, therefore we have been discouraged from taking the second dose.
Patient presented to hospital with myocarditis.  This was his booster dose of  Moderna COVID vaccine.  Dose 1 Moderna: 3/27/2021, Dose 2 Moderna: 4/24/2021
Stiffness in joints starting with legs, pain in joints, pain in muscles, overall body pain all lasting 24 hours. Headache lasting 2 1/2 days. Extreme fatigue 2 days following body pain.
This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 6-year-old female patient who received PEDIARIX (batch number 372DT, expiry date 4th July 2016). On 9th September 2015, the patient received PEDIARIX (intramuscular). On 9th September 2015, immediately after receiving PEDIARIX, the patient experienced extensive swelling of vaccinated limb, injection site redness and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site redness and injection site warmth were unchanged. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site redness and injection site warmth to be related to PEDIARIX. Additional details were received as follows: The injection site was right lateral thigh. The patient experienced injection site of 12 X 10 inch pyretic area (warmth) with redness and swelling (ELS). The case was not previously reported.
Note - Patient estimated date of vaccination, not sure exact date. 4 days after vaccine, he got chest pain and difficulty breathing.  this went on for a week and gradually improved.  seen in the office on 6/11/21, EKG showed ST segment elevations.  Troponin level was normal.  Vital signs normal.
Hives in diaper area 24 hours after flu vaccines maculopapular rash 48 hours after flu vaccine treated with BENADRYL.
Hot to the touch, an itchy rash, large lump that turned into little lumps.  This lasted a week before all the symptoms went away. Also, the night that I received my first injection, I had a couple of small drinks and I ended up vomiting from them.  These are something that I normally drink and have never gotten sick from them.  Not sure if it is related to the vaccine or not, but I have talked to others who have had the same reaction if they had a drink the same day that they received their first Moderna vaccination.
Sedation Narrative:  Reported extreme fatigue the day after receiving 2nd dose, leading to missed work x 1 day. No known prior COVID infection.    Other Relevant History:
Selling and numbness of tongue. Red rash/ sore under tongue. Unable to swallow properly.
5/21/2021  57 y/o female with past medical history of migraines who presents with itching to the left arm post vaccination. Patient states that this is her 1st vaccination in the two-dose series. Patient denies reaction to vaccinations in the past. Patient denies sore throat, difficulty swallowing, difficulty breathing, shortness of breath. NP and Paramedics at patient side. Patient with macular erythematous blanching rash to the left posterior upper shoulder, no other rash noted. Band-aid removed, and small area of macular erythema also noted, well demarcated. Patient provided with 25 mg PO Benadryl x1 and a bottle of water. Patient vitals within normal limits (143/85 BP, 75 HR, 96% RA and Resp 14). Patient monitored by the NP with resolution of rash post Benadryl (approx. 15 mins). Patient states that itching had resolved. Patient was discharged home in stable condition. Patient aware to take Benadryl 30mins- 1 hour prior to 2nd vaccination and not to place Band-Aid post vaccination, in case the rash was caused by the adhesive in the Band-aid.
Within 24 hours of 2nd dose I experienced tongue swelling and sores on my tongue.  Out of concern, I went for a covid test on 4/16. Results came back negative on sunday AM on 4/18. My tongue had gotten worse, and I was also now experiencing sinus pressure and ear pain. I went to the pharmacy minit clinic. They diagnosed the tongue pain and sores as thrush, and saw ear fluid. They felt there could be an infection going on. Nystatin oral suspension and Amoxicillin-Clav 875-125 were prescribed. About an hour after coming home, I started experiencing symptom  of Bells Palsy which progressed to fully affecting my right side of my face.  I saw my PCP on 4/19 and he confirmed Bells Palsy. Added Prednison 20MG and a Famciclovir 500MG, and order a blood test
muscle soreness, mild headache,  no appetite,  slept  more than 18 hours during the next 24 hours.  All symptoms gone by ten AM 2,13/21.
appendicitis; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is one of three reports. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04May2021 (lot number Rx261443606215) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 on 04May2021 (lot number Rx259586906215) for COVID-19 immunization. The patient experienced appendicitis on 20May2021 which caused hospitalization. Surgical treatment received for the event included appendectomy. The outcome of the event was resolved on 20May2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100963152 same product and event, different patient;US-PFIZER INC-2021599448 same product and event, different patient