chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 inch diameter area of erythema to left deltoid region. Warm to touch. No streaking. No drainage. Minimal swelling. Good, full range of motion. No changes in sensation or use of extremity. No rash, hives, respiratory complaints or itching.
Client traveled soon after vaccine administration.  Approx 12/3/07 L shoulder had burning pain that went down back, under arm & side of L breast.  Last about 3 weeks.  No rash was noted by client.  Client seen by a chiropractor.  Since Jan 08, client experiences burning & itching under arm & L breast that comes & goes.
scratch in my hole body; This case was reported by a consumer via interactive digital media and described the occurrence of scratch in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, pain and ophthalmic herpes zoster.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced scratch. On an unknown date, the outcome of the scratch was recovered/resolved.   It was unknown if the reporter considered the scratch to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 1-Jun-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient stated that it gave him/ her eye and it lasted two years and it hurts a lot on face and that hurts a lot but they gave the two vaccine and was no longer good. After receiving vaccine, the patient got a scratch on whole body, but it heals at the time of reporting. Additional Supportive Information: The case US2022AMR088279 was identified as duplicate of this case. The case US2022AMR088279 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient. The follow-up would not possible as no contact details were available.
The patient has Varicella.  Follow up on 12/10/2001: "
scar tissue form around injection site, patient requires surgery to remove scar tissue, pain and discomfort experienced by patient
Fever, chills, shaking, dizziness, heart palpitations, fast heart rate, extreme weakness, inability to taste or smell, allover muscular pain. Fell asleep in the late afternoon.  Woke up around 10 PM unable to move or function, wanted to call 911 but couldn't find phone, fever, shaking chills, dizziness, extreme weakness, could not sit up or get out of bed, severe headache.  Around 2 AM was able to call off work by email and answer a question by email.  Woke up Wednesday with muscle pain but fever, shaking chills and dizziness had subsided. Still feeling somewhat weak. Did not work Wednesday due to extreme tiredness and thursday due to come and go awful headaches.  May not work Friday.
Right deltoid redness, hard, occurred 8/29/02. Swollen; Mom placed cool compresses.
This FLUZONE vaccine expired 6/30/18. The patient exhibited no ill effects. She was made aware and revaccination was offered.
Well demarcated area of redness present on the anterior L upper arm (see photos) from shoulder to elbow. No induration or tenderness present. Note that it seems to be clearing proximally. No heat compared to surrounding skin.
I experienced a 5 day delay in my menstrual period. I regularly track my cycle. My menstruation was different in amount and appearance. I experienced unusual cramping in the middle of the cycle without spotting.  My cycle is always 25 days.   My cycle remained 25 days while working covid icu, doing rn travel contracts, loss of my parent, having covid, having flu shot, and going on and off other prescription medications.   I have yet to see what will happen next and with subsequent cycles.
Presented to private hospital.  EMG positive for Guillain Barre. 09/23/2010 ADDENDUM                      STATUS: COMPLETED Flu Shot FY11: Patient received flu shot at this encounter. Prior to receiving an influenza vaccination the patient was informed of the nature of the procedure, expected benefits, reasonably foreseeable associated risks, complications or side effects, and anticipated results if influenza vaccine is not given. During this encounter, the patient also received a copy of the most current CDC Vaccine Information Statement (VIS) titled "Inactivated Influenza Vaccine 2010-11" (08/18/2010). The patient consented to the influenza vaccination. 0.5 ml IM Right Deltoid. Lot Number: UH184AA Manufacturer: Sanofi Pasteur Expiration Date: 06/30/11 Tolerated well. Patient instructed to remain in area for 30 minutes after injection. 09/27/2010 ADDENDUM                  STATUS: COMPLETED Patient calling back to let PCP know that his chest congestion is getting worse again.  Reports he is coughing up yellow sputum again. States he told PCP he thought he was getting better but now he feels like he is getting worse and PCP told him to call back and she would order ABX.  HE will call outpatient pharmacy later today to see if ABX has been ordered for pick up.  10/28/10 NURSE COMMENTS PATIENT AND WIFE CALLING THIS AM, WIFE IS A NURSE, WIFE AND PATIENT STATE THAT THE PATIENT IS HAVING PAIN BETWEEN HIS SHOULDER BLADES THAT RADIATES TO HIS RIGHT ARM, STATES FEELS LIKE IT DID WHEN HE HAD HIS HEART ATTACK THE LAST TIME, DID NOT HAVE CP AT THAT TIME, DOES NOT HAVE CP TODAY, BUT  DID BEND OVER AND GET DIZZY AND FALL DOWN, DID NOT LOSE CONSCIOUSNESS WHEN HE FELL, STATES THAT HE JUST FEELS WEIRD, ADVISED TO CALL AN AMBULANCE OR GO TO HOSPITAL NOW. PATIENT HAS EXTENSIVE HEART HX INCLUDING PAST MI'S, 5 STENTS, PACEMAKER, ETC. PATIENT AGREES TO GOING TO ER, WILL CALL ON  10/15/10 AMBULANCE IF HE FEELS THE NEED TO. Caller: Wife Call back number:  The caller requested the following: 16 - Misc: Information, 20 - Misc: Physical Complaint Detailed request:  wife called-she is a nurse. She said that he got the flu shot at this clinic on 9/23 and went into resp. distress w sudden onset of mid back pain on 9/28. Was admitted to hospital and they did card cath/workup which was neg. Neuro called  in and did emg which was + for Guillain Barre, Miller Fisher Type 2. Was given Ig x 5 doses- never had to be intubated. Dr is his neurologist. She said that he was transferred to Rehab yesterday. She will keep us posted as he gets closer to discharge. Called MR and they will fax over dc summary and h/p
Information has been received from a medical assistant referring to a patient of unknown age and gender. On 02-JUN-2016 the patient was vaccinated with improperly stored GARDASIL (lot # M014929, expiration date 27-MAY-2017, dose was not reported) intramuscularly. The lowest storage temperature of the vaccine was 29.3 Fahrenheit and the cumulative excursion time was 136 hours. Data logger had been involved. No adverse effects were reported. This is one of several reports received from same source. Additional information has been requested.
she tested positive for COVID-19 on Sunday; she tested positive for COVID-19 on Sunday; 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 female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "she tested positive for COVID-19 on Sunday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Details:  Product: PAXLOVID Question: Caller just wanted to compliment and thank Pfizer because she tested positive for COVID-19 on Sunday, then started treatment with Paxlovid on Monday and today being Thursday she is already fine. Caller then mentioned to have all the 3 COVID-19 vaccines including the booster from Pfizer. She then stated being a big Pfizer fan.  potential Pfizer COVID-19 Vaccine AE E-transmitting to Safety, noticed during post-call documentation.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Macular-papular rash to lt. arm mainly-with slight rash area to rt. arm. Taking Benadryl and rash subsiding
I began getting severe hives about two weeks about my second Covid vaccination. I went to urgent care and was given steroid pills and that helped for a few days but then hives came back. I?ve been dealing with it for several weeks. I am going to an allergy doctor for testing on Monday and scheduled an appointment with my primary physician.
Vaccine administration not in accordance with VFC recommended childhood and adolescent immunization schedule 2005, Administration of vaccine not licensed for adolescents.
Pt presented with erythema about 5 hours after DTaP injection over left thigh. Lesion extended to 10 x 5cm, warmth indurated. Also with fever 102. Tx with IM/PO clindamycin for 48 hours.
PALPITATIONS AND SHORTNESS OF BREATH, PT WILL SEEK TREATMENT AT LOCAL WALK IN CLINIC FOR EVALUATION.
The day after this 2nd vaccine shot, patient had a fever if 101 and was so exhausted that she slept  through the day. She started to feel better by day 5.   On the date on 10/13, which is listed for the adverse reaction, patient began having hand tremors. She could not stop the shaking. This lasted for approximately 3weeks. It has never disappeared completely but we thought since it was easing up she would be fine.  Today the shaking cane back strong  so we will be taking her to a doctor ASAP.
approx 27 days p/vax pt exp a rash on rt arm but had lesions in other areas. addl information requested
Gave monovalent vaccine instead of Bivalent dose.  Called pts and let them know, no adverse events reported.
Ran routing slip for pt...the form specifies just DTP as an option. DTaP was given to a 12yo rather than the Tdap that should have been given. In future provider clearly documents what should be given DTaP, Tdap, or Td so no confusion potential exists.
This spontaneous report as received from a physician refers to a 15 years old male patient. The patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # H010428) IM in left arm in November 2011 and with the second 0.5 ml dose of GARDASIL (Lot # not reported) IM on 04-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. The physician reported that on 04-SEP-2012 the patient experienced pain and tenderness at the injection site. The physician stated that there was no redness or swelling at the site. The patient did not receive treatment for the adverse event. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Patient reported that arm is still swollen at appointment 5/9/23. Noted raised firm area measuring  9.5 x6 cm on left deltoid  where Tdap injection given on 3/3/23.  Patient reports arm started swelling that evening of injection on 3/3/23. Denies ever having any breathing difficulty, pain or itching at site.
15 November - I had the flu shot at treatment facility. 17 November - developed vertigo 2 days after vaccine. 18 November - Went to an urgent care clinic with vertigo and nausea. 20 November - Continued vertigo. Saw primary care physician but was no help. He suggested an ENT. 22 November - ENT did some initial work and suggested it was most likely BPPV and would go away after some time, which it did not. They checked my hearing and did other tests but was not helpful 29 November - saw the same ENT and they suggested physical therapy. 6 December 2017 - Went to physical therapist and did some PT, and it cleared up.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in arm left on 26Jan2021 at the age of 43-years-old (Lot Number: EL3247) as single dose, 2nd dose via an unspecified route of administration, administered in arm right on 15Feb2021 at the age of 43-years-old (Lot Number: EL3247) as single dose, for COVID-19 Immunization. Patient was not pregnant. The patient's medical history was not reported. There was no any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Reported event was COVID-19 confirmed by positive COVID-19 test, with onset date 05May2021. COVID 19 test on 07May2021 was positive. There was not any treatment for AE. The outcome of event was recovering.
Feb. 1, 2022, I started having joint, muscle, & tendon pain which continued to get so bad I could not move. On 2/22/22 primary care RX Medrol Dose Pak. By March 4th my pain was back & I received 5 10 mg. Prednisone from urgent care. March 11th I saw APRN with the Sports Medicine. He confirmed DX of psoriatic Arthritis. Gave me a shot of cortisone in hip, and RX Sulfasalazine 500 mg. Within 1 month I received another cortisone shot and more lab work. Will see in one month. I was fine before the booster shot.
Withing 2 min of vax pt inj site swelled to 4cm. Follow up states swelling reached 30-40 mm in size. Tx w/ice compress but remained 30 min. Swelling did subside & pt recovered
Beginning 17Dec2021, I have been experiencing occasional heart palpitations and tachycardia; rare mild headaches and lightheadedness.  This is still ongoing as of 20Jan2022.  I experienced similar adverse events after my 2nd dose of the Pfizer COVID-19 vaccine (vaccination date 04May2021 with AEs beginning 09May2021).
"My arm has hurt at the injection site since the minute they gave it to me and has never stopped hurting. I think they gave it to me in the tendon that goes into the muscle". "My left arm has pain and muscle loss". "The needle injection site hurts". "My whole left arm hurts from the injection site down".
Syncope after receiving COVID 19 vaccine, patient recovered within a few minutes after lying down.   Provided patient with water and food.
Vertigo for 5 days so far about 3 weeks after second shot. First day of vertigo was so bad I threw up twice and had to stay immobile to not throw up. Day 4 I had to take meclizine so I could return to work. Day 5 which is today still dizzy a little bit but not enough to make me sick to my stomach.
Immediate rapid swelling at injection site (golfball-sized within a minute), fever 101, headache, injection site pain, myalgias
Blurred vision, disorientation, memory loss. Time course: from 10:45 am to 6:00 pm of day of inoculation.
Severe heart palpitations, rapid heart rate, chest pressure, dizzy, immediate urge to urinate, tingling hands and feet, headache, tinnitus, brain fog, inability to finish sentences.  diagnosed with IST - no treatment given.  Sent home and told to follow up in 6 months
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 28-MAY-2015 the patient was vaccinated with a dose of improperly stored VAQTA (strength, lot#, dosage, frequency and route unspecified). The temperature excursion for VAQTA was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Covid-19 positive after first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19 positive after first dose) in a  patient of an unknown age and 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 COVID-19 (Covid-19 positive after first dose). At the time of the report, COVID-19 (Covid-19 positive after first dose) outcome was unknown.        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.   No Concomitant medications information was provided.  No treatment medications information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Non significant follow-up received and.denied further follow up.
I got both shots and developed shingles/Suspected Vaccination Failure; Developed shingles on my nose/down the side of my nose/over my right eye/mild case; Blister; 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: I got both shots and developed shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Developed shingles on my nose/down the side of my nose/over my right eye/mild case) and blister (Verbatim: Blister). The patient was treated with calamine + zinc oxide (Calamine Lotion). The outcome of the vaccination failure was unknown and the outcome of the shingles and blister were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and blister to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2023 The case was received from the patient via interactive digital media. The patient got both Shingles shots last year and developed shingles on his/her nose and down the side of nose, over right eye and a blister here and there. On Thursday, a week ago, the patient went to prompt care, received medicine and applied Calamine lotion.  The patient reported that it was about gone and praise the lord but it was only a mild case. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient reported following in an e-mail to the provider: Two days after the shot, which I had in the buttocks because I cannot have shots in the arm, I had a 4" square rash, hot to the touch and ITCHY!! It took about 4 days to disappear. I've never had any reaction to any previous flu shot, so this was a surprise.
rash and itching started again, but 2000 times worse than before; itching started again, but 2000 times worse than before; itching; prickly rash all over the body; rash was beet red and raised all over body; A regulatory authority report was received from a consumer concerning a 87-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed itching, bad rash, prickly rash.   The patient's medical history included Diabetes mellitus. Products known to have been used by the patient, within two weeks prior to the event, included Diabetic medication.  On 26 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01 Feb 2021, the patient developed bad rash and itching.  Patient reported rash spread all over the body and later got fused. Patient described rash was beet red and raised all over body. On 02 Feb 2021, patient went to emergency department.  Treatment received for the event include,prednisone and Benadryl  On 08 Feb 2021, patient again visited emergency department as she developed rash and itching again, but 2000 times worse than before. Treatment received for the event ,included Pepcid, Benadryl and  Prednisone   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event,developed itching, bad rash, prickly rash, was considered not resolved.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-014649:
At approximately 1626, patient reported tingling of throat to RN. Patient denied difficulty breathing, difficulty swallowing, itchiness and rashes. RN offered to take vital signs. Patient denied vitals signs. RN offered diphenhydramine. Patient denied diphenhydramine. Patient reported "I'm fine". Patient given water. Patient able to drink water. Patient reported similar reaction to the first dose of Pfizer Covid Vaccine (LOT# EW0168, exp. 08/2021) administered on 08/10/21. Patient reported she felt the "same thing" and "didn't say anything". Patient reported it "felt like a panic attack starting". At 1634, RN reassessed patient. Patient reported "it didn't get any worse". Patient denied itchiness, rashes, difficulty breathing and difficulty swallowing. RN offered diphenhydramine. Patient denied diphenhydramine. RN offered to take vital signs. Patient denied vital signs. At 1642, RN reassessed patient. Patient reported the symptom had "gone down". Patient denied itchiness, rashes, difficulty breathing, difficulty swallowing. RN offered diphenhydramine. Patient denied diphenhydramine. RN offered to take vital signs. Patient denied vitals signs. At 1645, RN reassessed patient. Patient reported the symptom is "gone". Patient denied itchiness, rashes, difficulty breathing and difficulty swallowing. RN educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider, and to sign up on v-safe. At 1647, patient left facility with steady gait and unlabored respirations.
Within seconds the patient lost responsiveness. This lasted for less than 5 seconds. The patient felt dizzy for about 10 minutes.