chrisvoncsefalvay/vaers-outcomes huggingface dataset:
brachial neuritis in addition to local redness, swelling  3/19/08 Reviewed office note of 2/22.  Vax record included & confirms as reported.   Patient experienced rectal bleeding & low abdominal pain.  Rectal exam WNL.  Referred for colonoscopy.  4/1/08 Reviewed additional PCP office notes of 2/25-3/14/2008.   FINAL Dx: adverse allergic reaction to vaccine w/brachial neuritis in addition to local skin reaction. Patient returned to office on 2/25 w/severe pain & burning in left axilla & left deltoid/shoulder regions since day after TDaP given on 2/22.  Her pain interfered w/sleep & caused her to feel SOB & anxious.  Exam revealed redness over several cm's upper outer shoulder, axilla & adjacent anterior chest & inner upper arm which was tender & warm.  Returned to office 3/14 & all shoulder symptoms including pain resolved within 3 days.
A consumer report has been received concerning a 5 year old male patient. The patient's concurrent disease included H1N1 virus infection. No concomitant medication was reported. The patient received FLUMIST (intranasal) on an unknown date. During an unspecified year in November he received the flu vaccine and came down with flu on 20-Dec. The patient experienced flu related complications. He was taken to the pediatrician when he developed a barking cough often characterizing croup. He was given doses of steroidal medication, prescribed by his pediatrician to combat the coughing, croup symptoms. His symptoms did not seem to be improving, so he was taken to the emergency room early Christmas morning. Doctors took a soft-tissue X-ray of his upper respiratory system and told it was collapsed a little. After spending the day with the patient, parents felt he needed to go back to the hospital. When his mother was changing his pants patient collapsed right in front of her and turned blue. Paramedics secured an airway. According to the patient's mother, the patient suffered severe brain damage due to a lack of oxygen from a collapsed airway. The patient died from flu related complications, collapsed airway and brain damage on December 29. It was unknown if an autopsy was performed. The reporter considered the events of flu related complications, collapsed airway and brain damage to be serious based on death and hospitalization criteria.
Received Pfizer vaccine, first dose on Wed. 01/13/21 between 12 and 1 P.M.  Thurs. 01/14/21  in the afternoon he began to note that he had  difficultly walking.  Went to bed when he woke up at  5:48 A.M.  he  reported he had ataxia.  Patient reported having to walk in tiny steps to stay upright.  He went to the emergency room.  Had CT scan  of head and found blood clots.  MRI performed.  Stroke found in right PCA territory, but no loss in strength in left lower extremity.  Sensation and vision intact.  Strength in all four extremities is 5 out of 5.
Pt recvd DTP/OPV/HIB 23JUL91 & 4 hrs later devel rash lasting 1 wk; Seen by MD mom felt that rash was from the shot;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Injection site pain within a few hours and continuing through 24-30 hours after. Mild fever after 20 hours, lasting an hour. Chills, fatigue, headaches starting after 9 hours after, lasting until 33 hours after the shot. Muscle soreness starting 9 hours after, lasting until 48 hours after shot.
I presented to the medical shot clinic event for my second COVID-19 injection on schedule. My injection was given by a nurse at the Hospital and while I did not watch the needle enter into my shoulder, I quickly developed the symptoms of adhesive capsulitis to my right shoulder within a few hours. Initially I did not realize why I was in such extreme pain but did notice that the injection site and bandage placed over top seemed very high. The next day I could not move my shoulder in any direction without severe pain. Regardless of this I still presented to work as I had no one to cover my shift but wasn't able to continue working due to the amount of pain and inability to use my right arm. My coworker is a family medicine Doctor who reached out to a local orthopedic surgeon and fortunately I was able to get a same day visit with the orthopedist. He diagnosed frozen shoulder on January 26, 2021 citing improper placement of the vaccine and I was prescribed a variety of medications including muscle relaxers and anti-inflammatory medicine. He offered to give me a shoulder joint injection however I was concerned about a corticosteroid affecting the efficacy of the Covid vaccine that I had just received. After only minimal relief with the medications that were prescribed hi was in directed by the orthopedic surgeon to start physical therapy which I did. Physical therapy sessions were only partially helpful, and I was still having limitations with my work duties as well as activities of daily living in my home (Such as being able to trust myself, wash my hair, use a blow dryer, doing light housework with my right arm well-being right hand dominant etc.). Finally, after eight weeks of conservative treatment not helping and daily pain I opted for a right shoulder joint corticosteroid injection at orthopedic office. Just a day after the steroid joint injection in my right shoulder I was significantly improved and for a few weeks I was actually pain-free. Unfortunately, a few days ago my shoulder pain started to recur and I have been advised by my orthopedic surgeon that the next step is an MRI and potentially more invasive treatments. I have no way of knowing the name of the nurse at the Hospital who administered my vaccine, and no reporting channels as I am not an employee of that facility. I was able to get the vaccine without being an employee because of my company's relationship with that facility. I have reported this to my employer however, as well as through the V-safe check ins.  I am discouraged and concerned that this may be happening to other patients going through that service for their vaccine.
Soreness at injection site. Developed red area in tricep area.  Redness developed 24 hours after second injection.  No fever, taking Ibuprofen. Did  not go to E.D. or urgent care.  Called office where rec'd injection and was given advise over the phone
Vomiting, extreme chills, uncontrollable teeth & mouth chattering, fever of 100.5 degrees.  Continued for about two hours.  I took a Tylenol pill and feel asleep.  The next morning my temperature was back to normal.  Felt tired and listless for next two days.
Time of vaccine 13:00 9/28/2009. At 16:00 swelling of throat, nasopharnx, and chest tightness began.  Benedryl 50mg PO taken at 16:30, followed by another 25mg PO at 21:00.  9/29/2009 - 3am 25mg Benedryl PO, still swelling of throat, difficulty swallowing and chest soreness. Albuteral inhaler utilized, 11:00 25mg Benedryl PO, 19:00 50mg Benydryl PO. 9/30/2009 am relief of 90% of swelling, no chest tighness, Zyrtec PO at 18:00.
Immediately post vax, the pt developed hives, burning, stinging, and redness at the injection site. Therapy with Benadryl was initiated, additional dose was given within 4-6 hours. She also developed a lacy type rash on her ankle. The reporter indicated that the pt's experiences were considered an important medical event. The pt recovered within six hours from the onset of episodes.
Left arm at injection site is red, painful, radiating heat, raised and hard. The circular sprawling area itches, as well. A rash was also present the day before I went to the doctor. I was just given a non-steroidal cream and antibiotics. I haven?t started them yet because I haven?t got them from the pharmacy yet.
Receipt of primary SPV on 1/6/2012 to left deltoid. No other vaccines given and no recent illness reported. Site checked 1/12/2012 with reported good take and bandage changed prior to drive home. Upon arrival home he complained of being tired. He awoke 1/13/2012 complaining of diffuse body stiffness and achiness stating it was hard to move (all joints/muscles ached). He noted bilateral axillary and cervical lymph node swelling which made it difficult to put arms down by his sides or lift overhead. He called medical and was advised reactions were normal to SPV but to report any onset of chest pain. He took "500 mg" Naproxen with partial relief of body aches. That evening his symptoms worsened and he reported "someone was standing on his chest". He complained of a sharp pulsing pain (4-5/10) to mid chest "as if bruised" and it "hurt to deep breathe". He took more Naproxen and got into his families whirlpool. His pain again eased (3-4/10) with heat, NSAIDs and position). His severe pain (7/10) lasted about 20 minutes. His symptoms continued with this on and off pattern over next 24-48 hours until returning to work on 1/16/12 when co-workers noticed him rubbing his chest (2-3/10) and he was directed to medical. 1/17/12 EKG normal-no ST-T changes, labs - hepatic panel nl with ALT 42, CBC low h/h 13.1/37.1, RBC 4.13 and platelets 126, differential nl w high neutrophils 79.9 and low lymph 13.4, CK panel normal (no troponin levels or LFT/chol levels documented), BNP high 274, and normal CMP, TSH and ESR. His echo was done 2/1/12 were normal with EF 65%. During interview with facility on 2/1/2012, this patient continued to complain of intermittent bouts of quick sharp midsternal chest aches that made him catch his breath. Duration of discomfort was about 2-10 minutes every other day. His last episode was during his 2/1/12 echocardiogram (resolved in 2 minutes). He advised position was a trigger (lying flat, on left side) otherwise bouts would occur at any time or day or position. Discomfort eased by changing position and slowing his breathing down. He was not taking any medication routinely. He denies any pain or restriction in ADL, and runs 1.5 miles every other day and does 100 pushups and sit-ups daily. He did admit to some chest pain when starting pushups but says this was a different pain and was more muscular in pectoris muscles by axilla. As of 2/8/2012 patient advised he has not had any recurrence of chest pain since taking Naproxen. He denied any other systemic symptoms (shortness of breath, n/v/d, joint pain, et al). Has f/u appt with PCP 2/24 for 6-8 wk check up...
Painful arm for 3 days, fever of 103 for 2 days, body aches chills, lots of appetite, and swollen lips and bad reaction of bumps on my lips
Two hours after injection I felt a fast heart rate and checked with an oximeter and my heart rate was over 100 up to 105. Then on 3/31 I recorded my heart rate throughout the day because I was getting scared feeling chest pain and feeling my heart pounding. I had readings of 115 to 120 and my normal is in the 70s. I tried to limit my activities, even walking, because my heart rate would increase when I was active. Again on 4/6 I was still having a fast heart rate of 113 to 115. Throughout this time my heart rate is staying higher than normal and I can feel it when it is beating too fast and strong. I have checked my heart rate with an oximeter today and it is still in the 90s, but better than it was a week ago.
I had body aches; fever; chills; fatigue  was Extreme - for 24 -48 hours Got really swollen, red and hot - at injection site; because of the information that Dr had give me before I went right in before it got bad again. Prednisone to treat it - four day course. I took all of it. That resolved the symptoms.
Accidental Error of administration of vaccination- Pfizer adult dose accidently was given to 11 year old pt. This is his 1st dose. Pt does not have any side effects or adverse event except injection site pain.
Covid arm; Covid arm; This is a spontaneous report received from a contactable consumer (reporting on herself). A 76-years-old Non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; lot number: EN6200 and Expiry Date was not reported) via an unspecified route of administration in Arm Left on Feb2021 06:30 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that on Mar2021 at 08:00, patient experienced COVID arm. No treatment was received for adverse event. Since the vaccination, patient was not tested for COVID-19.  Follow-up attempts are needed, further information is expected.
FELT ICKY; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced felt icky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt icky was not reported. This report was non-serious.
5-11 year old COVID Pfizer monovalent was administered to the pt (as the 3rd dose) when the pt should have received the 5-11 year old COVID Pfizer bivalent booster dose.
Patient reported a red knot the size of his fist at the injection site.  Knot is hard and painful
Pt complained of throat closing after the injection during the 15 minutes wait. Epipen 0.3 mg was given and EMS called
Initial case was received from a consumer on 21 November 2012. A male patient (age not provided) received a left deltoid intramuscular injection of ADACEL, sanofi pasteur Inc. lot number U4395AA, (corresponding sanofi pasteur Ltd. lot number C4210) on 25 October 2012. On the same day post vaccination, 25 October 2012, the patient complained of sharp pain and redness at left deltoid injection site with tingling down the left arm. He then started to notice a popping and clicking in left shoulder which persists to date, which required a doctor visit. The patient's past medical history was reported as unknown and illness at the time of vaccination was reported as none; however, he did have a bike accident in which he had injured his left arm prior to the injection. No diagnostic testing or treatments were reported. The patient's outcome was reported as not recovered. Documents held by sender: None.
Pt reported mild nausea and dizziness shortly after vaccine administered. Symptoms resolved in 5min without intervention. VSS. DC home NAD.
Vaccine administered 10/19. Patient developed red swollen painful arm. 10/26 came to pharmacy. Redness spread to elbow suggested medical attention.
Thyroiditis subacute; Dysphagia/Difficulty swallowing,; Lymph node pain; Lymphadenopathy/significant lymph node; pain; swelling worsening over a week; This is a spontaneous report from a non-contactable consumer. This is case 11 of 29. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration in 2021 (at the age of 50-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient had no past medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in 2021 (at the age of 50-years-old) (Batch/Lot number was not reported) for COVID-19 immunization. It was reported that the patient experienced thyroiditis subacute, dysphagia, lymph node pain, lymphadenopathy. She had difficulty swallowing, pain and significant lymph node, swelling worsening over a week. Calculated TTO (Time-to-onset) was reported as 21 days. On an unspecified date in 2021, the patient underwent lab tests and procedures which included Antinuclear antibody, Anti-thyroid antibody, Blood thyroid stimulating hormone, Full blood count, Metabolic function Test, Thyroxine free, Ultrasound thyroid (results were unknown for all). Outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883
Injection site reddness; Hives on chest; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 5KF37, expiry date 14th April 2020) for prophylaxis.   The patient's past medical history included injection site erythema and hives. Previously administered products included Unknown vaccination.   On 24th July 2019, the patient received Shingrix. On 24th July 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and hives. On an unknown date, the outcome of the injection site erythema and hives were unknown.   It was unknown if the reporter considered the injection site erythema and hives to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that patient reported injection site redness and hives on chest after receiving Shingrix.  The patient also reported that this was typically happens after she receives vaccinations and post operation. The reporter consented to follow up.
Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (Achy). At the time of the report, PAIN (Achy) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/24/2023 BILAT HEARING LOSS R09.02 HYPOXIA 4/9/2023 BILAT HEARING LOSS
Was a little achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 (Lot number: EN6200, Expiration Date: 20Jun2021) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: Verbatim: Allergies; "Sinus problems" (unspecified if ongoing), notes: Verbatim: Sinus problems; "Aches and pains" (unspecified if ongoing), notes: Verbatim: Aches and pains; "Neuropathy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Was a little achy".  No follow-up attempts are possible. No further information is expected.  Follow-up (12Jan2022): Follow-up attempts completed. No further information expected.
Her father let me know that patient felt nauseated a few mjnutes after vaccine.we had her remained seated with head down and she vomited a little
arm hurts a lot today compared to yesterday; Pregnant patient reported on 02Apr2021 that she received the vaccine on 01Apr2021.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts a lot today compared to yesterday) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient reported on 02Apr2021 that she received the vaccine on 01Apr2021.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Jan-2021 and the estimated date of delivery was 31-Oct-2021. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurts a lot today compared to yesterday) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient reported on 02Apr2021 that she received the vaccine on 01Apr2021.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 01-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient reported on 02Apr2021 that she received the vaccine on 01Apr2021.) had resolved. At the time of the report, PAIN IN EXTREMITY (arm hurts a lot today compared to yesterday) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-109463 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109463:Husband's case