chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 13 minutes of recieving  her first Moderna vaccine pt complained of  throat tightness and issues swallowing, no issues breathing. Epipen 0.3 administered to pt, after 1 minute pt experienced relief. Pt monitored for additional 45 minutes. Medical Director of our practice Dr. examined pt and pt seemed to be fine. Pt monitored for additional time then felt well enough to leave.
Patient received vaccine on 6/10/19, mother states no issues arose during administration. Mother noticed redness, swelling, and heat at injection site on 6/11/19 around 5pm. Pt did not have any fevers, trouble breathing, or tenderness to area. Mother has not administered any medications. Mother brought patient back to clinic for Same-Day appointment with Dr. Swelling has decreased today (6/12/19) however the redness and warm to touch has continued. Dr. has determined patient had a local reaction to vaccine but it will not prevent her from receiving vaccines in the future.
Patient is a 46-year-old male with a history of asthma and diverticulitis presenting to the emergency department with complaints of chest tightness and difficulty breathing times yesterday.  Patient states he recently received his second dose of his COVID vaccine 2 days ago.  Pain is described as mild upon onset is chronic mild.  No history of the same. Patient denies any vomiting or diarrhea. No fever.
8 days after my 1st dose I had a small rash appear at the injection site with itching. It has progressively gotten worse. I have swelling, redness, warmth and induration across my entire upper arm.
16 hours post vaccine child standing, went pale, coughed a "weird" cough, fell forward to the ground and was unconscious for few seconds, started shaking and drooling and was incontinent of urine. Once stood up he vomited in the hallway at school. EMT was called and examined child  O2 was around 90, no fever noted. Parent took child to Pediatrician. Child temp was at 101.2, Dr had him drink Gatorade in which he vomited. Took about 30 minutes at Pediatricians prior to going home.
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe
4/18 vaccination. Evening I had sore arm.  4/19 I woke up and felt like I was run over by a truck. Slight fever, flu like symptoms, coughing. I stayed in bed, drank fluids. The extreme fatigue started and progressed to a week later that I was beyond tired. I started to take xanax for the high anxiety. But I could tell the difference between medication tired and tired, lethargic.  Joint and body pain started in my neck and shoulder area and it started moving down my body. I went to my regular clinic, in tears, as I was in so much pain. They gave my muscle relaxers and prednisone. My BP was really low; 80/50's.  5/11 I saw my PCM recently and my Dr. stated it was a flare up caused by something. It was a possibility caused by vaccination but unsure.  The Dr. wanted to give me a compound medication to help but its not covered by my insurance.
19 days p/vax pt exp varicella w/less than 50 lesions & vesicles. no further info avail
mom states pt began crying approx 2 hrs p/vax & cried for 6 days; stopping only briefly to sleep; mom states took pt to MD immed; pt was examined & sent home;
Fever- 100.8, chills, sweats, bodyaches, headaches 1 week  Temp has resolved
Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Joint Pain-Severe, Systemic: Shakiness-Severe
Irritating raised red rash under the arm; Scattered, itchy, irritating raised red rash under the arm; irritating raised red rash under the arm of the arm; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021 at 15:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included prostate cancer.  Patient had no known allergies. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR), famotidine (PEPCID), loratadine (CLARITYN), and tadalafil (TADAL) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 12Mar2021 at 10:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 the vaccination. On 06Apr2021 at 20:00, the patient experienced scattered, itchy, irritating raised red rash under the arm of the arm the shot was given in, in the armpit covering about 40% to 50% of the skin's surface area. The patient received treatment for the events which included hydrocortisone topical cream and BENADRYL. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events red rash, itchy rash, raised rash was not recovered.  No follow-up attempts are needed. No further information is expected.
Two days after receiving  Boostrix in the right arm and Pneumovax-23 and Fluarix Quad (2019-2020) in the  left arm the patient experienced symptoms of feeling poorly, low grade fever, tenderness, swelling, warmth, and redness to left arm where Pneumonvax-23 and Fluarix Quad (2019-2020) were administered.  The patient was diagnosed with a vaccine reaction and likely uncomplicated cellulitis, prescribed antibiotics, and given instructions to return to clinic in two days if symptoms have progressed.  Two days  later (four days  after receiving vaccinations)  the patient stated some spread in redness but feels symptoms are resolving.
-itchy on site of injection -Big red circle on site of injection -Pain on left arm 3-4 wks -Left arm hurts when lifted
My nose started feeling stuffy and I had a headache which I thought was sinus pressure. I took OTC medicines and the next morning; I woke up with a fever. Then I went to Urgent Care.
This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, immediately after receiving BEXSERO, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site warmth was unknown. It was unknown if the reporter considered the injection site warmth to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The injection site became hot to the touch immediately after vaccination. The field representative was unable to provide any further details. The field representative requested to contact another nurse to obtain further details and the contact details were provided for the same. The nurse usually did not come in to the office until 3:00 pm.
Three friends die; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team. A 39-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Three friends die". The patient date of death was unknown. Reported cause of death: "Three friends die". It was not reported if an autopsy was performed.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835754 same reporter/drug/event for different patients.;US-PFIZER INC-202200835906 same reporter/drug/event for different patients.;; Reported Cause(s) of Death: Three friends die
Unknown flare ups; Itchiness in eye; Back pain; Arm sorness with pfizer injection shots; Arm sorness with moderna injection shots; Pain on knees; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Unknown flare ups), EYE PRURITUS (Itchiness in eye), BACK PAIN (Back pain), VACCINATION SITE PAIN (Arm sorness with pfizer injection shots) and VACCINATION SITE PAIN (Arm sorness with moderna injection shots) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Panuveitis and Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (Unknown flare ups), EYE PRURITUS (Itchiness in eye), BACK PAIN (Back pain), VACCINATION SITE PAIN (Arm sorness with pfizer injection shots), VACCINATION SITE PAIN (Arm sorness with moderna injection shots) and ARTHRALGIA (Pain on knees). At the time of the report, CONDITION AGGRAVATED (Unknown flare ups), EYE PRURITUS (Itchiness in eye), BACK PAIN (Back pain) and ARTHRALGIA (Pain on knees) had not resolved and VACCINATION SITE PAIN (Arm sorness with pfizer injection shots) and VACCINATION SITE PAIN (Arm sorness with moderna injection shots) had resolved.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of UNKNOWN FLARE UPS, ARM SORNESS WITH PFIZER INJECTION SHOTS, ARM SORNESS WITH MODERNA INJECTION SHOTS, ITCHINESS IN EYE, BACK PAIN and PAIN ON KNEES with HUMIRA(ADALIMUMAB) was no reasonable possibility and with PFIZER BIONTECH COVID-19 VACCINE was not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Fever; Headache; HCP called to report inadvertent administration of VARIVAX and PROQUAD to a patient. Patient was supposed to receive their second doses of VARIVAX and MMR-II but was instead given VARIVAX and PROQUAD simultaneously on 09/26/2023. No additional AE/PQC; This spontaneous report was received from a medical assistant, referring to a 4-year-old female patient. Concomitant therapies included diphtheria vaccine toxoid, pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (TETRAXIM). The patient's pertinent medical history, concurrent conditions,previous drug reactions, or allergies were not reported.  On 26-SEP-2023, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in the left lower thigh (strength and route of administration were not reported; lot number X018577 expiration date was reported and validated as 05-JAN-2025) and extra dose of varicella virus vaccine live (oka/merck) (VARIVAX) in the left uper thigh (strength and route of administration were not reported; lot number X006978, expiration date reported and validated as 07-MAR-2025) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (wrong product administered).  On 27-SEP-2023, the patient experienced fever (pyrexia) and headache. On the same date, the patient recovered from the events. No prescription drug treatment for the experience was required.  The causal relationship between the events and the suspect therapy was not reported.
Diarrhea, NauseaVomiting, loss of sense of smell Narrative:
This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. On 23-JUN-2014 the patient ws vaccinated with liquid PEDVAXHIB (lot # J016185, expiry date: 02-OCT-2016, dose and route of administration were not reported) that was exposed to temperatures out of range (multiple excursion over a 24 hour period, totaling 5 hours below 36F, including three cycles below 28F, have occurred on unspecified dates, reported as prior to the morning 23-JUN-2014). that were not supported by Merck's stability data. No adverse effects were reported. This is one of several linked reports received from the same reporter. Additional information has been requested.
Symptoms: Decreased mobility in right arm, arm pain, fever, chills, body aches, joint pain, extreme fatigue, migraine, head pain to the touch, abdominal discomfort.  Treatment: Tylenol extra- strength and fluids Time course: 5:00pm (4/20/21)- 1:30pm (4/21/21)
After a couple days, the patient because nauseous for a day or two and then developed stiffness in his arm, neck, back, and clavicle area. He has had these symptoms for about 5 weeks. Suspected administration being too high and accidental injection into the shoulder joint resulting bursitis.
Patient states on 2/7/15 had severe chills, body aches, sore joints. It affected her bulging discs in her spine and she could not move at all that day.
I started experiencing a very dry patch on the back of my neck about 1 month after receiving the second dose of the vaccine.  I actually thought it was just dry skin due to the climate that I live in.  I took a small break and went to another climate and it seemed to clear up, upon returning it did progress and my scalp was extremley dry and I had red patches on my neck as well in october but again did not think anything of it.  I finally made a appt to see a dermatologist I was able to seen on March 2, 2022 and was diagnosed with psoriasis.  I do not have any genetic history of this on either side of my family.
Started with a bump which was a little larger than a pea size. I was given the Pfizer eura at the time. I had no redness around the bump but was swollen and some bruzing and very sensitive to the touch with some hot sensation. Had some tingling sensation down the arm and under armpit. At this time symtons are not as they were when first given the vaccine but I do still feel some dull senstion in arm and in the shoulder area sometimes the feeling comes and goes but it's been well over a month now.
7/21/21 PMH of hypertension, obesity, CKD, left bundle branch block, CAD status post CABG, mechanical falls, hyperlipidemia and chronic pain; presented with shortness of breath
Approximately 30 min after receiving vaccination at office building, pt noted a feeling of 'warmth to the face' and 'burning eyes'. She returned back to vaccine admin site notifying of complaint. Dr. in adjacent building called to evaluate at 10:20 a.m. Exam unremarkable with mild conjunctival infection, though pt. also noting some facial flushing. BENADRYL 7.5 ml PO (12.5 mg/5ml) given. Pt noting resolution of symptoms by 11:20. Accompanied back to office after 30 min observation.
Bell's Palsy; Extremity Numbness; Initial Report Received on 04-May-2022 and 05-May-2022  A registered nurse reported that a 41 year-old patient (gender, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed Bell's palsy and extremity numbness.  Medical history was reported as newly diagnosed diabetes.  No relevant concomitant medications were reported.    On 05-Apr-2022, the patient received a dose of HEPLISAV-B (Lot # 937232, expiration date 04-Mar-2023 and NDC # not reported) in the right deltoid intramuscularly by a nurse practitioner.  On 22-Apr-2022, 17 days after having been vaccinated with HEPLISAV-B, the patient reported symptoms of photophobia, facial numbness (tingling of the mouth and then drooping) and numbness of the right lips progressing to all four extremities. The Emergency Room (ER) doctor diagnosed the patient with Bell's palsy. The treatment for Bell's palsy included steroids.  At the time of the report, the events were considered to be ongoing.   No additional information was reported.   Company Comment: Based on the temporal relationship, the events of Bell's palsy and numbness of extremities occurred 17 days after initiating the dose of HEPLISAV-B, a causal association between the events and HEPLISAV-B is possible. Risk factors include the patient's history of diabetes. The events of Bell's palsy and numbness of extremities are unlisted per HEPLISAV-B IB, Agency.; Sender's Comments: Based on the temporal relationship, the events of Bell's palsy and numbness of extremities occurred 17 days after initiating the dose of HEPLISAV-B, a causal association between the events and HEPLISAV-B is possible. Risk factors include the patient's history of diabetes. The events of Bell's palsy and numbness of extremities are unlisted per HEPLISAV-B IB, Agency.
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 70-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on unknown deltoid. The patient reported redness and swelling around the injection site that covered most of the upper arm and lasted for 2 weeks. The reporter did not know when the reaction started in relation to the 1st dose of SHINGRIX or if the patient self treated the symptoms.
Patient came to ED with swelling redness and soreness of right upper arm and generally not feeling well after receiving the PNEUMOVAX vaccine the previous day. After examining him it was determined that he had a reaction to the vaccine and had cellulitis on his right upper arm around the injection site. Symptoms: Symptoms: Rash, cellulitis Suspect Drug #1 Dosing: IM once. Treatment Drugs Used: Diphenhydramine Dose: 50 Units: MG Preq: OID Route PO, Sulfamethoxa/OLE/Trimethoprim Dose: 800/160 Units: MG Preq: BID Route: PO
Information has been received from a mother concerning her 22 year old daughter with allergies to unspecified therapy "SEPICOL" and therapy unspecified "SEPICHLOR" who on 06-DEC-2007 was vaccinated with Gardasil (first dose fo three).  There were no concomitant medications.  On 20-DEC-2007, "two weeks after the dose was administered", the patient experienced roughness and wrinkles on her knuckles and they felt like rubber.  A short time later, the skin on her hands, knees and elbows peeled.  The patient's roughness on her knuckles and wrinkles on her knuckles and knuckles felt like rubber and skin on hands, knees and elbows began peeling persisted.  The mother reported that she was unsure whether or not her daughter would receive the second and third doses.  Additional information is not available.
Initial misuse report received from a nurse on 07 November 2013. The 2-years-old patient had received FLUZONE 0.5 ml intradermal (site not provided). Reporter stated that 2 year old 9 month was given 0.5ml dose in early October. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
did not come in to work; was super sick; headaches; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (did not come in to work), ILLNESS (was super sick) and HEADACHE (headaches) in a 33-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (did not come in to work), ILLNESS (was super sick) and HEADACHE (headaches). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (did not come in to work), ILLNESS (was super sick) and HEADACHE (headaches) outcome was unknown.     No concomitant medication was reported.  No treatment medication was reported.
The morning of the 8th I had a stuffy nose I took an Alka-Seltzer. I went into work. By the afternoon, I felt awful, I was aching, really bad headache, and I felt cold also. I went home and went to bed. I decided to go through the weekend and the symptoms did not go away. I did an e-visit with my doctor and she prescribed an antibiotic. She advised to do the COVID-19 test. I received my chart notification and they told me I was positive for COVID-19.  I was on quarantine for 10 days. I also had pressure in my ears. I also lost my sense of taste and smell. I felt awful.  The first few days I felt awful and then the symptoms stared to get better over time. Now I have this lingering cough that will not go away, but it not productive.
This is a spontaneous report form a non-contactable nurse reported for a female patient. A female patient of an unspecified age and ethnicity received TRUMNBA, via an unspecified route of administration on and unspecified date at 0.5ml, single. The patient medical history and the patient's concomitant medications were not reported. The patient experienced rashes around the injection site, nausea and feeling crabby, all on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information expected.
Patient admitted to hospital over the weekend of 11-13 May 2007 with myocarditis. 05/22/2007 MR received for a 4 night admission (5/8-12/2007) for c/o chest pain x 2 days which was worsening. He had previously had a significant reaction to small pox vaccine evidenced by swelling and discomfort under his arm and swelling of the cervical and supraclavicular lymph nodes.  Chest pain was most significant with lying down and deep breathing, somewhat relieved by standing.  Upon exam in the ER pt. was febrile with redness and swelling at the small pox vax site on the L arm.  Otherwise PE WNL. ID consult 5/8/07 with DX:  Viral vs post-vaccination myopericarditis. Pt. experienced an episode of desaturation on 5/9/07, but improvement was noted and pt was d/c on 5/12/07.   Discharge DX: Viral myopericarditis.