chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I looked at my arm and the hole area is red and hot; I looked at my arm and the hole area is red and hot; Terrible headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (I looked at my arm and the hole area is red and hot), ERYTHEMA (I looked at my arm and the hole area is red and hot), HEADACHE (Terrible headache) and PYREXIA (Fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bone density abnormal. Concomitant products included ABALOPARATIDE (TYMLOS) for Bone density abnormal.    On 13-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced HEADACHE (Terrible headache) and PYREXIA (Fever). On 15-Sep-2021, the patient experienced FEELING HOT (I looked at my arm and the hole area is red and hot) and ERYTHEMA (I looked at my arm and the hole area is red and hot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 15-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, FEELING HOT (I looked at my arm and the hole area is red and hot) and ERYTHEMA (I looked at my arm and the hole area is red and hot) outcome was unknown and HEADACHE (Terrible headache) was resolving.            it was reported that reported reaction was not life threatening and at the time of report headache come and go, but not deadly as it was.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. He also presented to the ED on 4/20/2021.
Information has been received from a physician concerning a patient who on an unspecified date was going to be vaccinated with Gardasil (lot# unknown) late.  Follow-up information was received from a licensed practical nurse concerning a 19 year old white female with a "head cold" as per mother at the time of vaccination who on 19-DEC-2007 was vaccinated with a third dose of Gardasil (lot# 659439/1267U) IM in the left deltoid at 9:33 AM.  On 19-DEC-2007, at 9:41 AM after witnessing her sister have a syncope episode the patient felt dizzy.  The patient was assisted to the exam table.  The patient was in a supine position with her legs elevated with cold packs on neck and forehead.  The patient was continued to be monitored for 15 to 20 minutes.  The blood pressure measurement was 110/70.  On 19-DEC-2007 the patient recovered.  Additional information is not expected.
Patient received second flu vaccine in same season (first was in August according to patient and second was administered on 2/15/17).
A report was received from a health care professional on 22OCT2003 concerning a 69 year old female vaccine who developed a protruding, ping pong ball sized swelling immediately after receiving Fluvirin vaccine on 14OCT2003. On 14OCT2003, the vaccinee developed a protruding , ping pong ball sized swelling immediately after receiving Fluvirin vaccine. The reporter stated that the adverse event is most likely resolved. There was insufficient information to determine the investigator's causality assessment. Reference : PJP200300869, PJP200301318.
onset 3/1/2021 disabling pain in 3 arthritic areas simultaneously without prio overuse
When she breathed deeply it caused a pain across her back and ribs; When she breathed deeply it caused a pain across her back and ribs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, No events), administration date: 05Apr2021, for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), MUSCULOSKELETAL CHEST PAIN (non-serious) all with onset 27Apr2021, outcome "unknown" and all described as "When she breathed deeply it caused a pain across her back and ribs". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nasal congestion severe headache for two days, flush skin, nose dripping combined with congestion chills for two days irritated emotionally.
pain and swelling at injection site, headache, diarrhea, muscle and joint achy, chills. Took Ibuprofen for pain
Palpitations and irregular heart beat.  I am an RN (teach nursing)  Seemed like PVCS, definitely not A Fib.  Went away by next morning.  This was after first dose of Shingrix vaccine
Child fell in lobby about 15 min before Imm & hit head. Had redness on forehead & (L) cheek. Pt was very active & alert during vs at health dept. PEERL. Mom was advised to see PCP due to pt history. Imm given. Mom reports 2 hrs later child had seizure, 911 was called & pt airlifted to hospital where he was hospitalized x 4 days.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 17-SEP-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 552 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved . This is one of several reports received from the same reporter. Additional information has been requested.
Initial report received on 15 January 2010 from a health care professional. A 54-year-old female patient had received a first intramuscular injection of H1N1 (lot number UP064AA) on 12 January 2010. Two days post-vaccination on 14 January 2010, the patient complained of feeling like her head was swimming. When asked by the pharmacist if she was dizzy, the patient stated no she felt like her head was swimming. It was not reported whether the patient required medical evaluation or treatment. At the time of this report, the patient had not recovered. Documents held by sender: None.
Patient indicated that Dizziness, Headache, and Blurred Vision started after receiving the flu shot
Lips and jaw felt significantly numb and tingly, dizziness and faint feeling, approx. 30 minutes after injection. Symptoms lasted about an hour. Pharmacist had instructed me to wait 15 minutes after injection in case of a reaction, which I did. I felt fine when I left the store and got into my car, but while driving home, I began to have the symptoms described above. I pulled into a hospital ER parking lot and stayed in or near my car until the symptoms subsided. I called my GP and talked to a nurse, who said if I could breathe and swallow, I was safe to go home. I did not enter the hospital ER or seek medical treatment because the symptoms did not get worse. After returning home and waiting about another hour, facial numbness completely subsided.
weakness; Itchy hives at the left arm, right arm , at the top to the shoulder , upper chest , neck , back , and; A fast heartbeat; swelling under the right eye; Pain at the injection site and headache; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHENIA (weakness), PRURITUS (Itchy hives at the left arm, right arm , at the top to the shoulder , upper chest , neck , back , and) and INJECTION SITE PAIN (Pain at the injection site and headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to drug (allergic to piroxicam.) on 02-Mar-2021, Allergic skin reaction (allergic to propylene glycol) on 02-Mar-2021 and Allergic reaction to drug (allergic to polysorbate.) on 02-Mar-2021.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ASTHENIA (weakness), PRURITUS (Itchy hives at the left arm, right arm , at the top to the shoulder , upper chest , neck , back , and) and INJECTION SITE PAIN (Pain at the injection site and headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, ASTHENIA (weakness), PRURITUS (Itchy hives at the left arm, right arm , at the top to the shoulder , upper chest , neck , back , and) and INJECTION SITE PAIN (Pain at the injection site and headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Non-Significant information Appended - NNI received
GBS; SWOLLEN BLACK AND BLUE LEFT ARM; BLACK AND BLUE LEFT ARM; BASE OF THE FEET VERY RED; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cats allergy, and dust allergy, and other pre-existing medical conditions included: The patient never got flu shots before and never had the flu. Patient was very healthy prior to the vaccine, never missed a day of work. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205821A expiry: UNKNOWN) dose was not reported, 01 total administered at left arm on 10-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 78 years old. No concomitant medications were reported.  On 13-APR-2021, 3 days after the vaccine, the patient happened to have a blood test and saw the primary care doctor. The patient had already started to have symptoms, base of the feet very red, cannot stand to touch sheets, very sensitive. The patient used to be able to walk 4-6 miles per day now can barely walk. 1 week later the patient rolled over and fell to the floor while getting out of bed. Both legs were numb. Has progressed to tingling in legs. The primary care doctor initially let it go, and informed it was too rare. Then as symptoms gradually evolved the patient went to several specialists. The vision was affected (blurry) and swallowing became difficult, sometimes the patient could only takes liquids. The patient knew someone who got a flu shot when he was 18 and got Guillain Barre syndrome (GBS) and was paralyzed. For which the patient kept doing research and seeing specialists. The patient finally saw a neurologist, referred by the primary care physician, and got the official diagnosis of Guillain Barre last week of this report. On an unspecified date in APR-2021, the patient experienced swollen black and blue left arm lasted for weeks after vaccination, with pain.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen black and blue left arm, black and blue left arm, and left arm pain, and the outcome of gbs and base of the feet very red was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220806993- covid-19 vaccine ad26.cov2.s-GBS. This event(s) is labeled per Agency and is therefore considered potentially related.
Chills, uncontrollable shaking for 40 minutes, high blood pressure (150/80) taken by EMT, vomiting, oozing eyes (no redness), afebrile went away after vomiting.
Skin rashes, hives, wheezing, asthma, migraines, fatigue, heart palpitations, anxiety, ear ringing, facial flushing, increased BP, and HR.  Medics ordered rest and confined to quarters. Motrin, Tylenol, ice packs, and fluid replacement were administered.
NEUROPATHY 8/31/2021 ATRIAL FIBRILLATION, UNSPECIFIED
I had cough, congestive, fever, chills, and headache. These lasted for about a week or so. On Jan 31, I tested positive for Covid-19.
This spontaneous report as received from a Licensed Practical Nurse refers to 3 patients of unknown age and gender. On an unknown date, patients were vaccinated with, .5 ml PNEUMOVAX 23, IM, with 25 gauge needle, 1 inch (site of administration not reported, lot # reported as H012650, exp 27-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, patients experienced swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch. No treatment was commenced. Pain subsided in 2-3 days. The events went away in 3 days. Patients sought unspecified medical attention. There were no lab diagnostic studies performed. It was reported that PNEUMOVAX 23 was not reintroduced. The relatedness for swelling, "knot" in the arm, pain that runs down the arm that starts at injection site and site was warm to the touch is unknown for PNEUMOVAX 23. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Allergic reaction resulted in E.R. visit. Drs office visit today (11-27-12) cellulitis.
pt recv vax 20FEB96 & 21FEB96 pt exp vertigo problems;
normal activity and health after injection at 10:00 am. started feeling ill after a normal nights sleep upon awakening at 5:00 am. felt nausau,  drank water, did not feel like myself, did not go to work, Slept fittingly, threw up. spent remainder of day and that night in bed. check for fever several times but never had higner than 98. spent that time with zero energy, no appetite, no energy. 02/24/2021 woke up at 6:00 am feeling like my old self. went to work, returned home, ate moderate lunch, feeling like my old self, may eat normal supper though i still don't have an appetite., i am thinking since i never take any kind of medicene, am seldom sick with any ailment, the covid 19 vaccine was too strong for my system. i am concerned about taking the 2nd dose (due3/15/21). what do you discern? my wife had the vaccine the same day with no side effects. oh, we both had really sore injection sites (could not lift our arms over our heads).
I had pretty intense joint pain about 4-5 hours after the shot. It was primarily in my right shoulder, elbow, wrist, and fingers.; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP7533) via unspecified route of administration in the right arm on 26Mar2021 at 14:45 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. Medical history included inflammatory bowel disease (Crohn's). Concomitant medications included mesalazine (APRISO), women's multi-vitamin and ashwagandha (KSM-66); all from an unknown date for unknown indications. 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. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 18:30, the patient experienced pretty intense joint pain after 4-5 hours after the shot which was primarily in the right shoulder, elbow, wrist and fingers. The pain lasted most of the night but subsided the following morning. The patient did not receive treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event pain in joint involving hand was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated coding of history: IBD (Crohn's), Deleted concomitant drug Multivitamin and Concomitant therapy selected as yes.
Information has been received from a health professional concerning a 6 year old male pt who on 22-MAR-1999 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approximately 12-APR-2004, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that "there was no single report of
Information has been received from a physician concerning a 2 yr old female with no pertinent medical history and no allergies who on 15Nov04 was vaccinated with a dose of varicella virus vaccine live (lot650227/1110P). There was no concomitant medication. On 05Aug05 the pt experienced breakthrough. It was noted that she had 20 lesions around her lower trunk and upper leg. She did not have a fever and the lesions were described as not very itchy. Most of the lesions were crusted over but two were vesicular. The child was given hydroxyzine hydrochloride (Atarax). It was noted that there was no known exposure to chickenpox there were no lab tests performed. No product quality complaint was involved. Additional information has been requested.
Sore arm; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient had a sore arm after receiving the 1st dose of Shingrix. For tolerance after 2nd dose refer case US2019AMR180635.
Case number PHHY2011US63525 is an initial spontaneous report received from a nurse on 13 Jul 2011. This report refers to a 19 year old male patient. He was vaccinated with MENVEO (batch number: M10034) intramuscularly on 11 Jul 2011. However, the patient received only the Men CYW-135 liquid conjugate without reconstituting it with Men A powder conjugate. No adverse event was reported following this drug administration error.
After receiving the fourth dose, the patient is having a lot more of a sore arm than with the last shots; has a big painful and swelling lump under the armpit, lump is pretty large, it has the size of a baseball; lump is hard, sore, and very painful to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After receiving the fourth dose, the patient is having a lot more of a sore arm than with the last shots), AXILLARY MASS (has a big painful and swelling lump under the armpit, lump is pretty large, it has the size of a baseball) and AXILLARY PAIN (lump is hard, sore, and very painful to the touch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 039F21A, 045A21A and 031M20A) for COVID-19 vaccination.     The patient was never diagnosed or tested positive for COVID-19 disease. The patient did not have any allergies to medications, food and other products. The patient had no acute or chronic illnesses at the time of vaccination.  Previously administered products included for Flu: FLU VACCINE VII (patient does not remember the exact date of administration) in October 2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (After receiving the fourth dose, the patient is having a lot more of a sore arm than with the last shots), AXILLARY MASS (has a big painful and swelling lump under the armpit, lump is pretty large, it has the size of a baseball) and AXILLARY PAIN (lump is hard, sore, and very painful to the touch). At the time of the report, PAIN IN EXTREMITY (After receiving the fourth dose, the patient is having a lot more of a sore arm than with the last shots), AXILLARY MASS (has a big painful and swelling lump under the armpit, lump is pretty large, it has the size of a baseball) and AXILLARY PAIN (lump is hard, sore, and very painful to the touch) had not resolved.            Concomitant medication included multivitamins (over the counter medications).  On 30-Apr-2022, the patient received the second booster dose of Moderna COVID-19 vaccine.  The adverse event did not cause the patient to seek medical care.  The patient experienced sore arm with the other received doses of Moderna COVID-19 vaccine.  No treatment information was provided.   This case was linked to MOD-2022-555509, MOD-2022-556237, MOD-2022-556238 (Patient Link).