chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient was administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a 12-months-old female patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies or concomitant medications was provided.    On 25-AUG-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not provided) lot # S024364 expiration date 06-AUG-2021, for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).  The improperly stored dose experienced temperature of -14 degree Celsius (°C) to -10°C (average temperature was -13.04°C) for 45 min. There was no previous temperature excursions. The call was because a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA000691: US-009507513-2009USA000716:
Arm began hurting few hours after administration.  Around 1am that night after the vaccine he started with a fever and his arm was visibly red and swollen, and he complained it hurt especially when moving it. He slept until 11am the next day. When he woke up he still had a fever, redness and swelling in arm and slept off and on all day. He was unusually fussy even more so than usual when not feeling well. He was crying off an on all day over nothing.  He also started getting muscle tics and twitches. The tics occurred in his face and also his arms and legs, both while sleeping and when awake.  The fever and arm redness and swelling lasted for approximately 3 days before resolving. However the tics/twitches and mood/behavioral changes continued and got drastically worse.  He developed sever separation anxiety and just anxiety about things that he never had before and things that make no sense. It is becoming almost obsessive in these anxiety's and worries. He cry's frequently through out the day. The tics/twitches occur during rest and activity.
Shortly after vaccine admin, patient reported feeling dizzy. Patient appeared pale. Assist x2 into recliner chair and was physically weak. Reclined and provided water and snacks. Patient progressively felt better with 35 min observation, felt "normal" at discharge from clinic.
Headache; Blur in center of visual field and pulsing rim ofwhite triangles, affecting both eyes; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Feb2021 at 09:15 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history included The patient had no known allergies to medications, food or other products allergic respiratory symptom, allergy to molds and penicillin allergy. Concomitant medications included acetylsalicylic acid (ASPIRIN). The patient previously received azithromycin (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021 the patient experienced blur in center of visual field and pulsing rim of white triangles, affecting both eyes. On 26Feb2021 at 10:15 the patient experienced Headache. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event Blur in center of visual field and pulsing rim of white triangles, affecting both eyes and Headache was resolved.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
lightheaded, heavy feeling descend through body -- heavy rush fatigued feeling; intense for 30 minutes, and continued for the rest of day less intensely, intermittent chills, feverish feeling of tingling around head to toe, bad headache and ache in the back of neck . over the counter med Tylenol. 12/30/2020slight headache and back of neck ache continues and fatigue, heavy feeling resolved, Tylenol and ibuprofen today. Injection site is very sore.
8hr p/vax pt devel sz (fist clenching, teeth clenching, arm stiffening & cyanosis) lasting 45-60sec, assoc w/t104.9;pt evaluated @ hosp where subsequently in stable condition
PATIENT REPORTED SWELLING AND REDNESS. LASTED APPROX 1 WEEK.
Patient presented to a vaccination clinic on 10/20/22.  She requested and received a Pfizer Covid bivalent booster in her left deltoid at approximately 2:20pm, administered by an RN.  She did not experience significant discomfort at the time of the injection. By approximately 8:30pm she had significant increase of injection site discomfort, consistent with her expectations.  She did not sleep on her left side.  At approximately 8am the next morning, 10/21/22, she experienced ?shooting pain? down her left arm which quickly progressed to ?excruciating? pain in the left side of her neck and half-way down the left side of her back, mid-scapulae. The pain ?felt like nerve pain, not muscular.? The pain persisted until after she took Motrin 600mg at 11:30am.   She has residual moderate discomfort in the left side of the back as well as tenderness at the injection site. As we spoke on the phone at 2:45pm on 10/21/22, she viewed the injection site in the mirror.  The site has approximately 1.5inch diameter of swelling and a ?faint outlined rash.?  ?I don?t know if it?s my imagination,? but she notes that the skin has slightly discolored dot pattern outlining the swelling in a teardrop shape, with slight tapering distally. She has not sought medical attention and chooses not to at present.  She contacted the health district to report the symptoms with the assumption that they were related to the vaccination. She will consult with her physician, or go to Urgent Care if she becomes concerned.  I recommended medical evaluation, including cardiac evaluation, and the patient has taken it under advisement.
Shivering; Feeling cold; Fever; Headache; Fatigue; Felt like I was coming down with something; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 3rd October 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd October 2020, less than a day after receiving Shingrix, the patient experienced shivering, feeling cold, fever, headache, fatigue and feeling unwell. On 5th October 2020, the outcome of the shivering, feeling cold, fever, headache, fatigue and feeling unwell were recovered/resolved.   The reporter considered the shivering, feeling cold, fever, headache, fatigue and feeling unwell to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for himself. On Saturday, the patient received 2nd dose of Shingrix on left arm. Later that evening he experienced shivering, feeling cold, fever, headache and fatigue. He stated that he felt like he was coming down with something. The patient experienced these symptoms through Sunday. On the date of reporting, the patient was feeling much better and symptoms were resolved. The reporter consented to follow up.
sore arm; felt a little tired for 1 day; had a low grade fever; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (sore arm), FATIGUE (felt a little tired for 1 day) and PYREXIA (had a low grade fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced MYALGIA (sore arm), FATIGUE (felt a little tired for 1 day) and PYREXIA (had a low grade fever). At the time of the report, MYALGIA (sore arm), FATIGUE (felt a little tired for 1 day) and PYREXIA (had a low grade fever) 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 medication reported. No treatment information was provided.   This case was linked to MOD-2021-408555 (Patient Link).
Diarrhea; Stomach pain; felt little weak; This is a spontaneous report from a contactable consumer, the patient. A 24-Year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 17Mar2021 at 14:00 (at the age of 24-year-old), as a single dose for COVID-19 immunisation. The patient's medical history was none. The patient was not allergic to medication, food and other products. Concomitant medications included Vyvanse (MANUFACTURER UNKNOWN), lutera (MANUFACTURER UNKNOWN), melatonin 3mg supplement as needed (MANUFACTURER UNKNOWN). The patient had not received other vaccines within 4 weeks prior to COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since vaccination. On 17Mar2021 at 12:00, the patient experienced diarrhea shortly after receiving vaccine, stomach started hurting, stomach pains and felt little weak. The patient received no treatment for diarrhea, stomach started hurting, stomach pains and felt little weak. The clinical outcome of diarrhea, stomach pains and felt little weak was resolving.   Information about lot number cannot be obtained. No further information is expected.
sleepiness; Achy joints; He experienced fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness), ARTHRALGIA (Achy joints) and FATIGUE (He experienced fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (He has usual migraines). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SOMNOLENCE (sleepiness), ARTHRALGIA (Achy joints) and FATIGUE (He experienced fatigue). On 06-Apr-2021, SOMNOLENCE (sleepiness), ARTHRALGIA (Achy joints) and FATIGUE (He experienced fatigue) had resolved.            No treatment were provided.   This case was linked to MOD-2022-462964, MOD-2021-062088 (Patient Link).
On 5/16/03 @ 3:10 pm patients mother reported patient had rash on LAT and Patient  c/o itching, scratching at injection site.  Also reported soreness at site.  5/19/03 mother of patient stated rash gone.
Vaccine was labeled with expiration date provided on Moderna website 11/01/2021 . It was discovered that this was for frozen storage not for refrigerated storage. Label should have stated 10/03/2021. Patient received expired vaccine on 10/29/2021. Vaccine expired 10/03/2021
Burning tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (Burning tongue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced TONGUE DISCOMFORT (Burning tongue). At the time of the report, TONGUE DISCOMFORT (Burning tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reportedly, the patient experienced burning tongue which started 4-5 hours after receiving the vaccine. No relevant concomitant medications were provided. No treatment information was provided. No lab data was provided by the reporter
Next day developed cough and congestion in lungs, Dr prescribed antibiotic (Amox-clav 500 mg) 3 days later they gave no relief or made any difference. Cough still persisting 24/7. Patient has been for whole month. Still suffering. Had some fever first two wks.
No adverse reactions occurred with resident. We would like to report resident had gotten other brand dose. Resident did not inform staff in our facility that she already received Pfizer first dose about 2 months ago, and she consented to receive Janssen dose when agency came yesterday (6/16/2021). Resident received Janssen vaccine yesterday, there is no adverse event nor illness related to Janssen COVID vaccines. This report is to make you aware that resident didn't receive 2nd dose of Pfizer, but received Janssen instead per resident and spouse request.
Bruising, 7 in long x 3 in wide, pink, red, purple, feels warm, no itch/painful, painful when pressed on does not affect ADLS, appeared over the weekend.
This spontaneous report was received from a registered nurse and refers to a 3 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-AUG-2016. On 30-SEP-2016, the patient was vaccinated with an improperly stored PROQUAD, lot # M019233 with expiration date of 17-OCT-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 3 degrees Fahrenheit for 3 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA013888:
Vaccines given 1/26/05. About 12 hours later vomited. Vomited again thru night and again on 1/27/04 about 22 hours after vaccine given. Had temperature of 100.9.
BREAST TENDERNESS; NIPPLE TENDERNESS; HOT FLASHES; MENOPAUSE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: not reported) dose was not reported, once a total administered on 12-MAR-2021 to left arm as prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced menopause. On 13-MAR-2021, the subject experienced hot flashes. On 25-MAR-2021, the subject experienced breast tenderness. On 25-MAR-2021, the subject experienced nipple tenderness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes on 16-MAR-2021, had not recovered from breast tenderness, and nipple tenderness, and the outcome of menopause was not reported. This report was non-serious.
Massive migraine, massive body aches, vomiting. The worst of it lasted 2 days and gradually eased up. Took nausea meds and drank lots of fluids. Still waking up with a headache every morning. Hasn?t gotten as bad as it was. I?m taking a lot of ibuprofen on a daily basis.
new onset erythematous pruritic rash started on Arms 02/02/2021 and then spread from neck to ankles
face red; loss of appetite; chills; fever; headache; muscle aches; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA, DECREASED APPETITE, CHILLS, PYREXIA, and HEADACHE in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ERYTHEMA, DECREASED APPETITE, CHILLS, PYREXIA, HEADACHE, MYALGIA, NAUSEA, and FATIGUE. At the time of the report, ERYTHEMA, DECREASED APPETITE, CHILLS, PYREXIA, HEADACHE, MYALGIA, NAUSEA, and FATIGUE had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment medication not provided   Most recent FOLLOW-UP information incorporated above included On 10-May-2021: Event outcome updated to resolved.
The chills began about 8pm. I had a fever which went to like 101 so I took tylenol but the fever went up a little higher.  I fell asleep and woke up about 11:30pm with a 103.4 fever so I stayed awake a little and took ibuprofen and tylenol throughout the night.  When I woke the next morning the fever was 101 but went down to like 99 later that evening.  The fever finally broke about 11am the next day but returned later  that day for a little while.   I was so tired  I slept like a solid day and woke up yesterday feeling sluggish and developed another 100.3 fever last night, took motrin and I feel better today.
Following vaccine and during observation client complained of being "light headed" and "dizzy" for a few minutes.  EMS and Dr on site and client reclined briefly in her car seat.  Blood pressure was 150/90  pulse 66 02 saturation 95%.  Client was alert and oriented and released when she was feeing better. Advised to seek medical attention later if needed.  Client stated she has her "life line" and was wearing it around her neck.
Student was given the  above immunization.He immediately start c/o nausea and dizziness.Skin noted to be pale, diaphoretic. VS B/P 100/70, HR -74, pulse Ox -98%, no loss of consciousness.Student remained alert and oriented X3.Water given, cold compress applied ot neck and forehead. Student verbalized feeling better after drinking water. Escorted to another room to rest and to be observed. Steady gait, student stated " I am OK ".  VS rechecked after 15 minutes ,B/P 105/70, HR-82, pulse Ox 98%. Student denies any dizziness or nausea. Home with his Dad.
Intense arm pain; Mouth ulcer; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EIN 0151) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no food and drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 03:00, the patient experienced intense arm pain and mouth ulcer. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events intense arm pain and mouth ulcer was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
broke out in a red rash, not terrible, it is about 2 inches or like 3 inches and it itches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 14Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "not recovered", described as "broke out in a red rash, not terrible, it is about 2 inches or like 3 inches and it itches". Additional information: Consumer stated, "I am 79 years old and I got the RSV Shot (As consumer was not sure about the name) last Saturday, so it is been a week, and I broke out in a red rash, not terrible, it is about 2 inches or like 3 inches and it itches and that is not going away." The consumer does not know what shot they used. When paraphrased, patient broke out with a rash the very next day, that is not terrible. Patient was not sure if it is a side effect and wanted to know if it was normal.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
pt recvd vax & approx 2 1/2" below acromian process, quarters sized circular erythema; on rt arm 1 1/2" down > than quarter size, firm w/erythema & warm to touch;
resulted in hematoma.; This is a Spontaneous report from a Pfizer-sponsored program. A contactable Pharmacist reported for a Patient that. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. The pharmacist stated that they have an issue with the administration of the second dose. He said that their nurse hit the blood vessel of the patient and resulted in hematoma on an unspecified date. The pharmacist is asking if it may have an effect with the efficacy of the vaccine due to the blood coming from the injection sight. Asked if they can get another dose if it won't be able to work. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Initial report received on 22 July 2009 from a health care professional. A 51 year old female patient received ADACEL reported as both intradermally in the left forearm and intramuscularly in the left deltoid (lot number not known) and APLISOL (manufacture JHP, lot number 111056) intramuscularly in the right forearm on 20 July 2009. On 21 July 2009 the patient experienced a burning sensation at the site which was a 5x5 cm area. The next day the patient had a 5x5 cm raised red area with a 1x1 cm higher raised area in center with a white area in the center of this inner raised area. The patient required a doctor's visit. No further information was provided. The patient was not recovered at that time. List of Documents held by Sender: none.
Patient experienced sweats, lightheadedness, and nauseousness approximately 5 minutes after administration. Patient last ate 10 am that morning of 9/28/21. Patient sat additional 20-25 minutes after side effect and was fine to leave. Pharmacist called patient at home on 9/28/21 at 7:25 pm and patient stated feeling better.
Patient described left arm was swollen and "hard as a rock"; sx began afternoon of 12/6/16. Advised patient to call his MD.
Felt fine immediately after Zostavax given in left subcutaneous upper arm, but approximately 5 hours later, noticed redness around site on her left deltoid.  The next morning she felt flu like symptoms, bodyaches, low grade fever, cold sweats, chills, nausea for 2 days. Didnt treat with tylenol or other medication.  At 2-3 days post injection she  noticed lower deltoid with large area of swelling and redness covering half her upper arm.  Arm improved gradually since then. Then, 5 days after shot, noticed mosquito-bite like welts on both arms from upper arm to forearm. Noticed finger itching at 6 days after injections where there was no bite.  She has been using diphenhydramine cream topically which seemed to help. she is allergic to benadryl PO which she didnt realize is the same medication.  No shortness of breath, throat swelling or coughing.
Patient developed 3 inches of marked erythema and induration with slight bruising in left deltoid where DTAP was given.
At the injection point on my arm a red, swollen spot developed. Which after research I came to find out I ended up developing "COVID arm".