chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up at 7 in a bad mood, usually is happy. Sister reported patient lay down, started shaking, eyes rolled back, not responding, lasted a few minutes, sleepy afterwards, taken to clinic and then the ED.
Local redness 2 x 2 cm with swelling, no induration, non-tender.
3cm X 3cm redness with raised area at right upper arm. Area is warm to the touch. Pt denies any soreness, pain or discomfort.
Pain at injection site - sudden and more painful compared to that of dose 1.  Other adverse events that happened with second dose that did not happen with 1st dose:  - Insomnia on 1/28/21 night up to 1/29/21 early morning, needed melatonin to help with falling asleep. - Grogginess/lightheadedness on 1/29/21 morning, some mild headache. Proceeded to take 2 Tylenol 650 mg tabs. - Headache, dizziness, and fatigue worsening during 1/29/21 throughout the day. Severe headache/dizziness, especially if moving head quickly, on 1/29/21 evening - prompting to take 2 Advil 200 mg tabs.  - The headache and injection site pain were lessened significantly, but still there on 1/30/21. All other symptoms resolved.  - All symptoms resolved by 2/1/21.
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown dates, the patient received improperly stored doses of VARIVAX lot # L020002 with expiration date 02-JUN-2017 and lot # M000757 with expiration date 06-JAN-2018 (dose and route of administration were not reported). The vaccines underwent a temperature excursion of 14.4 degrees Celsius for 30 minutes and 13.3 degrees Celsius for 1 hour. Data logger was used. It was provided that vaccines underwent previous excursion at 9.0 degrees Fahrenheit for 7 hours on an unspecified date. No adverse effect reported. This is one of two reports received from the same source. Additional information has been requested.
around midnight (about 14 hours after vaccination) started to shake and shiver (chills) very severely. Low grade fever. Body aches all over, excessive sleepiness. Unable to really do anything because my body was so sore and the chills were so bad. This stopped around 10pm on 01/31/21
Patient received 1st dose June 3, 2021 and then came in June 17, 2021 to receive 2nd dose however it was too early to get second dose
Pt calls to report generalized red rash since last Friday. Started in antecubital space of left arm and has progressed to cover bilat arms, chest and abd, back, buttocks, and lower extremities to calves. Denies throat swelling, breathing diff, or fever. States rash is red, raised, and itchy. States looks like mosquito bites. Pt states rec'd TDaP at clinic on Thurs and wonders if injection could have caused rash. Pt is not using any OTC tx.
ER 4 days p/immun w/swelling of lt leg; getting worse by the next day face swelling & leg; adm to hosp; temp cont;
Gland in throat became very swollen, under left ear (side of vaccination in arm). Gland became so swollen that my face went numb for 2 days on the left side.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # M000996 with an expiration date: 07-JAN-2018) (dose, and route of administration were not reported). No adverse effects were reported. There was no product quality complaint involved. Additional information is not expected as there was no consent to contact the reporter.
Was sick; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-455427, MOD-2022-455428 (Patient Link).
Approximately 43 hours after vaccines were given, he spiked a fever of 102.8F axillary.  He ran a continuous fever and was very irritable for approximately 48 hours, but had no other symptoms.
She received her immunizations on 1/16 and developed urticarial rash 1/21. Patient had 0 previous hx of reactions to vaccinations and had 0 previous hx of Urticaria. Antihistamines were suggested.
asthma; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team, Program ID: (159558).  A 5-year-old male patient received BNT162b2 (COMIRNATY), on 19Jul2022 as dose 1, single (Lot number: FT9142, Expiration Date: 31Dec2022) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ASTHMA (non-serious), outcome "unknown".  Additional information: Caller clarifies that the patient received a dose of the Pfizer Covid vaccine with the maroon cap 21 days ago on 19Jul2022. At the time of his first dose, the patient was 4 years old. NDC unknown. Caller states the patient appears to a have asthma according to medication profile at pharmacy but it is not confirmed. Patient has not yet received the second dose,
Deltoid area swollen 4x4 1/2 inches warm to touch, BENADRYL Q 6 hrs, TYLENOL PRN.
Approximately 10 mins after vaccination, client c/o "feeling different". Started to feel "dry throat". Client assisted to exam table and then reported felt as if throat was tightening. Nurse who gave vaccine reported "normal breathing". Shortly after laying down, client reported feeling like her "throat was closing up". Client was given 10ml benedryl po. Medical workers were called for transport to hospital to be evaluated. BP 120/80, P-92, R-18 even unlabored. Skin pink. PO 100%. Medical workers arrived and transported to hospital.
PT was given 0.3ml of UNDILUTED vial of vaccine. No sx at time of administration. Pt asked to wait 15 minutes in car and leave if no sx.  Attempt to call patient when error noted at 1452. Also sent portal message.
Patient required hospitalization due to breakthrough infection. She received Pfizer vaccine (2nd dose in series) on 03/03/21. Hospitalized from 08/10/21 - 08/11/21. Below is copied from her discharge summary:   Hospital Course:  Patient is a 70 y.o. female with PMHx of low grade MDS, MGUS, iron deficiency anemia, hypertension, GERD, hyperlipidemia, restless leg syndrome, chronic lower back pain who is being admitted to the hospital for suspected community-acquired pneumonia and COVID positive.  Patient was in the heme Onc clinic in the morning for her monthly follow-up in regards to her MDS and it was noted that patient was very tired and minimally responsive with blood pressure of 99/44.  She was then brought in a wheelchair over to the emergency department.  Vitals in the emergency department within normal limits with the exception of a mild elevated temperature of 100.1 degrees/  Labs with an elevated creatinine of 1.92, prior baseline appears to be around 1.3. Mg low at 1.6. Troponin 41 and 33 with delta <0. LA wnl. TSH wnl. Hg 7.2, previously 8-9 range. COVID positive. CXR with patchy opacities in RUL.  On my evaluation, pt reported she was very tired in the clinic as her husband was not well the night before and she was awake most of the night with him and had to call EMS after he slid off the bed around 3 am. She denied any other symptoms including SOA, CP, cough, nausea, vomiting, fever, chills, abdominal pain, diarrhea, loss of appetite. She is FULLY vaccinated with Pfizer, received in 3/2021.  She was started on ceftriaxone, azithromycin and received a one time 1L LR bolus. She was monitored overnight. She did not require any oxygen and continued to endorse to feeling well without any SOA, CP, nausea, vomiting, cough. Afebrile and BP with systolic 130-160 range. Repeat labs with improved Cr to 1.2. She was advised to d/c naproxen she was taking at home for pain due to AKI. She was advised to resume home blood pressure meds of HCTZ and lisinopril on d/c with BP monitoring at home and repeat BMP and PCP f/u in 7-10 days. She was prescribed 4 more days of Augmentin for CAP.
Feeling tingling in her body everywhere; Numbness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Feeling tingling in her body everywhere) and HYPOAESTHESIA (Numbness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX in December 2021.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, the patient experienced PARAESTHESIA (Feeling tingling in her body everywhere) and HYPOAESTHESIA (Numbness). At the time of the report, PARAESTHESIA (Feeling tingling in her body everywhere) and HYPOAESTHESIA (Numbness) outcome was unknown.            No concomitants were provided. No treatment was provided.
Pt. given MENACTRA (meningitis) vaccine today by error had received this on 9/7/07.
L upper deltoid area increase swelling/ redness (8.5 x 10cm) mild tenderness received DTaP and varicella on 2/20/04 c/o discomfort x increase sx post vaccination.
shingles; Information has been received from a lawyer concerning a case in litigation and refers to patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. In 2016, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, vaccination site, lot # and expiry date were not specified) as prescribed and/or administered by a healthcare provider at a hospital for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider. As a direct and proximate result of the patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, the patient has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
Had a one minute spell of starring into space on the day after getting vaccines. Was immediately well. Has history of myoclonic activity prior to 1 yr of age.
Patient Received the Fluzone High Dose even though patient was not indicated for high dose and should have received the regular version of the flu vaccine. Per staff, patient has not experience any issues.
She has experienced issues with restriction of motion in her left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "She has experienced issues with restriction of motion in her left arm". The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "She has experienced issues with restriction of motion in her left arm".  Additional information: With her previous Pfizer BioNTech COVID-19 vaccinations and boosters she had issue with restriction of motion of her left arm. The caller asked Do any clinical trials support the bivalent COVID-19 booster administration in buttocks or other muscles in the gluteus area.  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-202201368440 same patient, drug, event, different dose;
Pt was fully vaccinated for COVID19 with Moderna Vaccine (3/7/21 and 4/4/21). He presented to the ED with complaints of chest pain that began 8 days prior. He noted the pain to result in severe coughing with sputum. Also had reports of generalized weakness, SOB, fatigue, chills, dry heaving, diarrhea, nausea, bilateral leg pain, and fever. The patient denied knowing or being around any sick contacts. He was found to be COVID19- positive and admitted to hospital for COVID pneumonia with hypoxia. He was discharged 2 days later after he was stabilized on room air with ambulation.
24 hours after shots left leg had small red area. 48 hours after shots area had increased to 9cm  x 7 cm, hard, red, warm to touch: treated with Augmentin x 10 days in case of cellulitis.
dizziness; headache; muscle pain; chills; since then, she cannot get her blood pressure under control. It is a pretty high; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot: Number: Unknown) via an unspecified route of administration on 28Jan2021 as single dose for covid-19 immunisation. Medical history included cancer and bladder infection (cancer survivor and did get a bladder infection) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that she had received our 1st vaccine shot last 28Jan2021 and since then, she cannot get her blood pressure under control. It is a pretty high on 28Jan2021, reason why she took losartan and hydroxyzine. She also mentioned that she used to be a cancer survivor and did get a bladder infection. There are also some little side effects such as dizziness, headache, muscle pain, and chills on an unspecified date. Therapeutic measures were taken as a result of since then, she cannot get her blood pressure under control. it is a pretty high and included treatment with losartan and hydroxyzine. The clinical outcome of the events was reported as unknown.   Information on Lot/Batch number has been requested.
Sick with chills, nausea,  bone aches, fever, breathing issues (down to 92% for a couple days). Lasted 9 days. Could barely get out of bed. Still feel fatigued nearly two weeks later
6pm I got worse started having chills, body echs, extreem shaking, high fever, heart palpatations, bonding heart beat, nausea, dizxy achy and very fatigue. Felt like a bad case of the flu except with heart palaptations racing out of control. Did not take anything, I called my doctors office last night and was recommended to go to the ER if needed.
Stomach ache, cramps sometimes, after second vaccine; Sneezing, after second vaccine; Runny nose, after second vaccine; Cough, after second vaccine; Sore throat, after second vaccine; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 19-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8733, Expiration date: Unknown) via an unspecified route of administration, administered in arm left on 02Apr2021 (age at vaccination 19 years) as dose 2, single for COVID-19 immunization. The patient medical history and family medical history related to adverse events was reported as no. The patient's concomitant medications were none. Additional vaccines administered on same date of the Pfizer suspect was reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE(s) following prior vaccinations was reported as no. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6208) via an unspecified route of administration, administered in arm left on 12Mar2021 19:00 as dose 1, single for COVID-19 immunization. The patient experienced cough, after second vaccine on 03Apr2021 07:00, stomach ache, cramps sometimes, after second vaccine on 05Apr2021, sneezing, after second vaccine on 05Apr2021 07:00, runny nose, after second vaccine on 05Apr2021 07:00, sore throat, she stated that she woke up with the stomach ache yesterday on 06Apr2021 12:00. It was reported that patient got the second shot last Friday and she started having side effects on Saturday. Caller stated, the effects, have lasted almost a week. She was having coughing, sneezing and a runny nose. Caller asked if these, side effects, were normal to have. Adverse events did not result in physician office visit or Emergency room visit. Investigation assessment and relevant tests was reported as no. The outcome of the event cough, after second vaccine was resolving, sneezing, after second vaccine was not resolved, runny nose, after second vaccine was resolved with sequel on 07Apr2021, Sore throat, after second vaccine was resolved on 07Apr2021 and stomach ache, cramps sometimes, after second vaccine was not resolved.  No follow-up attempts are needed. No further information is expected
I contracted COVID-19 on 05/18/2022 with symptoms of runny nose, congestion, cough, for the first couple of days, and then developed fever, O2 levels dropped to 88 before going back up, sinus headache, myalgia, fatigue, and diarrhea. I was prescribed PAXLOVID 05/19/2022 which I think could have caused my diarrhea, and the nasty taste in my mouth. My symptoms are cold like symptoms and are beginning to resolve.
her neighbors also got sick from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (her neighbors also got sick from the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (her neighbors also got sick from the vaccine). At the time of the report, ILLNESS (her neighbors also got sick from the vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications taken by the patient were not provided.  Treatment activities for event was not provided.
Very large, extremely swollen, very dark pink (almost red)--area of injection.    The area was about 4 inches by 3 inches.  It was enormous.  It continued to look this way for about 5 days.  Then it slowly lightened in color and declined in swelling for the next 11 or 12 days all in the same exact dimensions as the first day after the shot when it first appeared --for a total of 11 days.    The injection itsself , at the time of the inoculation was very painful (an achy pain) and some bad soreness from the shot lasted the first 3 or 4 days.   My arm is still somewhat sore in the swollen area today on the 11th day and it is still light pink.
Rash began at 4pm.  I noticed a fever of 101at 9pm.  Fever of 102 through the night. 3/21/2011 woke up with more bumps (looked like bites) and still have a fever.  Fever all day, 4 hour nap in the afternoon (very unusual) and she probably would have slept longer if I hadn't gone in to her room.  Fever of 99.2 before bed.  Slept until 8am 3/22/2011, normally up by 6:30am, got to my mom's (sitter for the day) at 8:30am and she already looked like she was ready to go back to sleep.
Pt has hx of anaphylaxis, her daughter has the same allergies as pt. Daughter had vaccine first and was taken to ER due to adverse reaction. This pt spoke with her primary who consulted an allergist and recommended pt pre- medicate with Benadryl. Pt did take Benadryl prior to vaccination
CLIENT GIVEN VACCINES BECAME DIZZY AFTERWARD FEET ELEVATED AND GIVEN COOKIE. DIZZINESS ABATED AFTER FIVE MINUTES.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Eczema. Concomitant products included DUPILUMAB (DUPIXENT) for Eczema.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 15-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided    It was reported that after reaction of shingles patient had gone to the urgent care on 15-JAN-2021 and patient was not able to remember the medication prescribed for shingles. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Patient details updated, reporter details updated, concomitant drug detail updated, medical history detail updated, first dose and second dose details updated
pt recv vax & devel a serum sickness rxn, fever, inc ESR & 2 episodes of pneumonia; No further details were provided;
09/06/2021 I passed out for ten mins. I have had several episodes of passing out since then. Still happening at random till this day. Each time I pass out something gets added to that, like dizziness, headache, pulse raises. Right arm sometimes has shooting pains. Now I am also having chest pains before passing out. 09/13/2021 passed out, taken to ER. 09/14/2021 taken to the ER again. Still passing out to the present day. On the 09/14/2021 I was give a shot called Toradol. On 10/05/2021 I was given a heart monitor to wear, till tomorrow is my last day wearing it, given to me by my doctor. I will not know the results of the heart monitor for a few weeks.
I experienced a very buzzed/drunk-like feeling. So, I decided to walk back in to the clinic and asked an office worker if I could sit there for a bit as I didn't feel it was safe for me to drive. She noticed that my feet got incredibly purple/red a very ugly shade. That did subside within a short time. My head, face, and lips felt numb as well. I was able to swallow some water. After about 20 minutes, I felt "sober" enough (for lack of a better word) to drive. It's 4:29 and I still have slight facial numbness and lingering buzzed, sort of  feeling "high". Definitely an endorphin rush of some sort. Very bizarre.