chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax;on 4mar95 exp stiffness down the center of spine which was tender to touch;stiffness spread to shoulders & neck & then to mid/lower back & rt arm;muscles were sore & tender to touch;f/u: sx cleared & not to recv 3rd dose hep b
Admitted 66 y.o. male who was recently discharged from Hospital last week after undergoing burr holes placement to evacuate SDH.  Pt did well after surgery his spech and strength improved at time of discharge.  Since being at home,he has slowly declined some.  Not as active.  Not eating, sleeping more and having more problems with his speech.  Not able to express what he wants.  Pt was +COVID last week - asymptomatic.  No new symptoms now and has been at home since discharge.
Service member became lightheaded, clammy and nauseated. Within 10 mins, he was feeling better.
I have been on my contraceptive and skipping placebos with no issues or bleeding for 2-3 years. On May 19, I started having vaginal bleeding, very light, which continues today, day 33.
Post vaccination, recipient c/o dizziness, lightheadedness, and HA. He remained awake and alert. Skin was cool, clammy and diaphoretic. Denied any SOB or itching. Layed recipient on the floor in a supine position with legs elevated. VS monitored. Observation by physician on site. Assisted to sitting position and then onto a chair. Recipient remained awake, alert and conversant. Escorted to observation area and monitored. Ambulatory with steady gait. Released at 1215 without incident.
Patient ended up having two grand mal seizures day after vaccination and ended up in emergency room. Patient's wife stated this has occurred the last 2 years now after flu vaccine, so may be a coincidence.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 02-SEP-2016 the patient was vaccinated with expired ROTATEQ with lot number L0044554 and expiration date of 07-AUG-2016. No concomitant medications were reported. No adverse effects were reported. The lot number L0044554 with expiration date of 07-AUG-2016 has been verified to be a non valid lot number for ROTATEQ. Additional information has been requested.
Patient had redness around the immunization site. On 3/23 her lips were dry. On 03/26 she developed itchy, tingly blisters around her mouth. On 3/27 she was examined by her husband's physician (while at an appt with him) and was told the blisters were not open or seeping.
Fever of 103 (oral) chills joint pains sore throat, headache, nausea these lasting approx 48 hours followed by gradual decreasing of initial symptoms with new symptoms of severe diarrhea for three days along with weakness, cough, sore throat and congestion.  I called physician to report per phone, nurse told me I had contacted the flu concurrent with receiving vaccine (total baloney) was finally given Rx for phenergan for the nausea and offered an appointment for the next afternoon (soonest available) but told would just need to let the flu run it's course.
nausea; joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 27-year-old male 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had a blister at 1000 o'clock from injection site (L) mid upper arm - posterior aspect.
Reaction to ZOSTAVAX vaccination. Pt states "Bothered on Sunday, rash by Monday - big and hot, about the size of a silver dollar at injection site on back of arm, 2" above elbow."
Vaccine administered 12/21/12, states "rash started "around" Christmas Day." Reported: 1/18/13 to EHS to report rash, cough, runny nose, sore throat.
local rxn 15cm x 7cm lt arm (w/o fever, encephalopathy);red, swollen, hard, tender x 3 days;
Initial report received from a consumer on 08 January 2014. A female patient had received a dose of Flu Vaccine (therapy dates, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. The patient had family history of heart disease. The patient had received hypertensive medicine in October 2013. The patient had also received birth control pills to assist in regulating periods. The patient had received AUBAGIO 14 mg per oral daily from 04 January 2014 for the indication of multiple sclerosis. On an unspecified date after vaccination, the patient continuation in hair thinning, numbness in right leg and tingling sensation in left leg. Patient was fatigue too. Laboratory investigation and corrective treatments were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information was received on 21 March 2014: No new information was provided.
dizziness 5 minutes post shot, blacked out/ fainted 5 minutes post shot, injection pain, headache, sinus pressure, flushed skin, nasua
red, sl raised rash on face, trunk & extremities;T104;DPH,APAP, and pus fluids;
Immediately after vaccination client passed out for approximately 20 sec. evaluated by MD and paramedics onsite. diaphoretic, with dizziness, nausea and vomiting x 1. Per client felt better. Client picked up from site by father and driven home.
Tinnitus. Started out being intermittent. For at least 2 months now it is constant, day and night. It sounds like Cicadas or crickets. It's a high-pitched continuous (non-rhythmic) hissing sound. It's not super loud, but I am constantly aware of it. I can still hear real sounds from outside, and the tinnitus doesn't interfere much with my normal hearing. But it is very tiresome and annoying.
After administering the MENACTRA shot, the second of two shots given, the patient fainted and had a brief convulsion lasting 10 seconds. He then recovered. I monitored the patient, had him lower his head between his legs. Once he was stabilized, I got him cold wet rags and ice for his neck and wrist in an attempt to cool him, gave him a glass of water for hydration and stayed with him until he felt strong enough to depart. I called him 3 hours later to check on his status which was very good. He did not know the name of his new medical provider who he has yet to meet. Therefore, at present I do not have their contact information, waiting on the patient to provide this. At that time, I will call the provider and provide them with these details.
Vaccine was expired on 01 Apr 2022 and was stored on 04 Apr 2022 and was administered on 19 Apr 2022; Vaccine was expired on 01 Apr 2022 and was stored on 04 Apr 2022 and was administered on 19 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and was stored on 04 Apr 2022 and was administered on 19 Apr 2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was stored on 04 Apr 2022 and was administered on 19 Apr 2022) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was stored on 04 Apr 2022 and was administered on 19 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and was stored on 04 Apr 2022 and was administered on 19 Apr 2022). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was expired on 01 Apr 2022 and was stored on 04 Apr 2022 and was administered on 19 Apr 2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was stored on 04 Apr 2022 and was administered on 19 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the pharmacist was calling to verify an expiration date for lot 026L21B. The pharmacist said that when the pharmacy received the vaccine on 23 feb 2022 that a staff member looked up the expiration date and came up with an expiration date of June 2022. However another pharmacy member looked up the expiration date of the moderna COVID-19 and confirmed 01 Apr 2022 was the expiration date. Date the vials was initially stored in refrigerator was 04-Apr-2022. 80 numbers of doses were administered. Date of administration of vaccine was from 05 April 2022 to 19 April 2022. Vials did not undergone any temperature excursions. No treatment information was reported.
Fever 101 degrees F., taken orally.  Skin red, tense, pruritic around injection site measuring 6 inches by 4 inches, ongoing for 5 days.
dry mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Mar2021 09:00 (Lot number: EN6208) at the age of 47 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Sjogren's Syndrome" (unspecified if ongoing), notes: Comments: not given results from dc office. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: EL3302, Anatomical sight of injection: Rt Arm, Time: 09:20 AM, Route of administration: Intramascular), administration date: 18Feb2021, for COVID-19 immunization. The following information was reported: DRY MOUTH (non-serious), outcome "recovered", described as "dry mouth". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dry mouth.  Additional information: Patient prior vaccination with in 4 weeks was none. Patient treatment drug included Antiviral Valtrex medicine, Dry mouth rinse, toothpaste. AE Term: 1 month.  No follow-up attempts are possible. No further information is expected.
PATIENT RECEIVED VACCINE AND WAS INSTRUCTED TO WAIT FOR 15 MINUTES IN WAITING AREA AFTER VACCINATION.  HE WAS SITTING IN CHAIR, AND ANOTHER PATIENT NOTIFIED US THAT HE HAD FAINTED- HE SLID OUT OF CHAIR WAS WAS LYING ON FLOOR, VERY PALE.  HE WOKE UP QUICKLY, WAS GIVEN WATER BOTTLE  AND LAID DOWN ON FLOOR FOR 45 MINUTES UNTIL COMFORTABLE.  HE CALLED SOMEONE TO COME PICK HIM UP, HEADING HOME TO REST FOR REMAINDER OF THE DAY.
On 3/17/18, Patient reports that within one hour of receipt of the vaccine, on, 3/15/18, a red, raised, sore mark, approximately 2 X 2 in. in diameter, developed at the site of injection of SHINGRIX, on her left arm. Initially the mark was about the size of a nickel, but today, is bigger than a half dollar, and appears to be getting bigger. Patient was advised to take Benadryl and report to Urgent Care if the mark does not subside in pain, size, or redness, or if it grows in size, or severity.
side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse drug reaction in an unspecified number of patients who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that the physician administered flu shot to many patients and experienced side effects from the flu shot. The reporter stated that the physician found out there was something bad in the formulation that she was administering, something like formaldehyde. The reporter stated that the physician ordered the flu shots that were made in specific countries and this formulation did not contain any of the other ingredients (just the flu strains).   The reporter stated that at the time of reporting the this formulation was administered none of the flu shot patients got any side effects any from the flu shot any more. This case has been linked with case US2019221818, reported by the same reporter.
Pt received vaccine and had a safety barrier bandaid put on. Seconds later, the injection site started heavily bleeding over and around the bandaid. Rph applied constant pressure using cotton balls to the area for 5-7 minutes. Bleeding had stopped and a new bandaid was applied. Injection site adverse event was then resolved. Pt expected this due to her having a medical condition of anemia and taking subsequent B-12 injections. Pt was observed for 30 minutes and no bleeding re-occurred or was seen. Pt was directed to put ice and pressure on it for further home care.
Fainting; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced fainting on an unspecified date with outcome of unknown.  The action taken in response to the event for bnt162b2 was not applicable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006219 same reporter/drug/event, different patient
A couple weeks after vaccine, I noticed shortness of breath, and chest tightness. This would happen with minimal exertion. After about 20 to 30 minutes it would pass, I'd then have an incredible amount of energy, that would last as long as I wanted. I researched what was happening, and found that it was somewhat common in many people. This gradually has lessoned over the past several months. I went to oral surgery and was shocked what my blood pressure reading was. I went to Dr. and we are awaiting test results. I've been monitoring my BP several times a day since then.  When I wake, my pulse is about 65, but my BP is extremely high. After an hour+ workout when my Pulse is 100+, my BP averages about 40/30 lower than when I awoke. This happens every day.  I am a very physical person.
Date place in refrigerator- 17-Nov-2021; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator- 17-Nov-2021) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date place in refrigerator- 17-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator- 17-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in refrigerator on 17-Nov-2021. It was reported that the expired lots were administered due to the confusion with expiry date printed in the carton and the expiration date when the code was scanned. The vials did not undergo temperature excursion. The patient did not experience any adverse event.  No treatment medications were reported.   This case was linked to MOD-2022-491837 (Patient Link).
High pitched cry, sometime after that he began having infantile spasms.  He was diagnosed with the spasms specifically on 8/25/2016 and hospitalized.  After two courses of treatment, he is now recovering as of 11/09/2016.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 65 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
felt very sick; nauseous; injection site is very sore; lightheaded like he was going to pass out; lightheaded like he was going to pass out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 6 (booster), single (Lot number: HG2282) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "heart attack" (unspecified if ongoing), notes: massive heart attack, widowmaker He had code blue died on the table for 6 minutes. The patient took concomitant medications. Vaccination history included: pfizer covid 19 vaccine (Dose:1, Lot: EL9262), administration date: 24Jan2021, when the patient was 67-year-old, for COVID-19 Immunization; pfizer covid 19 vaccine (Dose:2 , Lot: EL9269), administration date: 11Feb2021, when the patient was 67-year-old, for COVID-19 Immunization; pfizer covid 19 vaccine (Dose: 3, Lot: 301308A), administration date: 26Sep2021, when the patient was 67-year-old, for COVID-19 Immunization; pfizer covid 19 vaccine (Dose: 4 , Lot: FG9943 or FY9943), administration date: 16Mar2022, when the patient was 68-year-old, for COVID-19 Immunization; pfizer covid 19 vaccine (Dose: 5 , Lot: GJ6796 or CJ6796), administration date: 13Dec2022, when the patient was 69-year-old, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), PRESYNCOPE (non-serious) all with onset 27Sep2023, outcome "unknown" and all described as "lightheaded like he was going to pass out"; ILLNESS (non-serious), outcome "unknown", described as "felt very sick"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site is very sore". Therapeutic measures were not taken as a result of dizziness, presyncope, illness, nausea, vaccination site pain. Additional information: He takes his blood pressure every day and it is good, his numbers are good, weight is good, and he takes his medication. Reports he is sick from being lightheaded. Feels a little nauseous and injection site is very sore which is normal. He is not feeling too hot right now. He is not sure what he should do yet.
Noticed large, red, inflammed area to left deltoid. Area had some swelling and discomfort. Over the counter pain killer taker one time only. Area faded and went away after four days.
Entire lt upper arm fr below shoulder to elbow extending around to inner surface; swollen, hot, erythematous, double in size compared to opposite extremity;
Instantly had metallic taste in mouth and felt like stinging and burning in the nose, developed headache and fatigue hours later. Was seen in the ED next day for  Persistent (NON-STOP) coughing, scratchy throat, and full body itching. Site of injection is red raised and hard.
Local reaction to Pneumococcal 23 polysaccharide vaccine given 9/27/16. Fever, chills right of vaccine and with local left upper arm pain. Left arm swelling and area 3 cm rash.
States after getting immunization on 10/25/07, she had pain from her left shoulder up into neck lasting at least 8 days - taking Tylenol
Complex febrile seizures- 2 within 24 hour period; up to 8 minutes; MOTRIN/TYLENOL; CIPRODEX gtts; OMNICEF.
Patient experienced large bruising at injection site involving whole upper outer arm, with some warmth. Bruise is starting to dissipate with some dark spots and yellowing. Patient is going to his dr to have his arm evaluated.
Injection Site hurting after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection Site hurting after 2nd booster) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2022, the patient 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced VACCINATION SITE PAIN (Injection Site hurting after 2nd booster). At the time of the report, VACCINATION SITE PAIN (Injection Site hurting after 2nd booster) had not resolved.            No concomitant product use was reported.   The patient reported that he received 4 Moderna COVID-19 vaccines ( 2 primary and 2 booster shots). He also stated that after the 2nd booster yesterday (at the time of report), his left arm was hurting.  No treatment information was provided.