chrisvoncsefalvay/vaers-outcomes huggingface dataset:
accidently gave the 6 year old child .25 of the red top vial; no adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (accidently gave the 6 year old child .25 of the red top vial) and NO ADVERSE EVENT (no adverse event) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (accidently gave the 6 year old child .25 of the red top vial) and NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (accidently gave the 6 year old child .25 of the red top vial) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (accidently gave the 6 year old child .25 of the red top vial).    No concomitant information was reported. It was reported that a family came in and the nurse doing the vaccine accidently gave the 6-year-old child .25 of the red top vial Moderna with the blue label instead of from the pediatric dose vial.  No treatment information was provided.
bump; swelling and redness at the injection site; swelling and redness at the injection site; the muscle felt hot/ warmth at injection site; syringes that came in this package of PNEUMOVAX "all have about 30 little black or blue dots" / PQC Packaging: Foreign matter or Extraneous Marks or Matter Seen on the; syringes that came in this package of PNEUMOVAX "all have about 30 little black or blue dots"; This spontaneous report was received from a pharmacist and refers to a 66-year-old female patient. The patient did not have pertinent medical history, concomitant medications, drug reactions or allergies.  On 26-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter, 1 dose syringe, intramuscular in the left arm, lot #R017900, expiration date 26-MAR-2020 (exact dose and frequency were not reported), for prevention of pneumonia.  On 26-SEP-2019 (also reported as that same day), the patient started to complain about swelling and redness at the injection site in the left arm. The patient also had a bump and the muscle felt hot. She sought medical attention (also reported as she went to the doctor). Laboratory tests were not performed. As a treatment for the events, the patient received antibiotics (unspecified), prednisone and anti-inflammatory (unspecified). On 26-SEP-2019, the pharmacist reported that all 10 syringes that came in the package of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) had about 30 little black or blue dots circling around the syringe where the label was. The pharmacist reported that it was hard to tell whether black and blue dots were on the inside or the outside of the syringe and they did not rub off from the glass. There was no damage noted to the packaging or the products and the vaccines were not exposed to moisture. Prior to use the vaccines were kept in refrigerator. The products were never exposed to storage temperatures outside of recommendation. One other pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe from this package was administered to another patient. On an unknown date in 2019, the patient recovered from injection site mass, injection site warmth, injection site erythema and injection site swelling. The outcome of 30 little black or blue dots circling around the syringe where the label was was not provided.  The causality between the events and suspect therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1910USA011769:
On 10/05/2022 I started noticing worsening sinus symptoms like cough; sore throat; fatigue , green mucus; and nausea. I reached out to my doctor in October and was prescribed Amoxicillin. Symptoms are still ongoing was prescribed  Augmentin after reaching out to the doctor again.
Patient began experiencing diplopia the day following COVID vaccine administration. Determined to have cranial nerve 6 palsy of right eye. No improvement. Suspected to be due to poorly controlled diabetes.
"Click in left ear which is intermittent and goes on all through the day and night. This continued and got worse on the day of second vaccine"; This is a spontaneous report from a contactable consumer, the patient. A 73-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 22Jan2021 at 09:00 (at the age of 73-years-old) as a single dose and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient had no known allergies to medication, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included balsalazide (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN) and azathioprine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Jan2021 at 15:00, on the day of her first Pfizer vaccine, the patient started to get a click in her left ear which was intermittent and goes on all through the day and night, this continued and got worse on the day of her second vaccine. The clicking has continued for 5 weeks. The patient will be having an MRI on 01Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with removal of ear wax, steroid ear drops and prednisone; from unknown start dates to unknown stop dates. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event "Click in left ear which is intermittent and goes on all through the day and night. This continued and got worse on the day of second vaccine" was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
A rash and hives that has spread day after day from legs to arms and feet and hands. The rash and hives are extremely uncomfortable and itchy.
This spontaneous report as received from a medical assistant via a sales representative, refers to a male patient of unknown age. On an unknown date the patient received a first dose of GARDASIL, (route, lot # and expiration date was not provided). Co-suspect therapy was not provided. Concomitant therapy included Tdap and meningococcal vaccine (unspecified). It was reported that the patient fainted after received the first dose of GARDASIL on an unknown date. The patient recovered on an unknown date. The relatedness between the event and suspect therapy was unknown. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 14 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
pain on both her hands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on both her hands) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC DAIICHI) for an unknown indication.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced PAIN IN EXTREMITY (pain on both her hands). At the time of the report, PAIN IN EXTREMITY (pain on both her hands) 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.   Treatment included Advil
Within minutes of receiving vaccine pain began in my left shoulder.  The pain continued to increase until it was SEVERE.  I treated it with Ibuprofen which offered some relief.  However, 3 weeks s/p the shot, though improved somewhat, the pain continues and some ranges of motion are almost impossible.
received only powder component; received only powder component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the powder component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. It was unknown which patient received the incomplete dose out of 4 patients. The reporter did not consent to follow up.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed  lot  007B21A and indicated vaccine maintained activity necessary to protect against covid 19 at time of administration. Also patient did not call in and complain of adverse event.  This is administrative error without adverse event.
About a month after 2 dose, I began experiencing joint pain in my hands and knees.
Headache, nausea, fever onset next day and spiked to 102, upset stomach, diarrhea two days later, swelling and soreness in both arms.
Today, 11/28/2017, patient called me that she has been having pain in her arm since she got a flu shot on 10/31/2017. I asked her if she can come in so that we may suggest a treatment option for her. She said that she is out of town and that she will be back on December 5th. I left a message on her phone suggesting that she seeks a medical help.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 49 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular at 0.5 ml.. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
soreness in arm, 8 hours after the injection I had a temperature of 100.4, body soreness especially in back and spine, experienced shakes followed by sweating, loss of appetite/nausea, difficulty standing/moving.  I used ice packs down spine to ease soreness, took a melatonin around 10pm, woke up at midnight and vomited, took 500 mg of Tylenol (symptoms lessened after Tylenol), continued to take Tylenol every 4-5 hours until symptoms were gone, approximately 24 hours after injection.
Information has been received from a physician's assistant concerning a female who on 11/2/98 and in 12/2/98, was vaccinated with the first and second doses of varicella virus vaccine live. A titer drawn on 6/2/04 indicated that the patient failed to seroconvert. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that another patient failed to seroconvert (WAES0407USA00982). Additional information has been requested.
Headache, mild nausea - started day-of injection and continued  thru today sore arm at injection site - started day-of injection and lasted  thru yesterday swollen and tender armpit - started day after injection and continued thru today
06/26/99- received anthrax #1 06/27/99- developed bilat shoulder pain, which lasted about six weeks and was completely resolved.    09/02/99- received anthrax #2 09/03/99- bilat shoulder pain reappeared- quality of pain similar to the pain he experienced with his first anthrax vaccine but the intensity was much more severe- no other associated sxs- pain interfered with his ADL, sleep, and with his performance at work- bilat shoulder pain slowly went away over the next several months and it completely dissipated by 02/00.
Increased heart rate, panic attacks, nausea, diahrea, stomach cramps, headache, body aches 2nd dose on 2/1/21
Increased SOB; cough with minimal sputum. COPD and smokes 2 packs per day. Positive for COVID-19 two weeks ago. Wheezes present. Patient experiencing AMS. PO2 46; PCO2 51. Chest X-ray shows infiltrate in left base.
It was reported that a 10-year-old female patient received a TD Adult vaccination on 5/18/01. Reportedly that same day the patient developed severe redness on the injection site. Was advised to apply ice pack. The patient recovered from this experience.
Temperature of 105 started the evening of 10/31/99. On way to physician's office on 11/1/99, child seized in car seat, lasting 1 to 2 minutes. Parents began to rush to hospital. Child stopped breathing, called 911 and father performed CPR. Ambulance transported pt to hospital.
Approx 1 hour after administration developed fever up to 104, felt dizzy and c/o arm soreness.
Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A, 042620A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (On chemo).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.
heart started to increase again/keep heart rate to 103 beats per minute; Restlessness/lack of sleep; nightmares; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VITAMIN D COMPLEX; PROBIOTICS. Past drug history included: Torado. Vaccination history included: Bnt162b2 (Dose 1, lot number=EN5318, lot unknown=False, administration date=06Feb2021, administration time=06:30 PM, vaccine location=Left arm.), administration date: 06Feb2021, for Covid-19 Immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 07Feb2021 22:00, outcome "recovered" (2021), described as "heart started to increase again/keep heart rate to 103 beats per minute"; RESTLESSNESS (non-serious) with onset 07Feb2021 22:00, outcome "recovered" (2021), described as "Restlessness/lack of sleep"; NIGHTMARE (non-serious) with onset 07Feb2021 22:00, outcome "recovered" (2021), described as "nightmares". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, restlessness, nightmare.  Additional information: After dose 2, 2nd night heart started to increase again this time she learned tips to lower heart rate (cold pack on face) did immediately and was able to keep heart rate to 103 beats per minute, fine next morning. Restlessness/lack of sleep - nightmares and other general common well documented symptoms. No COVID prior vaccination. Not tested COVID post vaccination. No other vaccine in four weeks. other vaccine same date details: [other vaccine same date product= Pfizer, other vaccine same date lot number=EN6203, other vaccine same date vaccine date=25Feb2021, other vaccine same date dose number=2, other vaccine same date vaccine location=Left Arm].  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician via company representative refers to an approximately (currently) 22 year old male patient. There was no information about concomitant medication, pertinent medical history and drug reaction, allergies reported. On unknown date, as a child, the patient was vaccinated with a 3-dose series of RECOMBIVAX HB (lot#s, expiration dates, doses, frequency, routes and sites of vaccination were not reported) for routine vaccination. On an unspecified date in approximately 2015, reported as "recently", the patient had the titers drawn, which showed the hepatitis B titers were too low. There was no product quality complaint (PQC) involved. The outcome of the event was unknown. The patient sought medical attention and was seen by a physician. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information has been requested.
Swollen forearm on right arm. Shot given on left arm. Arm turned black from wrist to elbow. Extremely sore, just like a bad bruise. Lumps inside top of arm. Lasted about 10 days.
I was up during the night with flu like symptoms. I woke up at 8am and thought I felt so much better than I had through the night. I got up for get some water and my heart felt like I was beating out of my chest. I grabbed my Watch that measures bpm and it was 157!!! Once I laid down it went into the 120 range. I finally was able to sleep and when I woke it was 98. If I get up it goes into the 120 range.  It?s 7:18 pm now and  going between 88 - 105 when I?m up and moving.
In July, I had an abortion. Then my periods haven't been regular ever since. When I went to see a doctor I was prescribed Lutera. My periods are regular while taking the medication.
10 days p/MMR pt broke out w/rash on face, arms & torso-fever & chills; fever & chills lasted 24 hrs; rash lasted 1 wk;
scalp tenderness; This case was reported by a consumer via interactive digital media and described the occurrence of scalp tenderness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced scalp tenderness. On an unknown date, the outcome of the scalp tenderness was unknown.   It was unknown if the reporter considered the scalp tenderness to be related to Shingrix.     Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient wanted to ask if Shingrix vaccine could cause scalp tenderness. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
About 15 minutes after her second moderna covid19 vaccine patient had a reaction and was about to faint in her chair in the observation area. The MA noticed the patient about to faint and our Pharmacist and provider/APRN on duty, who also took the vitals, was  able to quickly place the patient at our back clinic. Vitals were taken once she was taken to our clinic area around 10:30
allergic event full body hives w/in 24 hrs of vax; no other adenopathy, rash, sz, fever, neuro signs;
A nurse reported that a female received an injection of Pnu-Imune 23 on 10/21/99. The pt reported that, 30 minutes, post vax, she developed an injection site reaction characterized by redness and soreness and an itchy nose. The pt was seen by the reporter on 10/23/99, who described the injection site as red, swollen and tender distal to the elbow and proximal from the site up to 1" below the shoulder area. A few vesicles were also noted. The pt was sent to the ER to treat the cellulitis and was prescribed oral antibiotics. The pt refused the antibiotic therapy. Follow-up information received from the reporter on 1/7/00, provided pt information, indicated that a CBC was performed but the results were not provided, and that the pt recovered.
didn't want to eat; her whole body was wet with sweat; headache; felt sore all over. Her body was as sore as her arm; a nauseous feeling and she wanted to throw up, but she didn't; freezing to death, shivering, shaking, and couldn't get warm; had a restless night in bed; her arm was very sore; a sore arm for four or five days; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a sore arm for four or five days, her arm was very sore, freezing to death, shivering, shaking, and couldn't get warm, had a restless night in bed, headache, felt sore all over. her body was as sore as her arm, a nauseous feeling and she wanted to throw up, but she didn't, didn't want to eat, her whole body was wet with sweat.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 02L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 016M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced the event(s) a sore arm for four or five days. On 17 Feb 2021, the patient experienced the event(s) her arm was very sore, freezing to death, shivering, shaking, and couldn't get warm, had a restless night in bed. On 18 Feb 2021, the patient experienced the event(s) headache, felt sore all over. her body was as sore as her arm, a nauseous feeling and she wanted to throw up, but she didn't, didn't want to eat. On 19 Feb 2021, the patient experienced the event(s) her whole body was wet with sweat.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 17 Feb 2021 the outcome of event(s), her arm was very sore, freezing to death, shivering, shaking, and couldn't get warm, had a restless night in bed was resolved. On18 Feb 2021 the outcome of event(s), headache, felt sore all over. her body was as sore as her arm, a nauseous feeling and she wanted to throw up, but she didn't, didn't want to eat was resolved. On19 Feb 2021 the outcome of event(s), her whole body was wet with sweat was resolved. The outcome of event(s), a sore arm for four or five days was unknown.