chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was administered too early/ no AE; Initial information was received on 02-Sep-2021 regarding an unsolicited valid non-serious case received from a Physician via Medical Information (Reference number- 00752429) and transmitted to Sanofi on 02-Sep-2021.  This case involves a five-month-old female patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] too early with no adverse event (Inappropriate schedule of product administration).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided  On 30-Jul-2021, the patient received a 0.5 mL (total) dose of suspect HIB (PRP/T) VACCINE [lot UJ575AA and expiry date not provided] via intramuscular route in unknown administration site for prophylactic vaccination.  It was reported, "Caller calling regarding dosing schedule of ACT-HIB. Caller than placed MD on the phone for more information. Dr. stated she is requesting to know when to give the next shot due to the child getting the shot too early Dr. stated the child got the first shot on 6/30/21 and the next dose on 7/30/21. Caller is wanting to know if a repeated dose needs to be given. Doctor did not provide all info needed due to just wanting the answer to the question she had. MD was provided information on dosing too early."  Product used: Used. First time product used: Yes. Still using product: No.  It was a case of actual medication error due to Drug dose administration interval too short (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The dose "beat him up"; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (The dose "beat him up") in a 66-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (The dose "beat him up"). At the time of the report, IMMUNISATION REACTION (The dose "beat him up") outcome was unknown.            Concomitant product use was not provided by the reporter. It was reported that after receiving the first Moderna primary series dose, the patient did not experience any side effects. Treatment information was not provided.   This case was linked to MOD-2022-593083 (Patient Link).   Reporter did not allow further contact
ARM PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 217A21A, and expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced arm pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain at injection site. This report was non-serious.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Vomiting-Mild, Additional Details: Ptient reported dizziness few minutes after injection, also reported nausea. Had patient elevate the feet, and lay on the back. Patient felt little bit better after few minutes, and she asked to be sitted up on a chair. After 15 to 20 minutes later, patient reported numbness in the mouth, and patient asked to call 911. Patient was offered one 25mg benadryl tablet, but vomited out as soon as it was taken. Then, 911 service showed up.
Pt had swelling, irritation from MMR, area of cellulitis and it was delineated red/white.
Case number PHEH2014US003640 is an initial spontaneous report received from a pharmacist on 20 Feb 2014. This report refers to a 69-years-old female patient. Her medical history and concomitant medications were not reported. It was reported that this patient over 55-years of age was vaccinated with MENVEO (batch number: not reported) intramuscularly on 10 Jan 2013. No adverse events were reported following the maladministration.
Temp. of 99.3, red, elongated area approximately 2x4inches which caused discomfort.
Approx. 24 hours post Menactra/Tdap immunizations - temp 101.3, severe H/A, malaise, dizzy, fine scaly rash forehead cheeks, up trunk - improving over course of day. Recommended Tylenol PRN.
Information has been received from a 19 year old female with no known drug allergies who on 05-JAN-2009 was vaccinated with the third dose of GARDASIL vaccine. There was no concomitant medication. On 08-JAN-2009 the patient experienced a rash that originally appeared on one arm and then the other arm and was all over her body in small patches at time of the report. She stated the rash was extremely itchy. The patient did not perform any lab diagnostics studies. At time of the report the patient was not recovered. The patient sought medical attention via telephone. Additional information has been requested.
I can hardly get undressed and dressed and it's it's falling.; my arm is very sore; horrible chills; I had a temperature of 100.4. This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can hardly get undressed and dressed and it's it's falling.), CHILLS (horrible chills), PYREXIA (I had a temperature of 100.4.) and PAIN IN EXTREMITY (my arm is very sore) 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 03-Jun-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 first 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2022, the patient experienced CHILLS (horrible chills) and PYREXIA (I had a temperature of 100.4.). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can hardly get undressed and dressed and it's it's falling.) and PAIN IN EXTREMITY (my arm is very sore). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can hardly get undressed and dressed and it's it's falling.), CHILLS (horrible chills), PYREXIA (I had a temperature of 100.4.) and PAIN IN EXTREMITY (my arm is very sore) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (High) 100.4. No concomitant medication information provided. On 03-Jun-2022, patient received the second booster dose. On Jun-2022 patient had sore arm and could hardly get undressed and dressed. No treatment medication information provided. This case was linked to MOD-2021-028783, MOD-2021-042448, MOD-2022-583956 (Patient Link).
About five minutes after the shot, I started feeling tingling going up my face. The muscles on the right side of my face felt a little bit numb and then a little bit stiff. I could still smile. After about an hour, this wore off.
contracted COVID even though she was inoculated with a vaccine; contracted COVID even though she was inoculated with a vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient contracted COVID even though she was inoculated with a vaccine. Outcome of the event was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
tired; head feels fuzzy; throat and neck pain; throat and neck pain; hurts to swallow; Low grade fever/low grade temp of 99.4; Headache; body aches; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left deltoid on 20Jan2021 11:00 at 0.3 mL, single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient received her first dose yesterday at 11:00am. She was talking to someone and all of a sudden she got throat to neck pain that was intense that lasted two minutes on 21Jan2021. It has been about 10-15minutes since and if she hold her neck straight she is fine, but if she looks up it hurts. She can breathe fine. It hurts to swallow all of a sudden on 21Jan2021. Asking if it is normal to experience this. She had a low grade fever/low grade temp of 99.4, body aches, and a headache that started today 21Jan2021. She received Tylenol as treatment. States she is a nurse and she is tired. Her head feels fuzzy, she has not taken her temperature recently and it still hurts to swallow. The events did not require a visit to emergency room or physician office. Relatedness of drug to events from reporter for throat and neck pain, hurts to swallow, low grade fever, headache, body aches was reported as related. Reporter seriousness for throat and neck pain and hurts to swallow was medically significant. Event outcome of throat and neck pain was recovered, of hurts to swallow was not recovered, of others was unknown.   Information on the lot/ batch number has been requested.; Sender's Comments: The reported events were likely causally related to the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.  However, it is worth noting that the reporter/user of the vaccine was nurse, and her tiredness from job could have confounded with the events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Histamine reaction within 5 minutes, itchy rash on face, chest arms and lower back just over tailbone. Given benedryl within ten minutes.   Followed up with a facility on 3/25 telehealth appointment told to take an antihistimine for two weeks to prevent further complications  I noticed dizzyness the days after the second vaccine. Had a vertigo spell May 24th began evaluation by numerous doctor appointments. discovered mild hearing loss June 8th and was given a Vestibular Migrain diagnosis in July. Currently waiting to see Neurology in October.
Provided the flu vaccine in left deltoid. After the flu vaccine, I gave him a PPD on the left arm. He said that he was "trying to get used to this" as I was giving the PPD. Within seconds he the patient's eyes started rolling back in his head, and I noticed that his body was shaking a bit like a convulsion. I lowered the patient to the floor and put his knees up, patient was visibly sweating and was very pale. He continued to lay down for several minutes. The patient did not lose consciousness. I took his vital signs which were 93% for 02 70 for BPM, and 100/70 for BP. The patient got up, and sat in the clinic room for a half hour until he felt better. He stated that he had a head ache before he left. No drugs were administered.
Patient became diaphoretic, reported tingling on tongue, hoarse voice.  Hx. of allergies.  Epi administered on site.  Patinet transferred to ED and discharged with prednisone.
Tremor Arm; Tingling Arm; Strong Weakness Left Arm (Injected Arm); This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremor Arm), PARAESTHESIA (Tingling Arm) and MUSCULAR WEAKNESS (Strong Weakness Left Arm (Injected Arm)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced TREMOR (Tremor Arm), PARAESTHESIA (Tingling Arm) and MUSCULAR WEAKNESS (Strong Weakness Left Arm (Injected Arm)). At the time of the report, TREMOR (Tremor Arm), PARAESTHESIA (Tingling Arm) and MUSCULAR WEAKNESS (Strong Weakness Left Arm (Injected Arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Mother states son awoke 12/22 AM with 99 degree temp and vomiting. 3.5x2.25cm reddened area noted on top of (L) thigh yesterday (12/21) - area is swollen, warm to touch and reddened at this time. T 96.9 ax.
cold chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (cold chills) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (cold chills). At the time of the report, CHILLS (cold chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No treatment medication details were reported.   Reporter did not allow further contact
I got red rashes on the right side of the stomach and on the back of the Body; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 20Mar2021 11:30 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation.  The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications was none. No other vaccine in four weeks. No other medications in two weeks. The patient reported got red rashes on the right side of the stomach and on the back of the body on 28Feb2021 with outcome of not recovered. No treatment was received for the events. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
she became dizzy during her 15 minute wait. she got better when I told her she had to wait 30 minutes. she said that she gets dizzy normally from vertigo and is not sure if it was the shot. Lasted for 30 minutes.
on 5/2/2021 approx. 1 week after receiving the 2nd dose, I began to develop testicular pain primarily in the right testicle. I have not been overly physical nor have I been introduced to new sexual partners or behaviors. There is no redness or swelling. The pain comes in waves sometimes more painful sometimes less. There is infrequent pain in the left testicle but much less than the right and not as often. Today the pain on the right testicle rates at 4-5 on the pain scale and is now a cause for concern. I have ejaculated manually twice in the past week in efforts to relieve the pain, which was only temporary as the pain did return.
very rash itchy on the neck; rash on the chest that is hardly itchy at all; Rash quite large at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (very rash itchy on the neck), PRURITUS (rash on the chest that is hardly itchy at all) and VACCINATION SITE RASH (Rash quite large at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included SPIRONOLACTONE (ALDACTONE A), MINOXIDIL, LEVOTHYROXINE SODIUM (SYNTHROID), SOLIFENACIN SUCCINATE (VESICARE), MIRABEGRON (MYRBETRIQ) and VENLAFAXINE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced RASH PRURITIC (very rash itchy on the neck), PRURITUS (rash on the chest that is hardly itchy at all) and VACCINATION SITE RASH (Rash quite large at the injection site). At the time of the report, RASH PRURITIC (very rash itchy on the neck), PRURITUS (rash on the chest that is hardly itchy at all) and VACCINATION SITE RASH (Rash quite large at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided.
warm to the touch; kind of red; injection site started itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (injection site started itching) and VACCINATION SITE ERYTHEMA (kind of red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy (Thyroid surgery with half of thyroid removed). Concurrent medical conditions included Hypertension.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection site started itching). On 16-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE ERYTHEMA (kind of red). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (injection site started itching) and VACCINATION SITE ERYTHEMA (kind of red) outcome was unknown.            Patient's concomitant medications included unspecified medicines for high blood pressure and thyroid.
Received vaccine on 7/5/00 and had redness, swelling and fever. Treated with fluids, Motrin,  cool compresses and Benadryl Elixer 1 tsp po every 6 hours.
This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a nurse and from the emergency room medical record concerning a 23 year old female hair stylist with irregular menstruation, attention deficit/hyperactivity disorder and a history of anaemia, Crohn's disease and infectious mononucleosis who on 08-FEB-2007, at 14:15 PM was vaccinated IM in to right deltoid with a first dose of Gardasil lot #654702/0011U. She received the second dose of Gardasil on an unspecified date. Concomitant therapy included azathioprine (IMURAN (azathioprine)), ethinyl estradiol (+) levonorgestrel (SEASONALE) and balsalazide disodium (COLAZAL). On 08-FEB-2007 later that day patient experienced nausea and vomiting. She was seen in the emergency room (ER) that night. She was treated with an unnamed antinausea medication and intravenous fluids. She was sent home later. She had no adverse symptoms after the second injection. The patient recovered. The reporter felt that getting unnamed antinausea medication and intravenous fluids was to prevent patient from being serious and considered this as a serious other medical event. Additional information has been requested. In the follow up it was indicated that on 08-FEB-2007 patient began experiencing nausea and vomiting approximately 1/2 hour after receiving her first dose of GARDASIL was unable to hold down any food, fluids through the afternoon or evening. She went to the emergency room (ER) for evaluation and Intravenous (IV) fluids. ER record indicated she wen to the ER complained pain in her back, legs and abdomen. She had nausea, vomiting, fever and she was pale and weak. The pain characteristic was cramping, sharp and constant. She also had bodyache and myalgia, she was treated in the ER with TYLENOL gram by mouth, ANTIVERT 12.5 milligram intravenous (IV), TORADOL 30 milligram IV, ROCEPHIN 2 gram IV and 2 litters of normal saline solution (NSS) IV. Initially patient went to the ER her temperature measurement was 102.4 F, pulse was 135, respiration was 20 and blood pressure was 88/52. Patient's blood pressure measurement was 88/55, heart rate was 108 and respiration was 19 at the time of discharge from the ER. Pulse Oximetry was 100% on room air (RA). On 09-FEB-2007 the patient recovered. On an unspecified day she received the second dose of GARDASIL and had no adverse symptoms. The reporter no longer considered the events to be other important medical events. Additional information is not expected.
next day i had a bad headache and racing heart and cold sweating and nausea  next day after that bruises appeared on my thighs and hurt badly to the point it hurt to walk i went to Er. they gave me tylenol and nausea medicine and did a bunch of tests and sent me home
right arm (injection site arm) was swollen; had a red rash; and was itchy; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 25Feb2021 (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received Pfizer-BioNTech COVID-19 Vaccine first dose a week ago today, 25Feb2021. The patient mentioned that on Saturday, 27Feb2021, she woke up with her right arm (injection site arm) swollen, red rash and itchy. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information expected.
left axillary lump Narrative:  on 4/2/21 patient reported via telephone developing a single swollen lymph node in his left axillary region following his second covid vaccine. States the area of swelling is a discrete, soft palpable lump the size of a plum; denies tenderness, redness, hardness of lump or changing with time. No other associated  symptoms such as fever, fatigue, or generalized feelings of illness. Due to covid restrictions, patient has not been seen in clinic thus no vital signs or weight. PCP encounters have been through agency.
Soreness in Arm approx 4 hours after administration of Vaccine, and remained sore at time going to bed.  Woke up in the AM on 1/13.  Unable to feel the entire left Arm.  Left Arm was completely numb.
After temperature excursion of 83 degrees F for hours, vaccine should have not been administered.  Patient received dose of nonviable medication