chrisvoncsefalvay/vaers-outcomes huggingface dataset:
horrible headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On 25th June 2022, the patient received Meningococcal B vaccine. On 25th June 2022, less than a day after receiving Meningococcal B vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Meningococcal B vaccine.     Additional Information: GSK Receipt Date: 25-JUN-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that patient got meningitis B shot and same day horrible headache all day.  The patient said that why should not she get the booster in 6 months. The follow-up would not possible as no contact details were available. Additional Supportive Information: On 25th Jun 2022, the patient had 2nd dose of meningitis vaccine.
AT TIME OF INJ. INTO LT. DELTOID FELT CRAMP IN L. LEG. THAT PM SHE HAD SEVERE LEG CRAMPS, FEVER, CHILLS. LATER THAT NIGHT BEGAN ITCHING, NOW HAS RASH COVERING ENTIRE BODY. AT PANEL PHYSICIAN NOW TO BE TREATED. NO CHEST PAIN OR SHORTNESS OF BREATH.
Itchy and sensitive skin developed about 11 days after receiving the Moderna booster. When skin is irritated or scratched, hives develop immediately. If left untouched, the hives abate in 15 to 30 minutes. Hives will develop all over the body, including the palms of hands, abdomen, neck, head, legs, and feet. Treating hive severity with over the counter antihistamines.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid"; Tetracaine, reaction(s): "Known allergies: tetracaine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment information was Paxlovid from 22Jul2023 to 27Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Approximately 25 minutes after vaccination, recipient complained of hives and itching. Redness noted on both cheeks and nose and forehead. watm to touch. No shortness of breath, hoarseness to voice, cenied sore throat. No redness or swelling to tongue in throat. breath sounds clear. denied abdominal pain or nausea. Small macular red rash noted on arms. Vital signs stable.  Recipient was being observed for 30 minutes due to history of anaphylaxis with bee stings, multiple allergies to antibiotics and  is asthmatic.  When questioned in observation area, she did recall having anaphylaxis with an injectable drug which she had not mentioned in the prevaccination questionnaire.
Child developed fever to 102 ax (103.7 pr later). At 5:30, given Tylenol. At 1 AM 2/13/01, the child was found in status epilepticus. EMS called. Patient given 4 different anticoagulants, intubated. Given dopamine; ICU care. Depressed neuro function persisted. The death certificate received on 11/21/03 states pneumonia, pulmonary failure, and CP.
Information has been received from a registered nurse referring to a 19 years old patient. On 19-FEB-2015, the patient was inadvertently administered the dialysis formulation of RECOMBIVAX HB (lot number, expiry date, and dose were not reported), instead of the pediatric/adolescent formulation. No adverse effects reported. Additional information has been requested.
C/O INSOMNIA, DIAPHORESIS, LACK OF APPETITE AND OVERWHELMING FATIGUE.
VACCINE ADMINISTERED (02/07/2022) AFTER BEYOND USE DATE(02/06/2022).CUSTOMER IS FINE AND NO ADVERSE EFFECTS
Patient had no signs or symptoms of adverse reaction when vaccine was administered. Two days later the patient noticed an approximately palm sized area or redness at the right deltoid where the influenza vaccine was administered. He also complained of pruritus and had a self-inflicted scratch at the site. The following day, redness and itching was reduced on the deltoid, however patient was itching near his right axillae. Miconazole powder was prescribed to apply as needed to the area.
didn't feel well the next day; right arm has been aching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel well the next day) and MYALGIA (right arm has been aching) 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 12-May-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 12-May-2021, the patient experienced MYALGIA (right arm has been aching). On 13-May-2021, the patient experienced MALAISE (didn't feel well the next day). At the time of the report, MALAISE (didn't feel well the next day) had resolved and MYALGIA (right arm has been aching) had not resolved.            No concomitant and treatment medications were reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown booster, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTURER UNKNOWN" (where X=1, 2, or number unknown)), for covid-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti viral details product: COVID 19 Treatment, Paxlovid from 26May2022 to 30May2022, other medication in 2weeks product: Mucinex from 24May2022 to 25May2022  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
COVID break through report. I received my second booster shot on 04/29/2022. I contacted Covid on 05/09/2022. My adverse event started on 05/07/2022. I was very very tired, through the night I had body ache, then the next day I had a itchy throat. I couldn't breathe I was having difficulty breathing when I try to move around. My head is so congested. I had no fever. On May 13/2022 I contacted my doc through tele health she prescribed antibiotics 10 day. I am on my second day as of today. My cough is better now. I did home COVID test where I tested positive on May 9/2022 and May 13/2022 for COVID.
This spontaneous report was received from a medical assistant and refers to a 24 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-MAR-2016, the patient received improperly stored GARDASIL 9 (lot number L037339 and expiration date 09-FEB-2018, dose, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either plus 1 or minus 1 Celsius degrees for 255.5 total cumulative hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever; Arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Arm pain at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] and SPIRONOLACTONE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Arm pain at injection site). At the time of the report, PYREXIA (Fever) and VACCINATION SITE PAIN (Arm pain at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No medical history reported by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-438549, MOD-2022-438572, MOD-2022-438548 (Patient Link).
TIGHTNESS IN STOMACK, THEN VOMITTING AND DIARRHEA
Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021 at 11:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021 at 11:30 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. The vial was kept under Moderna recommended temperature range the entire time. There was nothing else wrong except that the vaccine was administered beyond the manufacturer's expiration date.   This case was linked to MOD-2021-396137 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow-up received contains no new information. On 29-Nov-2021: Follow up received: Additional reporter added. Patient Information updated.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FA7484) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "headache". Therapeutic measures were taken as a result of headache. Additional information: Reporter was concerned because her son did not generally get headaches and she had given him Ibuprofen repeatedly to treat.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning "around 12 year old" female who on an unspecified date was vaccinated with a first dose of Gardasil 0.5 mL injection.  On an unspecified date after receiving the Gardasil the patient experienced a depressed white cell count.  Medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  Additional information has been requested.
This spontaneous report was received from a consumer and refers to a 49-year-old patient of unknown gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with two 0,5 milliliter doses of GARDASIL 9 (route of administration, lot number and expiration date were not reported) for prophylaxis. The patient wanted to know if GARDASIL 9 was safe to take if you are "49 going on 50 years old".
Sore and numbness in arm 8 hours after vaccination, lasting 3 days. Sore throat, body aches, headache and mild fever 24 hours after vaccination lasting 4 days. Strep test performed with negative results. Patient was given Motrin to relieve mild fever, body aches and headache.  Extreme fatigue set in 8 hours after the vaccination and lasted 4 days.
Rash around injection site. Small red very slightly raised bumps. Took about a week and a half to clear up.
migraine today 08may it had still not gone away and was getting worse; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 33-year-old non pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Lot Number: EN5313) via an unspecified route of administration, administered in arm left on 04May2021 12:45 pm (at the age of 33 years) as dose 2, single for COVID-19 immunisation. The medical history included as none relevant history. Concomitant medication were metformin hydrochloride (METFORMIN ER); spironolactone (SPIRONOLACTONE), all from an unspecified date to an unspecified date taken for an unspecified indication. Historical vaccine included first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Lot Number: EL9267) via an unspecified route of administration, administered in arm left on 13Apr2021 12:45 pm as dose 1, single for COVID-19 immunisation. She had no known allergies. She was not diagnosed with COVID prior to vaccination. she was not tested for COVID post vaccination. She did not receive any other vaccine in four weeks. On 05May2021 03:30, the patient experienced migraine today 08may it had still not gone away and was getting worse. The resulted events lead to visit emergency room. Therapeutic measures were taken. The clinical outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
PFIZER KIDS 5 - <12 YO VACCINE FIRST BOOSTER DOSE GIVEN IM LEFT DELTOID TO PATIENT THE EVENING OF 08/26/22. THE MORNING OF 08/27/22, PARENT CALLED WITH PATIENT SIDE EFFECTS. THESE WERE DESCRIBED AS SWOLLEN LYMPH NODE IN THE ARMPIT OF THE SAME ARM THE VACCINE WAS GIVEN. IT WAS DESCRIBED AS THE SIZE OF AN EGG, PROTRUDING AND PAINFUL. PT DID NOT HAVE ANY OF THESE SIDE EFFECTS WITH THE FIRST TWO DOSES OF PFIZER. PARENT ALSO DESCRIBED REDNESS DOWN THE ARM AND PAIN AT SITE OF INJECTION. DUE TO THE DISCOMFORT OF PATIENT AND AGE, THIS RPH RECOMMENDED PARENT TO CONTACT ON CALL PEDIATRICIAN/ SEEK EMERGENCY CARE ASAP.  CALL PLACED TO PARENT BY THIS RPH ON 08/29/22 TO FOLLOW-UP. PARENT STATED THAT THEY REACHED THE ON-CALL PEDIATRICIAN ON 08/27/22 AND TOLD THEM THAT THIS SIDE EFFECT HAS BEEN COMMON IN THIS AGE GROUP FOR BOOSTER DOSE, AND TO MONITOR PATIENT FOR SIGNS OF WORSENING SYMPTOMS.  PCP TOLD PARENT TO START A COURSE OF CETIRIZINE THAT PATIENT USES PRN, RX ON FILE. PARENT SAID PATIENT WAS FEELING SLIGHTLY BETTER ON 08/29/22.
Rash at injection site started on 9/21, arm described as itchy, warm, and painful
6/25/2021   Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms:  loss of consciousness.   Assessment : Time of assessment 0831am. Pallor, Clammy and disoriented.   Actions taken:  Vitals sign taken  EMS called at  0831. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 856am. Patient refuses EMS transport. Water given 0835- BP- 67/44, P- 39, O2- 100 %, recheck- at 0839- BP- 105/66 , 0915- bp 012/82, P- 44, O2- 100%       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. EMS accessed patient, patient refuses transport. Wife with patient.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 6/25/2021  8:27 AM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8736   NDC: 59267-1000-2
Pt developed a chicken pox like rash approx. 2 wks after vaccine.
PT CAME IN FOR 1ST DOSE IN MORNING AROUND 11:15AM. SHE STATED THAT NIGHT IS WHEN SHE EXPERIENCED COLD EXTREMETIES. IT WAS JUST HER LEFT PALM THAT SHE SAID WAS VERY COLD. PATIENT SAID SHE USED A HEATED RICE PACK TO HEAT UP THE AREA. IT EVENTUALLY RESOLVED THAT NIGHT. She also mentioned that her extremities are usually always cold. but this night, It was just the arm that she received the vaccine.
Chronic chest pain. Also sharp stabbing pain from left leg all the way to the chest. Chronic chest pain. Also sharp stabbing pain from left leg all the way to the chest; Dose 1 was on 03Apr2021 and Dose 2 was on 21Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 21Apr2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously 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 03Apr2021 at 01:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 17:30, the patient experienced chronic chest pain and sharp stabbing pain from left leg all the way to the chest. The events resulted in doctor or other healthcare professional office/clinic visit.  Since the vaccination, the patient had been tested for COVID-19. On 19Apr2021, the patient underwent SARS-CoV-2 test (Saliva) and the result was negative. It was unknown if therapeutic measures were taken as a result of the events. The clinical outcome of the events chronic chest pain and sharp stabbing pain from left leg all the way to the chest were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
I had my covid booster on November 11. I had Pfizer the first two doses and chose the Moderna booster.   On December 3, at a previously scheduled specialist doctor's appointment, I had blood work drawn related to the appointment. Felt a bit lightheaded after blood draw and nurse left room to get juice. She returned and I was nonresponsive ... was out for about a minute and took some time to feel normal again. For most of 'Saturday was still incredibly fatigued. I have blood work regularly for my thyroid checks and have done other fasting blood work and never reacted like this. I was doing a smartphone based check in after the event and reported seeking care and having a reaction and was called by the app administrator and given this website and told I could make a report, or not. My choice. I have no idea if my reaction that day was in any way related to my booster or vaccine series or if it was totally in isolation. It was three weeks after the booster dose was administered.
Narrative: COVID infection following COVID vaccine series 03/05, Pfizer, dose #1 03/26, Pfizer, dose #2 08/22 pt cc: chills, fatigue, myalgias, congestion, rhinorrhea exposure: unknown 08/25 COVID swab, result: detected 08/25 SARS-COV-2 Variant Sequencing result: pending
Day 5:  upset stomach and blurry vision Day 6: Brian fog Day 7: flu like symptoms and slept or 12 hours
1. Pain in arm at injection site that begin approximately 4 hours after injection. Gone approximately 36 hours after shot.  2. Most concerning adverse event is sensitivity and intermittent tingling on the left side of my body, including fingers, palm, toes, and bottom of foot. Currently (1.25.2021), five (5) days after shot, am still experiencing these symptoms. When I scratch my finger nail to the tip of fingers, the skin of the fingertips on my left hand feels thicker than than the ones on my right. They are less sensitive. This did not occur before the vaccination shot.   3. Occasional "pressure" in the head in the first couple of days, but would not describe it as pain or headache.
Received seasonal flu vaccine @ 11:30 2/22/10. Developed n/v, tachycardia, profound hypotension temp of 102.5. Presented to E.D. for evaluation.
Immunization reaction at injection site of DTaP: right arm swollen from shoulder to elbow, with yellow-fluid filled blister (1 X 3 cm) at site of injection. No fever.  (reaction noted 2 days after administration).  Pt was seen by Dr on 4/17, and due to concern for infection he was treated with Amoxicillin and Benadryl, in addition to Tylenol as needed.  Pt continued to have swelling, so went to Urgent care on 4/19 where the blister was unroofed and sent for culture. (at this date, no cells/organisms noted, no growth).  He was switched from Amoxicillin to Keflex.  Mother of Pt applied triple antibiotic ointment.  Pt seen in follow-up on 4/21 with resolution of symptoms.
Swollen injection arm like the size of a golf ball; Very severe pain at Injection site/Probably go to the emergency room today because the pain is that bad/It has been really bad since last week/Symptoms gradually started since the 1st day of the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen injection arm like the size of a golf ball) and VACCINATION SITE PAIN (Very severe pain at Injection site/Probably go to the emergency room today because the pain is that bad/It has been really bad since last week/Symptoms gradually started since the 1st day of the 1st dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen injection arm like the size of a golf ball) and VACCINATION SITE PAIN (Very severe pain at Injection site/Probably go to the emergency room today because the pain is that bad/It has been really bad since last week/Symptoms gradually started since the 1st day of the 1st dose). At the time of the report, VACCINATION SITE SWELLING (Swollen injection arm like the size of a golf ball) and VACCINATION SITE PAIN (Very severe pain at Injection site/Probably go to the emergency room today because the pain is that bad/It has been really bad since last week/Symptoms gradually started since the 1st day of the 1st dose) outcome was unknown.            No concomitant medication was given by reporter. No treatment medication was given by reporter.