chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gotten the 2 doses of the COVID-19 vaccine/He tested his IgM and IgG /and they were negative; This is a spontaneous report from a contactable physician reporting for himself. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation on an unspecified date. Patient reported he has gotten the 2 doses of the COVID-19 vaccine 2 weeks before. He got his second dose on 06Jan2021. He tested his IgM and IgG yesterday (19Jan2021) and they were negative. He wanted to know information from the clinical trials if Pfizer has tested the patients' IgG and IgM and what was done for them to have immunity. Outcome of the event was unknown.  Information about lot/batch number has been requested.
The first day right after vaccination, the symptoms were headaches, fever, weakness on both knees, and neck tightness. Then a weak after the vaccination, I experienced burning on my head, weakness of left eye muscle, and numbness.  The numbness and tingling are still waking me up at night with the electric shock feeling in my head.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 9:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 9:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 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.  Age of patient was reported as 68.95 for dose administered on 28-Apr-2021.  Batch number 007C21A underwent temperature excursion with temperature 33 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. 4 vial was moved to clinic, Product moved to clinic on 28-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Client requested water prior to vaccination. Client requested for a snack just after receiving vaccination. Fruit bar and gold fish crackers were provided to client as he was sitting in vaccination chair. Client appeared diaphoretic, face was becoming pale, and eyes were fixated directly to his front. Client dropped water bottle and then client was safely transferred from chair to the ground at 3:20 PM with two person patient transfer. Client was instructed to take deep breaths while client had his eyes closed. Reporter asked client if he was still present with us and client stated, "Yes, I am feeling fine now." Reporter assessed client to which he was alert and oriented to person, place, time, and situation. Client's face mask and beanie were removed to assist client with cooling down. When client was ready to get up, he stood up immediately and then sat down into the gravity chair at 3:22 PM. Client was advised to continue eating snacks and drinking water and to wait in the gravity chair for a 30 minute observation. Reporter took vitals at 3:22 PM which were the following: blood pressure of right arm 108/58, pulse 60, O2 SAT 96%. Client stated verbally, "my blood pressure always runs low, that is a regular reading for me." Client denied taking any medications and denied having any diagnosed medical conditions. Client revealed, "I've had syncope episodes in the past. Needles make me anxious and makes my blood sugar drop. I just need to eat something to feel better." Reporter recommended for client to follow up with his primary care physician and notify them of the syncope episode. Client was also referred to V-SAFE. Client called his brother at 3:29 PM to drive him home which is a 10 minute drive from the vaccination site. Second blood pressure reading at 3:45 PM on right arm 108/50. Client was escorted by reporter as a standby assist to the entrance. Client left facility safely alert and oriented x4 with steady gait at 3:46 PM.
Flu symptoms-achiness all over, fatigue, slight fever; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 12:15 (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, start date: 22Nov2021, stop date: 22Nov2021. Vaccination history included: Bnt162b2 (Dose 1, Single, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Single, Location of injection: Arm Left), administration date: 11Jun2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "Booster"; INFLUENZA (non-serious) with onset 30Nov2021 12:00, outcome "not recovered", described as "Flu symptoms-achiness all over, fatigue, slight fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza.  Additional information: Anatomical location where vaccine was administered was reported as Upper (not specified clearly). Facility of most recent Covid-19 vaccination was reported as other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had been tested for Covid-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sore, red around site injection, happened day after got vaccine. Treating with BENADRYL 25mg capsule of maybe BENADRYL cream (on left arm).
urticarial rash began 3hrs p/vax;no new foods or new soaps;no resp problems;no hx hives in past;
Pt received flu shot (FLULAVAL Quadrivalent) NDC# 19515-0895-11 on 1/13/14. Pt came to pharmacy on 1/21/14 to report ill effects 1 day following including loss of short term memory, loss of attention, feeling warm sensation in the head region, somewhat of a fever. To date, symptoms have not abated. Pt will f/u with her PCP.
Initial unsolicited report received from Nurse on 30-Mar-2018. This case involves 4-year-old male patient who was vaccinated with 0.5 ml single dose of QUADRACEL (Batch number: C5248AA, expiration date-21-Aug-2019, site- unknown, dose in series not reported) intramuscularly on 27-Mar-2018. The patient's medical history and concomitant medications were not reported. On 28-Mar-2018, one day following the vaccination, the patient had 6 X 8 raised area on the left thigh. Lab data was not reported. Corrective treatment was not reported. Outcome of the event was unknown. List of documents held by sender: none.
First day cough, second day cough, Then 2 days of achiness, temperature, and fatigue.  I took a COVID-19 Home test, it was positive. I called my doctor, she prescribed Paxlovid. I had  2 days of just fatigue and the then the cough came back for 3 or 4 more days.
Intense metallic taste in mouth; This is a spontaneous report received from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the right arm on 20Mar2021 at 13:30 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included etonogestrel; ethinyl estradiol (NUVARING) for an unknown indication on an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Mar2021 at 14:00, the patient experienced intense metallic taste in mouth. The patient did not receive treatment for the event intense metallic taste in mouth. The clinical outcome of the event intense metallic taste in mouth was not recovered.  No follow-up attempts are needed. No further information is expected.
Arm very swollen, 5" square red, very hot, and very heavy, headache and tired lasted this way 10 days, sore joints and rash on arm
SWELLING IN HER LEFT ARM STARING FROM 6-24-20 TILL 6-28-20, WITH HOTTNESS FEELING. SHE WENT TO HER DOCTOR, SHE SAID HER HEART RHYTHM WAS ABNORMAL TOO. SHE TRIED ICE BAG , BUT IT DOES NOT WORK.
Pt developed varicella infection on 1/26/02, at least 50-100 lesions on face, abdomen, chest, and extremities. Treated with ? Augmentin.
mom reports pt screamed for several days p/vax;almost constant screaming leg, swollen where inj;onset of crying p/vax;
Patient received the rotavirus vaccine and had extreme pain within 24 hours of the vaccine. He had severe diarrhea. He was screaming uncontrollably. I took him to the doctor's office and the doc said he may be having his intussusception, where his intestines flip inside out???? I took patient to the ER, where they found no evidence of intestinal damage, but he was dehydrated from the diarrhea.
Adverse reation: itching where injection was, swelling in entire arm, raised red rash on forearm. Treatment: 50mg of Benadryl and prior to ER. While waiting to be seen in ER: experienced edema in arm, back and chest. Treatment: icepack, oxycodine, and 50 mg of Benadryl. Monitored in ER for several hours.
Injection site soreness started almost immediately, 12 hours after shot body ache and headache and slight fever. Tiredness, dizziness  also. All symptoms lasted 24 hours.  Feeling good 48 hours after shot.  Didn?t take any medication for symptoms. Just rested and slept.
Per husband: "Wife developed severe chicken pox all over body. Wife got shock- for two days, she had sore shoulder, on the 3rd/4th day she starting developing rash on site where she got the shot. Then rash spread to her other side and now rash has spread all over the body. Thought it would go away in a day or two, but hasn't. She has had the rash for 8 days."   Further investigation on interview: It started approximately 3-4 hours after vaccination. First a sore arm then it felt itchy. She then noticed red raised spots. This rash has resolved slowly but "almost back to normal" as of Feb. 1. She still wants to get her second dose on Feb. 2 as scheduled.
Patient came in for his 1st COVID Pfizer vaccine, he was 12 at the time of the vaccine and the Pediatric 5-11 year dose was given, 0.2ml. He should have receievd the Pfizer 12 and older dose, 0.3ml. I emailed department to ask what the next step is. They informed that the patient will receive his 2nd dose at the 0.3ml dose for 12 and older. I notified dad of error and he had no questions or concerns.
3hrs p/vax rash area lt thigh @ site of shot; bruising, swelling of lt thigh, purplish discoloration; screamed for 2 hrs;
First 24 hours: Severe chills, migraine, total body aches, fatigue, nausea 1-5 days: Fatigue, slight chills off-on, waves of nausea, headaches
Pain, swelling, redness at injection site for over seven days, after the second dose.  None after the first dose.
Site of injection red, hard, quarter sizied blister (sveral blisters). Denes fever. Denies difficulties breathing.
0.5 mL leaked out of patient's arm; vacination site discharge; A spontaneous report was received from a pharmacist concerning a patient of unknown age and unknown gender who received the Moderna COVID-19 vaccine and experienced incorrect dose administered and Vaccination site discharge.  A different nurse administered vaccine to patient and they noticed 0.5mL leak out of patient's arm.  Moderna vaccine, it  was a second dose, administered to just one patient. Pharmacist wants to know if they should repeat dose. Only 1 injection was involved, and Pharmacist has no patient specific information. Ok for safety to contact. HCP wants in writing.   The patient's medical history was not provided.  Concomitant product use was not reported by the reporter.     On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273  Batch number not provided on unknown date. Prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273  Batch number not provided intramuscularly in the for prophylaxis of COVID-19 infection.    On 04 Feb 2021, a different nurse administered vaccine to patient and they noticed 0.5mL leak out of patient's arm., the injection site leaked. Moderna vaccine was a second dose, administered to just one patient. Pharmacist wants to know if they should repeat dose. Only 1 injection was involved, and Pharmacist has no patient specific information. Ok for safety to contact. HCP wants in writing.  Treatment information was not provided.     Action taken with mRNA-1273 in response to the events incorrect dose administered and Vaccination site discharge  was not applicable.  The outcome of the event was considered as recovered on 04 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered and Vaccination site discharge for mRNA-1273.  There were no reported adverse events associated with this case.
2/6 Awoke with arm muscles very sore & couldn't lift arm high.  By Sum 2/7 was a little less sore.  Didn't check injection site until Thurs 2/11 and large reddish/pink area around site & arm was sore to elbowl
Patient missed her 2nd dose, more than 42 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient missed her 2nd dose, more than 42 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient missed her 2nd dose, more than 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient missed her 2nd dose, more than 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
2 to 3 days later pt reports that a red blistering rash spot appeared on inside of elbow right above & below the crease on left arm only. (Arm the shot was given) on 03-25 pt came in to show rash - about the size of a quarter above & below inside elbow crease. It looked blistered and red. Pt says it was itchy. No other symptoms reported- asked pt about possible exposure to poison ivy or other allergen, does not think had any other exposures. As of 03-25 pt still has rash.
Developed a fever the night following receiving the shot of 101.7 degrees Fahrenheit. Fever did not dissipate until the evening of the next day (Tuesday). Came down with a headache Wednesday afternoon that is still persistent to the present.
Since getting the Pfizer Covid vaccine, I haven't had a period since December. Many other women have reported this same issue but it still has not been addressed or acknowledged publicly or privately by the CDC.  My concerns and questions are:   1. What studies have you performed in regards to covid vaccine and women's periods? 2. What permanent side effects will this cause to my cycle and ability to have children? 3. Will my periods normalize back to what they were before  I received the vaccine? 4. Will I need medical treatment? 5. Does the vaccine cause premature menopausal symptoms? 6. Will this issue with the vaccine and periods be publicly addressed soon?
Fever up to 101 degrees & maculopapular (widespread) rash w/ a few target lesions.  No vesicles, no itching.  Symptoms have been present x 48h at time of visit today.
101° F fever; Headaches; muscle aches; Chills; Fatigue; A spontaneous report was received from a consumer concerning a 70-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 101 f fever, headaches and muscle aches, chills, fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 26 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 01DM20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event(s) 101° f fever. headaches and muscle aches, chills, fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), 101° f fever, headaches and muscle aches,chills,fatigue was unknown.
1 wk p/receiving flu vax, 60 yo pt presented to hosp w/ PO2 50 & bilateral interstitial pneumonitis; sxs began w/in 24 hrs p/vax; pt had neg gallium scan of lungs & is responding to Prednisone; pt improved & was discharged;
Mother called stating son broke out in hives all over body.  Day after getting HIB.  No new foods or dye, No impaired airway.  Rx'c BENADRYL - told to go to Urgent Care or Dr/ 911 if airway impaired.  To caller come in to f/u.
Case number PHEH2012US016490 is an initial spontaneous report received from a medical assistant on 20 Aug 2012 with a follow up information received on 04 Sep 2012: This report refers to 11-year-old male patient whose current condition included Penicillin allergy. He was vaccinated with MENVEO (batch number: A10135 and expiry date: Feb 2013) along with BOOSTRIX (manufacturer and batch number: unknown) intramuscularly in same arm on 13 Jul 2012. On 14 Jul 2012 he experienced symptoms of swelling which was greater than 10 cm, redness, tenderness and warmth at vaccination site. The final outcome of the events was reported as complete recovery with a stop date of 16 Jul 2012. No further information about the seriousness and causality of the event was reported. Follow up information received on 04 Sep 2012: Patient demographics (height and weight), current condition, batch number, event (tenderness), event stop date and outcome updated.
had the second vaccine, the injection site bled; Sneezing a lot, after the first and second vaccine; This is a spontaneous report from a contactable consumer (mother). A 17-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0171) dose 2 via an unspecified route of administration in right arm on 12May2021 at 4 pm (At the age of 17 years old) as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included ongoing ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE, Tablet) oral 1 mg/10 mcg monthly for birth control (started two months ago). Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161) dose 1 via an unspecified route of administration in right arm on 21Apr2021 (evening) (At the age of 17 years old) as single dose for COVID-19 immunization. No prior vaccinations within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. Her daughter had the second vaccine, the injection site bled around 4 pm on 12May2021. When the provider stuck the needle in her daughter's arm it bled for a few seconds and they wiped the blood off with a cotton ball. Her daughter did not see any blood on the Band-Aid. She was sneezing a lot, after the first injection and then it got more intense/worsened after the second injection in 2021. Her daughter's school is making all the seniors get the shot to go back to school. Because she is her daughter's mother and told her daughter to get the vaccine. A visit to emergency room or physician office was not required. The outcome of event injection site bled was recovered on 12May2021; Sneezing was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 25-MAR-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J004159 and expiry date: 08-APR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.