chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE information provided.; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product wadministering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing; This spontaneous report was received from the registered nurse and refers to a patient of unknown age, and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 31-AUG-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W002453, expiration date: 24-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided).  The suspect vaccine was diluted with 0.5ml of normal saline, and then the nurse after drawing up 0.5 ml, administered it to patient (product preparation error, accidental underdose). No additional adverse event information was provided.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-2209USA008037:
myalgias, nausea, vomiting, diarrhea, fever, fatigue
Heat and redness at  the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (Heat and redness at  the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001653) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Heat and redness at  the injection site). On 26-Apr-2021, VACCINATION SITE ERYTHEMA (Heat and redness at  the injection site) had resolved.        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.   No Concomitant medication were reported. Treatment medication was not provided.
I am 4 ½ months pregnant, due to deliver 4/29/2022. I received my COVID-19 booster on 10/27/2021 and started getting hives and being very itchy in various places all over my body developing welts and rashes. I have been taking Benadryl orally every 4-6 hours and applying hydrocortisone topically which seems to help but it keeps returning 4-6 hours post Benadryl. My sister had her COVID-19 booster (Moderna) on 10/22/2021 and experienced these exact same symptoms, including hives/rash/welts starting on 11/1/2021. She is not pregnant and able to take steroids for the itch/rash and experienced these symptoms for a few days.
Swelled and itching at sight of vaccine - patient not feeling ill reaction to ZOSTAVAX.
Vaccine was administered at employee clinic on a Thursday evening around 5pm, just before the nurses left for the day. On the next day, Friday, I experienced significant soreness, headache, and mild left sided (full body) weakness. Saturday and Sunday this weakness increased such that I was unable to walk without assistance, maintain items held in my left hand, or sustain my left arm in a raised position. I began to recover the following day.
DAY AFTER SECOND COVID VACCINE HAD A ISCHEMIC CVA, WITH TOTAL LEFT SIDED PARALYSIS NOT RESPONSIVE TO MEDICAL INTERVENTION, HAS BEEN IN HOSPITAL SINCE 4-17-2021, IS NOT EXSPECTED TO EVER LEAVE HOSPITAL
Muscle ache; Fatigue; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired.; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 2022, outcome "unknown" and all described as "The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired."; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache"; FATIGUE (non-serious), outcome "unknown".  Additional information: Caller was asking about the gray cap vaccine. The vaccine was expired and was administered to 5 patients. Caller mentioned that she was going to report this to VAERS and wants to check on what to do next. She said that this vaccine has an expiration date of 15Jun2022. Caller said at least that helps with one patient and all the patients were similar. No one of the 5 really had adverse reaction to the expired doses though 3 did report they had several days of side effects - so they thought event though expired that the vaccine had some effect on their sometimes muscle aches, fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (18Aug2022): This is a spontaneous follow-up report received from a contactable Other-HCP. Program ID. Updated information included: Reporter information updated (Address, city, state added. Phone Number updated for primary reporter).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (26Sep2022): New information received from the same contactable other HCP. Updated information includes new events (Fatigue, muscle ache).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201070713 Same reporter/drug/event, different patient;US-PFIZER INC-202201093830 Same reporter/drug/event, different patient;US-PFIZER INC-202201098081 Same reporter/drug/event, different patient;
Information has been received from a medical assistant concerning multiple unspecified patients. The medical assistant reported that multiple doses of improperly stored GARDASIL 9 (lot # M037770, expiration date 01-JUN-2019) were administered to multiple patients on unknown dates and times (route of administration unknown). No adverse effects reported. Temperature: 32°F to 35°F Time frame: 22 hours 22 minutes Previous temperature excursions: No Data logger involved: Yes. Additional information has been requested.
Information has been received from a physician via a field employee referring to a 20 years old female patient. There was no pertinent medical history, drug reaction or concomitant medication reported. On unspecified dates in 2008, the patient was vaccinated with all 3 doses of GARDASIL (dose, route of administration, Lot# and expiration date were not reported). On an unspecified date, the patient developed human papillomavirus (HPV) infection. The physician reported that the HPV was probably a different strain than what was in the vaccine. The outcome of the event was not reported. The causality was not reported. Additional information has been requested.
Nausea; Diarrhea; Headache; Body aches; Administration date 07Oct2021 at 11:00, dose number=3; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 07Oct2021 at 11:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included valsartan (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date 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 as a single dose for COVID-19 immunisation. The patient previously received alprazolam (XANAX) and experienced drug allergy.  On 07Oct2021 at 11:00, the patient had "administration date 07Oct2021 at 11:00, dose number=3." On 07Oct2021 at 15:00, the patient experienced nausea, diarrhea, headache and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events nausea, diarrhea, headache and body aches. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, diarrhea, headache and body aches was resolved with sequelae on an unknown date in Oct2021. The clinical outcome of the event  "administration date 07Oct2021 at 11:00, dose number=3" was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient at age 12, was vaccinated with a dose of GARDASIL (HPV4) (dates of administration, dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient at age 17, was vaccinated with a dose of GARDASIL 9 (dates of administration, dose, route, lot # and expiration date were not reported) for prophylaxis. No adverse events were reported. No additional information was provided. Additional information has been requested.
Pt became lightheaded 15 min after dose that was better upon lying down. BP 156/82, 99% o2sat, 92 HR. Attempted several times to sit up but became lightheaded again. Reported headache 5/10 at back of the head at 09:45am and tension in the neck (stiff). At 10am, pt vomited and vomited several times more afterwards.  At 10:07am, pt was cleared for d/c home by NP. Pt told to take rest of day off and at 10:30am, pt was escorted via WC to car, husband driving. Pt still was lightheaded, nausea was improved, still had HA and stiff neck.  Pt and husband given ER precautions.
Patient reported chest pain that lasted for one day (chest pain went away within the day), body aches, loss of appetite and loss of energy a day after receiving flu shot on September 10, 2020
45min post vax pt went into trance-like state lasting approx 1 min & during this episode was unresponsive to mom--shortly p/child became drowsy & took a nap; no elevated temp; leg sore to touch; MD called & child taken in for exam;T 101.4
Patient received her second dose of her Covid shot (Moderna). After vaccination, patient stated that she felt very anxious, light-headed and had a headache. Tried to get up and stated that she almost fell and began crying. Counseled the patient on potential effects of the vaccine and offered to call emergency services, which she declined. She stated that she would have someone else pick her up since she felt like she couldn't drive and felt dizzy. Patient tolerated 1st vaccine and no allergic reaction present.  Patient left under her own power from the pharmacy for her ride. Sent message to prescriber as well regarding patient and incident.
This spontaneous report as received from a registered nurse refers to a patient of unknown age (no demographic details were provided). The patient's medical history was unknown. On an unspecified date (calculated as March 2013), the patient received a dose of ZOSTAVAX. No dosing information was provided. The expiration date of ZOSTAVAX was reported as 06-MAR-2013 and the lot number as 0169AE. No concomitant medications were reported. The reporter stated that the patient that the administered dose of ZOSTAVAX was expired. Additional information has been requested.
After 1st shot :  arm soreness, raised red and hot to touch. Pain in hips as day went on, pain traveling to lower extremities, then upper extremities. Lethargy and chills.   After 2nd shot:  Similar s/s but  worse than 1st dose. Painful to move upper and lower extremities, extreme lethargy, slight temp, overall unwell feeling.    My concerning issue is that arm soreness diminished after few days but then returned at approximately 3 weeks after 2nd dose . As of right now, I?m continually feeling pain, sometimes sharp and radiating pain above and below site. Seems to be covering more area of arm, armpit.I have hard time sleeping on left side, waking up from pain if on it too long, weakness in left arm, pain if lifting arm  or turning it certain directions.  If I press on injection site i can feel pain and tenderness.   Affecting daily living. I?m also a nurse and it?s worrying me at this point.
Vaccine administered 9/10/08 and noticed swelling of face, neck, nose and lips next day. Reports that she had difficulty breathing. Reports that she went to local Emergency Room was given a shot and placed on steroids and she improved.
This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. No medical history or concurrent conditions were reported. On 30-OCT-2013, the patient was vaccinated with the first dose of GARDASIL, (HPV-4), the patient was vaccinated with the second dose on 30-DEC-2013 and the third dose on 21-JAN-2015 (inappropriate schedule of drug administration). On 28-MAY-2015, the patient was vaccinated with the fourth dose of GARDASIL, 0.5 ml, intramuscularly (extra dose administered). No adverse events were reported. The outcome of the event was unknown. No product quality complaint was involved. Additional information has been requested.
Redness, swelling, hot to the touch, painful. Advised ice pack and appointment with PCM for further care.
The patient was administered an improperly stored dose of Vaqta; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On 31-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (Strength, dose, frequency, route and anatomical location were not reported) of lot # S010727 with an expiry date of 26-JUL-2020 for prophylaxis (product storage error). The hepatitis a vaccine, inactivated (VAQTA) underwent a temperature excursion at 31.6 Fahrenheit for a time period of 13 hours and 35 minutes. There was no previous temperature excursion involved. Digital data logger was involved.
Right thigh where the patient received Proquad and Kinrix the day before. The area appeared red, swollen, and was pruritic. Treatment with diphenhydramine as needed. Follow up closely.
Child had facial swelling hives body approximately 3 hours after receiving immunization contacted PCP- MD given ZYRTEC not seen by PCP. Mother reports sx x 3 days resp. difficulty called PCP wasn't seen by PCP.
THE PATIENT DEVELOPED AN ITCHY RED RASH ON THE ARM WHERE THE VACCINE WAS GIVEN.  THE RASH CONTINUED TO GROW LARGER AND SPREAD FROM HER SHOULDER TO ELBOW AND ON TO HER ABDOMEN.
10 minutes after dose experienced tachycardia, dizziness shortness of breath, and flushing. It lasted about 30 minutes.
Day after flu shot patient relied complaining of numbness in her left side and hoarseness in her throat.  I referred her to ER since the phone # on VIS form thought could be Guillain Barre.  I called her two days after shot and numbness was improving but throat swollen.  Recommended ER again and couldn't breathe.  Pt taking BENADRYL & calling MD next day.
chills; 102 temperature/ a low grade fever; Ached all over; swollen glands under the arm where I received the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "not recovered", described as "102 temperature/ a low grade fever"; PAIN (non-serious), outcome "unknown", described as "Ached all over"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen glands under the arm where I received the shot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia, pain. Additional information: About 15 hrs after receiving vaccine, patient began getting severe chills. Had 102 temperature. Ached all over too. Took Tylenol. After 2 days, patient still have a low grade fever and swollen glands under the arm where she received the shot.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning an approximately 16 year old female patient who on an unspecified date in the past was vaccinated with a dose of VARIVAX (Merck) (Lot# 658936/1350U). It was reported that the patient was recently found to have negative varicella antibody titers. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. No further information is available.
Patient came in as a Nurse Visit, walk in. All paperwork completed, EUA form given along with handouts,  and patient answered questions on consent form and signed. We talked about his Immune Globulin Therapy and he stated his provider still recommend he get vaccinated. Vaccination given at 12:03 in left deltoid. Patient was released in stable condition at 12:18. Patient made second appt for vaccine and left clinic. Patient got to car and stated his throat "felt itchy." I had patient lie down and dimmed lights, call bell placed on the exam bed with him. He was advised to use it as I stated I was going to go get him some juice and check with provider. I went to get some juice and the epi pen kit. Went back to room and asked how he was doing. He stated he was feeling lightheaded and dizzy. Tingling sensation going down his left arm. Told him I would be right back. Went and advised Dr of situation. Asked if I could give a diphenhydramine 25mg . She said, "yes, and wheel patient to ED." This was administered at around 12:30. He was then put in wheelchair/escorted to ED where report given and he was released to ED nurse a few minutes before 1 PM.
SHARP PAIN IN STOMACH; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, non smoker, high blood pressure, and testosterone replacement, and other pre-existing medical conditions included patient had no known allergies any allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced sharp pain in stomach. On 29-JUN-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) 99.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low grade fever, and had not recovered from sharp pain in stomach. This report was non-serious.
Muscle pain and edema after a few hours. Fever (over 101) after 18 hours. Fever lasted more than 12 hours. Joint and muscle pain increased with fever and lasted about 2 days. Day two: lymph nodes swollen in shoulder and underarm area. Difficulty lifting arm. Edema lasted about 3 days. I received the second shot in the series 48 hours ago. I began running a fever about 12 hours later. Fever reached 101.5. I slept 12 hours. joint and muscle pain is decreasing. I have edema in my arm muscle. Shoulder lymph node is swollen. Reaction after 2nd shot is not as bad as first, but was still significant.
.Client previously received Janssen on 4/8/21. Client reports that one month after receiving Janssen client experienced pain in both calves. Client states she had pounding pain 2/10. And still comes and goes. Client denied having headache, chest pain or shortness of breath. And reports developing varicose veins after vaccine. RN submitted a medical consult via text message to clinical lead. Approval was received by MD for client to receive Pfizer booster. Client was vaccinated.
red spot; Pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spot) and PAIN (Pain) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH MACULAR (red spot) and PAIN (Pain). At the time of the report, RASH MACULAR (red spot) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. Treatment details was reported as ice pack.
REACTION:  SEVERE DIARRHEA, CHILLS, HEADACHE, LOCAL SWELLING & SORENESS
Patient became diaphoretic, pale, felt faint and  vomited a small amount/ BP 94/54.
Patient received ROTARIX on 05/24/16. Presented to ER on 5/28/16 with abdominal pain, vomiting and bloody stool. Ultrasound confirmed intussusception, reduced by radiology.
Localized swelling, pain, redness, warmth at injection site. Whole body aches. Tiredness. Lasted for 2 days. On day 10 the site swelling and redness came back along with upper body aches.
Loss of smell; Loss of taste; My face become numb; it was hard to manipulate my tongue; it has moved up toward my eyes are becoming numb as well.; my lips became stiff; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date not reported), via an unspecified route of administration on 22Mar2021 08:00 (at the age of 65 years) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22Mar2021 20:00, almost exactly 12 hours later, patient lost all sense of smell and taste for about an hour, his face become numb like he went to a dentist with novacaine shot (intent: reference), his lips became stiff, and it was hard to manipulate the tongue. It was reported that, this has continued till the current date, and it has moved up toward his eyes are becoming numb as well. Patient reported that, taste and smell came back after an hour, but it comes and goes and its ability, means its sensitivity is 30% past. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.