chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse referring to the patients of unknown ages and genders. The patient's medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates in 2016 (reported as "after May 2016"), the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L040445, expiration date 15-JAN-2017, dose and route not reported). The vaccine was improperly stored at 9.36 degree Fahrenheit for 10 hours. There was no data logger. Central monitoring was used. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there is no permission to contact the physician.
This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 04-AUG-2015, the patients were vaccinated with improperly stored MMR II lot # J013316, expiration date 22-OCT-2015 and lot # K005175, expiration date 10-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
7 days p/vax devel fever 103, morbilliform rash, coryza, conjunctivitis & dry hacking cough lasting 2-3 days;also exp nasal congestion;pt devel right limp;pt somewhat irritable;
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition was reported).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I had palpitations, tachycardia and shortness of breathe.  I went to the ER, and was there for three hours. I have interment Tachycardia, and have seen a Cardiologist and now on medication.
Received vaccine yesterday. Pt. with (L) jaw pain that day. Also (L) arm, (L) leg weakness, tingling, pain. NL gait, no other S/S. TX = MOTRIN, Ice. F/up in 3 days.
At times, moderate to severe pain in left arm, left elbow, left wrist and fingers ,At times, a searing, burning pain that comes and goes. Also went into left chest muscles and left shoulder. Kept me awake a few nights after the shot. When pain was bad, little or no strength in left arm.
Dx Cough  ? Nasal Congestion  Clinical Support 3/11/2021 RN COVID-19 virus infection Dx Medication Infusion Reason for Visit Progress Notes RN (Registered Nurse) ? ? Encounter Date: 3/11/2021 ? ? Signed    Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90% Signs of potential reaction reviewed with patient. Tolerated IV start and MAB infusion without complication. Pt has access to pulse oximeter and thermometer for home monitoring Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions    Instructions  COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide     MAB Infusion Treatment Team:
Site reaction with redness and swelling; Site reaction with redness and swelling; Nausea; Pain; This spontaneous case was received on 27-Sep-2021 from other health professional via Communications (reference number: SEQW21-02807) and concerned a 46-year-old, female patient.  The patient had no relevant medical history. The patient's concomitant medications included Atorvastatin (atorvastatin calcium) and Zebeta (bisoprolol fumarate), both used for an unreported indication.  On 20-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 38518 and expiry date 30-Jun-2022.    On the same day, after receiving Flucelvax Quadrivalent, the patient experienced moderate to severe site reaction with redness and swelling.  On an unspecified date in Sep-2021, the patient experienced nausea and pain. She went to urgent care to treat symptoms. It was also reported that patient was treated with unspecified antibiotics.  The outcome for all events was not reported.   The reporter did not provide causality assessment.  The case was assessed as non-serious.  The case is linked to 202103207 and 202103208 (due to same reporter).  Company comment: A 46-year-old, female patient developed vaccination site swelling and erythema on the same day after vaccination with the suspect product Flucelvax Quadrivalent. On an unspecified date within the same month the patient experienced nausea and pain. Information regarding the related diagnostic findings have not been provided, although the patient started treatment with unspecified antibiotics. Based on provided information causality for the events vaccination site swelling and erythema is assessed as possibly related. Due to unclear chronology, causality for all other events is unassessable. Limited information precludes assessment of Brighton Collaboration criteria for cellulitis.; Sender's Comments: A 46-year-old, female patient developed vaccination site swelling and erythema on the same day after vaccination with the suspect product Flucelvax Quadrivalent. On an unspecified date within the same month the patient experienced nausea and pain. Information regarding the related diagnostic findings have not been provided, although the patient started treatment with unspecified antibiotics. Based on provided information causality for the events vaccination site swelling and erythema is assessed as possibly related. Due to unclear chronology, causality for all other events is unassessable. Limited information precludes assessment of Brighton Collaboration criteria for cellulitis.
After the 1st vaccination, I experienced pain in my right arm a few hours after receiving the shot.  The dull, but had a pulsating effect.  On the 3rd day after receiving the vaccine, the pain moved to my left shoulder for about a day and then went away.  During this time I also felt fatigued and slept a lot.   After receiving the 2nd vaccination, I didn't experience any pain in my right arm until 3 days later, on September 25th.  At approximately 4:30AM, I woke up because I was having the same pulsating pain in my right arm.  It was more severe this time, and I was unable to sleep.   The next day the pain in my right arm wasn't as severe, but the pain had moved to my left shoulder again.  This time it was much more severe than the first time.  This lasted about 2 days.   During this time the pain in my left shoulder would also move up my neck and down to my hand.  I was unable to sleep very much until the pain eventually went away.  However over the next few weeks, the pain in my left shoulder returned several times and would usually only last a day or for several hours.  I also experienced pain throughout most my joints and am still experiencing pain in my left elbow.
Arm got swollen twice it's normal size. Had a lot of pain, arm was red down to elbow. Couldn't raise arm. Became feverish and took benadryl then Atarax. Arm still red and sore.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other Moderna/vaccine brand Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 22Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Oct2022, outcome "unknown", described as "Vaccine brand other Moderna/vaccine brand Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of Drug ineffective, Covid-19 which includes Paxlovid treatment from 28Apr2023 to 03May2023. Clinical course: Patient had no known allergies.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300187520 same patient, different drug/AE.;
This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FM8027) via an unspecified route of administration in the left arm on 17Nov2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included discoid lupus, penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medication within two weeks of vaccination. The patient previously received codeine (MANUFACTURER UNKNOWN) and morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 15Mar2021 at 14:00 (at the age of 43-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 05Apr2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 18Nov2021 at 03:00, the patient experienced fever, chills, headache, extreme body aches, shaking and sweating. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, headache, extreme body aches, shaking and sweating was not resolved at the time of this report.
Information has been received from a licensed practical nurse concerning an approximately 10 week old female who on 18-APR-2007 was vaccinated with the first dose of Rotateq. On 26-APR-2007 the patient experienced rotavirus and was hospitalized. While in the hospital, the patient's stool was checked and was positive for rotavirus. Subsequently, the patient recovered from rotavirus. The patient was in the health care provider office to receive a second dose of Rotateq (date unspecified). There was no product quality complaint involved. Additional information has been requested.
EXTREMELY SORE ARE. 10 DAYS INTERMITENT FEVER. 3 MONTHS PERSISTENT BRONCHITIS.
diarrhea; heartburn; tired, worn out; fever for 3-4 days; 100 F; left arm is red and swollen from elbow to neck; painful arm, couldn't lift; itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (diarrhea), PERIPHERAL SWELLING (left arm is red and swollen from elbow to neck), PAIN IN EXTREMITY (painful arm, couldn't lift), PRURITUS (itchy arm) and DYSPEPSIA (heartburn) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (left arm is red and swollen from elbow to neck) and PAIN IN EXTREMITY (painful arm, couldn't lift). 07-Apr-2021, the patient experienced PRURITUS (itchy arm). On an unknown date, the patient experienced DIARRHEA (diarrhea), DYSPEPSIA (heartburn), FATIGUE (tired, worn out) and PYREXIA (fever for 3-4 days; 100 F). The patient was treated with CLINDAMYCIN at an unspecified dose and frequency. At the time of the report, DIARRHEA (diarrhea), PERIPHERAL SWELLING (left arm is red and swollen from elbow to neck), PAIN IN EXTREMITY (painful arm, couldn't lift), DYSPEPSIA (heartburn), FATIGUE (tired, worn out) and PYREXIA (fever for 3-4 days; 100 F) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.
some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020.  She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.
Heard this clinic giving shots: made appointment that very day (hands, feet, mass ice cold). Evening body very hot. Throat so sore: when to doctor, no strep throat. Took three weeks to get over the flu. My doctor said I got the flu from shot. He said take Tylenol twice a day.
experienced tiredness/tiredness feeling; more fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 89 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 (Lot number: EN6200) at the age of 89 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Supplementation therapy" (unspecified if ongoing); "Diverticulosis" (unspecified if ongoing). Concomitant medication(s) included: CENTRUM SILVER +50 taken for supplementation therapy; MIRALAX taken for diverticulum. Vaccination history included: Bnt162b2 (EL1283 first dose), administration date: 28Jan2021, when the patient was 89 years old, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset Feb2021, outcome "not recovered", described as "experienced tiredness/tiredness feeling"; FATIGUE (non-serious) with onset Feb2021, outcome "not recovered", described as "more fatigued".  Additional information: Centrum Silver, Dosage text: 1 tablet a day by mouth, MiraLax Dosage text: 1/2 dose as needed by mouth 2-3 times a week.  No follow-up attempts are possible. No further information is expected.
Approximately 10 days after MMR and Varivax injections, began having fevers 104 105. Demonstrated a maculopapular rash.
my brother had received a full non diluted dose; full arm is numb he can't even pickup a spray bottle and spray it; bad heart palpitation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "He never smoked" (unspecified if ongoing), notes: He never smoked. The patient's concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "my brother had received a full non diluted dose"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "full arm is numb he can't even pickup a spray bottle and spray it"; PALPITATIONS (non-serious), outcome "unknown", described as "bad heart palpitation".  Additional information: Name and telephone number: Reporter stated, "My name is  withheld (not alphabetically spelled hence not captured in tab) and my phone number is # (Further not clarified hence not captured in tab) you know what never mind, anyways I'm calling because my brother had received a full non diluted dose, so much higher, six dose bottle of the Pfizer vaccine and he is currently incarcerated in for medicine in withheld (further clarification unknown), now they did that about for like 70 something of this med(further clarification unknown), now mind you my brother called me the other day and he said that the CDC and Pfizer is saying that all these symptoms go away okay now my brothers full arm is numb he can't even pickup a spray bottle and spray it, now he is having bad heart palpitation now they received and take him to the hospital (further clarification unknown hence hospitalization not checked) and I'm just wondering like seriously what's going on, this is the reason why I will not get that vaccine, you not putting Nano bite in me which is basically turning me into living(Word not clear) so that I be susceptible to all this bio-terrorism, we are not doing this."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2nd BI-VALENT BOOSTER GIVEN ON 12/16/22 1st GIVEN ON 09/21/2022 MODERNA LOT # AS7162B NO ADVERSE SYMPTOMS NOTED
Infant reportedly co-sleeping. Found nonresponsive. EMS took to ER - 24 hr in PICU - arrested and died.
whole body ache , chest pain, palpitation, severe headache, persistent diarrhea 12 hour after COVID booster, then developed pinpoint itchy rash all over the body started 1 week later.   this COID vaccine is not safe and harming people.
My son experienced minor discomfort on the first day and I gave him Tylenol on the night following the vaccine.  It was not until the following night 11/19/21 that he developed a fever.  He had fever higher than 102 and sweating and chills for the following 24 hours.  He also complained of nausea and later headache.  With Tylenol his temperature was still close to 100 and did not normalize until the evening of 11/20.  He felt better, but easily fatigued on Sunday.
Fourth dose of Hiberix at 9 months of age; Fourth dose of Hiberix at 9 months of age; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 9-month-old female patient who received Hib (Hiberix) (batch number 5P244, expiry date 21st March 2023) for prophylaxis.   Previously administered products included Hiberix (received 3 dose on an unknown date).   On 2nd February 2022, the patient received the 4th dose of Hiberix. On 2nd February 2022, unknown after receiving Hiberix, the patient experienced drug dose administration interval too short and inappropriate age at vaccine administration. On an unknown date, the outcome of the drug dose administration interval too short and inappropriate age at vaccine administration were unknown.  Additional information was provided as follows: The nurse reported that the 9-month-old patient inadvertently received a fourth dose of Hiberix at an interval shorter than the recommended which led to shortening of vaccination schedule and inappropriate age at vaccine administration. The reporter consented to follow up via postal mail.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 6th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th March 2019, less than a day after receiving SHINGRIX, the patient experienced fatigue, cold and shivering. On an unknown date, the outcome of the fatigue, cold and shivering were recovered/resolved. It was unknown if the reporter considered the fatigue, cold and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient reported that she experienced fatigue in the afternoon and that evening she had chills and shivering and was cold. The patient could not warm up even after taking TYLENOL and using a heating pad. These symptoms prevented her from doing her daily activities. She felt better the next morning and her symptoms lasted about two days and then everything was resolved. The reporter gave consent to follow up.
very sleepy and drowsy; my joints were hurting; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy and drowsy), ARTHRALGIA (my joints were hurting) and HEADACHE (mild headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced SOMNOLENCE (very sleepy and drowsy), ARTHRALGIA (my joints were hurting) and HEADACHE (mild headache). On 31-Mar-2021, SOMNOLENCE (very sleepy and drowsy), ARTHRALGIA (my joints were hurting) and HEADACHE (mild headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes: Blood pressure pill No treatment medications were reported.