chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling on the upper lip  under the nose area, all that area; she took her heart rate and it was 101. She stated her heart rate was in the 90's the rest of the evening; 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), administered in arm left, administration date 16Mar2021 14:15 (Lot number: EN6204) as dose 1, snigle for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "tingling on the upper lip under the nose area, all that area"; HEART RATE ABNORMAL (non-serious) with onset 16Mar2021, outcome "unknown", described as "she took her heart rate and it was 101. She stated her heart rate was in the 90's the rest of the evening". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient wondered if anyone or others have reported this reaction before. Confirmed reaction with the patient. The patient stated about 4 hours after receiving her vaccine she started having tingling on the upper lip, under the nose area, all that area. She stated she took her heart rate and it was 101. She stated her heart rate was in the 90's the rest of the evening and that was not her normal. Confirmed with the patient product was Pfizer vaccine, COVID 19. The patient did not provide further details for this report. The patient stated she had just spoke with someone a little while ago and thought that the questions were getting too personal, when asked about filling out a report for Safety, she declined the report. The patient did not have a follow up report reference number to provide. The patient stated she would provide her email again and she would also provided the vaccine information and symptoms for this report.  No follow-up attempts are possible. No further information is expected.
Started on 03/23/2023 with sore throat, cough and no fever. I tested for COVID-19 on 03/23/2023 and it was negative. I then tested again on 03/25/2023 for COVID-19 and it was positive. On 03/25/2023 I had a video visit with urgent care and prescribed Paxlovid for 5 days. I tested negative for COVID-19 on 03/30/2023 and then started having same symptoms and tested on 04/03/2023 and results were positive.
This spontaneous report was received from a registered nurse refers to a 16 month old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot # M027347, 01-JUN-2018. No adverse effects reported. Additional information has been requested.
Flu-like symptoms for 24 hours. Muscle pain; shivering/chills and nausea in the morning. Lethargy and fatigue All symptoms gone at 24 hours other than injection site pain.
Appendectomy out of nowhere!; administration date: 16Apr2021 lot number: EW0151/administration date: 16Apr2021 lot number: EW0170; administration date: 16Apr2021 lot number: EW0151/administration date: 16Apr2021 lot number: EW0170; This is a spontaneous report from a contactable consumer (patient)   A 45-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 17:00 (Batch/Lot Number: EW0151) as single dose, and the second dose via an unspecified route of administration, administered in Arm Left on 16Apr2021 (Batch/Lot Number: EW0170) as single dose (at the age of 45) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Medical history included sulfa allergy. Concomitant medications included sertraline hydrochloride (ZOLOFT), spironolactone, silicon dioxide (VIVISCAL). The patient previously took wellbutrin, phenergan [promethazine], nubain and with all she experienced drug hypersensitivity. The patient experienced appendectomy out of nowhere! on 26Jul2021 23:00. The patient was hospitalized for appendectomy out of nowhere! for 1 day. The outcome was recovered. Patient had an incorrect dose administration with outcome of unknown.    No follow-up attempts are needed. No further information is expected
Pt complains of not being able to move arm is extremely painful and after aspercreme ibuprofen and massaging muscle and arm still can't move arm without pain.
child moved her arm and a small amount of the liquid came out of injection site; Initial information regarding an unsolicited valid non-serious case was received from pharmacist and physician via Medical Information (Reference number- 00809341) and transmitted to Sanofi on 12-Oct-2021.  This case involves a 5-year-old female child patient moved her arm and a small amount of the liquid came out of injection site (injection site extravasation) while receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 12-Oct-2021, the patient received 0.5ml (total) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7330MA and expiry date: 30-Jun-2022) (Frequency = once) (Strength = standard) via intramuscular route in the left arm for prophylactic vaccination.  On 12-Oct-2021 the child patient moved her arm, and a small amount of the liquid came out of injection site (injection site extravasation) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Caller (PharmD) (Doctor of pharmacy) requesting information regarding re-administration of FLUZONE QUADRIVALENT (Prefilled); caller states the facility administered a dose to a child (age 5/female) and as the injection was being done. Caller states that the guardian of the patient does not think that re-administration/re-vaccination is in order, but PharmD would like verification; all demographics obtained by MIA (manufacturing and importation authorization)".  No relevant laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was not resolved for the event.
Patient called 2/12/15 stated she had a rash under and over left breast wrapping around back that itched. Patient is in another state. Called primary care Dr. they wanted patient to visit a Dr. in the other state and then follow up Dr.
Blurry vision, eyes tearing a lot, joint pains, muscle pains in my elbows, difficulty in stretching my arms. About 15 nuts in random places on my body, feels like bumps in my muscle tissues, when I push the nuts down, they fell like a sharp pain.
This spontaneous report was received from a 52 year old female physician refers to herself. On an unknown date the physician was vaccinated with one injection of ZOSTAVAX, subcutaneous (dose, lot # unknown). On an unknown date the physician experienced a hyper reaction to ZOSTAVAX which included redness and irritation around the injection site. No treatment was given for the events. No medical attention was sought. The outcome of events was unknown. Additional information is not expected as we could not contact the physician.
10 minutes post innoculation I became very dizzy and lightheaded.  Nurses layed me down and took my pulse.  It was between 40 and 46BPM.  Nurses provided me water and checked my blood sugar which was approximately 140mg/dl.  I layed for about 30 minutes before nurses checked my pulse and determined it was back to normal.  I felt no pain, no soreness, or other symptoms than nearly passing out.
No adverse event; Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (No adverse event) and EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, NO ADVERSE EVENT (No adverse event) and EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient).    The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses.  No concomitant medications were reported.  The vial was initially stored in refrigerator on 07-Jun-2022.  A total of 35 doses were given from 4 vials. The dates in which vaccination were given from 1-Apr-22, 5-Apr-22, 8-Apr-22, 6-Apr-22, 11-Apr-22,  12-Apr-22, 13-Apr-22, 14-Apr-22, 22-Apr-22, 9-Jun-22, 10-Jun-22, 13-Jun-22, 18-Jun-22 and 22-Jun-22.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Swollen lymph node in left axilla occuring for 4+days   Severely heavy menstruation one week following first dose (menses on time, but heavy)
pt recv vax 29AUG95 & pt devel 25 to 35 pustules;
Fever 102 on evening of vaccine and day 2 following vaccine fatigue and sleep during daytime on day 2 and day 3, fever 100. 2 body aches for three days after vaccine intermittent dry cough on a daily basis post vaccine
HIVES, PINS ANS NEEDLES, BUGS CRAWLING FEELING, ITCHY AND PRICKLY SKIN, ANGIOEDEM, SWOLLEN AREAS ON BODY.
Muscles feel stiff, painful, mild body aches. Symptoms have worsened over past couple days but not bad enough to interfere with daily activities. Pt has not taken any pain reliever, recommended he try ibuprofen or acetaminophen.
Chills; Fever; Muscle aches; Headache; General fatigue; Nausea; Lymph node discomfort; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 02Apr2021 at 12:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included bronchitis asthmatic from an unspecified date. Patient received other medications in two weeks which included fluoxetine hydrochloride (PROZAC) from an unspecified date for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 12Mar2021 at 12:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. On 02Apr2021 at 22:00 the patient experienced chills, fever, muscle aches, headache, general fatigue, nausea and lymph node discomfort. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chills, fever, muscle aches, headache, fatigue, nausea and lymph node disorder were not recovered at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a lawyer concerning a 30 month old male who was vaccinated with the unspecified vaccines. It is alleged that through these unspecified vaccinations, the pt was exposed to thimerosal, and that each injection exposed the pt to between 12 and 25 micrograms of ethyl mercury. In approx. June 1998, the pt experienced neurological damage and mercury poisoning with developmental delays, lack of fine motor skills, limited attention span and diminished cognitive ability. It was reported that the pt received and at the time of this report, was receiving medical treatment in an effort to remove mercury from his body. It was noted that as the mercury levels in his body have decreased, the pt's symptoms have modestly improved. The reporter felt that neurological damage, mercury poisoning, developmental delays, lack of fine motor skills, limited attention span and diminished cognitive ability were related to therapy with the unspecified vaccinations. Upon internal review, the pt's neurological damage, mercury poisoning, regression of language skills, developmental delay, lack of fine motor skills, limited attention span, and diminished cognitive ability were considered to be an other medical event. No further info is available.
pt recv vax; devel raised area approx size of a half-dollar at inject site;employee felt there was a problem w/ lot;
Administered PEDIARIX instead of H1N1. Had 3 children in room getting imms.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 11-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M029598, expiration date 10-DEC-2017, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
I had Pfizer vaccination dosages in April 2021 batch lot#ew0169. I ended up with stiffness of the joints and my tendons became thicker and hard nonflexible. Like sticks. It happened to all joints of my body. Ended up with tissues being removed when the joints bend on the fingers and feet. Now all joints are weak and has no strength and aches all the times. I went to see the rhaumatologist. She said this is caused by pfizero and I do not have any rhaumatoid and arthritis disease and she cannot treat me. It has to be a disease in order to treat me. Now I'm stuck with no help. Joint's are damaging the bone. I need help.
pt recv vax & w/in 5min of vax pt became very pale & was not responsive for about 2second in mother's arms;lifted by mom to table, woke up c/o hurting in tummy, vomited, unable to hear BP-MD checked AP a little slow called 911;sent to
Immediately after the injection experienced mental confusion which lasted for ~3 hours. During that time she was involved in a MVA which totaled her car. She experienced similar neurologic sx's after the second dose of Pfizer which was administered on 4/13/21.
On 13-AUG-2020 a patient was administered improperly stored PEDVAXHIB; This spontaneous report was received from a Licensed Practical Nurse and refers to a 9-months-old male patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history, drug reactions/allergies and historical drugs was not provided.  On 13-AUG-2020, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(LIQUID PEDVAXHIB) (dosage regimen was not reported) intramuscular, lot #S036823 and expiration date 31-MAR-2022 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion above 47 degrees Fahrenheit (°F)/9 degrees Celsius (°C), 8.9°C for 33 minutes on an unknown date; no previous temperature excursion were reported.  The call was made due to a digital data logger.
Information has been received from a nurse concerning a 29 year old female who was vaccinated with VARIVAX (Merck). The nurse reported that the patient received VARIVAX (Merck) intradermally. The patient returned to the office the day after the administration of the vaccine with redness at the injection site. The patient was being treated for cellulitis. Additional information has been requested.
Pain, swelling of lt arm w/cellulitis 1 wk p/vax; Rx'd w/velosef Hydrocortisone cream, warm compresses 20MAR91;
Pt. was inadvertently given a double dose of the vaccine (FLUZONE 1mL instead of 0.5mL). Pt reported itching and redness at site, which gradually resolved and was completely gone by 10/13/08. Pt was seen in office 10/10 and 10/13
shot 2:30 pm  slept woke up got coffee, sat down  felt dizzy sweating weak nausea high blood pressure 172/113
Patient admitted to hospital for a bowel obstruction on 3-29-08. On 3/29/09 Lap appendectomy performed. Pt had RUQ intussusception reduced using endoscopy. On 3/29/09 at hospital.  5/8/09 Received hospital medical records of 3/29-4/3/2009. FINAL DX: Intussusception s/p laparotomy appendectomy Records reveal patient experienced abdominal pain & fever x 3 days, no BM x 2 days.  Seen in outlying ER 1 wk prior to admit for abdominal pain, nausea, projectile vomiting which resolved for a few days then recurred.  Returned to outlying hospital & was admitted.  Abdominal x-ray there c/w bowel obstruction & was transferred to higher level of care.  Temp there was 101.7 on admit w/distended abdomen & decreased bowel sounds.  Surgery consult done s/p enema reduction.  Taken to OR where lap appy & running of small bowel done, no sign of IS at that time.  Bowel was dilated but viable.  Tx w/NGT, IVF & IV antibiotics.  Febrile through post op day 1 then afebrile, diet progressed & d/c to home.
flu like symptoms; achiness; extreme fatigue, exhausted; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (extreme fatigue, exhausted) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (extreme fatigue, exhausted). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness) and FATIGUE (extreme fatigue, exhausted) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-435712, MOD-2021-435757 (Patient Link).
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 19-Nov-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.The patient experienced no signs or symptoms of any distress. No concomitant and treatment medications were reported.Most recent FOLLOW-UP information incorporated above includes:On 23-Nov-2021: Follow-up received: Secondary reporter details added. Patient date of birth added.
Severe Chills; Mild nausea; achy muscles; Severe headache; This is a spontaneous report from a contactable consumer. A 40-years-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 10Feb2021 11:30, at 40 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID after vaccination. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 20Jan2021 at 11:30 AM in left arm. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 21:15 the patient experienced sever chills, mild nausea, achy muscles and severe headache. No treatment was administered. The reported events were resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chest tightness; hives on the side of her neck; scratchiness in throat; gums were throbbing; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EJ1686, Expire Date: 30Mar2021), intramuscular at Deltoid Left on 15Jan2021 11:08 at the 76 years old at 0.3 mL, single for COVID-19 immunization. The patient medical history included allergies issues with shellfish (allergic reactions), hyperlipidemia and hypertension. The concomitant medications were none. There was no additional vaccines administered on same date of the suspect. The patient was experienced for over 20 minutes with no side effects. After she left on an hour after administration (15Jan2021 12:08), she started feeling scratchiness in throat, her gums were throbbing and chest tightness. She did say she didn't take any Benadryl. She didn't have airway issues, but she did have hives on the side of her neck on 15Jan2021 12:08. She got the shot on 15Jan2021. The side effects started shortly after she left on an hour after administration. Her symptoms were relieved by 15Jan2021 21:30, and she got the shot at 11:08 am. The patient had allergic reactions in the past. She knew what to expect. She got the shot in her Left Deltoid. The reporter had a gut feeling she didn't need to get the second dose.  The reporter assessed all the events were not serious. She did not require medical intervention. She did not go to the Emergency room or Physician Office. The patient was not hospitalized, or in the ICU. The Causality was not provided by the reporter. The outcome of the events was recovered on 15Jan2021 21:30.
expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (expiry date DEC-2022) for prophylaxis.   On 22-MAR-2023, the patient received Bexsero. On 22-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 22-Mar-2023. Pharmacist calls to report an expired dose of Bexsero was administered. Information for expiration date and lot number were asked but declined.  Initials and age about the patient were asked and declined.The reporter consented to follow up. Patient received an expired Bexsero vaccine, which led to expired vaccine used.