chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose received 3/dose number = 3; Mild fever; Chills; Myalgias; This is a spontaneous report from a non-contactable reporter (pharmacist).  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered intramuscularly in the left arm, administration date 03Dec2021 (Lot number: unknown) at the age of 45 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Route of administration: Unspecified), administration date: an unknown date in Feb2021, when the patient was 44 years old and Bnt162b2 (DOSE 2, SINGLE;  Lot Number: Unknown; Route of administration: Unspecified), administration date: an unknown date in Feb2021, when the patient was 44 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Dose received 3/dose number = 3"; PYREXIA (non-serious) with onset 03Dec2021, outcome "recovering", described as "Mild fever"; CHILLS (non-serious) with onset 03Dec2021, outcome "recovering", described as "Chills"; MYALGIA (non-serious) with onset 03Dec2021, outcome "recovering", described as "Myalgias". Therapeutic measures were not taken as a result of pyrexia, chills and myalgia.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. It was reported that patient developed the events 12 hours after Pfizer-BioNTech vaccine. The next day, developed fever and chills again. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TOOK AN UNREFRIGERATED DOSE OF VIVOTIF; This spontaneous case report (PVX201910-000844) was received from a consumer on 04-Nov-2019. It described a female consumer who "took an unrefrigerated dose of Vivotif" (PT: Product storage error), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer took an unrefrigerated dose of Vivotif.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable.
Mouth Sores; Swollen Lymph Nodes; This is a spontaneous report from a contactable healthcare professional. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 24Apr2021 at 10:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Apr2021 at 23:00, the patient experienced mouth sores and swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were 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 mouth sores and swollen lymph nodes was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Diarrhea/loose stools/high fevers within hours of vaccination. Progressive large local inflammation/induration at injection site. Up to 9 x 9 cm. Fever persisted x 1 week. Treated with clindamycin for presumed cellulitis.
No adverse reaction to patient noted. Vaccine administered over 12 hours after vial punctured.
Syncope episode with no pulse, shallow breaths and diaphoretic lasted 8-10 seconds. She was taken from chair and placed on floor supine after passing out and not able to feel or hear a pulse. Was unconscious on floor 5-8 sec After rousing from syncope BP 92/65, Pulse 86, O2sat 99%,  Respiratory rate 20  She had breakfast of a cereal bar at 9. 2:00 had not had lunch. Since she refused care with EMS a friend of hers was called.  EMS assessed her. She refused care. After they were leaving she was given water. She refused snack. States she will eat with her friend. Friend arrived she was escorted to car.
Sharp pain at injection and continued pain for several months; several visits and treatments tried to alleviate pain....somewhat reduced but continues with bouts of sharp pain and moreso at nighttime.
Prolonged  rash at injection site: erythematous, plaque like, itchy., easy to irritate, along with neuralgic pain to the entire arm.
Patient was vaccinated last on 8/26/21 and came back to pharmacy on 8/31/21. Patient was experiencing hives and pruritis throughout his  whole body. While consulting wit the patient, his symptoms were getting worse and was recommended to see a physician for more thorough evaluation. Patient did not have a history of allergies nor was exposed to any biting insects around the area.
Tingling/numbness in legs.  Started in lower legs & moved higher in both legs.  Called dr 7/4/08 am and was told to go to urgent care.  Urgent care on 7/4/08 with exam and lab work with follow-up on 7/6/08.  Symptoms slowly diminished.  11/20/08 MR received for OV 7/4/2008  with DX: Adverse rxn to Gardasil.           Pt presented with c/o 3 day hx of leg cramps which began 1 day after HPV vax. PE (+) for calf tenderness, otherwise WNL. Does not think GBS. F/U 7/6/08 with 80% resolution of muscle tenderness. No further c/o.
Had a little cough; Bronchitis; Sinus infection; This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2022, the patient received the 1st dose of Shingrix. On 6th January 2023, 175 days after receiving Shingrix, the patient experienced bronchitis and sinus infection. On 12th January 2023, the patient experienced cough. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On 10th January 2023, the outcome of the bronchitis and sinus infection were recovered/resolved. On an unknown date, the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the bronchitis, sinus infection and cough to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR004661   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The patient received the Shingrix vaccine and patient did not remember the location of administration. The patient had bronchitis and sinus infection over the weekend. The patient feels better but had a little cough last night. The patient was on antibiotics. The reporter did not consent to follow up. Additional supportive information: The case had been linked with US2023AMR004661 reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR004661:Same reporter
Booster dose of .5cc Patient c/o Exhaustion also pain and swelling in armpit-lymph nodes only on injection side
Within moments of injection: felt heat flush rushing from arm through chest to neck & face. Extreme itching in arm, felt anxious & lightheaded. Noticed eyesight blurred. Pharmacist told me my chest & face were bright red. I felt slightly nauseous & my mouth tasted like penny's. Pharmacist administered antihistamine. By this time I had a bad headache & feeling of pressure in chest & head. I was made to sit in lobby & wait 30 min. I continued feeling strangely unwell for 8 days. My b.p. went up & I felt anxious & exhausted. Arm hurt. No temp. On day 3 ( I believe..or day 4) arm became even more painful & A round rash appeared. My chest & neck were also red again . I took pictures of my arm, chest & neck.
Mother reports that child had several bouts of vomiting and dizziness within 24 hours.  No fever or diarrhea.  Symptoms resolved spontaneously thereafter.
Dose administered to patient after improper storage and handling; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  The treatment information was  not provided.  It was reported that patient  was given vaccine that was  thawed, frozen and thawed.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Additional information received and added patient details (race information, height/ weight),  suspect product details and additional information in I - narrative.
6/15/2016 - within 3 hours - sore and red in injection right arm, couldn't lift, warm to the touch. 2 days of that and also low grade fever and fatigued. Day 5 and 6 after shot: rash that hurt around neck area, low grade fever off and on, headache and body/joint pain. Day 13 post shot: very sore throat, low grade fever, difficulties swallowing, body aches, fatigued again, loose stools and stomach ache.
little bit of headache in the forehead; Chills; Muscle pain; Joint pain; This is a spontaneous report from a non-contactable consumer. The consumer reported for a patient that.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208; Expiration Date: 06Apr2021), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The medical history and concomitant medications were not reported.  The patient experienced little bit of headache in the forehead, chills, muscle pain, joint pain on an unspecified date. The patient underwent lab tests and investigations which included oxygen 93 and pulse was 96. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Temp of 99.6 Muscle aches Chills Rigors  Uncontrolled shaking
Information has been received from a registered nurse (R.N.) concerning an 18 year old female who on an unspecified date, was vaccinated with the second dose of GARDASIL and for a couple days after that the patient was experiencing a fever of 103 degrees. At the time of reporting, the outcome was unknown. No product quality complaint was involved. This is one of several reports received form the same source. Additional information has been requested. This is one of several reports received from the same source. Additional information has been requested.
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 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021 at 2:22 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 2:21 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 28-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, 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. On 28-Feb-2021 Age of patient was reported as 60.59 and 28-Mar-2021 Age of patient was reported as 60.67. No concomitant medications were reported. On 28-Feb-2021 at 09:00 A.M., the temperature recorded was 27 degree Fahrenheit and vial was initially moved to the fridge on 24-Feb-2021 and beyond use date was 26-Mar-2021. Product moved to clinic on 27-Feb-2021, and at 01:00 P.M., the temperature recorded was 26 degree Fahrenheit and vial was initially moved to the fridge on 24-Feb-2021 and beyond use date was 26-Mar-2021. Product moved to clinic on 27-Feb-2021. On 28-Mar-2021 at 10:00 A.M., the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 23-Mar-2021 and beyond use date was 22-Apr-2021. Product moved to clinic on 27-Mar-2021. Vial was stored on cooler 1, on 28-Feb-2021, Excursion duration At 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM : 37, 3 PM: 44, 4 PM: 45. 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 Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported.
administered a non-diluted dose of Pfizer 5?11-year-old bivalent to the patient prior to realizing the vaccine had not been diluted properly.
Mom called and said that her son's arm was red and swollen the day after he received the flu shot on 9/2/20. She said the red circle was about 3 1/2" in diameter. She mentioned that he has a possible egg allergy but did not indicate that on MR.
Information has been received from a company representative concerning a 10 month old patient who was the sibling of a set of 2 1/2 year old twins. The twins actually received doses of varicella virus vaccine live (Oka/Merck) and the 10 month old sibling experienced a full blown case of chickenpox via secondary transmission. This was one of several reports from the same source. No further information is available.
Patient returned to clinic with complaints of arm pain and limited range of motion. Patient was assessed by Dr. no acute distress, no respiratory difficulty, arm ender to direct palpation, slight amount of bruising around the injection site without swelling or redness. Range of motion is somewhat limited due to pain in the left shoulder but overall good range of motion and handgrip is normal. Patient advised to use Tylenol/Ibuprofen as needed for the discomfort. Return to the clinic as needed.
Fever, swollen lymph nodes in the collarbone (clavicula) area.  Swollen lymph node noticed on 2.11.21 around 12:30 pm. The temperature of 98.6F started later on the same night and last all night. Swollen lymph node feels sore and still persists 2 days after.
Patient fell on the floor, hitting her head first, a few minutes after getting the vaccine. She was conscious the whole time and the pharmacy staff and her mom made sure she was okay. She reported feeling nauseous and dizzy while laying on the floor. She sat down after a few minutes but laid down again because she was filling nauseous.  She and her mom waited a bit more while we monitored them. They left after waiting for about 15 minutes.
This spontaneous report as received from a physician refers to a 50 year old female patient. The patient's medical history included fibromyalgia. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and indication were not provided) (Dose/Frequency also reported as 1 injection) and PREVNAR 13. The following day after vaccine injection, the patient experienced dizziness and felt nauseated. The patient went to the Emergency Room because of her symptoms. The outcome of events was unknown. Additional information has been requested.
I got the FLU; Initial information received on 30-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves patient of unknown age and demographics who experienced i got the flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event i got the flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (I got the FLU).  At time of reporting, the outcome was Unknown for the event i got the flu.
Worst chills I?ve ever had during first night. Muscle soreness at injection site. Fever. Fatigue. Slight cough and tight lungs.
Temperature of 101F started around 9:30pm and lasted for around 24 hours. Headache lasted 24 hours Muscle ache Light Vertigo, 24 hours. "Brain Fog" lasted 3 days
12 days from shot started sweating alot, always cold chest retracting, could hear a sl wheeze; 1 month from shot pt dx asthma; 4APR92 dx cardiomyopathy;
she accidentally administered a Fluzone High Dose that expired / no AE; 24 year old received Fluzone HD / no AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff).  This case involves a 24 years old female patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ048AA (Expiry date 31-May-2019) via intramuscular route in the left deltoid on 18-Nov-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to Expired vaccine used and inappropriate age at vaccine administration.  At a time of reporting No adverse reaction reported.  It was reported that accidentally administered a Fluzone High Dose that expired.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This pre-term infant expired after a 6 month hospital stay due to extensive congenital heart defects.  Hospitalized from 07/30/2002-01/30/2003.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
the VARIVAX titer was "too low".; the patient received a second dose of VARIVAX. The second dose received was improperly stored; This spontaneous report was received from a pharmacist and refers to a 28-year-old female patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or provided. On an unknown date, in the past the patient received a first dose of varicella virus vaccine live (oka/merck)(VARIVAX) via subcutaneous route (dose, lot #, expiration date, anatomical location of administration were not reported) for prophylaxis. Then, on unspecified date, after first vaccination, she received a titer which showed that the varicella virus vaccine live (oka/merck)(VARIVAX) titer was "too low".  On 02-JUL-2020, she received second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S019584, expiration date: 25-JUN-2021) via subcutaneous route (dose, anatomical location of administration were not reported) for vaccination for school. The second dose received was improperly stored but reconstituted with properly stored sterile diluent (Merck DILUENT)(lot# and expiration date were not provided). No symptoms were reported.  The temperature to which the vaccine was exposed was from 15 degrees of Fahrenheit (F) to 46 F (24F) and the time frame was reported as 16 hours 15 minutes. No previous temperature excursions were reported. A data logger was used. The outcome of the events was not reported. The causality assessment between the event of the event of antibody test negative and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.