chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of Menveo reconstituted with sterile water; administration of Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 3-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA199A, expiry date 30th September 2020) for prophylaxis.   On 11th February 2020, the patient received Menveo (intramuscular) .5 ml. On 11th February 2020, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The health care provider asked for information regarding the administration of Menveo reconstituted with sterile water which led to  wrong solution used in drug reconstitution and inappropriate dose of vaccine administration. The vaccine was not mixed with the correct diluent thereby made the vaccine ineffective, it was unknown which staff mixed (reconstituted) the vaccine. The reporter discovered the error when there was one vial of vaccine left with no diluent. The patient was notified about the error and asked to return for revaccination.  The patient did not report any adverse effects. The patient was agreed to return but did not came till the time of reporting. This case has been linked with US2020036905, reported by same reporter.
Enlarged lymph left side in arm pit and neck, lower abdominal pain that resulted in Rectus Sheath Hematoma 6 days after second vaccine 2/24/2021.  Treated for pain control and administered IV fluids.
Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210166:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
No additional AEs were reported; Improper storage of product in use; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 09-MAR-2022, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot # T028582, expiration date: 04-MAR-2023, administered for prophylaxis (strength, dose, and route of administration were not provided).   The reporter informed that the administered vaccine had been possibly improperly stored due to lack of temperature readings (Product storage error). The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown to the reporter. There was no previous temperature excursion. No adverse events (AE) were reported, and no further information was provided.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA000524: US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000503: US-009507513-2205USA000540: US-009507513-2205USA000544: US-009507513-2205USA000564: US-009507513-2205USA000560:
On 9-18-08 had flu vac around 3pm. Between 5 and 7 pm he became very achy, especially in lges-no temp noted-gradually at better our 2-3 days
Information has been received from a Nurse Practitioner concerning a female who on an unspecified date in June 2007, reported as "about 1 year ago," was vaccinated with a first dose of GARDASIL vaccine (lot # not reported). It was reported that, on an unspecified date post first vaccination, the patient was sexually assaulted after her first dose of GARDASIL vaccine. "No adverse effect" was reported. Patient outcome was not reported. Additional information has been requested. Initial and follow up information has been received from a nurse practitioner and the physician's office concerning a female who on an unspecified date in june 2007, reported as "about 1 year ago", was vaccinated with a first dose of GARDASIL (lot # not reported). It was initally reported that the patient on approximately "25 or 25-JUN-2008", was vaccinated with a second dose of GARDASIL (lot # not reported) and on an unspecified date post first vaccination, the patient was sexually assaulted after her first dose of GARDASIL. "No adverse effect" was reported. Patient outcome was not reported. In follow up it was reported that there was no adverse drug related event. It was reported that the patient did not receive the second or third dose as scheduled. Additional information is not expected.
Mom stated around 7M pt was fussy temp 102.6 while rocking pt opened eyes big & started twitching;
Myalgia, Fever, Left arm pit lymph node swelling x 4 days Narrative:
This case was reported by a healthcare professional via a sales representative and described the occurrence of cellulitis in a subject of unspecified age and gender who was vaccinated with Pediarix (GlaxoSmithKline). In 2002 (5 years ago) the subject received unspecified dose of Pediarix (unknown). At an unspecified time after vaccination with Pediarix, the subject experienced cellulitis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. It was reported that the staff was squeezing the subjects arms before giving the Pediarix and that using this wrong technique was creating the cellulitis reaction because the vaccine was not going into the muscle completely. In the reporter's opinion, the event was probably related to treatment with Pediarix.
this case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 69-year-old female patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, several months after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received both shots of SHINGRIX but several months later had a singles recurrence. This case was considered as vaccination failure since laboratory confirmation was unknown at the time of reporting.
mysteriously died; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 16 years old and unknown gender patient who mysteriously died while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient mysteriously died (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) mysteriously died.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the event (mysteriously died).  At time of reporting, the outcome was Fatal for the event mysteriously died. It is unknown if an autopsy was done. The cause of death was reported as Unknown cause of death.; Sender's Comments: Sanofi Company Comment dated 03-Jan-2022: This case involves a 16 years old patient who mysteriously died while receiving vaccine INFLUENZA VACCINE. Based on limited information provided regarding this case, causal role of the company suspect product cannot be assessed. Further information of condition at the time of vaccination, latency to onset, past and concomitant medications, therapy details,  medical history, autopsy reports are essential for a comprehensive case assessment.; Reported Cause(s) of Death: Unknown cause of death
extreme swelling and severe pain in both wrists/ hands starting 2/7/21.seen in urgent care 2/8/21 and admitted through ER on 2/10/21.  Inpatient for 3 days. IV antibiotic DC'd when blood cultures negative.  Ultrasound left arm negative for DVT. Seen by Infectious Disease and he felt it was due to covid vaccine reaction.  Started on steroid
This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingly on both arms and left side of face), PARAESTHESIA (Right hand is still tingling), DIARRHOEA (Diarrhea x 2 episodes), MUSCLE SPASMS (Cramps) and INTERMENSTRUAL BLEEDING (Spotting (Period not due and Not Pregnant)) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No Medical History information was reported. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PARAESTHESIA (Tingly on both arms and left side of face). On 31-Mar-2021, the patient experienced DIARRHEA (Diarrhea x 2 episodes), MUSCLE SPASMS (Cramps) and HEADACHE (Headache). On 01-Apr-2021, the patient experienced PARAESTHESIA (Right hand is still tingling) and INTERMENSTRUAL BLEEDING (Spotting (Period not due and Not Pregnant)). On 01-Apr-2021, PARAESTHESIA (Tingly on both arms and left side of face) had resolved. At the time of the report, PARAESTHESIA (Right hand is still tingling), DIARRHEA (Diarrhea x 2 episodes), MUSCLE SPASMS (Cramps), INTERMENSTRUAL BLEEDING (Spotting (Period not due and Not Pregnant)) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medication was reported. Treatment information was not provided.
patient receied the second dose of GARDASIL 9, 30 days later.; no adverse effects reported; This spontaneous report was received from a consumer via company representative and refers to a 26-year-old patient of unknown gender. Patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The second dose was administered 30 days later, on an unspecified date (strength, dose, frequency, route of administration, anatomical location, indication, lot #, and expiration date were not reported for both doses) (Drug dose administration interval too short). No adverse effects reported.
Itching; Chills on and off; Red spot was size of saucer; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced chills (Verbatim: Chills on and off), localized erythema (Verbatim: Red spot was size of saucer) and pruritus (Verbatim: Itching).  The outcome of the chills was recovered/resolved (duration 2 days) and the outcome of the localized erythema was recovered/resolved (duration 2 weeks) and the outcome of the pruritus was not reported.   It was unknown if the reporter considered the chills, localized erythema and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the chills, localized erythema and pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the first shot and had chills off and on for two days. The red spot was the size of a saucer and stayed there for way over two week, also had inching. The reporter was not sure if he/she would get second shot. The follow-up could not be possible as no contact details were available.
rapid heart rate; trouble sleeping; This is a spontaneous report from a contactable healthcare professional. A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left deltoid on Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first vaccine approximately 2 weeks ago (Dec2020) and since then, patient have been having a rapid heart rate, especially at night time. He had trouble sleeping because it was beating fast. It was more pronounced the first week after vaccination on Dec2020. Patient will have a doctor's appointment on 08Jan2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Itchiness of vaccine site, other arm and parts of body, redness on both upper arms. Continues even now. Using cortisone cream prescribed. Itchiness abating.
No current symptoms. After administration, it was noted that vaccine was closer than 28 days from first injection in series. This is being reported in advance in case adverse reactions occur.
Very sore arm; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the right arm on 28Dec2020 08:30 at a single dose for COVID-19 immunization at the hospital. Medical history included hypertension (HTN) and diabetes mellitus (DM). The patient has no known allergies. The patient had received unspecified other medications the patient received within 2 weeks of vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very sore arm on 28Dec2020 12:00. Outcome of the event was not recovered. No treatment was given for the event. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The event was assessed as non-serious.
Red rash with large urticarial reaction that developed after injection in left deltoid. Gave oral Benadryl site better then left office.
Information has been received from a school registered nurse who heard of a case concerning a child who was vaccinated with one dose of VARIVAX "as a baby". The child developed shingles "a few years later". The child subsequently fully recovered. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Information has been received from a registered nurse concerning a 4 year old male with no known medical history who on 12/29/1998 was vaccinated with varicella. Concomitant vaccination included a fifth dose of DTaP given IM and a third dose poliovirus vaccine given orally. There was no illness at the time of vaccination. On 04/15/2001 the pt developed 25-10 red water filled vesicules that were itchy at times and a fever. Unspecified medical attention was sought. No further info is available.
Fever, cough, shortness of breath, body and headache, slight runny nose. This started on the 27th of April. It's moderate level of severity. It's currently on going.
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves an unknown demographic patient who experienced ripped tendons and arms swelled double in size, while he/she received vaccines PREVNAR 13 and INFLUENZA VACCINE. The patient's past medical history included allergic to chlorine and a long list of other unspecified things. The patient's past vaccination included pneumonia vaccine (reported as pneumonia shots). The patient's medical treatment(s), and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site and a dose of suspect PREVNAR 13 lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious ripped tendon and arms swelled double in size (Unknown latency) following the administration of INFLUENZA VACCINE and PREVNAR 13. (Other relevant tests included No lab data.) Final diagnosis was arms swelled double in size and ripped tendons. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for ripped tendons and as Unknown for arms swelled double in size. List of documents held by sender: none.
Extreme headache; chills; fatigue; aches; dizziness; nausea; Fever lasting over 24 hours/temp over 101,; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in left arm on 25Mar2021 at 08:30 (at the age of 53-years-old) as single for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in left arm on 05Mar2021 at 07:30 (at the age of 53-years-old) as single for COVID-19 immunisation. on 25Mar2021 at 20:30, the patient experienced extreme headache, temperature over 101 (UNSPECIFIED UNIT), chills, aches, fatigue, dizziness, nausea. Fever lasted over 24 hours and symptoms persisted over 48 hours. 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 the events headache, chills, aches, fatigue, dizziness, nausea were recovered on an unknown date; while that of fever was recovered on 25Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe headaches due to ventricular bleed, following bleed from arteriovenous malformation (AVM).  Headaches persisted starting March 12 and continued for following 11 days. A visit to the Emergency Department led to an MRI, which revealed the AVM. Craniotomy removed the AVM, followed by 12 days in intensive care. Post-surgical complication of intracranial hemorrhage. Patient is currently in rehabilitation.
Swollen lyphnodes under injection site arm; I had a 103 degree fever from Friday midnight until Tuesday 4am.; This is a spontaneous report from a contactable consumer (Patient).  A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0177 and expiry date was not reported), via an unspecified route of administration on 14May2021 at 10: 15 AM (Age at vaccination: 32-year-old) on left arm as dose 1, single for covid 19 immunization.  Medical history included: The patient previously received Monoclonal Antibodies on 11Feb2021 due to a positive COVID diagnosis. The patient had allergies to tetanus shot. The patient did not get tested positive for covid 19 post vaccination. The patient Neither received any other vaccines with in four weeks nor received any other medications in two weeks of covid vaccine. Concomitant medications were not reported. On 14May2021 at 11: 45 pm (midnight), the patient had fever of 103 degrees (from Friday until Tuesday at 4 AM). The patient had swollen lymph nodes on the injection site arm. Therefore, the patient visited doctor/other healthcare professionals office/clinic. The patient was treated with Tylenol, advil, and elective IV fluids. Outcome of event swollen lymph nodes on the injection site arm was recovered on unspecified date in 2021 and fever was recovered on unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
10cm x 10cm erythematous, indurated, locally tender area @ site of inject lt deltoid w/fever to 104 w/in 12-24 hrs p/vax;
I gave the shingles vaccine in the right deltoid and after administration, the injection site swelled up into a lump in the next minute. Swelling had gone down when patient came in 3 days later for tetanus vaccine.  Unknown if patient went to see a doctor about the adverse event.