chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 216 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Reported  tingling and pins prickles of both arms; SOB; decrease breathe snd at base of lungs;  disoriented; hypertension BP190/100; 186/100; 170/100;Pulse-79; 74; O2 sats 99%.
Post vaccin the injection site swelled up. Asked the patient to stay seated and relax. Checked back in 5 minutes patient said she felt light headed and clamy. Checked patient's blood pressure which was lower than normal
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2013 the patient was vaccinated with M-M-R II (lot # H015829, expiration date 24-AUG-2014). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 08-SE_-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes, no known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406, 1310USA008407 (same reporter linked). Additional information has been requested.
Massive pulmonary embolism with cardiac arrest with successful return of spontaneous circulation; received IV tPA 50 mg in arrest before ROSC. She presented with palpitations and shortness of breath, had a witnessed syncopal event in emergency department on ambulation to restroom with subsequent cardiac arrest.
I took the second dose of the SHINGRIX shingles vaccine yesterday at 4 o'clock. Woke up today with a fever of 100.4, severe muscle and joint aches, chills, headache, mild stomach cramps. I had no reaction except some soreness to the first dose.
This is a spontaneous report from a contactable physician, reported for himself, via Pfizer sales representative. A male patient of unspecified age and ethnicity received PREVNAR 13 at single dose on unknown date for immunization. Relevant medical history and concomitant medications were not reported. On unknown date the patient developed cellulitis. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Current limited information does not allow a full medically meaningful assessment, such as lack of medical history, concomitant medications, concurrent illness and especially event details description including the location of cellulitis and the time lag between the onset of the event and vaccination date of PREVENAR 13.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a physician concerning a 12 year old female who was vaccinated on an unspecified date with her first dose of Gardasil (lot# not reported).  Concomitant therapy included Varivax (duration and dose not reported).  Other concomitant therapy included MENACTRA and Tdap.  Subsequently the patient broke out into hives, became dizzy and started to sweat after receiving Gardasil.  The patient was recovering.  She sought unspecified medical attention.  Additional information has been requested. Additional information was received. The nurse indicated that without a patient's name she can not fill out the form. She was advised to call the MNSC, but they could not provide the patient's name.
The patient was here for his first Moderna vaccine. He did not exhibit any agitation or nervousness. His girlfriend got her vaccine first and was talking to him as he received his.  They were discussing how little it hurt when he fell out of his chair. He did not respond when we moved to him, but within five seconds he was awake and asking what happened.  He was alert and sat in a chair for 30 minutes with no adverse effects from the fall.  He noted he only slept 3 hours the night before the vaccine and had not eaten anything that day. The patient refused any further medical care.
Altered mental status, acute respiratory distress, COVID 19 positive, sepsis, anemia
Erythema at upper (L) arm, non tender, mild edema, increased skin temp.  BENADRYL, apply ice.
There is still pain at the injection site over 6 weeks after my second dose. The pain is not continuous, but comes and goes. It is very dull but still noticeable and uncomfortable.
3 hrs after shots, broke out with diffuse hives, no SOB, acting well, RX Benadryl.
Patient was given Pfizer Covid-19 vaccine by mistake instead. Patient received Moderna vaccine on 6/24 (first dose).
has now started experiencing pain in the hip; he might have just strained it; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 24Feb2021 as single dose for covid-19 immunisation. The patient's medical history included patient had new parts in his hip a year ago in 2020. Concomitant medications were not reported. On an unspecified date, the patient started to experience pain in the hip. He's not sure if it was from the vaccine or not. He still does PT for the hip whenever he think about it. He thinks he might have just strained it. Outcome of pain in hip and "just strained it" was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tactile fever, repeated emesis overnight, resolved in the a.m., <24h.
Patient experienced epistaxis the morning after the vaccine, and has continued to have mild-moderate headaches.   To note, patient?s baseline is typically: - Roughly 1 nosebleed every ~4 years  - Mild headaches 2-3 times per week
Itching on the inner arm in which injection was given (right arm) started approximately 10 days after injection.  As of today (4/8/2021) large raised rash that is sore to the touch like a bruise, redness, hot to touch, very itchy and encircles upper arm from injection site to inner elbow in patchy marks.  Using Zyrtec orally and Betamethasone Dipropionate topically for itching.  Reported to health care provider today who confirmed this as possible side effect from Moderna COVID-19 vaccine.
Very itchy; This is a spontaneous report from a non-contactable consumer. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Apr2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unspecified date in Apr2021, the patient was very itchy for several days following the vaccine. The event did not result in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with CLARITEN. It was reported that the issue improved over time and after taking CLARITEN. The clinical outcome of the event was very itchy was resolved on an unspecified date in Apr2021.  No follow-up attempts are possible; information about lot number cannot be obtained.
No adverse event/ No known pt adverse events; Indavertently administered improperly stored GARDASIL 9/ Temp excursion happened - Vaccines given despite; This spontaneous report was received from a licensed practical nurse (LPN) regarding to a 12-year-old male patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions, and allergies were not provided.  On 04-NOV-2021, the patient was inadvertently vaccinated with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) second dose, intramuscularly in left deltoid, lot number S023475, with an expiration date of 26-MAR-2022 (dose, strength and formulation were not reported) for prophylaxis and meningococcal vaccine a/c/y/w conj (diptox) (MENACTRA) first dose, intramuscularly in right deltoid lot number: U7191AA, expiry date: 18-JAN-2023 (strength, dose and formulation, were not reported) for prophylaxis (product storage error). There were no additional adverse event details and no known patient's adverse events (no adverse event). Administered dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced the temperature excursion of 27.2 degrees Fahrenheit (F) and 49.8 F for 8 hours 30 minutes and 21 hours and 15 minutes respectively. There were no previous excursions reported. Temperature excursion details for meningococcal vaccine a/c/y/w conj (diptox) (MENACTA) were not provided. Digital Data Logger was involved.  This is one of nine reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA007811: US-009507513-2202USA007814: US-009507513-2202USA007816: US-009507513-2202USA007817: US-009507513-2202USA007818: US-009507513-2202USA007812: US-009507513-2202USA002574: US-009507513-2202USA007813:
1st dose on 16Aug2022, 2nd on 12Dec2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 13-year-old male patient who received HAV (Havrix) (batch number 339TT, expiry date 30th November 2023) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 16th August 2022).   On 12th December 2022, the patient received the 2nd dose of Havrix. On 12th December 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Linked case(s) involving the same patient:  US2022186701   Additional Information: GSK receipt date: 14-Dec-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with case US2022186701, reported by same reporter for different vaccine. Additional supportive information: The patient received 2nd dose earlier than the recommended interval, which led to shortening of vaccine schedule.; Sender's Comments:  US-GSK-US2022186701:Same reporter
Information was received on 14-JUL-2017 from a registered nurse regarding a patient (age and gender not reported).  Medical history, concurrent conditions and concomitant medications were not reported.  On 12-JUL-2017, the patient was inadvertently administered a dose of PROQUAD (lot # M036158, exp 12-FEB-2018) and a dose of VARIVAX (lot # M046926, exp 28-NOV-2018)  (dose, route, site of administration not reported for either vaccine) at the same time. No adverse effects reported. No further information provided. The outcome of the event was unknown. Additional information has been requested.
Received call from Physician today, April 20,2006 in regard to childs imm. given Dec.20,2005. Approximately 7 hours after receiving vaccines, he developed a rash described by parents as"all over". He was seen by doctor on  Dec 21,2005. DR's letter stated "he was irritable but in no distress, and had  red, blanching, irregular patches, some raised, on his legs,arms, abdomen,back,neck, and face. A dime-sized, circumscribed, firm darker red spot was seen on left thigh, consistent with an immunazation site, and ther was a more lacy, blanching rash concentrated on both anterolateral thighs". Dr. is having him skin tested by an allergist for this reaction to attempt to see what vaccine he was allergic to.  The afore mentioned letter is a copy of the letter sent to the allergist.
Similiar to "Moderna Arm" as found on Internet while doing search for my symptom. Round "patch" on RIGHT ARM, NOT on left arm where vaccine was injected. It also had similar "patch" on torso where arm rested during nights sleep. Arm site began to BURN during shower morning of March 3, 2021 (one week after receiving injection) Applied thin coating of Vaseline which "cooled" the burning site. Festered later that day and applied more Vaseline and also the next morning (March 4, 2021)
SORE ARM; SLIGHT HEADACHE; LITTLE FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 20-MAR-2021, the subject experienced sore arm. On 20-MAR-2021, the subject experienced slight headache. On 20-MAR-2021, the subject experienced little fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, slight headache, and little fatigue on 21-MAR-2021. This report was non-serious.
Neurologic damage (Shaking/memory/speech/motorskills); DVT; Afib; Secondary hlh; Cytokine Storm; This is a spontaneous report from a Pfizer-sponsored program.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Mar2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient experienced neurologic damage (Shaking/memory/speech/motorskills), DVT, Afib, secondary hlh, cytokine storm on 2021. The patient was hospitalized for neurologic damage (Shaking/memory/speech/motorskills), dvt, Afib, Secondary hlh and cytokine storm from 12Apr2021 to an unknown date. The patient underwent lab tests and procedures which included platelet count: 15,000. The patient died on 12Jun2021. It was not reported if an autopsy was performed. The outcome of all the events was Fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.,Linked Report(s) : US-PFIZER INC-2021879892 same source, different reporter/ patient; Reported Cause(s) of Death: The Pfizer shots killed my beautiful mother
no adverse effect; patient inadvertently received Proquad and varivax instead of the intended Varivax and MMR II; This spontaneous report was received from a licensed practical nurse refers to a 12 month old patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-SEP-2019, the patient had inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) instead of the intended varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (anatomical location, route, lot# and expiry date were not reported for all the vaccines) for prophylaxis (wrong product administered). The nurse stated that the person administering the vaccines thought the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). Other suspect therapies included sterile diluent(STERILE DILUENT). No adverse effects were reported.
Pt reported on 3/25/22 in visit signs of hives and rash on left arm and mouth since Monday (3/21/2022), Patient concerns possible body reaction from the moderna vaccine.
Fever, achiness, swelling of the mouth and neck, unable to swallow and talk properly, was prescribed antibiotics for 3 days.
went to get out of bead and fell to the floor. Unable to get up; Chills; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration on 17Mar2021 at 10:00 (at the age 0f 64-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On unknown date in Mar2021, the patient experienced chills that night and woke at about 07:00 on 18Mar2021 and went out of bed and fell on the floor and was unable to get up which lasted for 12 hours. Since the vaccination, patient had been tested for COVID-19. On 24Mar2021, the patient underwent nasal swab test and result was negative. The patient did not receive any treatment for the events. The clinical outcome of the events chills was recovered on unknown date in Mar2021 and fell on floor and unable to get up was recovered on 18Mar2021.  No follow-up attempts are possible; information about lot number cannot be obtained.
Vial of vaccine was reconstituted with 1.5ml of diluent instead of 1.8ml.  Called patient on 6/12 to ask how she was feeling.  Starting 6/12 she had chills, was tired, sneezing, and had a runny nose.
ROTATEQ was administered to a 16 week old; No adverse event; This spontaneous report was received from a nurse, and refers to a 16 week old patient of unknown age. No information was received concerning the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, at the age of 16 weeks, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1742433 with expiration date on 19-SEP-2022 for prophylaxis. The dose was 2 mililliters administered per oral route.
doctor prescribed it to me anyway; older male; This non-serious case was reported by a consumer via call center representative and described the occurrence of off label use in a elderly male patient who received Men B NVS (Bexsero) for prophylaxis.   On 20-MAR-2023, the patient received the 1st dose of Bexsero. On 20-MAR-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: older male). On an unknown date, the patient experienced off label use (Verbatim: doctor prescribed it to me anyway). The outcome of the off label use and inappropriate age at vaccine administration were 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:21-APR-2023 The reporter reported that he was an older male but he would be in an immersive language school and live confined on campus and share a small room with another student. He had his first dose of Bexsero on and wanted to know when do he need to have second dose. The reporter was aware that that vaccine was mainly for younger ages. But his doctor prescribed it to him as he was living in a strict campus life for more than two months and after that doctor went away for a month but never mentioned when the second dose was recommended. The reporter for some reason could not find any straight forward guidelines for dose interval between 2 bexsero dose some said 2 month, some said six and 1 so it was confusing to him. The agent advised to contact another doctor for further direction as she did not want him to get a vaccine which he may not need. The reporter realized that was not medical advice and he will just follow what was recommended there. Follow-up would not be possible as no contact details were available. The vaccine was prescribed by doctor at wrong age which led to Inappropriate age at vaccine administration and off label use.
Patient received 30 ug of Pfizer bivalent vaccine rather than 3 ug. Multidose vial used with 10 doses however no dilution used and so patient received entire content of vial. Contacted the family later in the day when it was realized patient received incorrect dose to let them know of the error. Discussed starting Tylenol every 6 hours and to monitor for symptoms and to use ibuprofen for breakthrough fevers or pain. Reviewed if pain or fevers not resolving with medication or if any other concerning symptoms such as lethargy, inability to walk, poor tone needs urgent evaluation. Patient was asymptomatic at that time. Attempted to call family on 4/22 but no answer, left voicemail. Spoke to mother at 8:30 am on 4/24. Mother reported that patient had fevers over prior 2 days although did improve with Tylenol and Motrin. Did report that patient was having trouble walking however but she thought it might be related to pain. Patient not yet awake and so mother unaware of how he was doing at time of report. Let her know to seek evaluation in ER if unable to walk.
Swollen Injection Site (3-4" ); Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen Injection Site (3-4" )) and VACCINATION SITE PAIN (Sore Injection Site) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen Injection Site (3-4" )) and VACCINATION SITE PAIN (Sore Injection Site). At the time of the report, VACCINATION SITE SWELLING (Swollen Injection Site (3-4" )) and VACCINATION SITE PAIN (Sore Injection Site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.