chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient was mistakenly given Daptacel in the right deltoid instead of a Tdap vaccine with no reported AE; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced a patient was mistakenly given daptacel in the right deltoid instead of a tdap vaccine with no reported ae while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 03-Aug-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE once (lot C5829BA; 01-Mar-2023)  via unknown route in the right deltoid for immunization.  On 03-AUG-2022 the patient reported a non-serious event a patient was mistakenly given daptacel in the right deltoid instead of a tdap vaccine with no reported ae (wrong product administered) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.   Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event wrong product administered.   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 the guidelines. 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.
My heart was beating really fast and was pounding hard Very dizzy Blood pressure and pulse was high Jerky head movements
This is a spontaneous report from a noncontactable consumer (patient). A 33-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP6955), at the age of 33, via an unspecified route of administration, in the left arm, on Apr 17, 2021, at 13:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP6955), at the age of 33, via an unspecified route of administration, in the left arm, on Mar 29, 2021, at 16:00, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 18, 2021 at 01:00, patient experienced severe arm pain followed by fever, headache and fatigue. No therapeutic measures taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The outcome of severe arm pain followed by fever, headache and fatigue: resolving (at the time of this report). No follow-up attempts possible. No further information expected.
COVID vaccine expired on 4/4/22.  Patient was administered Pediatric Pfizer vaccine on 4/18/22.  No adverse reaction.   Patient's parent notified that patient needs to be revaccination.
Pt returned for 2nd dose 5/24 but was turned away due to allergic reaction.  Pt reported hives after first dose on 5/3. Timeframe for development of allergic reaction is unclear.  Unknown if patient took any rescue medication.
Since the shot I've had soreness in the arm where I got the shot. Brain Fog. Fatigue and nausea. Headaches
Blood pressure  178/105 Sore toe, then swollen foot with purple toes and bottom of foot, severe foot pain. Moderate hip pain. No treatment,  was advised to go to er if worsened. Blood work normal. Toe still lightly swollen with discolored joint. Moderate hip pain continues.
DEATH; FELT SICK; This spontaneous report received from a consumer (social media) via a company representative concerned a male of unspecified age. 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, Expiry date: Unknown) frequency 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after getting the vaccine, the patient felt sick. On the next dat, the patient was deceased. The cause of death was not reported. It was unknown whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: -covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Muscle spasm. Intermediate to intensive pain or discomfort. From my deltoid up to my neck to my ear (left).
After getting 4 y/o shots, 1 day post getting them arm (right arm) blister, red, sore.  Fussy all day 2 days post shots with red lacy rash, clammy, pale, cheeks red with activity.
Pfizer-BioNTech Covid-19 Vaccine EUA Adverse effects were a low grade fever (99-99.9),  feeling hot, headache, tired, sore arm muscle at injection site Effects lasting 2 days
Information has been received from a physician concerning a 13 month old female with no past medical history or known allergies who on 08/10/2001 was vaccinated with the first dose of varicella vaccine SC in the left arm. Concomitant therapy that day included the first dose of MMR vaccine SC in the right arm. There were no other concomitant medication. It was noted that there were no adverse events following prior vaccinations. On 08/26/2001, 16 days after vaccination, the child developed 3-5 vesicles. It was noted that the child was afebrile. In approximately September 2001, the child developed a mild cold/URI symptoms. Follow-up info reported the the child had recovered from her experience without sequelae. It was noted that other pts from the same doctor's office reported similar symptoms. No further info is expected.
Injection site slight pain; Fatigue; Chills; Stomach ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 14Oct2021 09:15 (Lot number: EW0217) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 26Sep2021; FLUOXETINE; KURVELO taken for contraception. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 25Jan2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "slight soreness in my right arm"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 15Feb2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "fatigue", "I had slight muscle soreness", "very slight chills", "My right arm was also a bit sore.". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Oct2021 21:00, outcome "recovering", described as "Injection site slight pain"; FATIGUE (non-serious) with onset 14Oct2021 21:00, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 14Oct2021 21:00, outcome "recovering", described as "Chills"; ABDOMINAL PAIN UPPER (non-serious) with onset 14Oct2021 21:00, outcome "recovering", described as "Stomach ache". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills, abdominal pain upper.  Additional Information: It was reported that, the patient received as fluoxetine (20 mg), Kurvelo for birth control as other medications within 2 weeks of vaccination. The patient was not received treatment for adverse events. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19 since vaccination  No follow-up attempts are possible. No further information is expected.
Severe pain in right arm, heat, knot, swelling, redness and bruising to right upper arm area.  Fever up to 102.9, chills, aches all over. freezing Antibiotics to be given for cellulitis of right arm, Tylenon and Motrin and Benadryl for symptom and fever relief.
This spontaneous report was received from a 61 years old physician reporting on himself who on 03-OCT-2012, was vaccinated with a dose ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that "last night" on 03-OCT-2012, he slept poorly, and then "today" on 04-OCT-2012, noted low grade fever, malaise and erythema at the injection site with four vesicles. Not thinking clearly, he took an took an aspirin 325 mg tablet. At the time of the report, the patient's outcome was unknown. The physician was wondering to know of he was at risk for Reye's syndrome. It was unspecified if the patient sought medical attention. The relatedness for I sleep poorly last night, not thinking clearly, injection site with four vesicles, erythema at the injection site, malaise and low grade fever was unknown for ZOSTAVAX. Additional information has been requested.
lost the ability to walk for a few days; muscles were extremely stiff and painfull; muscles were extremely stiff and painfull; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for Covid-19 immunization. The following information was reported: GAIT INABILITY (non-serious), outcome "recovered", described as "lost the ability to walk for a few days"; MUSCULOSKELETAL STIFFNESS (non-serious), MYALGIA (non-serious), outcome "recovered" and all described as "muscles were extremely stiff and painfull".  Additional information: Reporter type: Consumer. 64 year old female patient. On 12Jan2023, it was reported that a patient was vaccinated on an unspecified date with Pfizer BioNTech COVID-19 vaccine (tozinameran) dose 2 for Covid-19 immunisation. Reportedly, the individual experienced a severe reaction to the second dose, lost the ability to walk for a few days, but it came back fully after 6 months, their muscles were extremely stiff and painful. It is currently resolved. Their healthcare provider recommended that they do not get any more Mrna vaccines, so I had J&J as my booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had syncope within 5-15 minutes after shot. After LOC, fell and hit head.
Approximately 2-3 days after receiving the vaccine, patient broke out in a shingles rash on the forehead and continued to spread over a 2 week time period.
Migraine headache with aura began six hours after injection and lasted one hour. Menstrual spotting lasting one day has occurred twice since the injection
Patient reported 38 mins after getting the vaccine, feeling intense tingling going up the face, chest and shoulders and tight throat. Patient reported she went to the hospital and she was diagnosed with allergic reaction to the vaccine. She was given high-level Benadryl. Patient reported yesterday she started to feel the same symptoms.
PATIENT STATED THAT AFTER VACCINATION SHE EXPERIENCED REDNESS AND SWELLING IN THE LEFT ARM FROM SHOULDER TO ELBOW. PATIENT AND PHYSICAL THERAPIST DREW A LINE OF SWELLING AND REDNESS TO MONITOR IF REACTION WAS GETTING BETTER OR WORSE. SPOKE TO PATIENT AT 5:10 PM AND SHE STATES IT REMAINS UNCHANGED IN SIZE.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "chronic pain" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Pfizer product for treatment of COVID-19 from 11Jun2022 to 16Jun2022. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient started to feel better after finishing Paxlovid, but just a couple days later started having COVID symptoms again from 18Jan2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
sore shoulder; "flu-like" symptoms; chills; lightheadedness; extreme body aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder), INFLUENZA LIKE ILLNESS ("flu-like" symptoms), CHILLS (chills), DIZZINESS (lightheadedness) and MYALGIA (extreme body aches) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced ARTHRALGIA (sore shoulder), INFLUENZA LIKE ILLNESS ("flu-like" symptoms), CHILLS (chills), DIZZINESS (lightheadedness) and MYALGIA (extreme body aches). At the time of the report, ARTHRALGIA (sore shoulder), INFLUENZA LIKE ILLNESS ("flu-like" symptoms), CHILLS (chills), DIZZINESS (lightheadedness) and MYALGIA (extreme body aches) outcome was unknown. Not Provided    Treatment details include Nyquil, Dayquil  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a pharmacy technician refers to a newborn patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored RECOMBIVAX HB pediatric, lot # N020613, expiration date 05-MAY-2020 (dose and route were not reported) for prophylaxis. No adverse effects were reported. The patient did not received treatment. The temperature involved was 47 grades Fahrenheit to 77 grades Fahrenheit for four hours. There was no previous temperature excursion reported and a data logger was not involved.
Information has been received from a registered nurse via company representative referring to a 16 year old female patient. On an unknown date the patient was supposed to get a PEDVAXHIB (lot number L012838, expiration date 10-MAR-2018). No adverse effects reported. The outcome was unknown. Additional information has been requested.
Information has been received from a registered nurse and female consumer with no known allergies or medical history who on 10/07/99 and 11/16/99 was vaccinated with a first and second dose of varicella virus vaccine live. Concomitant therapy included prenatal vitamins (unspecified). On 06/29/01, the pt reported that her 2 year old child may have contacted the chicken pox "now" which resulted in the pt having a serum varicella zoster virus antibody test performed which showed no immunity to varicella varicella zoster virus. On 07/13/99,  the registered nurse reported that the pt called and reported that she was in the "early stages" of pregnancy and a titer shows that she has no immunity to VZV. Unspecified medical attention was sought. Addittional information has been requested.
Three days after A raised red painful rash that is spreading and much bigger than the actual injection site. Pain increasing so far each day as is the size of rash/reddened area
Headache; Hard to even stand; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 09:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (AFIB) and COVID-19. The patient had allergic to iodine. Concomitant medications included losartan (MANUFACTURER UNKNOWN), ELIQUIS, atorvastatin (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was diagnosed with COVID-19. On an unknown date, the patient underwent COVID-19 virus test, that resulted positive. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient underwent lab test and procedure which included body temperature and result was shown as 101(unspecified units). On 30Mar2021 at 17:00 the patient experienced extreme chills that rattled entire body and fever 101. The patient reported that this extreme body reaction made it hard to stand. On 31Mar2021 the next day the patient experienced a lingering headache. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events chills, fever, headache and difficulty in standing was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Day 1 - pain in arm where shot was administered.  Day 2 - 4 - pain down arm concentrated in left arm-pit, area surrounding arm-pit and left wrist and top of hand.
After vaccine patient felt very tired--more than expected. By midnight, patient started to get warm, developed headache, started shivering, had upset stomach, and had a little bit of itching.  Symptoms continued the next day.  The temperature was about 100.8 and noticed that vision was blurred compared to normal.  Symptoms somewhat improved by Saturday, temperature started to decrease,  still had blurred vision, soreness in arm,  and waves of nausea/upset stomach--did not actually throw up at any point.    On Sunday, symptoms continued to improve, fever and headache decreased. Today, patient has waves of blurred vision and nausea/upset stomach for no real reason.  Recovery is at 95% recovery.   After first dose of vaccine on 1/26/2020, only had soreness in arm; received vaccine at same facility.   Patient did not call doctor or pharmacist at any point.
This spontaneous report was received from a nurse, who referred to an unknown number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. The patients were administered improperly stored doses of LIQUID PEDVAXHIB (dose, route of administration and anatomical location were not reported) as prophylaxis on the following dates: with lot# M001813 and expiration date of 14-OCT-2018 on 07-JUL-2016, 08-JUL-2016, 14-JUL-2016, 15-JUL-2016, each day from 18-JUL-2016 till 22-JUL-2016, on 25-JUL-2016 and 26-JUL-2016; with lot# N000236 and expiration date: 24-OCT-2019 on 06-APR-2017, each day from 23-MAY-2017 till 26-JUL-2017, 30-MAY-2017, 02-JUN-2017 and 06-JUN-2017; with lot# M046133 and expiration date: 26-SEP-2019 on 12-AUG-2016, 11-APR-2017, 12-APR-2017, 17-APR-2017 and 18-APR-2017; with lot# M034189 and expiration date: 23-MAY-2019 on 21-MAR-2017, 24-MAR-2017 and 30-MAR-2017; with lot# M036058 and expiration date: 19-MAY-2019 on 27-FEB-2017 and 01-MAR-2017; with lot# 032149 and expiration date: 27-DEC-2016; with lot# L051123 and expiration date: 13-OCT-2018 on 23-AUG-2016. The doses of vaccine with lot# M001813 were stored for 8 hours at the following temperatures: on 07-JUL-2016 at 9.4 degrees Celsius (C), on 08-JUL:-2016 at 14C, on 14-JUL-2016 at 9.1C, on 15-JUL-2016 at 9C, on 18-JUL-2016 at 15C, on 19-JUL-2016 at 10C, on 20-JUL-2016 at 34.9 degrees Fahrenheit (F), on 21-JUL-2016 at 34.5F, on 22-JUL-2016 at 34.5F, on 25-JUL-2016 at 34.4F and on 26-JUL-2016 at 47.5F; with lot# N000236 for 8 hours at the following temperatures: on 06-APR-2017 and 06-JUN-2017 at 35.8F, on 23-MAY-2017, 26-MAY-2017 and 30-MAY-2017 at 35.2F, on 24-MAY-2017 and 25-MAY-2017 at 35.3F, on 02-JUN-2017 at 47.3F; lot# M046133 for 8 hours at the following temperatures: on 11-APR-2017 and 18-APR-2017 at 35.2F, on 12-APR-2017 at 35.5F and on 17-APR-2017 at 35.4F; with lot# M034189 for 8 hours at the following temperatures: on 21-MAR-2017 at 35.9F and on 24-APR-2017 at 34.2F; with lot# M036058 for 8 hours at the following temperatures: on 27-FEB-2017 at 34.7F and on 01-MAR-2017 at 35.8F; with lot# M032149 on 27-DEC-2016 at 32.7F for 8 hours; with lot# L051123 on 23-AUG-2016 at 34.9F for 8 hours and with lot# M046133 on 12-AUG-2016 at 33.8F for 8 hours. All temperature excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. It was also reported that several improperly stored doses of LIQUID PEDVAXHIB with the above mentioned lot# and expiration dates were not administered to patients. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004143: US-009507513-1706USA006151: US-009507513-1706USA006149: US-009507513-1706USA006150: US-009507513-1706USA006146: US-009507513-1706USA006148:
Blisters on six of my toes use Bacitracin when blisters break & wear white cotton socks. If any change call & see M.D. immediately
24 hours later fever, chills, body aches, fatigue 39 hours later rash that has spread all over abdomen, bilateral legs, face, and bilateral arms
Patient reports coughing up small amounts of blood between 10 & 24 hours post-vaccination.  The patient reports that the issue was not present prior to vaccination & resolved after the 24 hour period.  She did not seek further medical treatment at the time & did not report the reaction to the pharmacy until the time of her second dose of the vaccine.  The patient did receive the second vaccine dose & has been instructed to report any issues to the pharmacy promptly.
Muscle weakness, tenderness, pain, cramps and spasm in ankles, legs, back, chest muscles, arms and hands. Difficulty walking and lifting even very light objects.