chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness in arm for 9 months following injection; Initial information received on 03-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 62 years old male patient who experienced weakness in arm for 9 months following injection, while he received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Type 2 diabetes mellitus in 2008.  Concomitant medications included GLIPIZIDE (GLIPIZIDE) for Type 2 diabetes mellitus since 2009; and METFORMIN (METFORMIN) for Type 2 diabetes mellitus since 2017.  In October 2016, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and Expiry date unknown)via intramuscular route in unknown administration site.  On an unknown date, the patient developed a non-serious weakness in arm for 9 months following injection (muscular weakness) (Unknown latency) following the administration of INFLUENZA VACCINE.  in 2019, the patient received Prevenar 13 and experienced adverse events.  Final diagnosis was weakness in arm for 9 months following injection.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for weakness in arm for 9 months following injection.  Information on the batch number was requested.  Documents held by sender: none
After receiving her 1st dose of vaccine she got Covid virus; After receiving her 1st dose of vaccine she got Covid virus; This is a spontaneous report from a Pfizer sponsored program from a contactable female consumer (patient). er First  A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving 1st dose of vaccine, the patient got Covid virus now, she wanted to know if she still needed to take the 2nd dose of vaccine. The outcome of events was unknown.  Information about lot/batch number has been requested.
Narrative:  Patient received Moderna COVID vaccine #1 on 2/8/21 and #2 on 3/8/21. On 3/9/21, he had an appointment with pulmonology due to history of severe idiopathic pulmonary fibrosis that was worsening and he had c/o dyspnea even at rest. After discussion with provider, a hospice consult was placed. It was completed on 3/12/21 and per notes, he met hospice criteria, but declined for community hospice at that time. No further notes entered and a date of death was recorded as 4/4/21. No autopsy report available. Time from vaccine #2 and date of death is 27 days.
Three days after vaccine started feeling muscular pain all over body; Two days later also started feeling joint pain from my jaw to my feet; Called Dr and was referred to a Rheumatologist; Prescribed Meloxicam and it's helped a little but pain is still there; Currently waiting to get an MRI,  appointment is at the end of December.
I started with cold symptoms. I had runny nose and achiness. It moved very rapidly to a cough, due to my asthma it can develop into bronchitis. My doctor had me taking my olopatadine 2 times a day, albuterol six times a day. It helps open my airways and keeps me from going into long term bronchitis. I was feeling horrible on the 3rd so I called my doctor's office for PAXLOVID and they called in the PAXLOVID and benzonatate. Started PAXLOVID on the same day. It acted really fast and my symptoms were minor by the time I went to bed. I took it for the whole 5 days. I continued with my asthma medicine. I was eating fine and drinking a lot. After the PAXLOVID was over I had rebound symptoms 24 hours later. I had pretty heavy cold symptoms but not as bad as the first time. I t was all upper respiratory. Lots of nasal congestion. I had pretty heavy symptoms until the 22nd of January. My doctor's office suggested I switch to over-the-counter cold medicines to control the cold. I went and bought a variety of cold medication with something close to SUDAFED, SUDAFED HCI in in. I went to the emergency room on the 15th of January because I was having irregular heartbeat and shortness of breath. They said I was having premature ventricular contractions. I did a Holter monitor for 24 hours. I noticed that as I was starting to feel better I was trying to take walks. I was thinking t would help. I could walk into the house from the barn on level ground at a slow pace and I would be completely out of breath. I would have to take a couple hour nap. I was so fatigued that I would fall asleep while doing this 5 minute walk. I looked it up and I think it's called exercise induced malaise. Now I am able to do a brisk walk using hiking stick for about 15 minutes. That could be a partial symptom of my migraines as well. My asthma doctor started me on a new medicine, ADVAIR DISKUS. The breathlessness has gone away, I see him again in a month and if needed I will see a pulmonologist.
Acute urticarial rash on day of visit (7/25/01). Seen on 7/23/01 for 1 year well child visit and had routine immunizations.
Initial unsolicited reports received from pharmacist on 25 November 2014 and follow up on 01 December 2014. A 68-year-old male patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number U5042CA, expiry date 30 June 2015 and dose number was not reported) in the deltoid left on 01 November 2014. On 01 November 2014, the patient had experienced blood shot eyes, fever and body aches. The patient had no laboratory investigations and corrective treatment was not reported. The patient does not have any illness at the time of vaccination, pre-existing diagnosed allergies and birth defects. The event of blood shot eyes was resolved after one week, and the event of fever and body aches was resolved after few days. At the time of this report, the outcome of the event was resolved on an unspecified date. List of documents held by sender: none. Follow up information received from a non-healthcare professional on 25 February 2015. No new information was provided. Documents held by sender: none.
Chills 3 hours after injection, 5 hours injection sob and pain in chest. Patient went to ER for observation. They were not sure if these symptoms were due to Zostavax.
Patient presented in from a skilled nursing facility with other patients and staff requesting the Moderna vaccine. Patient indicated on the consent form they didn't have a COVID vaccine in the past and when directly asked the patient also verbally confirmed they didn't have the vaccine in the past. Director of the skilled nursing facility confirmed with the patient's wife they needed the COVID vaccine and that's why she brought him in. Later on in the day when billing the vaccine through Medicare insurance we couldn't get the vaccine to go through, at that time we checked the  state immunization database and discovered he already received the Moderna COVID vaccine on  1/20/21 & 2/17/2021.  Subsequently this is the 3rd dose he has received.
Fever, severe headache, body ache, redness at injection site for 3 days, slightly breathing difficulties (had an inhaler and was fine), chills/sweats
shortness of breath, swelling of arm Narrative: The patient reports that her left arm (injection side) is swollen and warm to the touch. This developed about 24 hours after the vaccination. The patient also reports dizziness and shortness of breath. She declines to come to the urgent room, but will contact her primary care provider. A report will be entered into system. Pt scheduled for visit with RN.
This spontaneous report as received on 17-APR-2017 from a medical assistant, which refers to unspecified patients (age and gender not reported). The patients' pertinent medical history, current conditions and concomitant medications were not reported. The medical assistant reported that improperly stored doses of vaccines were administered to unspecified patients on unspecified dates. The names of the vaccines involved (including Lot # and expiration date) are GARDASIL 9 (Lot number N00270, expiration date 12-MAY-2019), PEDVAXHIB (Lot number M036057, expiration date 18-MAY-2019), ROTATEQ (Lot number M016238, expiration date 07-DEC-2017) which were administered to unspecified patients on unspecified dates. No adverse events reported. The vaccines were exposed to Temperature 35F (35 degrees Fahrenheit) for the time frame of 4 hours. There were no previous excursions reported. The call was because of a data logger. No additional information was provided. Additional information has been requested.
The second day after immunization the patient stated that the area started itching, Visual verification of area showed an area of approximately 3 inches by 6 inches of redness. I advised patient to use hydrocortisone cream and if needed a diphenhydramine 25mg up to 4 times daily if needed. Patient stated that the redness and itching started to subside after another 24 hours.
felt weird; Headache; head off balance; feeling like it had the flu,"I felt like having the flu without the sick feeling; for a half second at that moment did get a feeling being nauseated; felt really Really tired; Light headed; skin hurts like when I had the flu or when I got a bad cold; started feeling like off balance; muscle achy; fever (99.5°F); chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), PAIN OF SKIN (skin hurts like when I had the flu or when I got a bad cold), BALANCE DISORDER (started feeling like off balance), FEELING ABNORMAL (felt weird) and HEAD DISCOMFORT (head off balance) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Nov-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced DIZZINESS (Light headed), PAIN OF SKIN (skin hurts like when I had the flu or when I got a bad cold), BALANCE DISORDER (started feeling like off balance), MYALGIA (muscle achy), PYREXIA (fever (99.5°F)) and CHILLS (chills). On 05-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEAD DISCOMFORT (head off balance), INFLUENZA LIKE ILLNESS (feeling like it had the flu,"I felt like having the flu without the sick feeling), NAUSEA (for a half second at that moment did get a feeling being nauseated) and FATIGUE (felt really Really tired). On 06-Nov-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced FEELING ABNORMAL (felt weird). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of every 4 hours on Saturday and once on Sunday. At the time of the report, DIZZINESS (Light headed), PAIN OF SKIN (skin hurts like when I had the flu or when I got a bad cold), BALANCE DISORDER (started feeling like off balance), MYALGIA (muscle achy), PYREXIA (fever (99.5°F)) and CHILLS (chills) had not resolved and FEELING ABNORMAL (felt weird), HEAD DISCOMFORT (head off balance), INFLUENZA LIKE ILLNESS (feeling like it had the flu,"I felt like having the flu without the sick feeling), NAUSEA (for a half second at that moment did get a feeling being nauseated), FATIGUE (felt really Really tired) and HEADACHE (Headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-378026 (Patient Link).
I assessed a 12 year old female who was alert and oriented but appeared nervous, comfort measures were taken.  I proceded to administer the vaccines.  I asked the child if she was okay, she replied that she was alright, but her left arm was in pain. The child left the room as I began to provide vaccines for the third child in the family.  She was out in the hallway near the exam room.  We heard a loud thump,the father abruptly left the room and was beside his child.  She was awake and cyring and responded with a nonverbal manner by nodding her head to the questions being asked of her.  Dr. came and asses the child.  After the assessment, Dr. recommended that the child be taken to the emergency room; for she had sustained a lump on her back of her head.  911 was called.  Shortly after the call was placed the paramedic arrived and took the child.
Large uncomfortable lymphadenopathy in L neck/clavicle area, the size of a lemon.  It hurt to move my neck, and is very tender to touch.  It is still present now, 10 days after receiving the vaccination.  I saw my MD today who assured me it is a typical appearance for a lymphadenopathy, but it still bothers me, especially never having had such an occurrence before.
pt recv vax 1NOV95 & 2JUL97 pt devel varicella which was described as mild to moderate per physical exam;pt recovered;
No adverse event noted patient received a dose that had been out of the freezer for >30 days
1 of 2 pts immunized from the same Tetramune lot who exp an adverse event; pt vaxed 16JUN94 w/in 1/2 hr p/vax began crying in a high pitched tone; crying cont on & off for 6 hrs; by 17JUN sx resolved; no MD visit; rx included APAP & Motrin
No additional AEs; Inappropriate schedule of vaccine administered; This spontaneous report as received from a pharmacist referring to a 22-year-old male patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      The pharmacist stated that the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) too soon. The first dose of 0.5 milliliter of varicella virus vaccine live (oka/merck) (VARIVAX) was received 18-JAN-2021 and the second dose (0.5 milliliter) on 26-JAN-2021 for prophylaxis (strength, vaccination scheme frequency, route of administration, lot number and expiration date were not reported). No additional adverse events reported.
COUGH, HA, CHILLS, FEELING TIRED/SICK, FATIGUE
Lymphedema / swelling of  lower left leg; Lymphedema / swelling of  lower left leg; Body aches, back pain and neck pain for following week.; Body aches, back pain and neck pain for following week.; Body aches, back pain and neck pain for following week.; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 23Jul2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient previously had tree nuts and experienced allergy to nuts. The patient also had peach previously and experienced fruit allergy. The patient did not have any other medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 02Jul2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 vaccination. On 23Jul2021 at 19:00, the patient experienced lymphedema / swelling of  lower left leg. The patient also experienced body aches, back pain and neck pain for following week on 23Jul2021 at 19:00. Therapeutic measures were not 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. The clinical outcome of the events lymphedema / swelling of  lower left leg; body aches, back pain and neck pain for following week was resolved with sequelae on an unknown date in Jul2021.   No follow-up attempts are possible. No further information is expected.
Chest pain, Chest cramping, left arm numbness/tingling, hand swelling, high blood pressure
feeling very confused; back was bothering her; brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 01Jan2021 13:00 (Lot number: EN5318) at the age of 80 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "blood thinner" (unspecified if ongoing); "hair and nails" (unspecified if ongoing); "stomach heart burn" (unspecified if ongoing); "heart" (unspecified if ongoing). Concomitant medication(s) included: MEDROXYPROGESTERONE, start date: 1989 (ongoing); CLOPIDOGREL taken for anticoagulant therapy (ongoing); ESTRADIOL, start date: 1989 (ongoing); BIOTIN taken for alopecia (ongoing); PANTOPRAZOLE taken for dyspepsia; IRBESARTAN taken for blood pressure measurement; BUSPIRONE, start date: 1989; CARVEDILOL taken for cardiac discomfort, start date: 2012.  The following information was reported: BACK PAIN (non-serious) with onset 03Feb2021, outcome "recovered" (04Feb2021), described as "back was bothering her"; FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "not recovered", described as "brain fog"; CONFUSIONAL STATE (non-serious), outcome "not recovered", described as "feeling very confused".  Additional information: After the first dose, the patient noticed that her back was bothering. The patient went to an acupuncturist and the acupuncturist told her she noticed people who have chronic pain are having flare ups after the vaccine. The back pain was resolved after seeing the acupuncturist. After the second shot, she went to the acupuncturist again and mentioned that she was having brain fog and feeling very confused when she was driving.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021273978 same patient/reporter/vaccine, similar events, and different dose
YF-VAX was administered after it was mixed with sterile water instead of the diluent provided with no reported adverse event; YF-VAX was administered after it was mixed with sterile water instead of the diluent provided with no reported adverse event; Initial information received on 14-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 68 years old male patient was administered Yellow fever vaccine (yf-vax) after it was mixed with sterile water instead of the diluent provided with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Typhoid vaccine live oral (ty21a) (VIVOTIF) for Prophylactic vaccination.  On 10-Feb-2023, the patient received suspect Yellow fever vaccine - Solution for injection at dose of 0.5 ml (strength were not provided) (lot UJ782AA and expiry date-17-Feb-2024) via intramuscular route in the left deltoid for immunization after it was mixed with sterile water instead of the diluent provided with no reported adverse event (latency-same day) (Vaccine preparation error) (Poor quality vaccine administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.   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
PATIENT COMPLAINED OF RED ITCHY HARD SWELLING OF SIZE 7 INCHES BY 3 INCHES AT SITE OF VACCINATION ON UPPER ARM, ALMOST AFTER 2 DAYS OF RECEIVING MENACTRA VACCINE. WE WERE GOING TO TAKE PATIENT TO EMERGENCY ROOM, BUT TRIED BENADRYL ADVICED BY THE NURSE HOTLINE AND ITCH WENT AWAY AN HOUR AFTER GIVING 25 MG BENADRYL, 2 DAYS LATER THE REDNESS AND SWELLING HAD DECREASED. PATIENT HAS NEVER HAD ANY REACTION TO ANY VACCINE BEFORE. THUS THIS WAS UNUSUAL.
This spontaneous report as received from a nurse practitioner via field representative refers to a male patient of unknown demographics. On an unknown date the patient was vaccinated with ZOSTAVAX and then developed a headache that had not gone away. The event outcome was unknown. The patient had visited the doctor to seek medical attention. Additional information has been requested.
Evening of 23AUG pt temp 104.4 w/vomiting; temp varied 102-104 w/APAP suppositories; Mom called ER 330AM 24AUG & told to continue APAP & sponge baths; To ER 24AUG; had PPND given ATB;
She is coughing stuff up; Sinus symptoms/congestion it's like having a cold; Terrible sinus congestion; Soreness in right arm; worried; Soreness in right arm; This is a spontaneous report from a consumer (patient) from Pfizer-sponsored program. A 74-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262), via an unspecified route on 03Feb2021 (at the age of 74-years) as 1st dose, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Feb2021, the patient experienced soreness in the right arm, on 05Feb2021 in the morning terrible sinus congestion and had sinus symptoms/congestion it's like having a cold. Patient stated that it felt liked she sounded liked she would if she had a cold which she had not in a long time. It was reported that arm soreness dissipated over the day yesterday. Patient stated that she was worried because they have a gathering this coming Sunday and asked if this is contagious. She said it was in her head. In the winter she did had sinus problems but this was sort of different. She was coughing stuffed up, blowing her nose, and in an exponential way that she had not had in the winter. She looked in her medicine chest and thought maybe she should take a Claritin but decided she shouldn't. She does not knew much about the vaccine. The outcome of the events soreness in right arm was recovered on 04Feb2021, terrible sinus congestion was not recovered and other events was unknown.  Follow-up attempts are completed. No further information is expected.
Gave flu shot, and pt started bleeding. Then almost immediately, hard, big lump at injection site formed. Gave pt ice pack!
Information has been received from a RN concerning a 29 year old female who was intramuscularly vaccinated with the second 0.5 ml dose of GARDASIL on an unspecified date. On 24-OCT-2008 the patient experienced redness, tenderness and warmth at the site of GARDASIL vaccine administration after her second dose. At time of reporting, the outcome of the patient was unknown. The patient called the clinic for medical attention. Additional information has been reported.
Lightheadiness, nausea, cool extremities, resolved with rubbing, warmth and 30 minutes