chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US019599 is an initial spontaneous report received from a nurse on 16 Sep 2013 with follow up information received from a nurse on 07 Nov 2013. This report refers to a 12 years old male patient. He had tolerated the vaccine well in the past. He received only Men CYW-135 liquid conjugate component of MENVEO (lot number: A12098) without being reconstituted with Men A lyophilized conjugate vaccine component intramuscularly in the upper arm on 13 Sep 2013. He also received a booster dose of Tdap (other manufacturer, batch number: not reported) 0.5 ml intramuscularly on the same date. He was vaccinated with Tdap and liquid component of MENVEO on separate arms. About 1 week ago patient came back and was re-vaccinated with the full dose of MENVEO because they were waiting for the vaccine to arrive. No adverse event was reported following this administration error. Follow-up was received from a nurse on 07 Nov 2013: Patient demographics (height, weight) dose, site and route of administration, lot number of MENVEO, concomitant medications and re-vaccination information were updated.
allergic reaction / "abdominal allergic" reaction; bloating; abdominal pain; I also had hives break out on my arms; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 23-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Concurrent medical conditions included alpha gal allergy and allergic to mammal products..   On 17th September 2020, the patient received FluLaval Tetra 2020-2021 season. On 17th September 2020, less than a day after receiving FluLaval Tetra 2020-2021 season, the patient experienced allergic reaction, bloating, abdominal pain and urticaria. The patient was treated with benadryl (nos) (Benadryl). On 17th September 2020, the outcome of the urticaria was recovered/resolved. On 20th September 2020, the outcome of the allergic reaction, bloating and abdominal pain were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, bloating, abdominal pain and urticaria to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The patient received FluLaval quadrivalent and she experienced allergic reaction, abdominal allergic reaction, bloating, abdominal pain and hives break out of her arms. The abdominal pain and bloating lasted three days which is pretty normal and the hives resolved later that day after taking Benadryl. The reporter consented to follow up.
Began with a few little tinglings in back of neck and down the back.  Now more noticeable and seems to be getting worse.  Describes "Feels like someone is pinching me on my back and like I've got a sunburn, but I don't see any rash or redness."  This is constant and covers the whole back, there is a small amount of itching.  Notices this off and on during the day, but activities and sleep are not impaired.  Sensation is not relieved with any particular activity or position.  Had chicken pox as a child, but a very light case.
04/22/04: DTAP given left arm IM.  Mom called 04/23/04: Describing 3 inch diameter redness, swelling, tenderness, using Tylenol.  Encouraged Motrin/Advil.  04/26/04: Continuing redness, decreased swelling. Encouraged Advil/Motrin.  Did increase to 4 inch diameter.
showing symptoms of allergic reaction, turned over care to ambulance standby paramedics. IV Benadryl given transported to hospital
Late second dose, not yet received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: The pharmacist reported that patient was late for second dose of Shingrix and not yet received.  The administration date of first dose of shingrix unavailable per pharmacist.  All other adverse event information unavailable at this time per pharmacist.  The health care professional gave permission for safety team  follow up. Additional Supportive Information: The patient was late for second dose of shingrix which was not yet received which led to Incomplete course of vaccination. This case was linked with US2022123223 reported by same reporter for Shingrix.; Sender's Comments:  US-GSK-US2022123223:Same reporter
Narrative: COVID infection following COVID vaccine series 03/27 Janssen, dose #1 09/12 pt cc: chills, cough, fatigue, fever, dyspnea, headache, exposure: unknown 09/14 COVID swab, result: detected 09/21 clinically resolved
Immediately p/inject pt's head dropped to one side, arms stiffened, pale diaphoretic, responsive almost immediately; vomited approx 50cc; ?fainted or petit mal sz, VS stable;
Janssen 3/5/21, 12/17/21. Positive on 10/13/22
DELAY IN MENSTRUAL CYCLE - 23 DAYS LATE FROM EXPECTED START DATE.
Mild reaction; This case was reported by a other health professional via sales rep and described the occurrence of nonspecific reaction in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced nonspecific reaction. On an unknown date, the outcome of the nonspecific reaction was recovered/resolved.   It was unknown if the reporter considered the nonspecific reaction to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After receiving a dose of Shingrix she had a mild reaction (not specified). The injection was given by a licensed practical nurse. This was all the information the sales representative had to report.  For tolerances of 2nd dose, refer case US2019112116, reported by same reporter for the same patient.
Flushing/Sweating, Dizziness, Nausea. BP 84/50 HR65 RR18, then 3 minutes later improved to 104/64, HR88, RR18. Received water, symptoms resolved, discharged with father
Vaccine was given after the 10 week expiration from being placed in the refrigerator. 10 week expiration should have been April 7, 2022 but vaccine was given on 4/9/22. All other proper storage requirements were followed.
Dose 1 : elevated BP ; pain in chest and arm; tightness in throat; sweats;headaches ; stomache pain ;elevated protein and blood in urines  malaise : Reactivation of IGAN Dose 2 : fever over 100; extream headache;stomach pain; back pain ; sever jump in protein (severe)and blood  in urines; urines red in color and tea colored ; swelling of legs w pain in right leg ; swelling of hands : normal  BP  4/9/21 Prednisone 40 mg daily ; still taking                   Tylenol as needed
Monday night 12/13/21 started with small bumps on legs and in hair, itching.  Tuesday 12/14/21, continued with hive like rashes that appear in different areas. Looks like dermatographia hives. Itching starts before line/rash appeals. Gets very itchy then disappears. This has continued to this day. Have taken Claritin BID, now on prednisone taper. Also using Sarna lotion and cortisone creams. Also noticed 12/16/21 feeling lump in throat as if my medication did not go down. Lasted for hours, even chest was hurting like severe heartburn when swallowing. Today, having hives on ears and eye lids. Throat itches at times, like an allergy itch.
She called the pharmacy the evening following the vaccine. She said her arm became swollen after 1-2 hours of receiving the 2 vaccines and that is was painful throughout the night. She said the swelling was worsening and was now from her elbow to shoulder.
My eyes started watering profusely the next day, and I saw that my left eye was drooping. About an hour after I noticed my eye, I started having heart palpitations, and I started coughing a lot and had shortness of breath, so I went to my PCP where she performed an EKG and did blood work. It was later determined that I have Hyperthyroidism. About a month later my eye was still drooping and I was sent for an eye exam. They did a full exam and couldn't determine a reason for this. But I was given Upneeq eye drops. From there I was sent to an Endocrinologist. I was given a CT scan with contrast to get a closer look at my Thyroid. I was told that my Thyroid results came back high and additional testing. I was given a CT scan with contrast to get a closer look; I was advised to keep using the Upneeq eye drops. I was then referred to a Neurologist, to make sure that she wasn't having any kind of stroke or brain reactions. I was given and MRI and the results were inconclusive.
found an extra diluent / have mixed a /lyophilized component with sterile water; found an extra diluent / have mixed a /lyophilized component with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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 provided as follows: The age at vaccination was not reported. The reporter mentioned that, 2 weeks ago, she found an extra diluent and healthcare professional must have mixed lyophilized component of Menveo which was reconstituted with sterile water, which led to wrong solution used for drug reconstitution and inappropriate dose of vaccine administered. The reporter also mentioned that, no additional details at the moment as they have not determined which patient received the dose. The reporter consented to follow up.
Woke up on 4/28 with what seemed to be a bite mark maybe but arm is itchy and has a small knot and looks like a small rash.
taste and smell started changing/ things started smelling weird and tasting weird again; taste and smell started changing/ things started smelling weird and tasting weird again; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in left arm on 01Apr2021, as 0.3 ml single dose for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to Dec2020. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6206), administered in left arm on an unknown date, as single dose for COVID-19 immunisation and after she had taste and smell went away and came back different. She was not able to smell bad smells like trash, boiled eggs, dog droppings or bowel movements or any other nasty smells. Post covid 1 month her smell started to return some and somewhat go back to normal. After the first dose of the vaccine, she was able to smell thing but not tell what it was. After received her second dose of the Pfizer COVID 19 vaccine, a couple of days, might be two days later things on 03Apr2021, patient started to notice that her taste and smell started changing/ weird again and now (at the time of report) she could not smell nasty smells and other things have changed. She stated it started with her toothpaste, the mint started smelling weird, and then bananas started smelling weird, chicken started smelling weird, charred, rancid smell. She noticed first with her toothpaste and the taste of chicken and bananas. She did see her primary care doctor for something else and she brought it up but they did not seem to know anything. She knew that everything was still ongoing and being studi changed of taste ed but it was just frustrated because she concerned about it went back to normal. The patient underwent lab tests and procedures which included COVID-19 test: negative on 06May2021. Outcome of the events was not resolved.  Follow up attempts are needed. Further information has been requested.
Unusual menstrual cycle. Much heavier than normal bleeding, longer than normal duration of bleeding (10 days vs normal 4 to 5 days), shorter cycle (period came early).
covid test date=14Oct2022, covid test result= Positive; covid test date=14Oct2022, covid test result= Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 15Nov2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 06Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Oct2022, outcome "unknown" and all described as "covid test date=14Oct2022, covid test result= Positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (14Oct2022) Positive, notes: Nasal Swab.  Additional information: if other vaccine in four weeks: No. Within 24 hours of receiving her first vaccine (15Nov2022) she felt as if her bladder was hit by a truck plus burning. She seen her doctor and long story short she attributed this incident to the vaccine, being that there was no infection present. It was 2022 now and she randomly urinate on herself, the floor. Shortly after that experience she could not walk for three days and was diagnosed with Osteoarthritis of the hip. Now, she was possibly being treated for pinched nerves in my neck due to her left arm and hand going numb and severe muscle pain. What did you do to me???. Patient did not experience covid prior vaccination and was tested post vaccination. Patient did not receive any other vaccines in four weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (VACCINATION FAILURE, COVID-19) and BNT162B2.
mildly delirious; a thumping headache; shivers; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient also received first dose of BNT162B2 on unspecified date (unknown lot number and expiration) for COVID-19 immunization.  The patient experienced a thumping headache, shivers, and mildly delirious after his second shot on unspecified date. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
arm was extremely sore; injection was in the right arm, about 6 hours later of the vaccination, there was mild tenderness; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via an unspecified route of administration in right arm on 12Jan2021 03:45 at a single dose for covid-19 immunization. Medical history included fibromyalgia, and allergies to Flexeril, benzalkomium chloride, iodoprophnyl butylcarbamate, Neosporin. Concomitant medication included prednisolone, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), magnesium, cobamamide (VITAMIN B12 [COBAMAMIDE]), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and colecalciferol (VITAMIN D [COLECALCIFEROL]).  The injection was in the right arm, about 6 hours later of the vaccination, on 12Jan2021, 22:00, there was mild tenderness. The following day, on 13Jan2021, the arm was extremely sore. 36 hours after the injection, the arm was no longer sore. The outcome of the events was recovered on 14Jan2021. No treatment was received for the events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.
Numbness in lips and tingling in fingers. She also had some difficulty walking, felt a little dizzy.
11/10/99:Pt recv'd flu vax.Following the vax, pt developed transverse myelitis & paralysis.Pt was hospitalized.
A 15 month old baby was inadvertently given Boostrix; was inadvertently given Boostrix Tdap, instead of Infanrix; This case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 22MS7, expiry date 1st April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In May 2022, the patient received Boostrix .5 ml and Boostrix Pre-Filled Syringe Device. In May 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 19-May-2022 Reporter's comments: Fifteen month old patient was inadvertently given Boostrix (Tdap) at her 15 month visit this week, instead of Infanrix (DTaP). No adverse events or issues were reported after administration of the vaccine. The reporter agreed to follow up. Additional Supportive Information: The fifteen month old patient inadvertently received Boostrix instead of Infanrix, which led to inappropriate age at vaccine administration and wrong vaccine administered.
stabbing headache on the upper left side that was like a migraine; Chills; Fever; Coughing straining or bending; This is a spontaneous report from a contactable consumer (patient himself). A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration in left arm on an unspecified date at 11:15 (at the age 30-year-old) as a single dose to prevent COVID/ COVID-19 immunization. The patient's medical history and concomitant medications were none. Family history included mother also experienced fever. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration in left arm on 23Apr2021 (at the age of 30-year-old) as a single dose for COVID-19 immunization. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administered on same date of the Pfizer suspect was none. It was reported that, caller was reporting additional adverse events after getting the second dose of the COVID-19 vaccine on Friday. He had chills the following day on 15May2021. He had to wait 15 minutes after getting the vaccine. He had fever on 15May2021. He took one dose of 500mg Tylenol and felt ok. He had a stabbing headache on the upper left side that was like a migraine on 16May2021. It worsened with coughing straining or bending on an unspecified date in 2021. He was fine when he was relaxed. The headache was still ongoing. The headache started on Sunday. Should he be worried or not. Was there anything additional that he could take or not. Questioned he received the second dose of the vaccine on Friday or not. Was it worth it to call the state health department or not. He had a fever the same date as chills. The fever was a slower onset. No investigation assessment. No relevant tests. The adverse events did not require a visit to emergency room and physician office. The patient was treated with Tylenol 500mg for the events fever and chills. The outcome of the event headache was not recovered, recovered on an unspecified date in 2021 for the event cough and recovered on 15May2021 for the other events.  Description of product complaint: He had a stabbing headache on the upper left side that was like a migraine. He took one dose of 500mg Tylenol and felt ok. It worsened with coughing straining or bending. He was fine when he was relaxed. The headache was still ongoing. Product strength and count size dispensed: Tylenol 500mg.   Follow-up attempts are needed. Further information is expected.
Knot in arm at injection site; Achy feeling joints; Arm was really sore; Hasn't had an appetite all day; Chills; Feels like I have the flu; metallicy taste in mouth; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Apr2021 at 14:00 (Lot number: EW0150, Expiry date: 31Jul2021) on the left arm as single dose for COVID-19 immunization. Medical history included ongoing hypertrophic cardiomyopathy that diagnosed probably 8 years ago. Family history included mother and father are diabetic. There was no concomitant medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 at 15:30 (Lot number: ER2613; Expiry date: 31Jul2021) on the left arm as single dose for COVID-19 immunization, that experienced a sore arm. There were no additional administered vaccines, no prior vaccinations within 4 weeks. Patient experienced a really metallicy taste in his mouth about 10 to 15 minutes after he received the Covid-19 vaccine. On 14Apr2021, the patient reported that he had a knot on his arm at the injection site. He had experiencing an achy feeling joints following the Covid-19 vaccine. His arm was really sore this morning, 14Apr2021, he can't lift his arm up past shoulder height without it hurting, and that when he went to rub his arm to massage the soreness out, he felt the knot in his arm. Patient also hasn't had an appetite all day long, he would think about eating something and it didn't sound good. Patient reported it was very unusual for him not to have an appetite, that he normally loves to eat. On 14Apr2021, patient was experiencing the chills off and on, he also felt like he had the flu. When queried for product details, patient reported that he was going to put his cheat glasses on, that the writing on his vaccine card was like micro writing. No events required a visit to emergency room or physician office. The outcome of events "Knot in arm at injection site", "Achy feeling joints", "Feels like I have the flu" was not recovered, while the other events was unknown.  No follow-up attempts are needed. No further information is expected.