chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, swelling, warmth and severe itch on injection site; Redness, swelling, warmth and severe itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and severe itch on injection site; This spontaneous case was received on 22-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04125) and concerned a 10-years-old, female patient.  The patient's current condition included pollen allergy. The patient's historical vaccines included two previous Flucelvax QIV vaccines in 2019 and 2018, with the same reaction of redness, swelling, warmth and severe itch on injection site. The patient was not taking any concomitant medications.   On 15-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283847 and expiry date 30-Jun-2021.   On the same day, after vaccination with Flucelvax QIV, the patient experienced redness, swelling, warmth, and severe itch on injection site.   On 16-Oct-2020, the patient took ibuprofen as a treatment medication.   On 18-Oct-2020, the patient recovered from all the events.   The reporter did not provide causality assessment but reported this was third year in a row with the same reaction, same product (FLV QIV).  The reporter assessed the case as non-serious.  This case is linked with cases 202005407, 202005408 (the same patient) and 202005414, 202005411 (the same reporter).  Company comment: A 10-years-old, female patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient experienced vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pruritus. Causal role of the suspect vaccine is assessed as possibly related for all events.; Reporter's Comments: Third year in a row with the same reaction, same product (FLV QIV).; Sender's Comments: A 10-years-old, female patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient experienced vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pruritus. Causal role of the suspect vaccine is assessed as possibly related for all events.
she had covid after the 2 doses and before the booster dose; she had covid after the 2 doses and before the booster dose; hot in the area; redness from flu shout and covid; burring eyes; She was sick in June and July; intermittent pressure at the back of the head; stuffiness; weakness; fever; nausea; could not taste anything; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient herself).  A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 07Apr2021 as dose 2, single for COVID-19 immunization. Patient medical history included autoimmune disease but no transplant. The concomitant medications were not reported. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 17Mar2021 as dose 1, single for COVID-19 immunization. The patient experienced covid after the 2 doses (4 weeks later) and before the booster dose, weakness, fever, stuffiness (with different food something her heard gets like this), intermittent pressure at the back of the head, headache, nausea, burring eyes, she was sick in June and July, could not taste anything, redness from flu shout and covid, hot in the area (full blown symptoms like when she received the shots) on an unspecified date in 2021. The patient underwent lab tests and procedures which included body temperature: 97 on an unspecified date, blood immunoglobulin g: positive on 09Sep2021, Quantitative test (investigation): 459.1 on 07Oct2021 (and 11Oct2021 result value 459.1- antibodies were detected) and antibody test: unknown, sars-cov-2 test (covid): positive result, serology test: 400 (in the last 3 to 6months) on 11Oct2021. she will be seeing her rheumatology. Patient was also interested in plasma donation. she did not specifically ask for the lab test that was ordered but is now wishing to have a better understanding of the lab results. She wanted to know if that meant she potentially had a breakthrough case, like her friend's parents and friend's husband. She reported she attempted to reach Lab, but they are not answer; her primary doctor is out for the weekend. She wanted to know if taking booster too soon could have caused the symptoms as she did test positive to covid after the 2 doses. The patient was administered with booster received on 26Oct2021 at 13:30. She wanted to know should she even gotten the booster dose since she had covid and with high antibodies. The clinical outcome of events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Tongue fluttering for 24 hrs. Temp up to 103F. Spontaneously recovered.
This is an initial spontaneous report by a contactable physician via Pfizer sales representative. A 6-month-old patient received PREVNAR 13 unknown dose unknown frequency at an unknown time at an unknown site of administration on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day included unspecified Flu vaccine. Vaccines taken within the last four weeks were unknown. On an unknown date while on PREVNAR 13 unknown dose unknown frequency patient experienced seizures. It was unknown if the patient had any siblings. Relevant lab data was unknown. At the time of the report, the clinical outcome of the above mentioned event was unknown.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA267265, 2018SA267274, 2018SA267305, 2018SA267294, 2018SA267282, 2018SA267295, 2018SA267293, 2018SA267253 and 2018SA267283 same reporter. This case involves a 57 years old female patient who received a 0.5ml dose of suspect vaccine FLUZONE QUADRIVALENT, lot UI815AA, expiry date 30-Jun-2018 via intramuscular route in the left deltoid on 17-Sep-2018. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. It was an actual medication error due to expired vaccine used. It was reported that patient was administered FLUZONE QUADRIVALENT vaccine on 17-Sep-2018, which was expired on 30-Jun-2018. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender - none.
A 58 year old female received an injection of influenza virus vaccine in 10/76. One year, post vax, she developed hypersensitivity to the following; sulfa products, penicillin, Floxin, Cipro, codeine, clindamycin, Macrobid, generic Klonopin, blue dye, red dye #40, yellow dye FC #5 and #6, eggs, beef, bacitracin, proparacaine, lidocaine, Tobrex, fluoracaine, Acular, Ocuflox, Vexol and chlorine in the drinking water. Her hypersensitivity symptoms include: nausea and diarrhea. FOLLOW-UP information received fromthe patient on 08/27/01, indicated that she also developed a hypersensitivity to Bactorban and band-aids glue. FOLLOW-UP informationreceived from the patient on 05/09/02 indicated that her symptoms have not related.
Pt stated that she started with little dots of rash on the 19th and it developed into a full itchy rash across the whole upper front of her body. she has allergy to coffee but seems unrelated.
The night of the Pneumonia injection, his right arm got very sore, red, hot to the touch, he said that the redness lasted for a couple days, patient showed up in our office on 12/10/18 to report the reaction to us. The redness had gone down and our provider did look at his arm, no antibiotic was needed at that time. We advised the patient to call the office if the symptoms started to worsen.
Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: I was observing the patient after about 5 minutes he said his vision was blurred he felt hot and looked pale so got the epipen and had the tech call 911 while I returned to the patient. He said "Oh I don't need that" so I did not administer it. Shortly thereafter EMT arrived and took over examing PT
Starting at midnight I experienced fatigue, chills, muscle aches, joint looseness, joint aches and pain - allover, headache, pain at injection site, low grade fever, nausea, gaseousness   Starting about 6 am 4/20/22 my lymph nodes one both sides were swollen, tender and sore Majority of symptoms went away about 36 hours after onset
The patient received Influenza vaccine. Indicated no prior history of fainting or getting dizzy with shots. Also didn't claim any medical conditions. The pt lost consciousness for seconds after shot. He awoke and said he had not eaten. Ambulance came and vitals were ok. Pt had somebody pick him up to take him home.
Approximately a week after vaccine administration a rash developed on torso. Then on April 12, 2021 after working throughout the morning sitting in front of my computer, I took a lunch break.  While preparing a meal, I felt discomfort in the left eye and it became very uncomfortable. When I checked in the mirror, I discovered my left eye was filling with blood.  Upon seeing an eye doctor that same afternoon, the doctor explained that my left eye had ruptrued a large vessel and hemmoraged. However, the reason for the hemmorage could not determined because I was not under stress, had not lifted anything heavy, was not on blood thinner medication, was not constipated and have no underlying health condition.
Missed second COVID-19 dose/ Second dose more than 42 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second COVID-19 dose/ Second dose more than 42 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second COVID-19 dose/ Second dose more than 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second COVID-19 dose/ Second dose more than 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.   Reporter did not allow further contact
Information has been received from a physician concerning a 6 year old patient who on 4/7/99 was vaccinated with a dose of varicella virus vaccine live. On 11/3/03, the patient experienced a case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought, but there was no treatment and no hospitalization. The patient recovered. No product quality complaint was involved. This is one patient out of 40 reported. Thirty nine other cases (WAES0407USA01446 and 0409USA01855 through 0409USA01883 and 0409USA01885 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
back pain; This is a spontaneous case received from a non-contactable consumer (patient himself). A 61-year-old male patient the patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. It was unknown whether the patient received any other product together with the vaccine. The patient complained of back pain when bending down. The patient was able to walk but when he bends down and get back up his back hurts. On an unknown date, the patient experienced back pain. It was unknown whether the patient was admitted to the hospital or received any treatment due to event. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The day after the vaccines his leg began to swell, and eventually became hugely swollen from his knee to his hip. It was also bright red and hot to the touch. He was given a shot of antibiotics and shot of Benadryl. He was released by doctor who gave me a prescription of Benadryl to administer every 3 hrs. Also, a week later he developed chicken pox and spread them to his brother.
Started off as bump at site of injection. Progressively got worse as the week went on and now is hot, red, with a 6 inch diameter and a bruise raised skin in the middle.  Father has had similar reactions to vaccines yet we are required to get these to go to school.  She is on a catch up plan as we chose not to vaccinate the first 4 years.  This could be an accumulation allergic reaction.
30 hours of 102+ fever; Headache; Chills; Nausea; sore arm; Large rash; Pain at injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 20Apr2021 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included birth control for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 15:30, the patient experienced 30 hours of 102+ (unspecified units) fever, headache, chills, nausea and sore arm. The patient also had several days layer large rash and pain at injection site. On the same day, the patient underwent body temperature test and the result was more than 102 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, headache, chills, nausea, sore arm, large rash and pain at injection site was recovered with sequelae on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
INJECTION SITE BECAME SORE ON 1/26/10 THEN THE NEXT DAY A BRUISE.  AFTER BRUISING RESOLVED HAS SOME LOSS OF SKIN PIGMENT WITH 3 LINEAR FORMATIONS, SOME SOB FIRST 2 DAYS AND NO FURTHER SOB AFTER THE 2 DAYS.
Headache, Myalgia, NauseaVomiting, c/o chills,injection site sore. Told to follow up with primary care physician. Narrative:
patient was given an expired vaccine. vaccine expired on 09/07/2021 and it was given 09/17/2021
Shortness of breath, chest pain, dizziness after the slightest of exertion.
arm / thumb and finger next to it / very painful; very painful from about the shoulder down it gets to about the elbow; tingling of her thumb and finger next to it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 19Feb2021 (Lot number: EM9810) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FISH OIL. Vaccination history included: Bnt162b2 (Lot number: EL3247 as dose 1, single), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Feb2021, outcome "unknown", described as "arm / thumb and finger next to it / very painful "; ARTHRALGIA (non-serious) with onset 19Feb2021, outcome "unknown", described as "very painful from about the shoulder down it gets to about the elbow"; PARAESTHESIA (non-serious) with onset 19Feb2021, outcome "unknown", described as "tingling of her thumb and finger next to it". Therapeutic measures were taken as a result of pain in extremity, arthralgia, paraesthesia.  Additional information: The patient was taking unspecified blood pressure medicine. It was further reported that the patient's arm, was very painful from about the shoulder down it gets to about her elbow. Her elbow becomes very sore and then it shoots down her arm. The patient experienced tingling not numb but tingling of her thumb and finger next to it. Only those two fingers, the rest of her hand and other fingers were not affected. This tingling was since 19Feb2021 and it doesn't hurt at all the time but when it does, it would wake her up from sleep and it would be very painful. It will shoot pain down the arm. The patient was using the arm as she normally have but did not see this side effects when reading and talking to other folks, so she just thought maybe it should be documented. Patient took some ibuprofen occasionally but not very often and seeing a chiropractor.  No follow-up attempts are possible. No further information is expected.
- Swollen, painful, stiff neck (lots of pain, can't look down or turn head easily). - Painful, swollen, sore lower back - Symptoms started on 12/1/22, worst days were 12/1/22-12/3/22 but continue still 2.5 weeks later. Per patient, symptoms are slowly getting better as of 12/18/22, but still 2.5 weeks later, pain and swollen neck and back continues. Patient has been managing pain and soreness with iced/heat pack every day.
Skin reaction to ZOSTAVAX inj. 10-1-13. Went to doctor for other issues, doctor prescribed KEFLEX 500 mg (1 TIX x 7D) for skin infection site of ZOSTAVAX injection.
i was curious if other people experienced itching basically everywhere and started between the fingers on both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, No events reported), for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 16Mar2021, outcome "unknown", described as "i was curious if other people experienced itching basically everywhere and started between the fingers on both hands".  Additional information:The transcription analyst had reviewed the transcription quality for the below catalog ID.Transferred to Live Agent was reported as no.Transcription Analysis Attached was the PDF for the reference.No Error Category.  No follow-up attempts are possible. No further information is expected.
Flu-like symptoms with erythema to proximal arm of injection. ZYRTEC 10mg daily.
Tested positive for flu; This is spontaneous case initially reported by consumer to Agency (reference number: SEQ19-05457) on 23-Oct-2019, concerning 31-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On 10-Oct-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine; batch number: P100110975; expiration date: 28-May-2020; dose: 0,5 ml; route of administration: intramuscular; anatomical location: deltoid] as influenza prophylaxis.  On an unspecified date in October the patient developed coughing, drainage, body aches, fever and chills. The patient advised she hurt all over.  On 23-Oct-2019, the patient went to physician and tested positive for flu.  On 27-Oct-2019, the patient recovered completely from the event flu.  The case was assessed as serious.  The reporter did not provide causality assessment.  Follow-up reported by other non-health professional to Agency [reference number: SEQ19-06012] on 01-Nov-2019: The event Flu was updated (stop date added; outcome changed from unknown to recovered). Additional Agency reference number added. Narrative amended accordingly.  Company Comment: The patient experienced influenza 13 days after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as related.; Sender's Comments: The patient experienced influenza 13 days after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as related.
11th in the evening, I suddenly had gastric pain in Stomach and was belching a lot. Then it started hurting with a lot of chest pain. The pain started going behind my back and pressure and we went to ER and when I went to take my urine test and I threw up a lot. I felt pretty good after that. My reports from tests came back okay. They told me to take over the counter Prilosec and gave a prescription for Zofran.
2 expired moderna doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 expired moderna doses administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0171F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 expired moderna doses administered). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (2 expired moderna doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. The vial was initially stored in the refrigerator on 08-Dec-2021. On 10-Dec-2021, the vial was first punctured and after dose administration, the vial was put back on the refrigerator. The vial was exposed to the room temperature range of 8 degree to 25 degree Celsius , not more than 20 to 30 minutes.
Nasal congestion, sore throat, fever of 101 degrees F.  Following day developed small papules on face, neck and trunk.  Also associated with cervical adenopathy.
An asymptomatic human immunodeficiency virus positive pt exp urticaria 3 days p/immun; No other details are available;
Felt fine for first 12 hours.  Went to bed.  Woke up at 3am with chills and headache.  Couldn't sleep.  Got up at 5:30am.  Fatigued.  Went back to sleep until 9am.  Feeling better.  Lingering headache.