chrisvoncsefalvay/vaers-outcomes huggingface dataset:
16 y/o male healthy p/w 5 days fever (Temp max 104), +nausea (no vomiting/diarrhea); + nasal congestion/rhinorrhea; +dizziness/fatigue, +intermittent chest pain, sx started the day after getting the 2nd Pfizer COVID vaccine; traveled in June; no known history of COVID infection/prior hospitalization; no known sick contacts.
I received the Pfizer vaccine 27Mar2021 and started to experience intense symptoms and trouble breathing later that night; Dose Number:1-13MAR2021/Dose Number:2-27MAR2021; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). An 18-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 at 12:00 PM (at the age of 18-year-old), as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no covid prior vaccination. The patient other medical history included asthma. The patient had known allergies to seafood. Concomitant medication(s) included Diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Left arm on 13Mar2021at 12:00 PM, as single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Mar2021 at 12:00AM, the patient experienced trouble breathing. It was reported that patient received the Pfizer vaccine 27Mar2021 at 12.00PM and started to experience intense symptoms and trouble breathing later that night 27Mar2021 at 12:00 AM. The event did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. No treatment was received to treat the event. Since the vaccination, the patient had not been tested for COVID-19. The case reported as non-serious. The patient outcome of the event was Not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Injection site redness/swelling; home care advice provided, will follow up tomorrow for clinic visit if not improving
Patient developed a red rash at the site of injection within 12 hours. Rash was itchy, raised and 2.5 inches wide. Rash went away after 48 hours. Patient did not apply topicals or take medication. This was the first time patient had a reaction to the flu shot.
Given Influenza Virus Vaccine Afluria 2012-2013 Formula by pharmacist at approximately 6:30 PM. Within two minutes she started reacting and had to go to the emergency room. Here were the symptoms she experienced: First her vision got blurred She felt like she was not as coherent and was going to faint Turned white as a ghost, hands became extremely cold like they had been in the freezer Started trembling really badly all over Started wheezing Bad headache She was really out of it  We called 911. The paramedics came and said she was just having a panic attack and insinuated we were wasting their resources. They were wrong as my daughter does not react to shots at all nor has she ever had a panic attack. We personally drove her to the emergency room close by, since we didn't want to "tie up resources". Our daughter was diagnosed with having an adverse reaction to an ingredient in the vaccination. After about one hour at the ER (we lost track of time), slowly she started trembling less and the warmth came back into her hands. The color returned in her face. Her vision came back. She was left with a bad headache and fogginess in her head.   The er doctor suggested we go back to Rite Aid and get a list of the ingredients to give to our primary physician. She suggested it could be the preservative in the vaccination. Doctor sent us home after some observation time and when she started to return back to normal. Gave us the option of them hydrating her through I.V. or we hydrate her. Since we have medical insurance with a $10K deductible, we decided on the latter.   Today she just had a slight headache but overall was fine.
No adverse effects reported; a patient received an improperly stored dose of PEDVAX; This spontaneous report was received from a medical assistant referring to an 8 weeks old female patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 03-OCT-2019, the patient received an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # R036177, expiration date was 08-OCT-2021) (exact dose and route of administration were not reported) for prophylaxis(product storage error). The administered dose was stored under the temperature of 46.5 degree Fahrenheit for 5 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA006415: US-009507513-1910USA006584: US-009507513-1910USA006414: US-009507513-1910USA006576:
Swelling under the left arm (Injection given in left arm) about the size of a quarter.  Was sore 12 hours later.
Injection site reddened  that extended to the elbow; Injection site reddened; injection site burning; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 06Apr2021 at 18:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa, iodine and alcohol allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEK) from unknown date for unspecified indication and unknown if ongoing. 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 06Apr2021 at 18:45, the patient experienced injection site reddened that extended to the elbow and injection site burning. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with 50 mg benadryl (MANUFACTURER UNKNOWN). The clinical outcome of events injection site reddened that extended to the elbow and injection site burning was resolved on an unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
Seen in Urgent Care for swelling, redness, pain, warmth at injection site. Treated with AUGMENTIN for cellulitis.
Pt recvd a dose of Engerix-B 5OCT91 & on 11OCT91 pt exp rash on trunk; rash resolved p/24 hrs; also exp swollen eyelids;
VACCINE WAS GIVEN IN THE 4 MONTH INSTEAD OF THE 5TH MONTH
coronavirus booster; soreness; cough; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Xeljanz xr, start date: 27Jul2021, stop date: 2021, for Rheumatoid Arthritis, notes: oral, Strength: 11MG, dose: 11mg, daily. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "coronavirus booster"; PAIN (medically significant), outcome "unknown", described as "soreness"; COUGH (medically significant), outcome "unknown", described as "cough". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
12FEB99 influenza A per throat cult, cough, nasal drainage, inc temp;flu dx;
Intense body aches; headache; muscle pain; arm pain; tiredness; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2023 as dose 6 (booster), single (Lot number: HH7595) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceclor, reaction(s): "Allergy: Ceclor"; Lisinopril, reaction(s): "Allergy: Lisinopril"; Topamax, reaction(s): "Allergy: Topamax". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "Intense body aches"; PAIN IN EXTREMITY (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "arm pain"; HEADACHE (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023); ARTHRALGIA (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "joint pain"; MYALGIA (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "muscle pain"; FATIGUE (non-serious) with onset 16Sep2023, outcome "recovered" (17Sep2023), described as "tiredness". Therapeutic measures were not taken as a result of pain, headache, myalgia, pain in extremity, fatigue, arthralgia.  Additional information: Patient did not received other vaccine in four weeks. Patient had received other medications in two weeks. The patient experienced intense body aches, headache, muscle pain, arm pain, tiredness, joint pain for two days. Patient had no covid prior vaccination and not tested covid post vaccination.
improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T006346, expiration date 20-FEB-2022 (dose, route and frequency were not reported) for prophylaxis.  The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
they missed their 2nd shot of vaccine on 3/30/2021 along with his; I don't feel well; Wheezing; I feel warm but I don't know the temperature according to my thermometer and I don't feel well; Coughing; This is a spontaneous report from a contactable consumer (patient) reporting himself. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date patient stated, "I think I am having some kind of side effect and for like wheezing like and coughing and I feel warm, but I don't know the temperature according to my thermometer and I don't feel well, I had the shot (COVID 19 Vaccine by Pfizer) on Friday and each day its worse and worse. Upon follow-up on 08Apr2021, it was reported that, called to advise they missed their 2nd shot of vaccine on 30Mar2021 along with his wife and his wife received the 1st shot on 9Mar2021. However, his wife was hospitalized due to kidney infection from March 24th to March 26th and they were in the hospital the whole week, mentioned that his wife was already out of the hospital and he is trying to figure out where to get their 2nd shot of covid vaccine since they've missed it. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Noticed a rash developing on my chest which was itching. Rash spread fast over my chest and back.
Four days after receiving these three vaccines patient started to experience diarrhea every day with an accompanying headache behind his eyes.  On the seventh day he vomited once. He has continued to have diarrhea currently three weeks and two days after the injections. He reported that his headache went away yesterday, although it was unresponsive to increased hydration and over the counter pain relievers during the last three weeks. He has an appointment scheduled to see his primary care Dr on October 23rd
Fever night of vaccine (3/21/23). Developed warmth and redness on left arm on  3/25/23 with body ache and chills. Pain shooting from neck, burning feeling inside shoulder joint, with lymphadenopathy.
Could not lift or control her head; could not focus her eyes and baby was very floppy. Diagnosed with developmental delay and genetic disorder. Follow up report received 10/29/02 states, " Mother report that her daughter is mentally retarded as a result of vaccine". The annual follow up received on 9/3/03 states pt is profoundly mentally retarded and requires 24 hrs assistance.
Patient received vaccine on 9/27. On 9/28, she noticed a rash around the injection site. By the evening of 9/29, she had developed rash on both arms and both legs. By 9/30, rash has also appeared on her abdomen.
Mild swelling in throat, shortness of breath,  then hives on trunk and arms. The hives and throat swelling improved with benadryl and allegra. She also had redness and swelling around the injection site 4inches by 3 inches.
vaginal infection; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL INFECTION (vaginal infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VAGINAL INFECTION (vaginal infection). At the time of the report, VAGINAL INFECTION (vaginal infection) outcome was unknown.            Patient was taking an antibiotic for a vaginal infection that she mentioed started prior to her first dose of the vaccine.
Vertigo intermittently for 3  weeks after first booster. A few says after the second booster.
Diagnosed with COVID 19 virus after 1st dose of Moderna COVID 19vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID 19 virus after 1st dose of Moderna COVID 19vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced COVID-19 (Diagnosed with COVID 19 virus after 1st dose of Moderna COVID 19vaccine). At the time of the report, COVID-19 (Diagnosed with COVID 19 virus after 1st dose of Moderna COVID 19vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Fatigue, joint pain, muscle pain, fever, headache, cough, sore throat, diarrhea
I called my OB office because i was bleeding when I wiped. I experienced the same bleeding with my first pregnancy. I went the following day in the morning to see my doctor. I was six weeks and six days far along with my pregnancy at that point. They did a vaginal ultrasound. The baby's heartbeat was 129 bpm. They said everything was fine. I went back a week later and there was no heart beat. I had a miscarriage. I didn't experience anything in between to think that something was wrong. Before I had left the first initial appointment I got the RhoGAM shot before I left the doctor's office. When I went in the following week on December 8th my OB scheduled a D&C on Deceomber9th.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 10:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 10:33 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially moved to the fridge on 08-Jan-2021 and proposed beyond use date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Severe chills for approximately 1 hour overnight. Fatigue during the next day followed by approximately 30 minutes of chills the second evening, No symptoms afterwards.
L upper arm with an area of erythema surrounding the vaccine entry point, about 4" X 5 " in size, mild induration noticed today- 1/25/08. Child c/o itching. Benadryl PO prn itching. Cold packs locally.
Very intense burning in both eyes; This is a spontaneous report from a contactable consumer. A 89-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 18Feb2021 11:45 (at the age of 89-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included known allergies to opioids and metal/jewelry from an unknown date and unknown if ongoing. Concomitant medication included sertraline, ascorbic acid/betacarotene/cupric oxide/tocopheryl acetate/zinc oxide (PRESERVISION), macrogol 400/propylene glycol (SYSTANE), tacrolimus and latanoprost all drugs were taken for an unspecified indication, start and stop date were not reported. The patient experienced very intense burning in both eyes on 18Feb2021 13:00. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Treatment included cold compress and Advil for the event. Outcome of the event was recovering.   Information about the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On unknown dates the patients were vaccinated with improperly stored doses (number of doses unspecified) of VAQTA (dose and route not reported, lot # L023936 with expiration date 15-MAR-2017). The reporter mentioned that the vaccines were stored at 52.2F for 2 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
One half hour after administration had soreness in L arm that gradually moved to the L neck. Subsequently with decreased range of motion in both the arm and the neck with 7/10 pain.
Started having chills and feeling feverish around 10am.  By lunchtime, I was feeling nauseous as well.  Spent afternoon and evening with chills, feeling fatigued and nauseous.  Nausea went away by bed time but still fatigued and chilled.  Never did spike a fever.  The next morning when I got up, I felt fine.