chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Really sick from the second and booster.Even sicker from the booster; She had 102 fever, chills, aches, and nausea.; She had 102 fever, chills, aches, and nausea.; She had 102 fever, chills, aches, and nausea.; She had 102 fever, chills, aches, and nausea.; She ended up having a problem because the lymph node was swollen (on the same side that she got the vaccine).; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Really sick from the second and booster.Even sicker from the booster), PAIN (She had 102 fever, chills, aches, and nausea.), PYREXIA (She had 102 fever, chills, aches, and nausea.), CHILLS (She had 102 fever, chills, aches, and nausea.) and NAUSEA (She had 102 fever, chills, aches, and nausea.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Flu vaccine. Past adverse reactions to the above products included Adverse drug reaction with Flu vaccine.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Really sick from the second and booster.Even sicker from the booster), PAIN (She had 102 fever, chills, aches, and nausea.), PYREXIA (She had 102 fever, chills, aches, and nausea.), CHILLS (She had 102 fever, chills, aches, and nausea.), NAUSEA (She had 102 fever, chills, aches, and nausea.) and VACCINATION SITE LYMPHADENOPATHY (She ended up having a problem because the lymph node was swollen (on the same side that she got the vaccine).). At the time of the report, ILLNESS (Really sick from the second and booster.Even sicker from the booster), PAIN (She had 102 fever, chills, aches, and nausea.), PYREXIA (She had 102 fever, chills, aches, and nausea.), CHILLS (She had 102 fever, chills, aches, and nausea.), NAUSEA (She had 102 fever, chills, aches, and nausea.) and VACCINATION SITE LYMPHADENOPATHY (She ended up having a problem because the lymph node was swollen (on the same side that she got the vaccine).) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 fever (High) 102 fever. On an unknown date, Mammogram: the lymph node was swollen Ended up having a problem because the lymph node was swollen (on the same side that she got the vaccine)..         It was reported that previously patient had received flu and pneumonia vaccine and got the similar events. Patient had never tested for Covid-19. No concomitant medication information was provided. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The patient states she powered through her symptoms. She didn't take any medications.   This case was linked to MOD-2022-585442 (Patient Link).
Patient calling with report of weakness, pain and knot in arm which he received TDAP developed within 24 hours.
Developed flat red rash at injection site right arm. Also has pain, warm to touch at injection site. Fever, lethargy.
Patient received a dose of IPOL that was no longer viable due to a temperature excursion with no reported adverse event; Initial information received on 18-Jan-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 8-year-old male patient who received a dose of IPV (VERO) [IPOL] that was no longer viable due to a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 06-Jan-2023, the patient received a 0.5 ml Total dose of suspect IPV (VERO) Suspension for injection (lot: U1A451M) (strength, expiry date: unknown) via unknown route in unknown administration site for immunization.  On 06-Jan-2023 the patient had a non-serious event of patient received a dose of ipol that was no longer viable due to a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: Unknown.    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.
Covid arm - swelling, redness, rash/itching, as well as hot to the touch, extremely painful
Left arm pain radiating from behind should/back, along underside of arm, at times tingling in forearm
Body aches, chills, nausea, vomiting, lip swelling, shortness of breath, throat swelling.
Initial unsolicited report received from a Pharmacist on 30 September 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose, site and route of administration were not reported) on an unknown date. Patient was allergic to eggs and concomitant medications were not reported. On an unspecified date in 1978, following the vaccination, the patient had a reaction to the flu vaccine. Lab data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Obstructive Sleep Apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydrochlorothiazide, reaction(s): "Known allergies: hydrochlorothiazide", notes: Known allergies: hydrochlorothiazide. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected..; Sender's Comments: Based on available information, a possible contributory role of the subject products  cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   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.
Hands hurting and itching severely, like a burning, deep itch that could not be scratched and not helped with lotion. Also, skin on tips of fingers were wrinkly like I soaked in a tub, but I didn't. Hands also burning, tingling especially fingers. I have never felt such a thing before.
Patient is a 7-year-old male who presents with his mother for evaluation of a fever. The patient went to his PMD's office for a routine checkup around 10 AM and received a flu shot. He returned to school and his grandma picked him up around 2:30 PM. His mom received a call around 3 PM that the patient was shaking, pale, and could not open his eyes. The patient's grandma found his temperature to be 40.5 C. At the time, the patient was complaining of right sided leg, arm, and abdominal pain. He denies nausea. Currently he denies leg or arm pain and is only complaining of abdominal pain. The patient is febrile in the ED.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant  and treatment were reported.     On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant  and treatment were reported.
This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of VAQTA, (dose, route, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
ER- TWO VISITS- 4/10/2021 4/12/2021. I've seen a couple doctors to get follow ups and get stronger allergy medications, I can't recall how many I have seen. I had a rash, difficulty breathing, dizziness, chills, shaking, fast heart rate, throat swelling, extremely fatigue. Still having breathing problems, still getting hives, started allegra and I take it daily, I also have to use my inhaler almost daily, I have never had asthmatic symptoms before this.
Boostrix administered instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Previously administered products included Dtap (On an unknown date the patient received 3 doses of Dtap.).   On 17th October 2022, the patient received Boostrix. On 17th October 2022, unknown after receiving Boostrix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: The reporter stated that Boostrix was given instead of Infanrix on 17th October 2022. The reporter also mentioned the Patient had previously had 3 doses of Dtap.  The reporter gave consent to follow up. Additional Supportive Information: The patient had boostrix instead of Infanrix which leads to wrong vaccine administration.
only DTaP-IPV portion of Pentacel was inadvertently administered to twin male patients on 04Jun2019/no AE; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that only Dtap-IPV portion of Pentacel was inadvertently administered to twin male patients on 04jun2019/no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  On 04-Jun-2019, the patient received 1st dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ104AA and expiry date: 13-Oct-2020 via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  No adverse event was reported.  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 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.
Pt was administered HPV, MENACTRA vaccine in right deltoid 6/19/13. Seen 6/20/13 for swelling in arm about 4-5 cm big. Dr then gave 15 mLs of MOTRIN by mouth due to pain.
Pt recv vax on 1/25/99; on same day pt exp hives w/ itching
Patient arm began swelling/inflammation rapidly before injecting a fraction of the vaccine. I withdrew syringe before injecting more and observed rash spreading approximately 2 cm. I quickly gave her 2 BENADRYL 25mg and water. She reported no SOB or palpitations, etc or spreading of rash after 20 minutes, so I refunded her and let her go home.
In 1/98, the pt developed varicella and sought unspecified medical attention. No further information is available.
5:45pm I recieved the shot in my left arm. A few hours afterward left arm was sore. Next morning, 10/8, I woke up around 7am and my whole body was sore. Went to bed that night and could not get warm, especially feet. Woke up next morning, 10/9, nauseous,  extremely weak, headache especially behind my eyes, and sore all over.
She received 4 shots at 4:30 on Tuesday 7/9/02 in the afternoon: DTaP, Hib, IPV, and PCV.  Within 3 hours of the vaccinations, she became very limp, pale and non-responsive.  She began crying in a very high pitched manor that came and went as she slipped in and out of sleep.  She never did fully wake and open her eyes during this time.  This lasted for three to four hours.  At approx 11 pm that evening, about six hours after the shot, her body, head and arms began trembling.  This shaking episode may have lasted 15-30 minutes.  I don't recall exactly.  She felt cold, clamy, yet feverish, but I never took her temperature.  Following this episode, she fell back to sleep.  The remainder of the night she slept very restlessly, and woke frequently.  The shaking, limp, and crying symptoms had subsided by midnight that evening, but she remained fussy for the rest of the week.
Patient received the shot around 3:30 PM on Oct. 01, 2010. Later that same evening, around 9:00 P.M., I noticed he was slightly warmer than ususal. He fell asleep on my lap around 10:00 PM. He woke up at usual time on Saturday Oct. 2nd, but was fairly lethargic, not his usual self, and warm. Around 3:00 PM, he was just burning up with a fever and laying around, so we gave him a fever reducer. He remained run-down and lethargic all evening, complaining that his head hurt, and he received another dose of fever reducer before his bed time (around 9:30 PM). He was burning up in his sleep when we checked on him. He woke up around 3:45 AM on Sunday morning and had diarrhea. Around 4 AM, 30 minutes later, he tried to climb into bed, but fell down and had a febrile seizure. He had slight vomiting and a lot of diarrhea after his seizure. The ambulance was called, and he was transported to Hospital.
PATIENT WAS GIVEN HIGH DOSE FLU SHOT INSTEAD OF NORMAL DOSE FLU SHOT. NOT ADVERSE REACTION.
4x5 inch erythematous area with warmth, swelling on left deltoid arm
I woke up after midnight I felt very nausea, I did not vomit but I felt very sick,  I was very weak and fell down and hit my face on the toilet, I was also having chills and hot flashes, had a tingling sensation on the pinkie side of my hands and up the forearms on both sides.  I was so weak after I fell that I could not hold the wash cloth that my husband was trying to give me.  I finally staggered back to the bed and went to sleep but was better after about an hour or so. When I spoke to my Dr. she said it may have been VasoVagal Reaction. I am not sure if it this was vaccine related because it was two to three days after my shot.
Fever; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A non-pregnant 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the left arm on 31Mar2021 09:00 (Lot Number: ER8733) (at the age of 26 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history included known allergies: Citrus foods. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. Concomitant medications included phentermine (PHENTERMINE) taken for an unspecified indication. The patient previously received BNT162B2, administered on the left arm on 10Mar2021 08:30 (Lot number: EN6206) (at the age of 26 years old) as dose 1, single for COVID-19 immunisation and experienced soreness at injection site. On 31Mar2021 at 13:00, 4 hours after the vaccination, the patient experienced soreness at injection site, and at 23:00, 14 hours after the vaccination, the patient experienced fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. Therapeutic measures were taken as a result of the events soreness at injection site and fever which included paracetamol (TYLENOL) and ascorbic acid (VITAMIN C). The patient recovered from the events on unspecified dates in 2021.  No follow-up attempts are possible. No further information is expected.
HEADACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's past medical history included allergy to morphine, and concurrent conditions included acute migraines. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: sumatriptan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Headache itchy upper lip. BPs 208/87 (pulse 78), 174/66. 98% O2 sat.
have the flu; Initial information received on 25-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who had the flu after receiving vaccine Influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 05-Oct-2022, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, expiry date, strength, form and dose not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient have the flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Immediate reaction after flu vaccination 2 cm round area of erythema. Tx with BENADRYL 50 mg PO & ice 1 hour later c/o chest tightness & resp distress neb with XOPONEX 0.63 mg kept for 6 hour of observation. All sx resolved.
On 0/02/2021 I had fever, headaches, dizziness , body ache, nausea and fatigue.  Next day 04/03/2021  fever was control but,  fatigue,  headaches  and nausea continue and getting worse. 04/04/2021 around 2:20 pm I had a severe headache follow with nausea and vomit then after dizziness and nausea continue for few hours around 10 pm another severe headache, dizziness and nausea continue. I was taken to emergency room because my head feel like was going to blow and I lost my balance. I had a ct scan, blood test and no abnormalities was found. is been a week and fatigue, dizziness and nausea continue.
Chills, fever, body aches, muscle aches, flu like symptoms, loss of apatite, extreme discomfort lasting ~ 2 days
Swelling of left upper arm 16cm X 14cm with redness, tenderness.  Systemic fever.  Gave ibuprofen, Benadryl and ice.
Patient presented to the ED with fatigue, nasal congestion, and chills. Patient was treated and discharged on 5/4/23.
Patient felt tingling in the arm after administration & informed vaccinator that he felt like he was going to pass out. He started to lose consciousness shortly after & EMS was called to clear before he was allowed to leave. Patient was out for only a couple of seconds before regaining consciousness. He remembered feeling dizzy & like he was falling during the episode.
So the area around where I had my vaccine shot was red itchy, and swollen, but then it started to itch really bad by Nov 1, and then it started to have like a rash around it.  Sent a message to the system of doctors on Nov 3 and they responded that it was a local reaction to the vaccine and to continue the use of the hydrocortizone, and ice every 15 min, and to also look for an infection called celluitus that could happen but it did not in my case.
Severe pain in legs, muscle loss and nerve damage in both legs. Guillain Barre syndrome, pathology results show presence of CIDP. Severe pain lasted 3-4 weeks.  Treated with IVIG and intravenous steroids.