chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient felt light headed when she sat down in observation after receiving her Moderna Booster. BP elevated 173/115, continued to be elevated on repeat. HR 92 O2sat 99%. Pt hyperventilating at times, trouble keeping eyes open, slurred speech. EMS called, EMS brought pt to Hospital.  Staff called patient 1/20/22 she reported she is feeling much better, no interventions in ED, they just monitored her and discharged her after 4 hours.
Large Itchy rash below injection site that extended to the elbow. Hot to touch. Lasted approx 5 days.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Date the vial was initially stored in the refrigerator was unknown. The vial didn't undergo any temperature excursions. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant information received.
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent, (intranasal), 0.2 Millilitres. FLUMIST quadrivalent, (intranasal) startedon an unknown date. It was reported that the patient had been given a few doses of FLUMIST this season from the frozen supply. The outcome of the event of GIVING FLUMIST that had been frozen is unknown. The report was considered to be non-serious.
when pt got in the car to leave; told mom felt funny; stated couldn't see or hear, felt nauseated & had urge to deficate; lasted approx 10 min; vision problems;
patient was administered expired ACTHIB with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 15-month-old female patient who was administered expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past vaccination(s) included diphtheria vaccine toxoid,HIB vaccine CONJ (TET TOX), pertussis vaccine acellular 5-component,polio vaccine INACT 3V (MRC 5),tetanus vaccine toxoid (Pentacel) and was given 3 doses of same. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and influenza vaccine INACT SPLIT 4V (Fluzone Quadrivalent) both for Immunisation.  On 02-Nov-2022, the patient received suspect HIB (PRP/T) vaccine at a dose of 0.5 ml (lot UJ585AAA, expiry date: 16-Oct-2022) via intramuscular route in the left thigh for immunization.  On 02-Nov-2022 the patient was administered expired acthib with no reported adverse event (expired product administered, same day latency).  Action taken: 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.
Chest tightness/SOB. BP 143/70, pulse 67, and O2 sat 97%.  Patient sent to the ED.
Pt was admitted to hospital on 4/12 and was negative for COVID on 4/08. The pt developed sinus and nasal congestion along with a sore throat and was found to be COVID positive on 6/3.
Reported site is warm to touch and redness. Redness measured 7.5cm x 4.5 cm.
Severe and persistent joint pain and fatigue.  Severe joint pain started approx. 8 hours after 1st vaccination on 3-27-07.  Joint pain did not subside.  Increased on 4-9-07 at second vaccination.  Third vaccination on 5-26-07 has resulted in persistent and severe joint pain and fatigue that I am still dealing with presently.  Currently dealing with severe joint pain that is not affected with Naproxen, Tramadol, Flexeril, or Vicodin.  Headaches have subsided recently.  Have recorded a fever as high as 101.  Dealing with severe fatigue.
Phone call 07/25/13 from Patient saying at midnight he had a headache and body aches.  Took ibuprofen then.  Woke up dizzy, "almost blacked out" had nausea, vomiting, severe sweats, headache and felt like "needles pricking my body".
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016) and (batch number HM4FY, expiry date 6th December 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Nurse at this time did not have any other information. 10 patients received BOOSTRIX that was exposed to temperature of 30.4F Two Lot Numbers 3P9CL exp 4/15/2016 HM4FY exp 12/6/2016. This case is one of the 10 cases reported by the same reporter for the same vaccine.
Vision blurriness 15 minutes later, subjective throat tightness 3 hours later, gone by next day. no symptoms with second dose.
Patient was administered the Moderna vaccine by nurse. Parent requested the vaccine to be given to her child even though she was a minor and outside of the age guidelines for this vaccine.
Vaccine ran out of the syringe when the plunger was pressed.  Little or none of the vaccine actually got injected. A second vaccine was mixed and immediately administered to the patient.
Swollen lymph node in armpit of injection arm (left arm); booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 09:00 (Lot number: FH830) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 08:00), administration date: 11Mar2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 09:00), administration date: 01Apr2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Dec2021 09:00, outcome "recovering", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 13Dec2021 20:00, outcome "recovering", described as "Swollen lymph node in armpit of injection arm (left arm)". Therapeutic measures were not taken as a result of immunisation, lymphadenopathy.  Additional information: Patient had no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, had not been tested for COVID-19. Device Date : 15Dec2021  No follow-up attempts are possible. No further information is expected.
Vaccine side effects 25 min  - random chest pain/tightness lasting 5 minutes. Similar to panic, but felt calm during the episode. According to fitness Watch, heart rate stayed steady around 65bpm  1hr sore arm. Red mark at injection site. Upper arm swollen and tender, difficulty with mobility. Typical with vaccinations   29 hours. Arm still sore, swollen, red mark, and difficulty with mobility. Sitting in a colder room  skin is cold, but injection site is very warm to the touch (almost fever warm).   36 hours. Arm still swollen/tender. Wider range of motion without pain, but not full range yet. Woke up with chest pain running down right side(5 on the 1-10 pain scale), inner pectoral near the sternum and weaker (3) pain near the appendix. Sat up and felt a similar pain in the left (minus the lower torso pain).  Chest and side pain disappeared within 1.5 hours.   48.45 hrs. Significantly wider range of motion without pain. Still hurts for particular exercise (ex push-up). Still red, swollen, tender at injection site. Chest and side pain are gone, but now feeling pain in right hand. Comes and goes. When it comes, it?s a slow pulsing creating a sharp pain on the left side of the left hand middle finger knuckle. Current pattern falls close to an interval of every 2 hours lasting 10-15 minutes each.   72 hrs. While working out, noticing an increased heart rate higher than usual. Using fitness watch to track heart rate. Prior to vaccine, heart rate would spike to 180 and settle between 160and 175during physical training. Continuing the same exercises with the same intensity, heart rate now spikes as high as 210 and settles between 187 and 198. Reported back to pharmacy (vaccine administrator) these findings and was told to continue monitoring my symptoms.   09/12/21 no longer waking with chest pains. Now the pains come and go at random, but still attack the same. Same location, same duration, same intensity. Only difference is no pain in appendix area, just the chest. No other changes.   09/16/21. Full range of motion in arm without pain. Swelling nearly gone entirely and Injection site no longer red. However, injection area still sore presenting a minor tenderness. Still having random chest pains. This morning 0600 possibly the worst. Duration of 2 minutes. Pain on the right edge of the sternum reaching a 7 on the 1-10 pain scale. Breathing had no effect on the pain heart maintained steady pulse. Weaker pain in the left (5) at the same time.  Other updates, heart rate still elevated higher than normal during physical training.  Hand pains have ceased.
Patient had been very sick with 2nd Moderna dose and concerned about Pfizer booster today. Patient complaints approximately 20 minutes after vaccine of tingling down left arm and heart area. BP 130/93, P 60, RR 16. Patient currently takes Metoprolol ER 50 mg daily for BP. BP somewhat elevated.  He denies wanting any Benedryl for possible mild allergic reaction. After further assessing patient for about 10 minutes reports having a shooting sensation in his chest area and some difficulty breathing and headache. His wife drove him here today. I asked permission for him to contact her via phone and she came in to sit with him. He further explained he was having chest pain and EMS services were initiated. Fire Dept arrived on the scene at 1:11 pm assessed patient BP 160/11 P 66 RR 18 OSat 98%. Ruled out any cardiac involvement or breathing difficulties. Released patient to wife who drove him home.
Immediately after administering FLU MIST intranasally pt had episode of perioral pallor-child stating to mom I feel funny in mouth and ears. Holding ears-very pale. EPI given 0.15 IM-stating feels better in 2 min.-gave BENADRYL 25 mg and ORAPRED. 12/29/2009 PCP records stating patient with c/o's pallor, feeling funny in mouth and ears immediately after vaccine, given epi, benadryl, rx'd orapred, sx resolved.
Fever; Chills; Body aches; Skin pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 12May2021 at 09:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO164) via an unspecified route of administration in the left arm on 20Apr2021 at 07:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 13May2021 at 03:00, the patient experienced fever, chills, body aches, skin pain and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and 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, chills, body aches, skin pain and headache was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
cured from chronic pain; Soreness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (cured from chronic pain) and VACCINATION SITE PAIN (Soreness at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chronic pain, Facial pain, Myalgia and Hip injury. Concomitant products included VITAMINS NOS, CALCIUM, ESCITALOPRAM OXALATE (LEXAPRO), HYDROCODONE and HYDROCODONE BITARTRATE, IBUPROFEN (VICOPROFEN) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 07-Feb-2021, the patient experienced PRE-EXISTING CONDITION IMPROVED (cured from chronic pain). At the time of the report, PRE-EXISTING CONDITION IMPROVED (cured from chronic pain) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Flu-like symptoms started about 8 hours after vaccination and trailed within 24 hours of starting. One week later hives began and continued on and off for 5 days. Advised to use antihistamines prn and was prescribed anti itch cream.
had COVID-19 after getting the vaccines; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (had COVID-19 after getting the vaccines) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had COVID-19 after getting the vaccines). At the time of the report, COVID-19 (had COVID-19 after getting the vaccines) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.   Reporter did not allow further contact
Body aches, fever, chills, lightheaded, difficulty walking, chest pain/tightness, back pain.
Fever 99.8 degrees lasted for a day. Severe headache happens when I'm jet lagged or hold my pee. Earache, ringing of the ear is getting better. Arm ache, sore arm on my right arm. Swollen purple arm last 4 to 6 days after the shot on my right arm. Lymph node.
Pt had large local reaction to immunization on R anterior thigh where PENTACEL was given. Large patch of erythema of 20cm that resolved over several days w/benadryl.
Patient had fever, body aches, lethargy, and rash over the course of a few days.
My friend got Shingles shot and got severe case of shingles / suspected vaccination failure; severe case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient got Shingles shot and got severe case of shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
This spontaneous report was received from a nurse referring to a multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patient was vaccinated with improperly stored GARDASIL 9 (lot # N020139, expiration date 24-FEB-2020; lot # N026812, expiration date 22-JUN-2020; lot # 021475, expiration date 31-JAN-2020; lot # N021572, expiration date 01-MAY-2020; lot # N022583, expiration date 20-JUN-2020), ROTATEQ (lot # N012757, expiration date 27-JAN-2019; lot # N013886, expiration date 19-DEC-2018; lot # 022173, expiration date 15-MAR-2019) and PNEUMOVAX 23 (lot # N023650, expiration date 20-MAY-2019; lot # N024384, expiration date 18-MAY-2019) for prophylaxis. The temperature and time frame was reported as below 32 Fahrenheit (F) (also reported as 29.1 F) for 18 hours. There was no previous temperature excursion. The data logger was involved. No adverse effects reported in any patients.
Headache and dizziness, constant for 3 days. For the next 2 weeks, I had it but it was not constant.
This spontaneous report as received from a registered nurse refers to a patient of unknown age, unknown gender. On 11-MAR-2013 the patient was vaccinated with the third dose of an expired ROTATEQ, oral (lot # 670243/0921AA, expiry date 15-DEC-2012). No adverse effect reported. The outcome was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
BACK PAIN; SHIVERS; SORE LIMBS; JOINTS PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced back pain, shivers, sore limbs, and joints pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the back pain, shivers, sore limbs and joints pain was not reported. This report was non-serious.
Syncope, eyes rolling back, fell down (no injury) low grade temp. 99.0.
Fever, 101-102 Severe body aches Lasted until 03/05/2011 late afternoon Treated with ibuprofen
Blood clots in arm; Arm was sore; A spontaneous report was received from a healthcare professional concerning a 67-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in arm and blood clot in her arm/thrombosis.  The patient's medical history, as provided by the reporter included diabetes. Concomitant medications were not included.  On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of  mRNA-1273 (Lot number: 031M20A) in the left arm for prophylaxis of COVID-19 infection.   On 15 Feb 2021, post vaccination the patient experienced sore arm and her condition got worse. She was then taken to emergency room with blood clots in her arm.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events, sore arm and blood clot in her arm, were not known.; Reporter's Comments: This case concerns a 67-year-old, female patient, who experienced thrombosis and pain in arm. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient's medical history of diabetes is a risk factor. Further information has been requested.
Pt recvd vax & 2 days following vax devel generalized red pruritic rash;
On 11/06/2000 the patient experienced a rash, fever, arm soreness and site burning. The patient had 20 lesions that were noted with draining and crusting of a few. The patient's fever lasted for 5 days. In follow up, the physician reported that "no work-up was done". Additional information has been requested.
Patient received the wrong dose of the COVID 19 vaccine. Patient was given 0.2ml of the vial containing the 0.2ml/10mcg dose instead of the 0.25ml/25mcg
About a week later, I have a severe fatigue, SOB, headaches, body aches, muscle cramping, and congestion. These lasted for about 8 days. I went to the doctor about this. They did a strep, pneumonia, sinus, and a UTI test.
Patient was sitting in chair and head tilted back with eyes rolling back in head. Head started to tilt forward and shaking of arms and legs happened. Shaking lasted for around 3 seconds and stopped. Once done shaking, the patient became highly alert with wide eyes )as if she was unconscious). Lost color in face and lips. Took pulse of patient and was slightly elevated around 70bpm (however, could be normal for her). Placed cold pack on back of neck. Patient was able to talk and was responsive. I had water available for her if she needed.
pt recvd vax;began screamy unconsolable cry;seemed limp exhausted;t 103;shivery;restless;?tongue & put to side of cheek;hard to swallow;possible sore throat;note greenish mucous drainage;