chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1-2 days after?Swollen lymph node in left neck, soreness in arm and other muscles in left side of body, exhaustion.  1 week after ? randomly racing heart, anxiousness, diarrhea, headache, odd breathing, restlessness.
Ear fullness, loss of hearing, severe tinnitus in both ears, and some head pressure
Patient has quarter sized raised rash on arm that injection was given - not at injection site. 2 days after shot, patient had severe diarrhea.
This case was reported by a other health professional via call center representative and described the occurrence of injection site itching in a 6-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9PX3H, expiry date 30th June 2017). On 14th October 2016, the patient received FLUARIX QUADRIVALENT (intramuscular). In October 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site itching, injection site redness and injection site pain. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site itching, injection site redness and injection site pain were unknown. It was unknown if the reporter considered the injection site itching, injection site redness and injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: After receiving FLUARIX QUADRIVALENT in left deltoid, the patient experienced redness, itching, and pain at the injection site. The redness, pain, and itching had spread past the injection site to underneath the affected arm. The reporter did not have an exact date, and assumed it was bout 2 weeks ago reporting date. The reporter stated that they did not know that the events were began relating to receiving the vaccination. The reporter's call was transferred from vaccine service center. This case has been linked with US2016159820 by same reporter.
From initial information received on 29OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 39 year old female patient received a dose of FLUZONE administered IN on 27OCT2003. Bout 15 minutes later, the pt experienced swelling of the hands, weakness,hives and idaphoresis. The pt was given Benadryl IM and ice packs were applied to the injection stie. The patient rested for 45 minutes and the events fully resolved. The patient recovered from these events.
Left shoulder still sore. At first hard to even drive car or sleep without putting arm around head.  Still hurts when raising arm over head. Not excruciating pain but frustrating not knowing when if ever it will go away. Shot was too high on arm.
Slight constant headache  since the first dose of the Pfizer vaccine. I did not have headaches before, or in years! Sometime dizziness.
an expired dose of Menactra was given to a 12 years old patient, No AE; Initial information was received on 09-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 12-years-old male patient who was vaccinated with a 0.5 ml first dose of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6208AB and expiration date 08-Jul-2020) via an intramuscular route at an unknown administration site on 08-Sep-2020 for prophylactic vaccination (latency was same day).  The patient's medical history, concomitant medication, past medical treatment, vaccination and family history were not provided.  The patient had concomitantly received a dose of vaccine DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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.
GRAND DAUGHTER CALLED NEXT MORNING REPORTING THAT THE ENTIRE RIGHT SIDE OF THE PATIENT'S BODY WAS SWOLLEN. SHE SAID THE FACILITY SENT HER A PICTURE WHERE THE RIGHT SIDE OF FACE, RIGHT ARM AND RIGHT LEG WERE SWOLLEN.
Day following immunization, patient had soreness of arm when lifting, pain that caused restlessness when lying on that side, small bump at site.  The following day (1/30/16) bump had turned into hard nodule.  No fever.  Unable to reach mfg to determine whether nodule development would necessitate urgent care or if she should follow up in 2 days when ob/gyn available.  Called local ER to inquire about the protocol they follow post imz reactions, and referred pt to call to determine need to be seen.
Upon injection patient complained of discomfort he described as pressure. Over the afternoon this developed into severe pain. When I spoke with him around 6 this evening he was not getting relief from the pain using topical pain relievers.
severe arm pain & weakness, unable to move the arm - limited shoulder abduction, flexion, extension, adduction.  unable to active forward flex elbow.  only able to passively move left arm.
large lump at vaccination site on left arm, red, hot, itchy and painful to touch; large lump at vaccination site on left arm, red, hot, itchy and painful to touch; large lump at vaccination site on left arm, red, hot, itchy and painful to touch; large lump at vaccination site on left arm, red, hot, itchy and painful to touch; large lump at vaccination site on left arm, red, hot, itchy and painful to touch; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0167) via an unspecified route of administration in the left arm on 17May2021 at 14:45(at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient had no allergy to food, medication or other products. The patient did not receive any other medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 15:00(at the age of 54-years-old) as a single dose for COVID-19 immunisation. 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 COVID vaccine. On 18May2021 at 00:00, the patient experienced large lump at vaccination site on left arm, red, hot, itchy and painful to touch. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent. The clinical outcome of large lump at vaccination site on left arm, red, hot, itchy and painful to touch were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Mother stats "patient has had personality changes since receiving Hep A vaccine. He is aggressive, hyperactive and had lost some language skills".
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 25-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a 8 week old female who on 04-MAR-2009 was vaccinated with a first dose of ROTATEQ vaccine (lot # 663263/1489X), oral. On 04-MAR-2009 the patient vomited after receiving the ROTATEQ vaccine. The reporter believed the patient vomited the complete dose. The patient sought medical attention through an office visit. Additional information has been requested.
Sleepy, tired, followed by a 24 hour fever,  as high as 101.5 Achy, malaise, weakness, could barely stand., no appetite.
Myalgia, Arthralgia, Fever & NauseaVomting Narrative:
Experienced a flare up; This is a spontaneous report from a contactable nurse and a contactable consumer via a Pfizer-sponsored program. A 57-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as single dose (at the age of 57 years old) for COVID-19 immunization; and tofacitinib citrate (XELJANZ XR), oral from Feb2020 (Batch/Lot number was not reported; Expiration Date: 28Feb2023) to an unspecified date, at 11 mg, daily for rheumatoid arthritis. Medical history included rheumatoid arthritis. Concomitant medications were not reported. When the patient got her covid vaccines (reported as "covered vaccines") she had to go off her medicine for a week each time and experienced a flare up noticed a difference. The action taken in response to tofacitinib citrate was unknown. The outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known disease pathophysiology, the event is assessed as unlikely related to the suspect drugs and more likely due to the pre-existent disease. 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.
Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.   This case was linked to MOD-2021-022058 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Report: non safety info, updated address and email of the reporter
Inability to walk properly. Progressed to gait instability with pelvic girdle weakness.  Presently there is no diagnosis. The pt has consulted a neurologist and needs a can or wheelchair for mobility.
tested positive with the covid-19 after getting the first dose; tested positive with the covid-19 after getting the first dose; This is a spontaneous report from a contactable consumer reporting for himself from a Pfizer sponsored program, Pfizer First Connect. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on Jan2021, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient experienced cough, runny nose and tested positive with the covid-19 after getting the first dose of the covid-19 in Jan2021. He asked if he should still get the second dose three weeks after the first one.  Information on the lot/batch number was requested.
After administering a covid vaccine, patient reported hot, weak & shaky. Temp: 97.6F ; BP/ HR: 157/98 (80); 136/86 (79); 150/92 (71) (1-10 min apart)
Developed headache, chills, hot flashes, body aches, burning eyes, nausea, and fatigue 4 hrs after vaccination. Symptoms wax and wane in severity, but have not resolved. She was seen by pediatrics and family practice by telemedicine. Treated with Tylenol and Advil.  Then presented to Hospital ER 5/3/21 with worsening fatigue and weakness. ER work-up included normal/ negative CBC, d-dimer, monospot, CMP, ESR, CK, UPT, UA, RP Covid, and Influenza. Only noteworthy finding was mildly elevated CRP at 0.51. Treated with Zofran.  Outpatient follow-up work-up included normal ECG, normal repeat CBC, CMP, CK, ESR, A1C. CRP 3. EBV, CMV, Parvovirus, Covid antibody, ANA, and RF pending. She briefly D/C'd Amitriptyline, so advised to resume.
Patient felt tired and beginning to feel sore in evening 12/5/18 after choir practice, then morning of 12/6/18 felt feverish and tired but did go about her day as normal, she did not let it stop her routine, but was uncomfortable, she noted a round, red, warm area on ventral side (inside) of right arm above the elbow. On 12/7/18 husband insisted she go to have NP look at it. She has used ice and ibuprofen. She saw NP on 12/7 and pharmacy received call from NP office regarding 2 vaccines on same arm. Pharmacy contacted husband, husband contacted patient, patient did come to pharmacy for observation on 12/7/18. Pharmacist noted red round approximately 5 inch diameter circle on inside of right arm. Patient was feeling better and felt like the fever was gone.
Patient developed a rash/infection on the arm that the vaccine was given in.  The exact time of onset is unknown.
Patient had hives to abdomen and back the morning after receiving vaccine (noticed them around 8am on 3/10/21).  Patient also reports swelling to the bottom lip.   Patient received vaccine as part of a COVID vaccine clinic.
Patient developed fever up to 103.8, body aches, especially in the arm that the 2 vaccines were given into,  nausea and headache.
Significant changes in menstrual cycle/hormones, such as: heavy periods last twice as long as normal, painful cramping, extreme exhaustion, hot flashes. These have occurred monthly since vaccine. I just ?reset? my body with a very restrictive diet and seem to be recovering back to normal.
DEEP VEIN THROMBOSIS; COVID-19 PNEUMONIA; COVID-19; This spontaneous report received from a Health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System concerned a 49 year old female of unknown race and ethnicity. 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, intramuscular, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total administered on 23-JUN-2021 on left arm (LA) for an unspecified indication. Drug start period was 235 days. No concomitant medications were reported. Patient had second bout of covid infection after 5 week of hospitalization for covid pneumonia with pulmonary embolism (PE), deep vein thrombosis (DVTs) on 12-NOV-2021. On 13-FEB-2022, the patient experienced covid-19, covid-19 pneumonia and deep vein thrombosis. On an unspecified date, the patient was hospitalized for unspecified number of days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19, covid-19 pneumonia and deep vein thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000219430. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the RA evaluation/investigation performed.   Additional information received from Central Complaint Vigilance department on 04-MAR-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation results.; Sender's Comments: V2: Follow up information updates about product quality complaint investigation results. This does not alter the previous causality assessment. 20220258546-covid-19 vaccine ad26.cov2.s-Covid-19, Covid-19 pneumonia, Deep vein thrombosis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
I received a pneumonia shot and a flu shot, one in each arm. My arm with pnemon. shot started throbbing & itching about 3 hrs later, Sat. morning I woke up with my arm from shoulder to elbow very, very red & swollen, looked like full of fluid - my lymph sys. became swollen & very painful. Mon. I called my Dr. & was able to go in. Swelling & fever started to subside, but lymph system continued to swell. Took 2 weeks to get better.
Heart Palpitations; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number EN6208 and expiry date: not reported), via an unspecified route of administration in left arm on 10Mar2021 at 11:00 (at the age of 25-year-old) as Dose 1, Single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient previously took sulpha drug and experienced allergy. On 10Mar2021 at 12:00, patient experienced heart palpitations. Patient did not receive any treatment in response to the event. Outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Patient received the MMR, DTaP and IPV vaccinations at 10:30am.  He was dropped off at school at 11:00am.  At 3:30pm, when he was picked up from school by his mother, he asked to be carried because his legs hurt too bad to walk.  His mother gave him Advil at 4:00pm.  He fell asleep at 5:00pm.  At 7:00pm, mother attmepted to wake him.  He aroused briefly and returned to sleep.  His skin was ashen and he felt cold to the touch.  At 9:00pm, 4 hours into his nap, he was still sleeping.  Mother attempted to wake him and moved him to his bed due to cold skin temperature.  He remained difficult to arouse.  Called 911 at 9:15 at the advice of clinic phone call nurse.  Paramedics were able to wake him but advised transport to  Hospital ER due to low heart rate (55) and low body temp (95 F).  The paramedics monitored heart rhythm in transit to ER and reported irregular heart beat, rate 58.  Level of consciousness reported by paramedics was 'responsive to voice'.
On 11/26, reported Myalgia, chills, dizziness, nausea and malaise that onset 24 hours after injection and lasted for 24 hours.  Didn't check temperature.  Used Tylenol , Ibuprofen but felt wasn't helpful in relief.  Stopped series her request.
PT WAS ADMINISTERED VACCINE AND WENT TO SIT IN WAITING ROOM. WITHIN 5 MINS CALLED FOR HELP. I WENT OUT AND HE LOST CONSICOUSNESS, PUPILS DILATED, FACE GOT RED AND HE WAS UNRESPONSIVE, WITH A PULSE. CAME BACK TO US, REALIZED WHAT HAPPENED, WAS OK, VERY PALE, SWEATING, SPEAKING, WE CASLLED 911 THEN HE SAID IT WAS GOING TO HAPPEN AGAIN AND IT DID, SAME SYMPTOMS AND REACTIONS. 911 ARRIVED AND TOOK OVER, ADMINISTERED IV FLUIDS AND MONITORED FOR HALF AN HOUR OR SO.
Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VOMITING (Vomiting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced HEADACHE (Headache). On 05-Apr-2021, the patient experienced VOMITING (Vomiting). At the time of the report, HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
2:00 p.m. day of injection - suddenly very tired; 6:00 p.m. heart pounding; 7:00 p.m. blood pressure spiked to 181/93 (headache); 9:00 p.m. blood pressure dropped to 112/53 - then chills,  muscle/joint pain, felt very unwell 3/7/2021 - small red itchy spot appeared on belly 3/9/2021 - full blown itchy red rash on belly
pt developed myo-pericarditis, admitted to Sunnyside medical center on 3/27/21 overnight. Treated with Ibuprofen and colchicine.
Syncope at time of vaccine administration. Patient was placed in a supine position with head lower than up. He regained consciousness spontaneously without complication.
did not received 2nd dose yet, (Day 55); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not received 2nd dose yet, (Day 55)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not received 2nd dose yet, (Day 55)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not received 2nd dose yet, (Day 55)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported. Treatment information as not reported.
Swelling or granulomas developed on face; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9264) via an unspecified route of administration in the right arm on 23Mar2021 at 12:30 (at the age of 53-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 30Mar2021 at 00:00, the patient experienced swelling or granulomas developed on face where artefill polymethylmethacrylate (PMMA) filler was placed 8 years ago. She stated granulomas appeared around 1 week after first Pfizer vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling or granulomas developed on face was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.