chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIARRHEA; VOMITING; BODY ACHES / INTENSE PAIN; HURTS TO BREATHE/BREATHING PROBLEMS; FATIGUE; CHEST PAIN/CHEST PROBLEMS; BED RIDDEN; NAUSEA; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2216279 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest pain/chest problems. On APR-2021, the subject experienced bed ridden. On APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced vomiting. On 07-APR-2021, the subject experienced body aches / intense pain. On 07-APR-2021, the subject experienced hurts to breathe/breathing problems. On 07-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from hurts to breathe/breathing problems, and fatigue, had not recovered from diarrhea, vomiting, and body aches / intense pain, and the outcome of nausea, chest pain/chest problems and bed ridden was not reported. This report was non-serious.
3/22 pt had multiple red spots on both thighs. Advised to apply cool compress and may use Benadryl but should come in to be seen by doc, mom declined. 3/23 rash all over body. Dx by doc as reaction.
Pt's arm became red and started hurting  on Saturday afternoon.  Sunday it got worse and the redness and warmth was spreading.  Pt's Mom called the pharmacy and was advised to call their MD office.  MD office called in prescription for Keflex 250mg/5ml.  Pt came and picked up medication.  Pt was taking prescription Keflex as well as Ibuprofen and applying ice. Sunday night, pt complained pain was worse and parents took pt to ER.  ER dx cellulitis and prescribed Bactrim susp.
Dose 1 - Moderna on 1/11/21 (Lot 037K20A) - menstrual cycle late, 37 days Dose 2 - Moderna on 2/8/21 (Lot 004M20A) Since dose 1, menstural cycle has continued to be abnormal, ranging from that initial 37 day stretch to as few as 12 days between cycles during 2021.  Following Dose 3 listed above, left arm and left armpit swelled around 12 hours after injection.  Today, lymph nodes in armpit are still swollen, but pain and discomfort are decreasing.
Arm was sore/sore right arm; Broke out in hives (ER visit); This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   In December 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and PNEUMONIA VACCINE (intramuscular). In December 2022, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm and hives. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The patient was self-reported this case. The patient reported that 2 weeks ago he started to took oral cholesterol medication and also received Shingrix vaccine and pneumonia vaccine around the same time. The patient stated that after received Shingrix vaccine and pneumonia vaccine he experienced sore arm and he broke out in hives about 1.5 weeks later of received these two vaccines and starting of new cholesterol medication. The patient was ended up going to the emergency room, but were treated and released.  The patient reported that the hives are better, but still not gone. The emergency room doctor thought it was the cholesterol versus the Shingrix vaccine. It was unknown if the reporter considered the injection site pain and hives to be related to Pneumococcal vaccine The reporter did not consent to follow up.
-High fever (102F+) for 2 days after injection -Dizziness impacting ability to walk for 2 days after injection -Significant facial swelling, left and right side near ears, starting 2 days after injection lasting 1 day -Body aches, lethargy, headaches for 2 days after injection -Significant pain at injection site, and radiating inwards to underarm for 3 days after injection
Numbness and tingling in BL fingertips, unsteady gait, question of transverse myelitis.  Pt has had MRI C spine showing severe central canal stenosis, seeing neurosurgeon, will have repeat C spine, T spine MRIs, pet scan.
This spontaneous report was received from a nurse via other company Pfizer regarding a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. In 2004, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route of administration, lot # and expiration date were not reported). In 2004, the patient had an allergic reaction on PNEUMOVAX23, it was severe light headedness and presyncope. It was unknown if the patient received any treatment. The patient's outcome was unknown. The relatedness between the events and the therapy with PNEUMOVAX23 was not provided. Additional information has been requested.
Child received on 8/18/2008. Parents report that within 24 hours both vaccine sites became red, warm and swollen. Child complained of itching at sites. Cool compresses applied.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 16-AUG-2016, the patient was vaccinated with an expired (wistar ra 27-3) M-M-R II lot # K010318, expiry date: 22-JUL-2016 (dosing details were not reported). No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Severe headache; severe body aches; severe joint aches; chills; sweats; fatigue; loss of appetite; This is a spontaneous report from a contactable pharmacist (patient). This 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 11Jan2021 17:30 at single dose on the left arm for COVID-19 immunization. The patient's medical history included depression and gastrooesophageal reflux disease (GERD). No known allergies. The patient's concomitant medications included bupropion, famotidine and birth control medication received in two weeks. The patient previously took the first dose of BNT162B2 (Lot number=Ej1685) on 23Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. No other vaccine received in four weeks. Facility type vaccine was workplace clinic. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced severe headache, severe body aches, severe joint aches, chills, sweats, fatigue, loss of appetite on 12Jan2021. No treatment received. Outcome of the events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
Muscle soreness; This case was reported by a consumer via interactive digital media and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was not recovered/not resolved.   It was unknown if the reporter considered the muscle soreness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's Comments: This case was reported by consumer (patient) via interactive digital media. The patient asked could he/she take an aspirin or ibuprofen for muscle soreness on 2nd day of first shot.
Indurated, erythematous, slightly elevated area about 5.5cm X 4.0cm on right posterior lateral thigh. Presumed recovered.
Received vaccination yesterday in right thigh.  That night parents noticed their son right thigh was swollen, red and painful from mid thigh at sight of injection to knee.  Patient was unable to bear weight of bend knee for pain.  The did not report fever or other symptoms.  Seen in pediatric clinic today.  Right thigh erythema measuring 10cm X 5 cm laterial to injection sight and edema form injection sight to knee cap. Tender to palpation, knee was not tender.  Child able to walk and bend knee with mild discomfort.
Case number PHEH2015US021297, is an initial spontaneous report received from a pharmacist on 19 Oct 2015. This report refers to a 16 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157801) intramuscularly on 18 Oct 2015. It was reported that, before administration, the FLUVIRIN was out of temperature range at 49 Fahrenheit for 4 hours. No adverse event was reported following this maladministration.
swollen lymph nodes in neck, stiff /sore neck for 3 days & fatigue tightness in the throat
Onset of muscle weakness, increased CPK approximately 1 week after administration of MMR, DTAP, and IPV.
After receiving her first dose of the Moderna Covid-19 Vaccine at 10:55 a.m., the patient fainted while in her chair in the waiting area and had convulsions.  We immediately called 911 and we were able to get the patient to the floor safely and elevate her legs. Her convulsions stopped shortly after they began, and I stayed at the patient's side.  She had normal breathing and pulse and began to wake up shortly after her legs were elevated.  I applied a cold pack to the patient's forehead with her consent.  She was very disoriented upon waking up.  EMS arrived at 11:08 a.m. and took her blood pressure and blood glucose reading.  She was conscious when they arrived but still disoriented.  Her blood pressure was low and the patient said she felt like she was going to pass out again after they stuck her finger to check glucose.  EMS transported the patient to Hospital because of her persistent low blood pressure.  I attempted to call the patient this evening to check on her but was unable to reach her.
Pt was being observed for 15 minutes after covid vaccine administration. Pt was noticed to be "sleepy" and  RN SB went to talk to pt who appeared to be lightheaded. I went and got the available emergency kit for RN   SB to check pt's pulse ox. Pt's SaO2 was 99% and Pulse was 89. Pt reports that she had a recent heart cath and high blood pressure. Pt reports not taking her blood pressure medication prior to coming. 5-10 minutes after covid vaccine pt was more alert and stated she was feeling better but had vision changes. Pt's blood pressure was checked and it was 160/110 which was taken manually, pulse ox 98% and pulse was 87. Pt denies difficulty breathing or shortness of breath. Pt able to speak in full sentence. Pt was told that we would like her to stay for further evaluation. Pt was able to ambulate without difficulty to another place in the auditorium for further observation. 30 minutes post covid vaccination pt was alert and respirations were even/unlabored. BP 130/110 on both arms manually, pulse 67 and SpO2 99%. Pt still complaining of blurred vision/double vision. Pt was talking to husband on phone without difficulty and asking him to move to garage area to pick her up. Pt was told to follow up with her cardiologist and PCP. 45 minutes after vaccine admin pt asked if I could help her call her cardiologist office. I told her yes. I called Doctor's office and was transferred to the nurse line. The nurse told me that she was not Doctor's nurse but she would send him a note and recommends pt go the emergency department for vision changes. Pt was told the recommendation and called husband to tell him to meet her at ED while we were waiting for a wheel chair to transport pt. Pt works in nutrition and there was a supervisor or manager that knew her and said that he would let them know what was going on. She was supposed to work at 1330 today. Pt walked to wheelchair without difficulty and pt was transported to ED. Pt's husband was at the ED waiting when we got there. ED triage nurse was updated that pt had received 2nd dose of covid vaccine, had a recent heart Cath and was told by cardiologist office to go to ED for vision changes.
pt recv vax 10JUN95 & 18JUN96 pt exp erythema & urticaria w/ 3 to 5 cm lesions;no further details were provided;
pt recv vax in later summer to early fall 1994 & pt fainted & fully recovered w/o tx;
Confirmed no side effects or symptoms reported; HBP called to report a patient was due for PROQUAD and VAQTA, but the parent requested for patient not to receive VAQTA, however they received it incidentally because the Medical Assistant thought it was PROQUAD, but they actually administered VAQTA; HBP called to report a patient was due for PROQUAD and VAQTA, but the parent requested for patient not to receive VAQTA, however they received it incidentally because the Medical Assistant thought it was PROQUAD, but they actually administered VAQTA; This spontaneous report was received from an administrator, concerning a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-OCT-2023, the patient was supposed to be vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and hepatitis a vaccine, inactivated (VAQTA) but the parent requested for patient not to receive the later. However, the patient was incidentally vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milliliters (ml) once,  as prophylaxis (lot #X004814 has been verified to be valid for syringe presentation, expiration date not reported but upon internal validation established as 10-OCT-2024) (strength, route of administration, and anatomical location were not provided) because the Medical Assistant thought it was measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product confusion) (wrong product administered). It was confirmed no side effects or symptoms were reported.
E.R. on 04-29-09: Dry heaves - headaches - tightness in chest - 05-13-09  Dr. Nausea/headaches- spleen pain/swollen- weakness/fatigue - Dr - 6-16-09 - Chronic fatigue syndrome by blood test - continues to this date -09-11-09.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (painful injection site after the first vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.  No Medical History information was reported.On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (painful injection site after the first vaccine). At the time of the report, VACCINATION SITE PAIN (painful injection site after the first vaccine) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.No concomitant medication was reported by the reporter.No treatment was reported by the reporter.This case was linked to MOD-2021-395870, MOD-2021-395871 (Patient Link).
Sore throat, swollen glands (neck), achy bones, teeth hurt, head hurt, fever/chills, eyes sensitive, very weak, headache, effort to move, cough, sneezing, fast pulse 80-100 for 3 days, pale, slept and slept day and night, still need naps. After 12 days, still not feeling normal: some sore throat, coughs, sneezing, nose running.
Panic attacks; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient, not pregnant, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration administered in arm left on 06May2021 10:30 as 2nd dose, single for covid-19 immunisation. Medical history included ulcerative colitis, and hypothyroidism. Concomitant medications included adalimumab (HUMIRA); levothyroxine; and balsalazide disodium - all taken for unspecified indications, start and stop dates were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 15Apr2021 10:15 AM administered in the left arm for covid-19 immunisation. There were no other vaccines received within 4 weeks prior to the covid-19 vaccine. The patient was not diagnosed with covid-19 prior to the vaccination. Vaccination was done at a pharmacy or drug store. The patient experienced panic attacks on 07May2021 which resulted in emergency room/department or urgent care. The patient had not recovered from the adverse event at the time of the report. Since the vaccination the patient has not been tested for covid-19.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2014US016762 is an initial spontaneous report received from a nurse on 19 Aug 2014. This report refers to a patient of an unspecified age and gender. The past medical history and concomitant medications of the patient were not reported. The patient received only Men CWY-135 liquid conjugate component of MENVEO (batch number: not reported) intramuscularly without reconstitution with Men A lyophilized powder component on an unspecified date. No adverse events were reported following this maladministration (inappropriate preparation of medication).
Patient appeared to have multiple seizures shortly after receiving her 1st covid vaccine (within 10 minutes).  Mom reports last seizure was yesterday.  Patient maintained airway and breathing during the incident.  911 was called and patient was transported to hospital.  She also had nausea and 1 episode of vomiting.
Bruising on my chest; Lymph node reaction fromlymph n vaccines/like she has a base ball under her arm; Felt a little breathless; Arm was completely black and blue,the whole front part of her mastectomy is black and blue too; Fluid under her arm on the mastectomy side,fluid got larger over the days,like she has a base ball under her arm/fluid got larger over the days/fluid under her arm on the mastectomy side; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Felt a little breathless), SKIN DISCOLOURATION (Arm was completely black and blue,the whole front part of her mastectomy is black and blue too), SWELLING (Fluid under her arm on the mastectomy side,fluid got larger over the days,like she has a base ball under her arm/fluid got larger over the days/fluid under her arm on the mastectomy side), CONTUSION (Brusing on my chest) and LYMPHADENITIS (Lymph node reaction fromlymph n vaccines/like she has a base ball under her arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy in 2000. Concomitant products included ACYCLOVIR [ACICLOVIR] for Herpes NOS, LORAZEPAM for an unknown indication.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced DYSPNOEA (Felt a little breathless), SKIN DISCOLOURATION (Arm was completely black and blue,the whole front part of her mastectomy is black and blue too) and SWELLING (Fluid under her arm on the mastectomy side,fluid got larger over the days,like she has a base ball under her arm/fluid got larger over the days/fluid under her arm on the mastectomy side). On an unknown date, the patient experienced CONTUSION (Brusing on my chest) and LYMPHADENITIS (Lymph node reaction fromlymph n vaccines/like she has a base ball under her arm). On 04-Nov-2021, DYSPNOEA (Felt a little breathless) had resolved. At the time of the report, SKIN DISCOLOURATION (Arm was completely black and blue,the whole front part of her mastectomy is black and blue too), SWELLING (Fluid under her arm on the mastectomy side,fluid got larger over the days,like she has a base ball under her arm/fluid got larger over the days/fluid under her arm on the mastectomy side), CONTUSION (Brusing on my chest) and LYMPHADENITIS (Lymph node reaction fromlymph n vaccines/like she has a base ball under her arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   When she went to bed  on that night (07-Nov-2021), she noticed the whole front part of her mastectomy was black and blue too. The fluid was still there, but it was better. She kept heat on it because she did not know any better and applied cold on Saturday, but it was too late to do any good.   This case was linked to MOD-2021-378670 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant  live Follow-up received and contains an additional event bruising on my chest
Pt previously healthy other than controlled HTN received her 2nd moderna vaccine on 4/15- hospitalized on 4/18 (sxs starting 4/17) with a large L thalamic cryptogenic CVA/ sepsis/acute bacteremia/encephalopathy/lactic acidosis. carotid dopplers neg for acute pathology, echo normal and neg bubble study. Pt now with short term memory impairement, flat affect, and amnesia surrounding events of admission and hospitalization. She is a  Lifelong non smoker. No past hx of atrial fibrillation- no atrial fibrillation noted on tele. PT/OT/speech path seen. ldl 108- started on lipitor, started on aspirin. aic 6.0, Gram negative bacteremia/e coli in cx- unclear GI source. Possibly diverticular.  MRCP showed nothing acute. Home with a few more days of augmentin per ID dc home with home health services 4/22
p/ pt recv vax approx 14 days later pt devel approx 20 lesions. a general vesicular/papular rash. pt also itchy.
felt tired after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "all kinds of injuries over the years, including martial arts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt tired after the first dose".  Additional Information: The patient received his first dose in the latter part of January and he is not sure of the exact date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
USING A BD INTEGRA 3ML 1 INCH 25 G SYRINGE A JANSSEN VACCINE (0.5ML BOOSTER) WAS GIVEN TO PT IN HER RIGHT ARM, VACCINE LEAKED OUT IMMEDIATELY OUT OF SYRINGE ONCE PLACED IN PT'S ARM WITH VACCINE DRIPPING DOWN PT'S ARM AND ON HER SWEATSHIRT WAS A BIG WET MARK, VACCINE WAS THEN REDOSED IN PT'S LEFT ARM WITH NO ISSUE AT ALL