chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm is so sore she can't lift it; So tired as if she ran a marathon; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is so sore she can't lift it) and FATIGUE (So tired as if she ran a marathon) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FATIGUE (So tired as if she ran a marathon). On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm is so sore she can't lift it). At the time of the report, PAIN IN EXTREMITY (Arm is so sore she can't lift it) and FATIGUE (So tired as if she ran a marathon) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Woke up with severe tinnitus and vertigo. Went to ENT had sudden hearing loss in left ear. Was treated with steroids for a month , couldn't work so was fired...Then  tried steroid injections with no improvement. Tinnitus and severe haring loss has persisted for 319 days with no explanation.
Feel like he has flu without the fever; Stomach does not feel right; When he stands up it's like his equilibrium is a little off, he is unsteady when he stands; Almost like the upper back of his head is very tight; He had to walk with a cane; His blood pressure is elevated because he is worried about his side effects; Unsteady when he stands; Excruciating headaches; Itchiness few days after he received vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feel like he has flu without the fever), ABDOMINAL DISCOMFORT (Stomach does not feel right), BALANCE DISORDER (When he stands up it's like his equilibrium is a little off, he is unsteady when he stands), TENSION HEADACHE (Almost like the upper back of his head is very tight) and GAIT DISTURBANCE (He had to walk with a cane) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Headache NOS. Concomitant products included IBUPROFEN and FISH OIL for an unknown indication.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRURITUS (Itchiness few days after he received vaccine). On 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feel like he has flu without the fever), ABDOMINAL DISCOMFORT (Stomach does not feel right), BALANCE DISORDER (When he stands up it's like his equilibrium is a little off, he is unsteady when he stands), TENSION HEADACHE (Almost like the upper back of his head is very tight), GAIT DISTURBANCE (He had to walk with a cane), BLOOD PRESSURE INCREASED (His blood pressure is elevated because he is worried about his side effects), DYSSTASIA (Unsteady when he stands) and HEADACHE (Excruciating headaches). At the time of the report, INFLUENZA LIKE ILLNESS (Feel like he has flu without the fever), ABDOMINAL DISCOMFORT (Stomach does not feel right), BALANCE DISORDER (When he stands up it's like his equilibrium is a little off, he is unsteady when he stands), TENSION HEADACHE (Almost like the upper back of his head is very tight), GAIT DISTURBANCE (He had to walk with a cane), BLOOD PRESSURE INCREASED (His blood pressure is elevated because he is worried about his side effects), DYSSTASIA (Unsteady when he stands), PRURITUS (Itchiness few days after he received vaccine) and HEADACHE (Excruciating headaches) was resolving.            Other concomitant medications included cholesterol medications and blood pressure medications. Treatment information was not provided by the reporter.
GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer concerned a 7 decade old female of an unspecified race and ethnicity. 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, batch number and expiry date were not reported) dose was not reported, 1 in total was administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced myalgia and also stated that a physician had mentioned Guillain-Barre syndrome (GBS). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221054971-covid-19 vaccine ad26.cov2.s -guillain-barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
injuries; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from License Party.  A 13-year-old female patient received BNT162b2 (BNT162B2), in Jan2023 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for Covid-19 immunization. The following information was reported: INJURY (non-serious) with onset 2023, outcome "unknown", described as "injuries".  Additional information: Having experienced severe symptoms following the administration of the second dose of the Pfizer-BioNTech vaccine in January. participation in a vaccine trial, a 30-second advertisement was prepared by the Vaccine Safety Research Association, which was intended to raise awareness of her injuries and to coincide with the 26Oct meeting of the FDA advisory committee meeting to review Pfizer data on its COVID vaccine for children 5-11.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  SUSPECT PRODUCT is under agreement with BIONTECH.
From the time of the injection my asthma gradually got worse and worse. I was on a special diet and it was completely better prior to the vaccine. When I was on  a walk I would have to use my albuterol inhaler so I did not have a complete collapse on the street.  On 10/31/2021, were my 1st symptoms of COVID-19. On day 5 of having COVID-19 I received the monoclonal antibodies. It knocked out the asthma and in addition to the COVID-19 virus. I was having excruciating headaches and the sore throat.  I did a home test on day 3 and it was positive.  I have had no asthma attacks since 12/05/2021 and that is amazing because I was having to use the pro Hale inhaler with the active Albuterol sulfate daily.
Redness, warmth, hardness, and soreness and vaccine injection site. (Left upper arm in the muscle). Noticed several days later. I took over the counter Ibuprofen and applied a cold pack to area. The color became lighter and it wasn't as warm, but it still has a hard spot and is sore to touch.
Initial and follow up information has been received from a physician concerning a 9 year old male who in 1999, also re was vaccinated with a 0.5 ml dose of VARIVAX (Oka/Merck) by subcutaneous injection (lot number and injection site not reported). In 1999 the patient developed chickenpox after receiving the vaccine. On approximately 28-JUL-2008, also reported as 2 weeks ago, the patient developed chickenpox with nausea, vomiting and fever. In follow-up the physician reported that there was no adverse event. "The kids simply got chickenpox after being vaccinated". It was reported that the patient had routine office visit. The patient's events persisted. Additional information is not expected.
Gave patient wrong vaccine; was suppose to give patient Hep B not Hep A.
Varicella Vaccine received 08/13/2008 and 09/16/2008. Five days post second administration I developed neuropthay including tingling with pins and needles pain through my hands, ar,s. feet and legs which is very painful.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid disease" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicilin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient has taken Paxlovid for treatment of COVID-19. Treatment start date was16Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
About 12 hours after - chills, fever , headache, body aches, joint ache (like flu) - lasted 36 hours. I hydrated - Took Imitrex that I still had; Tylenol and was back to normal after 36 hours. Called Urgent Care
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer. A 7-decade-old female patient (in her 60s) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. A pharmacy student received this drug information question in which a female patient in her 60s received the first Covid vaccine on 23Dec2020 and tested positive for Covid on 04Jan2021. Could the patient receive antibody treatment? Could she get the second vaccine and when? The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Arm rash- painful, hot, red, swollen area about 3.5 inches in diameter on arm of injection site.   Fever- fever over 100°F for 48 hours starting at 3 a.m. the night of receiving vaccine. Tylenol and Advil taken but did not lower temperature. Fever broke and has not returned on the third day after the vaccine.   Headache- severe headache 72 hours after receiving vaccine. Advil has helped to treat this symptom.
Pt. presented to our office on 3/1/11 w/ redness, warmth, slight swelling and tenderness. Severe local reaction - upper arm.
-multiple hives on leg and armpit (red, itchy) -swollen and painful lymph nodes
1536 pt felt lightheaded following his vaccine he was assisted to the ground.  he was then transported to the observation area to be monitored.  BP 128/80 HR 68 oxygen sat 98% on room air.  Patient was given fluids and some crackers.  he then felt back to his normal self and then released from observation at 1550.  he was escorted to the exit via wheelchair and staff
Pt had a seizure today 6 days after receiving the booster shot. This may not have  anything to do with the booster shot, but she has never had a seizure before. we are taking her to see her primary care physician in the morning.
Patient went to wait outside after 15 minute observation period. Came back inside at 1500 for family member. 1505 Started complaining of itchy throat, forehead, dry mouth/throat while sitting in observation. Nurse practitioner was called at 1507 and assessed patient. EMT was called at 1510. First set of vitals sitting position 136/93   99% O2  82 HR    RR16.   1515   vitals   119/83   98% O2   HR 85   RR 16.  1515 NP performed physical assessment.  NP instructed patient to open mouth and stick out tongue to assess throat. No signs of anaphylactic shock noted. Checked integumentary system for rashes. None noted. Provider does not believe allergy is related to vaccine. 1516 Patient feels dry mouth and throat has subsided.  Patient continued to be monitored for 15 minutes. 1530 NP reassessed patient. NP instructed patient to open mouth and stick out tongue to assess throat. No signs of anaphylactic shock noted. NP cleared patient to go home. Patient left with family members.
Chills, injection site pain, tiredness, headache, fever, nausea, and feeling unwell.
Erythema Multiforme Began Friday, April 4, 2003 in A.M. Head to toe hives, different sizes.   Tx: Benadryl
Patient stated she faints when receiving vaccines or blood draws. Vaccinating nurse placed her on cot to give first dose of Moderna vaccine. Patient became lightheaded and dizzy after receiving vaccine. Became unresponsive for a few seconds, came to with the nurse calling her name. Responded to her name and complained of lightheadedness. Vitals were taken. Patient sat up after stating she felt better. Patient was able to sip water and stand without help. Advised patient to inform nurses for her second dose of vasovagal response, patient verbalized understanding. Vitals: 1703: BP 120/70 HR 82, O2: 99%.  1705 BP 107/54 HR 78, O2: 99%. 1711: 112/68, HR 74, O2 99%.
suspected vaccination failure; got the shingles; they are very painful; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case reported by the patient herself/himself. The age at vaccination was not reported. The patient stated that he/she got the Shingles vaccine and got the shingles been would be a year the 27th of reported month and shingles was very painful. The patient knew how someone felt. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
1st symptom: Friday, April 25, 2003 apprx.10a.m.              Vomited once 2nd symptom: Saturday, April 26, 2003 all day              coughing, fever(99.6 underarm)
18 days after 2nd VX had intense pain cramping that woke me from sleep affected deltoid and trapiesiest muscles. Pain was not relieved with any anti-flamatorial medication. Pain was relieved with hot showers. Then 7 days later started developing motor weakness and unable to move his arm where he rec'd vx. Got MRI of the Cervical spine and it was normal then went to Neurology 26 days after onset of symptoms weakness during shoulder abduction with shoulder flection was 5 in 1, external rotation was 5 and 4. Had normal motor function elsewhere.  He's a physician and diagnosed himself initially as having Parsonage Turner Syndrome,  then saw Neurologist and he confirmed it as well and prescribed gabapentin, then had an EMG and MRI, both also confirmed the diagnosis. Was also advised to get Physical Therapy and eventually gained motion in shoulder. Still feels pain but not the intense pain when it started. Left with cramping pain.
According to family, 3 hours after immunizations given, patient had vomiting and temperature of 103. Arrived in ER 2/26/04 at 21:15; temp was 106 rectally.  C/C to ER; was crying, fever, vomiting. Died 2/26/04 at 23:58. The hospital discharge summary received on 3/23/04 states meningococcaemia/ sepsis and congenital heart dx.  Nurse follow up on 09/21/04 states: "septic shock, adrenal hemorrhage."
gave 0.3ml of the bivalent booster dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (gave 0.3ml of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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) .3 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (gave 0.3ml of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave 0.3ml of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave 0.3ml of the bivalent booster dose).    No concomitant medications was reported. No treatment medications was reported.
Patient didn't experience any adverse effects, but was supposed to get Shingrix instead of COVID vaccination. COVID vaccine was given incorrectly to patient.
extreme fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (extreme fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extreme fatigue). At the time of the report, FATIGUE (extreme fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
This spontaneous report was received from a consumer, through social media, concerning a 14 year old girl. No pertinent medical history, concurrent conditions, or drug reactions/allergies of this patient were provided. No concomitant medications were reported. On an unspecified date, the patient had been vaccinated with an unspecified Human Papillomavirus Infection (HPV) vaccine (manufacturer unknown) (Dose, Lot # and expiry date were not provided). On an unspecified date, after the shot, the patient developed cervical cancer. The consumer stated that they had researched this vaccine extensively and spoken to those who have gotten. It was unknown if the patient received any treatment, sought medical attention or about the outcome of the event. The causality between Human Papillomavirus Infection (HPV) vaccine (manufacturer unknown) and cervical cancer was unknown. A PQC was not involved. Upon internal review, the cervical cancer was considered medically significant. Additional information is not expected because the primary reporter cannot be contacted privately.
It started off just feeling really tired. I thought I had a temperature just above 100 degrees. I think that night I took a COVID-19 test and it was positive. The next day I was achy, and I had a teleconference with the doctor. That morning I took another COVID-19 test for confirmation. They called in PAXLOVID and I started it that afternoon. I felt really bad for several days. I was feverish and tired. the PAXLOVID tasted horrible. After the 4th or 5th day I felt fine and tested negative but then had a case of rebound COVID-19 for a few days. It took long time to get over the fatigue. It took up until the end of February that I started feeling like myself.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient. On 10-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J001004 (expiring 24-APR-2014) (dose, route and site not provided). On 11-JUN-2013 the patient experienced injection site reaction in the form of redness, swelling and a significant rash, extending from the top of shoulder, down to the elbow. The reaction occurred within 24 hours of the administration of the vaccine. The patient consulted the pharmacist for medical attention. Topical antibiotic was prescribed as a treatment for the adverse events. The outcome of events was reported as recovered. The causal relationship was not reported. It was noted that this dose was one of the two doses from the same lot and pharmacy for with an AE had been reported. Each dose represented the last remaining doses within that lot. Additional information is not expected.
This spontaneous report as received from nurse refers to a 51 year old female patient. Patient's medical history, drug reaction and allergies were reported as none. On 26-FEB-2014, the patient was vaccinated with first dose of VARIVAX (Merck) injection, (lot number J007350, expiry date 13-JUN-2015), dose 0.5 ml once, subcutaneous as she was in an environment where there was a chickenpox outbreak. Concomitant therapies included atenolol and hydrochlorothiazide. On 20-MAR-2014, the patient called (yesterday) into the office, reporting that she got vesicular like rash on her body. No treatment was given for the event. No lab diagnostics were performed. No product quality complaint was involved. The outcome of vesicular like rash on her body was reported as not recovered. The reporters causality assessment for the event of vesicular like rash on her body with the therapy of VARIVAX (Merck) was not reported. Additional information has been requested.
Temperature at 7:30 PM: 100.8  Temperature at 9:30 PM: 102, began vomiting violently.  Brought to ER.  Temperature over 103.5.
Student received Td vaccine approx 1:45pm.  At approx. 4pm student was at track practice running up and down a hill for long distance running, he collapsed.  Hitting his head.  He never regained consciousness. Medical records received from ER which revealed patient arrived in full arrest & was unable to be resuscitated.  Additional information from autosy report rec'd 06/13/2005-- arrhythmia.
DTaP-HIB combo given before 15 months of age. no side effects reported.
6" diameter inj. site rxn - redness, swelling, pain, tenderness. 4 days after inj.
- 5 x 6 cm area of Erythematous Swon, (+) Tenderness on Rt Shoulder at site of vaccine Administration  - Keflex 500 TID
nausea chills/sweating diarrhea fatigue weakness stomach pain  It hit me while I was in class very suddenly, though all day I had felt unusually tired.  I left class, went home and slept until 5:30, then was fine though still tired
One day after taking the flu vaccine I was itchy all over my body and my eyes. Had a red itchy rash.
Approximately 2 days following PNEUMOVAX, patient developed fevers, chills, cough, wheezing. Seen in office 11/21- labs done. Tx'd with nebs and prescribed certain labs resulted 11/22 - CRP 120.9, CO2 15 Cr 1.08. Pt referred to ER. CO2 improving. Pt tx'd with nebs. to f/u in office.
Evening of injection, large red irritated,painfully hot area down injection arm, large bruising at site occurred next day, redness continued for 3 days, slight improvement on 4th day.