chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very fatigued) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very fatigued). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Very fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
TESTED POSITIVE FOR TB; ACHY; A spontaneous report has been received from a consumer. The report concerns a female patient of Unknown ethnic origin (age 49 years).    The patient's past and current medical history included asthma (ongoing). The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine (live, attenuated)) (batch number Unk) once/single administration, via nasal route, for flu season on an unknown date.     Patient reports that she has had no problems with Flumist nasal spray but she had gotten achy (preferred term: Pain) the same day usually when receiving the Flumist nasal spray and would take Tylenol for the aches and it passes and then she was fine and that was minimal compared to the complications from the shots she had been forced to take, explained as she has had TDAP and Tuberculosis and MMR and wanted to chop her arms off, and it made her feel like it was more painful to keep the limbs than to lose them and then said she was told by the hospital that she did not have a reaction to the TB test but she tested positive for TB (Tuberculosis) (preferred term: Tuberculosis) but she did not have TB. Patient reiterated that the side effect of being achy from Flumist nasal spray was minimal further explained as she did not want to cut her head or her body cut off or her limbs removed when she takes the Flumist nasal spray. She was terrified of needles and that has been something she cannot overcome even with a hypnotist and she was prone to getting the flu.    The patient recovered from of achy on an unspecified date. The outcome of tested positive for TB was unknown.     The events achy and tested positive for TB were considered non-serious.     The reporter considered the following event(s) related to treatment with Flumist Quadrivalent (influenza vaccine (live, attenuated)): achy.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. "A year prior to 05-NOV-2015", in approximately November 2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#/expiration date, dose and route not reported). On 05-NOV-2015 the patient was vaccinated with another dose of PNEUMOVAX 23 (dose and route not reported, lot # K009107 with expiration date 21-JAN-2016) (inappropriate schedule of vaccine administered, outside the recommendations for PNEUMOVAX 23). It was reported that the patient received the 2 doses of vaccine after 65 years old. No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1512USA005469). Additional information is not expected because the reporter did not want to be contacted.
This spontaneous report was received from a physician and refers to a 24 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in unspecified deltoid, lot # L042846, expiration date: 15-SEP-2017). No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by post office.
red raised palm size area in the evening after injection. Previous Palm area on arm is clear. Red tender when touch approximately 3 inches long 3 inches wide extends down arm under area where the palm size red was seen after injection on March 18th.
received vaccine after temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (received vaccine after temperature excursion) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (received vaccine after temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (received vaccine after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
2-3 days after receiving vaccine, patient reported having neck swelling/neck stiffness and non-itchy red hives on torso and thighs. Denies difficulty breathing, shortness of breath, or or pain.
Information has been received from a physician concerning a 12-year-old female who in June 1995, was vaccinated with one 0.5mL dose of Varivax. The physician reported that in April 2006, the patient presented with a case of shingles. The patient was hospitalized and she needed "pain injections" for a "couple of weeks". A couple of weeks after onset, the patient's shingles resolved. Additional information has been requested.
Pain in upper left arm and shoulder, limited mobility in left arm secondary to pain since day of injection.  15 days at this time. No improvement since initial onset
Severe pain and limited movement of middle finger on right hand  after first shot. Pain became even more severe after second short and this time included  my thumb on left hand with the same type of pain and limited movement.
pt fainted after receiving 1st dose of Moderna Covid vaccine.  Pt fainted approximately 10 minutes after vaccine was administered.  Pt came to after 10-15 seconds, and fainted 2nd time after about 90-120 seconds.  pt came to after about 10-15 seconds.  Pt felt weak, was sweating, had chills.  Pt was able to talk, breath and swallow water which pt requested to drink.  Pt and mom decided that they would like EMT's to check him out.  EMTs brought pt to ER and was released after a couple of hours..
Slightly sore right arm after first vaccine; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 65 years old, administered in arm right on 19Mar2021 11:30 (Lot Number: ER2613) at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced slightly sore right arm after first vaccine on 19Mar2021, it started 15 minutes after the injection. The outcome of the event was recovered in 2021.  No follow-up attempts are needed. No further information is expected.
Vaccine administered 12/28/2007. Seen in Urgent Care clinic 1/05/2008 with facial rash, viral culture obtained verifying Herpes Zoster infection.
an expired dose of Havrix was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received HAV (Havrix) (batch number AT47C, expiry date 28-APR-2023) for prophylaxis.   On 14-JUN-2023, the patient received Havrix. On 14-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: an expired dose of Havrix was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 The medical assistant called to reported that patient was administered with expired dose of Havrix vaccine. The patient received an expired dose of Havrix vaccine, which led to expired vaccine used. The reporter consented to follow up.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Lymph Node Swelling-Medium, Error: Wrong Dose of Vaccine - Too Low-
6 hr. after shot, felt unwell, went to bed, awoke after 12 hours with chills, fever, nausea, arm so sore I could not move it without excruciating pain. Began forcing fluids as symptoms persisted. Slept almost all of the following two days and nights. Now 3 days have passed, much better now but no appetite, still forcing water and juice. Worse than any flu I have ever had! This was my 2nd shot. After my first shot I had slight fatigue and a sore arm only.
Woke up 6 weeks ago and could not move (L) side. To Emergency Dept. Questionable stroke due to increased blood pressure. Stroke ruled out. Dr. did bloodwork. Pt was told she did not have Guillain-Barre but feels differently.
Temp of 103 for approx 24 hrs; extreme fussiness from 8PM to 6AM; lethargic the day p/vax given; 2nd day p/vax was acting normal again; examined by MD no abnormalities found; MD suggested Pertussis not be given;
pt recv vax in rt arm-little swelling @ site on Monday but on tuesday swelling inc @ iste;Wednesday arm swollen all over like a ballon;
Pt recv vax on unknown day; post vax pt exp redness, hives, itching at vax site w/ numbness; tx=Benadryl, ice, Atarax
Speedy racing heart; Bleeding nose; Red arm itchy; No appetite; Red arm itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Speedy racing heart), EPISTAXIS (Bleeding nose), PRURITUS (Red arm itchy), DECREASED APPETITE (No appetite) and ERYTHEMA (Red arm itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PALPITATIONS (Speedy racing heart), EPISTAXIS (Bleeding nose), PRURITUS (Red arm itchy), DECREASED APPETITE (No appetite) and ERYTHEMA (Red arm itchy). At the time of the report, PALPITATIONS (Speedy racing heart), EPISTAXIS (Bleeding nose), PRURITUS (Red arm itchy), DECREASED APPETITE (No appetite) and ERYTHEMA (Red arm itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Blood pressure measurement: high mmHg (High) Greater than 200.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were specified. No treatment information was provided.
TINGING IN THE RIGHT LEG, MOSTLY IN LOWER RIGHT LEG; NO APPETITE; SEVERE HEADACHE; MUSCLE SORENESS; NAUSEA; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 165 pounds, and height was 162.56 centimeters. 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 16:45 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced no appetite. On 13-APR-2021, the subject experienced severe headache. On 13-APR-2021, the subject experienced muscle soreness. On 13-APR-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) Headache - 9.5/10, Muscle Ache 7.5/10. Treatment medications included: paracetamol. On 14-APR-2021 20:30, the subject experienced tinging in the right leg, mostly in lower right leg. On 15-APR-2021, Laboratory data included: Pain scale (NR: not provided) Headache - 1 to 2.5/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinging in the right leg, mostly in lower right leg, severe headache, muscle soreness, nausea, and no appetite. This report was non-serious.
Pt was not in office when reaction occurred; was a few hours after administration of vaccine; she reported arm was painful and hot, from fingers to injection site, had to keep arm stiff, she went to the hospital, not treatment was given; reported this to my office on 2/2/2015.
Patient developed chills, shaking and shivering about 15 minutes after her shot. No fever. No allergic symptoms such as throat tightness, SOB, itching, rash or hives. No wheezing. Symptoms resolved slowly and progressively over about 50 minutes of observation. She has similar symptoms at home about 24 hours after her first shot. VSS stable throughout.  Initial BP 111/72, pulse 102, O2 sat 99%. No orthostasis at dismissal. Nothing to suggest vasovagal or allergic reaction. Likely anxiety reaction
Did not get the 2nd dose of the vaccine; Horrible headache; Could not think; Got very very sick; Could not eat; Could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Could not think) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced MENTAL IMPAIRMENT (Could not think) (seriousness criterion medically significant), ILLNESS (Got very very sick), DECREASED APPETITE (Could not eat), BEDRIDDEN (Could not get out of bed) and HEADACHE (Horrible headache). On 16-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose of the vaccine). In April 2021, MENTAL IMPAIRMENT (Could not think), ILLNESS (Got very very sick), DECREASED APPETITE (Could not eat), BEDRIDDEN (Could not get out of bed) and HEADACHE (Horrible headache) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose of the vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
PT had an adverse reaction to first dose of Pfizer and was advised to switch to Janssen by PCP.  No reaction to first dose of Janssen. This is her booster shot. At 1125 PT developed redness on chest, felt heat radiating from shoulders to neck, itchy throat, felt faint and swelling of eyes 9 minutes post vaccination.  Vitals at 1125 BP:195/118, SPO2: 100%, HR: 100.  At 1128 PT complained of feeling congested and feeling the need to clear throat, 1 tablet of 25mg PO of Benadryl was given to PT at 1128.  EMS was contacted and PT was transported at 1151. Last vitals at  BP: 182/93, SPO2:100%, HR:100.
Customer came to pharmacy 2 days later. Stated arm at injection site felt hot to touch was itchy and red, stated on day after injection. customer was counseled to apply cold compress, take BENADRYL and TYLENOL. Pt. will f/u with dr. if need be.
Pt was vaccinated with Pfizer vaccine on 1/24/21 and 2nd dose on 2/14/21. 2 days ago, pt presented to ER and admitted to hospital with COVID and PNA.  Pt also received Moderna booster 12/13/21.
Tightness in chest. Hourly Sharp pains on both sides of chest in heart region. Tingling in arm. Headaches. Shortness of breath. Dull lingering pain in chest.
Herpes Zoster - Information has been received from a registered nurse concerning a 41 month old female patient who on 17 Jan 1998 was vaccianted sc in the left arm with a first dose of varicella virus vaccine live (lot 624443/1106E).  Concomitant therapy included a first dose sc in the right arm of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation Msd lot 0620E diluent vial and a fourth dose in the left thigh of HIb/Titer Lot M265RT.  There were no illnesses at the time of vaccination.  On 27 Mar 2000 the patient developed shingles.  it was noted that the rash was located down her leg, on her lower abdomen, back and it stops at the midline and extends slightly to her groin.  The patient was seen on two separate occasions in the physicians office and was afebrile at both visits.  It was reported that the patient was treated with acetaminophen (-) codeine phosphate (tylenol - codenine for pain.  follow up information from a physician reported that the patient developed a vesicular rash with an crythematous base at the waist line from the mid back around to abdomen on the right side, consistent with herpes zoster.  On an unspecified date, the patient recovered.
hives; itching; patient never went back to get the second dose; This case was received via a Regulatory Authority (Reference number: MOD21-131443) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (itching) and PRODUCT DOSE OMISSION ISSUE (patient never went back to get the second dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.  Treatment medication for hives include Steroids.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced URTICARIA (hives), PRURITUS (itching) and PRODUCT DOSE OMISSION ISSUE (patient never went back to get the second dose). At the time of the report, URTICARIA (hives) and PRURITUS (itching) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient never went back to get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by reporter.  No concomitant medication reported.  Treatment medication for hives include Steroids.   Reporter did not allow further contact
Sore/Dry throat, difficult to swallow, fever, & chills lasting until 11/19/2009 2:00 AM, then all ended.
Information has been received from a registered nurse concerning a 3 year old male with asthma who on 08-nov-2005 was vaccinated subcutaneous in right arm with a dose of pneumococcal 23v polysaccharide vaccine.  The patient was given a flu shot (unspecified) in the same arm as pneumococcal 23v polysaccharide vaccine.  On 08-nov-2005, 6 hours after the vaccination, the patient developed a cellulitis reaction, 103 F fever, erythema and pain.  The pain was reported as recovered.  There was no product quality complaint involved.  A lot check has been requested.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with the standard and revealed that there were no open quarantines registered against this lot/fill.  Additional informational has been requested.
Employee reports had flu shot on 10-17-17 and immediately after had itching, swelling, redness. Reported this on 10/19/17 was better but still itching.
CONSTANT BURPING/ BURPING EVERY FEW  SECONDS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problems, and gerd (gastrooesophageal reflux disease), and other pre-existing medical conditions included patient currently took medications and had some medical conditions but nothing serious. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. 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 MAR-2021, the subject experienced constant burping/ burping every few seconds. On 04-MAY-2021, Laboratory data included: Nissen fundoplication (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant burping/ burping every few seconds. This report was non-serious.
Arm Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness). At the time of the report, PAIN IN EXTREMITY (Arm Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also include Inhaler and Hypertensive medicines. No treatment information was provided.   This case was linked to MOD-2021-209053 (Patient Link).
Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of Gardasil. Subsequently, the patient presented with a welt at the injection site. At the time of this report, the patient's outcome was unknown. This is one of 2 reports from the same source. Additional information has been requested.  Additional infromation is not expected.
Pfizer-BioNTech Covid-19 Vaccine EUA. Tiredness Chills Fever sore arm headache
Experienced seizure event on 5/11/2021 ER reports non- verbal upon admission, altered mental status, urine screen positive marijuana & benzodiazepines. Tested positive for Covid-19 5/11/2021 Hospitalized 5/11/2021- 5/18/2021. D/C diagnosis: Acute metabolic encephalopathy Active issues: hypolalemia, Seizure (HCC) , Covide infection, AKI (Acute kidney injury), elevated troponin, elevated LFTs.  Hospital Attending Hospitalist MD Consults: Doctor of teleneurology
Shortly after receiving vaccines patient became diaphoretic with grunting, nasal closing and retractions. Poor air exchange, Sats 89%, Pulses thready; Received O2, epinephrine, Benadryl, fluid bolus, Xopenex.  8/19/09 MR received for DOS 8/14/09 with dx: anaphylactic reaction.  Pt became pale, sleepy and diaphoretic with grunting and thready pulse. Tx with Benadryl and Epi and transported.  PE (+) for wheezes.  Monitored and d/c home on steroids.
I tested positive for Covid on 12-18-22 after starting a fever of 101.8 and later that evening a very sore throat and yellow/bloody sinus drainage.  This was just 4 weeks after the bi-valent vaccination and 110 days after my previous bout of Covid on Sept. 7th.  I had been taking Moderna for the first 4 vaccinations but took Pfizer this last time.  Did that make a difference?