chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She doesn't think her 2nd booster dose  was 0.25 ml; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (She doesn't think her 2nd booster dose  was 0.25 ml) in a female patient of an unknown age 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (She doesn't think her 2nd booster dose  was 0.25 ml). At the time of the report, PRODUCT ADMINISTRATION ERROR (She doesn't think her 2nd booster dose  was 0.25 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. Patient received 4 shots of Moderna COVID-19 vaccine (2 primary doses and 2 boosters). Patient reported that the 2nd booster dose with start date year stated as 2022 didn't looked like 0.25ML. Nurse reported that the HCP refused to show the vial and told her 2.5ml but immediately corrected and informed as0.25ml. No treatment details were reported.
At 20:00, pt had nausea, followed by pain in left cheek radiating to left temple and down to jaw. A feeling of paralysis or numbness, lasting 2-3 hours, then disappearing.
tingling in their leg; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in their leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in their leg). At the time of the report, PARAESTHESIA (tingling in their leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Trouble breathing and extremely severe hives. Acute on chronic urticaria, improved over 5 days with high dose steroids. Breathing also improved slowly over same period.
Wide awake all night long. Pulse seemed normal and body was tired but mind was busy and awake all night. Then early morning started feeling nauseous and threw up bile (nothing in stomach) and then had diarrhea. Achy in stomach and back (flu like) still at 2PM.
light headedness very soon after shot, discomfort in chest, tingling in fingers, low blood pressure. several hours later very fatigued and slight body chills
Severe psoriasis flare and psoriatic arthritis flare.  Was well controlled before.  I had before only plaque psoriasis and this was a guttate flare.  Getting worse with time. Swollen and painful joints.
severe pain at injection site. (severely decreased ranch of motion starting 3-4 hours after injection) Severe facial pain the following morning. Insomnia due to being extremely hot and dehydrated. Increased thirst over the next 24 hours. Drank 5+ 16oz bottles of water in the next 12 hours. severely swollen lymph nodes in the axilla of the injected arm (painful and unable to properly move and use arm and hand due to pain and discomfort.
type II diabetes; This spontaneous report was received from a registered nurse, referring to a 61-year-old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant therapies were not reported.      On an unspecified date in 2010, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), as prophylaxis (strength, dose, frequency, route of administration, anatomical vaccination site, lot number and expiration date were not provided). The patient was 55-years-old at the time of vaccination. Afterwards, on an unspecified date in 2016, she was diagnosed with Type II diabetes (type 2 diabetes mellitus). Then, on an unspecified date in 2018, at the age of 63-years-old, she was administered pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (strength, dose, frequency, route of administration, anatomical vaccination site, indication, lot number and expiration date were not provided). On an unspecified date in 2019, at the age of 64-years-old, she received a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route of administration, anatomical vaccination site, lot number and expiration date were not provided) as prophylaxis.         At the reporting time, the event  type 2 diabetes mellitus was ongoing. It was reported that the patient sought medical attention, and was provided metformin as treatment for the event.   The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the event was not provided.  Upon internal review, the event type 2 diabetes mellitus was determined to be medically significant.
Pfizer-BioNTech COVID-19 Vaccine EUA: three days after immunization patient hospitalized for hyponatremia, decompensated cirrhosis, and mesenteric thrombosis. Given albumin, sodium, antibiotics, and continued anticoagulation. Discharged to home medically stable.
Information has been received from a certified medical assistant referring to a 53 year old female patient. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On 22-JAN-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # L029073, expired date 19-APR-2017, one single dose, subcutaneous) in the arm. On an unknown date in January 2016 the patient experienced pain in the arm at the injection site, decrease in range in motion of arm, had trouble moving her arm above head. The pain woke the patient up, that pain had worsen and was in the armpit at the time of reporting after receiving PNEUMOVAX 23. The patient was given TYLENOL as treatment. The outcome of the adverse events was reported as not recovered. The patient had called the physician for medical attention. Additional information has been requested.
Three days after vaccination I incidentally had blood pressure checked and systolic was 20 points higher than usual. I asked for a recheck. 155/86, 160/83. Before this, it was most recently ~ 135/82.  Note: It had NOT been checked very recently and it was NOT checked before or after shots 1 and 2 (February 23, March 26 2021).
Herpes zoster in 2-dose varicella vaccine recipient. Symptoms: rash on left side of belly. Duration: less than 4 weeks. No antiviral treatment.
This case was reported by a pharmacist via sales rep and described the occurrence of vomiting in a patient who received FLUARIX QUADRIVALENT for prophylaxis. On 18th October 2018, the patient received FLUARIX QUADRIVALENT. On 18th October 2018, less than an hour after receiving FLUARIX QUADRIVALENT, the patient experienced vomiting, nausea and diarrhea. On an unknown date, the outcome of the vomiting, nausea and diarrhea were unknown. It was unknown if the reporter considered the vomiting, nausea and diarrhea to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at the vaccination was not reported. The reporter was reached out to by their medical director because they had a patient presented the day before reporting within 1 hour of receiving the vaccine with what was considered grade 3 gastrointestinal symptoms (vomiting, nausea and diarrhea). This typically was not a side effect they had seen with flu vaccine, but they realized it was listed. This case was linked to the case US2018GSK192197, reported by the same reporter.
Site: Pain at Injection Site-Medium, Additional Details: patient said muscle soreness and still unable to move arm fully up or backwards
Severe headache, body aches, stabbing pains in joints, nausea, fever (101.2) and major fatigue within 16 hours of receiving first dose of the vaccine.   Took 2 extra strength tylenols  8 hours after onset of the symptoms, and then every 4-6 hours after that.  Symptoms did not go away.  36 hours later, severe headache, nausea, stabbing pains in joints and low grade fever( 100.0) persisted.  48 hours later, fatigue, headache and nausea  continue with mild case of diarrhea.
03/30/2006 08:30 client's mother calls and states patient had a reaction to a vaccine.  Mother stated his left arm is swollen from his shoulder to elbow.  Encouraged Mom to apply ice to decrease swelling.  Mom stated it was red and very swollen.  Mother stated she did not have a doctor.  Encouraged Mom to apply ice and call at 2PM.  Mom called at 2PM stated swelling was not any better.  Encouraged mother to take patient to emergency room.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 29th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and Influenza vaccine Quadrivalent 2018-2019 season. On 30th October 2018, 1 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced headache, chills and nausea. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache was recovering/resolving and the outcome of the chills and nausea were resolved with sequelae. It was unknown if the reporter considered the headache, chills and nausea to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: On Monday, the patient got a dose of SHINGRIX. He also got a flu vaccine right before the SHINGRIX vaccine. The next day the patient experienced headache, chills and nausea. The patient had been taking TYLENOL to treat the symptoms. At the time of reporting, the patient still had a bit of a headache, but the chills and nausea had resolved. The reporter gave consent to contact the safety physician and provided contact details for the same. The reporter refused to provide his own address, but he did grant permission to contact his healthcare professional.
This case was reported by a physician via call center representative and described the occurrence of injection site rash in a adult female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema and injection site swelling. In August 2018, the outcome of the injection site rash, injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The healthcare professional was unsure of the date the dose was given, but stated it was in middle August. Beginning 2 days after receiving SHINGRIX, the patient experienced a red, raised, swollen, rash area, below the injection site, which resolved after 4 days. No treatment was required. The vaccine was administered at the patient's pharmacy and not by the reporting doctor.
Soreness/ achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness/ achiness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM, HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Soreness/ achiness). At the time of the report, PAIN (Soreness/ achiness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-418822, MOD-2021-419686, MOD-2021-419760 (Patient Link).
Fever blisters; Fevers; This spontaneous case was reported by a nurse and describes the occurrence of ORAL HERPES (Fever blisters) and PYREXIA (Fevers) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Dec-2021, the patient experienced ORAL HERPES (Fever blisters) and PYREXIA (Fevers). At the time of the report, ORAL HERPES (Fever blisters) and PYREXIA (Fevers) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-411041 (Patient Link).
COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a 62-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 an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 07-Mar-2021, the patient received their first dose of Moderna vaccine and was diagnosed with COVID on an unspecified date post receiving their first dose of Moderna vaccine.   Reportedly, the patient was scheduled to receive their second dose of Moderna vaccine on 10-Apr-2021.  No Concomitant product use was reported. No treatment information was provided.
c/o swelling & warmth @ inj site 15mins post vax;subsided considerably p/application of ice compress;no other complaint, no rashes, no SOB or tightness of throat/chest;pt kept @ clinic for over an hr post vax;advised to cont ice compress
Ringling in ear. Has happened twice since vaccine was administered on Saturday. It happened on Sunday and today, Monday.
sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.
Initial report received on 25 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3591AA received on 14 April 2010, lot number C3805AA received on 12 May 2011 and lot number C3967AB received on 13 January 2012 (routes and sites of administration not reported). The subject developed a cough on 19 September 2012, approximately 8 months after the last dose. Paroxysmal coughing began on 22 September 2012. The subject also experienced cold-like symptoms and posttussive vomiting (dates not reported). Laboratory testing included positive PCR on 24 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 04 October 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
A day after shot, March 15, severe discomfort in right leg, could not find one comfortable spot to sit or lay, leg became weak and numb, difficulty walking and standing.  Did not sleep for 3 nights because of discomfort.  Went to urgent care March 18, prescribed muscle relaxants and steroids, March no effect.  Leg was painful and numb across front of thigh and down to right ankle, severe weakness, giving out when walking.    Emergency room visit March 19, 2021 given IV meds of  Toradol, fetanyl, Lidoderm, Prednissolone and oral Valium.  Slight relief for 1 or 2 days.  Leg numbness did not subside.   April 17 returned to urgent care worried about continuing numbness and tingling in leg.  Sent for an ultra sound to check for blood clots. Began physical therapy April 17.  Some improvement to strength but numbness continues.  May 10 begin to have numbness and tingling in arms and face as well.
Developed a rash lasting from days 3-11, located just below and towards the inside of the injection site. The area was bright red and itchy, and eventually welted. It has since resolved.
Pretty much been a mess today with headache; Body aches; Chills; Fever; This spontaneous case was reported by an other and describes the occurrence of HEADACHE (Pretty much been a mess today with headache), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On 01-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) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (Pretty much been a mess today with headache), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, HEADACHE (Pretty much been a mess today with headache), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.
No aditional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 06-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S023499 and expiration date 24-AUG-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Patient with nausea, vomiting, fatigue and arm pain. "Bedridden" for 4 days.
Suspected vaccination failure; also on my right foot; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the dose of Shingles vaccine and had shingles. It was stated that patient also on his/her right foot and had the shot. 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. This case was linked with US2021AMR097825 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR097825:
about an hour after the injection uncontrollable coughing for about 30 min. and heavy sweating. did not do anything different or new after the shot just drove home and walked up 3 flights of stairs as; about an hour after the injection uncontrollable coughing for about 30 min. and heavy sweating. did not do anything different or new after the shot just drove home and walked up 3 flights of stairs as; This is a spontaneous report from a contactable consumer (patient) reported for herself. An 18-years-old (non-pregnant) female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 mRNA Vaccine, Solution for injection, bath/lot number: ew0186), via an unspecified route of administration in left arm on 16Jun2021 at 16:00 (at the age of 18-years-old) as single for COVID-19 immunisation (lot unknown reason: Not available/provided to reporter at the time of report completion). The patient's medical history and concomitant medications were not reported. No covid prior vaccination. The patient was not aware that she had any known allergies. No other vaccine in four weeks. On 16Jun2021, the patient experienced about an hour after the injection uncontrollable coughing for about 30 min. and heavy sweating. did not do anything different or new after the shot just drove home and walked up 3 flights of stairs as usual. No covid tested post vaccination. No treatment received. The outcome of the events was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Patient received his 2nd Moderna vaccine. Afterwards as he was waiting his required time to sit, he got up to move to a different chair and fainted, hitting his head on the plexiglass of pharmacy window and knees on the floor. He also had not eaten that day. His wife gave him peanut butter crackers, and we gave him water and an ice pack. He had no injuries and was able to walk out on his own.
This patient began having vague flu like aches 1/2 hour after receiving vaccine. Four hour later she had a temp of 100, very bad flank pains, and nausea (mild).
Information has been received from a registered nurse concerning a female patient with no pertinent medical history or no known drug allergies, who on 23-MAR-2009 was vaccinated with 0.5 ml of the first dose of GARDASIL intramuscularly. In approximately April or May 2009 did not have her menstrual cycle. She did have her menstrual cycle in June 2009 so not believed to be pregnant. She did report unprotected sex but that was in June 2009 not during the time of the amenorrhea. The patient sought medical attention in the office physician. Additional information has been requested.