chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning several females who were vaccinated with Gardasil.  Subsequently all the patients experienced stinging at site.  Subsequently, the patients recovered.  On 14-MAY-2007 the nurse indicated that she could not confirm a number of patients but that she had given over 100 shots and all of the female patients "complain after receiving it."  She also reported that "it did not matter what shot in the series it was."  Additional information has been requested.
Had a rash that appeared about one hand width away from the injection site on the left leg.  Was itchy, itchiness and rash resolved with Benadryl (as directed by physician.)  Later that day did not recur.
Tongue swelling throat tightness at 20 minutes after injection  3/26/2021.   Swelling in face red checks  pink blotches all over body.  Extreme whole body itching throat is still a little  tight swelling in tongue mild
LOW PLATELET COUNT; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, and cigarette smoker, and other pre-existing medical conditions included the patient has no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced low platelet count. Laboratory data included: Platelet count (NR: 150 - 450) Platelets 138. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low platelet count was not reported. This report was non-serious.
Within 1 hour of receiving the Hib vaccine, our son clenched both arms in front of him, head got completely red and body shook and he was groaning for apprx 30 seconds. His eyes appeared vacant. The right side of his body was tense on 3 occasions. He stopped using his right hand, clubbed things he used to grab with left hand, stopped smiling, laughing, clapping and waving. He did not recognize/respond to his parents the next morning,stopped responding to pain, the list goes on. He cried and screamed throughout the night for the first week and we now observe absent seizures. He has continued to display behavior completely uncharacteristic to himself and can no longer eat the foods he once ate with no reactions.
Due date 10/15/2021 Baby has cleft lip/palate. Does not run in either family whatsoever.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 26-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administration date 2021 (Batch/Lot number: unknown) at an unspecified age as dose 2, single and via an unspecified route of administration, administration date 2021 (Batch/Lot number: unknown) at an unspecified age as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test (COVID-19 home test): (Dec2021) positive. Additional information: The reporter was asking how long they have to wait after testing positive for COVID-19 to get the booster shot. Someone told the reporter 3 weeks and someone else told the reporter 90 days, so just wanted to het the right answer.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Causality cannot be excluded for the serious event tested positive for Covid-19 and the suspect vaccine BNT162B2.,Linked Report(s) : US-PFIZER INC-202200131930 same reporter/drug, different patient, similar event.
Patient received booster dose, rather than 3rd dose. Booster dose volume 0.25mL (50mcg) and third dose volume 0.5mL (100mcg). The error was discovered upon administration of her booster on 3/30/2022, when it was realized the recorded dose was insufficient. Patient states she was tested for COVID-19 infection on multiple occasions since her third COVID-19 vaccine, but did not have a positive result. She said felt better after her third and fourth doses than after her first and second, which she thought could be attributed to the lower dose of each.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported. ). On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm). At the time of the report, VACCINATION SITE PAIN (pain in arm) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information not provided. Concomitant medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-053044 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-053044:CROSS LINKED WITH WIFE CASE.
Patient indicated that  after her vaccine she had an immense reaction of body aches, and flu like symptoms that occurred within the day. She has continued to have side effects of muscle aches and chills per the patient for the past 8 days and is following up with the provider to find out if there are any underlying conditions occurring.
5-6-12 Decreased appetite & vomiting x 2. 5-7-12 Watery diarrhea x 6 - & seen at ER.
2 TIA's one day apart went to ER s7 testspent 2 days in hospital had 17 tests Am now shedding the vaccine with 5 symptoms of feeling drugged, running nose, trouble sleeping , headaches  dihearra
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. On 12-JUN-2014 the patient was vaccinated with first dose of PNEUMOVAX 23, inejction (dose and lot number unknown), intramuscular. On 17-OCT-2014 the patient was inadvertently received another dose of PNEUMOVAX 23 (intramuscular) (dose and lot number was unknown). No symptoms were reported. No product quality complaint was involved. The outcome of the event was unknown. Additional infomration has been requested.
2 hrs post admin of vax, PT presented w/redness and itching, bilateral forearms. PT was advised to take Benadryl. Immediately after taking PT had relief of Sx's.
69y/o F Hospital Course and Significant Findings: # COVID PNEUMONIA Symptom onset on 7/26 - 7/27. Patient reported dizziness, fatigue, SOB, cough, with a few episodes of diarrhea. She brought herself to the hospital and was found to be COVID positive on 8/4. Patient reports receiving 2/2 vaccination (last in March 2021). Patient was given one dose of 6mg decadron which was not continued due to stable respiratory status and poorly controlled blood sugars. Received 5x doses of remdesivir (8/5-8/9). Patient continues to sat ~95% on room air, however reports some SOB on ambulation. Patient showed clinical improvement but CRP trended upwards to 13 prompting further monitoring. CRP decreased to 12.6 on 8/10 and she continued to show clinical improvement, saturating well on room air. D-dimer also trending down on day of discharge (0.67 -- > 0.6). Patient discharged with oxygen PRN. Told to self-isolate 20 days since symptom onset (until 8/14).    #DM2 Hgb A1C 10 on 7/31/21. Patient says she has been adhering to insulin regimen at home and has not missed injections but reports frequent blood glucose measurements in the 200-300s range. Throughout hospitalization, patient blood glucose was elevated so regimen escalated to insulin sliding scale, with 2u insulin before each meal, and 15u NPH bid. Discharged on home regimen.   Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  COVID Pneumonia
Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022; Pharmacy gave Moderna COVID-19 vaccine past its beyond use date to 21 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022) in a 62-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its beyond use date to 21 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Pharmacist does not know which arm the patient received the Moderna COVID-19 vaccine in. The Pharmacist does not have any other adverse events or side effects to report. The Pharmacist wrote an expiration date of 24-MAR-2022 on the Moderna COVID-19 vaccine instead of 24-FEB-2022.The Moderna COVID-19 vaccine was transferred from the Freezer to the Refrigerator on 24-JAN-2022. No concomitant and treatment medication were reported by the reporter.
Patient noted that she had the Hep. B vaccine a couple weeks ago. C/O legs, arms, tingling and heavy. Dry mouth, flushed, nausea, headache,  NO rash, or difficulty swallowing, site of flu vaccines free from swelling or redness. Blood Pressure monitored. 8:40- 148/98, Pulse 106 Treatment Initiated: Benadryl 25 mg, orally by request of patient. Symptoms started at 8:40 a.m. and continued to 9:07 a.m. at which time she was driven by a coworker to the ER. BP 8:45 a.m.-102/88, Pulse 104 8:50 BP- 137/88, Pulse 97 9:00 BP-144/110 Pulse 103 9:05 BP-132/103 Pulse 102 R- 20.
Cellulitis left deltoid. Keflex 250mg quid x 7 days
DEVELOPED FEVER NEXT DAY, THEN PROFOUND FATIGUE FOR PAST 8-9 DAYS, LEADING TO FALLING ASLEEP AT THE WHEEL OF CAR TODAY DESPITE SLEEPING 11 HOURS LAST NIGHT.   LABS SHOW SUSPECTED BACTEREMIA, STARTING PT ON ANTIBIOTICS FOR 10 DAYS, CULTURES PENDING.
weak; tired; swell around ear; swell around head; very pain full; This case was reported by a consumer via (GSK Chatbot) interactive digital media and described the occurrence of weakness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2021, the patient received Shingrix. In September 2021, less than 2 weeks after receiving Shingrix, the patient experienced weakness, tiredness, ear swelling, swelling and pain. The patient was treated with antivirals nos. On an unknown date, the outcome of the weakness, tiredness, ear swelling, swelling and pain were unknown.   It was unknown if the reporter considered the weakness, tiredness, ear swelling, swelling and pain to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient was weak and tired post vaccination. The patient had swelling around the ear and head and it was very pain full.  The patient was treated with antiviral medications.  The patient asked if he/she was contagious.
severe cramping in my back muscles causing me pain and to be bent over unable to stand straight and restricting my breath
Patient presented to the pharmacy with a warm itchy rash on the inside of her right arm. The redness didn't start at the injection site but rather about 2 inches away from injection site and went down and underneath arm.
first dose of Shingrix in 2018 / like to get her second dose today? Does she have to restart the series?; This case was reported by a other health professional via (Shingrix) and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time if reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. The reporter asked whether the patient get her dose today of if she need to restart the series.
Menstruation started 5 days early. I  have a 27-28 day cycle and my period started on day  22 and it was unusual. Much heavier flow than usual.
fLUBLOK ADMISTERED, PATIENT 17 YO. NO ADVERSE REACTIONS AS OF 11/2/21
Itchy rash from thighs to feet covering 30% of lower extremities. Improved after 2 oral Benadryls. no other complaints or symptoms.
Pt received Varivax in 1996. Presented to office on 12/22/03 with chickenpox vesicles.
Pain at injection site.  Red, blotchy patches and increased visibility of veins and arteries.  Patient took 650mg of acetaminophen three times a day - that helped with pain.  Still unresolved at time of this report
Pneumonia; Viral titer decreased; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (Pneumonia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and VIRAL TITRE DECREASED (Viral titer decreased). At the time of the report, PNEUMONIA (Pneumonia) and VIRAL TITRE DECREASED (Viral titer decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: inconclusive (Inconclusive) Viral titer decreased, Less than 60 of titer in blood.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Concomitant medications were not provided. Treatment information was not provided.  Company Comment  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.   This case was linked to MOD-2021-198286 (Patient Link).; 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.
sore arm at the injection site; left neck pain; left elbow pain; skin sensitivity; weakness; flu-like symptoms; my whole body is sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm at the injection site), NECK PAIN (left neck pain), ARTHRALGIA (left elbow pain), SENSITIVE SKIN (skin sensitivity) and ASTHENIA (weakness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE PAIN (sore arm at the injection site), NECK PAIN (left neck pain), ARTHRALGIA (left elbow pain), SENSITIVE SKIN (skin sensitivity), ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (my whole body is sore). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (sore arm at the injection site), NECK PAIN (left neck pain), ARTHRALGIA (left elbow pain), SENSITIVE SKIN (skin sensitivity), ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (my whole body is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported.
Patient presented on 9/11/17 with a bruise roughly the size of a nickel.
Left upper arm (deltoid) slight swelling, erythema, warm to touch. To use Tylenol for discomfort
2 hrs poxt vac, experienced stiffness and dull pain in l/arm. 12/7/99 pt expereinces elbow area swelling, red, hot to touch. 12/8/99, still felt dull pain at touch, less swollen, less red, moving arm.  12/14/99, no pain, swelling, redness.
Pt. developed bruise, redness, warm to touch at site and around site of injection for about 5 days after receiving injection.
Low grade fever, chills, severe headache, muscle ache, joint pain, fatigue, foggy cognition
I went to have a minor surgery on my hand and they took my blood pressure and my pressure was elevated. I contacted my doctor because my pressure stayed high. I increased my blood pressure meds and it was able to stabilize.
This spontaneous report as received from a registered nurse refers to an 18 year old female patient with no reported medical history. On 24-JUN-2013 the patient was vaccinated with GARDASIL lot # H021861, 0.5 ml, intramuscular. No other suspect therapy or concomitant medication was reported. On 24-JUN-2013, a few minutes after administration, the patient experienced that her head was thrown back and her arms were jerking. "The patient then closed her eyes for a second and opened them and she was alert and coherent". The patient then said "What just happened? That was really weird". The nurse reported that the patient was "extremely pale and dizzy" and was taken to a room in the physician's office to "eat crackers and water and lay down". The patient then stated that "her face and hands were tingling". The nurse reported that the patient's "blood pressure and heart rate were check and they were fine". The patient remained in the office for "about an hour" at which time "she was feeling better and was able to walk out of the office". The nurse reported that the patient "had gone running in the morning and had not eaten before receiving GARDASIL". "The physician had given the patient water and crackers to eat" before GARDASIL was administered. No treatment information was reported. The outcome of after administration the patient's head was thrown back and her arms were jerking, dizzy, her face and hands were tingling and extremely pale was reported as recovered/resolved. The reporters relatedness of after administration the patient's head was thrown back and her arms were jerking, dizzy, her face and hands were tingling and extremely pale to GARDASIL is unknown. Additional information has been requested.
Client reported developing a headache approximately 30 min. after receiving vaccine for which she took 2 Tylenol.  At 2:20, B/P was 190/100, HR 84, and O2 sat 99%.  At 2:28, B/P was 200/110, HR 86, and O2 sat was 99%.  Client refused ambulance and her husband picked her up at 2:31.  He reported that he would take her to the MD or ER.
Following 1st dose of Recombinant developed pruritic papular skin lesions, arthralgia; P/2nd dose Recombinant skin rash recurred began tx w/Penicillin for a sore throat; 4 days later developed pruritic urticaria & macular rash;
Rash, fever 102, h/a over 1st 24 hrs then resolved in another 24 hrs;
Red Rash appeared at site location, noticed today, 3 days after getting flu shot. Slightly raised red rash is 1 inch by 3 inches. Never had a rash appear. No other reactions or issues so far.
Dizziness, Headache, ErythemaMultiform, HYPERtension, diaphoretics Narrative:
Chest pain /  woke up to soreness of the chest; Pressure in the chest, Tightness in chest; sensation of throat closing; Difficulty breathing / I could not breath; Numbness in my feet; Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain /  woke up to soreness of the chest), CHEST DISCOMFORT (Pressure in the chest, Tightness in chest), THROAT TIGHTNESS (sensation of throat closing), DYSPNOEA (Difficulty breathing / I could not breath) and HYPOAESTHESIA (Numbness in my feet) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced MYALGIA (Soreness of the arm). On 22-Jul-2021, the patient experienced CHEST DISCOMFORT (Pressure in the chest, Tightness in chest), THROAT TIGHTNESS (sensation of throat closing), DYSPNOEA (Difficulty breathing / I could not breath) and HYPOAESTHESIA (Numbness in my feet). On 22-Jul-2021 at 8:50 AM, the patient experienced CHEST PAIN (Chest pain /  woke up to soreness of the chest). The patient was treated with NAPROXEN from 06-Aug-2021 to 18-Aug-2021 at a dose of 200 microgram twice a day. On 13-Aug-2021, CHEST DISCOMFORT (Pressure in the chest, Tightness in chest), THROAT TIGHTNESS (sensation of throat closing), DYSPNOEA (Difficulty breathing / I could not breath) and HYPOAESTHESIA (Numbness in my feet) had resolved. On 13-Aug-2021 at 4:15 PM, CHEST PAIN (Chest pain /  woke up to soreness of the chest) had resolved. At the time of the report, MYALGIA (Soreness of the arm) outcome was unknown.        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.   Patient had started Concomitant medication on 12-MAY-2021 Natures bounty-iron (28mg, 1 day for vitamin D) and on 24-JUN-2021 It works-slim gummies(400 mg. 4 day) to reduce fat.  Patient was received 2nd dose on 15-AUG-2021 in right arm and batch no.017E21A.  Patient had an follow up visit with cardiologist on 13-SEP-2021.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Significant FU received contains second dose information,& Events added like sensation of throat Closing,Chest tightness,Numbness,Difficulty breathing.