chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RASH AND HIVES IN CHEST ABDOMEN BACK AND NECK; INJECTION SITE SORENESS; LOW GRADE FEVER; FATIGUE; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/illicit drug use. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. Concomitant medications included liothyronine for energy booster, ascorbic acid/biotin/calcium carbonate/calcium pantothenate/chromium nicotinate/colecalciferol/cupric oxide/cyanocobalamin/ferrous fumarate/folic acid/magnesium hydroxide/manganese gluconate/nicotinamide/phytomenadione/potassium iodide/pyridoxine hydrochloride/retinol/riboflavin/selenomethionine/sodium molybdate/thiamine hydrochloride/tocopheryl acetate/zinc gluconate, levothyroxine, and spironolactone. On 24-MAY-2021, the subject experienced body aches. On 24-MAY-2021, the subject experienced chills. On 24-MAY-2021, the subject experienced injection site soreness. On 24-MAY-2021, the subject experienced low grade fever. On 24-MAY-2021, the subject experienced fatigue. On 29-MAY-2021, the subject experienced rash and hives in chest abdomen back and neck. On 01-JUN-2021, treatment medications included: prednisone. Additional treatment medications (dates unspecified) included: diphenhydramine, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 26-MAY-2021, and injection site soreness, low grade fever, and fatigue on 25-MAY-2021, and had not recovered from rash and hives in chest abdomen back and neck. This report was non-serious.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2022 as dose 1, single (Lot number: PM 9992) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No other medication in 2 weeks. Past drug history included: Fentanyl, reaction(s): "known allergies: fentanyl", notes: known allergies: fentanyl.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound Covid six days after negative test; Positive, notes: Rebound Covid six days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: patient did not take any other medications with 2 weeks.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
within 15-30min of getting the vaccine the rashes and hives began to appear on my arms and shortly after my throat got tight and hard to breath. Went to the ER were they treated me. They determined it was anaphylaxis and prescribed an Epipen.
01/10/2022:  Event occurred after 2nd vaccine.   41-year-old female with a past medical history of hypertension and diabetes presenting to the emergency department with pleuritic chest pain over the last 2 to 3 days associated with coughing.  The patient states that she is COVID-positive and she tested positive on Wednesday (5 days ago), but has had COVID symptoms since New Year's Day (10 days).  She did receive the monoclonal antibody treatment this Saturday.  01/11/2022; Remains in hospital
Pt was given a booster dose of Pfizer vaccine before the minimal interval was met, no ill effect noted or reported
Patient was given an expired dose of polio vaccine. Polio vial expired 7-17-21 and was given 8-17-21. Showed no signs of reaction from dose.
Extreme sharp pain in node in left armpit bad enough to prevent sleep or movement. Moderate shooting pain from node down arm to hand. Extreme swelling of node in left armpit, the size of a plum. Used ice pack almost constantly for a whole day. Extreme pain decreased after 18 hours. Swelling decreased slowly for a few days.
Got out of bed at 8 am, within 5 mins felt nauseas, did not vomit, lost balance and vision, only returned when laying down for 14 min
Patient had syncopal episode in observation area about 10-15 minutes after receiving 2nd dose of Moderna vaccine.  Episode witnessed by wife who stated he "briefly lost consciousness" but denied any injury as he was already seated when it happened.  Patient taken to extended observation, where Dr  came down to assess.  Patient was alert, awake, oriented, and stated he felt "sweaty".  Patient laid flat on exam table with legs elevated.  VSS on RA.  Patient given orange juice and snack bar as he reported he had not had anything to eat since breakfast around 0900 today. Patient was observed for 90 minutes and reported dizziness when sitting and standing. Patient's vital signs remained stable. Patient was discharged with wife and was advised to go to emergency department per doctor's recommendation. Unknown if patient actually followed up with emergency department.
Pt developed facial flushing, throat itchiness and "chest tightness" post-vaccination. Pt with reported history of anaphylaxis. No shortness of breath or chest pain.    - Pt given 25mg diphenhydramine - Sxs gradually resolved without further intervention
Pt. awoke and parent found he had a bald spot on anterior scalp approx 2x3 cm triangular in appearance,no redness, no swelling, no pruritis.
This spontaneous report was received from a medical assistant (also reported as office manager) regarding unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medications were unknown. On 02-JUN-2017, 05-JUN-2017, 06-JUN-2017, 07-JUN-2017, 08-JUN-2017, 09-JUN-2017, 10-JUN-2017, 12-JUN-2017, 13-JUN-2017, 14-JUN-2017, 15-JUN-2017, 16-JUN-2017, 19-JUN-2017, 20-JUN-2017, 21-JUN-2017, 22-JUN-2017, 23-JUN-2017, 24-JUN-2017, 26-JUN-2017, 27-JUN-2017, 28-JUN-2017, 29-JUN-2017, and 30-JUN-2017, the patients were vaccinated with improperly GARDASIL 9 lot # M040412 (expiration date 30-JUN-2019) (route and dose unknown) for prophylaxis. No adverse effects were reported. There was no previous temperature excursion. The temperature excursion was from 32 degrees Fahrenheit (F) to 35 degrees F (34 degrees F) for 300 hours and 47 degrees F to 77 degrees F (52 degrees F) for 250 hours. This is one of two reports from the same reporter (1708USA010032).
23 y/o female AD SM is referred to the VHC by physician for possible 'urticaria' and other systemic symptoms after AVA #1 and #2. Pruritus Start: 08/17/2007 Comment: Patient developed itching across the upper chest/clavicular area the day following AVA #1. Rash, pruritic Start: 08/18/2007 End: 08/20/2007 Comment: Patient developed clusters of itchy, red bumps in patches across her upper chest, neck and upper back. Blurred Vision start: 09/12/2007 Comment: Patient described 'hazy vision' and 'like seeing in a tunnel' about 20 minutes after the 2nd AVA shot. Dizziness Start 09/12/2007 Comment: Patient describes a 'little dizzy' about 20 minutes after the 2nd AVA. No presyncope or syncope. Headache, general Start: 09/12/2007 Comment: Patient developed a headache about 2 hours after the 2nd AVA shot. No nausea, vomiting, photo- or phonophobia associated with this HA. Pruritus Start: 09/12/2007 End: 09/13/2007 Comment: Patient developed itching in the neck, upper chest area again after AVA #2 but no associated skin rash.
pt vaxed on 29JUN91 then devel local swelling & redness @ inject site;
1 minute after administration of the vaccine the person became diaphoretic and complained of dizziness.  His resp. rate was noted to be 22.  BP checked @ 314p was 67/38,  hr. 42.  He was given water, then  placed on the floor with his feet up.  Spoke to my medical director Arsalan Sheikh who recommended calling 911.  Informed pt. of same but he asked that they not be called.  Called pts. wife and informed her of the situation.  Rechecked BP @ 315, 70/39  hr. 42.  After lying prone for 6 mins. he reported feeling much better BP 119/66  hr 52, oxygen sat. 95%.   Please note the patient informed us upon entering for his shot that he didn't believe in it and was only getting it so that he could keep his job and appeared anxious.
headaches; stomach cramps; like if he had food poisoning; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), FOOD POISONING (like if he had food poisoning) and HEADACHE (headaches) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. In April 2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps) and FOOD POISONING (like if he had food poisoning). On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), FOOD POISONING (like if he had food poisoning) and HEADACHE (headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Headache could not sleep - fatigue - joint aches - muscle weakness  chills (with four blankets on) heat sweats
pt recv vax & w/in 24hr post vax & exp nausea, vomiting, fever of 102, & lumpy rash over whole body;rash is worse when is working;ER or MD visit was required;sx persist;
This spontaneous report as received from a consumer refers to herself: a female patient of unknown age. Medical history was not provided. On an unknown date the patient was vaccinated with GARDASIL. Concomitant medication was not provided. It was reported that on an unknown date the patient experienced drug reactions/allergies to GARDASIL. No further details were reported. The outcome of vaccine hypersensitivity is unknown. This case was linked to case 1312USA004322. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Vomiting-Severe, Additional Details: She became lightheaded, dizzy and hypotensive as measured by BP cuff. She looked pale and also mentioned that her hands felt numb. I had her put her legs up, gave her water, offered Tylenol & Benadryl but patient was too nauseous. Patient then vomited, color came back to her face and she immediately felt much better. I kept her here to observe & suggested a salty snack to help with BP. When she felt better & after a snack, I retook her blood pressure and it had improved.
Developed shingles-like rash on neck and chicken pox-like spots on stomach and legs that faded with the use of topical ointment/steroid over the next week
Information has been received on 2/28/02 from a licensed practical nurse concerning an adult female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 641130/1161L). Subsequently, within 24 hours of being vaccinated, the pt developed redness a few inches below the injection site on the inner aspect of the arm. The pt was treated with Keflex. The nurse also reported that an adult male pt had a similar reaction (WAES0203USA00045), as well as several cases in a doctor's office 'across the hall," (WAES0203USA00276). The reporter had questioned concerns with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. the lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-JUL-2014, the patient was vaccinated with a single dose of improperly stored PNEUMOVAX 23 and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 336 hours and then at 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for a total of 1000 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
almost like a heart attack; Sharp and intense pain in the heart; Fever; Chills; Swelling of the arm; Very lethargic; Nausea; Swelling at injection site; swollen injection site that is also hot to the touch.; injection site is still tender; This case was reported by a consumer via call center representative and described the occurrence of heart attack in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 31st October 2020, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMONIA VACCINE. On 31st October 2020, less than a day after receiving Shingrix and PNEUMONIA VACCINE, the patient experienced heart attack (serious criteria GSK medically significant and other: GSK Medically Significant), cardiac pain (serious criteria GSK medically significant and other: GSK Medically Significant), fever, chills, swelling arm, lethargy, nausea, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the heart attack, cardiac pain, fever, chills, swelling arm, lethargy, nausea, injection site swelling and injection site warmth were recovering/resolving and the outcome of the injection site tenderness was not recovered/not resolved.   It was unknown if the reporter considered the heart attack, cardiac pain, fever, chills, swelling arm, lethargy, nausea, injection site swelling, injection site warmth and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and Pneumonia vaccine in the upper left arm. Within 24 hours of receiving Shingrix and Pneumonia vaccine, the patient experienced the whole list of side effects.  The patient reported experiencing 3 separate incidents of pain in the heart that was sharp and intense almost like a heart attack, fever, chills, swelling in the arm, very lethargic, nausea, swollen injection site that was also hot to the touch.  The patient stated the hot and swollen injection site lasted until Wednesday night, on 04th November 2020.  She reported symptoms have improved, but injection site was still tender; it was no longer painful like before.  The patient reported seeing a cardiologist on a regular basis, and her heart was in great shape. The reporter consented to follow up. Not all information was available. It was unknown if the reporter considered the heart attack, cardiac pain, fever, chills, swelling arm, lethargy, nausea, injection site swelling, injection site warmth and injection site tenderness to be related to Pneumonia vaccine.
Initial report received from a healthcare professional on 01 July 2013. A 34-year-old female patient had received an intramuscular dose of ADACEL vaccine (batch number: C4385AA and site of administration was not reported) on 27 June 2013. The patient was pregnant. The patient's last menstrual period date was reported as unknown. The estimated date of delivery was not reported. At the time of the report, the patient had not experienced any adverse events. Patient health was good at the time of vaccination and risk factors were not reported. Concomitant medications and past medical history was not reported. Treatment for infertility was reported as unknown. Documents held by sender: none.
Patient reported intermittent pain from shoulder to elbow.  Reports small lump.  The pain has gotten better but still present at times.
w/in seconds of 1st vax rt arm pain/burning felt in beds of nails on middle 2 fingers rt hand; pain did not abate rapidly;pain on sides of fingers & in 1st free joints;2nd vax in other arm sl pain, flareup on rt w/in hrs;
Pt had 1 dose of Moderna @ hospital. Rec'd Moderna 3/5/21. Rec'd J&J 3/16/21
This 70 year old female received the Covid shot on  4/9/21    and went to the ED on  5/5/21   died on 5/5/21.
Information has been received from a consumer concerning a 24 month old female patient with no known allergies who in approximately 10/97 was vaccinated with a dose of MMR (second generation) (lot number not reported). There were no concomitant medications. In approximately 10/97, the patient experienced a high fever for 2 days after being given the vaccine. Subsequently, the patient developed autism. Unspecified medical attention was sought. Upon internal review, autism was determined to be an other important medical event (OMIC). Additional information has been requested. Reported on 02/27/2003: "The receptionist reported that the patient had not had an office visit since 10/12/2002.  Upon internal review, autism was determined to be an other important medical event.  Additional information has been requested.  Recorded on 03/26/2003: "Information has been received from a consumer, a receptionist at the physician's office and follow up information from a physician concerning a 12 month old (previously reported by the consumer as an approximately 24 month old) white female patient, who was born at 39 weeks gestation weighing 7 pounds and 12 ounces, and per the physician with no past medical history, no known allergies and who at the time of vaccination had a slight cough and cold for one day, but no fever.  The receptionist and physician reported that on 12/16/1996 the patient was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 618617/07340).  The physician reported that it was a first dose and the vaccine was given subcutaneously.  The consumer had reported that when the child was around 24 months, (estimated to be in approximately October 1997), the child was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # not reported).  per the consumer and physician, there were no concomitant medications.  The physician reported that on 12/16/1996 (previously reported per the consumer as around 24 months, estimated to be in approximately October 1997) the patient experienced a feer of 102 degrees Fahrenheit after having the vaccine.  The physician reported that the feer lasted for 2-3 days and got better with acetaminophen (Tylenol).  The consumer had reported that the patient experienced a "high fever" for 2 days after being given the vaccine.  The physician reported that the patient recovered from the fever after three days.  The consumer reported that subsequently the patient developed autism and unspecified medical attention was sought.  The receptionist reported that the patient had not had an office visit since 10/12/2002.  Upon internal review, autism was determined to be an other important medical event.  No further information is expected.
Noticed a lump and pain at injection site, scab still not healed. Next morning (4/10/2021) red heated circle around injection site and pain.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 103F-104.4F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever 103F-104.4F). At the time of the report, PYREXIA (fever 103F-104.4F) outcome was unknown. Not Provided. No concomitant product use was reported. No treatment information was provided.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received FLUARIX QUADRIVALENT (batch number 3FK72, expiry date 15th May 2017). This case was associated with a product complaint. Co-suspect products included FLUARIX QUADRIVALENT (batch number 3FK72, expiry date 15th may 2017). On 10th August 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) and FLUARIX QUADRIVALENT. On 10th August 2016, an unknown time after receiving FLUARIX QUADRIVALENT and not applicable after receiving FLUARIX QUADRIVALENT, the patient experienced underdose. On an unknown date, the patient experienced injection site pain, pharmaceutical product complaint and injection site pain. On an unknown date, the outcome of the injection site pain, underdose, pharmaceutical product complaint and injection site pain were unknown. The reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. The reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The reporter tried to administer a FLUARIX QUADRIVALENT vaccine in the left deltoid of the patient, she pushed the plunger and thought that she had pushed it down all the way. She indicated that she did experience some resistance when she first went to push the plunger but she thought that went away. She withdrew the needle and all of the medication was still in the syringe. The plunger appeared to only be partially depressed. She slightly pushed the plunger and noted that a little medication came out of the tip of the needle. This led to an underdose. She was unsure what the problem was but wanted to report it in case this situation was seen again. The reporter stated that she was an experienced user and had never experienced this before. She stated that it could be a problem with the needle she used or the syringe and was unable to sent back the syringe because she disposed of it in the sharps container. On the same day, the patient received another FLUARIX vaccine in the right arm. On 11th September 2016 (the day before reporting), the reporter talked with the patient and the patient stated that she had soreness at the injection site in both her left and right arms. Follow up information was received from QA department on 26th September 2016: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.
5 min after injection c/o itchy from shoulder to fingertips and erythema without resp signs and symptoms. 10 min later 50mg BENADRYL given QID x 3d. Prednisone 60mg everyday x3d given. BP 120/80 no acute distress.
Paper screening/admin form says Janssen was delivered 3/17, even though client got Moderna Dose 1 2/17. Clients CDC card states receiving Moderna dose 1 and 2 on 2/17 and 3/17. Discrepancy between CDC card and screening form/WIR entry of Janssen is irreconcilable, however either Moderna or Janssen would lead to a completed series of some kind.
Local tenderness and swelling over posterior aspect of left upper arm on 5/28/09 @16:53. Treatment: Ice to area 3-4 times daily, Medrol dose pack, Follow up with Employee Health on 05-30-09.
REDNESS AND EDEMA AT VACCINE SITE WITH  EXTRA WARMTH NOTED.