chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme pain in the left stomach and back; Extreme pain in the left stomach and back; Extreme pain in the chest and abdomen area; Extreme pain in the chest and abdomen area; Vaccinated arm got a lot of muscle soreness; Fever; Heart beat so fast; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received unknown dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) via an unspecified route of administration in the arm left on 24Apr2021 at 12:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any other medications within two weeks of COVID-19 vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in 2021, the patient experienced heart beat so fast and fever. On 24Apr2021, the patient experienced muscle soreness of vaccinated arm and about 6 days later, arm was no longer have any soreness. On 30Apr2021 (on 6th day) the patient got extreme pain in the chest and abdomen area. It was reported that, it was happened when the patient was sleeping. It was so painful that the patient had to wake up in the middle of the night. The patient cannot  even lie down on the bed. On the 8th day, chest and abdomen pain went away. On an unknown date in May2021, the patient got extreme pain in the left stomach and back and it was still painful. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event muscle soreness was recovered on an unknown date in Apr2021, while that of extreme pain in the chest and abdomen area was recovered on 02 May2021. The clinical outcome of the event extreme pain in the left stomach and back was not recovered while the clinical outcome of the events heart beat so fast and fever were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
patient was given PNEUMOVAX23 that was recalled; Incorrect Product Storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 22-OCT-2020, the patient was vaccinated with a recalled, improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # S036495 with expiration date 13-SEP-2021) via an unknown route for prophylaxis. No other adverse event information was given at this time. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Redness and rash, swelling and bump, itching at the injection site developed seven days after the initial dose. The redness and swelling grew to approximately 4" across and 5" long. Treated the rash and itching with topical Benadryl, and the rash, swelling, and itching subsided.
On September 1 arm became warm and itchy. On September 3 area around injection site became red and swollen, swelling went around entire circumference of arm.  On September 8 lymph node swelling in right axilla with difficulty moving right arm. On September 14 hard cord under right axilla with sharp pain on extension of right arm.
sore arm; rash; headache; This case was reported by a consumer and described the occurrence of pain in arm in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On 15th December 2020, unknown after receiving Shingrix, the patient experienced pain in arm, rash and headache. On an unknown date, the outcome of the pain in arm, rash and headache were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, rash and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had headache, rash and sore arm . The patient was on his or her 4th day. The patient was still not feeling well and stated they would wait a day more. The patient asked about the duration that the side effects lasts.
11 hours after influenza shot had fever with seizures. Emesis x 3. Went to ER- received Motrin. No further treatment.
No adverse event noted.  Patient tolerated vaccine.  Second dose given too early.  First dose given on 5/8/2021.
Arthralgia, UrticariaPruritus, chills, injection site pain/arm pain, fatigue Narrative:
This spontaneous report as received from a physician assistant refers to an adult female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with an unknown dose of PNEUMOVAX 23 (route, lot # and expiry date were not reported). Concomitant medications were not reported. On an unknown date, after the vaccination, the patient experienced swelling of the whole arm. The patient was in Emergency Room, where she was told that the reaction was probably due to latex in PNEUMOVAX 23. The reporter wanted to know if the vaccine actually contained latex. The outcome of the event was reported as recovered/resolved on an unknown date (reported as "the patient was fine now"). The relatedness between the events and PNEUMOVAX 23 was not assessed by the reporter. Additional information has been requested.
fainted immediatley with slight jerking motion.  B/P 80/40, pulse 60.  Woke a couple seconds later very cold, shaky, 80/50.  Very diaphoretic, pale, weak.  Client did not eat this AM.  Had "bad taste in mouth" Client stayed lying down for 30 minutes before she felt strong enought to stand.  Last B/P before leaving was 80/50.  Gave her a glass of apple juice.
From initial information received on 4/27/04 regarding an adverse event occurring in the USA, it was reported that a four year old male patient received an IPOL vaccination, lot number W0460, administered in the right thigh, an MMR II vaccination, lot number 644415/1008M, administered in the left arm, a VAQTA vaccination, lot number 643816/1061M, administered in the right thigh, and an INFANRIX vaccination, lot number SS7A2, administered in the left thigh on 2/10/03. 15 days later on 2/25/03, a registered dietitian reported that in February 2003, the patient lost all of his hair. The patient's mother noticed a patch on the back of the boy's head the day after vaccination, and within two weeks all of his hair was gone. On 1/14/04, the patient's hair had not returned. In follow up information received from the patient's mother, it was reported that the patient had allergies to soy and peanut products. She also reported that on 2/10/03, the patient received his second dose of VAQTA. The first dose was given on 12/11/03. It was reported that the patient was not ill at the time of vaccination. The reporter indicated that the patient received four shots in one day and about two weeks later, on 2/25/03, the patient had bad stomach aches and had to go to the doctor for diarrhea. Reportedly, the patient woke up with a bald spot the size of a quarter and within three months he had no hair, eyebrows, or eyelashes. The patient's mother noticed a different behavior, almost like she had a different child. She reported that the patient had memory loss on and off. The change in the patient's behavior was noticed by the mother after vaccination with VAQTA on 2/10/03. According to the reporter, the physician diagnosed the patient with alopecia. The patient's experiences were considered to be disabling by the patient's mother. Additional information has been requested. The patient has not recovered from these events. From additional information received on 10/May/2004 from another manufacturer, ID number WAES0401USA01070, it was reported that the change in the patient's behavior was noticed by the mother after vaccination with the first dose of hepatitis A virus vaccine inactivated (manufacturer, lot number and administration information not reported) on 11/Dec/2002 (also reported as 11/Dec/2003) and the hair loss after vaccination with the second dose of hepatitis A virus vaccine inactivated on 10/Feb/2003. This report was previously sent to PLA V205C.
Left arm was a bit stiff; Allergy reaction to the bandage; Left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Left arm was a bit stiff), PAIN IN EXTREMITY (Left arm hurt) and HYPERSENSITIVITY (Allergy reaction to the bandage) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Left arm was a bit stiff), PAIN IN EXTREMITY (Left arm hurt) and HYPERSENSITIVITY (Allergy reaction to the bandage). At the time of the report, MUSCULOSKELETAL STIFFNESS (Left arm was a bit stiff) and HYPERSENSITIVITY (Allergy reaction to the bandage) outcome was unknown and PAIN IN EXTREMITY (Left arm hurt) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient was not on any concomitant medication. No treatment was given to the patient.   This case was linked to MOD-2022-465764 (Patient Link).
Fainted/Passed Out a few minutes after administration of injection. Lost consciousness for less than 1 minute. 911 called. Determined patient had adverse vasovagal syncope after injection. Would like procedure for all flu shot providers to include sitting for 10 minutes following injection to prevent avoidable potential fall and further injury.
No other adverse events; temperature excursion occurred/ ROTATEQ was administered at the temperature excursion occurred; This spontaneous report was received from a physician assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 18-MAR-2021, the patient was vaccinated with incorrectly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1707585 with expiration date on 21-FEB-2022, 2 milliliter, orally for prophylaxis. The vaccine underwent a temperature excursion of 35.4 degrees Fahrenheit for 1 hour and 13 minutes. Digital data logger was not involved.
Information has been received from a pharmacist who reported on 23-OCT-2012 one unspecified patient received expired ZOSTAVAX (Merck) (lot #0618AA exp date 26-JUL-2012). The patient was not experiencing any known symptoms. The outcome was unknown at the time of report. This is one of several reports received from the same source. Additional information has been requested.
difficulty breathing/coughing/sore throat/dyspnea/diagnosed with pneumonia; difficulty breathing/dyspnea/diagnosed with acute chronic obstructive pulmonary disease exacerbation; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history and concomitant medications was provided. His concurrent conditions included chronic obstructive pulmonary disease. On or around 20-OCT-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered an acute onset of difficulty breathing, coughing, sore throat, dyspnea. He was diagnosed with acute chronic obstructive pulmonary disease exacerbation and pneumonia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of pneumonia and chronic obstructive pulmonary disease exacerbation to be related to zoster vaccine live (ZOSTAVAX).  The events of pneumonia and chronic obstructive pulmonary disease exacerbation were considered to be disabling.  Upon internal review, the event of pneumonia was determined to be medically significant.
The day after the injection, the injection site became red for approximately three days.  After three days the redness began to disappear.  On the morning of the 8th day, a large red rash developed at the injection site.  Over 24-hours the rash has grown and become warm to the touch and swollen.   The rash is itchy.  At this time the rash is approximately  2.5-3 inches in diameter.
Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% normal saline, preservative free. Consulted FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised. Outreach team contacted impacted patient and offered consult with a physician to discuss.
Severe itching in different places of her body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Severe itching in different places of her body) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PRURITUS (Severe itching in different places of her body). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Severe itching in different places of her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.   Reporter did not allow further contact
Patient under 18 years of age had vaccine administered; A spontaneous report  was received from other healthcare professional (Nurse) concerning a 17-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 043L20A), unknown route for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the Moderna vaccine was administered to patient under 18 years of age.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event Moderna vaccine was administered to patient under 18 years of age was considered recovered.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 043L20A  with no associated AEs.
This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L038534, expiry date: 19-AUG-2017; lot # L039297, expiry date: 19-JUN-2017; lot # L047185, expiry date: 17-SEP-2017; lot # L038536, expiry date: 19-AUG-2017; lot # L027719, expiry date: 28-APR-2017; lot # L037921, expiry date: 31-MAY-2017). Nurse reported that the vaccine underwent a temperature excursion at 11 degree Celsius in a large refrigerator for a time frame of 1 hour 18 minutes which came back to its temperature range. She reported that the vaccine also underwent 2 temperature excursions previously on an unknown date: at 0.2C as minimum for 96 hours plus a second exposure at 1.5C for 7 hours 22 minutes (evaluating 0.2C for cumulative time of 103 hours, 22 minutes). No adverse events were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
Patient reported difficulty breathing within 1 hr of receiving H1N1 vaccine.  Reported SOB & wheezing, denied other symptoms - no swelling, tingling, or hives.  Patient reports history of tracheal stenosis requiring frequent surgical procedures.  Seen at local ER, then transferred to other hospital (ER record available, if needed).  11/25/2009 MR and DC summary for 10/23-10/24/2009,Dc Dx trachael stenosis  patient with a hx of subglottal stenosis presents with c/o's SOB w/out exertion. Patient was intubated and underwent a Microlaryngoscopy with dilation. IV steroids were given. Dc'd in stable condition.
Information has been received from a physician concerning a 5 year old male with reactive airway disease and food allergies to eggs, milk, and peanuts. It was also noted  that the patient had a history of some behavioral problems "that he seemed to get through". These behaviors "were related to autism". On 06-MAR-2006, the child was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no concomitant medication. On 19-MAR-2006, about 2 weeks post-vaccination, the patient experienced behavioral regression. It was noted that there was "definitely a change". Unspecified medical attention was sought. The outcome was reported as not recovered. There were no laboratory diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
HBP reporting AE for improperly stored administered vaccine.   Names of vaccines involved/ ROTATEQ/ Temperature (28.0F) BELOW 36°F Time frame 96Hours; This spontaneous report was received from an office manager and concerns an 8-week-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-MAY-2022, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, once, one injection, orally, lot number: U038909 was confirmed to be valid, expiration date: 26-MAR-2023 for prophylaxis (exact dose was not reported).The administered dose was exposed to the temperature excursion of 28 degrees Fahrenheit (F) for 96 hours. There were no previous temperature excursions reported. An other healthcare worker stated that the form would be filled and sent back all available information. No further information provided.; Sender's Comments:  US-009507513-2205USA005882: US-009507513-2205USA005906: US-009507513-2205USA005914: US-009507513-2205USA005815: US-009507513-2205USA005621:
MMR was administered 23 days after pt received his first Varivax vaccine . Since both vaccines are live vaccines, spacing should be at least 28 days. Manufacturer has been contacted and concluded that such dose deemed invalidated.
Information has been received from a 66 year old female patient with penicillin allergy, no pertinent medical history, who on 23-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included LIPITOR and COUMADIN and blood pressure medication (unspecified).  On approximately 30-JAN-2009, the patient experienced shingles on her face.  The blisters were on her temple, eye, scalp and a little bit on her lip.  The patient also experienced nausea, stomach problems, headache, and fever.  The patient did have some tingling sensation but did not experience any nerve pain where the blisters appeared.  She had to go to an eye doctor who told her it was shingles.  There were no laboratory or diagnostic tests performed.  At the time of reporting, the patient had not recovered.  Additional information has been requested.
spasm, like epileptic jerking of legs and arm.; muscle drop; almost had a nervous breakdown; muscle aches; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (spasm, like epileptic jerking of legs and arm.), DYSKINESIA (muscle drop), FATIGUE (exhausted), NERVOUSNESS (almost had a nervous breakdown) and MYALGIA (muscle aches) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (exhausted). On 08-Feb-2021, the patient experienced MUSCLE SPASMS (spasm, like epileptic jerking of legs and arm.), DYSKINESIA (muscle drop), NERVOUSNESS (almost had a nervous breakdown) and MYALGIA (muscle aches). On 09-Feb-2021, MUSCLE SPASMS (spasm, like epileptic jerking of legs and arm.), DYSKINESIA (muscle drop), FATIGUE (exhausted), NERVOUSNESS (almost had a nervous breakdown) and MYALGIA (muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. No treatment information provided.