chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On an unknown date, an unspecified number of patients were vaccinated with an improperly storage doses at a temperature of 47 °F to 77 °F for 9 hours and 54 minutes of GARDASIL 9 (lot # M033583 and expiration date 14-APR-2019) (lot # M040412 and expiration date 30-JUN-2019) for prophylaxis (dose and route of administration were not reported). The vaccine did not have a previous temperature excursion and this information was provided due to the data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004698: US-009507513-1705USA004699: US-009507513-1705USA004700:
Mom states that pt started with small knots in both legs after vaccinations were given on 05/18/2020. The knots have gradually gotten bigger since that time. Mom brought her into the office today, 06/10/2020, for evaluation because the patient acts like the legs hurt where the knots are.
Pain,  at injection site 9/25/2020. Pain, redness and swelling at injection site 9/26/2020 thru 10/2/2020. Fatigue and malaise 9/26/2020 thru 9/27/2020.
flu like symptoms; This is a spontaneous report from a contactable consumer (patient's brother). A 49-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 28Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient started experiencing flu like symptoms on Aug2021, which only got worse for the next few days. He passed away Monday, 30Aug2021. His death was extremely unexpected since he was feeling great before the Pfizer vaccine. The patient died on 30Aug2021. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: flu like symptoms
Starting when I woke up around 5:30 the morning after the shot, it felt like my skin was a giant balloon and when I breathed in, I breathed in electricity, shooting it all over my body, expanding the balloon with lightning, and threatening to break it into a million tiny pieces. I was also sore. Sore all over. Like I ran a marathon.   Managed to get out of bed at noon and eat and take 800mg ibuprofen, which helped along with sleep. By 4pm have less pain and electricity, but still some soreness.   It?s not as bad as after shot 2, but the same type of symptoms.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild, Additional Details: Patient received 1st dose of Pfizer vaccine on 5/29/21. 5 minutes post-vaccination, patient complained of feeling lightheaded, tingly in the hands/feet/legs, mildly nauseous, dizzy and sweaty. 1st BP (77/41 & HR 55) and 2nd BP taken 20 min later (86/53 & HR 56). Patient was given water and a cool towel and after 30 minutes of monitoring, patient confirmed feeling better and stated ok to leave (did not feel dizzy when standing up) with mother attending her.
Development of severe redness, swelling, warmth and pain without fever on left upper arm at site of DTAP injection.
3/22/2021 Headache in the back of the head to base of skull. Still on going. 3/29/2021 Facial Droop, Can't shut left eye. Can't smile or puff out cheeks. Can't blink left eye. Top of tongue has a burnt feel.  Reduced taset.
8/1/03 left upper thigh with redness, swelling, bruising size 11.5cm x 6cm; c/o pain with palpation at injection site. Dr instructed Augmentin 400mg/5cc. 4cc po Bid for 10 days. Keep leg elevated with warm compresses and stat CBC, WBC.
Tinnitus, only in left ear?high pitched hissing sound - first mild, now severe
Moderna  side effects: fatigue,  nausea, unable to sleep hot flashes, rash 3 was later vesicles on arms  and trunk .
I noticed discharge from my left nipple on a few occasions. It seems like of random, but it hasn't in several days. I saw the physician and she ordered a diagnostic mammogram that I am getting in a couple of weeks.
02/12/23 presents to EC ED for "shortness of breath". PMHx of "emphysema on 3.5 L O2 NC (4 L at bedtime), non-insulin-dependent diabetes mellitus, hypertension, dyslipidemia and BPH"
From the day I got the vaccine (Jan 20), I got fever and body aches. Next day, fever went down but body ache kept increasing and hands and feet's started to get stiff. The stiffness increased along with swelling and pain. The pain increased every morning. I got 101 degree fever on 27th January. By then I couldn't make a fist or move my fingers properly. The pain in my joints and muscles increased daily. I couldn't go to work for 5 days from the 28th.  I started taking Ibuprofen (200mg) before bed to decrease the pain. But, the effect of Ibuprofen didn't stay long. My whole left hands including arms and shoulders stopped working. The the pain started moving, sometimes the pain would be in the left and and sometimes on the right. Then I couldn't even do the simplest thing, like using toilet paper, opening water bottle cap, opening water tap. It then started became hard for me to walk. My jaw on the right started aching as well which prevented me from being able to open my mouth fully therefore only being able to eat liquid foods. I contacted my family doctor who then suggested me to see a Rheumatologist. I couldn't see the Rheumatologist right away. I took the second dose while taking the pain killers. I took the second dose on 18th Feb. After the second dose, the pain increased to the point I couldn't even stand because of the pain in hip, knee, thigh, calves and had to be taken to the emergency on 24th Feb. By then my hands and legs had turned blue and was swollen. Next day, we went to Rheumatologist and out that the vaccine had given rise to the Rheumatoid Arthritis.
Two days following the injection I began breaking out in rashes. First my arms and wrists, then by legs, ankles and feet. The worst is the back of my head and neck. In the beginning it was really bad. No hospitalization was needed.
Several patient were administrated with below freezing vaccines; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Engerix B and Menveo. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Havrix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Engerix B and Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable. Several patients were administered with below freezing vaccines, which led to incorrect storage of drug. At time of report health care practitioner was unware of number of vaccines, which vaccine and when or to who it was administered no patient's identifiers provided, no batch number and expiration date provided no vaccination date provided. No adverse event was reported. The reporter consented to follow up.
ACUTE PULMONARY EMBOLISM 9/6/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 7/12/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION  HYPOTENSION 9/6/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION  ACUTE PULMONARY EMBOLISM 9/6/2022 LEFT HAND ABSCESS  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 7/12/2022 LEFT HAND ABSCESS  HYPOTENSION 9/6/2022 LEFT HAND ABSCESS  ACUTE PULMONARY EMBOLISM 9/6/2022 HYPOKALEMIA  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 7/12/2022 HYPOKALEMIA  HYPOTENSION 9/6/2022 HYPOKALEMIA  ACUTE PULMONARY EMBOLISM 9/6/2022 ALTERED MENTAL STATUS, UNSPECIFIED  REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME 7/12/2022 ALTERED MENTAL STATUS, UNSPECIFIED  HYPOTENSION 9/6/2022 ALTERED MENTAL STATUS, UNSPECIFIED
children who were administered GARDASIL 9 were listed as 'compromised'; This spontaneous report as received from a health care business professional refers to a child patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # S020255, expiration date: 09-DEC-2021 for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  It was reported that the child was listed as 'compromised' (Ill-defined disorder) within registry, on an unknown date; Immunization registry entry was entered incorrectly as confirmed by Healthcare Business Professional at call time. Healthcare Business Professional was not able to further clarify the meaning of 'compromised' (Ill-defined disorder) on unsuccessful clarification attempt at call time. The healthcare business professional had extremely limited information.Health care business professional requested a  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) expiry check. No additional adverse event. The outcome of ill-defined disorder was unknown.  The causal relationship between the aforementioned event and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020255; expirationdate: 09-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Headache, Myalgia, Arthralgia, fatigue Narrative: swollen lymph node under right arm pit (resolved 4 days later)
anticipated reaction of malaise; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (anticipated reaction of malaise) and PAIN IN EXTREMITY (Sore arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced MALAISE (anticipated reaction of malaise) and PAIN IN EXTREMITY (Sore arm). In February 2021, MALAISE (anticipated reaction of malaise) and PAIN IN EXTREMITY (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported. Patient experienced anticipated reaction of malaise, sore arm for 3-4 days.   This case was linked to MOD-2021-375534 (Patient Link).
Within 10 minutes of the vaccination into my left arm, the entire left side of my body (face, arm, leg and foot) began feeling numb. There was no strength deficit but a persistent feeling that the left side of my body was asleep and had decreased sensation to touch compared to the right side. This feeling has persistent but is somewhat less than the day of the vaccination but is still present. Other than that at this time the only other events that have happened are fatigue and injection site soreness.
Parents state that infant cried screaming episodes for 3 hours per episode, for 24 -36 hours after receiving immunizations. Increased T. Eyes and face "puffy".
GOLF BALL SIZED LUMP UNDER SKIN AT INJECTION SITE COUPLED WITH 7/10 PAIN ALMOST IMMEDIATELY AFTERWARDS. PAIN CONTINUES TO 5/10 6 DAYS LATER. HAS TAKEN ALEVE DAILY SINCE THE INCIDENT.
Nov 1 entered ER vomiting ..said I had pancreatitis....needed a procedure to remove gall stones and then operation to remove gall bladder. Procedure happened with no problems. Went to have surgery on Nov.  5 ....never touched me and I went into cardiac arrest for 10 minutes. Never had gall bladder removed
1- day of swelling at site, 2- second day swelling about 3 inches in diameter then a ring of erythema around the swelling.  general malaise and arthralgia and myalgia intense for one day. 3- third day malaise gone arthralgia and myalgia persisted. 4- the arthralgia and myalgia have persisted but decreased in intensity. 5 now most intermittent myalgia.
Pt with sleepiness, fussy, abd distention and vomiting.  Diagnosed 2/9/13 with intussuception.
arm pain at injection site, hot flashes Narrative:  Per nursing report: "received injection on  2/10/2021; c/o hot flashes and arm pain [2/11]".   Other Relevant History:
A fever, soreness at the site of the shot and neck, body aching, slight coughing, and headache.
Vaccine was incorrectly diluted.  0.7ml of sterile water was used.
left side of body went numb; they thought she had MS (multiple sclerosis); This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 03May2021 15:30 (Lot Number: EW0167) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously administered first dose of bnt162b2 in left arm on 12Apr2021 14:30 (Lot Number: EW0162) for COVID-19 immunisation. The patient experienced left side of body went numb. Spent a week in the hospital- they thought she had MS (multiple sclerosis) but it was all from the covid vaccine. There's documentation that the prognosis was from the vaccine. The events onset date and time was 04May2021 09:30. The adverse events result in any of the following doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment steroids received for the adverse events. But she was still numb on the left side. The events were reported as serious, due to hospitalization and life threatening. Hospitalized for 5 days. The patient underwent lab tests and procedures which included nasal swab: negative on 05May2021. The outcome of events was not recovered.
Feverish; sore shoulder; This is a spontaneous report from a contactable consumer(patient son). A 43-year-old female patient  received bnt162b2 (BNT162B2, Solution for injection, Lot Number: 017121), via an unspecified route of administration on left shoulder on 21Apr2021 (at the age of 43-year-old) as Dose 1, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported.On an unknown date, the patient had feverish and sore shoulder. No treatment received for the events. The outcome of the events was unknown.  No follow-up attempts were possible. Information about lot/batch number could not be requested.
24 hours after injection I had a fever of 103, severe headache, nausea, diarrhea, decreased appetite  body aches and back pin. 48 hours after injection bodyaches  decreasing, back pain decreasing but have developed neck pain, fever 102.0
Information has been received from a nurse concerning a 4 year old female who on 23-JAN-2009 was vaccinated with ZOSTAVAX SQ, 0.65ml (lot # 663195/1416X) instead of VARIVAX due to human error. This was to be the second dose of VARIVAX. No adverse effects noted. Unspecified medical attention was sought. Additional information has been received from a nurse who verified that a 4 year old female patient received ZOSTAVAX instead of VARIVAX. It was a case of human error and not product confusion. The floating nursed who was unfamiliar with the placement of vaccines in the freezer, picked up the wrong vaccine. Both were kept on the same, but opposite, sides of a shelf in the same freezer. Additional information has been requested.
shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 23-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a bad case of the shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event shingles to be disability.
Mom reports left arm pain radiating to hand, swelling at vaccine site, able to rotate wrist and move fingers.  Occurred 4 hours post vaccine - spoke with mom today - improving and decreased swelling.
This case was reported by a consumer and described the occurrence of adverse drug reaction in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, if he suffered from all the side effects except a fever with 1st dose of the 2 part shingles vaccination and would be he had same side effects after the 2nd vaccination.
4 days of severe stomach pain, nausea, vomiting, and diarrhea.
Information has been received from a physician concerning an adult female in her mid 20's who on unspecified dates as an adult was vaccinated with first and second doses of Varivax. Subsequently, a varicella titer was done and the patient remains seronegative for varicella. No further information was available. There was no product complaint involved. Additional information has been requested.
Could not determine site of injection; was not noted right or left arm on medication administration record.  However, peripheral line was inserted in right arm same day as administration of vaccine. 6/19/12 @8:30 -> swollen and tenderness in right arm, edema noted. Pain noted 9/10. Warm blanket wrapped around area and elevated.  6/19/12: peripheral line switched from right to left arm due to swelling. 6/19/12 @15:40 -> arm remains swollen, ice pack applied. 6/19/12 @1915 -> 1 tab percocet for 8/10 elbow pain.  6/20/12 @7:45 -> right arm pain, swelling to right elbow. 6/20/12 @1205 needle aspiration performed. 6/20/12 @1920 -> pain noted 3/10. 6/21/12: right elbow remains swollen, site drained.  6/21/12 @1530 -> pt denies pain.
Headache, Myalgia, Fever, NauseaVomiting, chills, pain at injection site Narrative:  Other Relevant History: