chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site wheal, varicella - Information has been received from a pharmacist concerning a 1 year old female patient who on 01 Apr 2000 was vaccinated with varicella virus vaccine live.  subsequently the patient experienced a red welt on the leg at the injection site which looks like a bug bite.  the patient also developed pox on the face and a low grade fever.  unspecified medial attention was sought.  additional information has been requested.
the spot has a small white head; I had a red spot come up on my right arm; This case was reported by a consumer via call center representative and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2020, the patient received Shingrix. On 14th May 2020, 1 days after receiving Shingrix, the patient experienced red rash. On 15th May 2020, the patient experienced blistery rash. On an unknown date, the outcome of the red rash and blistery rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash and blistery rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix in right arm and had red spot come up on right forearm. At the time of reporting the spot has a small white head. The reporter asked was this the live vaccine showing.
Received 0.3 - 0.4 ml; Syringe fracked and leaked out; A spontaneous report  was received from a pharmacist concerning a 66-year-old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the syringe fracked and leaked out and the patient received 0.3 - 0.4 ml.  The patient's medical history was not provided. Concomitant product use was not reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly (Lot number: 042L20A) for prophylaxis of COVID-19 infection.   On the unknown date, during vaccine administration, the syringe fracked and leaked out and the patient received 0.3 - 0.4 ml of the vaccine dose.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, syringe fracked and leaked out and received 0.3 - 0.4 ml, was considered resolved.; Reporter's Comments: This case concerns a 66-year-old patient who received their dose of mRNA-1273 (Lot 042L20A), reporting patient received 0.3 - 0.4 ml and syringe issue without any associated adverse events reported at this time.
Patient developed redness to injection site same day of injection. Patient reported to our walk in clinic 2 days after injection for redness, warm, soft, non tender at injection site. Patient prescribed prednisolone and benadryl 2.5ml every 6 hours prn. Advised to report to clinic for a recheck and also advised to go to ER with any emergent concerns.
Vaccination site hypoaesthesia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (Vaccination site hypoaesthesia) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE HYPOAESTHESIA (Vaccination site hypoaesthesia). At the time of the report, VACCINATION SITE HYPOAESTHESIA (Vaccination site hypoaesthesia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On unknown dates, the patient experienced pens were kept below recommended temperature in refrigerator for two days/readjust refrigerator and numbness on left side and left arm after COVID 19 vaccination. On an unknown date, numbness on left side and left arm after COVID 19 vaccination resolved. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
The patients did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 15 months old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 07-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, route of administration and anatomical location were not reported) of lot # S006647 is an invalid lot number, expiry date reported as 05-MAR-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
arm pain; muscle pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), MYALGIA (muscle pain) and HEADACHE (Headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 006021A) for COVID-19 vaccination.     Concomitant products included METFORMIN, ACETYLSALICYLIC ACID (ASPIRIN 1000) and ATORVASTATIN for an unknown indication.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced PAIN IN EXTREMITY (arm pain), MYALGIA (muscle pain) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (arm pain), MYALGIA (muscle pain) and HEADACHE (Headache) outcome was unknown.            Treatment medications were not provided by the reporter.
Got tetanus shot nex tday was very painful and swollen. Measured 10cmx10cm. Has been in US for 5 months.
My arm was sore; Excruciating pain; Can't put it behind me; Aching in the left shoulder joint; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was sore), PAIN (Excruciating pain), MOVEMENT DISORDER (Can't put it behind me) and ARTHRALGIA (Aching in the left shoulder joint) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced ARTHRALGIA (Aching in the left shoulder joint). On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm was sore), PAIN (Excruciating pain) and MOVEMENT DISORDER (Can't put it behind me). The patient was treated with ACETAMINOPHEN at a dose of UNK, q4h. At the time of the report, PAIN IN EXTREMITY (My arm was sore), PAIN (Excruciating pain), MOVEMENT DISORDER (Can't put it behind me) and ARTHRALGIA (Aching in the left shoulder joint) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns an 81-year-old male with NS unexpected events of pain in extremity, pain and NS expected events of arthralgia and movement disorder.  Event onset with unknown latency after the first dose of mRNA-1273. 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.
12 hours post injection onset...  fatigue, severe chills, fever, hot sensation, increased and sever sensation to temperature, myalgia of back and facial muscles, insomnia. Persisted for 18 hours.  Injection site soreness, Polyuria, migraine and severe tension headache, fever 101+, loss of appetite with paradoxical polyphagia, increased metabolism, cold perspiration, moderate fatigue persisted for 36 hours after onset.   These side effects are worse than any sickness, condition or pain that I've ever experienced.   Migraine and myalgias resolved for 3 hours at a time using regular adult Excedrin
Began to give the vaccine nasally then realized error and stopped. A new vaccine was opened and administered orally.
bad diarrhea; extremely weak; slightly disoriented; nausea real bad; threw up stone black liquid; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (bad diarrhea), ASTHENIA (extremely weak), DISORIENTATION (slightly disoriented), NAUSEA (nausea real bad) and VOMITING (threw up stone black liquid) in a 70-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (bad diarrhea), ASTHENIA (extremely weak), DISORIENTATION (slightly disoriented), NAUSEA (nausea real bad) and VOMITING (threw up stone black liquid). At the time of the report, DIARRHOEA (bad diarrhea), ASTHENIA (extremely weak), DISORIENTATION (slightly disoriented), NAUSEA (nausea real bad) and VOMITING (threw up stone black liquid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
I received the shot around 11am, and around 3am I woke up with a fever, sweating and chills. I was also experiencing a headache and body aches. My fever went down around 6am, but I was still experiencing severe body aches. The overall affect was similar to the flu. I took some over the counter medications to treat the fever and body aches (Advil and Tylenol) and began feeling better around noon.
Red and swollen arm.  She was in shopping and thought she should tell me.  It lasted about a week per patient but wasn't red or swollen at the time.
Patient was recuperating in nursing home from a fall injury (broken leg). Patient had first dose of vaccine on 1/8/21. Patient tested positive for Covid 19 on 1/22/21. Patient got second dose of vaccine on 1/30/21. Patient declined and passed away on 2/4/21.
No additional AE's reported.; administering an expired VAQTA vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, historical drugs and concomitant medications was provided.  On an unknown date in August 2020, the patient was unknowingly vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # s018772, expiration date: 07-JUL-2020 (dose number, dose, route of administration and anatomical location were not reported) for prophylaxis.  No additional adverse event was reported. The outcome of medication error is unknown.
Had vaccines on morning of 10/18/2016. According to patient, experienced redness and swelling 4 PM 10/18/2016.  Sought medical treatment of decadron injection, Benadryl and ice on 10/21/2016.
Muscles ache at multiple areas of body, similar to having a cold. The injection area has a big lump under the skin and it?s hurt when touched. Also I feel fatigue and tired and it?s the fourth day after the vaccine. Also I feel thirsty and drank a lot of water.
4/1/2021 developed GI pain which increased in severity over the next several days, particularly after meals. After several days was unable to eat without significant pain, sensation of swelling and sloshing in ULQ with movement.  4/6/2021 Sought treatment from PCP/Urgent care. Lab values returned with Lipase over 800. Was instructed to report to emergency room  4/6/21 - 4/7/21 evaluated in ED at the Hospital for Pancreatitis. Lab values now showed Lipase 1,258. Held overnight for fluids, pain management, abdominal rest, and evaluation. Discharged home on a low fat diet.  Ongoing significant pain for several weeks, affecting ability to partake in normal daily tasks. Returned to work after one week, had difficulty with typical physical work tasks and took several additional days off for further recovery.  5/14/21 Specialist appointment in GI clinic. MRCP showed no pancreatic abnormalities. Advised to slowly increase fat intake to normal levels.   Continued with intermittent mild pain for several months with normal lipase levels.  Slow return to normal, maintaining  some care with fat and alcohol intake as of this report (1/4/21).
This spontaneous report as received from a other health professional refers to a 12 month old patient. On 23-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Product was stored beyond 30 days use.; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product was stored beyond 30 days use.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was stored beyond 30 days use.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product was stored beyond 30 days use.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. No temperature excursion and adverse event was reported. Vials was placed in the refrigerator on 29-Sep-2021.
I gave birth. The delivery was generally uncomplicated. About 2 weeks later, I had a postpartum hemorrhage that began about 12 hours after receiving my 3rd dose of the Pfizer vaccine. I had a large gush of blood around 2am on 10/20/21, which was followed by a slow trickle for about an hour. The bleeding stopped and I felt comfortable waiting to call my OBGYN's office when they opened. Based on my symptoms at the time, the doctor recommended over the phone that I get an ultrasound to rule out retained placental fragments. My ultrasound was scheduled for the following day (10/21/21 at 3PM). I felt another gush during my ultrasound and immediately went to the emergency department. At the hospital, I was given a second ultrasound, multiple units of blood, and was taken to emergency surgery. The doctor tried multiple ways to stop the bleeding (D&C, balloons, etc.), but had to perform a hysterectomy in order to stop the bleeding.
DTaP given on 3/19/03. Mom noticed swelling and redness on 3/20/03.
This spontaneous case was reported by a nurse and describes the occurrence of FLUSHING (Face was flushed), DIZZINESS (Dizziness), RASH PRURITIC (Very itchy all over where the rashes are, scalp is itchy also), RASH PAPULAR (Rash is like many small red red bumps all over upper body) and VACCINATION SITE PAIN (Soreness at injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included Sinus infection. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FLUSHING (Face was flushed), DIZZINESS (Dizziness), RASH PRURITIC (Very itchy all over where the rashes are, scalp is itchy also), RASH PAPULAR (Rash is like many small red red bumps all over upper body) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, FLUSHING (Face was flushed), DIZZINESS (Dizziness), RASH PRURITIC (Very itchy all over where the rashes are, scalp is itchy also), RASH PAPULAR (Rash is like many small red red bumps all over upper body) and VACCINATION SITE PAIN (Soreness at injection site) 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. This patient was on antibiotics NOS for a sinus infection up until Tuesday, 26-Jan-2021. She developed a rash on her back, chest, upper abdomen, to the side of the abdomen and a little bit on her face. She took loratadine, which cleared up the rash on her chest and face, but when the effect wore off, the rash came back. The rash on her back seemed to be getting worse. The rash on her abdominal area seemed to be clearing. Treatment included loratadine and topical hydrocortisone cream.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 11-JUN-2017, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). The day after receiving the ZOSTAVAX vaccine (12-JUN-2017), the patient suffered sudden and significant speech and right-sided deficits. The patient was hospitalized and diagnosed with acute ischemia cerebral infarction. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, 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. As a direct and proximate result of the use of the ZOSTAVAX vaccine, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Upon internal review, acute ischemia cerebral infarction was determined to be a medically significant event. The event of acute ischemia cerebral infarction was disabling. Additional information has been requested.
Case number PHEH2013US008711, is an initial spontaneous report received from a pharmacist on 16 Apr 2013. This case refers to a 26-years-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (ACWY (conjugated-CRM 197), batch number: M11041), intramuscularly without being reconstituted with Men A component on 21 Feb 2013. No adverse reaction was reported following this administration error.
I started experiencing joint pain the next day continued until two weeks ago. My large joints (hips, fingers, knees, and toes). I had to get acupuncture done had a detox it has helped.
Patient was accidentally added into another patient (with same first/last name) chart which had received pfizer as first dose.  When in room with provider, patient was asked if this was his second pfizer and he replied yes. Iinjection was given and then patient gave card which showed his first shot as moderna, not pfizer.  Patient does  not speak English very well.  Patient was then advised of what had happened.  He was informed that he did not need another covid vaccine.  He was told to contact the clinic with any questions or concerns.
33-year-old male without past medical history presenting with 10d of nausea and vomiting associated with dysequilibrium.   Patient notes he received his second dose of Moderna on April 9. On April 16th, patient woke up and started to feel disequilibrium, unsteady on his feet.  This was associated with nausea and vomiting.  Patient will vomit about 2-3 times per day nonbloody nonbilious.  He notes that the vomiting is associated with movements of his head.  He went to urgent care where he was given prescription of meclizine.  This did not work.  Was also given prescription for prednisone and Augmentin for question of vestibular neuritis.  This did not help either.  Patient then went to see ENT today.  He was told that his symptoms were not consistent with a vestibular process.  He was recommended to go to emergency room for further evaluation.  Patient has not been able to really hold down any food or liquids.  He denies any fevers, chills, headache, vision changes, neck stiffness, abdominal pain, constipation or diarrhea, chest pain, dyspnea.  In the ED, patient afebrile, HR 67, BP 135/97, RR 18, SpO2 96% on RA. Labs notable for Hb of 17.3.   CT head -10 millimeter periventricular hypodensity in right parietal lobe chronicity.
Anthrax Vaccination (booster) developed redness, itch and pain Right upper arm spreading distally, reported limitation in ROM. Began after taking hot shower the night of vaccine adm. Phy. exam: Afebrile, erythemia,swelling and tenderness below site of vaccination.  No lymphadenopathy. Assessment: Reaction consistent with subcutaneous adm of vaccination.  Plan:  NSAID's, antihistamine, elevation of arm.  Quarters for 24 hrs. RV for assessment 2 days.
In July I started to experience major hair loss. I have talked to several people that have experienced the same. I have always had thick hair an few month after 2nd dose, I started loosing it. Still loosing it.
8cm X 5cm splotchy, erythema, mostly medial to injection site of DTAP.
limited shoulder mobility; This case was reported by a pharmacist via call center representative and described the occurrence of joint range of motion decreased in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number FK77A, expiry date unknown) for prophylaxis.   On 10th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 10th September 2019, immediately after receiving Shingrix, the patient experienced joint range of motion decreased. On an unknown date, the outcome of the joint range of motion decreased was unknown.   It was unknown if the reporter considered the joint range of motion decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid. On the same day, right after vaccination, the patient experienced limited shoulder mobility. The reporter did not consent to follow up.
Patient given Moderna vaccine at 4:40pm in L deltoid.  Pt c/o tightness in chest, mouth, and throat at 5:00pm.  V/S 164/98, 76, 16, o2 93%.  O2 applied at 2L per NC.  Patient developing rash on neck and chest with dry cough present.  Patient has hx of anaphylaxsis x2.  Patient given 0.5mg Epinephrine IM in the R deltoid.  V/S at 5:10 158/86, 76, 16, O2 97%.  Ems called.  Patient transported to hospital via EMS at 5:23 pm.