chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a father concerning his 15 month old female child with an egg allergy and peanut allergy who on 10-JUL-2006 was vaccinated subcutaneously with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # unknown). On 10-JUL-2006, soon after getting the vaccine, the patient developed a rash. After being administered diphenhydramine hydrochloride (BENADRYL), the patient recovered. It was reported that the patient was "agitated and screaming" during the night of 12-JUL-2006. The outcome was reported as recovering. No product quality complaint was involved. Unspecified medical attention was sought. Additional information has been requested.
Headache, Myalgia, Fever, SkinRash, Rash Palpitations, fatigue Narrative:
Moderna COVID-19 Vaccine EUA 15-20 minutes after IM injection, pt developed subjective swelling in the back of throat, "heart racing", tachycardia On physical exam, clinically well, no airway compromise, no visible posterior oropharyngeal swelling, no NV, no rash/hives, HR 120s, no hypotension Treated with PO Benadryl, symptoms resolved, HR resolved Observed for 1 hour with no symptom recurrence
Patient received HEP A #1 1/22/08.  She came to office to receive HEP A #2 6/24/08 - after it was given the nurse realized it was only 5 months since HEP A #1 was given and the MD was notified.  Health department contacted - mother notified - will repeat in 6-12 months.  6/24/08 dose not valid.
Chills, muscles aches, nausea, headache, sweating fatigue , pain at injection site, arm soreness and stiffness. Onset began 1 hour after vaccination with mild symptoms. Severe symptoms onset 8 hours after injection and lasting 12 hours before beginning to taper off At home treatment- ibuprofen , rest and fluids
Woke up this morning with red circle around site of injection. Redness, some swelling and itching... Shot administered 1/11/2021. No side effects until today.
This case was reported by a other health professional via sales rep and described the occurrence of adverse event in a patient who received BEXSERO. The patient's past medical history included heart disease. Concomitant products included HPV vaccine and Flu vaccine. In August 2017, the patient received BEXSERO. In August 2017, less than a month after receiving BEXSERO, the patient experienced adverse event, abdominal pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the adverse event, abdominal pain and vaccine administered at inappropriate site were unknown. The reporter considered the adverse event to be probably related to BEXSERO. It was unknown if the reporter considered the abdominal pain to be related to BEXSERO. Additional details were reported as follows: This case was considered as a master case. The age at vaccination was not applicable. The office was administering the product for years, but has had there were 4 patients who experienced serious adverse within the last 2 weeks. The reporting representative did not have any specific demographic information at this time, but would visit the office on 24th August 2017. The 2 patients were female. One patient reported abdominal pain, other patient had a previous heart condition, another one patient co-administered HPV. The 1 patient administered the product in the left. The 2 patients required emergency room visit (ER). The field rep called back on 24th August 2017 to provide the further details. The vaccination date for the 2 of the 4 patients was 15th August 2017. One was vaccine on 22nd August 2017 and the 4th patient was vaccinated sometime around that time. Exact date was unknown for 4th patient. The vaccines were administered by more than one nurse and came from different lots. Names of nurses and lot numbers are unknown. It was the second dose for 1 patient who was a 19 year old male who was also given a non-GSK flu vaccine at the same time. The manufacturer was unknown. The patient who had received concomitant HPV vaccine was an 18 year old girl. It was unknown that which patient experienced which adverse event.
Illness set in either the day of the vaccination being administered or the day after, according to phone records. Signs include: nausea/vomiting, back aches, fever, chills, passing out, lack of appetite, extreme fatigue and low energy, bitter taste in the mouth and water tasting bitter.
Received MMR on 11/16/2001. return to clinic on 11/19/2001 complained of rash for one week on upper extremities. Treated with Benadryl. On 11/14/2001 called AM RN, mild fever 100, took Tylenol, see on clinic at same day 2 PM with fever 101, had seizure in clinic around 2:20 PM, pt also decreased response.
Slight itching of site over the entire week following injection, but nothing  bothersome. As of Friday evening, Feb. 19, it became sore again. By morning on Saturday, Feb. 20, there was a pink blotch on the skin above/around the injection site, and there was a noticeably hard lump under the skin. The site was also very feverish. (I did not have a fever, just the upper arm was quite warm.)  This all lasted until midday Sunday, Feb. 21. By bedtime, it felt better. Monday there was still a pink spot on the arm, but the hardness & fever were gone.
After first dose a terrible itch and rash in my butt.; After first dose a terrible itch and rash in my butt.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6205 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08Mar2021 at 11:00 AM (age at vaccination: 63 years), as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included fibromyalgia. Concomitant medications included estradiol, levothyroxine sodium (SYNTHROID), liothyronine sodium (LIOTHYRONIN), and cyclobenzaprine hydrochloride (CYCLOBENZAPRIN). The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not have any known allergies. On 08Mar2021 at 06:00 PM, the patient experienced after first dose a terrible itch and rash in my butt. She had neither problem before this. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
The second time I had COVID-19 was worse than the first time. It started as a cold with a runny nose but no fever. At night I had the chills, and it also affected my lungs. My doctor put me on PAXLOVID and then the following Thursday I was fine. I also had a runny nose and a cough.
p/vax pt noted to behave unusually;became aggressive & angry;began yelling, hitting & crying cont w/o provocation;vomited once;taken home & slept 3hr;pt pupils wide & dilated;hyper;dec appetite;leg sore inj site;
Information has been received from a registered nurse concerning an approximate 9-year-old patient who on 17-JUL-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
a over 55 years old patient received first dose of Menactra/ No AE; Initial information was received on 23-Jul-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via phone (under Medical Information (MI) Inquiry Number: 00694452) in.  This case involves over 55 years old female patient who had her first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Product administered to patient of inappropriate age).  The patient's medical history included Splenectomy.  The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a first dose of suspect MENACTRA VACCINE lot number and expiry date not reported via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported Caller says that she had her first dose of Menactra and then had a splenectomy. She was due for her second dose of Menactra soon as well as chemo treatment next week. Caller wants to find out how long she can delay her second dose of Menactra. The caller states that she was over 55 years of age. She would like to know if it was safe for her to get chemotherapy if she has only had one dose of Menactra and she does not have a spleen. She states that this was not a booster dose and that she was told that she needed a 8 week interval with a second dose of Menactra. She states that it had taken her an hour to get, she was not asked for additional Adverse Event information.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   There will be no information on the lot number for this case.
Vaccine was administered past its expiration date.  Vaccine Expired on 8/22/22
I had my 1st Moderna shot in my left arm on 3-2-21. I am still experiencing sharp pain.  It feels like fireworks going off in my arm and it gets warm to the touch.  It mostly happens early in the morning. Sometimes between 3-5 AM. But, now it is starting to happen at other times of the day as well.  If I take Extra strength Tylenol the pain will go away.
Patient received Moderna vaccine on 3/15/2021 as part of a small clinic. On 4/12 patient received pfizer as part of a large scale clinic.
Within 2-3 hours  developed significant muscle tightness, torticollis and limited ROM of Left shoulder / neck.  From the back, the curvature was so significant it appeared as if he had severe scoliosis. He was giving ibuprofen and heat packs x24 hours and symptoms gradually resolved after 7 days.  He had to miss gym, tennis and swimming due to symptoms.  I am a pediatrician thus I monitored symptoms at home and consulted my colleagues.
Pt had bruising, 2" around site of shot with a dime-sized nodule, that is ? still present.
acute right periventricular and right basal ganglia ischemic stroke; acute right periventricular and right basal ganglia ischemic stroke; vertigo; dizziness; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. No information regarding the concurrent conditions, medical history and concomitant medications was provided. On or around 06-OCT-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose, the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered left upper extremity and lower extremity weakness, facial drop, altered speech, altered gait and altered coordination and was diagnosed with acute right periventricular and right basal ganglia ischemic stroke (ischaemic stroke/basal ganglia stroke), vertigo and dizziness. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt's symptoms had resulted in physical limitations not present prior to inoculation. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the pt sustained sever 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, she also suffered and incurred damages, including medical expenses; loss of accumulations; and other economic and non-economic damages. At the reporting time, the pt had not recovered from ischaemic stroke, basal ganglia stroke, vertigo and dizziness. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the ischaemic stroke and basal ganglia stroke were considered to be medically significant events.
Localized erythema and swelling treated with BENADRYL AND KEFLEX.
was administered her 2nd COVID vaccine,  The needle entered her arm, plunger pushed and the my daughter moved, needle came out and I saw liquid run down her arm.; was administered her 2nd COVID vaccine,  The needle entered her arm, plunger pushed and the my daughter moved, needle came out and I saw liquid run down her arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 6 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 14Jan2022 (Batch/Lot number: unknown) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 14Jan2022, outcome "unknown" and all described as "was administered her 2nd COVID vaccine,  The needle entered her arm, plunger pushed and the my daughter moved, needle came out and I saw liquid run down her arm.".  Additional information: The technician inserted the same needle to give patient the rest of the dose. Nothing was mentioned of it and patient left. Reporters concern was that his daughter did not get the recommended amount of the vaccine.   Follow-up (07Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
I was getting up for work I had  and can not make it  Diarrhea Vomiting  Arm pain  At 5:00am
SHORTNESS OF BREATH DURING 15MIN WAITING PERIOD AFTER RECIEVED VACCINE. SENT TO THE ED
C/o dizziness when called to check out - bp 144/79 pulse 105. Given ice pack and put head down for a few minutes. Stated this is not unusual for her. Able to leave independently after symptoms resolved.
Pt vaccinated with DTP/OPV developed high pitched crying x 4-5 hrs- treatment - APAP.
Hives all over body, itchiness, swollen lips, face hands and feet. Pain and wormth in the swollen areas.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On 01-AUG-2013 the patient was vaccinated with PNEUMOVAX23 (lot number was not reported) (0.1 ml intradermal dose) in her right forearm instead of MANTOUX. On 01-AUG-2013 the patient sought medical attention in the physician's office due to redness and swelling of her right forearm. Treatment prescribed was KEFLEX 500 mg twice daily for 10 days. The patient returned to the physician's office for medical attention on 02-AUG-2013 for redness on her right forearm which had spread. The nurse also reported that the patient's right forearm was painful and there was "a little bit of streaking" at the site of administration. There was no lab diagnostics studies performed. The outcome was reported as not recovered/not resolved. Additional information has been requested.
15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; This is a spontaneous report from a contactable physician. This physician reported similar events for 15 patients. This is 4th of 15 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient received pfizer vaccine from vials that has been reconstituted with 1.3 ml instead of 1.8 ml and reported significant body aches. The outcome of the events was unknown. There was no product quality complaint (PQC) present.  Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient.
I have a cough, nasal and chest congestion, headache and body aches. I also had extreme fatigue.
At 6pm, one hour after recieving her vaccine patient states they experienced what she could only describe as a seizure. She felt herself shaking and like an out of body experience. After about 2 minutes she was able to regain awareness and after about 10 minutes the whole episode had passed.
Elevated blood pressure Elevated pulse Heart palpitations Light headedness All started within 3 hours of receiving injection
Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022; 4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered.) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 076C21A, 008C21A and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease, Hypertension and Hyperlipidemia.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered.) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter confirmed that no adverse events were reported.  No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow up received contains no new information.
The day after the shot and for the next 3 days, I experienced pain and swelling at the injection site. On day 3 after the vaccine and through to this day, I began running a low grade temperature usually around 99.3. I also experienced extreme fatigue and aching joints. On day 7 the injection site became extremely itchy and swollen. It is hot to the touch and hard in the spot surrounding the injection site.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. On an unknown dates, the patients received improperly stored doses of GARDASIL (batch/lot #, dose, route and site of administration were not reported). No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Shortly after receiving the 3 vaccines (order: Trumenba, Gardisil, Menactra), the patient experience what appeared to be a seizure episode lasting for around half a minute. The patient's mother was present at the time. The patient's informed consent and mother indicated that patient has not had history of seizure. When the episode ended, the patient stated that he thought he fell asleep.
Patient presented to the ED and was subsequently hospitalized within  6 weeks of receiving COVID vaccination. Diagnosis was Severe sepsis without septic shock.
This spontaneous report as received from a nurse practitioner via a company representative refers to a 17-year-old male patient. On 08-MAR-2017, the patient was vaccinated with PROQUAD (dose, route of administration, lot # and expiration date were not reported). Other suspect therapies included properly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported) used to reconstitute the dose of PROQUAD. On 05-APR-2017, the patient inadvertently received VARIVAX and M-M-R II (dose, route of administration, lot # and expiration date were not reported for both) reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported). No adverse events were reported. Additional information has been requested.
Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period; 1 Expired Dose Administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Expired Dose Administered) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Expired Dose Administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Expired Dose Administered) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
This patient had URI's, low grade temps, frequent swollen lymph nodes, 3 spontaneous abortions, very low protein count with pregnancy. Spots on arms developed (now diagnosed with autoimmune progesterone dermatitis), night sweats. Now diagnosed with sticky platelet syndrome, elevated factor VIII + XI, elevated TAT, + Anticardiolipin Antibodies.