chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the vaccination liquid in the syringe was not clear, and it was probably a little more than yellow; A spontaneous report was received from a consumer concerning a female patient who experienced the vaccination liquid in the syringe not being clear, and it was probably a little more yellow.   The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.    The patients received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patients recently got their first COVID vaccination and they were trying to contact the manufacturer using the lot number on their card, and they got to the place where it said  "enter the lot number" but when they entered the number  it said that it was not a good number and that the number does not exist. They were disappointed that the vaccination liquid in the syringe was not clear, and it was probably a little more than yellow and they were concerned about that.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event was unknown.; Reporter's Comments: This report refers to a case of vaccination liquid in the syringe not being clear, and it was probably a little more yellow (Product appearance cloudy) for mRNA-1273, lot # unknown). There was no associated AEs with the event of product appearance cloudy.
Weakness; fatigue; had to sit down; 10 minutes later blacked out for 5 seconds; sat in wheelchair and felt better;  drank orange juice and was able to walk to car feeling fine.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 8/26/2021 and 10/8/2021. Recently hospitalized 12/25/2021 to 1/4/2022 for seizures, work up revealed COVID-19. Discharged on home oxygen. Presented to the Emergency Department on 1/5/2022 for hypoglycemia, hypoxia, and weakness. Admitted for altered mental status, hypoglycemia, sepsis, and pneumonia. Treated with antibiotics. Went into cardiac arrest and expired 1/10/2022 at 0900.
1st Dose: Mild flu-like reaction within 24 hours, lasting 2 days.  2nd Dose: Moderate flu-like reaction to 2nd shot, fatigue, weakness, and body aches, lasting 3 days. On the 4th day, woke up in the middle of the night to elevated blood pressure (160/100) with skipping heart beats. Arrythmia was intermittent but persistant for about 14 days, interspersed with several bouts of elevated blood pressure lasting for about 1 hour. Sensation of pounding heart with skipping, but normal blood pressure, has lessened with time, but is still present.  Saw my GP about 10 days after the 2nd dose. Heart rhythm was normal during the visit, so no action was taken.
First Dose: Sore Arm; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection), via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced sore arm. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021665145 same reporter/ product, different patient.
About a week or so after the shot, I started seeing wavy, prism like distortion in my peripheral vison in my left eye, it lasted about 2 hours each time and only happened a couple times in April. I also have weird pin point headaches of and on, since the shot too, they are not general area headaches, the pain is random and not always in the same location, but always localized to a small area when I get them, before the vaccine I rarely, almost never, ever got any type of headache, since the vaccine shot I get them every other week or two, they are short only lasting a couple hours or so. I also am more fatigued and more brain fog since the vaccine shot too. My energy level sucks since I got the vaccine.
Pt had a fever then started twitching & shaking; mom called ambulance & took child to ER where blood was drawn & gave ice bath temp @ ER 104.2(R);
event: Patient complained of experience throat swelling and difficulty swallowing within 15 mins of administration treatment: 1 EpiPen was administered into thigh followed by 1 Benadryl 50mg capsule. RPH offered to contact paramedic for patient or have patient go to ER, but patient refused both. outcome:  patient reported feeling better within 30 minutes of treatment  and no more symptoms originally report. Patient was advised to still seek medical attention due possible symptoms returning  but refused. Patient said she will have a friend pick her up and stay with to make sure she has supervision at all time.
this individual has been tested for Covid numerous times after vaccination since it is provided for free at their site of work; this individual has been tested for Covid numerous times after vaccination since it is provided for free at their site of work; Booster was Moderna and the first two Pfizer; Booster was Moderna and the first two Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 25 year-old male patient received bnt162b2 (BNT162B2), administration date 13Jan2021 (Lot number: EL1283) at the age of 24 years as dose 2, single and administration date 23Dec2020 (Lot number: EH9899) as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administration date 19Nov2021 (Lot number: 066H219) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "Booster was Moderna and the first two Pfizer"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "this individual has been tested for Covid numerous times after vaccination since it is provided for free at their site of work". The patient underwent the following laboratory tests and procedures: Covid-19 test: positive. Clinical course: Patient had not heard of any adverse events, but since the booster was Moderna and the first two Pfizer, patient was reporting since patient wasn't sure if it was a risk to mix the two vaccines. It was also reported that location of vaccination based on picture stamp posted through social media. Patient was sorry and believe individual 25 YO as of recent. Forget ages during which received each of the vaccines, but I believe all dates are recorded. When the patient was asked to provide some further information on the experience (s) patient have reported and have attached a questionnaire, it was reported that one follow-up for this one, this individual has been tested for Covid numerous times after vaccination since it is provided for free at their site of work. They do not know how many times when this report was submitted, but it is a good amount (guess around 11x or more)  Follow-up attempts are completed. No further information is expected.  Follow up (11Dec2021): This is a follow up-spontaneous report from a contactable consumer. This consumer reported for the patient in response to consumer letter sent via email which included that: clinical information added  Follow-up attempts are completed. No further information is expected.  Follow-up (13Dec2021): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: New events: Covid-19 and Drug ineffective were added and case was upgraded to serious.
Muscle pain that is consistent every day and gets worse throughout the day. She says the pain is very deep. Says it feels like someone is pulling on her arm. It has been over 6 months.
pt recv vax & a RIBA test performed in NOV94 revealed neg titers for Hep C;lab testing performed during a physical in FEB95 indicated sl inc in lymphocytes & monocytes & was borderline neg for hep B;@ time of report pt was popping nodes
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown), on 29Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: Jan2010, stop date: Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative on antigen test; Positive, notes: I also tested positive on antigen test; Positive, notes: continue to test positive on antigen test; Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2 weeks. The patient had no known allergies and other medical history. After stopping Paxlovid after 5 day treatment, the patient had no symptoms and tested negative on antigen test. Two days later, he had congestion, sore throat and headache. He also tested positive on antigen test. Symptoms continue for 6 more days and continue to test positive on antigen test.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Chief ComplaintPatient presents witho Covid-19    SOB. The pt was admitted to the hospital on  1/3/2022 because of COVID-19 pneumonia.  IV Decadron was continued.  Oxygen was weaned.
Patient became flush and light headed after her 2nd shot of Pfizer. Patients BP was 140/78 and continued to rise to 170/80, pulse dropped from 78 to 62, patient developed facial redness and after 90 minutes of observation she became to feel a lump in her throat. No difficulty breathing or respiratory issues.
Patient is a 73-year-old female who presents today for left arm pain and itching right after the shot. She denies any fever, chills. She has not really taken anything for the itchiness. She has not use any cool compresses. She is right-handed. The redness has not spread significantly. It is warm.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant therapies provided. n 14-NOV-2017, the patient was vaccinated with improperly stored dose of PROQUAD (therapy type of recombinant human albumin (rHA)) (exact dose, dose number, route of administration was not reported; lot# M037011 with the expiration date of 21-FEB-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# L019488 with the expiration date of 11-FEB-2018). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion between minus 14 and minus 10 Celsius degrees for 10 hours and 33 minutes, and minus 9 to 8 Celsius degrees for 28 hours, 20 minutes. Digital data logger was involved to capture the temperature excursion. There were no previous temperature excursions reported.
This spontaneous report was received from a physician via social media refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with GARDASIL (lot#, expiry frequency, route and dose of administration unknown) for prophylaxis. Other suspect therapies included GARDASIL 9 (lot#, expiry frequency, route and dose of administration unknown) for prophylaxis. On an unknown date, the patient experienced auto immune disease (autoimmune disorder), side effect (adverse event), inflammation, neck pain, nausea, neck pain, rheumatoid arthritis, infection, injury, paralysis, tiredness (fatigue), rash, dizziness, arrhythmia, headache, fainting (syncope), numbness (hypoesthesia), and sinus congestion. The patient died on an unknown date.The outcome of arrhythmia, syncope, headache, dizziness, nausea, fatigue, inflammation, neck pain, adverse event, infection, injury, rash, hypoesthesia, sinus congestion, paralysis and rheumatoid arthritis was unknown. The causality of all the events were not reported. Upon internal review the events death, arrhythmia, autoimmune disorder, paralysis, and rheumatoid arthritis were considered to be medically significant.; Sender's Comments: US-009507513-1810USA005156:
pt received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 23rd June 2022, the patient received Havrix. On 23rd June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-JUN-2022 Reporter's comments: A medical assistant reported that the patient received an expired dose of Havrix. The reporter consented to follow up. Additional supportive information: The patient received Havrix which was expired on 18th June 2022, which led to expired vaccine used.
Thursday during the day I started feeling bad, I awoke with a sore throat. I went to work after testing on Wednesday with a home COVID-19 test that came back negative. I came home Thursday from work and retested, this one came back positive. I went to the quarantine room. I had body aches, swollen glands, hard to swallow, all over feeling bad. I went to the health clinic on Friday and had PCR COVID-19 test that also came back positive. I got Paxlovid that I am still currently taking, the highest my fever got is 101.3F. I have been taking over the counter medication to keep that down. I feel that I am making progress, I can swallow without cringing.
Approximated one week after administration the injection area became very itchy.  Upon briefly itching it and then inspecting it because it felt very warm I have a perfect rectangle raised above my skin.  The color is dark red / slightly bruised.  The area is warm to the touch.  There feels to be a knot underneath the injection site that is relatively large in comparison to the raised / welted rectangle.  The itch subsided after a few hours but it is still raised and warm to the touch.  It is now hour 14 after recognizing the reaction.  The area was painful in the days following administration of the vaccine, and I avoided touching or inspecting it at that point as it was reported to me to be normal to experience pain at the injection site.
Itchy, burning, painful rash on right lower buttock treated with prednisone. Some relief after one day. Rash completely cleared after 3 weeks.
Fever to 102, nausea, vomiting, headache, shaking chills, myalgias  that started about 8 hours after the injection and were very severe for at least 24 hours;
Pt developed small pimple on inner side of middle phalanx of little finger left on wk after HPV vaccine #3. 2 days later developed wart at site. Within on day was the size of pts finger on same finger (8-10mm). Mom treating at home with freeze spray.
received a 3rd Shingle shot; This case was reported by a consumer via(Shingrix GSK Chatbot) interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, the patient received 3rd dose of Shingrix, which led to extra dose administered.
BODY ACHES; TROUBLE WALKING; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced trouble walking. On APR-2021, the subject experienced injection site pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, trouble walking, injection site pain, and headache. This report was non-serious.
RECIPIENT NOT HAVING ANY ADVERSE REACTIONS AT THIS TIME.  REPORTING THIS DUE TO HAVING RECEIVED FIRST DOSE ONLY OF THE MODERNA VACCINE ON 01/06/2021.
From initial information received on 11/1/04 from the patient's spouse regarding an adverse event occurring, it was reported that a 78 year old male patient received a dose of FLUZONE, lot number U1512AA, administered IM in an unspecified site on 10/18/04. Two days later, the patient was hospitalized with sepsis, pneumonia, urinary tract infection and bleeding. Reportedly, the patient currently remains hospitalized. He is on a ventilator and is receiving blood transfusions and multiple antibiotics. At the time of vaccination, the patient also took Coumadin. Patient's pre-existing medical conditions include angina. His wife denied the patient having any illnesses at the time of vaccination. Reportedly, the patient received influenza vaccine annually with no reactions reported. He did not recover from these events.
12-10-2007 10am second dose of varicella given, within five minutes nausea vomiting began along with rash on hands and armpits and buttocks.1005 benadryl 25mg administered. rash spread to entire body denies difficulty breathing. people notified.1030am sleeping rash remains. Report for vaers completed.11am continues to sleep,rash abating.1145am rash almost gone patient discharged home.
Phone call-Mom states baby had shrill crying and lethargic-thinks 103F tamp at 2:00 AM 7/19/05. Advised to see pediatrician. Mom didn't give Motrin until 02:00 AM 7/19. Pediatrician advised to continue Motrin.
slight numbness on upper lip; light headed; head felt heavy; fast heart beat; jitteriness; sore arm; slight brain freeze; tightness in chest; facial numbness on left side; headache; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (slight numbness on upper lip), DIZZINESS (light headed), HEAD DISCOMFORT (head felt heavy), PALPITATIONS (fast heart beat) and FEELING JITTERY (jitteriness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (slight numbness on upper lip), DIZZINESS (light headed), HEAD DISCOMFORT (head felt heavy), PALPITATIONS (fast heart beat), FEELING JITTERY (jitteriness), PAIN IN EXTREMITY (sore arm), COLD-STIMULUS HEADACHE (slight brain freeze), CHEST DISCOMFORT (tightness in chest), HYPOAESTHESIA (facial numbness on left side), HEADACHE (headache) and NAUSEA (nausea). On 10-Mar-2021, HYPOAESTHESIA ORAL (slight numbness on upper lip), DIZZINESS (light headed), HEAD DISCOMFORT (head felt heavy), PALPITATIONS (fast heart beat), FEELING JITTERY (jitteriness), PAIN IN EXTREMITY (sore arm), COLD-STIMULUS HEADACHE (slight brain freeze), CHEST DISCOMFORT (tightness in chest), HEADACHE (headache) and NAUSEA (nausea) had resolved. At the time of the report, HYPOAESTHESIA (facial numbness on left side) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08-JUN-2021 contains non-significant information: Updated Reporter contact details and address.
Patient received immunization. After injection, patient experienced localized blood loss and swelling due to blood thinner use. Pressure was applied. Blood loss quickly stopped but swelling at the injection site remained. Patient was offered ice pack to reduce swelling but patient declined treatment. (time course 30 minutes)
Fever 101.4, vomiting, arms and legs aching. Symtpoms lasted for about two days and then resolved.
1st sx noted 7JUL96 fever (not real high-no thermometer) & chest pain;no swelling or redness @ inj site;fever started on Sunday 7JUL96 evening higher than before on 11th pt doing OK now;no more fever, no chest pain;
Elevated liver enzymes; Sick after COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after COVID-19 Vaccine) and HEPATIC ENZYME INCREASED (Elevated liver enzymes) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    No Medical History information was reported.   On 19-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and METHOTREXATE (unknown route) at an unspecified dose. On 19-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced ILLNESS (Sick after COVID-19 Vaccine). On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (Elevated liver enzymes). On 21-Mar-2022, ILLNESS (Sick after COVID-19 Vaccine) had resolved. At the time of the report, HEPATIC ENZYME INCREASED (Elevated liver enzymes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme increased: elevated.   The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19 vaccine clinical trial.  The reporter causality for events of sick after COVID vaccine and elevated liver enzymes most likely from methotrexate with Humira was no reasonable possibility.  No treatment medications were reported.  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.