chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Next day in the morning my temperature was 99 degrees. at 1 PM the temperature rose to 100.1 degrees; I also have a headache, nausea, and weakness; I also have a headache, nausea, and weakness; I also have a headache, nausea, and weakness; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient had no other relevant medical history and no known allergies to medications, food, or other products. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 09Feb2021 at 09:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. After getting second dose on 02Mar2021, next day in the morning on 03Mar2021 at 10:00, the patients temperature was 99 degrees (units unspecified), at 13:00 the temperature rose to 100.1 degrees (units unspecified). On 03Mar2021 at 10:00 the patient also had a headache, nausea, and weakness. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events next day in the morning temperature was 99 degrees (units unspecified), at 13:00 the temperature rose to 100.1 degrees (units unspecified); also had a headache, nausea, and weakness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Myalgia, Fever, Diarrhea, Nausea Vomiting, chills, no appetite Narrative:
nose bleed; This is a spontaneous report from a contactable consumer (patient's husband) Pfizer-sponsored program . A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient took the first dose and had a nose bleed this morning. She is on a blood thinner. The outcome of the event was unknown.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
redness and swelling at injection sites (thighs). Swelling in one arm and hand.
injection given. approx. 5 mins later patient experienced a syncopal episode. patient was given juice and menotired for 15 mins.
below injection site is a 3 inch wide welt, wrapped around inner arm itchy red hot
Patient was waiting in the observation area following her injection and approximately 30 minutes after injection she began to itch.  She stated that she felt the itching all over her body.  She did not have any apparent signs of rash.   Patient was given 12.5mg of diphenydramine liquid 12.5mg/5ml.  Patient stated that the itching had decreased and that she was not having any trouble breathing.  She declined any other treatment and went home.  Patient was called twice over the next  7 hours and she stated she had only mild itching.
Right leg pain and limping, fever, swollen eyes with green discharge, runny nose, fatigue.
High fever 38.8 degrees in Celsius or 101.84 degrees in Fahrenheit, right arm pain, back pain, bone pain, splitting headache, heart speeding up, diarrhea, fatigue, feeling very irritated.  No treatment but drinking a lot of cold water.  Body temperature back to normal and feeling much better 2 days after the shot.
Immediately after leaving facility, pt got HA, later nausea & vertigo, vomiting. Hot & cold spells. Mother took daughter to MD - MD felt she picked up virus. Tx anti nausea. MD felt it was OK to receive last vaccine.
Strange dreams during which I physically grab/shake/pull hair of my wife in bed.  Never did this prior to vaccine. Has happened at least 5 times since vaccine. Latest event occurred 5/4/21
Headache; Fatigued; Swollen Lymph Nodes; Chills; Nausea; Feeling Unwell; Body Aches; This is a spontaneous report from a contactable consumer (patient himself). An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL8982), via an unspecified route of administration (right arm), on 14Jan2021, at single dose, for covid-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. The patient experienced headache, fatigued, swollen lymph nodes, chills, nausea, feeling unwell, and body aches - all on 14Jan2021. The patient had none of these symptoms prior to the shot. The patient had no Covid prior vaccination, had no other vaccine in four weeks, and had not been Covid-tested post vaccination. The patient was recovering from the events. No treatment was received for the events reported.
had 1st vaccine 2-17, went to nail appt and had splinter hemmorages and subungual hematoma left hand, had 2nd vaccine on March 2 and went to nail appt on April 8 and now have issues on both hands all fingers affects
joint pain which started after the second dose of Covid-19 Vaccine; The severity of the pain has been high enough to wake her up from sleep a couple of times; This is a spontaneous report from a contactable consumer. An adult female patient (age and unit unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown that the patient been tested for COVID-19. The patient experienced joint pain which started after the second dose of Covid-19 Vaccine and the severity of the pain has been high enough to wake her up from sleep a couple of times on an unspecified date. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Has urticarial swelling of upper face, periorbital areas and upper back; no wheezing or throat swelling
Information has been received from a physician concerning a child with no reactions after the first dose of VARIVAX (Oka/Merck) who on approximately 10-JUL-2008, two weeks ago, was vaccinated with the second dose of VARIVAX (Oka/Merck). The patient experienced severe swelling under the arm, redness on the arm and nodules. The patient was taken to the emergency room but was not admitted. The patient's severe swelling under the arm and redness on the arm and nodules persisted. This is one of several reports from the same source. Additional information has been requested.
client complained of left hand tingling after receiving 2nd Pfizer.  Client informed EMTs of new onset of symptoms. PHN joined team shortly after. Per client had been in waiting area 20mins and new onset 8 mins ago. First vitals 1303: blood pressure: 130/90, pulse 74, oxygen 97%. Per client sensation to left hand as if "hand had fallen asleep". Sensory and motor intact on left hand. Client received vaccine in left deltoid. Client denied pain or radiation past wrist. Per client no reactions to first dose. Vitals 1308: blood pressure 120/80, pulse 71, oxygen 98%. Per client tingling sensation lessened. Medical history of diabetes, takes metformin. No history of allergies. at 1313 client ready to leave. Per client felt fine. EMT advised client to seek medical care of worsened symptom. Last vitals: blood pressure: 120/80, pulse 72, oxygen 98%. Client left facility with steady gait at 1315.
Information has been received from a licensed practical nurse concerning her son, a 4 year old male with milk allergy, no allergy to medication and a history of methicillin-resistant staphylococcal aureus infection in October 2010 (reported as last year), gastric issues and developmental issues during mothers pregnancy with the patient who on 28-SEP-2011 was vaccinated with a routing booster dose of MMR II, along with another unspecified vaccine and on 13-OCT-2011 was vaccinated with an additional dose of MMR II, as well as an tetanus toxoid (unspecified). Concomitant therapy included clonidine, 1/4 of 1 mg tablet. The nurse reported that her son began exhibiting "lethargic, weak, sick" behavior and that her son was "irritable, and not acting as he normally did, was not eating, waked up every hour at night and was very anxious and hard to console." Nurse reported that she noticed the behavioral changes starting approximately five hours after the vaccines were administered on 13-OCT-2011, and that these behaviors continue to the time of the report. Nurse reports that her son had been diagnosed with global developmental delays and autism. No treatment was given for AEs. No lab diagnostics studies were performed, however platelet count was being requested in near future. The AE did not improve. The patient sought medical attention via telephone calls. At the time of report, the patient had not recovered. Upon internal review, the autism was considered to be other important medical event. Additional information has been requested.
back pain; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced back pain. On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-OCT-2022 Reporter's Comment: This case was reported by a patient via (Shingrix) interactive digital media. The patient had back pain next day after receiving shingles vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Patient was given an expired Daptacel, no AE; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case is linked to case 2019SA327197 (same reporter).  This case involves 2 year old male patient who received a dose (fourth in series) of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]  lot C5307AA expiry date: 23-Oct-2019 via unknown route in unknown administration site on 15-Nov-2019.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was of actual medication error case due to expired vaccine used.  At the time of reporting the patient had no adverse event.  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 Directive and Module VI of the 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.
12 days later.  itchy scalp followed by hives in different places on my body.  still continues today.  hives appear- are intensely itchy- then disappear and reappear later somewhere else.  i have also had itchy hands and feet, as well as itchy ears.
shakiness; increased heart rate; horrible headache; i have almost passed out multiple times; slurred speech; This is a spontaneous report from a contactable other HCP. A 19-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL3247) via an unspecified route of administration, administered in arm left on 04Mar2021 at 11:00 for COVID-19 immunisation. The patient medical history not reported. The patient concomitant medications included alprazolam (XANAX), ascorbic acid, beta vulgaris root, iron amino acid chelate, rosa canina fruit, rubus idaeus leaf (IRON SUPPLEMENT). The patient historical vaccine included first dose on 09Feb2021 at 07:00 PM (lot number: EL3241) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received birth control, xanax, iron supplement medications within 2 weeks of vaccination. On 04Mar2021 at 11:00 AM, the patient experienced the same reaction that get anemic, shakiness, increased heart rate, horrible headache and patient had almost passed out multiple times, had slurred speech. These happened directing after the vaccine. No treatment was received. The outcome of the event was resolving.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
5-6 Minutes after varicella vaccine was administered patient broke out in total body hives, had severe itching and mild expiratory wheezes but in no respiratory distress.  Pulse ox 96% rr 24 pulse 124 bp 104/62  Given Benadryl 25 mg p.o. and with persistent severe itching epi 0.3 mg subQ and another 50 mg of Benadryl.
After vaccination I experienced very fatigue, nauseous, chills, fever, so cold, and sore, and today 48 hours it appears to have a menstrual cycle or vaginal bleeding that started today, I had a hysterotomy 20 years ago.
pt recvd vax; subsequently it was noted that vax carried expiration date 30sep90
nauseousness; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 15:30 as dose 1, single (Lot number: HG2282), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Statin drugs" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE; UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 06Oct2023 at 17:00, outcome "recovering"; NAUSEA (non-serious) with onset 07Oct2023, outcome "recovering", described as "nauseousness". Therapeutic measures were not taken as a result of dizziness, nausea.
Initial information received on 15-Jun-2018 regarding an unsolicited valid non-serious case received from a Medical assistant (health care professional). This case involves a patient (age and gender not reported) who was vaccinated with expired dose of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Expired vaccine used. No adverse event 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 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. Documents held by sender: none.
He noticed a slight rash within 2 days of 2nd vaccine and has gotten worse until the present time. Rash has spread all over the body including the chest, back, genital area, and upper thighs. Skin feels tight, itchy, and stings when touched. Also is areas of rash are swollen.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L043213 expiration date 28-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low -28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
12 hours after I had 103 fever, severe chills & body aches & headache that lasted 12 hours. Then a persistent headache came on left side & has been there for 5 days.
Patient (DOB 09/20/77) had a reaction to the Moderna Covid-19 vaccine given on 1/29/2021. On the screening form, patient indicated she had allergies. She verbally said she had multiple allergies and had an anaphylactic reaction previously to allergy shots received in a doctor?s office. She said she does carry an Epipen. RPh counseled on the cases of anaphylaxis with the Pfizer vaccine and recommended a 30 minute monitoring period following the vaccine in accordance with CDC guidelines. Patient agreed and received the vaccine at approximately 11:30am with instructions to check back in with RPh at 12:00pm.   A few minutes later (at least 5 minutes), a friend of Patient alerted RPh that patient had fainted. The friend was able to catch patient before she fell off the chair and lower her to the ground. Patient was awake and answering questions but appeared to be having trouble maintaining consciousness. She denied shortness of breath, itching, swelling, and no rash or wheezing was evident. An Epipen was available and present but not administered due to lack of respiratory symptoms. 911 was called at 11:39am with the patient?s permission. Her symptoms remained the same until EMS arrived and she left in the ambulance at 11:57am.
This initial spontaneous case, was received on 03-Nov-2017, from a nurse, concerning a 20-year-old, adult male patient. The patient's concomitant medication included amlodipine for an unknown indication and the medical history was not reported. On 29-Oct-2017, the patient was administered with AFLURIA (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: XT0338 (as reported), expiry date: 30-Jun-2018). On 30-Oct-2017, after 2 days of vaccination, the patient woke up with a red face and itching in the groin area and received BENADRYL, unspecified steroid shot, MEDROL DOSEPAK. It was stated, the symptoms were subsided for some time but reoccurred later and his face was still red. On an unspecified date, the patient went to the allergist, who diagnosed him with allergy. The reporter stated that, the patient went to visit a cardiologist. At the time of this report, the patient had not yet recovered from the event. The reporter assessed the event as non-serious and considered the causality of the event as related. Follow up received on 22-Nov-2017: New event (allergy) was added and symptoms (red face and itching) were merged to the Allergy. It was reported that, the patient's face was still red, and he went to the allergist, who diagnosed him with allergy and also went to visit a cardiologist. The narrative was amended accordingly.
test positive post vaccination; test positive post vaccination; This is a spontaneous report from a contactable Nurse (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got the Pfizer Covid-19 vaccine on the 17Dec2020. He would like to how likely is he to test positive post vaccination. He wants to know if the test results would be a false positive post vaccination. He is going to get tested at two different facility. Event outcome was unknown.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, a possible contributory role of the suspect product to the development of Drug ineffective and COVID-19 cannot be excluded.  The case will be reassessed if additional information becomes available.
Approximately a few days after my 2nd booster shot (Dose 4), I experienced the following symptoms: Fatigue, Raising heart palpitations, Tightness in the chest. I took my daily medication of baby aspirin to help ease my condition. I called my doctor and was advised that it's not unusual for them to hear for senior people to get the same symptoms after getting vaccinated. After a day, I was feeling back to normal again.
2 or 3 days after injection left arm started hurting felt tingling and numbness in left arm and 3 fingers and is slowly getting worse. TC to Employee health 11/11/2005 stated maybe hit nerve ant to see my doctor.
diagnosed with COVID (wait to take him to get his third vaccination); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with COVID (wait to take him to get his third vaccination)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced COVID-19 (diagnosed with COVID (wait to take him to get his third vaccination)). At the time of the report, COVID-19 (diagnosed with COVID (wait to take him to get his third vaccination)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided. No treatment information was provided.