chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient received her first dose of GARDASIL 9 three years ago and has not received another one; No other AE reported; This spontaneous report was received from a registered pharmacist and refers to a female patient, who was 28 years old at the time of the report. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date in June 2018 (reported as three years ago), the patient was vaccinated with her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). Since then, she has not received another dose of the vaccine (inappropriate schedule of vaccine administered). No adverse event (AE) was reported.  The pharmacist requested information regarding vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
PATIENT IS UNDER 18 YO AND RECIEVED MODERNA VACCINE. NO ADVERSE EVENT OTHER THAN AGE KNOWN
Death from SIDS. Autopsy shows congestion of thymus, lungs, adrenals and spleen. Also shows seborrhic dermatitis, conjunctivitis, unresponsive.
At about 10:30p-11:30p on 01-14-2021 I went to bed and I woke up feeling weird. I had a rapid  heart rate of 140bpm. I did not lose consciousness. I called 911 and they  came to my home with an ambulance. My BP was 200/100. My heart rate was 130. They told me i had tachycardia with BP elevated and my husband took me to the ER for evaluation. At the ER, lab work was done, they hooked me up to monitors and I had an episode where my heart rate increased. I was discharged home and to follow up with my PCP and everything seemed fine. About two weeks later I had same episode where heart rate elevated and now with chest pain. I went again to the ER and they did more tests on me. I saw a cardiologist and he had me wear a holster monitor. With the holster monitor I had one minor episode where my heart beat elevated. I will see my cardiologist next week. I did not receive my second dose of Pfizer vaccine.
Fatigue, Aches and myalgias, shoulders, neck and back, and syncopal episode (passed out in bathroom no injuries continues to monitor) recovered well
pt recv vax 9JUN98 & 12hr later pt devel a h/a, vomiting,neck stiffness & thrombocytopenia;pt was positive for Kerning's sign & Babinski sign upon physical exam;pt hosp;MD felt h/a,v, neck stiffness & thrombocytopenia were not r/t vax;
Patient tested positive for Covid-19 on 12/29/2021.  Admitting diagnosis of acute covid PNA, pneumonitis, hypoxic respiratory faliure secondary to covid PNA.
First three days 102 fever, legs were in so much pain I could not walk or get up.  The fourth and fifth day my lips and face would become tingly/numb and my left arm would get weak and I would feel a little disoriented, my sleep has been pretty disturbed. It felt like I was having a stroke. I did not have a stroke,  I continue to occasionally feel the above symptoms, a little less potent than they were, they might be going away, I can't tell. I will be calling my doctor if it continues.
I started on Sunday 12/27/20 with chills, body aches, headache (that was all over) reaction on my arm, felt like my arm was the size of baseball. I figured it was all from the shot because I, myself work in the health field so I knew these were all reactions. However, as the day went along the worse I got to feeling. I kept taking Tylenol (only thing I can take because of not having a spleen and having a bleeding disorder) and my headache would not go away.  So, then at midnight I ended up checking my temperature and it was 100.4. As the night went on I still wasn't able to get rid of my headache and I had even started adding Benadryl along with my Tylenol and still wasn't able to get rid of it. I ended up talking to my Hematologist and she had recommended me to go to the ED to be checked out.
This is a spontaneous report from a non-contactable consumer reported for oneself. A patient of an unspecified age and race received PREVNAR 13 at single dose for immunization on unknown date. Relevant medical history and concomitant medication. The patient experienced a bad case of flu. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
9 days after receiving the vaccine, my left arm broke out in a red, slightly raised rash that spread to my inner arm. I used 1 percent cortisone cream without any change. I called dr on demand on day 13 after the vaccine, and the doctor ordered a stronger steroid cream. The rash has gotten better, but I now have a 2-3 inch diameter bruise on my left arm at the injection site. It is warm to touch and sore to touch.
I experienced in my mouth tingling of my tongue, lips and mouth. Tongue felt swollen as well as the back of my throat. Ended up in Emergency Room hospital for 5 1/2 hours. Received Epi-pen, Solumedrol 60 mg po, Zantac 50 mg IV. Observed until 8:00 pm. Discharged with Epi-pen and took another Zantac 150 mg po. Some symptoms returned, but mild. I also had a similar reaction to Benadryl IV back on March 25, 2010. I am wondering if this is being caused by the preservative in these drugs.
Wife phoned nurse on 9/12/03 and informed her that 24 hours post travel injections, client developed ? hiccups with one episode of stomach spasms. The hiccups have continued unresolved for one week and chest currently Admitted to the local hospital. Client discharged after 2.5 days and diagnosis unknown.
05-17-07 Sore throat and ear pain. 05-18-07 Progressed to jaw and neck pain. 5-18-07 was seen by her family physician. Treated with "a shot" and antibiotics (unknown what the shot was.) 05-19-07 fever and fatigue.
Information has been received from a healthcare worker concerning a 31 year old white female pt with no pre-existing allergies, birth defects, or medical conditions who on 04/09/04 at 8:30 A.M. was vaccinated SQ in the LA with a dose of varicella virus vaccine, live. There was no illness at the time of vaccination. The pt was vaccinated because she had never had the chickenpox and was "planning a family soon". The HC worker reported that  the varicella virus vaccine, live, may have been recostituted with sailine instead of the dilutent provided. There were no sx reported. No Tx was required. There was no product quality complaint reported. Unspecified medical attention was sought. Follow up information received on 07/02/04 indicated that there was nothing furhter to report. Additional follow up information received 07/23/04 from a NP indicated that the pt was vaccinated with a dose of varicella virus vaccine,live that was stored in the refrigerator instead of the freezer for approximately 3 days.  Two months after the 2 vaccination, in July 2004, an IGG titer showed that antivaricella antibodies were "present but low" Additional information is expected.
BODY ACHES, CHILLS, NASEA, UPSET STOMACH, MAJOR HEADACHE
Extreme respiratory distress, Steroids and injectable Benadryl,  outcome: reduction in respiratory distress start time Time lapse: 11:30 AM - 6:10 PM
Within 2 minutes of vaccine, numbness across my face, lips, ears, neck, chest. Subsided on the left side within 25 mins. Now 5 hours post vaccine, I still have numbness in right side of face, right ear, right shoulder, left arm.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Additional Details: BRUISING AND PAIN REPORTED PER PATIENT'S DAUGHTER.
Symptom onset was 08-30-2021. Symptoms included cough, fatigue and myalgia. Patient tested positive for Covid-19 on 8-30-2021 (and on 9-02-2021 and 9-09-2021). She was hospitalized on 8-30-2021 through 9-4-2021 due to Covid-19 and heart rate, at Hospital.
Right after getting the vaccine I noticed that I was spinning, I had dizziness 190/120BP was high BP stayed high for two or three days. At the emergency room they gave me an IV for fluids.
This spontaneous report was received from a registered nurse regarding an 8 week old patient with no pertinent medical history reported. On 09-AUG-2013 the patient was vaccinated with RECOMIBAX HB (lot number and expiration date not reported) (dose and route not reported). Other suspect therapies included PEDIARIX (lot number and expiration date not reported) (dose and route not reported). The nurse reported that the patient received both RECOMIBAX HB and PEDIARIX due to human error. No adverse effect was reported. Additional information has been requested.
Patient came into store on 08/28/18 around 9:30am with a red swollen upper arm. She complained of pain and swelling in arm. Advised patient to take antihistamine and acetaminophen as well as using ice to help with allergic reaction. Patient stated that she felt well enough to return to work.
Patient received the 5-11 year old dosing of Pfizer instead of the intended 12 & up vaccine.
pulse go up to 180, even not being active; a racing heart rate ever since receiving the second Pfizer Covid vaccine; having chest pain; This is a spontaneous report received from a contactable nurse (patient). This 35-year-old female patient received the first dose of (BNT162B2, Lot number=EL3248) at single dose for COVID-19 immunisation on 23Jan2021 at 02:00 PM. Relevant history included  PCOS (Polycystic ovarian syndrome), seasonal allergies, migraines and known allergies: Aspartame and bee stings. Concomitant drugs included metformin, paracetamol (TYLENOL), multivitamin, aspirin, cetirizine hydrochloride (ZYRTEC). The patient previously received the first dose of BNT162B2, Lot number= EH9899, at single dose for COVID-19 immunisation on 02Jan2021. On 23Jan2021, the patient experienced chest pain and a racing heart rate ever since receiving the second Pfizer Covid vaccine. Her pulse would  go up to 180, even when she was not being active. No treatment was received. Outcome of event was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: The contributory role of the suspect product BNT162B2, Lot number=EL3248) at single dose for COVID-19 immunisation to reported events is possible based on temporal association and known profile of the product.
Patient woke up in the middle of that night around 1 or 2 am very dizzy and lethargic, patient said that he felt like the ceiling was spinning and he could not walk at all, he was like crawling to reach his destination.
PT came in 8/31 complaining of hot flashes/muscle aches/nausea/ dizziness She was sweating profusely. had her lie down with a cool cloth on her head. No fever very uncomfortable and restless, chills as well. Stated she had received COVID vaccine 8/29 which I verified with database. Dad came and picked her up.  Saw patient again 9/7 complaining of runny nose and coughing since 9/4, she also states she has been having memory loss since her COVID shot and cannot remember certain events that have happened to her example: conversations Advised dad to talk with doctor about symptoms before receiving her 2nd dose
PT REPORTED SHE FELT LIKE SHE LOST CONSCIOUSNESS FOR A MOMENT AND LOST CONTROL OF HER BOWELS.  PATIENT VISIBLY SOILED HERSELF IMMEDIATELY FOLLOWING VACCINE ADMINISTRATION.
Expired boostrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number AB374, expiry date 21st November 2022) for prophylaxis.   On 22nd November 2022, the patient received Boostrix. On 22nd November 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's Comment: The certified nursing assistant reported that the patient received a dose of Boostrix on the day of reporting and it was already expired.  The reporter consented to follow up. Additional Supportive Information: The use of Boostrix dose, which was already expired on 21st November 2022, which led to expired vaccine used.
I awoke from sleep freezing cold.  Colder than I have ever felt.  violent shakes.  So much that I was worried my muscles would begin to sieze up and cramp.  I had warm clothes and 5 blankets and could not get warm for over 2 hours.  Elevated heart rate and breathing.  Nothing warmed me.  Eventually (and with ibuprofen) the incident subsided.  I felt weak and just "off" with slight body aces and fatigue for the next day and a half.
Injection site pain for 1 day; This is a spontaneous report from a non-contactable consumer reporting for herself. This is the first of two reports. A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot En9264, via an unspecified route of administration in left arm on 02Feb2021 13:30 (at the age of 52 years) at single dose for covid-19 immunisation. Medical history included high blood pressure.  The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Allergies to medications, food, or other products were none. Concomitant medication included losartan, vitamin d3, ubidecarenone (Q10).  The patient experienced injection site pain for 1 day (non-serious) on Feb2021. No treatment was received for the event. The outcome of the event was resolved.    No follow-up attempts are possible. No further information is expected
Severe swollen lymph node in armpit; Dose 1: Moderna; Dose 2: Moderna; Dose 1: Moderna; Dose 2: Moderna; hindered my movement; hurt badly; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 07Dec2021 (Lot number: FH8030) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 013M20A, Location of injection: Arm Left), administration date: 03Feb2021, when the patient was 35 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 027120A, Location of injection: Arm Left), administration date: 06Jan2021, when the patient was 35 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 08Dec2021, outcome "recovered" (Dec2021), described as "Severe swollen lymph node in armpit"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 08Dec2021, outcome "recovered" (Dec2021) and all described as "Dose 1: Moderna; Dose 2: Moderna"; MOVEMENT DISORDER (non-serious) with onset 08Dec2021, outcome "recovered" (Dec2021), described as "hindered my movement"; PAIN (non-serious) with onset 08Dec2021, outcome "recovered" (Dec2021), described as "hurt badly". Therapeutic measures were not taken as a result of lymphadenopathy, off label use, interchange of vaccine products, movement disorder, pain.
Information has been received from a nurse concerning a 9 year old male who on 23-AUG-2007 was vaccinated subcutaneously with varicella virus vaccine live (Oka/Merck) (Lot #657996/0843U). The patient developed a 2X4 centimeter red rash with a 2 centimeter ring around it (total diameter of about 10 centimeters) after receiving the 2nd dose of varicella virus vaccine live. The patient sought medical attention. The patient was seen in the office for a visit on 28 AUG 2007. The outcome was not reported. No further information available.
Patient received the high dose flu vaccine prior to turning 65. Patient has not experienced and adverse effects from receiving the wrong vaccination
Body aches and nausea started at 9 pm  9:30 am started vomiting
tested positive after receiving the vaccine; tested positive after receiving the vaccine; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The nurse reported that the patient was tested positive after receiving the vaccine. The nurse asked if this had been an increasing occurrence. The nurse asked if someone was positive for covid but was unknowing positive was asymptomatic and did take the vaccine, what are the dangers. The nurse asked for information on efficacy if the interval is longer than 21 days, if it is the same efficacy. The outcome of the events was unknown.     Information about batch/lot number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Pateint was inadvertently given Menactra instead of the ordered HPV vaccine; patient had received the Menactra at 11 years and again on 13 years; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with 2019SA110183 and 2019SA110184 (same reporter).  This case involves a 13 years old female patient who was inadvertently vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6151AA, expiry date: 16-Mar-2020, via unknown route in the right arm on 17-Apr-2019 instead of HPV vaccine. The patient was previously vaccinated with a dose of MENACTRA on an unknown date at 11 years of age.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to wrong vaccine administered and extra dose administered.  It was reported that patients had received the Menactra at 11 years for routine vaccination and at 13 years the patient was inadvertently given Menactra instead of HPV vaccine.  It was not reported if the patient experienced any adverse event following vaccination.  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.  List of documents held by sender: none.
Swelling/redness on arm the size of an adult fist. Fever in arm/tenderness.
1hr p/recvd vax pt devel unusual crying for approx 3 1/2 hrs; pt was brought to MD; pt was crying but was consolable p/15 minutes; PE unremarkable; 7x5 cm area of swelling @ rt thigh & erythema @ the vax site;
A day after I received the shot, I began to experience pain and inflammation in my left breast, where I had a breast reconstruction revision in January 2021 involving an implant. This was a surgery that had previously healed fine and there was no pain around the implant. The pain and inflammation continues until this day and I am managing it through anti-inflammatories. I believe my body's immune response has kicked in and wanting to reject the implant.
Everything outside and in hurts/ It all hurts; My eyes want to pop out and I want to die the pain is so bad; My fingers and toes are completely numb; It hurts to breathe. It all hurts; This is a spontaneous report from a contactable consumer (Patient). A 41-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 20Jul2021 at 12:30 (at the age of 41-years-old) as a DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received PFIZER (Batch/Lot Number: Not reported), via an unspecified route of administration on 29Jun2021 as a DOSE NUMBER UNKNOWN, SINGLE for an unspecified indication. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient said, I'm trying to tell you how we sock I am. Patient reported that, on 20Jul2021 at 14:45, everything outside and in hurts/ it all hurts, my eyes want to pop out and I want to die the pain is so bad, my fingers and toes are completely numb it hurts to breathe and, it all hurts. Patient did not receive any treatment for the events. Outcome of all events were not resolved.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt recv vax on 8/19/98; on 8/21/98 pt exp injection site rx.
pt recvd vax; exp local rxn (size of grapefruit) consisting of redness, induration/swelling; tx w/ dph, pred & cold compresses;
Facial numbness and slight drooping of eyes occurred about an hour after receiving the vaccine. It has gone almost back to normal as of today 5/26/21.
Patient returned to the clinic 40 minutes(0720) after receiving the Rabies vaccine with c/o" A feeling of tightness and itching in the back of her throat". Patient was taken to the clinics treatment room and 0.3 mg of Epinephrine (Epi-Pen) was administered to the outer right thigh(Per the provider present) @0725 Patient also received 50 mg of Benadryl IM to the right deltoid(0727). Vital signs were monitored every 10 mins. and remained stable. The patients lungs were clear upon auscultation and no wheezing or stridor noted. The patient's throat was clear and without signs of swelling. Patient able to speak without difficulty and was alert and oriented. Patient  remained in the treatment room and monitored for 2.5 hours post medication. Patient was released with instructions to return to the clinic or report to the emergency if the symptoms should return
Patient has experienced soreness of injection site to return and sometimes has a mild sharp pain at injection site - also feels a small knot at injection site.
Chills, stomach upset, fatigue, headache, sore arm at injection sight, nightmares
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: 3 CM edematic rash at injection site-Medium, Additional Details: Shot may have been given lower than should have in arm as well
Developed a rash around the injection site that spread around my deltoid area.  It itches slightly, but is not painful.
administration past expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration past expiry date) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration past expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration past expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. The vial was initially stored in the refrigerator: It was stored in the freezer, thawed on the day of administration. The vial did not undergo any temperature excursions.