chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe joint pain in right hip.; This is a spontaneous report received from a contactable consumer or other non hcp. A 70-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6208) via an unspecified route of administration in Arm Right on 07Mar2021 02:30 (age at vaccination 70years old) as single dose for covid-19 immunisation. The patient had known allergies reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications in two weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN9581) via an unspecified route of administration in Arm Right on 4Feb2021 at 02:00PM (age at vaccination 70years old) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. On 13Mar2021 12:15 the patient experienced severe joint pain in right hip. The patient received treatment with OTC pain medication, rest for the adverse events. The clinical outcome of the event was not recovered. Therapeutic measures were taken as a result of severe joint pain in right hip.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
I developed Bell?s Palsy just over 3 weeks after my 2nd dose of the vaccine.  I don?t know if this was due to the vaccine because I know that Bell?s Palsy can come on for unknown reasons, but because of the proximity to the vaccine and the other questionable abnormalities that are being associated with the vaccine, my doctor thought it would be useful for me to report this.
24 hours after receiving vaccine, patient developed swelling, redness, tenderness in arm. Required Atenol, wistuart cream, and Keflex for therapy. Also added cool compressions
This spontaneous report a received from a healthcare worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (lot number and expiry date not provided). Other suspect therapies included VARIVAX (merck) and ZOSTVAX. On an unknown date, temperature excursion to ZOSTAVAX, VARIVAX (Merck) and PROQUAD (Merck) which was supported and no product was administered. However, the healthcare worker then stated that the freezer has had episodes of cycling after which the practice had administered all three products. ZOSTAVAX, VARIVAX (Merck) and PROQUAD (Merck) all supported post cycling events described. The healthcare worker had no knowledge of adverse effects note by any patient post administration. The outcome of temperature excursion and ZOSTAVAX, VARIVAX and PROQUAD all supported post cycling events described were unknown. This is case 3 of 3. This case is related to case 1405USA1785 and 1405USA004770 (same reporter link). Additional information is requested.
My heart rate is constantly high and won't slow down.  It started at 1am, 3 hours after I fell asleep and had a fever of 100.3 and a headache and soreness. I couldn't fall back asleep the entire night.
Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 years old female patient who had FLUBLOK QIV lot QFAA1833 in left arm on 31-Dec-2018. 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 Inappropriate age at vaccine administration. The patient outcome is reported as Not Applicable for flublok vaccine was administered to a 6 year old. 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.
After vaccination I got vertigo; vomiting; fever; headache; feeling sick; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in an unspecified anatomical site on 16Mar2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, after vaccination the patient experienced vertigo, vomiting, fever, headache and feeling sick. The patient did not receive any treatment for the events. The clinical outcome of the events vertigo, vomiting, fever, headache and feeling sick were not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.
Pt was given an expired  Moderna Covid 19 vaccination. This was his second dose in the series. Pt did not have any adverse effects.
Menveo only diluent portion administered; Only the diluent portion administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA729A, expiry date 30th September 2023) for prophylaxis.   On 19th September 2022, the patient received the 1st dose of Menveo. On 19th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comment: The reporter was a assistant quality care coordinator. The reporter reported that the patient received only diluent portion of Menveo vaccine. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The reporter gave by error Menveo diluent portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
A 73 year old male admitted as inpatient on 9-22-21 with obstructive uropathy. He did test positive for Covid on 9-18-21 at a hospital.
This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fatigue and fever. On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the fatigue and fever were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fatigue and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a practice manager. The age at vaccination was not reported. The patient experienced fatigue and fever for about 24 hours. The reporter agreed to be contacted for follow up.
Myalgia, Arthralgia, Pain along the spine, fatiques, injection site sore Narrative:
Syncope with bradycardia and Hypotension  BP 70/40 HR 44 O2sat 95%.
booster dose of the vaccine; booster dose of the vaccine; diarrhea; tongue and lips feeling very dry and sticky; tongue and lips feeling very dry and sticky; he checked his fever and it was 97.5; he can't pronounce words; This is a spontaneous report from a contactable consumer. A 73-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Oct2021 (Age at Vaccination 73-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient experienced booster dose of the vaccine (off label use) and booster dose of the vaccine (immunization) and diarrhea on 04Oct2021, on 2021 patient experienced tongue and lips feeling very dry and sticky, he checked his fever, and it was 97.5, he can't pronounce words. It was reported that Caller reports that he received his third booster dose of the Pfizer Biontech covid 19 vaccines yesterday. On Sunday he ate a bad plum and was experiencing diarrhea, however he is still experiencing this side effect. He states normally when he experiences diarrhea it only last 1-2 days, but this is day 3. Caller report he had it all day yesterday, he went to the clinic at 9:15 AM to get his booster dose, ran some errands and then was home at 2:30-3, then he didn't go to the bathroom until after eating lunch at 3-3:30 when he had diarrhea/ loose stool for a second time. He then took two immodium at 10 PM and one a 1 AM. Today he reports he only had one episode after his breakfast of kashi cereal, milk and oatmeal. Caller reports side effect of tongue and lips feeling very dry and sticky. Caller would like to ask, as he is talking all of a sudden, his mouth is dry and he can't pronounce words, was that part of it, his lips and tongue are dry. States he likes to speak. Caller states he knows he will be strong as a rock in a few days. Caller states he checked his fever, and it was 97.5. States he wanted to make sure his diarrhea goes away soon.The patient underwent lab tests and procedures which included body temperature: 97.5 Fahrenheit in 2021. Therapeutic measures were taken as a result of diarrhea. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
2/24/20 onset of nausea, vomiting, stomach pain, low grade fever 99.5, 99.9 degrees F, continuously including today 3/3/20 Temperature 100.0 degree F,
Monovalent pfizer covid vaccine given in error, intended to give bivalent booster.  Patient notified, advised to receive booster >= 2 months after this dose
On October 29, 2022, three weeks after my bivalent booster I had a fast heart rate, about 145. My normal rate is 62BPM.  The next morning, I went to a local urgent care clinic because my heart was still racing. I was diagnosed with Atrial Fibrillation. They referred me to the emergency room. I went in an ambulance from the clinic to the hospital. At the ER I was monitored, and my heart was about 165BPM at this point. I was given intravenous drugs and that slowed my heart rate. They also diagnosed me with atrial fibrillation. As of today, I am doing well, but I am now on a beta blocker.
After receiving vaccine booster, patient ended up going to ED for a local reaction. Swelling and pain at site of injection. Dx'd as mild allergic reaction, discharged to home with allergy treatment plan.
zoster-related eye injuries; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) by a healthcare provider at a physician's medical office for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a physician's medical office for zoster-related eye injuries. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of zoster-related eye injuries to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a nurse practitioner concerning a 16 year old female patient who on 06-JUN-2007 was vaccinated IM with a 0.5 ml second dose of Gardasil. On 06-JUN-2007 the patient felt dizzy. Unspecified medical attention was sought. Subsequently, the patient recovered from dizziness. This is one of several reports from the same source.
Patient informed nurse & doctor, "think I am having a reaction to the flu shot." Patient was flushed, having difficulty breathing, feeling anxious.
Moderna Booster and Fluarix administerd. opposite  arms. after second shot adm. pt fell faint, but remained conscious. Pt was hot, sweating and flushed. Paramedics called and pt cared for. Offered Ice pack, water and Glucose tablet . pt was seated.
Smelling smoke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 17:15 (Batch/Lot number: unknown) at the age of 55 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Shellfish" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAROSMIA (non-serious) with onset 22Aug2021 18:00, outcome "not recovered", described as "Smelling smoke". Therapeutic measures were not taken as a result of parosmia.  Additional information: Patient did not receive any other vaccine in four weeks. Patient received other Medications in Two weeks. Smelling smoke. started Sunday evening and was intermitten all day yesterday. Not as much during the day today but pretty constant all this wvening. Patient did not tested covid prior vaccination and post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain of injection site. Patient states she has been having pain for since the date of the shot. She said her pain medication has not dampened the pain. We are keeping up with the patient to see if she is getting better.
pt recv vax 13JAN97 & 1wk later pt exp urticarial all over trunk & body which waxed & waned over the next 2 days;ER or MD visit was required;pt was treated w/epi & antihistamines (DPH, claritin) & hydroxyzine & event resolved;
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received Herpes zoster (shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of shingrix. On an unknown date, less than a year after receiving shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to shingrix. Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. The reporter stated that the patient received dose of Shingrix last year and experienced flu-like symptoms for a day. The reporter did not consent to follow-up. For tolerance of 2nd dose, refer case US2022AMR001808. This is 1 of 4 cases reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2022001254:Same reporter; US-GLAXOSMITHKLINE-US2022001252:Same reporter; US-GLAXOSMITHKLINE-US2022AMR001808: Different dose.
Information has been received from a licensed vocational nurse concerning a 25 year old white female who on 01-MAY-2008, at 11:30 AM, was vaccinated with a first dose of GARDASIL (Lot # 654272/0073X), intramuscularly into the first deltoid. It was reported that on 01-MAY-2008 (reported as 11:30 AM), patient had not eaten and within minutes, she a fainting episode. Patient was given juice and cookies and responded favorably. The patient recovered. Subsequent injection, on 01-JUL-2008 went without problems. It was not specified if there was illness at the time of vaccination. No further information is available.
Ectremely anxious; rubber band sensation extended to neck; rubber band sensation extended to throat.; exhausted; pain behind the eyes, like there were pins and needles; rubber bands tightly bound on her toes.rubber band sensation extended to her; pain in the throat, described as constricting and odd; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd), ANXIETY (Ectremely anxious), EYE PAIN (pain behind the eyes, like there were pins and needles), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her) and MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd), EYE PAIN (pain behind the eyes, like there were pins and needles), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her) and FATIGUE (exhausted). On 16-Nov-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck) and OROPHARYNGEAL DISCOMFORT (rubber band sensation extended to throat.). On an unknown date, the patient experienced ANXIETY (Ectremely anxious). On 13-Nov-2021, OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd) and EYE PAIN (pain behind the eyes, like there were pins and needles) had resolved. At the time of the report, ANXIETY (Ectremely anxious), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her), MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck), OROPHARYNGEAL DISCOMFORT (rubber band sensation extended to throat.) and FATIGUE (exhausted) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter. The patient almost 4 weeks post booster and still have daily neuropathy. The patient had seen GP and had an appointment with a neurologist. That was concerning.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Non Significant Follow Up Appended; Reporters E-mail Address obtained. On 08-Dec-2021: Follow-up received on 08-Dec-2021: Narrative updated.; Sender's Comments: The only reported events in this case are non-serious, hence no CC is required.
My arm was sore and tender for several hours after the injection.  The next day the soreness was gone but my arm movement was and remains limited.  I'm unable to lift my arm over my head without pain.  I don't have the strength in my left arm that I have with my right arm.  Certain movements are still very painful and I don't understand why.  I've spoken to many people that have had this shot and no one I've spoken to has had this reaction.  I should also mention that this was the first time I've ever had a flu shot.
I started getting muscle aches and the pain was not excruciating, but it felt like the flu. I almost lost my voice. I had a very sore throat. I did not lose my appetite. No fever. My blood pressure was normal. I was not bed ridden at all. On 8/3/2022, I took a COVID-19 home test and it was positive. On 8/3/2022, I was prescribed Paxlovid, which was worse than COVID-19. If I had to do it again, I would not go on the medication, Paxlovid. The COVID symptoms went away within a week. The Paxlovid symptom started when I began the medication. I have Diverticulitis only on my left side. When I started taking the Paxlovid the pain feeling was all the way all across my lower GI. When I completed the Paxlovid the pain in GI also resolved. I received the 4th Dose of Moderna 10/3/2022.
Red rash about the size of a quarter may have started on the 19th of Sept.   Some mild itching.  When bandage came off on 20th of September is when notices.
Five days after second vaccine I had to have an emergency appendectomy.  No prior issues with appendix.  Pain started at 12:00PM on Saturday 4/24 and appendix was removed Sunday 4/25 at 8:30AM.
patient was diagnosed with Acute Leukemia 1 week after incorrect administration of Proquad with Pentacel; patient was diagnosed with Acute Leukemia 1 week after incorrect administration of Proquad with Pentacel; This spontaneous report was received from a physician and refers to a 4-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis and Hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL) (dose, route of administration, anatomical location, indication, lot # and expiration date were not reported).  On an unknown date, 1 week after vaccination, the patient was diagnosed with acute leukemia. The outcome of acute leukemia was unknown.  The causal relationship between suspect therapies and acute leukemia was not reported  Upon internal review, the event of acute leukemia was considered to be medically significant.
Got first dose on Saturday 9/11/21.  Within half hour had a headache, and within 1 hour began having heart pain deep within my chest.  A few hours later began having some bilateral lower abdominal pain.  Left shoulder pain and these other symptoms persisted consistently until Tuesday when most of them resolved except for the heart and chest pain, which has been persistent in sitting, standing, and lying positions.  Wednesday went to Urgent care and doctor said she believed the heart and chest pain was from the vaccine, and she prescribed meloxicam.  I've been taking that but my heart and chest pain have not resolved. Reported adverse reaction to vaccine provider today 9/17/21 at 2:30 pm.  I submitted a report of my symptoms.  Pharmacist recommended following up with a doctor and not getting the second dose of the vaccine unless my symptoms fully resolve and I am fully cleared by a doctor.
The patient received half of the recommended dose for the Janssen J&J Covid19 vaccine. The patient was contacted and returned the following day to receive the other half.