chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially soreness in injection area; body backs with back, hip, and knee pain limiting mobility; body backs with back, hip, and knee pain limiting mobility; limiting mobility; Fatigue; chills; This is a spontaneous report from a contactable Other HCP (patient). A 30-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685), via an unspecified route of administration in right arm, on 28Dec2020 03:30 PM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Relevant medical history included COVID-19. No other vaccines were received within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. The patient experienced Initially soreness in injection area on 29Dec2020 10:30 AM. At 19 hours after vaccination started to experience body backs with back, hip, and knee pain limiting mobility on 29Dec2020 10:30 AM. Fatigue and chills fan at 24 hour mark and are continuing now at 28 hours on 29Dec2020 10:30 AM. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
I got the first vaccine and it is very painful; sweat; feverish; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17-SEP-2023, the patient received the 1st dose of Shingles vaccine. In SEP-2023, several hours after receiving Shingles vaccine, the patient experienced pain (Verbatim: I got the first vaccine and it is very painful), sweating (Verbatim: sweat) and fever (Verbatim: feverish). The outcome of the pain was not resolved and the outcome of the sweating and fever were not reported.   It was unknown if the reporter considered the pain, sweating and fever to be related to Shingles vaccine.   It was unknown if the company considered the pain, sweating and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-SEP-2023 This case was reported by a patient via interactive digital media. The reporter stated that he/she got the shingles vaccine just yesterday (the day before reporting) and it was very painful after a few hours. The patient was still suffering the effects of the pain.  The reporter wanted to know if this was normal or he/she was very delicate. The patient still not had the other dose, he/she even felt feverish and really sweaty.
pt recv vax 26MAR98 & that evening & next day c/o arm being sore;no redness or swelling;cont weakness through 1APR98;mom to ER T99-100;lymph nodes in neck swollen;rash between breast & lt spots on face;
General fatigue, aches and pains, increased heart rate (95 bpm sitting, 100 bpm standing, 115-125 bpm walking, 130-150 light work [taking the trash out]) comes and goes, fuzzy vision, lightheadedness, slight shortness of breath (may be unrelated to vaccine, could be asthma)
This spontaneous report as received from a nurse referring to a 19 year old patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2016, the patient was vaccinated with a pediatric dose of VAQTA which had lot # M022531, expiry date: 23-FEB-2018 (dose and route not reported), which was outside the recommendations per VAQTA prescribing information. No adverse effects reported. No product quality complaint (PQC) involved. No further information provided. Additional information has been requested.
pt recv vax 25JUN96 1130AM & 7PM pt temp rose to 108.4 w/convuls;EMS called;pt was not taken to hosp;rapid cool down w/ice, antipyretic given @ time of vax & afterwards;
Information has been received on 10/9/02 from a medical supplier on behalf of 2 physicians concerning a female patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patient developed severe redness in an area 2-3 inches around the injection site, and flu-like symptoms. The patient sought unspecified medical attention. It was reported that two other females had a similar reaction. Additional information has been requested.
- pulsatile tinnitus in left ear after first dose worsened after second dose - after second dose, constant ringing in ears (both) - like crickets..still facing the same symptoms
Patient called pharmacy on 1/7/2010 to report reaction on day of vaccination (12/14/09). Chest felt heavy and throat/ears itched. Did not see physician on day of reaction. Saw allergist on 1/7/10 who told her to report this. No reaction to flu shot.
Within 30 minutes of booster, she developed hives. They first appeared on her arms and then on her legs. She was treated with Benadryl and then examined by urgent care. Her oxygen levels remained near 100 the entire time. She continues to experience hives and must continuously take Benadryl 24 hours later.
Severe headache, muscleache, high fever (38.7 'C under arm), dizziness, overall weakness.
About an hour a half after getting the Moderna shot on Thursday, I felt dizzy, I had a headache where the inside of my head was hurting, My legs were throbbing. The next day, I was tired but between Friday and Saturday, I had this piercing pain in my ears. I have ringing in my right ear, and my entire legs are throbbing - feels like they're vibrating. I also feel like I'm breathing faster. Is there anything that I should take?
Redness , itching and swelling started 2 days ago. It has continued to increased. Today dizziness and nausea. Feel very weak like fainting is possible
booster; delusional; drowning - could be suicide; drowning - could be suicide; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP).  An elderly male patient received bnt162b2 (Pfizer COVID-19) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1), for Covid-19 Immunization. The following information was reported: IMMUNISATION (death), outcome "fatal", described as "booster "; SUSPECTED SUICIDE (death), DROWNING (death) all with onset 19Nov2021, outcome "fatal" and all described as "drowning - could be suicide"; DELUSIONAL PERCEPTION (death), outcome "fatal", described as "delusional",the person was delusional after receiving the third vaccine shot. It does not appear that it was immediately after receiving the vaccine injection, but a few days. It was unknown if therapeutic measures were taken as a result of immunisation, suspected suicide, drowning, delusional perception. The patient date of death was 19Nov2021. The reported cause of death was suspected suicide, drowning, delusional perception. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: drowning - could be suicide; delusional; drowning - could be suicide
starting 16SEP96 w/fever, h/a, muscle aches, swollen glands;rash since 8SEP96;seen 9SEP96 tx w/Seldane & DPH;
Pain and swelling in the hands; Swelling in the hands; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain and swelling in the hands) and PERIPHERAL SWELLING (Swelling in the hands) in an 85-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. A57180B5) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On 11-May-2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain and swelling in the hands) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling in the hands) (seriousness criterion medically significant). The patient was treated with PREDNISONE at a dose of 20 milligram,taper dose. At the time of the report, PAIN IN EXTREMITY (Pain and swelling in the hands) and PERIPHERAL SWELLING (Swelling in the hands) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: osteoarthritis.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient had pain and swelling in the hands. The lab results showed osteoarthritis.  The patient did not experience any additional symptoms/events.  The patient was getting temporary relief from a 20mg taper off Prednisone.   Company comment:  This is a spontaneous case concerning a 85-year-old, male patient with no reported medical history, who experienced the serious (due to medically significant) unexpected events of Pain in extremity and Peripheral swelling. The events occurred on an unknown date after a dose of SPIKEVAX COVID-19 VACCINE NOS (onset dates and dose number were not provided so latency cannot be estimated). Clinical course was not provided. Lab tests results revealed osteo arthritis (no additional details were provided). The patient was treated with prednisone. The outcome of the events was reported as not recovered. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.   Reporter did not allow further contact.
Palpitations; Neurological side effects; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Palpitations) and NERVOUS SYSTEM DISORDER (Neurological side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations) and NERVOUS SYSTEM DISORDER (Neurological side effects). At the time of the report, PALPITATIONS (Palpitations) and NERVOUS SYSTEM DISORDER (Neurological side effects) had not resolved.            No relevant concomitant medications were reported.   At the time of report, the patient had palpitations and neurological side effects until today.  No treatment information was provided.
Hospitalized for myocarditis and high troponin. Potential worsening of chronic dysautonomia
Around the beginning of May, I realized by the end of the day that anywhere there is a joint, I was having pain every day. It was pain that was everywhere. I would lay down. It was pain that was persisting, joints tight and painful, especially in my left hand, my whole hand, in all my joints in that hand and it is painful. It makes it hard to do things. I feel it in my right hand too, but not my whole hand. I get odd pain throughout my body: back or legs. But right now it's settled in my hand. It's there every day. There isn't a day that I haven't had it. It hasn't gone away. It's been ongoing. I use essential oils, frankincense, lavender and peppermint to get some relief. It gives me some bit of relief but it still comes back. I take an ibuprofen occasionally. Within the first week after the vaccination is when I first noticed the pain. At first I thought it was a fibromyalgia flare up but I haven't had one of those in years. It is interfering with how I do things. I have to plan on doing things the first part of the day because by night time it is harder just because of the pain.
This spontaneous report was received from a 21 year old non-pregnant female patient. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On unknown dates, the patient was vaccinated with a series of GARDASIL (dose, frequency, route of administration, lot # and expiry date were not provided) for the prevention of human papillomavirus (HPV). On 20-JAN-2018, a biopsy was performed and patient was diagnosed positive for HPV-16 and on 12-MAR-2018, the patient was scheduled for a Loop Electrosurgical Excision Procedure (LEEP). The outcome of papilloma viral infection was reported as not recovered/not resolved. The causality assessment was not provided.
This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 68-year-old male patient who received SHINGRIX (batch number MX2LT, expiry date 29th May 2021) for prophylaxis. On 19th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced general body pain and injection site erythema. On an unknown date, the outcome of the general body pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the general body pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The caller reported that the patient had red patch at injection site and body aches lasting 3-4 days after receiving SHINGRIX vaccination series.
This spontaneous report was received from a licensed practical nurse refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions, and concomitant medication were not reported. On an unknown dates, patients were vaccinated with improperly stored (temperature 47.1 F for 10 minutes, because of data logger) doses of ROTATEQ, lot #L020865, expiry date, 09-FEB-2017, (dose, frequency and route of administration not reported). No previous temperature excursion was reported. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. GARDASIL 9, and GARDASIL appeared on the product list as temperature stability questions were asked, however, no doses of improperly stored GARDASIL 9 or GARDASIL were administered to patients. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sever upper body itching; This is a spontaneous report from contactable nurse (patient). A 37-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown) in the hospital via an unspecified route of administration on 13Jan2021 at 10:00 at a single dose on the right arm for COVID-19 immunization.  The patient's medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient previously took erythromycin and Polytrim and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe upper body itching on 13Jan2021. The itching started 7 hours after the vaccine. The patient received Benadryl, Zyrtec and Claritin as treatment. The patient recovered from the event. The event was reported as non-serious.
On 10/24/2016 I woke up to itching and a small rash on my up left leg. The patch has grown to about 3 in by 1/2 inch. Then another patch appeared on my stomach. The next morning on 10/25/2016 I woke up with my left eye almost swollen shut and red and itchy. Later that evening my left ear become swollen and itchy. Then later that night my genitals became itchy and red with a rash. This morning I woke up and the left side of my neck was the same way. I communicated with the Health Dept where I received the shots yesterday and the day before. Today I went to Hospital. They said it was an allergic reaction and gave me a steroid shot and a prescription for steroids. I have also been taking BENADRYL. I do not have health insurance due to my current employment situation.
my face is swollen and my underarm, there is some balls under my arm that are swollen; my face is swollen and my underarm, there is some balls under my arm that are swollen; behind my ear kind of under my neck and underneath my throat swollen like balls; I feel really sick like shortness of breath, this neck and arm swollen; I feel really sick like shortness of breath, this neck and arm swollen; I feel really sick like shortness of breath, this neck and arm swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2 (BNT162B2), on 10Jun2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), DYSPNOEA (non-serious), SWELLING (non-serious) all with onset 11Jun2022, outcome "unknown" and all described as "I feel really sick like shortness of breath, this neck and arm swollen"; PHARYNGEAL SWELLING (non-serious) with onset 11Jun2022, outcome "unknown", described as "behind my ear kind of under my neck and underneath my throat swollen like balls"; SWELLING FACE (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 11Jun2022, outcome "unknown" and all described as "my face is swollen and my underarm, there is some balls under my arm that are swollen".  Additional information: Concern: Consumer Stated, So, Yesterday I got the COVID Vaccine (clarified as Pfizer Covid-19 vaccine) and today my face is swollen and my underarm, there is some balls under my arm that are swollen and then also like behind my ear kind of under my neck and underneath my throat swollen like balls. Last time I got sick and I thought like if I had COVID, this is my booster shot but this time I feel really sick like shortness of breath, this neck and arm swollen. Consumer was informed about the role of Pfizer Drug Safety and requested to probe. Height and Weight: 160 pounds, 5 foot 3 inches (Voice distortion, not clarified)  No follow-up attempts are possible. No further information is expected.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The date of vial initially stored in the refrigerator was unknown. Number of doses/vials were 173. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant live follow-up: Additional reporter added.
Soreness in arm. 2 hours after mild headache fatigue. Starting at  24 hours after injection through 40 hours  after Injection headache body aches muscle tenderness exhaustion nausea.
Vaccine given after the adjusted use-by date but before the official expiration date. There was no adverse event, local health dept instructed us to file this report anyway.
Patient experienced extreme swelling 4inch about 6inch in diameter, hard to touch, and red on vaccine injection site within couple hours of administration.  On 7/31/19 the swelling significantly reduced but redness travel below elbow and experience slight pain and discomfort.  Swelling and redness disappeared on 8/4/19.  Patient was closely monitored by pharmacy staffs, and on 7/30/19 was advised to take diphenhydramine 50mg and to apply ice and heat alternatively
Information has been received from nurse concerning a patient who came into office to receive a dose of ZOSTAVAX (Merck) (MSD) but was given a dose of VARIVAX (Merck) "by mistake". No adverse effects reported as a result. Follow-up information received from the nurse. She reported that the medication error was a human error. Additional information has been requested.
This spontaneous report as received from a physician assistant refers to a 22 year old female patient. On 18-APR-2014 the patient was supposed to receive her first dose of VARIVAX, but was inadvertently vaccinated with ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Information has been received from a registered nurse concerning an approximate 7-year-old female who on 30-APR-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
In December I had a dental (tooth) infection treating with Clindamycin for 10 days, this resulted in a subsequent CDIF infection for which I've been treated with Metronidazole 500 mg (10 + 21 + 10 days) and currently with Vancomycin 125 mg (14 days, on day 12 as I report this)
High fever  after 2nd shot; Chills after 2nd shot; Throwing up after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever  after 2nd shot), CHILLS (Chills after 2nd shot) and VOMITING (Throwing up after 2nd shot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient stated that she had COVID prior to vaccination.).    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (High fever  after 2nd shot), CHILLS (Chills after 2nd shot) and VOMITING (Throwing up after 2nd shot). On 12-Apr-2021, PYREXIA (High fever  after 2nd shot), CHILLS (Chills after 2nd shot) and VOMITING (Throwing up after 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: high fever (High) High Fever.         Patient stated that The symptoms lasted 4-6 days. and also stated that she have an appointment to receive booster on 09-DEC-2021  No concomitant medication were reported No treatment information was provided   This case was linked to MOD-2021-407981 (Patient Link).
Pt was sitting in waiting room chair talking to mother following vaccine administration; her head slumped onto chest her body went rigid then jerked several times and she lost bladder control. Taken to exam room and lay with cool compress on head. Examined by doctor condition had returned to normal, estimated duration Loc = <1min
Patient completed vaccine series on 01/12/2021 and has tested positive for Covid 19, symptomatic