chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker, practice manager refers to a unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose and route not provided). The health care worker reported, the storage compartments that contained RECOMBIVAX HB were not monitored at all from 03-MAY-2014 until the report time. Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the un-monitored vaccines in during the period of time from 03-MAY-2014 until the present. The reporter stated that her practice has not been informed of any adverse experiences. No additional information was provided. This is one of several reports from the same source. Additional information has been requested.
Pt recvd DTP 4MAR92 & redness on backside of arm devel Sat; no temp; no limit to use of arm, just very tender; Advised to use APAP 2 or 3 x for next 2 days & apply cold compresses;
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-AUG-2017 the patient was vaccinated with VARIVAX lot # N002204 with expiration date 19-JAN-2019, and N009766 with expiration date 24-MAR-2019, for prophylaxis. Concomitant therapies included sterile diluent. On 31-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Sender's Comments: US-009507513-1709USA002196.
Information has been received from a registered nurse (R.N.) concerning her 14 year old daughter with adverse drug reaction to pertussis vaccine (caused muscle rigidity) who on 26-JUN-2008 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL. Concomitant therapy included unspecified birth control medication. On 07-JUL-2008 the patient started to experience intermittent episodes of heart palpitations. The episodes of palpitation lasted from several minutes to a few hours and resolved without treatment. On 12-JUL-2008 the patient was evaluated in a local emergency room. A complete blood count was normal. A 24 hours Holter monitoring was performed (results pending). At the time of the report, the patient was still experiencing 1-2 episodes of heart palpitations per day. Additional information has been requested.   This is in follow-up to report(s) previously submitted on 8/14/2008.  Follow-up information was received on 18-AUG-2008 from a R.N. indicating that they knew nothing about this report.  Additional information is not expected.
Patient received Shingles vaccine in left arm (SC) on 1-14-11 & reports injection site irritation that has persisted. Report came in on the evening of 1 21 11 & patient complains that area injected is itchy & hurts and feels "hard". Pt presented 1 22 11 - area is red & hard under skin.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: The follow up version is 19-Nov-2021 but taken as 23-Nov-2021 due to limitations owing the being 23-Nov-2021 of the initial version. The patient initials, date of birth, race, reporter details and dosing information updated.
Client called on 7/18/05 to report injection site pain since 11/22/05. Pain when raising R arm.
muscle weakness; joint pain; This is a spontaneous report from a contactable physician. A 60-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration in Mar2021 at single dose for COVID-19 immunization. The patient's medical history included G71.19 and concomitant medications included diclofenamide (KEVEYIS). It was unknown if the patient was diagnosed with COVID-19 and did receive any vaccines within four weeks prior to vaccination. The patient experienced muscle weakness and joint pain since receiving the vaccine, on an unspecified date in Mar2021. It was unknown if patient has been tested for COVID-19 since the vaccination and received any treatment for the event. Outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Infantile Spasms/Seizure Disorder began soon after the vaccination and worsened with the next set of vaccines when baby was 6 months old.
Swelling, pain to left deltoid area.  05/23/2003: Called mom, child much better, swelling down.
Patient fainted right after administering the vaccine. She was slumped on the chair for 10 seconds and I tried talking to her. She quickly regained consciousness and told her to stay in the clinic for at least 30 minutes for observation. Meanwhile, I have her water for hydration. The patient came with a friend and there was no further incident before she left the clinic.
No adverse effects after first Moderna shot, February 15.  4 hours after second Moderna shot, March 15, pre existing tinnitus that I have had for 5 years, volume increased from normal level of 1-2, to volume level of 7-8. This increase in volume lasted only 3 hours, then tinnitus returned to normal 1-2 volume out of 10.  On March 25, louder tinnitus returned, back to the volume of 7-8 out of 10.  As of this date, June 27, 2021, there has been a little bit of fluctuating to a level of 5-6, but most days its volume of 7-8 is all day long, 24/7. On April 5, 2021, I was prescribed 50 mg of Prednisone for 5 days, no changes in the volume of the tinnitus during or after the 5 days of Prednisone.
Patient medical emergency - post COVID 19 J&J vaccine   Episode started at 1126 - patient was in observation room with Mother at Side Patient became diaphoretic, clammy, pale white, then had a syncope episode. .3mg Epi given by this RN in left quad.    1129:  BP 77/33  P 92 Patient reported chest tightening Patient was brought to the ground legst propped up on chair. O2 applied at 8L via Nasal Cannula  Stat: 97%   RN instructed to call 911 911 dispatched 1134: P 47   O2 99% 1135: BP 141/58  P 58   1140: Patient transferred
The first shot I experienced a swollen upper lip and numb nose, cheeks, and lips some six days after injection. This time my inner right eye has swollen up 17 hours after the second injection. Both times I have also experienced a scratchy scalp like hives.  After this second shot I have had a fever and chills which seems to be the norm. I have no Botox or any such injections in my face or body so I wanted my allergic reaction to at least be recorded.
Vaccine was administered too high on shoulder, hit bursa, arm pain got progessively worse, three weeks to date. Had MRI, probably need cortisone injection to stop inflammation.
Received 1st COVID vaccine dose on 3/12/21 in the left deltoid.  On 4/4/21, developed itchy/burning pain and rash on left shoulder/back area.  Was seen by NP at PCP's office on 4/5/21 and diagnosed with shingles.
Shot at 11:30am on 1/23/2022 Symptoms Began ~ 8:30pm - Slight Fever, Fatigue, Tiredness, slight nausea (never vomited) 3:00am more symptoms (chills) By morning  ~9am (1/24/2022) I noticed tenderness and slight swelling of the armpit/pectoral area of the arm the shot was administered. Symptom of Fatigue has also continued on the day of 1/24/2022. 1/25/2022 ~12:30pm - still experiencing tenderness and swelling of armpit/pectoral area
I had dizziness. nauseas, no pain but pressure on my upper chest. I called the ambulance and was sent to the ER. The doctor examined me and hooked me up to an echocardiogram that showed a  fast pulse and an irregular heart beat. The doctor said the upper chamber of my heart was not connecting electrically with the lower chamber. I did not have a heart attack, but they diagnosed me with atrial fibrillation. They increased my dosage of aspirin so now I am taking 162mg of aspirin. I have not seen a heart specialist yet only my general practitioner who said to make an appointment with a cardiologist.
I feel overweight; Not sure if I got COVID due to the vaccine or not; I only had a runny nose and blowing my nose a little more then normal.; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Not sure if I got COVID due to the vaccine or not), RHINORRHOEA (I only had a runny nose and blowing my nose a little more then normal.) and OVERWEIGHT (I feel overweight) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ0M) for COVID-19 vaccination.     The patient's past medical history included Stroke and Aortic bypass.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Not sure if I got COVID due to the vaccine or not) and RHINORRHOEA (I only had a runny nose and blowing my nose a little more then normal.). On an unknown date, the patient experienced OVERWEIGHT (I feel overweight). At the time of the report, SARS-COV-2 TEST POSITIVE (Not sure if I got COVID due to the vaccine or not), RHINORRHOEA (I only had a runny nose and blowing my nose a little more then normal.) and OVERWEIGHT (I feel overweight) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided. No treatment information provided.
Fatigue, headache, bodyaches, lightheadedness and dizziness (possibly vertigo) These symptoms were present beginning 12 hours after vaccine through 36 hours after vaccine
Pt. states that after receiving the 3rd dose of Moderna 11/30/2021, started experiencing symptoms 12/01/2021 of fatigue and pain in the lymphnoids located under both arms. Still experiencing symptoms. No noted Primary visit/communications.
Muscle pain; Joint pain; Bone pain; Muscle stiffness; Headache; Fatigue; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04May2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and had no known allergies. 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 COVID-19 vaccine. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) XL for unknown indication from unknown date and unknown if ongoing. On 04May2021, the patient experienced muscle, joint, bone pain, muscle stiffness, headache, fatigue and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle, joint, bone pain, muscle stiffness, headache, fatigue and fever were recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (for tolerance of 1st dose refer case US2019GSK037379). On 19th February 2019, the patient received the 2nd dose of SHINGRIX. On 19th February 2019, less than a day after receiving SHINGRIX, the patient experienced joint pain, pain of skin, general body pain, injection site pain and loss of energy. On 21st February 2019, the patient experienced concentration loss and tiredness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the joint pain, pain of skin, general body pain, injection site pain, concentration loss and tiredness were unknown and the outcome of the loss of energy was not recovered/not resolved. It was unknown if the reporter considered the joint pain, pain of skin, general body pain, injection site pain, loss of energy, concentration loss and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported. The patient just received SHINGRIX and experienced pain and tenderness at site of injection, significant loss of energy, significant body pain, joint pain and skin pain. On 3rd day of vaccination, the patient had loss of concentration and progressive weakness and tiredness. The patient was asking a way to reduce the significant side effects and those events were enough to lose time off work. This case has been linked with US2019GSK037379, reported for same patient.
Information has been received from a registered nurse referring to an 11 year old patient of unknown gender. On 07-AUG-2015 the patient was vaccinated with GARDASIL 9 (lot # L014415, intramuscular, expiration date and dose were unknown) which excursed the storage temperature (incorrect product storage). No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-DEC-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208236.
Immediate muscle ache. As time progressed, intense headache occurred. Next day symptoms of fatigue, muscle ache and weakness, sick to stomach.
rash to arm, antibiotics started 1/10/21,  rash area has extended slightly since 1/10/21
rash on both sides of her face; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both sides of her face) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash on both sides of her face). At the time of the report, RASH (rash on both sides of her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment drug were not reported.
hypotonic, hyporesponsive episode, fever, hiccup like sounds, non responsive & could not arouse for few mins then completely resolved;pt had recv vax 12hr before;
Started with just flu-like symptoms and then 4 days after developed sinusitis and Pharyngitis. Also had yellowish gray phlegm and nasal discharge, periorbital pain, ear aches (right worse than left) Sore throat was worse in the morning, PND cough,  inspiratory wheezing  and  cold sores at corners of my mouth. 4-7 days after I had increasing worse fatigue and body pain. Talked to Nurse about my symptoms and was continue to use albuterol. Also, drink plenty of water and get CoVid test. 2 weeks later went to see Dr. on 07/30  and after a physical (no test or labs) was put on Prednisone and Doxycycline 5 days but it was not going well. On 8/9 went for a check up  and second opinion. After chest X-ray(normal) was put back on prednisone and doxycycline for 5 days. My status improve but still had not yet recovered.
Joint and body aches, chills, extreme fatigue and weakness lasting until 48 hours after onset. Experienced muscle pain, swelling, and itchiness at injection site.
pt recvd vax; itching, asthma flared up, then angioedema of the lips 24 hrs p/ vax;
BREAKTHROUGH COVID INFECTION ONSET 10/12/21 REGEN IM TODAY.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, joint pain, general body pain, activities of daily living impaired and myalgia. The patient was treated with CELEBREX. On an unknown date, the outcome of the influenza-like symptoms and general body pain were recovered/resolved and the outcome of the joint pain was not recovered/not resolved and the outcome of the activities of daily living impaired and myalgia were unknown. It was unknown if the reporter considered the influenza-like symptoms, joint pain, general body pain, activities of daily living impaired and myalgia to be related to SHINGRIX. Additional details reported as follows: The caller was a pharmacist reporting an adverse event on behalf of himself. The patient received SHINGRIX on left arm. The patient experienced flu like symptoms and body aches that lasted approximately 2 days. The caller stated that he had been experiencing pain in his joints (knee, back and hip) that had been going on for approximately 20 days. The caller stated that the joint pain was affecting his everyday life and that he was taking CELEBREX for the joint pain. The healthcare professional stated the joint pain he was experiencing could be myalgia.
lost sense of taste and smell 2/15/21 from shot 2/11/21 sinuses clogged 2/13/2021
Patient fainted a short period after receiving the vaccine. Pt was in a seated state when adverse event occurred. Recovered after 15 minutes.
This spontaneous report as received from a other health professional (health care worker) refers to approximately 23 year old female patient. Current conditions and medical history was not reported. On 24-OCT-2014 (reported as today) the patient was vaccinated with M-M-R II injection, lot # H017432, expiry date 20-SEP-2014, 0.5 milliliter (ml), subcutaneous in the right arm. Concomitant medications were not reported. On 24-OCT-2014 (reported as today) patient was vaccinated with expired M-M-R II vaccine. No adverse effects reported at this time. Product quality complaint was not reported.
woke up with a fever; chill; body ache after covid vaccine; This is a spontaneous report from a Pfizer. A contactable consumer (Parent) reported that a male patient (Son) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as Dose Number Unknown, Single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, Son woke up with a fever, chill and body ache after covid vaccine. No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. There were not any unaddressed medical questions referred or forwarded to Medical Information. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
11/30 Febrile seizure 5 minutes, general WBC 12,400 56P 32L 9 ml EO 2A7 L4, BMP NL,  NA 140, CA 9.7, Urinalysis Normal 12/3/07 Follow up visit-Exam normal
pt recvd vax;joint pain in knees 2 days after vax which has cont since 5nov93;as of 6nov93 generalized joint pains;no oth sxs except soreness at site;apap & motrin given;10jan94 predsone for arthralgia & myalgia;gradually better; ESR 27;
This spontaneous report was received from a nurse practitioner refers to a 4 month old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. The reporter stated that on 13-FEB-2015, the patient was vaccinated with a dose of VAQTA 25/0.5 (units not provided), 0.5 ml, intramuscular, once instead of RECOMBIVAX HB. No adverse effect was reported. Additional information has been requested.
Patient said she felt dizzy, sat her down and she vomited.  She then said she felt better.
Individual stated, "felt small bump on my left underarm, which is the same arm I received vaccination".