chrisvoncsefalvay/vaers-outcomes huggingface dataset:
- Red itchy injection site rash that spread. Became about 2 in x 2 in rash that developed blisters. Very itchy, red and inflamed. No fever. No swelling of throat or difficulty breathing.
whole left side paresthesia,tingling,His left index finder is the worst right now with the pins & needles; numbness; neurological side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of NERVOUS SYSTEM DISORDER (neurological side effects), PARAESTHESIA (whole left side paresthesia,tingling,His left index finder is the worst right now with the pins & needles) and HYPOAESTHESIA (numbness) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced NERVOUS SYSTEM DISORDER (neurological side effects). On an unknown date, the patient experienced PARAESTHESIA (whole left side paresthesia,tingling,His left index finder is the worst right now with the pins & needles) and HYPOAESTHESIA (numbness). At the time of the report, NERVOUS SYSTEM DISORDER (neurological side effects), PARAESTHESIA (whole left side paresthesia,tingling,His left index finder is the worst right now with the pins & needles) and HYPOAESTHESIA (numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
This spontaneous report as received from a registered nurse refers to a 12 year old non-pregnant female patient. The patient's pertinent medical history included: the removal of tonsils, "tubes" at 13 months, asthma and heart murmurs. The patient had no drug reactions/allergies. On 03-FEB-2015 the patient was vaccinated with PNEUMOVAX 23, lot # J004196, expiry date: 06-DEC-2014 because she was "only immune to 3 of the 14 strains of pneumonia". Concomitant therapies included ACTIFED, QVAR, SINGULAIR and FLONASE. The nurse reported that the patient was inadvertently administered an expired PNEUMOVAX 23 and after the injection, the patient experienced swollen lymph nodes in the left arm. The swollen lymph nodes went away on an unknown date, but now the patient had an upper respiratory infection and symptoms of a cold such as a sore throat. The patient did not seek a medical attention, there were no lab diagnostics studies performed and no treatment was given for the events. The outcome of the event: swollen lymph nodes was recovered/resolved. The outcome of the event: an upper respiratory infection and symptoms of a cold such as a sore throat was not recovered/not resolved. The relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
1 day after immunization had (left shoulder - neck pain x 7 days. MD appt - medication and massage.
Delayed reactions 1 week after receiving vaccine - major lip swelling (I do have Kysse filler in my lips), sore throat, muscle aches, and slight sever
This spontaneous report as received from a nurse refers to 4 patients of unknown age and gender. The patients' concurrent condition, medical history or concomitant medications were not reported. On 14-AUG-2015, VAQTA lot # L00271; expiration date 02-JUN-2017 and lot # L009445; expiration: 01-JUN-2017 were improperly exposed to 70 degrees Fahrenheit for 2 minutes and to 28 degrees Fahrenheit for 10 minutes. Then no unspecified dates in August 2015, 4 patients received the improperly stored doses of VAQTA, dose and route of administration were unspecified. It was unspecified which patient received which lot number. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
2 yr old male, previously healthy, presented 4 days after receiving imms with 1 day Hx of fever up to 101.7, diffuse generalized fine macular rash all over the body more confluent on chest and back: with conjunctivitis, eye periorbital, hands & feet puffiness - likely exanthem from measles vaccine.  Dimetap PL2 as per 10-14-08, will recheck in 2 days.
Pt presented to the ER 3/10/2021 c/o inability to ambulate  and progressive weakness and muscle pain. Pt received his 2nd covid 19 vaccination on 2/15/21 and was dx with shingles a week later of the l ear. Pt reported he was weak  after vaccine and never really got better progressing to inability to ambulate and groin/muscle pain resulting in the er visit. He was evaluated by PT and was found to be 2 assist with rapid decline.   He was living independently prior to this using no assistive devices. He was admitted to the hospital and ultimately discharged to rehab on 3/12/21 where he remains presently according to the daughter.
RED BUMPS ON FACE, HEAD, BACK AND CHEST. STARTING AS RED DOTS, DEVELOPING TO SMALL VESICLES AND THEN BURSTING. C/O OF INTENSE ITCHING.
Vaccine administered in right arm 4/23.  Starting 5/1 with right upper and lower extremity weakness as well as requiring 2-3 assist where she was standing independently before.  She was evaluated at the ER for stroke, neuroimaging negative.  Symptoms persist.  She has been referred to neurology and physical therapy for further evaluation.
Random Joint twitches after 2nd dose; Vision is getting bad after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Random Joint twitches after 2nd dose) and VISUAL IMPAIRMENT (Vision is getting bad after 2nd dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced MUSCLE TWITCHING (Random Joint twitches after 2nd dose) and VISUAL IMPAIRMENT (Vision is getting bad after 2nd dose). At the time of the report, MUSCLE TWITCHING (Random Joint twitches after 2nd dose) and VISUAL IMPAIRMENT (Vision is getting bad after 2nd dose) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow information received contain no new information
Two patients were given the ActHib portion of the Pentacel vaccine that was improperly reconstituted with "sterile diluent" from MMR and varicella vaccines/No AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves two patients of an unknown demographics who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which was improperly reconstituted with "sterile diluent" from MMR and varicella vaccines lot UJ015AAA, expiry 26-Oct-2020 via unknown route in unknown administration site On an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Wrong solution used in drug reconstitution.  Two patients were given the ActHib portion of the Pentacel vaccine that was improperly reconstituted with "sterile diluent" from MMR and varicella vaccines. A new nurse employee was responsible for the error. DTaP-IPV diluent lot (not administered) is U6469AC expiry 26-Feb-2021.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Dizziness, BP 122/52 (pulse 112). F/u BP 109/50 (pulse 105). O2 sats 97-98%.
Pain in that arm/pain in her left arm that "comes and goes"/described it as "pretty sharp pain"; This is spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). This 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had covid vaccine last week. Patient said had pain in that arm, from injection site. Patient got the injection last Tuesday but was still having pain in her left arm that "comes and goes". Patient described it as "pretty sharp pain". Outcome of the event was unknown.  information on the lot/batch number has been requested.
Initial solicited report received from an investigator (Defense Health Agency) in the trial on 09 June 2017 and follow up information received on 12 June 2017. A 24-year-old male subject with no significant medical history reported. The subject's concomitant medication were not reported. The subject received a dose of ACAM2000 (lot number and site of administration not reported) on 15 June 2010. On 14 July 2010, 29 days after vaccination the subject was diagnosed with 429.0 non-specific myocarditis, unspecified. The lab data included 14 July 2010, the Troponin I was 02.12 ng/mL (abnormal); on 25 July 2010 electrocardiogram (ECG) was abnormal; on 05 August 2015 Echocardiogram was normal. MRI (heart), MRI (brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: associated. Follow up information received on 29 September 2017: Review Date: 11-July-2017. Lab data was updated: ECG on 25 June 2010, which showed that (1) Diffuse ST changes and PR interval depression. ECG on 26 June 2010 which showed that (1) STE 1.0 mm leads II, III, AvF; (2) SB (48BPM) w/varying AV conduction PR interval average 0.198-0.204; and (3) SB (51BPM) with SA otherwise normal. ECHO on 05 August 2010, showed (Normal) EF = 60-65% with normal wall motion and trace mitral regurgitation and Troponin I reference range was listed as greater or equal 5 on 27 September 2017. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, noninterventional) study. Adjudication Committee consensus received on 09JAN2018: A consensus was determined by this study protocol adjudication committee:  Based on the information received the case meets the case definition for subclinical myopericarditis, but does not meet the case definition for myocarditis or pericarditis. No changes were made to the preferred term(s) of this case based on the adjudication committee decision.
Small and painful lump in right armpit (same arm where vaccine was administered).  The lump is sore but more painful if apply pressure to it.; Small and painful lump in right armpit (same arm where vaccine was administered).  The lump is sore but more painful if apply pressure to it.; This is a spontaneous report from a contactable Consumer. A 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248), via an unspecified route of administration, administered in right arm on 15Feb2021 at 13:00 at a single dose for COVID-19 immunisation. The patient medical history was not reported. No known allergies were reported. Patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248), via an unspecified route of administration, administered in right arm on 25Jan2021 at 16:00 at a single dose for COVID-19 immunization. Concomitant medication included vitamin c [ascorbic acid] and fish oil (FISH OIL). Other medications in two weeks included Multivitamin and Turmeric. Patient was not pregnant. No COVID tested post vaccination. The patient experienced small and painful lump in right armpit (same arm where vaccine was administered), the lump is sore but more painful if apply pressure to it on 17Feb2021 15:00. No other vaccine in four weeks. No treatment were given for the events. The outcome of the events was not recovered.
Cellulitis at site on injection. Large, swollen red area, hot to touch. Treated with antibiotic.
Left arm bruised; Left arm swollen; Left underarm swollen; Left underarm painful; Left side to waist swollen; Left side to waist painful; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto disease, COVID-19, anxiety due to COVID illness and COVID-19 anosmia. Allergies to medications included ampicillin and penicillin. Concomitant medications received within 2 weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and sambucus nigra (ELDERBERRY). Prior to vaccination, the patient was diagnosed with COVID-19 on unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 29Mar2021, the patient experienced events of bruise in left arm, swollen left arm, swollen left underarm, painful left underarm, left sided swelling to waist, left sided pain to waist. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse events was reported as no. The clinical outcome of events bruise in left arm, swollen left arm, swollen left underarm, painful left underarm, left sided swelling to waist, left sided pain to waist was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Had a rush of heat inside about around back side at waistline.  Lasted during the 15 minute stay after shot.  Reported to nurse, she looked and there was no redness.  She had me wait another 15 minutes.  Sensation was still there but she had me go ahead and go home.  This went away but I still have periodic times of the heat sensation.  My doctor wanted me to report before she would pursue.
On 5/29 woke up tired at about 2pm noticed that area under injection site was 4*4 raised, red, warm hard, itchy.  Called doctor who recommended ice treatments and BENADRYL.  Today it still is red and warm & a bit itching.
her arm has got a huge red splotch on it, down from the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (her arm has got a huge red splotch on it, down from the injection site.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE RASH (her arm has got a huge red splotch on it, down from the injection site.). At the time of the report, VACCINATION SITE RASH (her arm has got a huge red splotch on it, down from the injection site.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided
This report was received from a health professional on 10 October 2007.  A 43-year-old female patient, with an allergy to Levaquin, received a left deltoid intramuscular injection of Adacel (lot number reported as C2827AA) on 05 September 2007.  On 06 September 2007, she complained of muscle spasms, and soreness and tenderness at the injection site.  Per the reporter, the events had been ongoing for approximately one and one-half weeks, and the patient had required a doctor visit.  Other medications were "unknown"; the reporter was unsure if the patient had been ill at the time of vaccination.  At the time of the report, the events had not resolved.  Follow-up information received on 29 October 2007 from a health care professional.  Adacel lot number was corrected to C2824AA.  The case was reviewed, and there was no additional information at this time.
Numbness in face, arms, legs. Tremors, Dizziness almost blacking out. Chest pains. Paramedics called Blood pressure extremely low to very high. Taken to hospital. Events as such continue to occur.  Have been to ER , Neurologist, Cardiologist, Primary Care.
I received the 2nd dose of the COVID-19 vaccine (Moderna) on 02/03/2021. Since then, I have experienced a number of side effects, including headache, fatigue, muscle aches, alternating between hot and cold, etc. Most recently, I have felt a pins and needles tingling in my lower body, more severe in my left leg. I have also been having difficulty walking, and going up and down the stairs. At first, I thought it was just muscle weakness and general fatigue from the vaccine. But now, it seems more like numbness, instead of just muscle weakness, in my legs. Also, when I use chopsticks to eat food, it seems like I have less control than I usually do. My doctor suspects it might be Guillain-Barre syndrome, though I am still waiting for a consultation with a neurologist to properly diagnose the issue.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several weeks after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had soreness at injection site weeks after SHINGRIX vaccination. The caller could not provide any details about the patient or the vaccination.
This spontaneous report as received from a physician via company representative refers to an unspecified number of patients (patients demographics were unspecified). These Patients medical history and allergies were unspecified. On an unknown date, unspecified number of patients were vaccinated with PNEUMOVAX 23 injection, (dosage, frequency, route of administration and lot number were unspecified). Concomitant medications were unspecified. On an unknown date, unspecified number of patients developed large rash around the injection site after receiving PNEUMOVAX. No product quality complaint was involved. The outcome of event large rash around the injection site after receiving PNEUMOVAX was unknown. Also reported as the rash took around two to four weeks to go away. The reporter causality assessment for the event with the therapy of PNEUMOVAX 23 was not reported. No further information was provided. Additional information has been requested.
This is a spontaneous report received from a contactable consumer (patient herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot number: en6200) via an unspecified route of administration to left arm on 13Feb2021 11:00 at single dose for COVID-19 immunization. Patient medical history was reported as no. Concomitant medications included lisinopril-10mg, pantoprazole 20mg and risedronate sodium (RISEDRONATE) 35mg. Patient stated that 6 days after the injection, she woke up and the bottom left-hand side of her face was numb. In addition, her left thumb was numb. Today is exactly one week later and she still have some numbness in her lips and tip of her thumb on 19Feb2021 06:00. Treatment received was reported as no. Outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
PATIENT HAD A HISTAMINE REACTION POST DOSE. PATIENT TURNED RED AND FLUSHED. RESPONDED TO DIPHENHYDRAMINE.
Child received five vaccines on this doctor visit. But Hepatitis A (Havrix) and MMR+Varicella ( Proquad) were two new vaccines child received on this date 10/08/2019. Child started experiencing a rash on her back, arms and face maybe about 5 minutes after vaccines were given. Provider was called to look at her and Benadryl was given to child. She was checking out and had her wait a couple of minutes after Benadryl was given. Rash started disappearing.
Lost her sense of taste and smell; Lost her sense of taste and smell; Tested positive for Covid after receiving first dose of vaccine; Tested positive for Covid after receiving first dose of vaccine; Fever; body aches; Diarrhea; stomach symptoms abdominal discomfort; This is an initial spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNTl62B2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL8982; Expiration Date: 20May2021) first dose via an unspecified route of administration and administered in right arm on 23Jan2021 14:00 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Past drug included When she gets the flu shot, she gets a low grade fever and body aches for about 1 night. No Lot/NDC/Expiry for any of those Flu shots. States that this happens every year. On 08Feb2021 patient underwent lab test and procedures which included COVID-19 test and tested positive for first dose vaccine. Patient about the Covid-19 Vaccine. States that she doesn't know if there is something for self reporting, but her mom and her husband both got the vaccine, then 16 days later got symptoms of Covid, then on the 17th day, tested positive for Covid; and this was after the first dose of the vaccine. States that her mom, is on day 12 of Covid and still having symptoms. States that she was tested for Covid-19 on 08Feb2021, and it resulted on 10Feb2021 as positive. She started having symptoms such as body aches on 07Feb2021 to 08Feb2021, and the fever started 08Feb2021 to ongojng. She still had a fever yesterday. Caller states that the fever would disappear for a day or two, then come back, and this has been going on for the last 10 days. She also lost her sense of taste and smell about a week ago, and got it back about 1.5 days ago. Also had stomach symptoms as well, had diarrhea on 06Feb2021 and 17Feb2021, resolved that day 17Feb2021. The outcome of the events like Drug ineffective and SARS-CoV-2 test positive were unknown, pain, Ansomia, Ageusia and Diarrhoea was recovered and fever was not recovered.
Patient had a headache the day of the vaccine. Patient woke up on the morning of the 14th with a rash on his stomach and chest. The rash did not itch, but seemed to be warm and spread throughout the day. We did not seek medical attention because it did not interfere with his activities but did want to report it so you would be aware.