chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information about the patient's medical history, drug reactions or allergies and concomitant medications were not provided. On 15-MAR-2019, the patient was vaccinated with an expired dose (two days post expiration date) of M-M-R I) for prophylaxis, lot number N008365 and expiration date 13-MAR-2019 (dosage schedule, anatomical location and route of administration were not provided). The sterile diluent that was used to reconstitute the M-M-R II was not expired. No adverse effect reported.
Inappropriate schedule of vaccine Administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine Administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine Administered). On 13-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine Administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Follow-up received via TCR , updated previous event from missed dose to Inappropriate schedule of vaccine administered. Patient denied consent for further follow-up.
The patient received expired dose beyind expiratory date 13OCT2021; The product was refrigerated on 26OCT2021 beyond exiration date 13Oct202; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyind expiratory date 13OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 26OCT2021 beyond exiration date 13Oct202) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 26OCT2021 beyond exiration date 13Oct202). On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyind expiratory date 13OCT2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyind expiratory date 13OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 26OCT2021 beyond exiration date 13Oct202) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received booster dose. No concomitant medications were reported. The vial was placed in refrigerator on 26-Oct-2021 Vial did not undergone to any temperature excursion. No adverse event was reported. No treatment medications were reported.
Had joint pain and body aches on and off after 1st vaccine that seemed to resolve, no swelling or redness, afebrile, a little sluggish after the first day and then resolved. After second dose, felt very tired with increased muscle aches and joint pain, low grade or no fever, rash on lower left arm for 1+ weeks, all seemed to resolve except joint pain and aches in lower arms and legs. Joint pain and arms/legs aches seemed to go away during the day, and be on and off at night. Joint pain and extremity aches have been increasing for about 2.5 months and are much more significant when at rest. Motrin and Tylenol sometimes helps, haven't seen my healthcare provider, but thinking that I should since getting worse.
Rash around yellow fever injection site spreading extensively down back, legs, and to ankles and arms.  Maculopapular lesions slightly itchy. 1/27/06 Telephone call to patient rash mostly resolved took Benadryl.
Pr reported to nurse on the phone got home itching no dizziness. Rx for Hydroxyzine. Prednisone was given; Increase fluids.
Pentacel was administered in error with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional and transmitted to Sanofi on 30-Nov-2020.  This case involved a 4 year old male patient for whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was administered in error (product administration error).   The patient's past vaccination(s) included ACTHIB.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and INFLUENZA VACCINE (INFLUENZA).  On 19-Nov-2020, the health care professional stated DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE (Lot number UJ189AAA expiration date: 06-Apr-2021) via an unknown route in the right arm was administered in error (product administration error). Only the liquid was administered.  It was reported that the child was behind on his immunizations and reporter did not have a complete record of what patient had received but knew patient was up to date with his ActHIB so even though he didn't get that part he didn't need it.  At the time of this 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.
?Moderna COVID-19 Vaccine EUA? Symptoms started at roughly 9:30 AM, 5 minutes after receiving the Moderna Covid vaccine. She first experienced mild throat tightness that has persisted since onset. After about 20 minutes she additionally began to experience perioral numbness. Symptoms were consistent with prior anaphylactic reactions during which she did not develop hives and shortness of breath until 4-5 hours later. Currently she reports vague heaviness with breathing though denies feeling short of breath. Associated symptoms include lightheadedness and fatigue. She denies fevers, chills, recent illness, chest pain, abdominal pain, or hives. She was initially treated with diphenhydramine 25 mg and was observed for a couple hours. Symptoms did not significantly improve and she began to develop nausea so she was given a second dose of diphenhydramine and 1 L LR bolus. Roughly 45 minutes later she continued to be anxious and began to report mild chest pain and abdominal pain. She was given Epinephrine 0.3 mg and prednisone 60 mg at that time given concern for developing anaphylaxis. Symptoms did not progress further over the next 2 hours of observation in the ED. Discussed with the patient that symptoms were likely not a result of anaphylaxis and she was comfortable with discharge at this time.
5/13/05 developed 11 chicken pox lesions. Seen according to mom by school nurse; no fever. Spots were on left arm and back.
Client presented to the vaccination site on 11/04/2021. The client notified RN that she received a single dose of COVID vaccine on 04/30/2021. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the Janssen COVID vaccine. Per CDC guidance, approval to proceed with Janssen COVID vaccine was obtained from medical consult team via text message from RN, Vaccine Operations Lead . Client received COVID vaccine Janssen at 11:35 am.  The client did not report any symptoms during the 30 minute observation period. RN educated client on possible adverse reactions and when to seek medical care.
Started to get a severe headache later that night. Noticed rash on arms in next morning. Went to work the following day and was covered head to toe with severe red, itchy rash. Took antihistamines and ibuprofen. No relief.
Develped an itchy slightly raised pink blanching rash on left side of neck.  It keeps flaring on and off , worsening this summer.  I use to have eczema when I was around 6-8 years old on the antecubitol fossae and behind knees . It dissappeared until I got a COVID like infection Feb 26-March 6, 2020.  I started getting the same itching but with no rash initially in the same areas . It was a little worse that winter and started around my neck and now it is very bad  on my back , neck , arms and legs( daily intense itching mostly in evening ) and a rash is present now in those areas. My husband also had Covid like illness around March 9th, 2020 . He developed his first episode of " eczema" on his arms and upper back  the week after his COVID resolved  and he continues to have flares of it .
This spontaneous report was received from a 39 year old non-pregnant female patient concerning herself. The patient's concurrent conditions included asthma. The patient's medical history included pulmonary embolism. The patient's drug reactions/allergies included clarithromycin, neomycin(DIAXIN), amoxicillin (+) clavulanate potassium(AUGMENTIN), amoxicillin, prilocaine, corn and soy based ingredients, adhesive, perfume and dust-mites. On an unspecified date in approximately 2007 (reported as 10 years ago), the patient was vaccinated with the first dose of PNEUMOVAX23 as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported). On 06-FEB-2017, the patient was vaccinated with the second dose of PNEUMOVAX23 as prophylaxis (Strength, dose, route of administration, lot # and expiration date were not reported). The patient's concomitant therapies included cetirizine hydrochloride(ZYRTEC) and montelukast sodium(SINGULAIR). On 06-FEB-2017, 45 min after vaccination the patient experienced a drop in her blood pressure which was recorded by her hematologist as 77/56 (units not provided) (blood pressure decreased). As the day progressed she developed  aurora migraines (migraine), ear pain, congestion (nasal congestion) and persistent coughing (cough), fatigue, nausea and vomiting. On 07-FEB-2017 morning (reported as by the next morning), the patient felt like "the marrow in her bones was going to explode" also described as a feeling of intense pressure from the inside of every bone in her entire body (bone marrow disorder). On the same day, she experienced muscle fatigue all over her body and she could not move her left arm (injected limb mobility decreased) were the vaccine was administered, without excruciating pain (pain in extremity). On an unspecified date in February 2017 (also reported as several days after getting vaccinated), the patient experienced a bad cold (nasopharyngitis), the patient called her allergist and the allergist thought that she might had an "histamine reaction" to the vaccine, the patient belief that she may had reacted to the inactive ingredient called phenol found in the vaccine especially if the ingredient was derived from a corn source because she was allergic to corn based ingredients (reaction to preservatives). The patient reported that her symptoms lasted for about 18 days. She received an unspecified treatment for the events. A chemistry panel and a blood work were performed, however no results were provided. The outcome of the events was reported as recovered on an unspecified date in February 2017. The reporter did not provide the causality between the events and PNEUMOVAX23.        Additional information has been requested.
In for Flu shot received high dose Flu shot around 11AM - nauseated 3p - vomited repeatedly all pm 12-6-10 - weak - nauseated 23 hours later - recovering.
stings when I scratch it; At different times my arm has a low fever in it; My arm still itches; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PARAESTHESIA (stings when I scratch it), VACCINATION SITE WARMTH (At different times my arm has a low fever in it) and VACCINATION SITE PRURITUS (My arm still itches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced VACCINATION SITE PARAESTHESIA (stings when I scratch it), VACCINATION SITE WARMTH (At different times my arm has a low fever in it) and VACCINATION SITE PRURITUS (My arm still itches). At the time of the report, VACCINATION SITE PARAESTHESIA (stings when I scratch it), VACCINATION SITE WARMTH (At different times my arm has a low fever in it) and VACCINATION SITE PRURITUS (My arm still itches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported
Itching; She never got the second; Rash in upper left arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She never got the second), PRURITUS (Itching) and RASH (Rash in upper left arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was reported. No concomitant medication was reported.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced RASH (Rash in upper left arm). On 13-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She never got the second). On an unknown date, the patient experienced PRURITUS (Itching). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash, at an unspecified dose and frequency. On 17-Jan-2021, RASH (Rash in upper left arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (She never got the second) had resolved and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Significant follow up
Redness on the right arm shortly appear after the first dose of the Vaccine.  The redness continues to display for many days after the shot but on January 7th, I broke out in hives in the same area.  After consulting with my physician, he suggested that I take Benadryl and Ibuprofen.  I noticed the redness started to spread a lot bigger on Saturday January 9th.  At that point, I contacted my doctor and he prescribed me Amoxicillin and Prednisone.  As of today, January 14, the redness is slow dissipating but there are dark tone color around the infected area.
Patient had vomiting, dizziness, pale episode about 10 minutes post COVID vaccine injection. Feet elevated and patient was observed for approximately 20 minutes. Patient was given water, juice and Rice Krispie bar post vomiting episode. Patient released without further concern.   Temp: 96.4 (touch-free) PR 91 O2 95
2 days after vaccine I started having trouble swallowing and was choking on food. I went to dr. On 3/5/21. She ordered a barium swallow test. I had that done on 3/16/21. It indicated slow esophagus. However, between my 1st appointment and the swallow test, I developed extreme dry mouth. I went to Dr. again on 3/26/21 and he ordered bloodwork. My ANA test came back positive. I am awaiting an appointment with rheumatologist.
chills; Numbness; Pain right above injection site up my arm to back of neck and base of skull like a pulling sensation; some pain at injection site; nausea and headache came in wave; Headaches similar to past migraines; A spontaneous report was received from a nurse concerning a 63 year old patient who was participating in the mRNA-1273 Emergency Use Program and experienced numbness, radiating pain, injection site pain, nausea, migraine, and chills  The patient's medical history, provided by the reporter, included migraines and a positive test for COVID-19 in July 2020.  No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection on 24 Dec 2020.  On 25 Dec 2020, the patient experienced some pain at the injection site which kept her from sleeping on her left arm.  She also experienced pain right above the injection site up her arm to the back of her neck and base of her skull like a pulling sensation.  This was accompanied by nausea, numbness, and headaches like her past migraines.  The injection site pain and radiating pain resolved.    On 27 Dec 2020, the patient experienced chills.   On Dec 28 2020, headaches worsened before resolving.  The numbness, nausea, headaches and chills also resolved.  Treatment medications included Zofran and Excedrin.  Action taken with mRNA-1273 in response to the events was not reported.  The events, injection site pain and radiating pain, were recovered/resolved on 25 Dec 2020.  The events, numbness, nausea, headaches, and chills were recovered/resolved on 28 Dec 2020.; Reporter's Comments: This report concerns a 63-year old female patient  who experienced non-serious events of numbness, radiating pain, injection site pain, nausea, migraine, and chills all occurring within 1 week of her receiving the mRNA-1273. These events were considered as recovering after treatment with Zofran and Excedrin. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
One to two minutes after receiving the vaccine, patient felt queasy and light-headed; his face was red in color.   He was then asked to sit down.  He then passed out and fainted; his back was supported and his feet were elevated.  Patient became sweaty, pale in color, had a few muscle tremors/twitching in the arms, rapid pulse and clammy.  After 15 minutes he became more responsive and color returned.  EMS monitored blood pressure and pulse - determined within normal range.  After 30 minutes patient was more like himself, alert, oriented, and able to stand/move around.
Still ongoing 4 days after shot and still ongoing - fever, chills, stiff, achy all over, drowsy, sweats, headache, nausea, wheezing and congestion,  terrible pain in lymph nodes in L armpit and neck   - -  injection site is hard, hot, red, and worsening still today (three days later), getting bigger and bigger. Occasional sharp pain in injection site area.  Itchy skin in injection site area.
I had a sore throat, fever, chills, night sweats, body aches, a bad cough, and a runny nose. I thought I had Covid-19 but I didn't. I went to the doctor on December 13th. He did an exam and diagnosed me with bronchitis. I was prescribed an antibiotic and an albuterol sulfate HFA 90mcg inhaler.
Did not get the second dose within and it has been more than 42 days since 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not get the second dose within and it has been more than 42 days since 1st dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get the second dose within and it has been more than 42 days since 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get the second dose within and it has been more than 42 days since 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Patient Vomited and passed out. EMS was called and Patient recovered after resting and calming down
After receiving the vaccination I experienced headaches, face drooping on the left side possible Bells Palsy. I also experienced panic attack symptoms as well.
Approximately 10 days after my first dose of the Pfizer COVID-19 vaccine, a rash began to appear on my cheeks. By Day 14, it had spread to all regions of my face, but nowhere else.  It resolved by Day 16 or Day 17.  I received my second dose of the Pfizer COVID-19 vaccine yesterday, 28 April 2021, at 6pm. I woke up this morning with the rash on my cheeks.
After shot, got severe headache.; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An 18-year-old female patient (not pregnant) received meningococcal group b Rlp2086 (TRUMENBA), in Oct2021 as dose 1, single (Batch/Lot number: unknown) for immunisation; meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), in Oct2021 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (disability) with onset Oct2021, outcome "not recovered", described as "After shot, got severe headache.". The event "after shot, got severe headache." required emergency room visit. Therapeutic measures were taken as a result of headache. Clinical course: After shot, got severe headache. The patient went to ER. Multiple daily headaches, ever since that day, for 2 years.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: There is a reasonable possibility that the event headache was related to TRUMENBA based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Bad chills for the last 8 hours so far Mild nausea Lightheaded Tachycardic Temp 99.5
On 09/05/2000 the patient developed mild red areas and central vesicles on her abdomen, back and groin. On 09/20/2000 the patient recovered from her symptoms. Additional information is not expected.
Headache; This is a spontaneous report from a non-contactable consumer (mother) reported for a patient (her daughter) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date was not reported) first dose via an unspecified route of administration on 24Jun2021 single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Mother of the patient (who did not introduce herself) called for her daughter, withheld, who got the first dose of the Pfizer Covid-19 vaccine on 24Jun2021 and would like to know if patient can take either Tylenol or Ibuprofen for the slight headache she was experiencing after the shot. The outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.