chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the event, was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
35 weeks Gestation for Tdap Client called reports that has Knot came up on Left arm about size dime and is about same size today. It is red and itchy today. Encouraged her to apply cool compress and notify her OB/Gyn for further instructions due to Pregnancy.
This case is a part of cluster of 5 cases and is linked with 2012-10398, 2012-10467, 2012-10468, 2012-10469 (same reporter, same events after administration of FLUZONE ID batch number: UT4468BA). Initial report received from a healthcare professional on 06 November 2012. A female patient (age was not reported) whose illness at the time of vaccination and medical conditions were unknown and concomitant medications were not reported, had received an intradermal dose 1 of FLUZONE ID vaccine (batch number: UT4468BA) in the deltoid region on an unspecified date of September 2012. On an unspecified date, 3 months after the vaccination, the patient presented stomach upset with fever, diarrhea and vomiting. Corrective treatment and laboratory investigations were not reported. On an unspecified date, the patient had recovered. Documents held by sender: None.
Shortness of breath, swollen lips, dizziness, itchy throat. EpiPen 0.3 administered,  Patient was stable, patient sent to ER via private transportation to the ER for observation.
The site of injection is sore; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The site of injection is sore), PYREXIA (fever) and PAIN (body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (The site of injection is sore), PYREXIA (fever) and PAIN (body aches). At the time of the report, VACCINATION SITE PAIN (The site of injection is sore), PYREXIA (fever) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatments were reported.
Administered vaccine at 12:40pm Pt during administration of vaccine started to pull away but full dose was administered, pt was nervous about the needle. After instructing pt to sit in the post vaccine chair for 15 minutes I noticed visible distress at around 12:50pm. I rushed to her aid and asked her how she was feeling and she reported feeling dizzy. I then helped her out of her chair onto the floor to ensure she would not fall and hit her head - told her to lay supine. I then asked my technician to give me the bp monitor. I then checked her bp and it was below 80/60. I informed her this could be contributing to her dizziness and then asked for consent to help raise her bp. She consented and then I told her I would be lifting her legs in the air to raise her BP. I held her legs in the air for 10 minutes or so and then reassessed her BP and it was 110/48. She started to feel better but reported feeling as if ants were all over her left arm which is where I gave her the vaccine. I assessed once again for angioedema, anaphylaxis, hives, redness, swelling, but didnt see anything. Since the pt was dizzy I did not offer her benadryl liquid but instead offered clairitin. The pt was merely having a panic attack post immunization and said she could swallow tablets and was feeling better. I gave her one clairitn tablet otc. She wanted to sit up so I assisted her to a sitting position while she was on the floor. She sat there for additional ten minutes then moved into a chair and was brought food by her husband because he said she did not have breakfast and thought that could be why she was dizzy. She was not a diabetic so I was not concerned about her BG. She said that this never happened in the past when I reviewed her PCQF form prior to giving her the vaccine. She has had zero history of syncope so this was rare for her. After an additional 10 minutes she had a bp reading of 98/60 and left the store feeling much better
Had headache, with sneezing, congestion and coughing. Took home COVID-19 test - positive. I emailed my Dr. and she prescribed PAXLOVID. Took full dose and felt better 3 days later. Took another COVID-19 test and still tested positive a week later. Feeling better so I haven't retested.
Fever 101.7, severe body aches all over, chills, headache sore throat - began at 10am the day after vaccine - lasted until midnight that same day Next day headache remains.
Light-headed, dizziness, feeling of malaise, and flush which lasted about 15 minutes followed by a headache and feeling of coldness.
lost lot of hair; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0179), via an unspecified route of administration on arm right on 24May2021 10:15 (age at vaccination: 71 years) at single dose for COVID-19 immunisation. The patient medical history included ongoing CPRD since May1972. Family medical history was reported as unrelated vintage. The patient Concomitant medications included JANSSEN COVID-19 VACCINE taken for virus from an unspecified date and covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) taken for virus from an unspecified date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0179), via an unspecified route of administration on arm right on 03May2021 10:15 at single dose for COVID-19 immunisation. On an unspecified date in May2021, the patient experienced lost lot of hair (not life threatning). Therapeutic measures were taken and treatment included antibiotics. The outcome of the events was not recovered.  The reporter considered the events as not serious.
Information has been received from a receptionist in the physician's office and a Certified Nurse Midwife (CNM) concerning a 20 year old female patient with a history of prior contact dermatitis, hive reaction who on 26-FEB-2007, at 11:00 AM was vaccinated with a first dose of Gardasil. On 26-FEB-2007 at 11:15 AM she broke out in hives after the injection. The patient came back to office within about 15 minutes after getting the injection with some itchiness, some small red hive areas, with rubbing, the hives then extended. They were on both of patient's wrists, on her neck, and her right chest wall, patient had no papules and she appeared coherent. She was given immediately 50mg of liquid BENADRYL. The patient came back to the office in one hour and she had no hives. She had a residual headache from the experience that was persisting at the time of this report. The patien planned to go  home early and stated her boy friend would be home in the afternoon to check on her periodically to monitor for any signs of reaction. The reporter plan to contact the vaccine adverse event reporting system, to get some recommendation on whether or not they should continue the second and third injection. The reporter thought that hives and itchiness were other important medical event. Additional information is not expected.
Patient came into the clinic on 02/13/2019. Mom had noticed redness and swelling in the right thigh on 02/12/2019. No fever. Provider noted erythema and swelling localized around previous bandage and injection site of the INFANRIX on left lateral thigh. The area was warm to touch, tender and a 10 cm diameter. Dr diagnosed the patient with cellulitis and treated with Keflex.
Information has been received from a physician concerning a 10 year old male who on 13-DEC-2000 was vaccinated with the first dose of MMR II (route, site, dose and lot number not reported).  On 02-DEC-2003, the patient was vaccinated with the second dose of MMR II (route, site, dose and lot number not reported).  On 29-NOV-2009 the patient experienced mumps (date diagnosed was reported as 01-DEC-2009).  The patient was afebrile and had parotitis.  On 01-DEC-2009, the laboratory tests showed serum amylase 95, IgG 6.24 and IgM <1:10.  The outcome for mumps was not reported.  Follow up information has been received from the physician who reported that the 10 year old patient (also reported as 8 year old at onset date) experienced mumps on 02-DEC-2009 (previously reported as 29-NOV-2009).  The date diagnosed was reported as 03-DEC-2009 (previously reported as 01-DEC-2009).  The patient had fever of 102 F and experienced right parotitis.  On 03-DEC-2009, a blood work test showed IgM <1:10, IgG 5.81 and serum amylase 498.  At the time of the report the patient's outcome was unknown.  No further information is available.
Burning, tingling sensation on surface of extremities (hands, legs, feet). Reported to Dr., same day. The next day was seen with Dr.  No action.
4/14 around 11 AM had 5 minutesshortness of breath / cough.; 4/14 around 11 AM had 5 minutes shortness of breath / cough.; Around 11:30 to 12 started noticing eye lids started swelling half inches; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 13Apr2021 at 12:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic. 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 vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN) both for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 23Mar2021 at 12:30 as a single dose for COVID-19 immunisation. On 14Apr2021, around 11: 00, the patient experienced shortness of breath and cough for 5 minutes. Around 11:30 to 12 started noticing eye lids started swelling half inches. No itchy or water leak. The events did not result in doctor or other healthcare professional office or clinic visit or emergency visit. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shortness of breath and cough was recovered on 14Apr2021, while the event eye lids started swelling half inches were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sore muscle in upper arm of injection site, moderate headache lasting in to the next day, some mildly sore muscles in shoulders and neck area, and mildly upset stomach the evening of the day of the injection.
a 16 year old female patient received a dose of Flublok Quadrivalent vaccine in error/No AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 16 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] in error lot QFAA1941 and expiration date: 30-Jun-2020, via intramuscular route in the right arm on 30-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  Physician reported that Flublok Quadrivalent was given to a 16 year old patient in error.  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 holders 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.
The first shot made me hurt all over; This case was reported by a consumer and described the occurrence of generalized aching in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced generalized aching. On an unknown date, the outcome of the generalized aching was recovered/resolved.   It was unknown if the reporter considered the generalized aching to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The 1st dose of Shingles vaccine and it hurts the patient all over. The patient got 2nd shot as well but with no problems. The follow-up would not possible as no contact details were available.
Day 4 tremors in both hands and arms. Only when making a fist or holding an object that is not very heavy.
This spontaneous report as received from a healthcare worker refers to an unspecified number of the patients of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (route of administration defaulted to oral, dosage schedule and lot# were not reported) (exposed to 52F to 48 horus). No adverse event. Additional information has been requested.
In an unspecified date, the vaccinee received an injection of Infanrix; it was not known if she had received previous injections of Infanrix; Subsequently, she experienced cellulitis at the injection site She was seen in the clinic and unspecified medications was prescribed. As of 02/11/02, the outcome of the event was unknown.
fever; rash at injection site; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) and VACCINATION SITE RASH (rash at injection site) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE RASH (rash at injection site). At the time of the report, PYREXIA (fever) and VACCINATION SITE RASH (rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment medication reported.  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.; Sender's Comments: 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.
period two week earlier than it normally would occur; difficult to swallow; sore throat; severe headaches; dizziness; irritability; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (severe headaches), DIZZINESS (dizziness), IRRITABILITY (irritability) and POLYMENORRHOEA (period two week earlier than it normally would occur) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), HEADACHE (severe headaches), DIZZINESS (dizziness) and IRRITABILITY (irritability). On an unknown date, the patient experienced POLYMENORRHOEA (period two week earlier than it normally would occur) and DYSPHAGIA (difficult to swallow). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (severe headaches), DIZZINESS (dizziness), IRRITABILITY (irritability), POLYMENORRHOEA (period two week earlier than it normally would occur) and DYSPHAGIA (difficult to swallow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Limitol.
sore arm with moderate pain, redness and swelling at the site of the injection, tiredness, muscle pain, headache, shivering, fever, stomach pain, nausea and vomit
No side effects till 8 days after vaccination, Large circular red area approx 4 inches  in diameter appeared at injection site.  This area itched and was warm to touch but no pain. By morning of day 9 area of redness had grown to 9-11 inches in length down arm  almost to elbow and remained 4 inches in width at widest part.  Hydrocortisone cream was applied from day 9 three times a day and also Zyrtec  10mg daily was initiated. Ice was also used as needed for itching.
Got an adverse reaction which placed patient body into shock; Optic shingles; Lost part of my vision; This spontaneous case was reported by a consumer and describes the occurrence of SHOCK (Got an adverse reaction which placed patient body into shock) and OPHTHALMIC HERPES ZOSTER (Optic shingles) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SHOCK (Got an adverse reaction which placed patient body into shock) (seriousness criterion medically significant), OPHTHALMIC HERPES ZOSTER (Optic shingles) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Lost part of my vision). At the time of the report, SHOCK (Got an adverse reaction which placed patient body into shock) had resolved and OPHTHALMIC HERPES ZOSTER (Optic shingles) and VISUAL IMPAIRMENT (Lost part of my vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that patient received the first shot in March and got an adverse reaction which placed patient body into shock and gave patient optic shingles and patient lost part of vision.   After 8 months of treatment, patient was cleared by a doctor to receive pfizer second shot tomorrow under anti virals.  Company comment: This case concerns a female patient with no medical history reported, who experienced the unexpected events of shock and ophthalmic herpes zoster and non serious event of visual impairment. The events occurred after the first dose of mRNA-1273. As reported, the patient received the first shot in March and got an adverse reaction which placed patient body into shock and gave patient optic shingles and patient lost part of vision. After 8 months of treatment, patient was cleared by a doctor to receive pfizer second shot. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with no medical history reported, who experienced the unexpected events of shock and ophthalmic herpes zoster and non serious event of visual impairment. The events occurred after the first dose of mRNA-1273. As reported, the patient received the first shot in March and got an adverse reaction which placed patient body into shock and gave patient optic shingles and patient lost part of vision. After 8 months of treatment, patient was cleared by a doctor to receive pfizer second shot. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This is a non-serious spontaneous case, initially received from the other non-health professional on 14-Nov-2018, concerning a 29-year-old, adult female patient. The patient's current condition included multiple sclerosis (MS as reported) (since an unspecified date). On an unspecified date, the patient was administered non-company suspect product GILENYA (dose: 0.5 mg, frequency: once daily and route of administration: oral) for multiple sclerosis. It was reported that since the treatment with GILENYA, the patient's spasticity was not as bad in her legs/feet. The patient's shaking and balance had improved. On an unspecified date, the patient was administered influenza vaccine, [dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported]. It was reported that, right after the vaccination, the patient experienced cough and runny nose for a couple of days later. The outcome of the events was not reported.
Otitis- Information has been received from a consumer concerning her 13 month old female grandaughter with an allergy to penicillin who on 04 Jan 2001 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  Concomitant medication included zithromycin  (zithromax).  The night of post vaccination the patient was tugging at her ear and was noted to have an ear infection.  The patient visited a medical doctor the following day.  Additonal information has been requested.
Pt was given MMR while taking an immune suppressant. Pt had been vaccinated at least 2 times as a child. A CDC conference of experts was held to review the case in full.  Pt had NO adverse events.
Patient describes pain and limitation of movement.  Have limited information related to patients visit to doctor and treatment.