chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient mentioned she experienced soreness at site of injection, muscle aches, fever, shivering, and fatigue for a couple days starting the day after receiving the vaccination on 5/23/19
Major pain in arm; chills off and on; This is a spontaneous report received from a contactable consumer, the patient. A 41-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 left arm on 04May2021 at 18:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not take any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 13:00, the patient experienced major pain in arm and chills off and on. The clinical outcome of the events major pain in arm and chills off and on was not recovered at the time of reporting.   No follow up attempts are possible. No further information is expected.
Within one week after the vaccination I developed a 6 mm papule on my left arm-not at the injection site.  (Something I've never had before.)  Then, during the spring or summer months I developed shingles (for the first time), the rash located on the right side of my neck.
The vaccine was administered after the indications changed and the monovalent is no longer authorized.; No Adverse Event; HCP stated a patient received 1 dose of Moderna COVID-19 Vaccine monovalent on 20 APR 2023 for the 2nd dose of the primary series, but the vaccine expired on 30 MAR 2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated a patient received 1 dose of Moderna COVID-19 Vaccine monovalent on 20 APR 2023 for the 2nd dose of the primary series, but the vaccine expired on 30 MAR 2023.), WRONG PRODUCT ADMINISTERED (The vaccine was administered after the indications changed and the monovalent is no longer authorized.) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 20-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated a patient received 1 dose of Moderna COVID-19 Vaccine monovalent on 20 APR 2023 for the 2nd dose of the primary series, but the vaccine expired on 30 MAR 2023.). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (The vaccine was administered after the indications changed and the monovalent is no longer authorized.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated a patient received 1 dose of Moderna COVID-19 Vaccine monovalent on 20 APR 2023 for the 2nd dose of the primary series, but the vaccine expired on 30 MAR 2023.), WRONG PRODUCT ADMINISTERED (The vaccine was administered after the indications changed and the monovalent is no longer authorized.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated a patient received 1 dose of Moderna COVID-19 Vaccine monovalent on 20 APR 2023 for the 2nd dose of the primary series, but the vaccine expired on 30 MAR 2023.) and WRONG PRODUCT ADMINISTERED (The vaccine was administered after the indications changed and the monovalent is no longer authorized.).    No concomitant medications were reported. Patient received 1 dose of Moderna COVID-19 Vaccine monovalent for the second dose. It was unknown if the first dose of the primary series was Moderna but assumed that it was Moderna. No treatment details were reported.
pt recv vax 7/18/87 & 7/28/87 pt devel a generalized measles rash confirmed & dx by an ER md;pt recovered;
Patient developed a rash on the left shoulder that looked like shingles. it was painful and burned
Mild rash especially on upper chest and back; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 08Mar2021 at 16:30 (at the age of 45-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient received other medications in two weeks which included store bought allergy medication - brand. The patient previously took sulfur and experienced allergy. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient experienced mild rash especially on upper chest and back on 09Mar2021 at 06:00. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sensations to muscle in leg started to bother her; right side of neck started to hurt her; Sensations to head; Sensations to right side of throat; Sensations to face; Sensations to scalp; Gastric Reflux; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Sensations to muscle in leg started to bother her), NECK PAIN (right side of neck started to hurt her), HEAD DISCOMFORT (Sensations to head), OROPHARYNGEAL PAIN (Sensations to right side of throat) and FACIAL DISCOMFORT (Sensations to face) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (years ago) and Reflux gastritis (she took antacids for Gastric reflux). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), SIMETICONE (GAS X) and CALCIUM CARBONATE (TUMS 500 CALCIUM) for an unknown indication, FISH OIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced LIMB DISCOMFORT (Sensations to muscle in leg started to bother her), NECK PAIN (right side of neck started to hurt her), HEAD DISCOMFORT (Sensations to head), OROPHARYNGEAL PAIN (Sensations to right side of throat), FACIAL DISCOMFORT (Sensations to face), SKIN IRRITATION (Sensations to scalp) and REFLUX GASTRITIS (Gastric Reflux). At the time of the report, LIMB DISCOMFORT (Sensations to muscle in leg started to bother her), NECK PAIN (right side of neck started to hurt her), HEAD DISCOMFORT (Sensations to head), OROPHARYNGEAL PAIN (Sensations to right side of throat), FACIAL DISCOMFORT (Sensations to face), SKIN IRRITATION (Sensations to scalp) and REFLUX GASTRITIS (Gastric Reflux) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       8 hours later after 1st dose she had "sensations" of the muscles in leg started to bother her, right side of neck started to hurt, her head, right side of throat, face and scalp experienced "sensations" and Gastric Reflux. Patient states she took antacids for Gastric reflux
Pfizer Dose 2 was administered in left arm. After the needle was inserted and removed, there was liquid running down my arm.  I was immediately concerned as this was not the experience i had when I received Dose 1.  Also, I was aware that vaccines dont usually produce any liquid residuals on the surface of the skin. The 'nurse - male' rushed to answer my concern by stating that this happens sometimes as there may be residue left in the vaccine needle.  He reassured me that I had at least gotten 'some' of the vaccine so I would be OK.  Needless to say, I am still concerned that I did NOT in fact get all of the vaccine and have no idea how much of it I did get.
Red, non-itchy rash; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020, the patient received the 1st dose of Shingrix. On 9th August 2020, 2 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and 2 days later broke out in red, non itchy rash over torso, abdomen, arms and legs.
COVID PCR: Positive (Date: 12-FEB-2021); This is a spontaneous report from a contactable other hcp. A 34-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: EM9810, Pfizer NTEC), via an unspecified route of administration in arm left on 03Feb2021 09:00 as 1st dose, single for covid-19 immunisation. Medical history included post-traumatic stress disorder, anxiety, attention deficit hyperactivity disorder, depression from an unknown date and unknown if ongoing. Concomitant medications included sertraline, birth control, alprazolam and trazodone taken for an unspecified indication, start and stop date were not reported. The patient experienced covid pcr: positive (date: 12-feb-2021) on 12Feb2021. The events assessed as non-serious. Treatment was received for the adverse events, diagnostic and lab testing work up on going. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Feb2021 Nasal Swab. In Hospital where the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Patient went to doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as not recovered.  Follow-up attempts needed. Further information is expected.
it put him into a Myasthenia gravis crisis; This case was reported by a nurse via call center representative and described the occurrence of myasthenia gravis crisis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myasthenia gravis crisis (serious criteria GSK medically significant). On an unknown date, the outcome of the myasthenia gravis crisis was unknown.   It was unknown if the reporter considered the myasthenia gravis crisis to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced myasthenia gravis crisis. The reporter consented to follow up.
I've had horrible hot flashes from menopause for 4 years. Since 2nd dose I've had only 1 or 2 minor flashes; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer-sponsored program .  A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had both doses of covid vaccine. One great side effect has lasted more than 2 weeks. On an unspecified date the patient experienced i've had horrible hot flashes from menopause for 4 years. Since 2nd dose i've had only 1 or 2 minor flashes. Patient wanted to know could the vaccine have done that. The outcome of the event was unknown.   Follow-up (12Apr2021): This Follow-up report contains no new safety information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Fever (about 101.5) for day and a half; lethargy, achy; weak.
1st vaccine dose just a soar arm, went away in a couple days. 5 days after 2nd dose site is still red, raised (swollen) and feels like a rather large knot and itches . No other side effects, feel good besides reaction on arm site area.
Vaccine was pulled from Freezer on 5/19/23, giving an expiration of 6/18/23, since it is good thawed for 30 days.  Actual expiration date was 5/27/23.  This was noted on the box in the freezer but not on the box in the fridge.     No adverse reactions.  Moderna is doing a Lot assessment to determine the activity level of the vaccine.  The report will done in 3-5 business days and then we will know whether we have to revaccinate or not.
Reporting what I was told.   The patient had a low grade fever of 100.4 F, weakness and confusion.  Her assisted living facility sent her to the ER where they observed her for less than 24 hours for a discharge date of 2/10/22
Pain & Swelling in right arm that moved into the right clavicle area, then to the neck,  then to the Left clavicle area,  and then into both left and right  scapula  areas.  When pain and swelling moved into my neck and base of neck, I also had numbness in that area.  Along with the pain and swelling in my arm, I have also had itching off and on at the site of the injection.  This started the morning after the shot and has continued.  I am 3 weeks and 3 days out from the shot.
no further AEs reported; received an expired dose of ROTATEQ on 13MAY2021; This spontaneous report was received from a physician and refers to a 2-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660998, expiration date: 03-MAY-2021 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. No adverse event was reported.
Severe soreness, inflammation, redness, a bump formed, and a large bruise. Fever lasting two days.
Approx 4.5 cm irregular shapped raised pink patch to left upper arm in fatty area of arm. Nontender but warm to touch and blances easily.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated an improperly stored dose of PNEUMOVAX 23 injection, lot # M037533 with expiry date 17-MAY-2018 (exact dose and route of administration were not reported). The dose was exposed to the temperature of minus 1 degree Celsius or colder for one cycle (reported as 2 hours 15 minutes). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Additional information has been requested.
pt recv vax 1AUG97 & the following day 2AUG97 pt was found dead;
Patient presented in clinic by mother, another nurse evaluated the patient and the nurses stated that the patient complains of injection site being swollen, red, warm, and itchy. Also states that child complained of itching. Mother denies that patient has been scratching injection site, but patient is noted scratching the site with a magazine. Measurments of the injection site are 3"x 3", redness noted, it is warm and hot to touch. Patient's mother was instructed to take patient to an urgent care or private provider for assessment. The patient's mother was also informed that if she does not take the patient for assessment to continue applying cool towels and administer Motrin to help decrease the inflammation. Mother voiced understanding.
3rd dose, expired 9/17/2021; 3rd dose, expired 9/17/2021; This is a spontaneous report from a contactable Pharmacist (patient) via Medical Information Team. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Lot number: FD0809; Expiration Date: 17Sep2021), via an unspecified route of administration in left deltoid on 20Sep2021 at 10:30 (at the age of 61 years old) as DOSE 3, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first and second dose of BNT162B2 for covid-19 immunisation. Pharmacist stated that this was regarding a Beyond use date - was mixed on 17Sep2021 and in syringe at 10:04AM - and remained at room temperature until administered 20Sep2021 at 10:30am. She stated they gave a third dose to the patient, and it was expired. They did not realize at the time it was expired. Third dose was given because patient was immunocompromised. The outcome of events was unknown.
Patient reported swelling at sight of vaccine on 7/21. Patient then went to ER. Patient diagnosed with cellulitis and prescribed KEFLEX.
Macular Papular rash over trunk and extremities, fever 102.9,  32 after vax. Dx viral exanthema vs reaction to vax.
Patient was diagnosed with pneumonia after a series of asthma attacks following the vaccine. She also lost hearing in her left ear and to date it has not returned.
Patient communicated feeling drowsy with faint chest pains intervals. Reported at 11 am. Prior to administering vaccine, the facility of vaccine site operations temperature at 76-77 degrees. Fan's were provided by facility for airflow after reporting patient's symptoms.
97 Y/O male comes in with C/O Falls. States has chronic dizziness but fell when she lost her balance. Also C/O cough. Denies fever chills. Chronic leg swelling and takes Bumex. CT abd pelvis reported neg for acute pathology. CXR showed LLL consolidation. UA with > 182 WBC. Nitrite Neg She Lives in an ALF and uses walker to walk. PMHX HTN 2) Chronic Leg edema 3) HLD 4) GERD 5) achalasia 6) Hypothyroidism  4/14/2021 tested positive 4/16/2021: patient discharged.
Went to the ER at the Hospital the day after receiving the vaccination because I had zero energy, no strength in any limbs and could not get out of bed. Dehydrated and high fever were detected.
Patient diagnosed with aseptic meningoencephalitis. Symptoms include altered mental status and headache, both of which had mostly resolved by day 5 of treatment. Treated with IV acyclovir for 5 days, stopped when CSF cultures returned negative.
A non-serious spontaneous report of sore throat and fever has been received from a nurse concerning a 47-month-old female, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FluMist on 26-Oct-2009. On 01-Nov-2009, the patient developed sore throat and fever. The outcomes ere not reported for these events.
Patient called at 12:45 pm. Patient felt that her tongue was numb and dry. She took 2 Benadryl tabs and was going to repeat every 6 hours. I told patient that if at any point she felt that here throat was closing got straight to the ER or use her Epi-Pen and go straight to the ER. I called patient again at 3:30pm on 5/17/14 and she felt the same and did not feel worse. When I called the patient on Monday 5/19/14 she says she was feeling better in reference to the Zostavax injection but had a food allergy reaction on Sunday 5/18/14.
On Sat morning (12/5/09) the patient noticed swelling of her are to this size of a softball where the injection was given.  She also noticed tingling at that time.  Sunday (12/06/09) the patient noticed a red raised rash.  She described it as resembling prickly heat rash.  This rash was also tender to the touch, she described this pain as that like shingles.  The patient took ibuprofen and BENADRYL and the arm is feeling much better and less swollen today.
Starting at the injection site and spreading around right arm  and down to elbow; redness, heat, hardness, and itching.  Not yet meeting at 148 hours, 5 days.  This was preceded that am with chills.  Treatment is icing per hour and using a topical steroid. Plus arm movements.
They haven't gone away. I have been experiencing pressure in the head and sinus congestion. I am going for an MRI this Monday.
Information has been received from a registered nurse concerning a 32 year old male who on 30-SEP-2005 was vaccinated IM with 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot # 650649/0790P). On approximately 30-SEP-2005, the patient reported that he went to an urgent care facility due to a severe localized reaction. He was diagnosed with cellulitis and placed on cephalexin (Keflex). A product quality complaint was not involved. Cellulitis was determined to be an other important medical event (OMIC) by the reporter. Additional information has been requested.
Headache, fever (101.5), chills, body aches, nausea, and loss of taste and smell.
Developed bump behind left ear.  Another 2 bumps developed 1-2 later also behind left ear. Mildly itchy and mild discomfort associated with bumps. Bumps scabbed over.  Also itchy area on back that scabbed. No fever.  Does not feel ill. Reports getting better.
pt recvd vax;w/in 12 hrs, T 103; extreme irritability, high pitched cry, dec po intake; lasted thru pm;4apr95 v several times;
Pt was given proguad on left leg 7/26/06. Within 3 minutes, pt had a reaction. Red area about the size of a silver dollar with 1 small welt near site. Pt was given 1 tsp Benadryl and watched for 20 min. Pt will see allergist before next MMR or Flu shot.
itching at the site of injection with a ring around it; This is a spontaneous report from a contactable consumer (patient) via Medical information Team. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itching at the site of injection with a ring around it (non-serious) on an unspecified date. Caller has received his Pfizer Covid vaccine. Caller experienced itching at the site of injection with a ring around it. Caller asking if that's normal. The outcome of event was unknown.    Information on the lot/batch number has been requested
Information has been received from a health professional concerning an 5 year old white female who in the am of 4/28/1998 was vaccianted SC wit a 0.5ml first does of varicella virus vaccine live experienced breakthrough varicella. It was noted that she had over 150 lesions. Unspecified medical attention was sought. Subsequently, the patient recovered. A product quality complaint was not involved. No further information is expected. The patients 10 year old brother (WAES0505USA00241) developed varicella after vaccination.