chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever 99-100F; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 99-100F) and MYALGIA (body aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0141L20A) for COVID-19 vaccination.     The patient's past medical history included Small intestine carcinoma (Diagnosed in the past 3-4 years. Cancer tumors in the small intestines was removed.). Concurrent medical conditions included Type 2 diabetes mellitus and Pancreatic carcinoma (Diagnosed in the past 3-4 years. It was still there and being investigated.).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (fever 99-100F) and MYALGIA (body aches). On 20-Jan-2021, PYREXIA (fever 99-100F) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature: 99-100f 99-100F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  The patient did not had any history of allergies and history of COVID-19 prior to or after getting the vaccine. He was not undergoing any chemotherapy.  The patient had had fever and body aches after getting the 1st and 2nd doses and the 1st booster dose of the Moderna Covid-19 vaccine. He also stated that on all occasion he had fever and body aches the day after the vaccination which lasted for a day or two. After the first dose he had fever which was 99-100.  The patient received shingles vaccine first dose on 12-Oct-2021 and the second dose on 06-Apr-2022.  No treatment information was reported.   This case was linked to MOD-2022-541327, MOD-2022-541328 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Followup received with QE number added.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "very mild hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: retesting positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received vaccine and other medication in 2 weeks. No known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
x 1 week -- fever, lymphadenopathy, mouth ulcers, headache
Fever, chills, nausea, vomiting, headache, insomnia, muscle aches. Most symptoms abated in 24 hours, though the muscle aches continued for 72 hours.
Arm having pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm having pain) and FATIGUE (Fatigue) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm having pain) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Arm having pain) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, SARS-CoV-2 test positive: unknown (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Breast engorgement and pain. There has been deep pain as well as radiating pain. Breast as also so tender to touch that cannot be washed properly.  Consistent swelling and pain still 6 weeks later.  Getting warmer to the touch as they continue to increase in size with consistent swelling.   Extremities have been swelling since post shot.   Vaginal discharge has increased and changed in consistency.     Went to Gyn to speak about problem- was blown off and it wasn?t even charted in my emr. Any AE is highly encouraged to be reported I would think as a scientific community one would want to chart it.   Visited with PCP after the gyn appointment. She has noted the changes in my swelling and breast. Ran extensive blood work and have found elevated prolactin levels almost 7 weeks post dose.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06SF21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Nov-2021, Body temperature: 102.2 (High) 102.2 fever.         Patient takes a lot of different concomitant medications (Not specified)
"lump on my neck just above my collar bone that appeared after my shot on the left side of my neck"; "lump on my neck just above my collar bone that appeared after my shot on the left side of my neck. it was very painful in the beginning"; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 31Mar2021 at 13:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (HBP). Concomitant medications included irbesartan (MANUFACTURER UNKNOWN); taken for high blood pressure from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 03Mar2021 at 14:00, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00, the patient experienced a lump on neck just above collar bone that appeared after shot on the left side of neck. It was very painful in the beginning and had to apply heat for several days and now the pain was coming back. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event "have a lump on neck just above collar bone that appeared after shot on the left side of neck. It was very painful in the beginning" was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a licensed Practical Nurse regarding a male patient of unknown age. The patient's medical history, drug reactions or allergies were not provided. Two years ago, approximately in 2011, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not provided). On 19-SEP-2013, the patient was in office to receive a 3rd dose of GARDASIL approximately two years after the second dose was administered. Dose has not been administered yet. The patient did not received treatment for the adverse event and did not sought medical attention. Additional information has been requested.
marked erythema, heat, rash & mild tenderness lt shoulder & lt deltoid muscle; mild to moderate pain w/use of lt arm; itching;
This spontaneous report was received from a health care worker regarding four patients of unknown age and gender. The demographics were not reported. On an unknown date, the four patients were vaccinated with VAQTA (dose, frequency, product lot#, expiry date, route not reported) that were improperly stored. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unkonwn. This is one of the several reports from the same source. Additional information has been requested.
Extreme sharp pain on left arm right where the vaccine was given. Pain has been going on for 10 days now. I have been taking tylenol and Ibuprofen but it hasn't helped much. I have difficulty doing daily activities including raising my arm to change clothes etc and sleeping at night due to the pain.
Hot to touch; Almost like hives; Itchy; Very hard; Swollen at injection site; Red arm; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of DRY SKIN (Hot to touch), PAIN IN EXTREMITY (Sore arm), URTICARIA (Almost like hives), ERYTHEMA (Red arm) and PRURITUS (Itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no relevant medical history reported). Concomitant products included ROSUVASTATIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Red arm). On 12-Feb-2021, the patient experienced DRY SKIN (Hot to touch), URTICARIA (Almost like hives), PRURITUS (Itchy), INJECTION SITE INDURATION (Very hard) and INJECTION SITE SWELLING (Swollen at injection site). At the time of the report, DRY SKIN (Hot to touch), URTICARIA (Almost like hives), PRURITUS (Itchy), INJECTION SITE INDURATION (Very hard) and INJECTION SITE SWELLING (Swollen at injection site) had not resolved and PAIN IN EXTREMITY (Sore arm) and ERYTHEMA (Red arm) had resolved.        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.   Concomitant medications included OTC vitamins. Treatment included ice pack.
The fingers/toes(both sides), joints was inflamed and visible bumps(appearance of flea bites), My symptoms lasted for 2-2 1/2 weeks.
Excessive fussiness x 6 days after immunizations.  "Screaming like she's hurting.  Draws her limbs in and draws into a little ball."  Normal exam at office visit 8/14/06.  Signs and symptoms resolved by 8/15/06.
101.3 fever developed around 9 pm. Headache lasted about 24 with inset around 7 pm.  Tylenol reduced fever, headache, vaccine paused next day caused  anxiety. Anxiety is what caused me to call dr. Dr was more concerned about fever. He explained what to look for with clots. Reaffirmed rareness.
Bilateral ascending weakness from lower extremities (BL), progressively ascending to affect upper extremities of w/absent reflexes c/f guillane Barre (AIDP) with 4 days. CSF showing elevated protein levels (477). Being treated with IVIg for 5 days, with following of NIFs (-50 to -40).  Fortunately fairly stable. Sensory Sx/dysesthias a bit better. Resp-status stable. Negative inspir. pressure back to negative 50. Strength perhaps slightly better. Remains fairly ambulatory. Clear mental status.
Developed fever of 101 and parent describes "weird facial expressions". Parent states "mouth seizures but ER told mom "No seizure."
Patient presented to clinic to receive her COVID-19 Booster vaccination. The patient signed up for a Moderna booster post completing her primary series of Pfizer COVID-19 vaccine. At time of administration, the administrator communicated with the patient regarding her booster, and  an error in communication occured, the patient was administered the Pfizer booster.  .Post vaccination with the Pfizer booster, the patient expressed that she had desired the Moderna booster.
2 hrs later (around 6PM) pt ran fever 104-very sleepy-lethargic stayed lethargic all thru evening-wouldnt awaken for dinner or to nurse; slept until 4AM then very fussy still wouldn't eat or drink, fever 104.2 p/APAP; advised to take to MD;
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with on a compliance improvement plan and has been reinstated vaccination privileges.
fever, tender swelling of thigh (L) Motrin (sites DTaP given)
Patient developed exercise-induced anaphylaxsis following this vaccine. By fall of 2014, he was unable to exercise fully without breaking into hives, vomiting and requiring a visit to the ER due to constriction of air flow in his throat.  When exercising, his legs would begin to tingle and his body would develop hives and his face would swell.   In April of 2015, patient was diagnosed with exercise induced anaphylaxsis and  was tested for allergies by a local allergist.  He had never been allergic to anything but had now developed a life threatening allergy  to shellfish, treenuts. and a variety of fruits. He has has over ten ER visits and requires an Epipen with him at all times.  Patient began losing his hair shortly after the first dose of Gardisil in July 2013 (Lot No. H021861). Mood swings and depression also presented and his mental outlook was severely affected.   In April of 2019, patient was unable to walk  due to dizziness and weakness and was incorrectly diagnosed with "Labyrinthitis".   In August 2019, patient visited a primary care doctor to see why his hands, feet, and scalp were numba and tingling. Thyroid was checked but levels were normal.  Another bout of dizziness and loss of balance presented in  early  February 2020.  Following a visit and MRI with an ENT, the patient was rushed to the hospital on Feburary 24th where a battery of blood tests and a spinal tap confirmed multiple layers of lesions in his brain - he was diagnosed with MS.  He is currently a patient with a doctor.
employee states J&J covid vaccine. Now with right leg weakness, stiffness, and "locking". Headache, dizzy, weakness, congestion, fatigue, racing heart. Contacted PCP advised employee contact occupational health to report symptoms
Developed high fever; Very sick; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Developed high fever) and ILLNESS (Very sick) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia (Had leukemia for 30 years).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (Developed high fever) and ILLNESS (Very sick). At the time of the report, PYREXIA (Developed high fever) and ILLNESS (Very sick) outcome was unknown. Not Provided      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 medications were provided. Treatment details included use of Extra strength Tylenol and Motrin Alternating The reporter was concerned if its ok for fever to rise up to 101.8 degree F
still in a fog; right arm pit the glands feel full of liquid, glands are still swollen under my arm.; arm hurts at injection site; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (still in a fog), LYMPHADENOPATHY (right arm pit the glands feel full of liquid, glands are still swollen under my arm.), VACCINATION SITE PAIN (arm hurts at injection site) and HEADACHE (slight headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 089A21A, 31A21A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 28-Nov-2020.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (still in a fog), LYMPHADENOPATHY (right arm pit the glands feel full of liquid, glands are still swollen under my arm.), VACCINATION SITE PAIN (arm hurts at injection site) and HEADACHE (slight headache). At the time of the report, FEELING ABNORMAL (still in a fog), LYMPHADENOPATHY (right arm pit the glands feel full of liquid, glands are still swollen under my arm.), VACCINATION SITE PAIN (arm hurts at injection site) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided  No relevant treatment medication were provided.  Patient was home quarantined. Patient got better. Her taste and smell returned about 3 weeks later. Patient was reported to massage her right arm pit very gently once a day in the warm shower which she said helped her.  Patient reported that the she had swollen glands under the arm after the booster dose which was not there after the first two vaccinations.   This case was linked to MOD-2021-281964, MOD-2021-282508 (Patient Link).; Sender's Comments: This report concerns a 67 year old female patient with past medical history of COVID-19 who experienced non-serious unexpected events of abnormal feeling (reported as still in a fog), lymphadenopathy and non-serious expected events of headache, vaccination site pain. The events occurred after an unknown duration following vaccination with the third dose of mRNA-1273. The patient reports having received all the 3 doses of mRNA-1273, but had not experienced similar adverse effects with the previous 2 doses. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I received my first dose of the Moderna Covid Vaccine on 8-14 at 5pm.  I woke up 3 times during the night due to severe arm pain, severe weakness and fatigue, and sweating. The next morning, I woke up with severe fatigue, severe weakness, severe dizziness, and throbbing at the vaccine injection site. I lost consciousness within a few minutes of waking up and I hit my head on the floor in the process of losing consciousness and fainting. I have a concussion from this incident.   I then fainted again a few minutes later, approximately 5:45am.. I called in sick on this day (8-15) and did not attend work.   I fainted again a few days later on 8-17 on a day off from work.   Since the initial incident, I have visual, spacial, and concentration deficits that I incurred from the vaccine and concussion. I have also been experiencing daily headaches, sensitivity to light, sensitivity to sound, dizziness, fatigue, ear pain, and neck pain and tinnitus in both ears that has not gone away since the incident. It is a high pitched ringing.
Information was received from a consumer regarding her daughter (age not provided). The state sent the consumer a letter saying her daughter missed her third dose of GARDASIL. The consumer thinks her daughter had all three doses but the physician's office thinks she only had two. No AE symptoms were reported. No further information was provided. Additional information has been requested.
On 9aug94 recvd 3rd dose of vax & felt drowsy about 1/2 hr p/ vax;slept for 1hr then fine
Patient reported she received Moderna vaccine for first dose. However, when her information was placed into immtracc, it was found that she had initially taken the BioNTech Pfizer Covid-19 vaccine. This was a mixed series event, that was found after administration of vaccine. Patient has not reported any adverse reactions.
Headache & Myalgia  Narrative: dose 1 -day 1-2- redness ,soreness and discoloration at inj site/ ha dose 2-day 1-3-readness, soreness and discoloration at inj site; day 1-4- migraine ha; muscle ache
Information has been received from a RN concerning a 4 month old male pt who on 19-DEC-2000 was vaccinated in the left thigh with a second dose of Comvax. Subsequently, the pt developed a small knot under the injection site. it was reported that 4 other pts had a similar experience following exposure to Comvax. Follow up information has been received from a RN which states the parents did not report the lump and bruise at the injection site until the child's next visit to the doctor in approximately February 2001. The onset of the reaction is unknown. The pt has recovered.
Vaccine given in error to child under the age of 18.  Only recommended for ages 18 and older.
pt recv vax 27JAN99 & 28JAN99 pt c/o severe h/a, including forehead & eyes;h/a were followed by episodes of nausea, dizziness & blurred vision, lasting about 4hr;10FEB99 c/o chest pain, seen by MD rx med;
Notified by recall on 10/16/22 that the Pfizer Ped 5-11 COVID vaccine may have had an incorrect expiration date when we received it. We calculated the expiration date to be 10/21/22 and the date in the recall was listed as 9/30/2022.  Vaccine looked as it normally did when diluting, drawing, and administering. There was no reported adverse event at this time.
Pt did not notice any problems other than soreness at injection site. On unrelated visit to MD on 6/18/03, nurse at MD office told her the shot had been given on wrong location, then MD told her she had cellulitis and should report his diagnosis to Health Dept. She had a plantar war removed while at the MD's office. Pt stated she was unable to walk due to the surgery. I made a home visit on 6/20/03. She had a quarter size red area on her left deltoid at the injection site which was slightly warm to the touch. There were no visible blisters. Pt stated that her MD did not culture site or do a CBC. She was prescribed Biaxin daily for 10 days and Bactiovar to apply tid. I assured her that the Td was given in the appropriate site. She was instructed to call the H.D. if symptoms worsened.