chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via other and described the occurrence of fever in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, swelling arm, erythema and fatigue. On an unknown date, the outcome of the fever, swelling arm, erythema and fatigue were recovered/resolved. The reporter considered the fever, swelling arm, erythema and fatigue to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's spouse. The age at vaccination was not reported. This case was reported by the physician assistant. The reporter did not specify when they received the dose. It was unknown if the events caused the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if the reporting health care professional consider the events to be life threatening. It was unknown if the reporting health care professional consider the events to result in  persistent or significant disability or incapacity. The patient did not die. It was unknown if the events require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect. This case is 1 of 4 cases reported by the same reporter.
pt had a vasovagal reaction about 2 minutes after receiving the vaccine. no prior history of this reaction. pt was layed supine and given fluids until symptoms resolved. vitals were monitored
Nausea and tiredness that evening. Those lasted about a day. My arm at the injection spot was a little sore. Two weeks later I saw a video that made me cry and it shouldn't have made me cry. I took a pregnancy test and it was positive. Conception date would have been the 15th. I had been trying without success to get pregnant. I had been trying for a year and a half. I think the vaccine helped. Pregnancy history 2nd pregnancy 1st one ended in early miscarriage. Estimated of date of delivery 11/10/2021.
Chills from COVID-19 Moderna vaccinations; Fatigue from COVID-19 Moderna vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills from COVID-19 Moderna vaccinations) and FATIGUE (Fatigue from COVID-19 Moderna vaccinations) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced CHILLS (Chills from COVID-19 Moderna vaccinations) and FATIGUE (Fatigue from COVID-19 Moderna vaccinations). At the time of the report, CHILLS (Chills from COVID-19 Moderna vaccinations) and FATIGUE (Fatigue from COVID-19 Moderna vaccinations) had resolved.            No concomitant medication was reported.  The co-suspect Humira formulation was reported as solution for injection in pre-filled pen. After second dose, patient had reaction of chills and fatigue for three days. No treatment information was reported.  The reporter causality for events chills from COVID-19 Moderna vaccinations and fatigue from COVID-19 Moderna vaccinations with co-suspect Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623188 (Patient Link).
Hives all over the body. Itchiness. Rash. Headaches. Sever breast pain before the period (usually no pain).  Claritin and corticosteroid topical help to reduce itchiness and rash. Advil does not help with headaches.
rash around his waist; This spontaneous case was reported by a non-health professional and describes the occurrence of RASH (rash around his waist) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash around his waist). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, RASH (rash around his waist) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported
I do not get UTIs.  I came down with a very strong and bad unitary tract infection.  I was put on antibiotics to clear it up.  I had my second shot and have another UTI.  This is NOT common for me.  I haven?t had a UTI in over 25 years.
A non-serious spontaneous report of hand and foot disease manifested with tiny bumps, painful rash on hands, fingers and palms has been received from a physician concerning an eight-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Dec-2011. In Jan-2012, the patient experienced fine tiny bumps (1mm), painful rash on their hands (around her fingers and on the ventral side of her hands), but also palms. It was non-impressive. She was diagnosed with hand and foot disease (probably viral). She was seen again on 05-Mar-2012 and continued to have the rash. The reporter believed that the rash was probably due to viral infection, which began with the mother and was transmitted to the patient. Mother and her sister had similar complaints at the time of reporting. The outcome of event was unknown. Additional information was received on 26-Apr-2012 and incorporated into the narrative: event information.
H1N1 vaccine given at 5 mo of age. -0.25 cc Per mother's report, no adverse reaction of 10-12-09.
On 01/30/2023, we noticed a rash on her face.  Itchy, burning, along the hairline, cheeks, neck and it was patchy and blotchy. We went to the dermatologist and she was diagnosed with Eczema. She gave her a prescription for two topical medications as well as over the counter cream. She is much better. She also had stomach pain twenty four hours after the vaccine for twelve hours, on 09/23/2022.
Left arm local rash and itching at the injection site. Feel a little dizzy and sleepy.
Information has been received from a physician concerning his daughter, a 19 year old female who at 15:00 on 08-Nov-2006 "was feeling great anxiety" before receiving an intramuscular injection with the vaccination HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). On 08-Nov-2006 after receiving the vaccination the patient experienced throbbing pain, a tingling sensation down length of her arm, elbow, wrist, jaw line and down her neck, fever, swelling and redness at the injection site, was "terribly itchy", had veins protruding, swollen glands, nausea and "felt hot and sweaty" (the patient was reported to be afebrile). Unspecified medical attention was sought. At the time of the report it was unknown if the patient had recovered. Additional information is not expected.
Right thigh where she received vaccinations looked very red and swollen (itchy but does not hurt).
Arm hurt; Swelling at the injection site; Tenderness at the injection site; nausea; Fever; Tiredness; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Tenderness at the injection site), NAUSEA (nausea) and PYREXIA (Fever) in a 52-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 No adverse event.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Tenderness at the injection site), NAUSEA (nausea), PYREXIA (Fever), FATIGUE (Tiredness) and HEADACHE (Headaches). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Tenderness at the injection site), NAUSEA (nausea), PYREXIA (Fever), FATIGUE (Tiredness) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were not provided.  No laboratory investigations were provided. The Treatment information was not provided.
Fatigue, aching. slight fever on February 22,  rash on chest and back on February 23
12 hours after the vaccination my arm was really sore, and I experienced chills, fever, aches, dizziness, loss of balance. I slept for 20 out of 24 hours. Very fatiqued and disoriented
Client states left arm soreness began at injection site during night. Pain began 10-6-09 and noted "a dime size" area at injection site with a small amount of redness. Has been taking Advil 2 tbs. every 4 hrs since 10-14-09 small amt of relief. Here today and states rash appeared on 10-14-09 which are reddened irregular splotches from deltoid to elbow (lt arm). Blister noted at injection site, area warm to touch and painful to touch. Referred to MD for evaluation. 10-16-09 saw MD and was diagnosed with Shingles.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis (had pseudo relapse so I couldn't use my legs and arm).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with ONDANSETRON ongoing since an unknown date for Nausea, at a dose of 8 mg. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided          Concomitant product use was not provided by the reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-060436 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Contact information updated, NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060436:2nd dose case
patient had all over body itchiness, that progressed to her throat closing up. It started about 5 minutes following the vaccination.
Fainting. B/P 120/70. Ammonia Inhalant used. Alerted. Left arm no redness.
Fever for 2 days; Muscle ache only on the left side; Headache; Sudden UTI; This is a spontaneous report from a non-contactable other healthcare professional (patient).   A 25-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0180 and expiration date was not reported), via unknown route administered on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization (Age at vaccination 25 years). The patient medical history included COVID-19 and concomitant medication was not reported. The patient was not pregnant at the vaccination time. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 03JUL2021, the patient experienced headache, fever for 2 days, sudden urinary tract infection and muscle ache only on the left side. The patient was not received any treatment for adverse event. The patient had COVID test post vaccination Nasal Swab and COVID test result was Negative. The outcome of event fever was recovered on an Jul2021 and headache, urinary tract infection and muscle ache was recovering.,   No follow-up attempts are possible. No further information is expected.
Fever, heavy rash or hives all over front torso, body aches.  Tylenol and benadryl, water and rest for 24 hours.
Received new shingles shot. Arm sore for over a week and shot area is still sore to the touch. Also knees hurt for several days.
Recommended Prevnar 20 was not available at the time and pharmacy only had Prevnar 13. Patient also had a script from the doctor and patient requested for Prevnar 13. Patient is aware that she has to return 1 year later (3/2/23) to receive her second dose in the pneumonia series (Pneumovax 23).
Eye swelling which resolved with no shortness-of-breath of acute set with no improvement over 4 hours or more
Chills, nausea, I felt feverish but did not take my temperature, I had sweats, headache, warm and at the injection site it swollen and red happened in the middle of the night. For the next 2 days I had extreme fatigue and after that I was fine (by Sunday). I did not have any energy but no chills or nothing. I took Tylenol and it helped me. I was able to return to work on Monday and as the day passed I started feeling like myself.  I also developed a lump on my neck on 01/18/2021 on the left side (on my collarbone) and my PCP prescribed Doxycycline 2 tablets a day. I also developed a lump on my right side when I took the first dose and took a ZPack and that lump is still here on my neck.
large inflamed swollen lymph nodes under her arm / extremely swollen large lymph node under the right arm; large inflamed swollen lymph nodes under her arm / extremely swollen large lymph node under the right arm; fatigue; This is a spontaneous report from a contactable consumer reporting for a female patient (daughter). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown) via an unspecified route of administration in the right arm on an unspecified date at SINGLE DOSE for covid-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date via unspecified route of administration in the right arm at single dose for covid-19 immunization. She received both shots (first and second dose) in the same arm. The reporter stated that patient (daughter) took her second shot (Covid-19 Vaccine by Pfizer) on unspecified date (reported as "this past Tuesday") and the next morning she woke up with a large inflamed swollen lymph nodes under her arm; upper arm but certainly it's in her armpit side. Reporter wanted to know how long the lymph nodes will just take swollen. The event was further described as extremely swollen large lymph node under the right arm. This happened on unspecified date, reported as the night patient received the vaccine (also reported as occurred the next morning). She did have additional side effects such as fatigue but no fever, no diarrhea, no upset stomach. Fatigue to the point she couldn't go to work on the day after receiving the vaccine. The fatigue passed but not the swollen lymph nodes. Patient went to see the doctor and said it could be a possible side effect of the vaccine or something else. Ultrasound was performed on unspecified date with unknown results. No treatment was received for the event (not at this time) but patient has been to physician.  The outcome of the event "large inflamed swollen lymph nodes under her arm / extremely swollen large lymph node under the right arm" was not recovered. Outcome of the event fatigue was recovered on unspecified date.   Information about lot/batch number has been requested.
Breakthrough case admission after 3 vaccines Unknown Lot#023M20A;  Moderna 3/18/21 Lot# 002B21A;  Moderna 8/19/21 Lot# 040B21A
arm sore; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single dose for COVID-19 immunization; tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 11 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced arm sore on an unspecified date. Patient stated, "I took the Pfizer shot and it made my arm sore." The action taken in response to the event for tofacitinib citrate was unknown. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever; chills; headache; nausea; injection site swelling and pain; body aches; joint pain
Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.
No adverse event, just RN gave wrong vaccine.  Needed to get Tdap, but flu was adminstered instead.
Later that night after receiving the vaccine patient began to feel flu like symptoms that lasted throughout the night and into the morning. He also described that he arm was very sore but no redness or swelling. Today, he feels much better.
She got her vaccine, didn't bother her that day.  She noticed itching that night.  Then the following morning she woke up sluggish, but went to PT for her knee anyway.  She continued to feel tired.  She noticed itching on her arm continued, and then looked at it and it was red with a welt.  She measured it and it was 3 1/2" wide by 2 1/2" in length.  By Saturday it was 6" wide and 4" in length.  It was warm to touch and itchy.  During Saturday and Sunday she had chills, slight fever, took Tylenol, stayed covered up.  She broke her fever occasionally and started to sweat.  She had a doctors APT on Tuesday 1/18/22, it was still red and not as elevated.  She then started to get little bubbles/blisters in it.  She was advised to let it take it's course.  It has now all gone away.
Patient mother called stating child had welts at injection sites on both legs about 8 inches around. She could not bring child in to be seen. Stated no fever, and itchy at the site. Informed patient mom to use ice and BENADRYL. Patient's mother admitted to giving her an antihistamine already stated it is getting a little better. Patient was playing in background and sounded happy.
Headache, ErythemaMultiform, UrticariaPruritus, headache, feeling pressure to sinuses and head. had hard knot to left deltoid, warm, swollen, slightly red. she has been icing it. Narrative:
This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a licensed practical nurse concerning a 16 year old female who was vaccinated IM with the second 0.5 ml dose of GARDASIL. On 17-MAY-2007 after receiving the vaccine the patient fainted and was unconscious for 1-2 minutes. The licensed practical nurse reported the patient complained of pain as injection was given and suddenly slumped in the chair. They were able to arouse the patient by calling her name. The staff watched the patient for 10-15 minutes after she was asked to lie down. The patient reported to the staff that she thought she was swimming. The patient recovered quickly and was clear and ambulatory when she left the clinic. The patient sought unspecified medical attention. No treatment was required. Subsequently, the patient recovered from fainting. The patient did not experience any adverse symptoms after the first dose. No additional information is expected.
a patient was given a double dose of the bivalent booster (0.4ml instead of 0.2ml). The vaccine adminstration was today, 15Dec2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (a patient was given a double dose of the bivalent booster (0.4ml instead of 0.2ml). The vaccine adminstration was today, 15Dec2022) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (a patient was given a double dose of the bivalent booster (0.4ml instead of 0.2ml). The vaccine adminstration was today, 15Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (a patient was given a double dose of the bivalent booster (0.4ml instead of 0.2ml). The vaccine adminstration was today, 15Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (a patient was given a double dose of the bivalent booster (0.4ml instead of 0.2ml). The vaccine adminstration was today, 15Dec2022).    No concomitant medicine were reported. No treatment medicine were reported.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm on the site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. No Medical History information was reported.On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm on the site). At the time of the report, VACCINATION SITE PAIN (sore arm on the site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-395711, MOD-2021-395729 (Patient Link).