chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medicine were reported. No treatment medicine were reported. lot 042J21A should have been reported with a BUD of 17-Feb-2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non-significant follow-up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Information has been received from a pt's mother who is a registered nurse concerning a month old caucasian female with noNKDA who on 05/02/2001 was vaccinated with the first dose varicella virus vaccine live subcutaneously in left upper arm, no other vaccinations were given at this time. On 05/14/2001, the patient experienced rash around the injection site. The pt's mother described tha rash as "three red bump,
On and off joint pains on the knees and elbows; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (On and off joint pains on the knees and elbows) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced ARTHRALGIA (On and off joint pains on the knees and elbows). At the time of the report, ARTHRALGIA (On and off joint pains on the knees and elbows) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
migraine/headache; migraine/headache; chills; myalgia; arthralgia; sensitive skin; flank pain; This case was reported by a physician via call center representative and described the occurrence of migraine headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain. On an unknown date, the outcome of the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain were unknown.   It was unknown if the reporter considered the migraine headache, headache, chills, myalgia, arthralgia, sensitive skin and flank pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter believed that the adverse events were much more severe after 2nd dose compared with the 1st dose. No additional demographic information of patient was provided. The reporter consent to follow up. This is 1 of 11 cases, reported by the same reporter, for tolerance of 2nd dose, refer case US2019AMR208413.
Brain fog 24 hours after vaccination; waves of nausea; Very tired 20 hours after vaccination; Unable to keep eyes open 20 hours after vaccination; Very confused upon waking up 18 hours after vaccination. Extreme confusion 24 hours after vaccination; Very sore arm 4 hours after vaccination, lasted all second day; Very sore arm with burning sensation 4 hours after vaccination, lasted all second day; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 03May2021 at 12:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac, hypothyroidism, attention deficit hyperactivity disorder (ADHD), depression, obsessive-compulsive disorder (OCD), anxiety and allergy to strawberries. Prior to 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 ethinylestradiol; etynodiol diacetate (KELNOR) from an unknown date indicated for birth control, lisdexamfetamine mesilate (VYVANSE) and levothyroxine (MANUFACTURER UNKNOWN), both from unknown date for unknown indication. On 03May2021 at 16:00, 4 hours after vaccination, the patient experienced very sore arm with burning sensation, lasted all second day. On 04May2021 at 08:00, 18 hours after vaccination, the patient was very confused upon waking up. On 04May2021 at 10:00, 20 hours after vaccination, the patient was very tired, unable to keep eyes open. On 04May2021 at 14:00, 24 hours after vaccination, the patient experienced, brain fog, extreme confusion and waves of nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very sore arm with burning sensation, very confused upon waking up, very tired, unable to keep eyes open, brain fog, extreme confusion and waves of nausea was not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.
Received dose at 12:30 pm on Saturday. By 6:30 pm I had severe fever, chills, severe headache, and generalized aches until about 4 am. Woke up around 7 am feeling better. Mild heat flashes until about noon. Felt fine the rest of the day. On Thursday 3/25 around 6pm I started developing hives, itching and red rashes on bilateral lower legs. Thighs, knees, feet and ankles. I waited several hours to see if it would go away and it did not. By 10:30 pm it was much worse. I took a 25mg Benadryl tab. Rash went away. On Friday 3/26 rash and hives, itching and red rashes returned. Both kneecaps very red and hot. It mainly stayed on lower legs until about 5 pm. The rash then started on bilateral arms. I took another Benadryl at 6pm. It is currently 7pm.
This spontaneous report as received from a nurse refers to two patients of unknown age. ON 28-AUG-2014 the patients were vaccinated expired doses of M-M-R II (HSA, lot # H014647, expiration date 03-AUG-2014) (dose, route unspecified). No symptoms reported. This is one of several reports received from same source. Additional information has been requested.
chest pressure and pain a little over 12 hours following second vaccination; CT scan with dye/contrast revealed a pulmonary embolism
Red circle completely under the injection site appeared 3 hours after injection. Extreme swelling about 4 hours after.  Pain under the arm (possibly lymph nodes) 6 hours lasting past 48 hours. After 48 hours a frontal lobe headache and posterior neck stiffness occurred while the redness and swelling persisted.
Acute worsening of psoriatic arthritis joint pain that lasted 3 weeks after each shot
At approximately 10 pm on 11/03/2021, I began having body aches along with my left arm hurting at the injection site. At 5:00 am, I was awakened by severe chills that I couldn't get to stop. I took 2 Tylenol 500mg and went back to bed. Approximately 2 hours later, I was awakened by being drenched in sweat, severe body aches and a bad headache. At approximately 11 am, I took 2 Tylenol 500mg and went back to bed and slept on and off for the next 12 hours (taking 2 - Tylenol 500mg every 6 hours). At approximately 11 pm on 11/04/2021, my main symptoms began to dissipate. By 11 am, on 11/05/2021, all symptoms stopped except my left arm hurting at the injection site.
Patient presented to emergency department on 8/26/2021 with fatigue, cough, and congestion. She tested positive for COVID-19 on 8/23/2021 at an outside facility. She was treated with dexamethasone and supplemental oxygen. She was discharged to rehab facility on 9/1/2021.
Fever body aches vomited    Took 2 Tylenol every 4 hrs. Lasted 3 days
swelling; Flu like symptoms; low grade fever; headache; joint pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself.  A 64-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) intramuscularly in the left arm on 18Dec2020 at 12:00 am, and the second single dose intramuscularly in the left arm on 04Jan2021 at 12:00 pm (as reported), for COVID-19 vaccination. Medical history included osteoarthritis from an unknown date and unspecified if ongoing. No unknown allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), hydroxychloroquine, progesterone, colecalciferol (VITAMIN D), calcium, magnesium. No other vaccine received in four weeks. 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 experienced flu like symptoms, low grade fever, headache, joint pain and swelling on 05Jan2021 at 01:00 am. The events were non-serious. The patient received paracetamol (TYLENOL) and ibuprofen for the events. The patient was recovering from the events.  Information on Lot/batch number has been requested.
Vaccine 3/15, 4/8. Admit 5/1. Admit for hypoxia d/t COVID PNA. H/O RA w/interstitial lung disease. In ER temp 100.1, SpO2 94%. WBC WNL, later elevated. CXR shows interstitial lung disease. Treated w/steroid, dose of convalescent plasma, supportive care, oxygen.   Brief History: Patient who presented with the above complaints.  Patient with a history of longstanding rheumatoid arthritis who presents to the ER with above-stated symptoms.  Patient reports history of chronic dry cough which she attributes to having lung disease related to rheumatoid arthritis.  Patient has received both doses of Pfizer COVID-19 vaccine, 2nd dose on April 8th.  About 2 weeks ago he started having low-grade fevers with worsening of cough and shortness of breath.  Patient was tested at an urgent care center and tested negative for COVID-19.  Denies any known sick contacts.  No recent travel history.  Symptoms worsened about a week ago with persistent fevers, increasing cough and shortness of breath.  Patient went to see his rheumatologist and diagnosed with interstitial lung disease this week and referred to see pulmonology.  He was monitoring his oxygen saturations at home which have been dropping down to 88-89% on room air that made him come to the ER.  Patient tested positive for COVID-19 in the emergency room.  CT angiogram of the chest showed no evidence of any pulmonary emboli but evidence of interstitial lung disease bilaterally.  He is currently being admitted for hypoxia secondary to COVID-19 pneumonia.  Patient denies any chest pain   Hospital Course:  Patient was admitted.  Kept on steroids and oxygen.  Seen by Infectious Disease.  Got a dose of convalescent plasma   This morning he is on room air.  Past the walk study.  Feeling lot better.  Seems to be stable for discharge on oral steroids to finish up the course.
Body stiffness, possible tonic seizure, pale, passed out and hit face on bench when falling down. Pt does not remember.
needed an EpiPen after receiving the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Caller states that her 32 y/o son has a histamine allergy. When he drinks wine "his face turns beet red." He is scheduled to get the Pfizer Covid vaccine soon. She is worried because she heard from a friend who' s daughter needed an EpiPen after receiving the Pfizer Covid vaccine ,the patient experienced needed an EpiPen after receiving the Pfizer covid vaccine on 2021 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch cannot be obtained.
Initial and follow-up information has been received from a nursing student concerning a 19 month old male with no known drug reaction/allergies or pertinent medical history who on 22-JUL-2003 was vaccinated SQ with her first dose of VARIVAX vaccine (Oka) (lot # 644721/0018N) 0.5 mL into his left upper arm. There was no concomitant medication. The nursing student mentioned that the patient received his first dose of VARIVAX vaccine (Oka) and 2 days after in 24-JUL-2008, developed 1 or 2 lesion (also reported as spots) on his thigh (no adverse) as per the mother's report. No lab diagnostics were performed. The patient did not seek medical attention. On 29-JUL-2003, the patient recovered. There was no product quality complaint. Additional information is not expected.
Patient developed a fever to 102.7 the night after the vaccine was given and had significant left leg pain (4 of shots given in left thigh with 1 approximately 3 inches above the knee). Returned to clinic the next day for evaluation and no other source of fever identified.
After confirming multiple times with patient that she was receiving a flu shot, she informed the pharmacist after administration that she had already received a flu shot this year.
Called Dr 10-14-08 to report flu symptoms- nausea, fever 100-102, chills, aches, headache.  saw Dr. 10-15- took blood count, gave script for CIPRO and told to take MOTRIN.  Arm was sore & swollen at this visit.  Continued fever, headache, body aches, chills.  Saw Dr. 10-16-08 as arm was very red, sore & swollen with other symptoms.  He gave me antibiotic 3 times as strong as CIPRO, PREDNISONE & ARDAX.  Tylenol #3 for headache after checking my blood count.  I saw Dr.  again  10-18-08 to F/u feeling much better but arm still red & itchy.
Slight swelling and slight discoloration around the shot area.  As with the first dose, my arm was sore (6 on scale of 10) that night and the following day.   Not sure if related, but my right jaw is also sore. Can't close my mouth fully.    After 1st shot 29 days earlier, I had sore arm (didn't look or notice the discoloration or swelling).  Pain in arm was about a 6 on first day, 3-4 on 2nd day, and 2 on the 3rd day and gone on the 4th day.
Information has been received from a nurse concerning a 23 year old female patient with penicillin allergy and a history of kidney stones who on 10-AUG-2009 was vaccinated with a dose of GARDASIL, 0.5 mL, intramuscular route (lot # 661953/1130X). Concomitant therapy included birth control. The patient did not have any reactions with the first dose of GARDASIL. On 07-OCT-2009 the patient received the second dose of GARDASIL, IM left deltoid (lot # 663453/0249Y). The patient was kept at the clinic for 20 minutes after the vaccination and was okay and left the clinic. The patient returned 15 minutes later with diaphoretic, felt funny walking down the street and both hands felt numb. The patient was also given GATORADE. A blood pressure was monitored for 15 minutes. On 07-OCT-2009 the patient was recovered. Follow up information has been received from a registered nurse. The patient left the clinic after waiting 20 minutes. When the patient got to the street she felt very faint and she returned to the facility. The patient was monitored for another 15 minutes. The patient was given GATORADE and was discharged. No further information is available.
Pt with one day duration complaint of pharyngitis, fever, chills, intermittent headache, muscle aches including neck, limbs-UE/LE, resolved abdominal pain. Temp 100.8, pulse 102, BP 134/66, resp 14. NAD, right tonsil with eroded lesion, +2 bilateral tonsilar injection. Rest of exam WNL. Treated for viral pharyngitis w/ education re meningitis.
Pt called and stated that she began to experience redness, warmth,  swelling, and "splotchiness" around the injection site around 24 hours after receiving her vaccination
having all kinds of bone aches in his calf, elbow, back, neck,; when he coughs, his butt hurts; was sick for 2 days and then it disappeared; does not feel right; losing strength/he lifts the same weight for the past 10 years, but now he cannot; concerned he is not getting any better; butt hurts; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (having all kinds of bone aches in his calf, elbow, back, neck,), COUGH (when he coughs, his butt hurts), ILLNESS (was sick for 2 days and then it disappeared), FEELING ABNORMAL (does not feel right) and ASTHENIA (losing strength/he lifts the same weight for the past 10 years, but now he cannot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041CZ1A and 048B211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included EZETIMIBE (ZETIA) for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (having all kinds of bone aches in his calf, elbow, back, neck,), COUGH (when he coughs, his butt hurts), ILLNESS (was sick for 2 days and then it disappeared), FEELING ABNORMAL (does not feel right), ASTHENIA (losing strength/he lifts the same weight for the past 10 years, but now he cannot), MALAISE (concerned he is not getting any better) and MUSCULOSKELETAL PAIN (butt hurts). At the time of the report, ARTHRALGIA (having all kinds of bone aches in his calf, elbow, back, neck,), COUGH (when he coughs, his butt hurts), FEELING ABNORMAL (does not feel right), ASTHENIA (losing strength/he lifts the same weight for the past 10 years, but now he cannot), MALAISE (concerned he is not getting any better) and MUSCULOSKELETAL PAIN (butt hurts) outcome was unknown and ILLNESS (was sick for 2 days and then it disappeared) had resolved.            Patient stated that he does not had any health conditions and he doesn't smoke, drink, or do drugs.  No treatment medication was provided.
Information has been received from a physician concerning a 23 year old female who in approximately November 2007, was vaccinated with her first dose of Gardasil.  On 15-JAN-2008 the patient was vaccinated with her second dose of Gardasil.  On 15-Jan-2008, the patient experienced pain in her shoulder and pain in her elbow.  The patient sought treatment in the emergency room and was treated with acetaminophen (+) hydrocodone bitrartrate (VICODIN) and naproxen (unspecified).  The patient had trouble dressing herself and it was difficult to drive.  On 24-Jan-2008, the patient saw her physician and was still complaining of pain.  There was no visible swelling or redness.  As of the date of this report, the pain in the shoulder and elbow persisted.  No further details were provided.  Additional information has been requested. Follow-up received 04/16/2008. On 15-JAN-2008 the patient was vaccinated intramuscularly in the left deltoid with her second dose of GARDASIL (Lot # 659653/1448U). The patient had several office visits concerning the severe left arm pain and was treated with acetaminophen (+) oxycodone hydrochloride (PERCOCET) and naproxen (unsepcified). The patient was referred to a pain clinic and was diagnosed as having brachial plexus neuritis. As of the date of this report, the brachial plexus neuritis persisted and the patient is still undergoing treatment. No further details were provided. Additional information had been requested.
fever; rigors; myalgia; fatigue; huddled down in bed; headaches; shaking; This case was reported by a physician via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received vaccine on an unknown date).   On 4th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th September 2019, 21 hrs after receiving Shingrix, the patient experienced fever, rigors, myalgia, fatigue, bedridden, headache and tremor. On an unknown date, the outcome of the fever and rigors were unknown and the outcome of the myalgia, fatigue, bedridden, headache and tremor were recovered/resolved.   It was unknown if the reporter considered the fever, rigors, myalgia, fatigue, bedridden, headache and tremor to be related to Shingrix.  Additional details were provided as follows: The patient stated that after receiving vaccine experienced fever that felt like rigors and a lot of myalgia that was preceded by fatigue. The patient was huddled down in bed. The patient lost the whole next day because of the myalgia and fatigue. By that afternoon he went home and crawled into bed and  significant shaking and fever started. The patient also experienced headache and was gone by the next morning. The patient slept 17 hours in total. The shaking lasted about a good 3 hours. The patient consented to follow up.