chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Second Dose more than 60 days after the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Second Dose more than 60 days after the first dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Second Dose more than 60 days after the first dose). On 12-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received Second Dose more than 60 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
My vision became abnormal the following day after receiving vaccine.  I could see fine, but felt like both eyes were not in sync with one another.  It comes and goes.  It can last for hours at a time.  It has been ongoing, everyday for 4 weeks.  I have never had any vision issues prior to the vaccine.  I have seen an optometrist and eye specialists.  So far, they have seen no signs or not detecting any eye condition or problem.  I am to follow up with the eye specialists in 5 weeks.  They recommended giving it a few extra weeks to see if symptoms improved or went away before looking into further/other testing.
Redness and swelling to (L) upper arm w/ redness extending to elbow - onset 24 hrs post injection. Treated with antibiotic - improved.
Broke out into rash on 1 27 08 all over body then had fever 103 degrees F increase on 1 28 08 for 2-3 days.
Pain and numbness below the knee in bilateral legs. Patient saw primary care physician, Prednisone prescribed.
Arm Pain; Chills; Joint Pain; Nausea; Small reaction; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), VACCINATION COMPLICATION (Small reaction), CHILLS (Chills), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION COMPLICATION (Small reaction). On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 01-Feb-2021, PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION COMPLICATION (Small reaction) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Body temperature: 99.6 (Inconclusive) Fever 99.6 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   This case was linked to MOD-2021-018540 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: event added. dosage information updated.
Tested positive for COVID after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after receiving vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID after receiving vaccine). At the time of the report, COVID-19 (Tested positive for COVID after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was given by reporter. No treatment medication was given by reporter Caller stated that her son who has been vaccinated tested positive for COVID 19 vaccine on 2OCT2021. She does not have his vaccination information.  She gave safety consent to follow-up with her. Filing AE with limited information. She thought she was calling her vaccination facility, she did not realized that she called Moderna until towards the end of the call.; Sender's Comments: This case concerns a 51-year-old male patient with unknown medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred 18 days after receiving the Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the details only one dose was provided. The benefit-risk relationship of mRNA-1273 vaccine in not affected by this report.
He appeared tired in the afternoon of 11/30/21. Overnight 11/30-12/1 he became lethargic and vomited a large amount of tube feeding. Approx. one hour later his respiratory rate increased to 30  breaths/minute and his oxygen saturation dropped. In the morning of 12/1/2021 he became unresponsive and tachycardic, and was transferred to the hospital. At the Medical Center he was felt to be in septic shock secondary to pneumonia. His Covid-19 test was negative. Despite antibiotics and pressors his condition worsened and he passed away during the evening of 12/1/2021.
SERIOUS SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced serious side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious side effects was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Patient felt like she was going to faint, but never lost consciousness. BP evlevatged to 149/124 and 83 BPM. Quickly dropped to 110/92 with 62 BPM.
full body rash, itchy and swelling of face and eyes taking an antihistamine to calm reaction
On December 5, 2022, I went in to have a biopsy of an area on my shin, that came back to reveal that I had skin cancer. I scheduled a time to come in to have the areas removed. It did take time to get in for that, I was able to get back in on April 11, 2023, where the dermatologist was able to remove all of the skin cancer cells. The area on my leg is still healing, but all cancer cells are gone.
Extreme pain at injection site.  Unable to lift arm to the side beyond waist.  Cannot sleep on left arm.  Cannot lift or carry anything on shoulder.  Pain at rear rotator cuff and front shoulder.  Checked internet and many, many reported incidents of similar reactions at various sites for 2010 flu shot.
Discharge Provider:  DO Primary Care Provider:  MD Admission Date: 2/5/2023 Discharge Date: Feb 22, 2023  PRESENTING PROBLEM: Pneumonia due to organism [J18.9]   HOSPITAL COURSE: Patient is a 76 y.o. male with past medical history significant for CAD w/ bi-V ICD, AS, permanent AFib, hypertension, HLD, T2DM, CKD3A, history of remote right AKA, recent acute ischemic Left MCA CVA with right hemiparesis who is being admitted from IRC with new pneumonia and hypoxia.    Of note, patient with recent hospital admission 1/21-2/2 for this acute CVA. MRI could not be obtained 2/2 pacemaker.  Due to ongoing dysphagia a corpak was placed which he tolerated well. He was treated for COPD exacerbation during that admission as he was having some wheezing. He was ultimately d/c to IRC for continued rehab needs.    On 2/4 patient started developing increased O2 needs and a productive cough. Patient was requiring 3L when he had previously been on RA. IM was consulted and obtained CXR for evaluation. CXR showing possible L basilar pneumonia. IRC provider evaluated patient this AM and thought patient needed admission to acute care/medicine.   Pt was continued on IV antibiotics/CAP coverage. Film array positive for covid. Diuretics were held due to pt developing an AKI w electrolyte imbalance. IR was consulted due to corpak needing advancement. Nephro was consulted. Pts electrolyte imbalance resolved and aKI resolved. Corpak was advanced and tolerating feeds well. On dysphagia diet w no liquid intake. He finished his antibiotics on 2/9. All home meds restarted and pt stable fot discharge to rehab facility on 02/22/2023.
Was diagnosed with Crohns disease by October 2004, after suffering with stomach problems since mid-June. Follow up on 7/12/05: Same as stated on initial report - Crohn's Disease. Information from medical records state headache, asthenia, weight loss, nausea, diarrhea, colitis, abdominal pain. msv
Patient  developed mild problems. Low Vitamin A, Carotene. Given flu shot. Renial disturbance aggravated. Doctor does not feel any relationship to shot. Father feels there is. Seen at down state medical centers.
Flu vaccine  caused arm to wellp up and is itchy and heated. Also sore to touch.  Started right after shot.
Pt recvd 1st dose of Hep B vax on 29OCT91 & on 30OCT91 pt devel generalized pruritus but had no skin lesions, rashes or urticaria; In 10 days sx subsided & pt recovered;
Father states evening of immunization that baby experienced staring episodes x 3 - called sister FNP and CCPHC - was told to monitor and if condition worsened to go to ER. Did not have to take to hospital.
37 Year old female given MMRV instead of MMR and Varicella.  No adverse reaction to injection.
Starting Sunday, May 2nd around 5pm, I noticed a pain in my back near my right shoulder blade.  It started small ? just when I would stretch my right arm out, but as the time went by, it began to hurt from that starting spot going up my back into my neck, into my right arm, around the right side of my chest and down the right side front of my chest.  I took 2 ibuprofen which seemed to do nothing.  When I went to bed around 10pm, it became hard to move without pain, so I took 4 ibuprofen and a OTC sleeping pill.  I slept very restlessly, as any movement caused a lot of pain.                                                                                                  ?On Monday upon waking, I could not get out of bed without pain.  There was so much pain any way I would move, and found to get out of bed, I had to get onto my stomach, and slide out of bed like a snake.  Again, I took 4 ibuprofen hoping to have some relief, but it really didn?t do much.  Any movement that would make the muscles on my right side move, would cause a great deal of pain.  Just to lift my right arm, I had to do so using my left hand to lift my right arm.  Any movement at all was painful.  This continued all day.  I tried also switching ibuprofen to extra strength acetaminophen which did not help.  By the time I went to bed I could barely move.  Again, I went to bed with 4 ibuprofen and an OTC sleep aid.  Another restless painful night of sleep was the result.    ?Tuesday upon waking I felt better until I tried to get out of bed.  The pain was back and I found that I again I had to slither out of the bed on my stomach.  This time I took Excedrin Migraine as I found a migraine headache looming.  Taking this was the first true relief of pain.  Although I had twinges of discomfort, I didn?t have the extreme pain when I moved.  I was relatively good for the rest of Tuesday and Tuesday night.  As I felt I had some improvement in pain relief, I did not take any OTC meds.    ?This morning when I woke, I again found I could not sit up, push myself up or anything other than gingerly rolling onto my belly and sliding out of bed again.  I took a hot shower, letting the water beat down on my back, which seemed to help some and followed it up with 4 ibuprofen.  Currently I?m doing better, I can move without a lot of pain, but I do get the occasional jab of pain in my neck/shoulders/right arm/back (just beneath the right shoulder blade).     I know this sounds like an odd reaction, however I did not do anything that would have caused this issue with my muscles.  On Sunday I tossed a frisbee to my 6 year old grandson for about 10 minutes, and planted one planter with flowers.  I cannot think of anything different in my life other than this vaccine.  No new exercise, no new meds, no new anything.  Over a week prior to this vaccination, I was lugging large bags of mulch and potting soil with no issues whatsoever, so I find it hard to imagine that tossing a frisbee could cause this kind of pain.
Caller stated that she received his first vaccine on 4/18/2021 and on 4/18/2021 and has been having diarrhea since day of vaccine.
Redness pain and swelling (L) upper arm and is extremely sore. Received DECADRON 4mg IM. Started MEDROL Dose Pak 4 mg pack as directed, PEPCID 20 mg, 1 tab at office visit and then daily.
Information has been received from a nurse via a company representative referring to 6 female patients of unknown age. The nurse saw the information from an online article about GARDASIL on a website. On unknown dates the patients were vaccinated with GARDASIL (dose and route were not reported). On unknown dates the patients developed premature ovarian failure (POF), also known as premature menopause. At the time of this report, the event outcome was unknown. The causality between the event and the vaccination was not reported. Additional information is not expected since contact information is not provided.
On Wednesday swelling, redness at site of injection; swelling as big as palm of hand. Thursday underarms were itchy. Friday ears were swollen, oozing from ears. Today still itchy, rash starting to go away, sore, used ice packs.
PT came back with a bruised arm and was indicating that the night of vaccination this has happened to him.
Client states she developed a rash on her chest, flushing and feeling warm, but no itching after receiving Moderna  first and second dose.  Client also had swelling on vaccination arm. After first dose her symptoms appeared a day after vaccine. Client states the second time around her symptoms were less and client took Benadryl and Tylenol to help with symptoms for both instances. She denies going to emergency care or Doctor.  Symptoms subsided after some days. Client states she has an allergy to Papaya, where her face swells up. . Per CDC guidance, approval to proceed with COVID vaccine Pfizer was obtained from medical consult team. The client did not report any symptoms during the 15-minute observation period. RN educated client on possible adverse reactions and when to seek medical care.
Patient complaining of right elbow pain with difficulty straightening her arm since a few days after her 2nd COVID vaccine. Pain at olecranon and inability to extend elbow fully. No neurologic signs present- has equal sensation, no numbness or tingling, equal muscle bulk bilterally. Normal ROM and function of shoulder, wrists and fingers.
extreme tried; diarrhea; in bed and can hardly walk/she is very unsteady when she is walking; she has lost of appetite; dizzy; chills; not feeling well; very weak; very lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-2021748849 (Pfizer).  A 72-year-old female patient received bnt162b2 (BNT162B2), administration date 16Jun2021 (Lot number: EW0183) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "extreme tried"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "in bed and can hardly walk/she is very unsteady when she is walking"; DECREASED APPETITE (non-serious), outcome "unknown", described as "she has lost of appetite"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; CHILLS (non-serious), outcome "unknown", described as "chills"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; ASTHENIA (non-serious), outcome "unknown", described as "very weak"; LETHARGY (non-serious), outcome "unknown", described as "very lethargic".  Additional information: Reporter stated he is calling for his wife the Pfizer COVID 19 vaccine with the number of EW0183. Reporter stated she took the vaccine on 16Jun2021 and a day later she had extreme tried, diarrhea, in bed and can hardly walk, no appetite, very lethargic and dizzy. Reporter stated his wife is scheduled for the second dose on 07Jul2021. Reporter stated he is not sure if she will get the second dose. Caller stated that his wife got the first dose of the pfizer covid-19 vaccine on 16JUN2021. She started experiencing extreme tiredness, chills, diarrhea, she can hardly walk, she has lost of appetite, very weak and not feeling well, she is very unsteady when she is walking.  No follow-up attempts are possible. No further information is expected.
Covid symptoms started 06/05/2022; tested positive on 06/06/2022. I first went in on the 6th and I tested positive and stayed home for 5 days. I was coughing and that was it but by Friday the cough got worse and I was wheezing so I went back to the doctor and seen a PA and he gave me prednisone and an inhaler which I only use for when I have bronchitis and to continue taking MUCINEX and that was on 06/10/22. I was still coughing, had runny nose, no fever, and I took 3 days of prednisone and Monday I called my PCP and she put me on more prednisone and clindamycin. It's better and more loose now and other than that I'm just exhausted and the cough is worse. I'm getting retested on Thursday.
Vomiting for 24 hours; not feeling like moving; headache; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8734), via an unspecified route of administration in the left arm on 05Apr2021 at 16:30 (at the age of 17-year-old), as a single dose for COVID-19 immunisation. Medical history included pandas. Concomitant medications included LEXAPRO, naltrexone (MANUFACTURER UNKNOWN), hydroxyzine (MANUFACTURER UNKNOWN), VITAMIN D, PROBI from an unknown start date within 2 weeks of vaccination to an unknown stop date and unknown if ongoing. The patient was allergic to amoxicillin. 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 06Apr2021 at 02:00, the patient experienced vomiting for 24 hours, headache and the patient did not feel like moving. Therapeutic measures were not taken as the result of the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, vomiting for 24 hours and not feeling like moving was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
All of a sudden I had chills (couldn?t get warm), low grade fever and felt miserable.  I also had a a sudden appearance of a rather large  blister on my face near the left side of my mouth.  The bister reminded me of a core sore type of thing and it had clear fluid in it. The symptoms lasted for a couple of days..  Today feeling much better and the blister has scabbed over.
local reaction- redness, itching, swelling, hardness, afterwards area became infected due to pt scratching site.
Pt vaccinated with Influenza A/B chest tightness & pain. sore & hoarse throat.
20MAY92 fever (mom doesn't know how much) fussy; 21MAY92 t100.4 ax; no swelling or tenderness of either leg; dx w/sinusitis; MD did not think illness was related to vax;
There was an excursion from the freezer,vaccine administered to 118 patients; There was an excursion from the freezer,vaccine administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.  There was an excursion from their freezer on 01-OCT-2021.
Two days after receiving my second dose of the Pfizer vaccine. I started spotting, my cycle came early. It gradually became heavier. A month later and I am still on my cycle. I have never had irregular periods.. After the first dose my cycle was significantly lighter lasting only 3 days.
Itchiness; Swollen (Injection Site); A spontaneous report was received from a consumer concerning a 54 year old female patient who received Moderna COVID-19 vaccine (mRNA-1273) who experienced itchy, injection site swelling.  The patient's medical history and concomitant medication were not reported.  On 06Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011JZ0A) intramuscular route for prophylaxis of COVID-19 infection.  On 19jan2021, The patient experienced itchy, injection site swelling. No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event itchy, injection site swelling is unknown.  The consumer assessed the events itchy, injection site swelling were not reported.
Bell's Palsy noted w/in 24hr of vax;tx w/pred then weaned over 10 days;pt also w/documented strep pharyngitis;tx w/PCN;