chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painless bump inside upper lip/ formed lumps/ uneven swelling/ uneven hardness; Pain/ soreness; Swelling to both lips; Soreness to both the lips; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (Swelling to both lips), LIP PAIN (Soreness to both the lips), LIP SWELLING (Painless bump inside upper lip/ formed lumps/ uneven swelling/ uneven hardness) and LIP PAIN (Pain/ soreness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products HYALURONIC ACID (RESTYLANE) injection for an unknown indication and HYALURONIC ACID (JUVEDERM) injection for an unknown indication.    The patient's past medical history included Mitral valve repair and Dental implantation in 2020. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), MINOXIDIL, DULOXETINE HYDROCHLORIDE (CYMBALTA), ESTRADIOL (YUVAFEM), IPRATROPIUM, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 FATTY ACID), VITAMIN D3, IRON, COLLAGEN and AREDS 2 PLUS MULTI VITAMIN for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient started HYALURONIC ACID (RESTYLANE) (unknown route) at an unspecified dose and HYALURONIC ACID (JUVEDERM) (unknown route) at an unspecified dose. On 14-May-2021, the patient experienced LIP SWELLING (Swelling to both lips) and LIP PAIN (Soreness to both the lips). In September 2021, the patient experienced LIP SWELLING (Painless bump inside upper lip/ formed lumps/ uneven swelling/ uneven hardness) and LIP PAIN (Pain/ soreness). The patient was treated with PREDNISONE on 20-Sep-2021 at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swelling to both lips) and LIP PAIN (Soreness to both the lips) had resolved and LIP SWELLING (Painless bump inside upper lip/ formed lumps/ uneven swelling/ uneven hardness) and LIP PAIN (Pain/ soreness) had not resolved.     HCP attempted to inject reversal agent but patient found procedure very painful and could not tolerate injection of reversal agent. Patient did not have any fillers or toxins in the past except for the Juvaderm. 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.
About a week after the injection I felt itching at the injection site  along with redness and warmth to touch. Over the several days the redness has spread but the itching has diminished.
Patient states, "I got my flu shot on 10/26/2018 and 5 days later developed chills, headache and a fever as high as 100.4. It lasted 3-4 days. I saw my doctor who put me on Tamiflu for 3 days."  Denies current symptoms.
2 nd. Pfizer shot. I woke up freezing, had shivers all day. I had pains all over my body in odd places. Never felt this way in my life. Late morning, early afternoon hours, I was out of it, not aware of my surroundings. Husband and son took care of me. Four days after the shot I bled from my rectum again. This also happened with the first Pfizer shot. I missed work for two days. No strength on second day. My body was worn out from the first day.
After 1 week arm had large red mark around injection site.  Itchy, warm to the touch and painful.
Large, very sore, lump under left arm pit and side of left breast.  Chills, tiredness,  low grade fever, body aches and pains in neck and lower back mostly.
06/24/2022 Vaccination 07/02/2022 Patient had an ear infection, lethargic, extended naps which is unusual for him and spiked a fever of 103.2. I called Pedicatrian. We were out of town and to give him Motrin. It went down to 101 degrees.  07/03/2022 No fever.  07/06/2022 Patient was pretty fussy that afternoon. I asked the daycare to keep eye on him if he seemed more fussier. They called me and said they think something is wrong. I went to pick up Patient.  07/06/2022 Went to Pediatrician's office for Ear Infection. Tested POSITIVE for COVID-19.  I don't know if symptoms were due to the ear infection or COVID-19. He's doing better with Amoxicillin and Motrin.  07/11/2022 COVID-19 NEGATIVE
Shot administered on 12/13/01. The pt developed bilateral shoulder pain, though to be due to underlying impingement syndrome. The pt called the MD's office and was told to take Aleve but it didn't cut the pain. She was given a prescription to relieve the pain but it didn't help. While in another city, the pt broke out in a rash (MD gave different pain pills and that didn't work). Had extreme pain in both arms and couldn't hardly get out of bed. Has had shoulder X-rays and was thought to have some arthritis. Had MRI and pain still exists. They think it might be torn tendons, but my question is how could this affect both arms at the same time? Even today, I still feel pain where the shots were administered. I have had many shots in the military and since, but have never had an effect like this. Still in pain as of today. The follow up received on 5/1/02 states bilateral shoulder pain after administration of hep B vaccine #3 in R deltoid and hep A #2 vaccine in L deltoid.
4 hours after vaccination I had my menstrual cycle 2 weeks early; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (4 hours after vaccination I had my menstrual cycle 2 weeks early) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MENSTRUATION IRREGULAR (4 hours after vaccination I had my menstrual cycle 2 weeks early). At the time of the report, MENSTRUATION IRREGULAR (4 hours after vaccination I had my menstrual cycle 2 weeks early) had not resolved.            Concomitant product was not provided.  The patient was vaccinated last year in january and february (unspecified dates). 4 hours after vaccination the patient had menstrual cycle 2 weeks early, this happened again after her second dose. The patient had her period every 2 weeks for over a year, as well as new cyst on her ovaries and a hemorrhagic cyst as well. She would like more information on people who also had this side effect.   Treatment medication was not reported.   This case was linked to MOD-2022-594076 (Patient Link).
Started with symptoms the morning of 10/29/2021. Had body aches, chills, heart palpations with nausea and weakness that lasted on/off for 24 hours.
GBS in Jul2022 (now in physical/home therapy); This case was reported by a consumer via other and described the occurrence of guillain barre syndrome in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. In July 2022, between 8 and 10 months after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The patient was treated with immunoglobulin human normal (Gamma Globulin) and non-drug therapy (Physical Therapy). On an unknown date, the outcome of the guillain barre syndrome was recovering/resolving.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR176636   Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's Comments: The patient had good health before takign vaccine. The patient received Shingrix vaccine in October of 2021.  The patient was came down with Gullian Barre in July of 2022.  The patient had been through 10 infusions of gamma globulin and now the doing outpatient physical therapy and home therapy. The reporter consented to follow up. Additional supportive information: For 2nd dose refer case US2022AMR176636.; Sender's Comments:  US-GSK-US2022AMR176636:Same reporter
PAIN; TIRED/EXHAUSTION; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (PAIN) and FATIGUE (TIRED/EXHAUSTION) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (PAIN) and FATIGUE (TIRED/EXHAUSTION). At the time of the report, PAIN (PAIN) was resolving and FATIGUE (TIRED/EXHAUSTION) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   No treatment information was provided.  The reporter's causality for the event(s) of Tired/Exhaustion and Pain with Humira (Adalimumab) was no reasonable possibility.
ACHES; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination in left arm. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache and aches was not reported. This report was non-serious. Additional information: No Additional information received.
Initial report received on 09 September 2009 a nurse practitioner. A 33 year old female patient with a history of asthma, allergies to penicillin, sulfa, latex, and LEVAQUIN developed a reaction two hours post vaccination. On 01 September 2009 at 11 AM the patient received FLUZONE (lot number U3179AA). The number of doses previously received was reported as 10-15 doses, route and site of administration were not provided. At 1 PM the day of vaccination, the patient had pruritus, itching, and a rash at the site of injection. At 9 PM the day of vaccination, the patient had throat constriction which the patient describe as her "throat closing in". Treatment included BENADRYL, ZYRTEC, a five day course of MEDROL. The patient had relief in an hour and a half. The rash and itching lasted for three days. The patient did not have any further reactions. List of Documents held by Sender: none.
nonstop diarrhea/can't stop peeing through my ass/liquid-shat the bed; multiple side effects; I am going to die; I cant even type; I am throwing up with a green color right now; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (nonstop diarrhea/can't stop peeing through my ass/liquid-shat the bed), FEAR OF DEATH (I am going to die), ASTHENIA (I cant even type), DISCOLOURED VOMIT (I am throwing up with a green color right now) and VACCINATION COMPLICATION (multiple side effects) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced FEAR OF DEATH (I am going to die), ASTHENIA (I cant even type) and DISCOLOURED VOMIT (I am throwing up with a green color right now). On an unknown date, the patient experienced DIARRHOEA (nonstop diarrhea/can't stop peeing through my ass/liquid-shat the bed) and VACCINATION COMPLICATION (multiple side effects). At the time of the report, DIARRHOEA (nonstop diarrhea/can't stop peeing through my ass/liquid-shat the bed), FEAR OF DEATH (I am going to die), ASTHENIA (I cant even type), DISCOLOURED VOMIT (I am throwing up with a green color right now) and VACCINATION COMPLICATION (multiple side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication details was provided. No treatment medication details was provided.
swelling lt upper arm for 2 days w/erythema; treated w/Pediazole & DPH;
fever (twice up to 102), chill (twice), vomit, weakness (fell 4 times)
A 70-year-old female, currently unable to give any history because she is intubated and obtunded.  History is from the patient's boyfriend/POA, with whom she lives.  She does not have regular medical care or any known medical problems.  She has been having bloody diarrhea for about a week, along with fever up to 103.7, chills, sweats, hallucinations, and weakness.  She was diagnosed with COVID yesterday and has been bedridden from severe weakness.  He helped her to the bathroom earlier this morning, and she was so weak she slumped over on the toilet and he eased her to the floor.  She was unresponsive and he called EMS.  When they arrived, she was in asystole.  They performed CPR and ACLS with administration of epin epinephrine for 12 minutes before obtaining ROSC.  She was intubated in the field and brought to the emergency department.  In the ED, she went into PEA and underwent ACLS once again, and regained ROSC.  She  went to the CT scanner and had a third code that was also PEA.  After ACLS, she regained ROSC yet again and has maintained it since that time.  She has not had any sedatives, has had no gag reflex, and has had no purposeful movements or response since she arrived.  Cardiology was called and has come and evaluated the patient for possible STEMI.  A bedside echocardiogram apparently showed that heart wall motion was okay and there was a moderate pericardial effusion, but no tamponade.  She is currently on 2 vasopressors maxed out through 2 peripheral IVs.  There was an attempt to place a left subclavian central line,  but it was unsuccessful.  At one point, it was felt that the subclavian artery may have been entered and further attempts were aborted.   PT EXPIRED AT 1210 ON 1/30/2022.
Medium sized red rash with a ring on the perimeter, itchy and hot to the touch. Went away after putting lavender oil diluted in coconut oil on it after a couple days.
At 11pm on 3/4 I experienced an episode of tachycardia which lasted approx. 15 min. I was unable to obtain an accurate heart rate -it was over 200, pounding, regular rhythm. I felt weak, and was quite frightened. No pain, nausea or disorientation. I was in bed and not yet asleep - it began suddenly. Went to ER and by that time- just before midnight- the episode had subsided. An ECG and blood work were done and proved to be normal. I was set up with a Holter monitor the next day for 24hrs. and those results also were normal. I have a follow up apt. with my MD on 3/24.
3 days post vax has raised red rash @ site of MMR;tiny raised red rash in an area of 4cm circular;states is very itchy;
Arm pain which lasted four days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 11-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain which lasted four days) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) for an unknown indication.    On 12-Aug-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 pain which lasted four days). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain which lasted four days) had resolved.            Patient received 2nd dose of Moderna vaccine on 09-SEP-2021 in the right dominant arm lot 078C21A.   This case was linked to MOD-2021-316017 (Patient Link).
12 x 8 cm area of redness at injection site (L) upper arm. Reports fatigue & dizziness & moderate pain at site. Adverse event reported 2-3-12 at ER visit & Dx. with cellulitis.
Mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Lot number: ER8727) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Mild headache".  Additional information: Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Extreme and new/sudden otherwise unexplained feeling of dread/depression/anxiety about 30 hours after vaccine
GAVE PATIENT THE VACCINE STAYED IN WAITING ROOM FOR LIKE 5 MINUTES WHEN HE WAS LEAVING THE STORE WITH HIS FAMILY HE PASSED OUT AND BUMPED HIS HEAD THEN CAME TO WITHIN A MINUTE
Patient just reported that he had experienced moderate to severe arm soreness after 1st dose which he felt affected normal range of motion. He nonetheless requested to be given the 2nd dose 3 weeks later in the same arm, and stated that the soreness got worse so he decided to go to Dr. for evaluation. Dr.  told him he had shoulder/joint injury due to the COVID-19 vaccine, and patient states was administered two injections to relieve pain and setup for physical therapy. Patient says he is now okay and getting better and back to normal.
person who received vaccine was under the age of 18 when the 1st and 2nd dose of the series was given   Failure of intake process  no adverse events . has now received booster as well  and moderna fully approved
Subsequent to receiving third dose of Lymerix, pt developed a small, red, pimple like itching rash at the hairline at the back of her neck. Pt treated herself with anti-itch cream and symptoms resolved after a few days. The most recent information reports the outcome of the event as resolved.
5 blood blisters on her right stomach; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (5 blood blisters on her right stomach) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced BLISTER (5 blood blisters on her right stomach). At the time of the report, BLISTER (5 blood blisters on her right stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
On 03/10/2021, about 15 minutes of receiving the vaccine, I started having tightness in my chest, and marginal difficulty breathing, I alerted the national guard and they monitored me and I took albuterol. That event resolved itself and I left 45 minutes after taking the shot. Sometime in May I started having problems with my joints, mostly in my feet. In late August, early September, I went to see both my PCP and podiatrist because I had extreme pain in my foot and I was diagnosed with gout. I was treated allopurinol 100 mg once a day and that was changed in early December to 100mg twice a day. With new medication and diet it seemed to get better, but it did flare up in December because of another medication that was added in December, colchicine .6 mg. It is better, but it has not resolved. It is still being treated.
This case was reported by a lawyer and described the occurrence of joint pain and swelling in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). On an unspecified date after vaccination with Lymerix, the subject experienced joint pain and swelling, flu like symptoms, fatigue, cardiac problems, charley horse type pain in calves, headaches, sleep disorder, cognitive problems, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune mediated, or other mechanism. At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries. Follow up information was received on 18Aug06 via the attorney, who reported that the pt was a 55 yr old male who was vaccinated with Lyme disease vaccine recombinant (Lymerix) on 24May99, 01Jul99, and 27Jun00. Approx one and a half months after vaccination (unspecified which vaccination of the series), the pt developed symptoms including severe rheumatologic and neurological injuries, fatigue, and cognitive impairment. Treatment included intravenous immunoglobulin. According to the attorney, the pt's symptoms were debilitating to the point that he has been forced to go on private disability and subsequently apply for social security disability. The attorney also reported that the events had gotten progressively worse.
A week after the vaccine, I started experiencing full body joint pain. I have had joint pain ever since ranging from a few body parts to full body. I have not experienced full body joint pain before this event.
7/13/08    Re: 13yr healthy, 5'5" 106lb active, phsically fit, golfs, swims. Gardasil administered Thur, July 3.  Extreme pain at injection site and significant pain & discomfort for several days following.  Pain was at injection site, elbow up, upper arm, shoulder neck & upper back. My daughter began menstruating May.  Her period May was  light and June was normal.  This month however began July 11, the week leading up to menstruating she suffered incredible cramping.  With the onset of her period, she became bedridden and suffered horribly.  Call to triage nurse gave all helpful tips but I went through them with my daughter with very little relief. ie. Midol, we had reduced pain with Pamprin but still the level of pain was dibilitating and kept her in bed 2 days, rolling around in pain.  Pamprin has 500mg per pill. She took 2 every 4 hours just to keep the level bareable. Even with this level of pain medicine she was not able to resume normal activity.  This level of medicine is too much for a 13 yr old! other suggestions laying flat rather than crunched in fetal position that she had been, warm pad, deep breath to work through pain, TV to take mind off agony, massage, comfort foods - tried them with little relief.  The women on my side of family have no history of cramps or the severe reaction to normal healthy menstrual cycle as well as the females on my husband's side of family.  Menstrual flow is normal, nothing excessive to indicate another reason for such severe pain.  I feel the Gardasil vaccination is responsible for this unusual extreme pain.  She was too ill to drive to dr office but I will be calling them again Monday morning 7/14/08.