chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received 0.25ml on 8/14/2023. Patient was asked to come back to the pharmacy to receive another 0.25ml dose on 8/14/2023. Patient received  full 0.5ml dose for that day 8/14/2023.
Rash & ErythemaMultiform Narrative:  noted immediate redness at injection site with raised area and bleeding.
Yesterday her arm was very sore and swollen- she woke up 3 x during the night with pain. Arm feels hot, she feels tired and weak an has muscle aches. She has used ice and taken Ibuprofen.
Patient experienced a near syncopal episode within 5 minutes of receiving the vaccine at 9:35. She was moved to the back of the room and within 10 minutes was put into the prone position with feet elevated. First set of vitals was BP 147/119 HR 42 R: 14 O@ Sat 97%. At 9:55 her vitals were BP 149/122 HR 67 respirations had increased, pt. was feeling muscle tightness throughout her body, her hands and feet were cramping, she was experiencing decreased vision and EMS was notified. At 10:05 BP 145/94 HR 67 EMS was arriving and her Father was called. Pt. was able to give his name and number. Pt. was put on O2. Pt. was breathing rapidly and there was a concern of hyperventilation. EMS put in an IV and transported pt. with her belongings to Hospital. Her Father communicated that he was in the waiting room of the ER and that she had arrived at 10:34
Patient received an additional dose of influenza vaccine. She already received Fluad at her PCP office two days prior. No AE's reported by patient at this time.
FEVER, BODY ACHES, HEADACHE, NAUSEA, VOMITING, COUGHING
4.5 inch diameter warm red itchy welt appeared day 8 after vaccination at injection site.
Physician receiving Pfizer BioNTech COViD 19 vaccine experienced sore arm; This is a spontaneous report from a contactable physician (patient) via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration in 2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician receiving pfizer biontech covid 19 vaccine experienced sore arm within 24 hours of receiving vaccination dose in 2020 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patients right upper arm, at injection site, appears red, swollen, and warm and hard to touch. Swelling induration of 5 cm round. Patient stated area is painful to touch and itchy.
Pt states he woke up early and couldn't stand due to head spinning, but was okay laying flat. Lasted 20 seconds then able to stand slowly. Reports continues to have <5-10 second vertigo episodes 3-4 times a day ever since. Describes vertigo as if riding on a roller coaster and feels room spin in back of head by his neck area behind ears bilaterally. No issues with eyes or ears. Quick position changes or moving from flat to sitting/standing or turn head quickly side to side triggers sensation. No neck pain.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a 17 years old patient of an unknown gender. The patient's medical history and concurrent conditions were not reported. On 27-MAY-2015, the patient was vaccinated with a dose of GARDASIL (lot# K007828, expiration date 02-MAR-2017, dose, frequency and route of administration were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect was observed or reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
I woke up in the morning feeling some mild body aches. When I tried to stand up I became dizzy and immediately sat down. I started sweating, my vision started to turn black and I felt that like I was going to faint. I then became extremely nauseated and threw up. after about ten minutes the symptoms started mildly passing. I then began sweating again, feeling like I was going to faint, and I threw up a second time. These symptoms lasted for about an hour where I felt nauseous and faint. Then flowing these symptoms I felt dizzy for another 3 hours and continued having body aches for another 2 days.
12 days afterwards, my arm turned bright red and was on fire. I went to the ER and they referred to it as COVID arm. I was given antibiotics and advised to use calamine lotion. After 2 to 3 days it resolved.
Dull headache for several days prior, followed by tingling and numbness in feet, tingling of hands, lips, foods tasting unusual. Doctor visit on 11/30/2011; hospitalized on 12/2/2011 and diagnosed with Guillain-Barre' Syndrome. Remains hospitalized with partial paralysis following IV-IG & plasmapharesis, tracheotomy, feeding tube used during course of treatment.
About an hour after I received my second shot I felt extremely hot and my knees and elbows started to hurt. I felt so hot that I walked outside to my car (about .3 miles away) in freezing cold temperatures with no jacket and didn't feel the cold at all. I developed a brain fog shortly thereafter and made several mistakes while performing my job throughout the day. My supervisor provided me with extra strength tylenol and within an hour or so the joint pains subsided. By 7 PM that night I had very bad chills and was shaking under a blanket on my couch. My temperature got up to 99.8 which is pretty high for me. I went back and forth between  feeling like I was freezing cold and on fire.  I got very little sleep that night and had disturbing dreams. The following morning all my joints hurt and I felt extreme exhaustion. I laid on my couch all day the day after receiving the shot and felt exhausted and and had no appetite. From 6 PM the day of the shot to 9 PM the following day I ate NOTHING and had no desire to eat. As I'm typing this 60 hours after receiving the second shot the joint pain is  gone, the exhaustion is gone and my appetite is back to normal. There's a lingering pain at the injection site but otherwise I feel like I did prior to receiving the second shot.
Initial report received from a health care professional on 25 May 2007. A male patient was exposed to Menactra, lot number U1874A, transplacentally on 5 September 2006 during the mother's pregnancy at 13 weeks gestation. The mother's last menstrual period date was 20 May 2006. The patient was delivered via C-section and was found to have an extra digit on each hand. As per the reporter, there were no pregnancy complications and no complications of labor and delivery. No information regarding medical intervention or recovery status was reported. This case is linked to case 2006-02349, which involved the non-serous event of anemia in the patient's mother during pregnancy.
EPILEPSY, UNSPECIFIED ACUTE RESPIRATORY FAILURE 3/5/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Felt like skin was hypersensitive; Hive like rash; This spontaneous case was reported by a patient and describes the occurrence of SENSITIVE SKIN (Felt like skin was hypersensitive) and URTICARIA (Hive like rash) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical history was reported.  Concomitant products included VITAMIN D NOS for an unknown indication.   On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced SENSITIVE SKIN (Felt like skin was hypersensitive) and URTICARIA (Hive like rash). In 2022, URTICARIA (Hive like rash) had resolved. At the time of the report, SENSITIVE SKIN (Felt like skin was hypersensitive) outcome was unknown.            Patient received the first two Moderna shot and then got the first booster Covid shot and about 3 weeks after receiving the booster shot, patient got a hive like rash, felt like skin was hypersensitive. The rash lasted about 4 and 1/2 months and then around 5 1/2 month it went away. Patient  dealt with it topically and put skin cream on it and it would go away with that.  It was reported that patient was thinking about getting the new booster shot but wanted to know if the new booster shot has the same make up as the older booster.
local inj site soreness, warmth, erythema, swelling from deltoid to elbow;gen malaise, T103.6 x 15hr;dec over 48hr;h/a, numbness, tingling in arm to forearm;
Fever; Achiness; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient had Shingles and it was horrible. The reporter stated that you can had shingles more than once, so the patient received vaccination. The reporter stated that had a reaction after receiving vaccination was fairly common. The reporter stated that after received vaccination patient experienced fever and achiness. The patient was still recommended it, it was better than the shingles again. Additional supportive information: Follow-up would not possible as no contact details were available.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 83-year-old female patient who received SHINGRIX for prophylaxis. On 6th December 2018, the patient received the 2nd dose of SHINGRIX. On 6th December 2018, immediately after receiving SHINGRIX, the patient experienced nausea, fever, chills, headache, restlessness, fatigue and jumpy. On 8th December 2018, the patient experienced hair loss. On an unknown date, the outcome of the nausea, fever, chills, headache, restlessness, fatigue, hair loss and jumpy were unknown. It was unknown if the reporter considered the nausea, fever, chills, headache, restlessness, fatigue, hair loss and jumpy to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left arm. Shortly after receiving SHINGRIX, she came down with nausea, fever, chills, headache, restlessness, fatigue and feeling very jumpy. The patient stated that she decided to wash her hair 2 days later and realized that huge chunks of her long red hair was falling out. The reporter gave consent to follow up.
Immediately after receiving his 2 mo vaccines PENTACEL, PCV, ROTARIX he refused to eat and was taking only 1 oz at a time and crying increased fussiness increased GERD sx. H/O GERD and already on ZANTAC.
I did not have an adverse reaction to the vaccine. I started feeling sick after I got home from a trip on 06/29/2022 with nose, coughing and feeling weak. On 07/02/2022, I tested positive with a home test for COVID-19. I contacted a doctor with my insurance company and was going to get a prescription for PAXLOVID but never got it. I didn't take anything for my symptoms.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history and drug allergies were unspecified. On an unknown dates, the patient was vaccinated with M-M-R II (dose, frequency, route and lot# were not reported). Concomitant medications were unspecified. On an unknown date, the patient's blood test results showed that the patient "low or negative titers" for mumps. The nurse did not know if it showed "low or negative" as she had limited information. The outcome and causality of the event were not provided. Additional information has been requested.
her arm swelled up pretty bad; real red and redness keeps spreading further around in arm; Itches; soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING, ERYTHEMA, PRURITUS, and PAIN IN EXTREMITY in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 PERIPHERAL SWELLING, ERYTHEMA, PRURITUS, and PAIN IN EXTREMITY. At the time of the report, PERIPHERAL SWELLING, ERYTHEMA, PRURITUS, and PAIN IN EXTREMITY outcome was unknown.            Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided.
103.2 degree fever,( fever broke around 2pm, chills, whole body pain, headache. Lethargy.  600mg of ibuprofen taken at 6:30 am and at 12:00pm
Right neck, collar bone, shoulder dramatically drooped forward. Tingling in feet and toes started. a few days after shot 1. Tingling progressed up through legs and back. Waves of tingling felt when bending over and laying down. Progressed to chest. After second shot, developed voice loss, severe sinus, throat and chest congestions 3 days after second dose. Antibiotics round helpful but voice loss and neuropathy continued to advance with severe fatigue. Need cane to walk and cannot complete many normal day to day tasks. Was fully functioning prior to vaccine.  Rest, Physcial Therapy, and targeted exercise has started to provide some relief but symptoms persist and daily functioning is still very challenging.
Left deltoid area, red and firm radiating below elbow inner aspect 36 hours post injection. Also itching 2 1/2 days later dissipating. Cold pack applied 4-5 times qd.
Patient describes the injection site was raised, warm, and red. Her doctor prescribed clindamycin for MRSA.
Information has been received from an RN concerning a female patient who on 05 Dec 2006 was vaccainted with her first dose of HPV vaccine. While she was receiving the injection she developed syncope and a drop in blood pressure. The nurse reported that the patient recovered and was sent home after 30 minutes. Additional information has been requested.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN ACUTE DVT OF LEFT FEMORAL VEIN ACUTE PULMONARY EMBOLISM
Within 5 mins felt flush, neck and throat got red, throat got sore, scratchy and mouth started tingling Symptoms did not subside after monitoring for 45 mins-1 hour, asked to go to e/r ,at  e/r was given  Benadryl and monitored for another 2 hrs Continued to take Benadryl for 2 days, arm was very sore, fatigue, muscle weakness and pain, injection site red swollen and itchy for at least two weeks, Almost 4 weeks later and still have muscle weakness and pain, mark still on arm at injection
Pain, swelling, at injection site immediately after injection.  Pain worsened at night of day of shot, along with beginning feeling fatigue and malaise.  Fever (101.2) and moderate chills also began that evening.  24 hours later, still having all the previously mentioned symptoms.  Diarrhea started about 15 hours after injection.  Also has arthralgia.
Patient was taken to ED by parents due to increasing redness and swelling at injection site.  Patient would not walk on affected leg and complained if pain.  Treated with Tylenol and Benadryl.  Monitored for infection.
PAIN INTENSIFIED; COULD NOT GET OUT OF BED; SKIN FEELS LIKE BURNING; FEELS LIKE BRAIN NOT WORKING WELL; ITCHY BACK, ARMS AND SKIN; HIVES ON ALL OVER BOTH ARMS BILATERALLY AND POSSIBLE HIVES ON THE BACK; HEADACHE; PAIN THAT FELT LIKE A FIBRAL FLARE /FEELS LIKE WORSE FIBRAL PAIN  ALL OVER BODY; COULD NOT SLEEP LAST NIGHT DUE TO THE PAIN; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and concurrent conditions included fibromyalgia, allergic to sulfa drugs, migraines, plantar fasciitis, depression, bipolar disorder, high blood pressure, anxiety, back pain, and insomnia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the subject experienced pain that felt like a fibral flare /feels like worse fibral pain all over body. On 28-JUL-2021, the subject experienced could not sleep last night due to the pain. On 28-JUL-2021, the subject experienced headache. On 29-JUL-2021, the subject experienced pain intensified. On 29-JUL-2021, the subject experienced could not get out of bed. On 29-JUL-2021, the subject experienced skin feels like burning. On 29-JUL-2021, the subject experienced feels like brain not working well. On 29-JUL-2021, the subject experienced itchy back, arms and skin. On 29-JUL-2021, the subject experienced hives on all over both arms bilaterally and possible hives on the back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep last night due to the pain on 29-JUL-2021, and had not recovered from pain that felt like a fibral flare /feels like worse fibral pain all over body, pain intensified, could not get out of bed, headache, skin feels like burning, hives on all over both arms bilaterally and possible hives on the back, feels like brain not working well, and itchy back, arms and skin. This report was non-serious.
Blurred vision dizziness nausea headache arm pain Extreme fatigue low-grade fever and chills. Have knot the size of a quarter on my arm at the injection site along with redness and pain.  This was the one shot vaccine.
shortly after given injection(doesn't know if it was immediately after or weeks after) pt expereinced soreness to the deltoid muslce and shoulder/joint. those symptoms have been occuring since inject up until early June 2019. In early June 2019, pt started to experience neck soreness for the last 3 weeks.
Mild, flu-like symptoms: headache, joint aches, fatigue, some diarrhea.  Lasted just about 16 hours.
23 month infant given 0.35 cc. of injectable H1N1 Flu vaccine, instead of 0.25 cc.
For the first dose I got extreme cramping in my jaw in front of my left and right ear.  It would tighten really bad then pop.  The left side was a little worse than the right side.  This went away after about a week.  I also got tightness on the left side of my neck.  The tightness felt like it was in the muscles used to swallow.  It did not hinder me from swallowing so I did not go to the doctor. The neck tightness went away about a week after the shot.  The second dose (administered on 11/16/21) is where I had and am still having bad side effects.  About a day after the second dose I the jaw tightness came back to only the left side.  It is less extreme, but has not gone away.  When I whistle it tightens then pops.  So it is mostly an annoyance. The main problems is that from my belt line to my belly button (all the way around my core) I get very severe pain when I lay down.  It affects my sleep causing me to wake up during the night.  Likewise, I have a raw (like tendonitis) pain on the inner side of my left elbow.  I get cramping in my left wrist (especially when playing guitar which I never had before).  And worse of all I seem to fatigue very quickly, like my muscles are not getting enough oxygen.  I was running before the first shot, so I know this was not an issue before.  Now I breath hard when walking.  This has continued till today and has not lessened.
Sweating; Fever; Sore muscles; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Sore muscles) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2OA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 13-Jul-2020.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced CHILLS (Chills). On 22-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), PYREXIA (Fever) and MYALGIA (Sore muscles). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Sore muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
pt recv vax 20FEB97 & 27FEB97 pt devel a rash w/15 lesions;
Nausea (lasted 3 weeks) Fatigue (lasted 2 weeks) Extreme pain at injection site (7 days) Shortness of breath (lasted 3 weeks)
Patient reported numbness of lip after 2nd Pfizer vaccine.  Medicated with 25mg Benadryl.  Vital signs stable.  Patient discharged to home with family.
This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date the patient was vaccinated with twice the M-M-R II, (dose, route, frequency application site unspecified) (lot # and expiration date unknown). On an unknown date the patient has negative titer for measles. The patient's outcome was unknown. Additional information is not expected.
No adverse events experienced at the time of this documentation. Patient received incorrect vaccine and incorrect dose for patient's age.
Patient admitted to hospital on 06/29/2021 with non COVID reasons (compression fractures). Was (-) on admission. Discharged and readmitted on 07/03/2021 with admission screen of COVID (+). Asymptomatic. Hospital admission for non COVID reasons (back pain due to compression fractures). Had 2 subsequent (-) COVID tests on 7/4 & 7/6. Per clinic, patient still considered a (+) case but does not have to isolate. Being discharged to long term care on 7/7/21 to the rehab unit.
Mom called and child had swelling at injection site apprx. 2 in x 2 in
Extreme fatigue brain and brain fog. Excruciating migraine that has lasted three days straight and counting. Period one week early. Normal period symptoms are non existent. I feel like I?m dying.
NOTICED BREAST TENDERNESS AND DEVELOPMENT OUT OF NOWHERE.  WENT TO PRIMARY PHYSICIAN AND HAD BLOOD TESTS, MAMMOGRAM AND ULTRASOUND PERFORMED.  FOUND NO CONCLUSIVE PATHOPHYSIOLOGY FROM ALL THE TESTS CONCLUSION IS IDIOPATHIC.  NEVER BEEN OVERWEIGHT AND BMI IS NORMAL SO THIS WAS ALSO RULED OUT AS A CAUSE