chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a 17-year-old female patient who received BEXSERO. On 1st August 2017, the patient received the 2nd dose of BEXSERO. On 1st August 2017, 30 min after receiving BEXSERO, the patient experienced diarrhea. In August 2017, the patient experienced nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain. On an unknown date, the outcome of the diarrhea, nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain were unknown. It was unknown if the reporter considered the diarrhea, nausea, vomiting, joint pain, fever, hives, rash, headache, tingling of extremity, feeling cold, muscle spasm and abdominal pain to be related to BEXSERO. Additional details were provided as follows: On 1st August 2017, at 4 pm, the patient received BEXSERO. The patient woke up early morning as she was feeling cold. Next day at 4 am, the patient started to vomit, had nausea, muscle spasm and abdominal pain until 1 pm. In morning, the patient had fever and then joint pain started in knees, elbow and hips. On 2nd August 2017, the body temperature was recorded as 101 degree F. Two hours ago, the hives began on her arms and back. She had tingling of arms where she had shot.
On April 21st, patient began complaining of pain in his eyes (pressure at the sides, not in the middle), when looking to the sides he felt pressure and 'pain'/discomfort.  His mouth was also hurting  in 'certain spots'.  Describes a 'pain' but not an 'ache'.  He also intermittently complained of being very tired.  He was complaining of pain in his foot as well and limped occasionally.    On April 24th, I (mother) noticed some small red bumps behind and below his left ear.  I took a second look but was not alarmed at this point.  On the 25th, at 4:00, patient complained he had a rash.  After inspecting him myself, the small red spots I observed the night before had spread to his torso, arms and upper thighs.    We brought him to Hospital at 5:30 pm and were brought into a negative pressure room with patient wearing a mask as a precaution for having an active case of measles.  After vital signs were taken, and a visual inspection of the rash and mouth including visually observed Koplik spots, along with a verbal discussion of symptoms and timelines , patient was diagnosed with measles.  We were told he was contagious until Sunday/Monday, April  28/29, 2019 and he was not to go out in public, was to drink lots of fluids, and get rest.  Also we were told to follow up with his primary caregiver.  I did this at 10:00 am on 4/26/2019 and after the nurse conferred with the doctor on staff as well as the CDC, I was told that they decided patient did NOT have measles, but was suffering from and adverse reaction to the MMR shot administered about 2 weeks prior.
he was having trouble walking, he would get out of bed and take a couple steps and his legs would give out and he would try to get back up and would walk a few steps and fall again; fall; presuming he had a stroke; This is a spontaneous report from a contactable consumer (reporting for her fiance). A 47-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205), via an unspecified route of administration, administered in the right arm (in his right arm up by the shoulder joint) on 06Apr2021 at 14:30 (at the age of 47-years-old) as single dose for COVID-19 immunization (to stay safe and so he doesn't get it). The patient's medical history included diabetic for years, and End stage renal disease. There were no concomitant medications. There were no additional vaccines administered on the same date as BNT162B2. There were no prior vaccinations within 4 weeks. The reporter stated that they were presuming he had a stroke and were doing diagnostics. Everything was pointing to a stroke. The reporter stated it started Monday, 12Apr2021, he was having trouble walking, he would get out of bed and take a couple steps and his legs would give out and he would try to get back up and would walk a few steps and fall again. This started Monday evening. The reporter stated that she called 911 as she couldn't get the patient to the car. He kept falling and there was something clearly wrong. The patient was taken to the ER and was admitted around 1am on Tuesday morning (13Apr2021) and was still hospitalized. The patient has had lots of blood work to include checking electrolytes, thyroid, and vitamin and mineral deficiencies; all with unknown results on an unspecified date. Additional lab tests included Computerized tomogram (CT) scan on 13Apr2021, Electrocardiogram (EKG) on 13Apr2021, and Magnetic resonance imaging (MRI) on 15Apr2021; all with unknown results. The outcome of the events was unknown.
Stage 4 prostate cancer; toothache; leg pain/arm pain; left ankle; burning; muscle pain; body aches; weakness; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional via Medical Information (Reference number- US-SANOFI-00365438) and transmitted to Sanofi on 19-Nov-2020.  This case involves a 80 year old male patient who had stage 4 prostate cancer (prostate cancer), body aches (pain), toothache (toothache), leg pain/arm pain (pain in extremity), muscle pain (myalgia), weakness (asthenia), left ankle (arthralgia) and burning (burning sensation), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  Patient had a shingles shot some years back and he was in terrible pain in all of his teeth and it felt like 15 root canals for a year.   On 13-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (batch number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious stage 4 prostate cancer (prostate cancer) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious body aches (pain), toothache (toothache), leg pain/arm pain (pain in extremity), left ankle (arthralgia) and burning (burning sensation), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  On an unknown date, the patient developed a non-serious muscle pain (myalgia), weakness(asthenia)(2 day),while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].   No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  Information on lot number was requested for this case.; Sender's Comments: This case concerns 80 year old male patient who had prostate cancer, pain, toothache, pain in extremity, myalgia, asthenia, arthralgia, burning sensation after vaccination with FLUZONE QIV. The time to onset is compatible. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine can not be assessed.
As soon as medication was injected, the injection site swollen up. patient then complained of dizziness, tingling of the arm, not feeling right and tightness around should and neck. 911 was called .
splotches/ hives on my cheeks; splotches/ hives on my cheeks; face was swollen around my nose; sick; lightheaded; lethargic; This is a spontaneous report from a contactable consumer (patient) via a Medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced side effects following her first dose of PFIZER-BIONTECH COVID-19 VACCINE. She wants to know how well she will be protected if she refuses the second dose?  She stated it protected "up to 25%" in what she read. She also asked "if she could still spread COVID? Why would the CDC recommend social distancing and mask wearing if the vaccine works so well?" The patient experienced not severe splotches/hives on my cheeks and was just starting to subside. The patient stated, "I could see that my face was swollen, and my face was swollen around my nose (Wednesday). Then saturday I was so sick all day lightheaded and lethargic so I'm inclined not to receive the second dose since experiencing these effects". The outcome of the events was unknown.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
This spontaneous report was received from a Certified Nurse Practitioner and refers to a 20 year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated varicella virus vaccine live (oka/merck)(manufacturer unknown), (strength, dose, dose number, route, anatomical location, lot number and expiration date were jot reported), for prophylaxis. No other suspect or concomitant therapies were reported. On 14-JAN-2017,  a blood titer's test was performed to the patient and the patient "failed to seroconvert" (varicella virus test negative).  No adverse events were reported. Product quality complain was not involved. At the time of reporting, the outcome of varicella virus test negative was unknown, and the reporter did not assess the causal relationship between the  varicella virus test negative and the therapy with varicella virus vaccine live (Oka/Merck)(manufacturer unknown). This is one of several reports from the same patient.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA013594: US-009507513-1702USA005671:
Immediately after injections were done patient reported she started to feel weird, vision went blurry, and she reportedly passed out.  Medical assistant was in the room and Dad reports she was out for just a few seconds, definitely <10 seconds. Medical assistant was able to lay her down on the bed. By the time the doctor came into the room, patient was sitting up and having some juice.
Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix and experienced arm soreness and it was resolved shortly. The reporter did not consented to follow up. For tolerance of 2nd dose refer case US2021176172, reported with same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021176172:same reporter
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (lot # L014415, expiry date 25-JUL-2017, dose, strength, dose number, vaccination site, route not provided). No adverse effects were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Rash about 4-5 inches diameter appeared six days after getting the vaccine Slightly bigger now on the seventh day. Does not itch, just slightly swollen and a little warm to the touch; Rash about 4-5 inches diameter appeared six days after getting the vaccine Slightly bigger now on the seventh day. Does not itch, just slightly swollen and a little warm to the touch; Rash about 4-5 inches diameter appeared six days after getting the vaccine Slightly bigger now on the seventh day. Does not itch, just slightly swollen and a little warm to the touch; headache; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 at 07:45 AM (at the age of 73-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was none. The patient had no covid prior vaccination. The patient had no known allergies. The patient concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date (at the age of 73-year-old), as single for covid-19 immunisation. The patient had not been covid tested post vaccination. On 09Mar2021 at 05:00 AM, the patient experienced Rash about 4-5 inches diameter appeared six days after getting the vaccine Slightly bigger now on the seventh day. Does not itch, just slightly swollen and a little warm to the touch. Also had headache for a few hours. No treatment received for the events. The patient outcome of the events was Not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
The night of the vaccine, around 11 pm, I started getting hard hitting right sided muscle fasciculations that developed all along the nerve path endings in the right side of my face (this lasted until 29 MAY 2021 - I have had a history of this, which included blepharospasm and right sided facial muscle fasiculations x4 years, but they have been non existent past few years). My resting head tremor came back, which I haven't had in like 2 years (it is pretty much gone now, but it lasted until 29 MAY 2021 and it only happens at rest). I started getting heart palpitations the night of the vaccine (they lasted until 29 MAY 2021). I went to bed, woke up the next day, and those aforementioned symptoms continued all day long, PLUS my phrenic neuropathy came back, which I haven't had in like 4 years. With that, I get intense stabbing in the tip of my left shoulder, my LUQ/Spleen area, and lower left side of spine, and the stabbing occurs in all 3 spots simultaneously. That lasted for DAYS 2, 3, 4 after getting the vaccine. When this flared up before, my family doctor told me the pain in the tip of the left shoulder is called "referred pain" because the problem is actually with the diaghragm and how the phrenic nerve runs through the diaphragm up through the neck. Anyways, the vaccine flared up my pain for 3 days. It is 10/10 stabbing pain that takes your breath away and makes me freeze when i get it, but the pain is short. It is like 3-5 stabs, then it goes away for like a couple hours, then comes back. That lasted for days 2,3,4 after the vaccine. I also was having problems with depth perception and was having problems gaging myself going down steps. My balance was perfectly fine, though.. i just couldn't gage where i was as i was moving too well. I was also having confusion, loss for words, and problems speaking. My mouth muscles weren't working right and it was frustrating because it was making me stutter. I felt extreme muscle fatigue in all 4 extremities, like it felt like I ran a marathon. All those symptoms lasted until 29 MAY 2021, except the phrenic neuropathy was only those 3 days after the vaccine. Today is 7 JUN 2021 and I feel fine now. I am still having a little bit of jerky movements but not bad overall. Because I have had a history of all these same exact movement issues in the past, I did not go to the doctor, because I have been through this before, since i have lived with this for 7 years now, and again I wanted to reiterate that I have been without issues for 2 years, so being that my issues started the day i got the vaccine, it is likely my body had a neurological flareup due to my body's immune response to the vaccine. I have an appointment with a doctor tomorrow to discuss.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 1st April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st July 2018, the patient received the 2nd dose of SHINGRIX. On 21st July 2018, not applicable after receiving SHINGRIX and unknown after receiving SHINGRIX, the patient experienced underdose. On an unknown date, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the underdose was unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: Less than a year after receiving 1st dose of SHINGRIX, the patient experienced the injection site reactions which lasted 4 days.  The area of injection was unknown. The exact onset time was also unknown. On 21st July 2018, the patient received her 2nd dose in the left arm at different pharmacy at approximately 4:20 PM.  There was some concern that she might not had received the full dose because a droplet was seen on the counter near the area she had received the injection, which led to underdose. There were no injection site reactions reported for the 2nd dose. There were no additional details regarding the administration of the 2nd dose as the reporter was the not the person who administered it. The pharmacist did not have the lot number of the box. The reporter gave a lot number of the patient information sheet.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013547: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544: US-009507513-1708USA013537.
Hx generalized rash to arms due to heat. Presents with rash over both arms and spreading across chest, face and legs.
Progressive worsening bilateral legs numbness & weakness ascending up to chest about 1 week. Consistent with Guillain-Barre Syndrome.
Leg pain (both legs); Knee pain; Muscle pain (both legs); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain (both legs)), ARTHRALGIA (Knee pain) and MYALGIA (Muscle pain (both legs)) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011DZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced PAIN IN EXTREMITY (Leg pain (both legs)), ARTHRALGIA (Knee pain) and MYALGIA (Muscle pain (both legs)). At the time of the report, PAIN IN EXTREMITY (Leg pain (both legs)), ARTHRALGIA (Knee pain) and MYALGIA (Muscle pain (both legs)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.
pt recv vax 11FEB97 & 21FEB97 pt devel a rash w/less than 50 (15 on face) & a mild fever;
Before immunization, patient warned us that he sometimes gets light headed. We kept our eye on him after the immunization and he motioned to me that he was not feeling well. I went out just in time when he started passing out and I was able with the help of someone else to keep him from falling out of his chair. The other person and I were able to get him to the ground and put his legs up. After less than a minute, the patient became coherent again and we kept him on the ground for a little while. After patient was feeling better (around 5 minutes) we got him up to a chair and gave him some water. Patient stayed there for another 10 minutes and someone came to drive him home. Patient has a fear of needles and stated he would be fine the rest of the day
Day after vaccine, patient had joint pains and had trouble getting out of bed. patient states that she started taking 800mg Ibuprofen and extra strength Tylenol for pain.  patient continued to take medications from 05/27/21-05/31/21. patient stated she went to chiro doctor on 06/01/21. Patient stated she was given cortizone with lidocaine shot on 06/01/2021 and received 2 more shot on 06/03 and 06/04 and went to ER on 06/05/21.  patient received morphine shots and 2 shots of fetnyl of 06/05/21. patient also reported migraines.
7cm redness, swelling, induration color and mild pain to touch to left upper arm; but 7 range of motion.
Patient passed out and hit face on the floor which resulted in a severe nose bleed. She was taken into the ambulance. I do not know if she was taken to the hospital or not. This happened about 15 minutes after her vaccination.
Extreme cold very wet sweat night of shot accompanied by a deep fatigue.  Next day developed red blotch on bottom lip.  3 nights in a row following shot waking several times at night wondering around house (not normal behavior).  A few days after shot morning full of repetitive vomiting.   (My younger daughter also received polio shot at same time and had lots of symptoms and behaviors following shot as well which lead me to believe these symptoms were reactions to shot.)