chrisvoncsefalvay/vaers-outcomes huggingface dataset:
could no longer walk and could only crawl, just drags his feet; gets tired very quickly; seemed drunk and his feet from the knee down weren't working; A spontaneous report was received from consumer concerning a 26-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and seemed drunk and his feet from the knee down, he could no longer walk and could only crawl,  just drags his feet and was also getting tired very quickly.    The patient's medical history included aphasia. Products known to have been used by the patient, within two weeks prior to the event, included diazepam, duwalpro and another, unspecified over-the-counter product.  On 15-FEB-2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection.   That same day, according to report, the patient seemed drunk and his feet from the knee down were not working.  On 16-FEB-2021, the patient was unable to walk and could only crawl; he was just dragging his feet. He was also getting tired very quickly.     Treatment for the event included paracetamol and ibuprofen.    The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable.    The outcome of the events, seemed drunk and his feet from the knee down, he could no longer walk and could only crawl,  just drags his feet and was also getting tired very quickly, was considered unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. Fatigue is consistent with the known safety profile of the vaccine.
Vaccine administered at 5:38 pm without any prior issues, patient sitting in chair. After 1 minute she asks if she can sit for a while. I respond yes and ask if she is ok. She responds "yes, this happens sometimes, it didn't happen the last time though."  5:40 pm  I offered her water, handed it to her at which time she falls into a slump, becomes diaphoretic,  leans her head back against the wall, closes her eyes, water bottle falls and she clinches her fists and moans.  I support her head against my chest and inform her that she is ok. After 30 seconds she arouses at which time I call my assistant for help.  Apply cool compresses to her neck and head. BP is 100/48 and oxygen is 100%.  After an additional 1-2 minutes she asks if she can move to the exam table to lie down.  We allow her to stand, no symptoms, she takes a few step to the exam table and proceeds to sit of the exam table when she becomes limp and is placed back in the chair.  She becomes diaphoretic but remains alert. 5:55 pm  BP 102/62, oxygen 100%.  Patient provided water to drink.  After 1-2 minutes she transfers to the exam table without incident, legs elevated, drinks water with cool compresses.  Patient remains alert and she is monitored. 6:20 pm BP 123/70 oxygen 100%  patient is alert and oriented x 3 and stable, she is able to stand and walk around the room without incident.  Patient remains in the waiting area for an addition 15 minutes before being discharged
He got his vaccine, did not have any real reaction.  When he got up the next morning his legs were hard to walk on, the muscles in his calves and thighs were cramped.  He just put up with it, thought it was a reaction to the COVID shot as he had done nothing else.  On 9/25/23 his right leg seemed to be getting better, so he thought that it might be due to an accident as he had an accident and had trauma to that knee.  on 9/26/23 he saw his doctor on a 6-month check up and his right leg was almost back to normal.  He explained it to her, but his left leg was not doing so good.  On 9/27/23 the left leg got a lot worse, and by late that evening it was like his muscles were in a Charlie horse with sharp  pain and just laid down on the floor.  He went to the ER and they recommended some opioids and he is supposed to take that and to see his doctor on the Monday.  On the 30th he went back to the ER in the afternoon and talking to them what was going on they gave him another batch of opioids and some Narcan in case he overdosed on them.  He did not use the Narcan and only used 1 more pill at night when the cramps set in again.  The next day he didn't have to take anything as far as the opioids for the pain, not as bad but enough to know that they were leg.  The pain was diminishing over time.  On 10/4/23 the pain had moved over to his right leg and his left leg was doing a lot better.  Then there was numbness in both calves and his thighs, and he had right leg pain since.  The left leg pain is just kind of numb now, and his doctor told him on 10/16/23 and she started upping his dosage of the Gabapentin and he is to up the dosage every week, and in the 2nd week right now.  He is to see her again on 11/8/23.    He did not have problems with his legs prior to the vaccine.   The pain is sharp and it's just next to the knee and in the bones of his leg.  He has been taking Ibuprofen for the pain every 6 hours which seems to help.   He did have an US to look for blood clots and they said there was none.  He then had a CT scan and said that they did not see anything.  The pain during that scan was unbearable as his legs were killing him.   The leg pains do continue, especially the right leg.  He is on Hydrocodone for his pain but he uses them sparingly.
Left upper arm with demarcated 4-5cm area erythema; warm to touch.
The pt received her primary SPV on 8/16/13 in her upper left arm. She was in her normal state of good health at the time of vaccination. She does have a recent hx of insomnia (difficulty falling asleep and staying asleep which she attributes to personal issues). On 8/17/13: she noted sniffles and sneezing with no other sx. On 8/18/13 she noted generalized malaise and sniffles. She denied local site reaction symptoms (erythema, swelling, lymphadenopathy). On 8/19/13 when she woke and sat up she noted "soreness" (rated as a 3/10) across her upper sternum which increased slightly with deep breaths and palpation; she continued with her normal routine (she thought that the discomfort/"soreness" was from sleeping on her stomach). While at work at 0815 she noted an increase in the soreness to a 6 which lasted about 5 minutes. She felt "hot and weak" and the pain increased with deep breaths. When she was triaged in the ER at 0922 her discomfort was a 4/5. She had a negative Troponin (0.012ng/ml), normal CXR, and an EKG which showed NSR with no ST elevation. She took 800mg MOTRIN at 1600 and when she woke from a nap her pain was a 1/10. On 8/20/13 she still had the sniffles and she had a headache (frontal and temples; 2/10; described as annoying which she attributed to a lack of sleep) and "chest" discomfort (1/10) upper 1/4th of the sternum which increased slightly with deep breath and palpation. The patient denied a hx of GERD, reflux, or recent indigestion. She reported that the staff in the Immunization Clinic had started "circuit workouts" the previous week. She denied palpitations and the discomfort was non-positional. The lateral aspect of the upper sternum was tender to palpation. She was instructed to take 800mg of MOTRIN tid with food and was given a no PT chit until her follow-up apt on 8/29/13. On 8/29/13 she reported that she experienced 1/10 chest soreness which increased with deep breaths, palpation to her upper sternal borders and lying on her stomach until 8/23/13 at which time her previous symptoms (headache, chest soreness, malaise) resolved. The patient stopped taking the MOTRIN on 8/23/13. The patient states that her "sniffles" have almost resolved. The patient did note a small amount of erythema (1cm) around the vaccination site and mild axillary lymph node tenderness which started on 8/22/13. There was no tenderness noted to the upper sternal border when palpated. It is the consensus of VHC expert opinion that the patient's condition does not meet the case definition of pericarditis or myocarditis but was non-cardiac in nature possibly related to costochondritis-- possibly an inflammatory response from the SPV or the patient's recent expanded exercise regimen.
Pfizer-BioNTech COVID-19 Vaccine EUA: G4P2012 at 35w2d admitted for COVID-19 pneumonia. Received oxygen, steroids, and remdesivir. Discharged medically stable. One month later uncomplicated vaginal delivery. Mother and baby discharged medically stable.  Birth weight 3595 grams.
Day after "felt like I had razor blades in my throat"; "cough was excrutiating"; "everything in my body hurt"; "just knew I was not going to get out of bed"; lasted two days; today still feels a bit sick, but markedly better.
I got the Moderna Booster shot on 10/30/2021, at 12:15.  About 3 hours later, I had uncontrolled diarrhea.  About 10 PM on 10/30/2021, I felt chills and checked my temperature and it was 99.4 Deg F.  This morning, on 10/31/2021, it was 100.4.  That is all, not too adverse, but I am wondering what to do, other than to wait it out.  Thanks,
hurting; headache; This is a spontaneous report from a contactable consumer or other non hcp.   A 13-years-old female patient received BNT162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Lot No, NDC number, Expiry date was not reported), via an unspecified route of administration on 26Jul2021 as 2nddose, single for covid-19 immunisation. Historical vaccine was A 13-years-old female patient received BNT162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Lot No, NDC number, Expiry date was not reported), via an unspecified route of administration on unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hurting, headache on Jul2021. Upon follow-up on 27Jul2021 is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient characteristic (age at time of onset of reaction was 13 years female), reaction reported by primary source was headache, Drug information (Pfizer Covid 19 Vaccine, Lot number was unknown, action taken with drug was unknown). Narrative case summary and further information. Patient is not a reporter, reporter type is consumer or other non-health professional, specify Consumer or other non-health professional is mother. Dates for headache is unspecified. Yes, it is a Pfizer Covid 19 Vaccine a Pfizer product. Pfizer Covid 19 Vaccine manufacturer was unspecified, Dates for Pfizer Covid 19 Vaccine Start and Stop were unspecified. NDC number and Expiry date of Pfizer Covid 19 Vaccine was not reported. Reason for no lot number of Pfizer Covid 19 Vaccine was patient was unwilling to complete the report. Other products details not provided. Patient history was not provided, investigation assessment was not provided. Outcome of the events was unknown.    Follow-up (27Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient characteristic (age at time of onset of reaction was 13 years female), reaction reported by primary source was headache, Drug information (Pfizer Covid 19 Vaccine, Lot number was unknown, action taken with drug was unknown). Narrative case summary and further information. Patient is not a reporter, reporter type is consumer or other non-health professional, specify Consumer or other non-health professional is mother. Dates for headache is unspecified. Yes, it is a Pfizer Covid 19 Vaccine a Pfizer product. Pfizer Covid 19 Vaccine manufacturer was unspecified, Dates for Pfizer Covid 19 Vaccine Start and Stop were unspecified. NDC number and Expiry date of Pfizer Covid 19 Vaccine was not reported. Reason for no lot number of Pfizer Covid 19 Vaccine was patient was unwilling to complete the report. Other products details not provided. Patient history was not provided, investigation assessment was not provided.  Information about batch/lot number has been requested.
30 minutes following administration patient suffered vomiting.  Vomiting was severe and she had swelling of eyelids and peticheae surrounding eyes.  She also reported HA.
Fever 102.4 tx of APAP drops noted by mom @ 6AM 2JUN92; extreme fussiness most of day of 2JUN92 dec feeding; seen in office 2JUN92 mainly for parent reassurance;
Feeling a little bit of fever; Fever is very low it's not like high but it's been running since one week; Little bit of swelling on the face; Face swelling is there and she is also having pain on the face; Little bit of swelling on the face; Face swelling is there and she is also having pain on the face; This is a spontaneous report from a contactable consumer or other non hcp (Patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 05May2021 (Batch/Lot Number: EW0175) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced the fever was very low it was not like high, but it was been running for one week, now the face swelling was there, and she was also having pain on the face today. And wanted to visit doctor. The patient underwent lab tests and procedures which included body temperature: fever on an unspecified date. the outcome the events was unknown.  Follow up attempts are needed; Additional information has been requested.
I had a lot of coughing that was a dry hacking cough, that would not let me sleep at night. I was coughing so hard it was causing me to urinate on myself. Although I had a lot of phlegm it would not come up. The first time I had it was three days after I received the fourth dose, it lasted until February. The cough came back in March, the cough is still lingering. I was able to sleep last night, 06/13/23 for the first time without waking to take cough syrup. The fatigue is horrible, there will be days I come home fall asleep and don't wake up until the next day. The doctor did not run any test either time I went to see her, she did prescribe benzonatate for the coughing.
Patient was given a flu vaccine and was being monitored for 30 minutes due to an allergy to eggs. The administration was approved by a doctor.  20 minutes in the patient started to break out into a rash and the nurse retrieved a doctor to come check on the patient. The patient was given Zyrtec and was monitored for another 30 minutes. After the timer went off the patient was sent home with instructions to parents to monitor.
myocarditis with troponin elevation and arrhythmias diagnosed 7/1/21 after episode of chest pain and nausea
Pt. went home after the office visit and 4-5 hours post vaccination presented with vomiting temp of 100.9; irritability, poor appetite, all of these resulting in hospitalization due to dehydration.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Lot number: EL3249), in right arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 05Oct2021 as dose 3 (booster), single (Lot number: ff2588), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Plaque Psoriasis" (unspecified if ongoing), notes: other medical: history Plaque Psoriasis; "known allergies: bee stings" (unspecified if ongoing), notes: known allergies: bee stings. There were no concomitant medications. The patient did not receive any other medication in 2 weeks. 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, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19 with Paxlovid from 03Jul2022 to 08Jul2022.  Clinical course: He started feeling bad on Saturday 02Jul. After taking Paxlovid starting on 03Jul for 5 days his symptoms seem to go away. Then around 4 to 5 days later his symptoms returned. The symptoms were just about the same as the initial symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Golf ball size knot on arm under injection site, tenderness, redness the size of a half dollar at injection site. No fever or other symptoms. Lasted for approx. 2-3 days. Pt recalled sensitivity to eggs in childhood-stated no allergy.
This spontaneous report was received from a 66 year old male patient with hypertension. The patient's medical history included shoulder injury. His concomitant therapy included chlorothiazide. On 14-OCT-2018 the patient was vaccinated with a PNEUMOVAX 23 (dose, route and lot# were not provided) for prophylaxis. On 14-OCT-2018, the patient experienced itching at the injection (injection site pruritus). No treatment was administered for the event. The outcome of injection site pruritus was reported as recovered on an unspecified date in October 2018. The causal relationship between itching at the injection and pneumococcal PNEUMOVAX 23 was not provided.
January 8 patient developed  bilateral rash on mid back, hip, thigh,  hands, knuckles, feet however rash was primarily on the left side.  Patient visited his primary care provider who advise him to seek advise from public health. Medical director was informed. Patient did send picture.
Softball size area of redness, warmth, pain to right arm. Was seen by MD on 8/27/04 who told mother the arm had an abcess and rx'd Augmentin x 7d and Benadryl as needed. Purple after 7d with continued pain.
Severe digestion problems -- vomiting and diarrhea.  Continued for several days so went to hospital where CT showed inflammation of colon.  Received IV and antiobiotics; released after three days.  No fever or other symptoms.  Mostly better now.
4 mo infant rec'd 1st immun & later dx w/H. Flu meningitis confirmed by sp Tap. Infant is well & asymptomatic @ present.
Pt received injection, 5 minute post injection she c/o dizziness and nausea.  She had not eaten anything for 12 hrs due to testing she was to have that afternoon.  Symptoms subsided after 5 minutes.  No other c/o and was discharged with no c/o or further symptoms.
Reported 10/25/05 approx 1 1/2 - 2 hours after vacccine broke out in hives all over.  While driving home "felt lik I was choking", took Benadryl 150mg 3times over 12-15 hours
Patient's arm (left) is very sore to the touch and movement is restricted since receiving the FLUZONE HD 11/21/11. She is not able to move the arm comfortably across her body and is waking up at night when she rolls over. Still has arm soreness.
Pain on using my arm. A constant very low level pain. Movement sideways hurts between shoulder and elbow.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient had no drug reactions or allergies. The patient's pertinent medical history was not reported. On an unknown date approximately in 2012 (reported as about four years ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date approximately in 2016 (reported as approximately 4 years after receiving ZOSTAVAX), the patient developed a moderate case of shingles. The patient sought medical attention (an office visit) and received an unspecified treatment for the event. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Low fever 100-101, body ache, chest cough, joint pain at a 10 on a 1-10 scale.
I gained weight at  a rapid pace and a appetite that I could not control. I started getting dizzy and was feeling like I had been drugged. I had extreme soreness in my arm. My energy level dropped down to  the point of being extremely exhausted..
Breakthrough case admission after 2 vaccines Moderna 3/18/21 Lot# 030A21A; Moderna 4/19/21 Lot# 043B21A
Sleepy; She feel very tired; Nano second headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), FATIGUE (She feel very tired) and HEADACHE (Nano second headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced SOMNOLENCE (Sleepy), FATIGUE (She feel very tired) and HEADACHE (Nano second headache). At the time of the report, SOMNOLENCE (Sleepy), FATIGUE (She feel very tired) and HEADACHE (Nano second headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Patient took 1st day after the 1st dose aspirin.  Patient received a lot of concomitant medication.
Narrative:  66 year old male reported injection site pain and fatigue following his first dose COVID-19 Pfizer vaccine on 02/03/2021. No treatment needed.
02/03/22 presents to ED for "abdominal pain". PMHx of "recurrent pancreatitis, diverticulitis and intramular abscess (2020) and stable benign pancreatic IPMN"
Patient was seen yesterday where an order for a COVID Pfizer booster was ordered by provider. Patient was given pfizer bivalent 6m-4yr instead on accident. The entire multidose vial (10 doses) was given without diluent.   Patient did not experience any side effects when I called her on 6/20/23 at 10a.m. I called patient again on 6/21/2023 at 11am and patient stated she has been asymptomatic
Extreme fatigue, sleeplessness, aching, flushing, chills, nausea, depression and lights flashing around both eyes. This started roughly three months after the 2nd vaccination. Is still going on six months after the second vaccination. I have run little or no fever with it.  I am now having depression related to my husband's Dementia. On August 9, 2021 I finally contacted my doctor.  I was not having depression when these symptoms started. I cannot function and spend most days in bed.
p/vax pt was very hot;felt warm but didn't take temp;pt given APAP;pt kept home from school looked quiet & staring;called ER told fever common p/vax;sl h/a, stomachache;delirious;stiffened up & stared @ ceiling;T101, vomit;
pt recvd vax 21JUN93 & devel massive hives w/in 24 hrs p/vax;
Next morning swelling occurred in left eye lid.  Patient described eyelid felt like a bruise and was tender to the touch but not itchy.   Her chest felt tight and her heart rate increased to 100-102.  Her O2 sats were above 97.  She did have fatigue but no fever.  The swelling resolved the next day.  Today (8/30/21) she has a light cough.  She did have her teeth cleaned  prior to vaccination.  She does not have any dermal fillers or implants.  She does not think she has been around anyone who tested positive for COVID.   I recommended she take Tylenol, Claritin and Robitussin if needed for cough.