chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe generalized burning type pain; occasional pruritis in my feet, hands, extremities, & occasionally in the abdomen & back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have an autoimmune disease" (unspecified if ongoing), notes: I have an autoimmune disease. Concomitant medication(s) included: CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE] taken for autoimmune disorder; BENLYSTA subcutaneous taken for autoimmune disorder. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "severe generalized burning type pain/I have had this severe burning pain in my hands, feet, extremities and somewhat in my abdomen and in my back", "pruritus in my feet, hands, extremities, & occasionally in the abdomen & back"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "had minimal symptoms with the 2nd, 3rd and 4th doses", "had minimal symptoms with the 2nd, 3rd and 4th doses"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "had minimal symptoms with the 2nd, 3rd and 4th doses", "had minimal symptoms with the 2nd, 3rd and 4th doses"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "had minimal symptoms with the 2nd, 3rd and 4th doses", "had minimal symptoms with the 2nd, 3rd and 4th doses". The following information was reported: PAIN (non-serious), outcome "unknown", described as "severe generalized burning type pain"; PRURITUS (non-serious), outcome "unknown", described as "occasional pruritis in my feet, hands, extremities, & occasionally in the abdomen & back". Therapeutic measures were taken as a result of pain, pruritus.  Additional information: It was reported that patient had autoimmune disease currently prescribed cellcept 500mg b.i.d (two times a day) and Benlysta 200mg subcutaneous weekly. Patient had severe generalized burning type pain w/occasional pruritis in my feet, hands, extremities, & occasionally in the abdomen & back. These symptoms are unresponsive to OTC meds, partially responsive to oxycodone, & usually require short term use of prednisone.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient pregnant) in a 32-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-Aug-2021. On 08-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient pregnant). On 08-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She was 17 weeks pregnant.
Pt states she has pain/dull ache since receiving vaccine on 8/19/14.
Pericarditis/pericardial effusion noted on chest CT on 4/26/2021
Repeated emesis >24; high pitched crying x few hrs; irritability; crying x hrs; t100.6 (R);
Patient continued to deteriorate after second dose of vaccine with progressive weakness and shortness of breath.  When he presented to the emergency room he had new onset cardiomegaly and heart failure.  Patient also developed new onset atrial flutter but had bradycardia due to AV heart block.
Pt had red, inflammation at site of injection of Menactra vaccine, 2 days post vaccine right deltoid.
Felt fine, no problems or illness, all of the sudden lost the use of fingers(excluding the thumb) and right hand.  Progressed during the evening and night.  Next morning unable to use right arm and right hand.  Could not make a fist unless done so by using my left hand on my right hand.  Entire right arm with prickling sensations, burning at times in certain areas.  No problem with elbow or shoulder joints/movement.  Prickling/burning to right ankle and lower leg by tuesday 10/22.  Regained use of right arm by wednesday 10/23.  Some prickling sensation to left lower thigh area but not as significant as the right side symptoms and left hand, palm mostly. Today and since onset all sensations continue involving the right arm and right ankle, constant, at times more significant than others.  Left hand and thigh area on occasion.  Have used Meloxicam but unsure if helped at all.  Saw my primary care physician on 10/21/2013 and my neurologist on 10/23/2013.  Have a follow up appointment with neurologist on 10/30/2013.
pt devel excessive crying non stop for 6 hr acting as if rt leg hurting, cries when any part of leg is touched, or is repositioned in moms arms; fever 102 p/APAP;
Coughing up blood; occasional headaches; achiness from work; This is a spontaneous report from a contactable consumer or other non hcp.   A 44-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: was not reported), via an unspecified route of administration on 19Aug2021 as 1stdose, single for covid-19 immunisation (Age at vaccination was 44 years). The patient medical history and concomitant medications were not reported.  The patient experienced coughing up blood on an, occasional headaches, achiness from work on an unspecified date.  Therapeutic measures were taken as a result of occasional headaches. Patient confirms the that he is otherwise pretty healthy, does not even get the flu, and has no medical conditions aside from occasional headaches, for which he takes Excedrin. States he gets achiness from work, but not sure if he would be able to tell if that would be from the vaccine or not. He reports that he woke up at 4:30 AM, started coughing, looked at his hand, and saw blood. He felt like there was liquid in his lung, and when he coughed that out, it was blood. He thought he would do research to see if this is side effect, and states that he would rather reserve the ER for more serious things. Reports that he has never been to the hospital aside from for work. Thought it was more than a coincidence that he got this yesterday, and this happened today, again stating that he does not usually even get the flu. States that he will seek out an HCP, and maybe will get a lung x-ray. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Injection site sore, red, swollen, hot and hardness for about 36 hours then went away and returned on 7th day with a new symptom of itchy as well as other symptoms.
This case was reported by a consumer and described the occurrence of injection site pain in an adult female subject who was vaccinated with ENGERIX B. A physician or other health care professional has not verified this report. On 19 August 2008, the subject received 2nd dose of ENGERIX B (unknown, right arm). On 19 August 2008, less than one day after vaccination with ENGERIX B, the subject experienced injection site pain described as a prickly feeling at the injection site and a prickly feeling on the middle finger of the right hand. On 21 August 2008, two days after vaccination with ENGERIX B, the subject experienced facial pain pruritis. At the time of reporting, the events were unresolved. The caller was reporting on behalf of vaccination subject, and had minimal information to provide. The reporter stated that the vaccination series was neither discontinued nor delayed, but was unsure if the subject checked with her physician for treatment. Please reference report A0746681A.
Received injection. Normal sore injection site. The next day and following five days increasing muscle and severe joint pain. So much pain in hip joints bilaterally could barely walk. I am a registered nurse, retired, and do not exaggerate. Truly extreme joint pain. Would rate an 8 on a scale of 1 to 10. I called doctor and because I take almost no meds. I simply reported the reaction. No breathing or anaphylactic type reaction. In fact it was a delayed reaction. It slowly receded about day six and seven. I was very concerned and amazed at the severity of the joint and muscle pain.
crying from the pain in his head; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (crying from the pain in his head) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (crying from the pain in his head). At the time of the report, HEADACHE (crying from the pain in his head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: No new information
Slight rash" from ear drops/Rash on her neck and chin, and also a slight rash on "My chest and tummy; Ear infection; She was not sure if it is an allergy or not; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization; Bnt162b2 (Dose 2, single), for COVID-19 Immunization. The following information was reported: EAR INFECTION (non-serious) with onset Sep2022, outcome "unknown"; DRUG HYPERSENSITIVITY (non-serious) with onset Sep2022, outcome "unknown", described as "She was not sure if it is an allergy or not"; RASH (non-serious) with onset Sep2022, outcome "recovered" (Sep2022), described as "Slight rash" from ear drops/Rash on her neck and chin, and also a slight rash on "My chest and tummy". Therapeutic measures were taken as a result of rash, ear infection.  Additional information: She recently was prescribed eardrops for an ear infection. She developed a "slight rash" from ear drops, (Neomycin Polymyxin), 10th day taking the ear drops she stopped using them because she noticed a rash on her neck and chin, and also a slight rash on her chest and tummy. She took Benadryl and it went away. She was not sure if it is an allergy or not, and she had an appointment with an allergist to find out.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
SWEATY; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 240 pounds, and height was 74 inches. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 -last # unclear to caller, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 15:30 hours to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced sweaty. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, chills, and fatigue on 14-MAR-2021. This report was non-serious.
PT STATED SKIN TISSUE ATROPHY OF THE LEFT ARM WAS FIRST NOTICED BY HER BOYFRIEND IN OCTOBER.  SINCE THEN IS BEEN ACHY AND ITCHY AND PROGRESSLY GOTTEN WORSE.
Patient developed right sided hemiparesis on 2/5/2021. He presented to hospital on 2/7/2021 with these symptoms and diagnosed with an acute CVA and internal carotid artery occlusion. He was admitted to the hospital and discharged to inpatient rehab on 2/11/2021.
12 month vaccines given 10/19/2021. Parent called 10/22/21 due to concerns with a rash and low grade  fever 100.4  to torso 10/19/21 after vaccines. no swelling at injection site, rash did not appear painful or itchy. maculopapular  rash to torso. scattered dry patches (history of eczema) supportive care given and to monitor for worsening signs or symptoms
started having heart palpitations around beginning of Feb. 2022.  Initially thought it was due to levothyroxine dose change but blood work reviewed by endocrinologist ruled out levothyroxine as the cause (this has happened in the past where I experienced heart palpitations due to increased dose to 75mcg from 50 mcg.  Current dose is 62.5 mcg).   Spoke with my primary doctor who made a referral to a cardiologist.  I have an appointment on 19MAR2022
pt recv vax & 1 or 2 days p/vax pt devel a persistent (through 3OCT96) low grade fever, malaise, anorexia & a weight loss of 7 pounds;
Death Narrative: Family was able to be present at bedside shortly after patient was extubated. Fentanyl bolus given 10-15 minutes prior. Patient passed away soon after endotracheal tube removed. Time of death 10:14am.
sore arm; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
(L) arm pain; muscle aches over entire body; diarrhea; fatigue.
Started cramping the next day in stomach with it centered around left pelvic area. I left camping and by Saturday and Sunday it worsened in my pelvic area and could only sleep in certain positions. By the time I got home on Sunday it was to the point it would sharp shooting pains in left pelvic area, hurt to sleep and couldn?t stand upright fully, had to love slowly so called to make an appt and they got me in on Tuesday. By then it was slowly starting to get better
There have been 3 separate adverse events. 3/20/21 - 3/23/21: Left arm that had the injection was so sore I could not lift above the shoulder. The pain subsided after 3 days. 3/24/21 - Ongoing:  Swollen and painful lymph nodes under left arm. 3/30/21 - Ongoing: Swollen and painful lymph node the size of a marble under left collarbone.
Intense right shoulder pain, radiating down arm to hand. Has had expected level of injection site discomfort on days 2-12, then unexpected onset of this pain.
Broncho spasms, throat swelling, 12 minutes from injection Following two days included extreme joint and bone pain, fatigue, dizziness, and continued coughing.  Neuropathy just went away, 12 days later, still uncontrollable coughing and dizziness and fatigue
This spontaneous report was received from a healthcare worker referring to an unspecified patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was inadvertently vaccinated with an improperly stored dose of VAQTA (lot number and expiration date were unspecified) dose, route and anatomical location were unknown. No concomitant medications were reported. No adverse experiences were reported. No further information was provided. No Product quality complaint was involved. Additional information is not expected because there is no reporter contact information.
has been having erection for two days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 29Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: ERECTION INCREASED (non-serious) with onset Sep2021, outcome "not recovered", described as "has been having erection for two days.".  Additional information: Patient took the pills two days ago 29Sep2021 and took the pill again yesterday 30Sep2021 and confirmed that it was pills that he took but did not provide the name of medication and denied it was Viagra.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Gastrointestinal fistula; Constipation; Pain in arm; Diarrhea aggravated; Injection site pain; Injections hurt in the abdomen; This is a solicited report based on information received by Pfizer (Manufacturer Control Number: 21K-163-3872809-00). This is a non-interventional study report from the marketing program facilitated collect received from a contactable consumer or other non hcp. A 57-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported),via intramuscular route of administration on an unspecified date as 1ST DOSE, SINGLE, and BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via intramuscular route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported), subcutaneous from an unspecified date to an unspecified date, at UNK, (Citrate Free) for Crohn's disease. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced gastrointestinal fistula, constipation, injections hurt in the abdomen, pain in arm, injection site pain, diarrhea aggravated. Due to fistula had flare up with diarrhea. The outcome of the events gastrointestinal fistula, constipation, injections hurt in the abdomen was unknown. The outcome of the events pain in arm and injection site pain was not recovered. The outcome of the event diarrhea aggravated was recovered. Causality as per reporter was not reported.  Information about lot/batch number has been requested; Sender's Comments: Based on the limited information in the case and since fistulas usually are formed over time and rapidly, causality of the suspect BNT162B2 for the serious event Gastrointestinal fistula is assessed as Unrelated.
lightheadedness; "felt like I had a buzz"; no SOB; no orthostasis;
Rash that started on chest and moved to the torso, then arms and legs over 1 week; Extremely itchy; hives all over body; small red blotches; This is a spontaneous report from a contactable nurse(patient). An adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), second dose intramuscular, administered in right arm on 01Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history included neuropathy from an unknown date and unknown if ongoing. Patient had no known allergies. Patient did not had covid prior to vaccination. Patient was not tested for Covid post vaccination. Concomitant medication included estradiol, estriol, estrone (TRIEST estrogen replacement) taken for an unspecified indication, start and stop date were not reported. Patient received first dose of BNT162B2 via intramuscular route in right arm on 15Jan2021 at 01:00. On 08Feb2021 at 03:00, the patient experienced rash that started on chest and moved to the torso, then arms and legs over 1 week, extremely itchy, hives all over body and small red blotches. Extremely itchy, small red blotches, hives all over body. Patient received medication treatment for adverse events. The patient recovered with lasting effects. Therapeutic measures were taken as a result of events. Outcome of the events was recovered with sequel.   Information about lot/batch number has been requested.
About 10 minutes after receiving dose patient's wife said patient was passing out. Staff came to patient's side, not responsive to sound or arousal, unable to locate pulse, not blinking. Color looked gray.  911 response activated.  Pulse oximeter read 68%. As preparing for cpr, pt slowly started to come around.  Chest rise noted after approximately 1 -2 minutes. CPR not initiated.  Slowly became responsive to name, then interactive.  After approximately 5 minutes EMT arrived. Patient assessed and evaluated, no treatment needed at the time. Patient waited in observation area approximately 30 minutes, able to walk and leave on own.  Strongly recommended patient call physician that afternoon. Patient reported having history of "passing out" after shots in past.
Zostavax given to 1 year old child rather than ProQuad. Parents advised to watch for redness, swelling at inj site, C Pox rash in 1-3 wks, bring child in for ProQuad in 3 months.
On 12-29-06 patient vaccine by Rotateq following nite had a high fever of 102.8 - which persisted he was taken to ER where he was worked up for sepsis- which was (-). He had 23c dose of same vaccine followed by high fever.
Patient reports tingling on face and lips, and headache. Felt better after a few minutes, no flushing or dizziness. Cleared by EMS.
Information has been received from a MA concerning a male patient who on 12/05/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644103/0710M).  On 12/07/2002 the patient developed cellulitis and was treated with injections of ceftriaxone sodium (Rocephin).  The reporter expressed a concern regarding the lot number.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  It was also reported that another male patient was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644103/0710M) and developed cellulitis (WAES # 0212USA00848).  Additional information has been requested.
Pt became pale in the face and nonresponsive for about 5 min. Color and responsiveness returned after 5-15 min.
pt recvd vax & by the evening lt arm sore, swollen, red, welt, fussy irritable all evening & next day arm still sore to touch; won't eat or drink; fever 102.4;