chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Brings down the immune system; This is spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). This female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation; gabapentin, teriflunomide (AUBAGIO), carbamazepine (CARBATROL), all via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for an unspecified indication. Medical history included multiple sclerosis (diagnosed 14 years ago). Concomitant medications were unknown. The patient mentioned that she got a Tetanus shot 16 years ago and caused her to experience a series of electrical shocks known as "Lhermettis sign". The patient also mentioned that she no longer experiences the electrical shocks for 4 years and mentioned it could be brought about by the effects of the Tetanus shot wearing off. The patient also mentioned that she was taking in a medication that brought down the immune system ("Byzyul" unable to confirm correct spelling) along with anticonvulsants known as Carbatrol and Gabapentin, as well as "Aubagio". The patient stated that she took this in like a maintenance. The patient also mentioned that the needle size used by the pharmacist/vaccination provider when administering the Pfizer BioNTech Covid-19 Vaccine on her first shot was a little bit shorter as compared to the "long needle" used during administration that she saw on television. She also stated that her son (unable to obtain age information) who got the same vaccine shot on the same pharmacy did not experience any side effects. The patient wanted to know if the electric shocks (lhermettis sign) that she experienced after her tetanus shot 16 years ago would be triggered again after getting the Pfizer BioNtech Covid-19 Vaccine. The patient wanted to know if there was anything in the ingredients of the Pfizer BioNtech Covid-19 Vaccine that could potentially harm her. The patient stated that she is taking in a medication that brings down the immune system ("Byzyul" unable to confirm correct spelling) along with anticonvulsants known as Carbatrol and Gabapentin, as well as "Aubagio" and wanted to confirm if there is interaction information between these medications and the Pfizer Biontech Covid-19 Vaccine. The patient wanted to know if people with Multiple Sclerosis are included in the Pfizer BioNTech Covid-19 Vaccine clinical trial study. The patient wanted to let Pfizer know that they have to continue with the Pfizer BioNTech Covid-19 Vaccine studies focused on multiple sclerosis patients. Action taken with gabapentin, teriflunomide and carbamazepine was unknown. Outcome of the event was unknown.   Pfizer is a marketing authorization holder of [gabapentin] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [gabapentin] has submitted the same report to the regulatory authorities.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
3/14/23 I woke up with a headache, it felt like a sinus headache. I felt very tired, my muscles felt very heavy, when I walked upstairs my legs hurt which is not normal, a deep cough and I had chills. On 3/15/23 I took an at home COVID test which was positive. I spoke with the nurse practitioner and was prescribed PAXLOVID. I started taking the PAXLOVID that day. The medication made me feel slightly nauseous and had a bad taste in my mouth. I had no appetite and rested as much as I could. By 3/17/23 I was feeling better. The cough is mostly gone, but I do still cough. I have recovered.
Just before bed, about a week after getting the vaccine, I started to itch on my feet and arms. I fell asleep and woke up at about 3 AM with incredibly itchy skin from the tops of my feet all the way up to my shoulders. It was so itchy and uncomfortable that it woke me up. I took 2 Benadryl and put some anti-itch lotion on, and was able to fall asleep. I woke up the next morning feeling groggy, but better. The itch has not returned at all in the week since this happened.
First, I had the COVID vaccine-arm: a large red itchy swelling and welt that arrived 2 weeks after my first shot. But I'm reporting now because I have developed TWO NEW ALLERGIES since getting vaccinated: stone fruits and an extreme reaction to mosquito bites (giant swollen hot red raised round areas).  This is all harmless, but it seems relevant to considerations of booster shots, since my immune system seems to be kind of ... hyped up.
No visible adverse event, patient was given Vaccine which was about 16 days expired. But later the stock  has been  verified by Pfizer as no additional action needed
Throat got tight; Got really hot; Sweaty; Hives; Rash all over skin; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 15:30(at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient has known allergy to mint. Concomitant drugs included birth control (MANUFACTURER UNKNOWN), iron (IRON) and multivitamins (MANUFACTURER UNKNOWN) all for unspecified indications from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 17:00 about one hour after vaccination, the patient experienced hives and a rash all over skin, throat got tight and she got really hot and sweaty. No therapeutic measures were taken as a result of the adverse events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events hives and a rash all over skin, throat got tight and got really hot and sweaty was resolving at the time of report.   No follow-up attempts are needed, information about lot/batch number cannot be obtained.
10 to 15 days experienced "pins and needles" running from shoulder to fingertips- slight swelling lower arm/hand. At 7/7/04 numbness nearly disappeared; no swelling. No fever, no rash, no redness.
Information has been received from a female consumer who on an unspecified date was vaccinated with ZOSTAVAX (Oka/Merck) (lot no., route and site of administration were not reported). On an unknown date the patient developed redness at the injection site. It was unknown if the patient sought medial attention or not. Additional information is not expected.
Got redness/swelling started day after shot. Spread down center of arm to elbow. Felt sore for several days and nights.
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild
fast and severe onset of left arm pain and still going on. Have deltoid pain and pain radiates down to elbow and forearm and goes up to SCM and neck and radiates back to scapular muscles and rhomboids also. I cannot lift anything that does not cause it to hurt and  nothing helps pain. I am doc tor and have not gone to be seen about this yet
9Apr84 noc T& rash;15Apr84 T/w rash& neck rigid,pain to touch body;to hosp,Sed rate 125-indicates JRA;24Apr84 rheumat MD saw rash trunk/limbs no arthritis,21Jun84 polyarthritis,no wt bear,tx:Naprosyn,progress joint deform,flex contract;1990
post vaccine pt was noted to have a light rash on upper extremities, c/o of tightness in chest. Pt offered Benadryl and refused as pt had a full schedule planned today. Pt expressed that she was feeling well enough to leave on her own. Pt was released at 10:47 am vital as follows: 1032 BP  136/89 HR 94 RR 20 SpO2 97% 1040 BP 137/91 HR 92 RR 20 SpO2 98% 1045 BP 138/90 HR 83 RR 18 SpO2 99%
24yo male with witnessed syncopal event with 45s LOC after receiving vaccine. Pt reported history of aversion and sycopal events with needles and blood. Pt was evaluated, monitored, and given oral nutrition/hydration. He improved after 20min and was released.
pt recv vax 30NOV97 & 13FEB97 pt devel a raised area & a 3cm rash over the inj site that was described as macular & papular;
Information has been received from a physician concerning a patient who was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and developed a measles reaction afterwards. The physician is concerned it could be a full blown case of measles. No additional information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Pt seen on a walk in basis for an immunization reaction. DTaP given 2 days ago. Started to get red yesterday. No fever. Is using the arm fine without any apparent tenderness.
This case was  reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 3-year-old male patient who received INFANRIX. Co-suspect products included INFANRIX, INFANRIX and INFANRIX. On an unknown date, the patient received the 1st dose of INFANRIX, the 2nd dose of INFANRIX, the 3rd dose of INFANRIX and the 4th dose of INFANRIX. In July 2017, unknown after receiving INFANRIX, INFANRIX, INFANRIX and INFANRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and pertussis were unknown. It was unknown if the reporter considered the vaccination failure and pertussis to be related to INFANRIX, INFANRIX, INFANRIX and INFANRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was diagnosed with pertussis two and a half weeks ago after being administered an INFANRIX vaccine at his 15 month old visit. The exact diagnosis written by the physician was bordetella parapertussis. The patient was fully vaccinated at County Health prior to coming to this office to receive his 4th scheduled dose of INFANRIX. The field representative also noted that the office manager said they had seen 4 cases of pertussis. Two were from unvaccinated children. This case was linked to case US2017113119, reported by the same reporter.
Noticed pink large area on right arm of injection site on day 2 following Prevnar-13 pneumonia vaccine. Applied some ice. Following day redder and area going down arm and to inside of bicep. Very itchy and hot. Tried OTC cortisone cream and Benadryl spray and Benadryl pills for 2 days. More pink now rather than red on day 9 and itchiness stopped.
Pt. received vaccinations at 1008. Pt. became dizzy, diaphoretic, dizzy, N/V at 1020. Temp 99.2, BP 110/75, HR 125. Pt. laid down, given juice, water, wet cloth. BP 102/70, HR 104 at 1025. Went home with mom at 1030. Educated mom to contact PCP provider if she felt needed and to contact HD with any further questions if needed.
This spontaneous report was received from a 60 year old female with osteopenia reporting on herself.  The patient had no drug reactions or allergies. Approximately on 07-JUN-2017 (reported as "this Wednesday"), the patient was vaccinated with "1 dose vaccine" of ZOSTAVAX route: injected vaccine, (lot# and the expiration date were not reported) to protect herself. There was no concomitant medication provided. On 09-JUN-2017 (reported as "today"), the patient realized her skin was a little raised with redness around the injection side. The patient did not seek medical attention and there was no laboratory diagnostics studies performed. The outcome of injection site erythema was unknown. The relatedness between the therapy with ZOSTAVAX and the event was not reported. Additional information is not expected because the reporter refused additional contact.
Swelling of the left arm pit and side of breast where the shot was administered. There was soreness in the area too which all lasted about 3-4 days
Facial swelling, extremity swelling 30 minutes post vaccination administration, took Benadryl po  continued facial swelling and extremity swelling, fever 101.2, fatigue, body aches, congestion began 24 hours post vaccine
Blood pressure spike to 190/90 4 days after vaccination; severe headaches; Severe pain in the Jaw; Severe pain in the face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN JAW (Severe pain in the Jaw), FACIAL PAIN (Severe pain in the face), HYPERTENSION (Blood pressure spike to 190/90 4 days after vaccination) and HEADACHE (severe headaches) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN for Diabetes mellitus.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN JAW (Severe pain in the Jaw), FACIAL PAIN (Severe pain in the face) and HEADACHE (severe headaches). On 17-Apr-2021, the patient experienced HYPERTENSION (Blood pressure spike to 190/90 4 days after vaccination). At the time of the report, PAIN IN JAW (Severe pain in the Jaw), FACIAL PAIN (Severe pain in the face), HYPERTENSION (Blood pressure spike to 190/90 4 days after vaccination) and HEADACHE (severe headaches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Blood pressure measurement: 190/80 mmHg.         The patient visited the emergency room for PAIN IN JAW (Severe pain in the Jaw), FACIAL PAIN (Severe pain in the face) and HEADACHE (severe headaches).The emergency room visit lasted for  8 hours.  The patient received Tylenol and Gabapentin as treatment medication
Patient called the morning after her vaccine stating she had very tender arm around injection site, chills, headache, body aches, and she vomited.   She had to leave work after an hour to go home and rest.  She stated it feels like she has the flu.  It was recommended that she use an analgesic such as acetaminophen to help with the achy feeling.
Lack of energy; Severe headache; Lethargy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Lack of energy), HEADACHE (Severe headache) and LETHARGY (Lethargy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 22L20A) for COVID-19 vaccination.     No medical history was reported. No concomitant medication was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced ASTHENIA (Lack of energy), HEADACHE (Severe headache) and LETHARGY (Lethargy). At the time of the report, ASTHENIA (Lack of energy), HEADACHE (Severe headache) and LETHARGY (Lethargy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: unk.         Treatment information not provided. List of concomitant medication were not given.   This case was linked to MOD21-066084 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14-MAY-2021 contains non-significant information. Contact information updated.
Within first week after vaccination patient started having symptoms of increased moodiness, anger outburst, irritability, bloating, tearfullness.  Started menses 5/30/08 (day of vaccination) Patient states she has continued to have these symptoms periodically over the last 2 months.  She also feels her periods have become irregular since getting the shot.  Menarche, however was 2/2008 and pt reported irregular cycle the month prior.  Patient also has had many stressors recently, with maternal grandmother recently passing.  Patient in counselling and counselor is the one who states that she has had several clients with increased anger outburst and mood swings since receiving gardasil.  Currently patient states she is not having any anger or mood issues, still complains of bloating.  LMP 7/9/08
(10/6/14) Monday - swollen, red circle around it, itchy, burning. Low grade fever for a few days. Monday -> Friday it got smaller then gone by Saturday (10/11/14).
Vaccine given in right deltoid, same day pt  reports  tingling in left fifth digit.
09/16/2022, About 10 hours after my vaccination and over the evening I had experienced chills and went to bed. I was extremely lethargic, achy, and still had chills into the next day. I slept through most of the day until 05:00PM Saturday evening. I then went back to bed and did not get out of bed until the morning of Sunday. Fatigue and lethargy were the main symptoms from late Friday night for about 48 hours.  Now I am feeling just fine and back to normal.
Feeling Dizzy; nausea; Soreness of arm; Body ache; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling Dizzy), PAIN IN EXTREMITY (Soreness of arm), MYALGIA (Body ache), FATIGUE (feeling tired) and NAUSEA (nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm), MYALGIA (Body ache) and FATIGUE (feeling tired). On 25-Mar-2021, the patient experienced DIZZINESS (Feeling Dizzy) and NAUSEA (nausea). At the time of the report, DIZZINESS (Feeling Dizzy), PAIN IN EXTREMITY (Soreness of arm), MYALGIA (Body ache), FATIGUE (feeling tired) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported. Treatment information was not provided.
She called me this morning and said she started feeling muscle soreness the night of the immunization. She says both of her arms are hurting and below her buttocks. She takes some Advil and the soreness does away enough for her to perform her daily activities but the pain comes back. I asked her to follow up with her primary care in case it was related to her statin.
headache; numbness; tingling; whole side of her face felt numb/ left side of face was numb and tingly; lightheaded; fever of 102 degrees; body aches; didn't feel well for a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EW0172) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness"; PARAESTHESIA (non-serious) with onset 29Apr2021, outcome "recovered" (2021), described as "tingling"; HEADACHE (non-serious), outcome "unknown", described as "headache"; HYPOAESTHESIA (non-serious) with onset 29Apr2021, outcome "recovered" (2021), described as "whole side of her face felt numb/ left side of face was numb and tingly"; DIZZINESS (non-serious) with onset 29Apr2021, outcome "recovered" (29Apr2021), described as "lightheaded"; PYREXIA (non-serious) with onset 27Apr2021, outcome "recovered" (29Apr2021), described as "fever of 102 degrees"; PAIN (non-serious) with onset 26Apr2021, outcome "recovered" (28Apr2021), described as "body aches"; MALAISE (non-serious) with onset 26Apr2021, outcome "recovered" (01May2021), described as "didn't feel well for a couple of days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoaesthesia.  Additional information: Synthroid was taking for 15 years. The patient experienced some side effects including numbness, tingling, headache and being lightheaded. She did not feel well for a couple of days. Later she developed odd symptoms. The left side of her face was numb and tingly. On that Wednesday she had body aches and a fever of 102 degrees. On Thursday she went to work. She had a meeting and felt extremely lightheaded. Her son works where she does and gave her some protein. She felt better but not great. The numbness and tingling lasted for 2-3 days. She woke with a fever. Because of her adverse effects, her HCP advised not get the second dose. She was shopping for a car and felt bad while at the dealership. She was not able to leave because they were shopping. While driving home the whole side of her face felt numb. She had to pull over and have her husband drive. She went home and took some Advil. The next day she did not have that facial numbness. Maybe there was a little but it was not as bad. Time the vaccination was given at noon. There were no additional vaccines administered on same date of the Pfizer. The patient did not visit to emergency room and physician office. There were no prior vaccinations within 4 weeks.   No follow-up attempts are possible. No further information is expected.
ITCHY RED SPOTS IN BOTH HANDS; PAINFUL INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (route of admin not reported, batch number: Unk) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the subject experienced itchy red spots in both hands. On 20-JUN-2021, the subject experienced painful injection site. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from painful injection site, and itchy red spots in both hands. This report was non-serious.
Hard lump to left axilla - assumed to be enlarged lymph node, large, tender, swollen x 4 days then resolved started on day 5 after immunization with 1st dose of Moderna COVID 19 vaccine, same side as vaccine given
Soreness at injection site (difficult to move arm) and low grade temp (101F) Pharmacist recommended Tylenol for aches and fever.
Information has been received from a registered nurse concerning a female patient in her late 50's who was vaccinated (elsewhere) with a three-dose series of RECOMBIVAX HB. In 2004, she received one additional dose at the reporter's location and developed soreness in the injected arm. The pain perisited for a few months, and the patient sought unspecified medical attention. Subsequently, the patient recovered from the sore arm. Additional information has been requested.
Developed generalized erythemic rash. Patient states it felt bumpy in the beginning. No blisters. Note of entire body covered with rash except face. Hospitalized for 3 days.