chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left lower quadrant pain; Nausea; Fatigue; arm pain; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; she felt like she caught ' a bug' or 'flu-like symptoms'/experiencing flu-like symptoms; This is a spontaneous report from a contactable healthcare professional (patient herself). A 49-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 at 0.3 ml, single for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced arm pain on 08Jan2021, fatigue on 09Jan2021, nausea on 10Jan2021, left lower quadrant pain on 11Jan2021. The patient said that she felt like she caught "a bug" or "flu-like symptoms" after her first dose of the COVID vaccine. She would like to know if she should get the 2nd dose of the COVID vaccine after experiencing flu-like symptoms after her first dose. Therapeutic measures were taken as a result of  nausea and  left lower quadrant pain that included ciprofloxacin and metronidazole. Clinical outcome of arm pain was not recovered; for fatigue and nausea was recovering; for left lower quadrant pain was recovered on an unspecified date; while for the other events was unknown.
Suspected vaccination failure; A friend of mine got the shingles shot and still got shingles; This case was reported by a consumer via  media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported. The patient developed shingles after receiving Shingles vaccination. The reporter stated that take a coin and flip it might help you to decide. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.
Woke up feeling moderately achy and lethargic. As day progressed, more severe aching and lethargy. Fever of 100.4 at time of writing this. Sore injection site.
Large swollen bump at injection site, red, giving off heat, itchy; Large swollen bump at injection site, red, giving off heat, itchy; Large swollen bump at injection site, red, giving off heat, itchy; Large swollen bump at injection site, red, giving off heat, itchy; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot Number: EM9809) dose 1 via an unspecified route of administration in Arm Left on 08Feb2021 14:15 as single dose for COVID-19 immunization. Medical history included Arthritis, obesity, medicated for high glucose, medications for inflammation, pain and nerve pain. The patient's concomitant medications were not reported. The patient experienced Large swollen bump at injection site, red, giving off heat, itchy on 09Feb2021 13:00. Seriousness was reported as non-serious. Patient did not receive any treatment. Outcome of events was not recovered.
Pt called 11 days after vaccination stating that he is having hives and itching for the last 1-2 days. He was instructed to take an antihistamine and monitor symptoms.
10 pm started with uncontrollable chills and headache about 5 am fever body ache nauseated  Next day sat 1/9 2pm diarhea lasted 24 hours Monday fatigue headache and body ache continued Tues headache fatigued and short of breathe wed woke up with sl headache and weak by dinner time felt better
1st morning after shot I woke up on floor with lump on chin and urinated pants. Same the 2nd morning after vaccination  except lump on forehead. 3rd morning after vaccine I became light headed dizzy, had to pull over to store parking lot. 3 state police arrived after I had seizure like episode inside the store.  These events have never happened before in my life happened the first 3 mornings after my 1st and only dose. 3 less severe mild but similar incidents since.
On 05/11/2005, had a brief <1 minute febrile seizure. No TX, No focus of infection. Also had area of enlargement to left thigh. Had fever to 103 degrees F yesterday.
I got a light headache and soreness at the injection sight a few hours after the visit.  I took ibuprofen that helped with the headache and the injection sight pain. On Sunday, several members had a cold, so I'm not sure if the symptoms were related to the cold.  I had swollen lymph nodes in my throat, and I took over the counter Dayquil.  Most of it has cleared up, but my lymph nodes have been on and off since getting my vaccination.
Clotting issues; he had stroke on Jul2021; 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. The reporter is the patient.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1), administration date: Mar2021, for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Jul2021, outcome "unknown", described as "he had stroke on Jul2021"; COAGULOPATHY (non-serious), outcome "unknown", described as "Clotting issues". Clinical course: patient got the first dose of the Pfizer BioNtech COVID-19 Vaccine in late Mar2021 and the second dose in early Apr2021. Patient stated that he had stroke on Jul2021. He was considering to take the protease inhibitor pill. Patient experienced a mild stroke after the second dose. He had a question, he was clotting issues and asking about getting the booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
The patient complained of throat tightness 15 minutes after receiving her 2nd booster dose of Moderna. No shortness of breath, no difficulty breathing. VS: BP 141/63, HR 73, 100% on RA. The patient was not in any noticeable distress. Urgent Care was called and the  Physician Assistant was notified. Zyrtec 10mg was ordered and the patient was instructed to wait an additional 15 minutes.   She was observed for a total of 1 hour. Symptoms did not get any worse she would be able to discharge home. The patient stated she felt a little better prior to leaving. She refused the Zyrtec PA had ordered.
Mother called 12/3/09 4:00 pm to report that the child came home from school with a fever of 101.8, no other s&s > called her back 12/4/09: used Tylenol overnight, fever this am 101, denies other s&s, states many children he has been exposed to have "colds" .
Arm is numb; Arm is sore; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness and numbness in her vaccinated arm.  The patient's medical history was not reported. Concomitant medication was not reported.  19-JAN-2021, prior to the onset of the events, the patient received their first planned dose of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  Same day patient was experiencing soreness and numbness in her vaccinated arm. Soreness went away after a few days.    No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event hypoaesthesia is Unknown.
Headache, Myalgia, Arthralgia, EXTREEM FATIGUE. Narrative:
Sore at injection site on day of vaccine, day2 -  woke up in early AM achey & chilled. During the day continued with fever of 101.7, extreme arm pain (hard to move arm), muscle aches, chills, fever max of 104.1. Injection site swollen, warm, painful with pain radiating down arm. Day 3 slight headache, fever of 100.6, injection site still red & swollen but better. Day 4 PCP consulted, advised to use cool or warm compresses to arm. Day 5 injection site slightly swollen, a little warm.
Patient had red arm and swollen at injection site. Painful to the touch and hot to the touch. It took place 3 days after her second dose and went away slowly over period of time.
Client reports aching am after shot in shoulder progressing to aching all over & into his back. Reports he feels weak & gets "clammy" if he does too much. States he does not have a temp. To M.D. today- Given Rx Gabapentin & hydroco/apap. To f/u with Dr. on Nov 4th 2010.
No Adverse Event; Moderna Covid-19 monovalent were administered BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD).    Concomitant medications details were not reported by the reporter.  This case was considered for 2nd adult patient out of 15 recipients who received moderna vaccine after by used date.  Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live Follow up : Patient demographic details adding On 28-Feb-2023: Live Follow up On 28-Feb-2023: Live Non Significant FU; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 2
After the first one, two weeks later, patient was awakened by severe joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (After the first one, two weeks later, patient was awakened by severe joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (After the first one, two weeks later, patient was awakened by severe joint pain). The patient was treated with LORATADINE (LORATAB) for Joint pain, at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) for Joint pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (After the first one, two weeks later, patient was awakened by severe joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter.    This case was linked to MOD-2021-309996 (Patient Link).   Reporter did not allow further contact
PATIENT PRESENTED TO OUR OFFCIE WITH RIGHT UPPER ARM REDNESS, SWELLING AND TENDERNESS FROM SHOULDER TO JUST ABOVE THE ELBOW. HAD RECEIVED PPSV23 YESTERDAY AT COUNTY HEALTH DEPT.
she developed Lichen Planus after she received the second dose; This spontaneous case was reported by a physician and describes the occurrence of LICHEN PLANUS (she developed Lichen Planus after she received the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LICHEN PLANUS (she developed Lichen Planus after she received the second dose). At the time of the report, LICHEN PLANUS (she developed Lichen Planus after she received the second dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment mediations were reported.
Severe headaches and fatigue for 36 hours. It?s been 3 months since and I get headaches almost daily.  Onset is usually when I?m working out but not always. My normal was 7:15 minute miles for a sustained 4 miles. I am having a hard time getting to that without suffering debilitating pain in my lungs. I have experienced a multitude of what I can only describe as pin needles in my lungs where it hurts to breath.
Sensitive to touch painful; inflammation pimple-like small pus --on the spot of Flu Injection.
The patient was given a dose of Adacel or Tenivac via subcutaneous route, no Ae; Initial information received on 21-Jan-2021 regarding an unsolicited valid non-serious case from pharmacist.  This case involves patient of (unknown demographics) who was administered DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], (lot numbers and expiration date were not reported) via subcutaneous route (incorrect route of product administration) in an unknown administration site for prophylactic vaccination on an unknown date.  Medical history, past medical treatment(s), medical treatment(s), concomitant medications, vaccination(s) and family history were not reported.  This was an actual medication error due to incorrect route of product administration (latency was same day).  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Pain at the vaccination site/throbbing pain at the site of the injection/bad pain near the shot.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the vaccination site/throbbing pain at the site of the injection/bad pain near the shot.) 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 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE PAIN (Pain at the vaccination site/throbbing pain at the site of the injection/bad pain near the shot.). At the time of the report, VACCINATION SITE PAIN (Pain at the vaccination site/throbbing pain at the site of the injection/bad pain near the shot.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.  Patient would call back if he had any symptoms after getting the 2nd shot.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow Up Received on 01sep21 includes Significant Information and Reporter Declined FU
herpes zoster; severe cough, wheezing and shortness of breath/ diagnosed with pneumonia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 60 year old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On or about 10-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Patient suffered the following injuries and was diagnosed on the following dates as a result of zoster vaccine live (ZOSTAVAX): severe cough, wheezing and shortness of breath and was diagnosed with pneumonia on 22-JAN-2017. Additionally, patient has suffered with recurrent episodes of herpes zoster, which was initially diagnosed on 25-NOV-2017. The outcome of the events was unknown.  Upon internal review, pneumonia was considered to be medically significant.
Lump - Near Injection Site; Rash - Near Injection Site; Headache; Chills; Arm Tenderness - Near Injection Site/Arm Pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (Arm Tenderness - Near Injection Site/Arm Pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE MASS (Lump - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (Arm Tenderness - Near Injection Site/Arm Pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Lump - Near Injection Site), VACCINATION SITE RASH (Rash - Near Injection Site), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (Arm Tenderness - Near Injection Site/Arm Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
Pt noticed morning of 10/25 deltoid of (L) arm inflamed, red, but not painful. Shot received 10/23/15.
Pt recvd vax 14MAR92 & began inconsolable screaming 15MAR92 & 4PM until 17MAR92 w/only minimal sleep time; local sx of blisters on both legs from hips to knees; crying & blisters subsided w/o med tx;
Skin reaction to the opposite forearm (right). Looks like stretch marks/wrinkles, the area is also itchy. Has been coming and going about 24 hours since I had the injection to present.  Have not been able to identify any other cause.
I had weird feeling in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Jun2021 15:00 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  Vaccination history included: Flu shot (I got flu shot in Nov2020), administration date: Nov2020, for Immunization.  The following information was reported: ORAL DISORDER (non-serious), outcome "recovered", described as "I had weird feeling in my mouth". Additional information: The first COVID shot I had weird feeling in my mouth the hospital had me stay longer to keep an eye on me. Prior Vaccinations (Within 4 weeks) was none.  No follow-up attempts are possible. No further information is expected.
UrticariaPruritus Eventual 10cm round erythematous, painful, puritic induration was diag with cellulitis
Pt. was seen in the clinic to receive a Mantoux/tuberculin skin test. Two LPNs interviewed the patient regarding the requested test and left the procedure room to retrieve supplies. Both LPNs returned with one syringe of translucent solution already drawn up in the syringe with an intradermal needle at the end. LPN administered the dose in pt. right forearm, intradermally. Pt. indicated that it stung, which was unusual. Pt. left clinic with plans to return in 48 hours to have the arm looked at to confirm a negative/positive reaction. Pt. received a call from LPN approximately 7 minutes after leaving the clinic and was informed that instead of a Mantoux/tuberculin skin test being administered, the polio vaccine was given instead. Pt. was instructed to return to the clinic to receive the correct medication and a provider was being consulted in the meantime to give a recommendation for follow-up considering the wrong solution was delivered into pt. right forearm, without consent, and by the wrong route for that medication.
Following the 2nd shot I had rapid heart beats and high fever. Within 48 hours the heartbeats and chest pain continued to intensify. In 2.26.2021 I went to the ER and my heartrate was in the 150s/160s and my heart presented to be in failure. I was admitted to the hospital for 2 days because my troponin level was high and indicated heart issues. I had mulitple EKGs and other tests as well as a heart catheterization. The catheterization showed no blockages. My heart continued to have an arithmyia and PVCs as well as chest pain. I was diagnosed with myocarditis or periocarditis due to the effects of the vaccine and referred to a cardiologists. I have been seeing the cardiologist for 6 weeks. I had to wear a heart monitor, have an echo cardio gram and many EKGs. I have never had any heart issues prior to this vaccine. I am still under the care of the cardiologist and on heart anti-inflammatory medications due to the myocarditis. I have rapid, irregulary heart beats and am unable to do any physical activity.
I woke up around 2 in the morning with body aches, chills, and nausea. I started having muscle seizures that made me unable to talk, but I was still somewhat aware of things going on around me. I went to the ER where they observed my pulse and oxygen levels. I was also completed a full blood panel and an EKG was administered.   woke up aroound 2 am with body ached, chills nausea i started havieng mucle seizurs, where I couldn't talk .I went to the ER week to get better
Swelling of lymph node near collar bone same side as injection; swelling up into neck and shoulder
On 11/3 she started to feel ill. On 11/4 took off work with a stated (undocumented) fever and remained off work on the 5th and 6th. She did not see a physician but she was told she might have an allergic reaction.
Mother reports child has varicella disease verified by school nurse. Vaccinated 06/95.
Pt recvd 5 doses of Hep B vax on 28SEP88 & OCT88 & 14MAR89, & 7JUN91 & 10JUL91 & exp malaise;