chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up feeling weak; Blood pressure and it is low; Tremors to my whole head and my hands/ Tremble in head and hands; Tremors to my whole head and my hands; This is a spontaneous report from a contactable consumer or other non hcp.   A 80-year-old female patient bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 30Jul2021 13:30 (Batch/Lot Number: FA7485) as Dose 1, Single (age at vaccination:80-Years-old) for Covid-19 immunisation. Medical history included head tremors from an unknown date and unknown if ongoing (I have had head tremors for years, but it has been 5 years since it bothered me last, and underwent surgery on 16Jul2021(She had surgery on 16Jul2021, but she doesn't know if that would've had anything to do with it. There were no concomitant medications. Family medical history relevant to AE(s) was None. On 02Aug2021 the patient experienced woke up feeling weak, blood pressure and it is low, and tremors to my whole head and my hands/ tremble in head and hands. States she woke up feeling weak, and it did not get better so she checked blood pressure and it was low; it usually comes back up, but its staying low, also feeling tremors to whole head and hands. On 02Aug2021 the patient underwent lab tests and procedures which included blood pressure measurement: low. States she doesn't know if they are side effects or not but her blood pressure is really low, and she can't get it to come back up, she also had trembles in her head and hands. Patient was asking are these normal side effects from the vaccine. Case is non-serious. The events not resulted in emergency room visit/ Physician office visit. The patient had not received treatment for all the events. The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Initially night of the vaccine 3/2/2021 body felt hot, felt sweaty but temp was 98.0, unable to sleep through the night. just felt uncomfortable. Morning of 3/3/2021 woke up with extreme pain in injection sight, sweaty, but cold, dizzy and weak, no fever., Could not stand up.  Was sat down on sofa for maybe 2 mins. all of a sudden shoulders drooped, head fell forward, I asked "dad are you ok" there was not a response, I walked closer to him and his head flew back, his eyes were slit open, and he started gasping for air 3 times then slumped forward and passed out. 911 was called paramedics checked all vitals including blood sugar, oxygen, heart rate etc everything registered as normal.
Red, some small and some big splotches; Itchy, some small and some big splotches; Flu-like symptoms 10 days before second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu-like symptoms 10 days before second dose), RASH ERYTHEMATOUS (Red, some small and some big splotches) and RASH PRURITIC (Itchy, some small and some big splotches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included LORATADINE and FLUTICASONE for Allergy.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced INFLUENZA (Flu-like symptoms 10 days before second dose). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red, some small and some big splotches) and RASH PRURITIC (Itchy, some small and some big splotches). At the time of the report, INFLUENZA (Flu-like symptoms 10 days before second dose), RASH ERYTHEMATOUS (Red, some small and some big splotches) and RASH PRURITIC (Itchy, some small and some big splotches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. The patient reports that she suspects she is now dealing with shingles, although not diagnosed by a doctor. The patient thinks that she overlooked the onset of the shingles flare up that started on her leg (after the first dose), and progressively spread to her arm, neck and back.   This case was linked to MOD-2021-169634 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up
2nd appointment for 12Mar2021. 46 days apart; A spontaneous report  was received from a consumer concerning a 90 years of age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reporting Inappropriate schedule of product administration.  The patient's medical history was not provided. No concomitant were reported.   On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown)  in the unknown route for prophylaxis of COVID-19 infection.   On 25 Jan 2021, prior to receiving mRNA-1273, patient got 2nd appointment for 12 Mar 2021 which was 46 days apart. No treatment  information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event,  2nd appointment for 12 Mar 2021 which was 46 days apart  was considered as recovered.; Reporter's Comments: This case concerns a 90 year-old female patient who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration without any associated adverse events.
Patient came out from her room and standing at nurses's station for her 2nd and 3rd GARDASIL appointment. Suddenly she fell on ground and hit her head. Remain unconscious for less than min turn pale and clammy.
Leg cramps, paresthesia in hands, calves and feet, some numbness, muscle spasm in upper back, worsening of headaches, nerve irritation and excitability evident during nerve studies.
soreness at vaccination site, achy muscles and joints, feel feverish but no fever, slightly nauseous. Symptoms started about 12 hours after vaccination and lasted about 48 hours.
Narrative:  Pt is a 91 YO male with PMH of OSA, dyspnea, EtOH abuse, HLD, HTN, sarcoidosis, and bradycardia. Facility was notified by agency of the patient's death.
fatigue Narrative:  64 year old patient with pertinent PMH of active metastatic RCC, adrenal insufficiency on hydrocortisone reported to ED on 2/09/2021 with nausea, vomiting, diarrhea and change in metal status. Given fever and hypotension, initial suspicion was for sepsis. During the ED visit as the infectious workup continued to return largely normal, suspicion shifted towards complications from adrenal insufficiency. Notably patient has a history of COVID in December which he has recovered from and received his second dose of COVID vaccine 02/08/2021. Upon admission patient showed improvement with empiric broad spectrum antibiotics given initial SIRS+ diagnosis, stress dose steroids and fluid resuscitation. At that time, highest suspicion was for a reaction to the second COVID vaccine which may have caused a mild adrenal crisis resulting in the GI symptoms and hypotension which resolved through out admission. Patient did have dental carries which was suspected as the potential source of infection. Inpatient work up ruled out urinary, pulmonary, substance ingestion and acute intracranial processes as sources of infection. Patient was discharged on 2/11/2021 (2 days later) with the medical team in agreement with patient's oncologist suspecting that patient had a strong reaction to the COVID-19 vaccine which caused fever, fatigue and nausea. Because he previously had COVID infection with adrenal insufficiency, an inflammatory response to the vaccine was more adverse for the patient.
interchange of vaccine products; open heart surgery; the right side of her head has less hair than the other/ thinning; the right side of her head has less hair than the other/ breaking off on one side; anxiety; high blood pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): CMOD22-04197 (Moderna).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: Moderna covid-19 vaccine (DOSE 1, SINGLE, LOT: UNKNOWN), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE, LOT: UNKNOWN), for Covid-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; CARDIAC OPERATION (medically significant), outcome "unknown", described as "open heart surgery"; ALOPECIA (non-serious), outcome "unknown", described as "the right side of her head has less hair than the other/ thinning"; TRICHORRHEXIS (non-serious), outcome "unknown", described as "the right side of her head has less hair than the other/ breaking off on one side"; ANXIETY (non-serious), outcome "unknown"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High, notes: high blood pressure. Therapeutic measures were taken as a result of anxiety, hypertension.  Clinical course: Reporter calls in to report that she had the first and second doses of the Moderna Covid-19vaccine and Pfizer for the 1st booster dose. She would like to know if these vaccines could cause her hair to come out. She states that the right side of her head has less hair than the other. It is thinning and breaking off on one side. She said she was not in too much trouble after the 1st 2 doses. She does not have any allergies. She had open heart surgery, anxiety and high blood pressure (not clear if these were present prior to getting the vaccine). She takes Xanax and unspecified medication for the high blood pressure. No other information was provided as she only wanted to know if her hair problem was caused by the vaccine, submitted AE with limited information. Seriousness criteria client data: Method of contact disc used: Yes. There was no product complaint associated with this case.  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.
Not immunocompromised got the booster shot for 0.5ml; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Not immunocompromised got the booster shot for 0.5ml) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced OFF LABEL USE (Not immunocompromised got the booster shot for 0.5ml). At the time of the report, OFF LABEL USE (Not immunocompromised got the booster shot for 0.5ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The reporter stated that they knew someone who was not immunocompromised and got the booster shot for 0.5mL.
Immediate pain, then swelling and bruising at injection site.  Over 7 - 10 day period developed right radiculopathy (back pain with numbness right leg.)  Not responsive to conservative treatment (rest, ice, NSAID, PT).  Exam has been unremarkable, but symptoms have persisted.  Neurology consultation unrevealing.
Also got a cough; I have a cough too; Did have a fever when they gave me the shot; This is a spontaneous report from a contactable consumer (reported for herself). A 74-year-old female patient received BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot number: EN6207 and Expiration date: Not reported), via an unspecified route of administration on 17Mar2021 (age at vaccination 74-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history included diabetes, cold. There were no concomitant medications. It was reported that she went in with the cold, she had cough too, she did have a fever when they gave me the shot. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021322551 same reporter/SD, different patient/AE
Abdominal pain; pain and soreness at the site of administration; Slight headache; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), INJECTION SITE PAIN (pain and soreness at the site of administration) and HEADACHE (Slight headache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Past medical history not provided).    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE PAIN (pain and soreness at the site of administration) and HEADACHE (Slight headache). On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain). At the time of the report, ABDOMINAL PAIN (Abdominal pain), INJECTION SITE PAIN (pain and soreness at the site of administration) and HEADACHE (Slight headache) outcome was unknown.            Concomitant medications taken by the patient were not provided. Treatment information was not provided.
No reaction immediately after receiving vaccine.  Next day, 1/10/2021, noted left axillary pain, minimal pain at left deltoid injection site.  Used Tylenol for ineffective relief of discomfort.  Next day, 1/11/21, noted swelling and pain along left collarbone area on chest/neck area.  Called to speak with Dr.  Told that I had left supraclavicular lymph node swelling causing discomfort, and still had swelling of left axillary lymph node causing discomfort.  Also noted minimal left groin lymph node enlargement with no pain.  Told to monitor symptoms and continue to use Tylenol or Advil as needed.  Recommended that I call back if symptoms worsen, change or have additional symptoms.
Severe rash, followed by hives and 12 hours of vomiting. MD visit 10/25/2001 AM. Treatment: cortisone, liquid Benadryl, liquid Prednisone and Phenegran suppository. Mom is an RN.
Patient said vaccine hurt immediately following administration. I told her some soreness was to be expected particularly with the Gardasil vaccine. She came to me on 09/28/2015 stating that her arm hurt so much she couldn't lift it and couldn't even use it to straighten her hair this morning. She also had a softball sized bruise on her arm.
Within a few hours I experienced widespread joint pain and headache. The next day (just over 24 hrs after receiving the vaccine) I developed a fever. My fever reached 101 at its highest. 48 hours after injection my fever had reduced to 99.6. This morning  (72 hrs after injection) my fever has resolved itself. I continue to have pain and swelling at the injection site and a reddish rash in the same area.
Injection site: Swelling, itching for 1 week. Headache, chills, diarrhea, upset stomach, joint and/or muscle aches for 6-7 days. No treatment given/sought by patient.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-AUG-2013, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 30-JAN-2017, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Beginning 36 hours after injection. noted red, swollen from DtaP site and more distally. Total area 4x4 inches with mild swelling and tenderness.
Noticed a cold sore type place in the middle of her top lip after receiving her 3rd Gardasil dose earlier in the day. Denies any other side effects. States sister does get these cold sores but that she has never had one before. Client states that she did not run a fever with the vaccine.
Hypotonic-hyporesponsive episode following Pediatrix (DTaP/IPV/HepB).
reactive arthritis; joint pain; This is a spontaneous report from a contactable other healthcare professional.  An 80-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced reactive arthritis on an unspecified date with outcome of unknown, and joint pain on an unspecified date with outcome of unknown.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101133832 Same Reporter/Patient/AE/Drug, Different Vaccine Dose
Pt. developed rash on both lower legs he states it does not itch, but he feels kind of "queasy".
1. Patient received Pfizer monovalent Covid vaccine after authorization for use expired April 18, 2023 2. Patient was prescribed Pfizer Bivalent Covid vaccine and was administered monovalent in error.
Child fainted immediately after vaccine administered, some stiffening of legs but no tonic-clonic movements.  He was pre-syncopal prior to the event and sitting when it happened, the nurse caught him.
I have a lump on the left side of my neck. It doesn't seem to be going down either. I have a lump in my throat as well and it feels like someone is choking me. This is still going on at this time.
Fever 102-103 for 14 hours, chills, extreme aches, severe headache
11/9/11 - Vaccine administered without incident. On 11/10/11 client began to not feel well in school with c/o "legs" hurting, fever -102.6. Client instructed to call pediatrician. Client reports on 11/15/11 that child's temp increased to 103 degrees & then child started saying that he could not walk because of the pain. On Friday clients leg pain resolved on MOTRIN in alternating with TYLENOL. Fever until 11/12/11 & coughing & aching for 1 week past vaccine. All symptoms resolved.
short of breath started 12/26, loss of appetite, myalgias, cough, fever, and feeling excessively weak started on decadron and remdesivir
Pt.  received the Pfizer covid-19 vaccine at 4:30pm after about 5 minutes (16:35) he indicated to technician  that he was feeling dizzy. Pharmacy manager  was informed of the patient status. I then went to sit with to engage in conversation. After about 5 minutes (16:40)  did not respond to any questions. I instructed technician  to call 911. then began to heave and then vomited at (16:42). Post emesis he regained alertness and EMS arrived on the scene (16:45) an provided care for . He was in their care for about 20 minutes and began to feel better.  left the store at about 5:15 under his own power.
Patient went to an urgent care today and she said she has cellulitis.  The doctor gave her a prescription for Doxycyline Hyclate 100mg capsule - 1 capsule twice daily for 10 days.
Reports on 2/18/15, she had itching at site of vaccination and felt some bumps on (L) upper arm. States she rubbed her arm/area and did not look at it. Reports on 2/19/15 after waking up, she looked at her arm and it is red and warm to the touch. States redness is from 1 inch below (L) shoulder down around muscle, reporting the whole upper arm. No treatment applied by client.Cleint state she has called her primary doctor and is going to go by there later today for them to look at it. States it does not hurt or is painful. 2/19/15 630 pm Phone call to client to follow-up after dr visit. Client states she did not go to her Primary dr. after all. Reports that she ran into one her friends and friend' daughter that is "higher than an RN." Said she had that nurse look at it and she told client that "it was from the shot and it looked like a normal reaction from pneumonia vaccine" and recommended BENADRYL. Client states she started taking BENADRYL po this afternoon.
Information has been received from an investigator via agency concerning a patient who was enrolled in a study. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 and RECOMBIVAX HB (manufacturer unknown). This report was part of a post-marketing surveillance program. Subsequently the patient experienced erythema (grade 3). The reporting investigator felt that erythema (grade 3) was definitely related to PNEUMOVAX 23 and was not related to RECOMBIVAX HB (manufacturer unknown). Erythema (grade 3) was considered to be an other important medical event.
Covid vaccine was administered to patient past BUD date and therefore was not valid. Patient did not have any adverse event post vaccination. Due date 12/11/2023