chrisvoncsefalvay/vaers-outcomes huggingface dataset:
spine so hurt and hurting on the left side; hurt in my left kidney in the back; short breathe; afraid to sleep; temperature go 104, 102; back pain/back so hurt/feel pain in my left back; feels so bad, unbelievable; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain/back so hurt/feel pain in my left back), VACCINATION COMPLICATION (feels so bad, unbelievable), SPINAL PAIN (spine so hurt and hurting on the left side), RENAL PAIN (hurt in my left kidney in the back) and DYSPNOEA (short breathe) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021 and Stroke.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced BACK PAIN (back pain/back so hurt/feel pain in my left back), VACCINATION COMPLICATION (feels so bad, unbelievable), DYSPNOEA (short breathe), INSOMNIA (afraid to sleep) and PYREXIA (temperature go 104, 102). On 08-Oct-2021, the patient experienced SPINAL PAIN (spine so hurt and hurting on the left side) and RENAL PAIN (hurt in my left kidney in the back). At the time of the report, BACK PAIN (back pain/back so hurt/feel pain in my left back), VACCINATION COMPLICATION (feels so bad, unbelievable), SPINAL PAIN (spine so hurt and hurting on the left side), RENAL PAIN (hurt in my left kidney in the back), DYSPNOEA (short breathe), INSOMNIA (afraid to sleep) and PYREXIA (temperature go 104, 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2021, Body temperature: 104-102 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she had an appointment on Monday 11Oct2021 with her doctor. had hurt in her left kidney in the back She states that this is the same as when she had COVID previously  No concomitant medication were reported  No treatment information was provided
Forearm of injection arm went numb; Tingling in fingers of injection hand; Injection site was extremely sore,level 10 pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Forearm of injection arm went numb), PARAESTHESIA (Tingling in fingers of injection hand), VACCINATION SITE PAIN (Injection site was extremely sore,level 10 pain), PYREXIA (Fever) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced HYPOAESTHESIA (Forearm of injection arm went numb), PARAESTHESIA (Tingling in fingers of injection hand), VACCINATION SITE PAIN (Injection site was extremely sore,level 10 pain), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Mar-2021, HYPOAESTHESIA (Forearm of injection arm went numb), PARAESTHESIA (Tingling in fingers of injection hand) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection site was extremely sore,level 10 pain) had not resolved and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 99.1 (normal) 99.1 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Instant arm pain, red hot cheeks, high heart rate, numbness and tingling on face and in nasal passages,  Was told to take benedryl and Pepcid.
9/6/2019 12:35 pm c/o quarter size bump at (L) deltoid; hot & itchy, sl. redness. (- SOB, - fever) 9/6/2019 4:21 PM - swelling @ (L) lymph node 9/9/2019 9:33 AM - (L) clavicle pain/swelling resolving
Joint aches, extreme fatigue x 3 wks; raised red bumps on chin lasted 1 mo; fever 101 x 48-72 hrs;
Developed fever, body aches, headache, uncontrollable shivering within 12 hours of administration.  This lasted 72 hours.
Patient complained of her arm/hand feeling funny/numb about 10 minutes after 1st Pfizer dose was given.  Offered patient water and asked if she'd like me to call EMS but she did not want me to.  At that point I offered to give her a dose of bendryl to which she declined.  She stayed in the waiting area for about 5-10 more minutes before leaving and stated that she was ok.  At that point I advised her to still take benadryl once she got home.  Prior to giving her the vaccine she started crying in the booth and voiced her concerns about the vaccine impacting her fertility and that her employer made it mandatory. She left to go to the bathroom and returned 30 minutes later but at that time we were closing for lunch so she ended up coming back right after 2pm to get her vaccine.
Patient had redness quarter size around the area of the injection, she stated she had no SOB, swelling, or pain in the injection site
Patient reports having chest discomfort about 5-10 minutes after getting vaccination. Vitals stable, she was observed for 30 minutes and patient notes symptoms have improved.
Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023; No adverse event; Dose were administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose were administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023) and NO ADVERSE EVENT (No adverse event) in a 7-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7644C and AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Aug-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose were administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose were administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose were administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 10-JUL-2023 and administered to patient on 11-AUG-2023).    Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 10-JUL-2023. Vial did not undergo any temperature excursion. Vial size was reported as 2.5 milliliter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-737985, US-MODERNATX, INC.-MOD-2023-737989 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737985:Patient 2 US-MODERNATX, INC.-MOD-2023-737989:Patient 3
had diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart disorder" (unspecified if ongoing); "Blood pressure abnormal" (unspecified if ongoing); "Blood cholesterol abnormal" (unspecified if ongoing); "swelling on my leg" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for peripheral swelling; ESPERAL taken for peripheral swelling; CALCIUM and other routine medicine for blood pressure and cholesterol. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "I had in the first two shots and I had no problem but ever since I had the shot the very right next day I have had diarrhea". The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "had diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea  Additional information: Patient was treated with Alka Seltzer, Tums and Imodium.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
6 days after injection developed severe armpit pain and lymph node swelling. Day 7 woke up with hard, red, warm bump below site of injection with excruciating pain and limited arm movement. Seen by MD and started on antibiotics for cellulitis.
This spontaneous report as received from a 43 year old female patient refers to herself. The patient had no pertinent medical history and no drug allergies. There was no concomitant medication. On 19-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not reported). It was reported that "while on PNEUMOVAX 23" (date unspecified), the patient was diagnosed with having an unknown immunodeficiency issue. The patient experienced more infections. The patient did not seek medical attention. No lab diagnostics studies were performed. No treatment was given. At the reporting time, the patient was still fighting some of these infections. The outcome of the event was reported as not recovered. Upon internal review, unknown immunodeficiency issue was considered to be medically significant. Additional information is not expected because we are not allowed to contact the reporter and her physician.
Patient states hives in "creases/warm areas" called on day four and reports she had been taking BENADRYL for the hives and they are almost gone now. Advise 25mg BENADRYL is 10mg ZYRTEC BID.
Nausea; chills; has not been feeling well; Feel like been run over by a MAC truck; Headache; 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 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 13:30 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "copd", start date: 2011 (ongoing), notes: she was diagnosed with beginning stages of COPD in 2011.; "had cancer removed", start date: 23Dec2020, stop date: 23Dec2020; "cancer" (not ongoing).There were no concomitant medications.  The following information was reported: HEADACHE (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 11Apr2021, outcome "not recovered", described as "Nausea"; FEELING ABNORMAL (non-serious) with onset 09Apr2021, outcome "recovering", described as "Feel like been run over by a MAC truck"; CHILLS (non-serious) with onset 11Apr2021, outcome "not recovered", described as "chills"; MALAISE (non-serious) with onset 09Apr2021, outcome "unknown", described as "has not been feeling well".  Additional information: Patient received the covid vaccine on 9Apr2021. She would like to know how long will the symptoms last. The patient felt fine up until the night of Friday, 09Apr2021 and had not been feeling well since the night of Friday, 09Apr2021, after receiving the first dose of the Covid-19 vaccine that afternoon. She felt like she have been hit by a MAC truck and was feeling a little better but all she wants to do was sleep. She was at work and wasn't feeling well and ended up leaving her purse at work. So she was unable to provide product details as her vaccine card was in her purse. The patient reported that headache, nausea and chills were worsened. No Additional vaccines Administered. AE did not require a visit to Emergency Room and Physician Office. No Prior Vaccinations (within 4 weeks) and no AE following prior vaccinations. No Family Medical History Relevant to AE and no Relevant Tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm IM injection of Pneumovax:  Two red "streaks" horizontally at injection site, 1-1.5" length, raised, not itchy.
15DEC91 flushed face & rash/whelps; 20DEC91 fever-102-105; pt seen by MD rash on face then spread to entire body itchy;
Developed left axillary lymphadenopathy 48 hours post 2nd dose of vaccine. Lymph node measured 4 cm x 2.9 cm x 3.9 cm and is described as having a thin cortex and fatty hilum. Said lymph node was biopsied via core needle and fine needle aspiration on 02/02/2020 and pathology is consistent with reactive lymphoid changes, with lymphocytes and red blood cells present. Sample was sent to Lab for additional testing and results remain consistent with reactive follicular and paracortical hyperplasia.
Pink blotch; vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Pink blotch) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE RASH (Pink blotch) and VACCINATION SITE ERYTHEMA (vaccination site erythema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Pink blotch) and VACCINATION SITE ERYTHEMA (vaccination site erythema) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-060111 (Patient Link).; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.
Moderna COVID?19 Vaccine EUA  I received a Moderna covid-19 vaccination (Lot # 007M20A)  at 10:20 AM on Monday 02-01-2021 at the VA Clinic .  Between 3 and 4 minutes later I began to experience difficulty breathing, sweating and feeling warm, and then I passed out behind the steering wheel of my parked car, while sitting with my wife.  I came to after few minutes as people were attempting to get me out of my car and into a wheelchair, but I had difficulty breathing, couldn?t move, and had to be pulled out.  After being put in the wheelchair, I passed out again and came to after I had been taken out of the wheelchair and laid on my left side on the ground by Fire Dept. EMT?s.  I then began to retch, but did not vomit.   My wife said that one of the EMT?s pumped my chest a couple of times. They lifted me onto a gurney and put me in an ambulance, hit me with an EPI pen, and placed an oxygen mask on my face, as I was having great difficulty breathing.  I was unable to move or lift my arms to help them place a blood pressure cuff on my arm, a pulse monitor on my finger, and lift my shirt to help them attach EKG pads. Atthat point I realized that I had also lost control of my bladder at some point. I continued to have difficulty breathing, and started to experience extreme shivering all the while to emergency Room. Once in the Emergency Room, I could not move myself off the FD gurney, and they had to lift the sheet that I was laying on in order to move me onto the hospital gurney. I had great difficulty helping the technicians remove my shirt so that they could administer another EKG and start an IV (LR 1,000ml bolus).   I continued to have difficulty breathing and kept shivering and sweating for some time.  I was advised that the EKG?s both appeared normal.  After a lengthy period of I gradually reached a point where I stopped shivering and sweating, and returned to almost normal breathing.  I was finally released around 1-1:30 PM.
1) Polymorphous Light Eruption, 5/3/21 to present. 2) Shingles, June 14, 2021 for approximately 4-5 weeks. 3) Following PLE, Gluten and sulfites sensitivity also emerged, ongoing.
Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left arm and severe headache 12/19/20
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted after injection but was fine after laying down for roughly 15 min.  gave h2o and waited 30 min before ok to drive home.  consulted parents... will drive son to next appt.
INTESTINAL OBSTRUCTION; Information has been downloaded (US-EMA-20110128-slalp-153927830).  This spontaneous report was received from a physician referring to a 2 month old female patient.  No information was provided regarding the patient's medical history, current conditions or concomitant medication.     On 30-APR-1999, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # 0602 for an unspecified indication (dose, route of administration, and expiration date were not reported).    On 27-MAY-1999, the patient was vaccinated with hib conj vaccine (crm197)(HIB-TITER VACCINE), lot # 402203A, poliovirus vaccine inactivated (unspecified)(POLIO VACCINE "PASTEUR"), lot #M1295, both therapies for an unspecified indication (dose, route of administration, and expiration date were not reported).  Other suspect therapies administered on the same day included rotavirus g1 g2 g3 g4 reassortant vaccine live (human-rhesus)(ROTASHIELD) oral solution, lot # 4988055, via oral, for immunisation, and diphtheria toxoid, pertussis acellular biken vaccine, tetanus toxoid(TRIPEDIA)., lot # 0089570 (dose, route of administration, lot number and expiration date were not reported).      On 30-MAY-1999, the patient experienced intestinal obstruction and was hospitalized.  The outcome of intestinal obstruction was reported as recovered (on an unspecified date).   The reporter did not assess the causal relationship between suspect therapies and the event.  The Agency considered intestinal obstruction medically significant.  Lot number 0602 is an invalid lot number for hepatitis b vaccine (recombinant).
No adverse event - patient was just given vaccines that he was too young to receive. Patient was 25 days old when he was given Hepatitis A and Proquad (MMRV) which are not due until 12 months of age. Patient was also given a Hepatitis B vaccine, which is age appropriate for patient. Parents stated no issues or reaction to vaccines being given. Patient to be monitored once weekly for the next 6 weeks.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was reported. This case was linked to MOD-2021-395985 (Patient Link).
Fever & hoarseness 10/27/11 onset x 5 days duration; maximum temperature 101.5 degrees F. Cough, sore throat & nasal congestion 10/28/11 onset x 2-3 day duration. Decreased appetite & "weakness" 10/28/11 onset x 3-4 days.
Bells Palsy; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 25-Apr-2021, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). On 24-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, BELL'S PALSY (Bells Palsy) outcome was unknown.            Action taken with the mRNA-1273 in response to the events was not applicable. Treatment medication are Valacyclovir, Prednisone and Gabapentin. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Within a few minutes of receiving the vaccine, I felt constriction in my throat and a tightening in my chest. These symptoms continued to build in the next hour, with feelings of complete body pain and a general feeling of being ill. My blodd pressure was elevated when I got to the doctor office. I ended up in the ER where they gave me an anti inflammatory shot.  I went home and continued taking a high dose of over the counter anti inflammatory  for 3 days until my stomach couldn't handle it. I had breathing difficulty for 9 days with tremendous fatigue, I am a high energy person normally. For 9 days I also had high blood pressure whenever I was on my feet for 30 minutes or more. I had a lot of nausea, dizziness, and a deep headache. I had lung pain and a deep back pain. 11 days after my vaccine, I still have back weakness and trouble breathing if walking upstairs, minimal activity.
Dizziness, nausea, backache soon after, but went to work 1/31/21 woke up and had palpitations, dizziness, vomiting, chills, body ache, headache, runny nose intermittently all day 2/1/21 continued to have palpitations into the evening 2/2/21 no further palpitations today