chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: SUSPECTED COVID-19 (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown" and all described as "COVID"; GAIT INABILITY (hospitalization), outcome "unknown", described as "he can't walk". Additional information: Patient's daughter withheld called for assistance with colestipol. She stated my mom has C diff and she's taking colestipol hydrochloride but at this point my dad is in the living room in a hospital bed because he can't walk since COVID even though he got all 3 of your vaccines and than she yeah he's a whole another ball game but meanwhile my mom has C diff and colestipol the only thing stopping it and we can't afford to buy it anymore. The information on the batch/Lot number for [BNT162B2] has been requested and will be submitted if and when received.
Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Feb-2022, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.  The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-512521 (Patient Link).
First day: migraine, chills and stomach upset. Second day: headache and constant chills.
Hib component of the vaccine was inadvertently reconstituted; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 1 years old male patient who received Hib component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without DTaP-IPV component.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 23-Apr-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5543AA.  It was of actual medication error due to  inappropriate reconstitution technique.  It was not reported whether adverse event was experienced.  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.  List of documents held by sender: none.
Localized red, itchy rash on both right and left thigh. Father reported the rash started in only a small area, but spread the more the child itched it. Father reports putting VANICREAM on it, which helped but the child has continued to itch the rash. Father reports a fever today, but believes that is unrelated.
Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in an 8-month-old male infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding since 30-Jan-2021.    No Medical History information was reported.    On 30-Jan-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Jan-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Reporter email added.
Localized reaction surrounding injection site.  Fatigue Nausea Abdominal pain  Numbness/tingling in fingers and arms.  Feeling that things are moving faster than usual or things appear larger than normal. Decreased appetite Headache. More emotional than usual.  Feels like his body feels heavy.
Red rash that has become itchy and increased in size day 5 post injection underneath injection site
By 1400 had low grade HA, by 1600 more severe.  Managed with Tylenol.  1800 no appetite, and nauseated.  Continued through night.
Within 20 minutes after below vaccines, child broke out with severe urticaria and pruritis. No wheezing or respiratory problems. Appeared to start on arm injected with MMR and DTaP. Treated with oral Benadryl.
Client received TDP on 1-20-11 at approximately 11A, felt like she had flu within 15 min., 1230p had diarrhea, at 4pm felt itchy, developed red rash from shoulders up, swelling noted at injection site. At 5pm received 50 mg IM (RD) Diphenhydramine. 1-21-11 reports still itchy - took BENADRYL PO 830 1-20-11 - 11A 1-21-11.
I took the Pfizer vaccine/ last dose in March. That following year I did not have a period for 7 months, my GFR decreased/ kidney function issues, my heart rate began sky rocketing to 145 just when walking up steps and my asthma flared
11/18-Chills all over the body. 11/19-Runny nose, headache, body aches, fever.
pt recv vax & mom reports pt rt leg had become very swollen, red, hot & hard;called MD & was told to put head on it;MD felt it was infected;very sore when touched;abscess @ rt mid thigh;
Transverse myelitis aggravated; She feels her spine is broken in two; Can't walk without pain; This spontaneous case was reported by a consumer and describes the occurrence of DISEASE PROGRESSION (Transverse myelitis aggravated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myelitis transverse.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DISEASE PROGRESSION (Transverse myelitis aggravated) (seriousness criterion medically significant), SPINAL PAIN (She feels her spine is broken in two) and GAIT DISTURBANCE (Can't walk without pain). At the time of the report, DISEASE PROGRESSION (Transverse myelitis aggravated), SPINAL PAIN (She feels her spine is broken in two) and GAIT DISTURBANCE (Can't walk without pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was unknown. Treatment information was not provided.  Company comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Redness and swelling of upper left arm near injection site. Currently a large whelp at the site. Dr. examined the injection site 10:30 A.M. on 1/16/2014: a reaction to the shingles vaccine.
This spontaneous report was received from a 65-year-old female patient via a registered pharmacist. Current conditions included asthma, "heart", gout and an unspecified reaction to penicillin. On 14-MAY-2013 the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot # J000494, expiration date 14-APR-2014) subcutaneously in the right arm. No concomitant medications were reported. On 15-MAY-2013, the patient experienced a red area on her right upper arm about the size of a quarter below the Band-Aid. The area continually got bigger, described as red, swollen and to the point of redness being coffee-cup size and still swollen. Treatment was ice packs. It was unspecified whether laboratory diagnostic tests were performed. Medical attention was not sought by the patient. The events did not resolve at the time of this report. Causality was not reported. Additional information has been requested.
Patient stated that the same day she received flu like symptoms. She started having a pounding in her chest and she was breathing hard. Patient stated that she is still having severe fatigue. patient also stated that after she eats she experiences the chest pounding.
I have PCOS - and normally my periods are up to 40-50 days apart but they were normal in type of period but beginning May 7th 2021 and ending 5/13/2021 - is when I had a cycle for that month and May 27-June 2, 2021 had another cycle that month. The one again on June 11th -17th - and then another on July 9-15th and another on July 23-27th and then here we are in August and so far I started on the 16th of August and still have that one. It seems like I have been getting periods every other week since May.  Last normal length for me was in March and then it got shorter times between cycle each month since. The vaccines are the only thing I thing I can think of to cause an issue. I saw a GYN and I have had blood work done. They started me on Metformin (not for A1C - that's fine) - that stopped my Spironolactone. I have been going through changes to get my cycle to regularity.  I am taking Metformin right now and taking Prenatal and my cycles are really, really really heavy. Very heavy now at this time. I do get clots when I get my period and and they can be big now. It wasn't like that before. Note: In 10/20/2020  (1st in  MMR series) and then a month or two after the second vaccination of this second COVID Moderna  vaccine - I had an MMR vaccination done for work. I had a titer result that encouraged them (my work) to request the MMR vaccine.
This is a spontaneous report from a contactable nurse practitioner and another contactable nurse. A 17-year-old male patient of an unspecified ethnicity and race received, on 10Aug2016, the first dose of TRUMENBA, (lot M74091, expiry date Jun2017) intramuscular, in the deltoid (unspecified if left or right), at 0.5 ml, single dose, for immunization (prevention of meningococcal B). The patient medical history was not reported. Concomitant medication included intramuscular human papilloma vaccine (GARDASIL 9, Lot. L043214, Expiration date: 30Aug2017), received on 10Aug2016, for immunization. The patient experienced chills and fever, both on an 10Aug2016 with outcome of unknown. Emergency room or physician visit and hospitalization were not required. Specific tests and/or treatment were not required. The patient's mother did not think that the patient's experience was a reaction to the medication when the patient received the product. The nurse stated that there was a reasonable possibility that the events were related to meningococcal group b rlp2086. Follow-up (26Sep2016): New information reported from the contactable nurse includes: patient details, suspect drug and concomitant medication details, reaction data and reporter's assessment. Follow-up attempts completed. No further information expected.
This non-serious initial spontaneous case, was received from pharmacist on 22-Nov-2017, concerning a 55-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 22-Nov-2017, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration; intramuscular, anatomical location: deltoid, batch number: 195229, expiry date: May-2018). It was reported that, the patient received 2 doses in the same season (explicitly coded as inappropriate schedule of vaccine administered) and no adverse effects were noted. The reporter assessed the event as non-serious.
About 12 days after my vaccination, I began to experience ringing in my ears and lightheadedness. On May 9, it began, and it was very loud (more so on my right ear). Then it subsided and became more high pitched but less loud and noticeable, but more noticeable in my left ear. It continued for me as a new background noise for weeks. After some time, I went to an ENT, they did a hearing test, which came back normal.   The ringing continued. I saw my primary doctor. He suggested it might be seasonal allergies, despite this never happening to me before during allergy season. He prescribed an OTC nasal spray. The ringing continued and finally subsided during the 1st week of June. Every now and then my ear will feel full and ringing will return, but it?s sporadic now (really only happened twice from 5/30 - 6/3 and not constant anymore. Sometimes noticeable at night now.
NauseaVomiting Narrative:  Received vaccine on 12/28/2020 . Was doing well until one hour before the call. C/O of abdominal cramp, distention, nausea. No vomiting, temperature was 99.7F. No similar episodes before. No rash.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Nausea-Medium, Additional Details: after getting vaccine, pt felt dizzy/lightheaded. pt has had hx of fainting after getting vaccines due to anxiety. pt was very sweaty/hot. laid pt on the ground and instructed her to put legs up on the chair. provided water stated that was helping. nurse, lpn came and checked pts vitals. while we called 911. ambulance came and took her away. mom came back and said daughter was feeling better and did not go to ER
have shingles now, had shot years ago/Suspected vaccination failure; shingles; pain is unbearable; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comments:  This case was received from Consumer via interactive digital media. The reporter stated that the patient had shingles at the time of reporting. The patient stated that when told you get the shot. The patient had the shot years ago but  still got them and the pain was unbearable. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
FELT MISERABLE; VOMITTING VIOLENTLY; COULDN'T EAT; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (FELT MISERABLE), VOMITING (VOMITTING VIOLENTLY) and FEEDING DISORDER (COULDN'T EAT) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (FELT MISERABLE), VOMITING (VOMITTING VIOLENTLY) and FEEDING DISORDER (COULDN'T EAT). At the time of the report, FEELING ABNORMAL (FELT MISERABLE), VOMITING (VOMITTING VIOLENTLY) and FEEDING DISORDER (COULDN'T EAT) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications are not reported. The Treatment information was not provided.
Developed acute onset of back pain which then moved to RLQ, with fever to 103.8, nausea, and inability to tolerate PO intake.  C-reactive protein was 90.7.  CT scan revealed "thickening of the ascending colon, compatibile with inflammation, as in colitis."  Seen by peds GI, felt to be an acute process.  Was NPO for 2 days, CRP normalized by hosp day #4, and was discharged on hosp day #5, still with mild residual RLQ pain but much improved.
Redness, swelling about 6 inches x 3 inches (L) upper arm at injection site.
TIA (transient ischemic attack). ED visit to hospital admission. This visit was within 6 weeks of receiving the covid vaccine.
She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever.  By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids.  She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital.  We arrived at the hospital just before 0700 and she immediately threw up in the trash can.  We went into a treatment room and they took blood and started fluids as she became incoherent.  She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver.  She was air evade about 0930 to Medical center and just over 30 hours latter she was dead.  There is a pending autopsy.  She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl.
Six (6) hours post-injection, I started feeling tired, which I chalked up to the vaccine as colleagues had reported similar symptoms.  By late evening, the lethargy increased to to point that I retired early for the night, around 8:30pm.  By 9:00pm, chills and a feeling of having a fever overtook me to the point that I thought I had a severe case of the flu.  For the next 2 hours, I was basically trying to remain still and not touch any cool sheet or pillow as it was exceedingly cold to me.  Although I felt as if I had a fever, my temperature remained normal.  At approximately 11:00pm, the "veil" lifted and the chills and "fever sense" were abating.  By 11:30pm, I was able to get out of bed and use the bathroom, albeit somewhat weak, unsteady and having lower back soreness.  Sleep was uneasy for the remainder of the night but I did manage some.  When I awakened at 7:30am, the only symptoms were the previously reported lower back pain and now all my joints were sore.  As of late afternoon, the back soreness ended, but the joint soreness continues even now at 3:00pm, but is lessened with ibuprofen.
10 MINUTES FOLLOWING VACCINE - SOB, COUGH, TIGHTNESS IN CHEST, THRAOT SWELLING, DIFFICULTY SWALLOWING, LIGHT HEADEDNESS, AND ELEVATED HEART RATE.  ORAL AND IM BENADRYL ADMINISTERED, 2 DOSE OF EPINEPHRINE, 2 NEB TREATMENTS, O2 PLACED. 911 CALLED AND TRANSPORTED TO EMERGENCY FOR FURTHER TREATMENT AND MONITORING. AT HOSPITAL IV STEROID ADMINISTERED. SYMPTOMS SUBSIDED WITH SECOND DOSE OF EPINEPHRINE, HOWEVER RETURNED 3 HOURS LATER AND ANOTHER DOSE OF BENADRYL ADMINISTERED. ELEVATED HEART RATE CONTINUED AND IV FLUIDS ADMINISTERED TO ATTEMPT IN BRINGING DOWN HEART RATE. IV FLUIDS WERE NOT EFFECTIVE. HEART RATE (118-120) REMAINED ELEVATED INTO THE OVERNIGHT HOURS AND SUBSIDED AROUND 1:30A ON 12/29/2020. CONTINUED HEADACHE, NAUSEA ONSET, FATIGUE, DIFFICULTY SWALLOWING AND COUGH  ON 12/29/2020.
Case number PHEH2016US008122, is an initial spontaneous report received from a health care professional via pharmacy on 01 Apr 2016. This report refers to a 71 years old male patient. Historical condition was not reported. Current conditions included asthma, aspirin allergy and epilepsy. Concomitant medication included KEPPRA. The patient received FLUVIRIN (lot number: 1516001, expiry date: 30 Jun 2016) at a dose of 0.5 ml intramuscularly into left arm on an unknown date. Since the vaccination the patient experienced pain in upper right arm. The outcome of the event was unknown. The seriousness and causality was not reported.
Initial unsolicited report was received on 12 December 2014 from a consumer who is also the patient's spouse. A male patient had received on an unspecified date an Influenza vaccine (Sanofi Pasteur lot number and administration details not reported) and an unspecified amount of time later developed flu like symptoms including fever, headache and body aches. The patient was treated with antibiotics. The patient was being hospitalized for pneumonia at the time of the report. Outcome was not reported. Documents held by sender: none.
Severe headache, swollen and severely painful cervical lymph nodes,  sore throat, sneezing, extremely runny nose, severe fatigue,  burning eyes and lie grade fever which started approximately 23 hours after vaccination and were mostly resolved 30 hours later. Completely gone the next morning (41 hours after vaccination)