chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 83 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "hypothyroidism" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: Amlodipine; Aspirin [Acetylsalicylic Acid]; Hydrochlorothiazide; Levothyroxine; Klor-Con M20; Glucosamine + Chondroitin Sulphate; Calcium. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Computerised tomogram head: (unspecified date) Closed fracture of nasal bone and, notes: to ED CT head neck face. EKG. Closed fracture of nasal bone and laceration of nose; Computerised tomogram neck: (unspecified date) Closed fracture of nasal bone, notes: to ED CT head neck face. EKG. Closed fracture of nasal bone and laceration of nose. resulting in sutures; Electrocardiogram: (unspecified date) Unknown results, notes: EKG. Closed fracture of nasal bone and laceration of nose. resulting in sutures; SARS-CoV-2 test: (25Jul2022) Positive, notes: COVID positive 25Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks includes Amlodipine, aspirin, hydrochlorothiazide, Levothyroxine, Klor con M20, Glucosamine/Chondroitin and Calcium. COVID positive 25Jul. started Paxlovid that evening. Developed diarrhea on 27Jul. stood from toilet, took several steps, syncopal episode and hit head. to ED CT head neck face. EKG. Closed fracture of nasal bone and laceration of nose. resulting in sutures. Patient received treatment for AE and AE stop on 29Jul2022.
patient was supposed to receive Pneumovax but she received Prevnar by accident. She had already received Prevnar last year and she was due for Pneumovax. She doesn't really report any side effects.
Extreme muscle weakness, spasms and inflammation of joints requiring 2 week round of prednisone
Pt got shingrix on Tuesday, started feeling pain in front chest/ abdominal area on Friday.  Went to doctor on Saturday . Doctor said it?s likely shingles. Patient got shingles sores appear in his lower back on Sunday
given an expired Ipol vaccination/No AE; Initial information regarding an unsolicited valid non-serious case was received from a Nurse via consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00533472) and transmitted to Sanofi on 24-Mar-2021.  This case involves a 5 years old female patient who receive expired dose of IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  On 15-Mar-2021, the patient received once 0.5 mL dose of suspect IPV (VERO) lot R1B25, expiry date 15-Mar-2021 via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of report there was no adverse event was reported.  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.
Pt received JJ vaccination, and subsequently moved to the patient monitoring area. Approximately 2 minutes after waiting in the monitoring area pt states he experienced flushing, dizziness and clamminess then ?passed? out for approximately 20 seconds while in a seated position. Syncope was witness by patients girlfriend. RN didn?t witness pt syncope, but noted patient laying in the seat then immediately alerted me. Pt was recovering in a seated position when I arrived, with noted pt w/ diaphoresis with no associated respiratory distress. While I was collecting pts history said he didn?t want to talk about it anymore in an attempt to calm himself down, approximately 2-3 minutes later I witnessed pt have another syncopal episode which lasted 15-20 seconds while in seated position. Pt regained consciousness and I had an employee help me move pt to the floor for recovery. Pt displayed no signs of respiratory distress, denied chest pain and headache. Pt states syncope is his typical response after vaccinations or blood draws, last occurrence was 8 months ago during a blood draw. Pt states these syncopal episodes initially started in childhood and has gotten worse as he has gotten older, pts father also experiences these episodes. Pt declined EMS several times. Pt was monitored for 41 minutes, vitals taken twice while pt was in recovery on the floor, vitals were stable. I had pt lay supine on the floor for approximately 15 mins post syncopal episode. After recovering for 15 mins I had patient sit upright on the floor, reassessed him and repeated vitals which were stable, pt reported feeling well. After approximately 10 mins pt was helped up into a seat, vitals were stable and patient reported feeling well and having no complaints. I had pt stand and repeated vitals which continued to be stable and pt reported no complaints. Pt drove to the vaccination site in a rental care which he states he will leave parked close to vaccination site and initially states he?d walk. I recommended pt and girlfriend take a free ride home which the agreed to do. I personally walked the patient up the stairs which pt was able to do with no problem and no reported complaints. Pt was given strict ER precautions and given resources for primary care also. Pt stable at the time of discharge. Pt declined follow up.  Pt stable at the time of discharge. Pt accompanied by with girlfriend, who will get pt home via ride.
Pt noticed sandpaper-like rash on legs near kneecap on both legs. small rash on upper abdomen. Benadryl helped a little. Site of injection with problems.
1/21/21:  Immediate swelling at injection site, hot to touch and arm soreness 1/22/21:  I woke up at 7:30am with a sore throat and right ear pain.  This is typical for me when I am starting to fight something off.  I was managing okay until around 1pm when I started to low grade fever at 99.8.  By around 4pm, my body was really starting to ache and I was getting chills.  After the training, I took some Thera Flu, but I couldn?t really move from the couch to the bed because my body was so sore.  My fever fluctuated between high 99?s to low 100?s.  I felt like I got hit by a truck.  I managed to fall asleep around 8:00pm and was able to sleep until 1:00am.  I took more Thera Flu, water, and was able to fall back to sleep at 3:00ish am. 1/23/21:  I woke again at 11:00am and my aching was still there but not nearly as bad as the previous day but now I felt heavy congestion in my head and chest.  I also had sneezing, and a stuffy then runny nose off and on throughout the day.  I was also very, very tired and had no energy to do anything but lay there.  Today is when the diarrhea started 1/24/21:  Body aches at this point are still tolerable but I?m sore.  My arm injection site is bruising and starting to itch and still slightly warm to the touch.  I have sneezing, a dry cough, and an off and on runny nose and diarrhea  1/25/21:  Body aches are mild today, dry cough is here, post nasal drip mucus I am assuming as well.  All I want to do is sleep.  I?m so tired.  No diarrhea today so far but I haven?t had anything to eat yet.
Pfizer-BioNTech COVID-19 Vaccine- Chills, low grade fever 99.8, body aches/ joint pain, fatigue, start 12/19/20 and continued symptoms to present 12/23/20
Diarrhea; Pimples on face; Tiredness; Fever; Nausea; Headache; Chills; This case was reported by a consumer via call center representative and described the occurrence of pimples in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2022, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2022, 5 hrs after receiving Shingrix, the patient experienced headache and chills. On 30th July 2022, the patient experienced tiredness, fever and nausea. On 31st July 2022, the patient experienced pimples. On 1st August 2022, the patient experienced diarrhea. On 1st August 2022, the outcome of the fever, nausea and chills were recovered/resolved. On an unknown date, the outcome of the pimples, tiredness and headache were not recovered/not resolved and the outcome of the diarrhea was recovering/resolving.   It was unknown if the reporter considered the pimples, diarrhea, tiredness, fever, nausea, headache and chills to be related to Shingrix.     Additional Information: GSK receipt date: 02-Aug-2022 Reporter comment: This case was self-reported by the patient. The patient received Shingrix vaccine on the left arm. The patient received the Shingrix vaccine after 5 hours and patient developed a headache and chills. One day after receiving vaccination, the patient experienced a fever, nausea and feeling very tired. The fever and nausea resolved, but the tiredness persisted. Two day after receiving vaccination, reported small yellowish puss filled pimples on her face including the forehead, chin and between the eyebrows and cheeks.  Last night 3 days after receiving vaccination, the patient experienced diarrhea not yet resolved but was better.  The reporter does not give permission to contact health care professional, but does give permission to contact her.
This case was reported by a medical assistant and described the occurrence of leg knots in a 15 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 13Jan04, the pt received the fourth dose of Infanrix in her left leg. The following day, on 14Jan2003, the pt's mother called the physician's office and reported that the pt experienced a knot in her leg and swelling and redness of the leg. The reporter did not specify the site of the reaction. The leg swelling and redness resolved on 16Jan2004 and the knot in the leg resolved on an unspecified date. The medical assistant considered the leg knot, swelling and redness to be related to the vaccination with Infanrix.
headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided.  Patient does not have Tylenol and asking if she can take Aleve.   Reporter did not allow further contact
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 56-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The date of vial initially stored in the refrigerator was unknown. Number of doses/vials were 173. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up included additional reporter added.
FORGOT TO TAKE LAST DOSE; This spontaneous case (PVX2019-1015) was received from a pharmacist on 25-Apr-2019. The report described a male consumer who "forgot to take last dose", while being on Vivotif for an unknown indication.  Case report: The consumer took three doses of Vivotif but forgot to take the last one.  Action taken with Vivotif with was not applicable.  The clinical outcome of the event "forgot to take last dose" was unknown.  Company's Comment: The causality of the event "forgot to take last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take last dose" was considered as not applicable.
after receiving the vaccine, I was fine for 10 hours, then got sick for 24 hours -high fever, chills, headache. Was getting better for a week after the vaccine, and then started to feel worse and worse.   I have swollen throat, swollen face and body, foggy head, feeling cold, then sweating. Used to be very active person, would walk a lot, jog, ride bicycle  for miles. Now can't go even for a walk, feel very tired. , have to force myself to work. on day off could not get out of bed for 3 hours. sleeping poorly, waking up because my hands go numb, have to shake them. Coming up stairs making me to seat and catch the breath , and calm the fast heart beat. Fell like hear is squeezed.  Went to my physician 6/03, took blood test on 6/04, blood showed higher than normal thyroid. It was perfectly fine in February of this year. Physician sent me to endocrinologist, had phone appointment today, will be taking an other blood work next week. Endocrinologist said to contact Infectious disease doctor, as these are not his symptoms, left a message for appointment with Infectionist , don't think will get a quick one.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 08-MAY-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
diagnosed with shingles; a lump on my left ear; This is a spontaneous report from a contactable nurse(patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 27Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  On 31Dec2020 there was a lump on her left ear.  On 04Jan2021 there was a rash on her eyes. On 05Jan2021, the patient had a rash like shingles and the doctor diagnosed with shingles. She was taking an antiviral: acyclovir. The doctor said it's a side effect from the vaccine. The patient had no history of sickness. It's so rare. The doctor said shingles was dormant, a sleeping virus that's in her spine. She was not sure if it's because Covid was virus, and it activated her dormant virus. Her 2nd vaccine was soon, 5 days from now. She asked that "Is it ok to get the 2nd dose? Do I need to wait? I spoke with my doctor and infectious disease and they stated after a month; if my immune system was better". The outcome of events was unknown.  Information about lot/batch number has been requested.
lt upper thigh -lateral 7x5cm red macular patch w/central induration; fussiness/crying/whinny 28 hrs p/shot;
Patient was scheduled for 2nd dose of covid vaccine. Patient had a severe resp reaction to 1st vaccine shot. Patient was ok to recevie seoncd dose per PCP documentation. Upon receving 2nd dose patient had severe allergic reaction to dose. Patient couldnt breathe, throat was swelling. EPI was administstered. EMS was called. Vitals were stable blood pressure148/85, heart rate 81 2liters 02 100%. Patient passed out for 10seconds at 2:08pm. Pt just had a flat affect. Patient abruptly woke up and started to hallucinate. 2:10pm ViItals at this time were blood pressure 168/98, heart rate 79, 2 liters 100%. At  2:15 patients throat was closing and pt was gasping for air. Patient was super anxious and a 2nd dose of EPI was given. EMS arrived at 2:24 BLood pressure 157/77 heart rate 87 2 liters 02 100%. EMs took patient to hospital to be further evaulated. Patients husband was at bedside with patient the whole time. Went to ER and was discharged 5 hours later to home.
doses administered past 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The patient had received 2nd booster.  The dates of administration were 03-May-2022, 04-May-2022, 09-May-2022, 11-May-2022, 17-May-2022, and 20-May-2022.  No treatment medication was provided.
Case PHEH2016US023370 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 60 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 21 Jan 2016. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
Rash at site of injection two days after injection. Client took OTC benedryl that resolved local rash, but came back a couple of days later. He has reached out to his primary care for help with symptoms.
PAIN & SWELLING AT INJECTION SITE THEN DEVELOPED CHILLS AND BODY ACHES HAPPENED ALL OF A SUDDEN, HAD  A MILD HEADACHE, THE BODY ACHES LASTED FROM FRIDAY EVENING THROUGHOUT THE FOLLOWING DAY SATURDAY, ON SUNDAY A.M. I STARTED TO FEEL LIKE MYSELF.  UP UNTIL YESTERDAY I DO HAVE MILD SENSIVITY ON THE INJECTION SITE WITH ITCHING.
Pt recvd vax & 1 day p/vax exp hives which subsided in 3 days;
Starting 04/24/2021: muscle weakness that got worse over 3 weeks, lost of balance, loss of ability to walk and use of fingers. Antibodies trashed my thyroid.
Flublok Quadrivalent was given to a 3 year old patient because she has a severe anaphylactic reaction to egg products with no AE; Initial information received regarding this unsolicited valid non-serious case from a nurse was received and transmitted to Sanofi on 08-Nov-2019.   This case involved a 3 years old female patient who received a dose 0.5 ml of Flublok quadrivalent INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] Lot- QFAA1930 (Expiry date-30-Jun-2020) via intramuscular route in unknown administration on 05-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug were not reported.   Concurrent condition included severe anaphylactic reaction to eggs.  It was a case of actual medication error case due to Inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  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.
Pt stated Feeling funny. Extendened obersrvation to 30 min. A + O x 3
Following day 12/24 couldn't drive with arm. 12/27, worst headache of her life with nausea and vomiting. Worse than her concussion. Lasting about 8hrs. Took oxycodone and threw it up. Went to sleep. Started getting whelps/hives.  Worsened al through new years. Took Benadryl. Hives around the eyes. 1/1 started bruising on leg and thigh. 1/5 started feeling better. Rash and bruising is gone.
Narrative:  73yo male pt died on 12/12/2021 per daughter. Pt with past medical history of: PMH: Lower back strain Osteoarthritis Dyspepsia GERD Hyperlipidemia Bipolar disorder, generalized anxiety disorder, PTSD Avoidant personality disorder, antisocial personality disorder Narcissistic personality disorder Pt had received covid vaccines on 5/14/21 6/10/2021. This length of time from vaccine administration.
complained that both of her feet were numb to her ankles.  She said that she could not feel when she touched her feet. She also stated it felt like she could not feel the floor when she walked.  She said their was no tingling sensation.  I looked at both feet and they were natural color, warm to touch and she had strong pulses in both feet.  No weekness in either foot or leg.  This sensation lasted until Thursday morning.
Growing pain over 2 days to severe pain which lasted x 4 nights. Needed pain medication for relief. Now pain is gone, but still experiencing "frozen shoulder" or movement difficulties in affected shoulder. Doctor reported arthritic changes on XRAY.