chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylactic reaction; Heartbeat fast; Hands were shaking; Dizzy and lightheaded; Could not swallow; Flushed; This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 38-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 Rhinitis (She did have severe sinusitis 2 years ago) and Sinuplasty (This responded well to sinuplasty). Concomitant products included BIOTIN, KERATIN (BIOTIN PLUS KERATIN), COLLAGEN BOVINE and LINACLOTIDE (LINZESS) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), TACHYCARDIA (Heartbeat fast), TREMOR (Hands were shaking), DIZZINESS (Dizzy and lightheaded), DYSPHAGIA (Could not swallow) and FLUSHING (Flushed). The patient was treated with EPINEPHRINE 14-Jan-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) 14-Jan-2021 at a dose of 1 dosage form. On 14-Jan-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction), TACHYCARDIA (Heartbeat fast), TREMOR (Hands were shaking), DIZZINESS (Dizzy and lightheaded), DYSPHAGIA (Could not swallow) and FLUSHING (Flushed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood pressure measurement: 106/71 (normal) 106/71. On 14-Jan-2021, Body temperature: 36.6 (normal) 36.6. On 14-Jan-2021, Heart rate: 87 (normal) Temporal pulse 87. On 14-Jan-2021, Oxygen saturation: 98 (normal) 98%. On 14-Jan-2021, Respiratory rate: 18 (Inconclusive) 18 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taken to ER, treated with IV fluid and also IV steroid. Patient was observed for 4 hours, improved completely and discharged form the ER. She was recommended to take epi-pen, vitamin D, vitamin C and zinc.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Added medical history, lab data, concomitant medications and new event; updated patient demography and event stop date.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
13 doses administered on 25Oct2021 has an expiration date of 10/24/2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered on 25Oct2021 has an expiration date of 10/24/2021) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered on 25Oct2021 has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered on 25Oct2021 has an expiration date of 10/24/2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided.  No treatment medication details was provided.  Moderna vaccine was pulled from the freezer on 13 Oct 2021 with a use by date of 12 Nov 2021 (30 days storage viability in the fridge). The Moderna Vial did not have an expiration date on it. However,The expired vaccine was administered to patients on 25 Oct 2021 and 26 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contain no new information.
Patient was given 0.5ml instead of the correct 0.25ml booster dose as a third dose - pt states no symptoms at this time
A nurse reported that a 9-month-old female received an injection of Prevnar on 09/11/2001. Subsequently, the infant developed a "hive-like" rash on her face and arms. She was treated with Benadryl (diphenhytamine). No further information was available at the the date of this report. Information regarding this event has been forwarded to MSD, manufacturer of Recombivax-HB. Follow-up information received on 10/26/2001 from the physician indicated that the infant developed an erythematous, macular, diffuse rash. She was seen by the physician on 09/13/2001 and has subsequently recovered.
I started having shivering, chills,headache, really bad body ache all of symptoms like Covid except lost of taste/smell lasted for 48 hrs.
1st injection hit her hard. 2nd injection really took her down. I took her for a walk, sat her down outside, and then suddenly she couldn't walk. I took her inside and sat her down. After that point, her thyroid meds went from 50-150micrograms and her blood pressure meds were raised as well. 4 months this went on. She had hospice care. Things weren't well. I took her to church on a Sunday and she had  a good day, saw her friends in the park. The next Sunday, I got her up for church and she threw up and was unwell. She went back to bed andShe lost blood flow in her left leg through the day, it was cold to the touch and she was having discomfort/pain in the leg.  Then the hospice nurse came and administered morphine around 11am-noon.   By 4:30 am she passed away, 9/9/2021.  She had been very active, still doing the books and working and writing her checks for monthly bills. After the vaccines her BP tripled and thyroid went out of wack and that was it.
Lethargy. Absence of muscle control (arms, neck). Pale color. Light breathing stopping at times (had to be woken to start again). Swelling (all body, leg in particular). Extreme pain. Absence of appetite. Leg tremor. Fever. Feeling of absence (looking but not seeing, not recognizing objects or people). Lost Sucking reflex - inability to feed effectively.
The patient came to the pharmacy to receive her second COVID vaccine (Pfizer).  She did not have her card with her and she thought she was due for her second shot.  We administered the vaccine. We later discovered that she was not due for her second dose until September 14th.  The patient has not had any adverse effects from receiving the vaccine early.
Had a hard lump, 30 minutes, post vax. It was warm at bedtime and felt a little itchy. Had blood on arm the size of a 50 cent piece and site was king of blue. On 2/7/01 AM, still had bruise (blue). At noon it started severe itching and area got redder and hard spot grew to 1" to 1 1/2" in diameter. By the evening, area was 6" to 8" long and 3" wide (red, hard and hot). She used cool compresses and ibuprofen. The next AM, she went to MD and was prescribed Augmentin.
Not so much an "adverse event" however, pt came into the office on 11/05/2021 to see provider for a routine follow-up appointment and his second dose of Pfizer. Upon speaking with the provider, he did confess that he has received 5 doses of Moderna (3/21, 4/21, 7/21, 8/21, and 9/21). Unfortunately, he was not honest during his 10/14/21 appt and did receive a dose of Pfizer from our facility as he stated he had not been vaccinated against covid-19.
80 year old female patient inadvertently received the fluzone quadrivalent instead of fluzone high dose, no AE; Initial information received on 25-Aug-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2020SA228800.  This case involves a 88 year old female patient who inadvertently administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing has cancer and receives chemo.   On 24-Aug-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ428AA and expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and product administered (same day latency).  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.
The day after vaccination, pt experienced generalized tonic-clonic seizure lasting 10 seconds, with return back to baseline post event. No fever noted prior to event, however temperature when patient presented to office was 101.8 (ax). Mild URI sx also noted, but exam is reassuring and nonfocal. MOTRIN 1 tsp given (100mg/5mL).
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for 3 patients. This is the 1st of 3 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose. The patient's medical history and concomitant medications were not reported. The patient experienced significant cellulitis at the point of the shot on an unspecified date with outcome of unknown. The doctor attributed the significant cellulitis to PREVNAR 13.
Information has been received from a registered nurse concerning a male who on 01/11/2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient experienced pain, swelling, and warmth at the injection site.  Unspecified medical attention was sought.  The patient was treated with Tylenol.  The patient's outcome was unknown.  The nurse requested a lot check into this lot number.  No product quality complaint was involved.  Additional information has been requested.  It was also reported that another patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and experienced adverse events.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards and was released.
expired fluzone quadrivalent with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who reported expired fluzone quadrivalent with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 11-OCT-2022, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE once (strength, formulation, route, lot number, route: not reported) in unknown administration site for Influenza.  On 11-OCT-2022 the patient reported a non-serious event expired fluzone quadrivalent with no reported adverse event (expired product administered) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.  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 the 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.
Back pain; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the 1st dose on 15Apr2021 and 2nd dose supposed to be today (06May2021). The patient was not able to get the 2nd dose because he got a back surgery and had a back pain. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient in her 50s received a dose of GARDASIL; no adverse event; This spontaneous report was received from a physician assistant referring to a female patient of exact age unknown. The patient's medical history included human papilloma virus test positive for 2 strains of HPV.   No other information was provided regarding the patient's concurrent conditions, past drug history or concomitant medications.   On an unspecified date, within the past 6 months to 1 year, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported) while in her 50s (product administered to patient of inappropriate age). No adverse events were reported.
Diverticulitis. Same response after second Pfizer dose (4/22/21).
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-year-old patient of unknown gender. On 27-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Blood clots in my lungs, symptoms: shortness of breath,difficulty breathing, chest pain, and back pain. Time and date was September 29th at 1:00pm
After flu vaccine client c/o itchy all over. Then 5 min later hives appeared on arms and a few scattered welts on abdomen. Took 50mg of BENADRYL within 1 hour rash gone. Itching last for 24 hrs with a temp of 100.2 by next day completely recovered and free of s/s.
reports that she starting having a flutter in right side of chest ( a little catch) and then went away on the drive home from receiving vaccine. then 5 hours later her teeth and nose began to hurt. Fatigue, headache, nausea, continued pain in nose and teeth over the weekend. seen NP on Monday and was prescribed allergy meds and was told that this is symptoms of the vaccine. she reports today that the right side of her face is swollen and that she feels like there is a boil in her nose.
When I got my second dose a week later my entire voice was gone and I was having joint and muscle pain with no fever. I could no longer walk so I had to get crutches and visited the doctor a week later. The doctor stated they didn't have a clue what was going on and didn't prescribe any medicine but offered to undergo a surgery to retain my voice. My voice is still gone but my joint pain have gotten better as time passes.
This serious spontaneous case, initially received from other non-health professional (consumer) on 27-Apr-2018, concerning a 60-year-old, adult, male patient. The patient received influenza vaccine (reported as 5 years ago), which lead to thoughts of hopelessness turned into suicidal thoughts and took 5 months to resolve. The patient had been sensitive to dyes, chemicals and was on very strict plant based diet due to it. The patient did not receive any concomitant medications. On 08-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported). On 08-Dec-2017, after 1 month 1 day of vaccination, the patient experienced thoughts of hopelessness which turned into suicidal thoughts. The reporter stated that, the suicidal thoughts were gradual. The patient received RISPERDAL (1/2-1mg per day) and had appointment with psychologist in 2 weeks. It was reported that, patient was feeling better with RISPERDAL but upon discontinuation, he again experienced the thoughts of hopelessness. At the time of this report, the patient had not yet recovered from the events. The reporter considered the causality of the event as related to the suspect vaccine.
PULMONARY EMBOLISM (THE VACCINE IS COMIRNATY +12) NDC 00069-2392-10
Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with no known drug reactions/allergies and a history of headache and heartburn who on 15-OCT-2009 was intramuscularly vaccinated with the first dose of GARDASIL (Lot#663552/1350Y) 0.5mL. Secondary suspect vaccine included measles-mumps-rubella vaccine and Tdap (manufacturer unknown). Other concomitant therapy included ZANTAC and TYLENOL. On 17-NOV-2009 the patient was intramuscularly vaccinated with the second dose of GARDASIL (Lot#663552/1350Y) 0.5ml. It was reported that the patient LMP was in "late September 2009" and estimated date of delivery (EDD) is approximately on 07-JUL-2010. On an unspecified date a serum pregnancy test was performed and the result was positive. The patient sought medical attention by an office visit. Follow-up information has been received from a registered nurse who reported that the patient was with no medical history/concurrent condition. During pregnancy, intrauterine growth restriction (IUGR) was found. On approximately 12-JAN-2010, the patient developed heartburn that was treated with PRILOSEC and ringworm that was treated with LOTRISONE. Ultrasounds for growth anatomy and amniotic fluid Index (AFI) were done on 19-MAY-2010 1139 grams, on 16-JUN-2010 1673 grams, 22-JUN-2010 (no result reported). The patient experienced group b strep infection, and was treated with penicillin C (dose not specified) in labor on 07-JUL-2010. On 29-JUL-2010, at 39 4/7 weeks from LMP, the patient delivered a normal male baby, weighing 6 lb 5.9 oz, APGAR ( Appearance, Pulse, Grimace, Activity, Respiration.) score 8/9. The baby experienced umbilical mass (also reported infant normal). The baby's umbilical mass was considered a congenital anomaly. The baby's experiences had been reported in WAES# 0912USA01991A. Additional information has been requested.
nausea & vomit once AM, 3" the other night; expanding redness, heat around inject site; cellulitis;
12/8/21 pt admitted to hospital from  Medical Center with dx of LLE BKA; infection following a procedure; tested positive for COVID on 1/11/22; pneumonia due to COVID; pt's condition worsened and he was admitted to another hospital (no records received from them); pt was dc'd on 1/25/22 to facility with hospice care where he expired on 1/27/22.
Within 10 - 15 minutes of receiving vaccine in left deltoid, a single hive (typical wheal & flare) developed on the left volar forearm approximately 10 cm proximal to the wrist crease. It was itchy. I also demonstrated dermatographism on the same volar forearm. No other hives elsewhere. No shortness of breath or wheezing. Two physicians, a nurse and a pharmacist examined me. We were all puzzled initially but decided it was a localized allergic reaction. I was treated with 50mg. Benadryl and observed an additional 30 minutes with no progression and was then released from the clinic. No further problems. Hive faded gradually over 36 - 48 hours.
Right after the shot, I felt not myself.  I felt like I was drugged up or high on drugs.  It happened two times on the way home as well.  I kind of felt like I was having a panic attack. I was awake and would have a memory of a dream that I had.  It was like I was spaced out for 30 second.  I fell a sleep and go I wake up.  I had a horrible pain, and purple tough with a bit mark.  I went to the ER.   They did an MRI on me to rule out a seizure.   They did an EEG. They also did blood work as well.  I was referred to the neurologist.  He did a 30-minute EKG to monitor my heart.  He thinks it is a panic attack.  I feel like I am having memory loss.  I am more forgetful.
consumer reports that child had shock-like event, fever, unable to eat p/1st DTP; following 2nd DTP had GI reflux; referred to neurologist; pt recvd DT & had convuls day p/vax; no fever; taken to ER; h/o convuls during ear infect 1 yr ago;
11/15/13: (10 AM) client called RN stating he became very ill at 7 PM on 11/14/13 (5 1/2 hrs. after influenza vaccine). Chills, severe body aches, feeling as he was "in a fog" - RN encouraged client to call family member and cardiologist. Also encourage client to increase fluid intake and take temperature. (11:30 AM): client states "feeling better" after soup, fluids. Temperature 100.9 degrees F. No c/o "feeling foggy". Denies dizziness. Encouraged him to notify PCP.
Small red bumps across body. Non itching or irritated but diffuse across entire trunk and back.
Red, swollen, hot area to right thigh, pain, herpes zoster at injection site.