chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a 17 years old patient received a dose of Flublok Quadrivalent vaccine/ No AE; Initial information received on 16-Dec-2021 regarding an unsolicited valid non-serious case from an other health professional via Physician.  This case involves a 17 years old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No other concomitant vaccines.  On 16-Dec-2021, the patient received a 0.5 ml total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE strength: standard, frequency: once, lot number: UJ725AA, Expiry date: 30-Jun-2022 via an unknown route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  It was reported "Calling in regard to a 17 year receiving a dose of FLUBLOK. Caller would like to know if there are any side effects/ safety information available."  Product used: Used, First time product used: Yes, Still using product: No and Was Device Used: Yes.  At the time of reporting, 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 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.
Information has been received from a physician concerning a 70 year old female patient who on an unspecified date was vaccinated with the second dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date on 04-JUL-2011). The physician reported that the patient developed fever of 39 degrees C that lasted for 2 days and cellulitis within 12 hours of receiving the vaccine. The patient may have been treated with antibiotics. The physician did not provide any information on the duration of cellulitis. The physician reported that she had never seen so many adverse reactions with this vaccine and had stopped using this lot number. The physician requested an investigation of the specific lot. At the time of the report, the outcome of the patient was not reported. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (665904/0866Z) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the physician concerning the 70 year old female patient with hypertension (HTN), noninsulin dependent diabetes mellitus (NIDDM), obesity, hyperlipidemia, depression and no illness at time of vaccination who was vaccinated the first dose of PNEUMOVAX 23 (Lot # unknown) in November 2005, and the second dose of PNEUMOVAX 23 (Lot # 665904/0866Z) IM into her right deltoid on 10-SEP-2010. On 11-SEP-2010, 7:00 AM, the patient developed high fever up to 102 and severe local reaction consistent with cellulitis. The patient was treated with OTC nonsteroidal anti-inflammatory drug (NSAIDS). No antibiotic. On 16-SEP-2010, the patient's events recovered. The patient's high fever up to 102 and severe local reaction consistent with cellulitis were considered to be other important medical events by the physician. No further information is available.
a 11 years old male patient received a fifth dose of Act-Hib- instead of an HPV; a 11 years old male patient received a fifth dose of Act-Hib- instead of an HPV; a 11 years old male patient received a fifth dose of Act-Hib- instead of an HPV, 4 th dose being completed in Oct-2009; Initial information received on 02-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old male patient who received a 0.5ml fifth dose of HIB (PRP/T) VACCINE [ACT-HIB] lot UI959AA, Expiration Date: 19-Jun-2020 via intramuscular route in the right deltoid on 25-Jun-2019 instead of HPV VACCINE.  The patient's past vaccination(s) included ACTHIB in OCT-2009 with fourth dose.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  It was an actual medication error due to extra dose administered, inappropriate age at vaccine administration and wrong vaccine administered.  Adverse event was not reported.  The outcome of events was reported as unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Client did fine after receiving the JE, Rabavert, and DPT vaccines. Moments after giving the YF vaccine client c/o feeling funny and confused, stated she was going to pass out. Pupils became dilated eyes rolled up, skin turned bright red, back arched and she became stiff, muscle relaxed then stiffened again, voided, then turned pale. Respirations deep and rapid, pulse easily palpated and regular, approximately 88 bpm. Head down and feet elevated. Slowly regained consciousness and color returned. Post ictal was disoriented and weak. Shortly after regaining consciousness began to vomit . Vomiting off and on for the next hour. Told to go to the ER for anti-emetics if vomiting continued on the way home. Sister was driving her home. Will be staying with father who is an MD.
Chills, shivering, headache and general flu-like feeling. Arm very sore.
Ears started ringing loudly; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ears started ringing loudly) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus (mild ,for the past 18 years).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced TINNITUS (Ears started ringing loudly). At the time of the report, TINNITUS (Ears started ringing loudly) outcome was unknown. Not Provided          concomitant product details not provided. patient decided not to take the second dose of Moderna COVID-19 vaccine
After receiving her flu shot the patient started to feel dizzy getting up from her chair so she asked if she could sit back down for a couple minutes. Shortly after sitting she passed out and had a brief period of seizure-like convulsions in her face. It lasted less than 20 seconds. She recovered soon after and said she felt like she was waking up from a dream, but otherwise felt ok. Paramedics were called to make sure her vitals were ok and she didn't have any more convulsions.
child recv vax & mom serum varicella zoster virus antibody test revealed negative varicella titers;devel rash w/approx 15 vesiculopapular lesions d/t questionable secondary transmission;exp sore throat & cough
Initial medication error report received from a physician on 05 November 2013. The 03 year old unknown gender patient received FLUZONE 0.25 ml (lot # was unknown) at unknown site on 04-Nov-2013. (No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
An Eyelid Edema appeared (on the top lid and inner corner of his left eye) giving him the appearance of a black eye, though no injury occurred to cause it.
Information has been received from a pharmacist concerning a female in her "late 70's" who on 28-JAN-2011 was vaccinated with ZOSTAVAX (Merck) (Lot# not reported) subcutaneously. On the morning of 30-JAN-2011 the patient noted a "red, raised, round, warm-to-the-touch, 2-inch by 3-inch rash, with mild stiffness at the injection site". The patient was given treatment of warm compress. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Heart flutters; dizziness; shortness of breath; headaches; chest pressure; fatigue; This is a spontaneous report from a contactable consumer (reported herself). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration, administered in arm left on 04Apr2021 12:00 (age at vaccination 49-year-old) as dose number unknown, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Medical history included heart problems from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced heart flutters, dizziness, shortness of breath, headaches, chest pressure, fatigue on an unknown date of 2021 12:00 PM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment medication was received for the events. Since the vaccination, the patient was not tested for COVID-19. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt received varicella vaccine on 6/10 at clinic. 6/14/11 - Pt called with left upper arm golf ball size, firm, dark pink, hot and mild itching. Firmer small site at actual injection point. Looks better overall today compared to yesterday.
Started as the typical expected redness at injection site, warmth, slightly swollen and hard.  After about 7-8 days it started to itch and the circumference expanded from the size of a nickel to about a 5? diameter, became hot, hurt if touched and had some red streaking coming from the border.  I went to be seen at Urgent Care and was seen by the PA I stated in this report and was diagnosed with cellulitis and I am presently taking Cephalexin for treatment.
fever; tiredness; achey all over; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 3P25J, expiry date 21st September 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date).   On 25th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced fever, tiredness and general body pain. On an unknown date, the outcome of the fever, tiredness and general body pain were unknown.  Additional information received were as follows: The patient experienced sore arm after receiving 1st dose of Shingrix. The patient received 2nd dose of Shingrix on left arm. The patient experienced achey all over and soreness in arm.
diarrhea/possible food poisoning; diarrhea/possible food poisoning; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea/possible food poisoning) and FOOD POISONING (diarrhea/possible food poisoning) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea/possible food poisoning) and FOOD POISONING (diarrhea/possible food poisoning). At the time of the report, DIARRHOEA (diarrhea/possible food poisoning) and FOOD POISONING (diarrhea/possible food poisoning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Petechiae on legs noted 7/23 (4d after imm) not sick AF observed overnight in hosp resolved sport w/o complications.
I experienced severe abdominal pain with diarrhea and fever on Wednesday 3/17 about 1 week after vaccination. It lasted for about 48. Went to urgent care, tested negative for Covid. Symptoms were reduced by Friday evening 3/19.
Rash and hives.  Comes and goes.  Can appear anywhere on the body.  Usually disappears after several hours.  Extremely itchy.
3 pts received a dose during the excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22nd April 2023) for prophylaxis.   On an unknown date, the patient received Boostrix .5 ml. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The reporter informed that their facility had a medication refrigerator excursion occur and patient received the Boostrix dose during excursion. The temperature range was from 35 degree F to 9.5 degree F and total duration was 11 hours. The reporter asked was this Boostrix vaccine was still viable. The vaccine was not a part of a prior temperature excursion. Additional Supportive Information: The patient received the Boostrix dose during excursion, which led to incorrect storage of drug. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081064:Same Reporter US-GLAXOSMITHKLINE-US2022AMR080983:Same Reporter
Woke up around 3pm flushed with temperature in the low to mid 99 degrees with a sore left arm (3 days) and some weakness (2 days). Accompanied by a painful headache as well as nausea. Headache for most of the day with varying pain severity. Nausea for about two and a half days on and off which is unusual for me to be nauseated.
Cerebral venous sinus thrombosis, intraventricular hemorrhage, subarachnoid hemorrhage:  Headache beginning 2/1/21; diagnosis via CT 2/6/21
After dinner on day Varicella vaccine was received she experienced H/A and itching at site. Day 2-swelling Day 3-swelling gone- site red. No hardness at site Headache continues. Pt. taking TYLENOL for H/A.
Patient came in for health maintenance exam and flu vacc. After giving it was noted 0.5 cc were given instead of recommended 0.25 cc for patient's age. No immediate reaction noted.
approximately 12 hours after administration of 2nd dose, fever to 101F, rigors, diffuse myalgias - lasted approximately 24 hours
Patient received dose #2 at 2:35 pm, at 2:45 pm onset of severe pruritis, shortness of breath with rapid onset of dyspnea. Epinephrine Injection, USP Auto-Injector 0.3 mg administered. Code blue called. This occured in hospital setting, emergency department responded to vaccination clinic.  Oxygen therapy, Methlyprednisolone 125 mg IV push,  Diphenhydramine 50 mg IV push.
3/22/21 (day of injection): Pain at and around injection site including shoulder joint from 12 hours after shot & continuing for 2 more days. Mild itching and small patches of redness down left arm over the following week.  3/30/21: Injection site and around approx. 1.25" diameter around began itching considerably in the evening. By the next morning, the area was inflamed, hot and swollen with severe itching that lasted for approx. 3 days. As of 4/6/21, the site still itches but less severely and the inflammation has resolved.
The next week i got cold sores in my nose mid week, and a cold sore on my lip. By friday my throat started to get a little irritated. Saturday 10/20/23 I woke up with no voice at all which continued through the weekend, Tuesday it started to come back but I was extremely tired.  Wednesday I woke up and felt horrible, my throat hurt, my neck and neck glands were swollen and painful to the touch from bottom of my ears down the front of my neck. I felt so tired but went to work, where i continued to feel run down. Wasn't until about noon my cheeks were so red my co workers asked if i had a fever. I decided to leave and go straight to an urgent care. IN the waiting room i started to feel warm and burning behind my eyes ( feverish). they had a head thermometer which only registered slightly high but she didn't even touch me. I tried it with their machine by the end of my visit and it registered 104.5 another time 102.9.  COVID- Negative, Monostat- Negative, Flu- Negative. So i remembered reading about Flu vaccine sometime causing Epstien barr in autoimmune compromised patients. With my hoshimotos being  evaluated at the time, i asked the dr to test me for it as it didnt occur to me it could have been from the flu vaccine. So i am reporting it here because i just received the results and it was positive/ High.
Starting 05/25/2022, in the AM, I had post nasal drip and I thought it was odd due to taking allergy medicine. I knew it wasn't allergies, and I also had a scratchy throat and a runny nose. When I got home from work, I did an at home COVID test which was positive. So, I made an appointment at the urgent care for a PCR test and it was positive. I called into work and had to stay home. My symptoms have been the same since then: Minimal scratchy throat, post nasal drip, runny nose and fatigue.
Reports right ear discomfort, right ear congestion sensation 30 mins after injection. Persists 72 hours later.
NEEDLE BROKE COMPLETELY; MEDICATION ERROR; SYRINGE LEAKED AND AN UNKNOWN AMOUNT OF LIQUID LEAKED OUT/ PARTIAL DOSE GIVEN; PARTIAL DOSE GIVEN; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced syringe leaked and an unknown amount of liquid leaked out/ partial dose given. On 11-MAR-2021, the subject experienced partial dose given. On an unspecified date, the subject experienced needle broke completely, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the syringe leaked and an unknown amount of liquid leaked out/ partial dose given, partial dose given, needle broke completely and medication error was not reported. This report was non-serious.
Triggered typical Mast Cell Reaction (e.g., severe Facial Migraine + Migraine exactly like those encountered in Histamine onslaughts triggered by certain foods/Allergens). The Reaction may have been Delayed due to double Premedication (H1+ H2) before shot. This was not a regular Headache (Tylenol did nothing), rather a typical Mast Cell Degranulation event (additional H1) abated within about 12-15 hours.  There were also Cardiovascular Symptoms typical to Mast Cell events (e.g., Hypotension, Palpitations/Flutter, inability to stay awake, etc.), but I cannot be sure that these were not caused/contributed to by the Antihistamines. Notably, there is Liable Hypotension-Relative Hypertension at the Baseline, so difficult to parse this component.  But, the nature, severity and degree of the Histamine Symptoms would seem clearly attributable to the Drug.  I would recommend that anyone who has Mast Cell Disease should Pre-Medicate with H1 + H2 +/- Monteleukast, but continue this on for at least 1-2 days after the Second MRNA Pfizer COVID Vaccine.   The effect was severe Pain and discomfort, but would do the Shot again due to short duration. HOWEVER, I would have some concerns if a third Booster Dose becomes necessary. In my experience, that?s how Anaphylaxis/Severe Systemic Drug Reaction goes... worse with each following Dose.
Patient was administered 2nd dose of Pfizer Vaccine at 3:30 PM. At exactly 3:37 PM, patient was seated in waiting area and was exhibiting symptoms, specifically circumoralcyanosis, turning blue around the mouth. Patient was also perspiring all over the body, (arms, face, etc) Patient was also warm and clammy. Patient was disoriented and unable to respond typically. 911 was called. Patient was given a sprite and could not hold the sprite independently. Directly after, blood pressure  Pulse and oxygen levels were checked and were below normal. (Blood pressure - 54/47) (Pulse - 87 BPM).  Patient then became more responsive and was able to say name and specified location upon asking. Within 5 minutes of 911 call, ambulance arrived and emergency response took over care. Patient was then transported to local hospital.
Day 13 onset of several large diffuse areas of redness around injection site No itching or pain Reporting@ day 14- still present Took Allegra Never had this previously
CHILLS; FREEZING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced freezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 06-MAR-2021, and the outcome of freezing was not reported. This report was non-serious.
Rash started on chest and spread to chest, trunk and legs after receiving MMR. No fever.
Dizziness, Nausea, Vomiting, Chills, Fever began at 11 am on Wednesday continuing thru Friday October 29th
Patient reported numbness in left side of face 15 minutes after H1N1 vaccine administered in left deltoid. Minimal swelling noted in left cheek. Vital signs taken. Patient is stable 6 hrs and left side infected red and swelling is increasing around left eye. Called 911, BENADRYL 50mg IM given in R arm-Patient in supine position, monitored vitals. Transported to EMT after sec vital