chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 pulmonary embolisms from a flu shot; Initial information received on 05-Dec-2022 regarding an unsolicited valid social media serious case received  via consumer/non-hcp.  This case involves patient of unspecified demographics who experienced 7 pulmonary embolisms after receiving vaccine INFLUENZA VACCINE (flu shot).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination. Information regarding batch number requested.  On an unknown date, the patient developed a serious 7 pulmonary embolisms from a flu shot (pulmonary embolism) at unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event 7 pulmonary embolisms from a flu shot.  Seriousness Criterion: Event was assessed as medically significant.; Sender's Comments: Sanofi company comment 05-Dec-2022: This case involves patient of unspecified demographics who experienced 7 pulmonary embolisms after receiving vaccine INFLUENZA VACCINE (flu shot). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Less than five mins after admin GARDASIL pt c/o not feeling well (nauseous). Had pt sit then pt started panicking saying she could see stars, everything was getting dark. Pt was pale, diaphoretic and clammy. We had pt lie down and checked bld pressure. Had pt stay for 20 minutes. Pt soon improved.
Headache 2 days post Yellow Fever vaccine (3/8/08) until 4/3/08 after he had a fever overnight. They were in a foreign country at the time without a thermometer to measure his fever. (Wife has the same headache.)
I did not have an adverse reaction to the vaccine. I began no feeling well on 02/19/2023 with a scratchy throat, congestion and runny nose. The symptoms progressed and I test positive for COVID-19 on 02/20/2023. I contacted my doctor and got the prescription for Paxlovid. I tolerated the medication and was able to take the whole prescription. I still have a lingering cough.
PATIENT WAS GIVEN SHOT AND ASKED TO WAIT FOR 15 MINS TO OBSERVE ANY REACTIONS.  AFTER 5 MINS HE SAID HE WAS DIZZY. I WALKED UP TO HIM AND HE STARTED TO SLUMP IN HIS CHAIR BUT WAS RESPONSIVE. HE COMMENTED THAT HE GETS DIZZY WHEN HE SEES NEEDLES.
Normal labor and delivery on 10/26/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). Previous and/or concurrent vaccination included DTaP; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant; manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose of Fluarix (.5 ml, unknown) intranasally (intramuscular formulation administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental overdose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as "Flumist" and administered intranasally. There were no other adverse events other than "bad taste."
Acquired Covid, prescribed Paxlovid, hospitalized for secondary pneumonia x 3 days.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 04-SEP-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 240 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 15JUL96 & p/a few days pt devel a lump @ the inj site;
83 year old male was here at our clinic to receive his first COVID vaccine. After leaving the building he was getting into his car, fell and hit his head on the adjacent car. His wife came into the office asking for help, he could not get up himself . Clinician and three providers went out to the parking lot to assist and evaluate the patient. Patient was alert and talking. He was complaining of pain in his r ankle. He was assisted on to the wheelchair, brought back into the office and the ambulance was called. While he was waiting for the ambulance he had a loss of consciousness for 90 sec. Heart rate and pulse ok. EMS arrived and patient was taken to hospital for further evaluation.  Pt required ORIF of the right ankle.
Over the 24-48 hours after vaccination, started c/o left upper arm itching and hurting. Mom noticed redness and swelling the 2nd day and was seen at ER. Keflex for possible cellulitis and Benadryl PRN were prescribed. mild pain, itching and discoloration still remained 4/5/06.
Diagnosed with Covid after exposure.  About one week of fever, followed by one week of congestion and coughing.
09/13   headache , felt dizzy and tired and injection site was very sore ,   09/14 back of head hurt even hurt to turn his neck side to side , are still extremely sore eyes hurt   90/15 same arm hurt,  headaches , dizzy very tired  Low grade fever in the evening 100.3   09/16 arm still very sore , extremely exhausted, dizzy spells , feels his eyes can?t focus on something very long , headache low grade fever again in the evening 100.1
Patient describes as severe pain and loss of mobility in the left arm ranging from the neck/shoulder area down to the elbow. Pain started day of vaccination few hours after administration, and worsened over time.
he has diarrhea from food he ate; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as a 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to reschedule an appointment for second dose, because patient had diarrhea on an unspecified date and can't make it to his appointment. The patient had diarrhea from food he ate. Outcome of the event was unknown.  Follow-up attempts are needed. Further information is expected.
Patient telephoned on 11/13/02 10am to describe "twitching of the right eye at 9pm on 11/12/02. At 4am on 11/13/02 he awoke with "numbness of the right side of the face." He stated that it "feels like it is full of novocaine."
0 8-4-2021 COVID-19 pfizer vaccine given to 10y/o. Doctor notified at6:37pm. Admin notified at 6:41pm. Patient did 0 display an adverse effects at time monitored after vaccine was given. Mom aware of typical side effects of vaccine. Staff at facility notified. Vaers Report completed. Will follow c mother tomorrow to check on Patient. Both parents aware of med error - Lpn
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. In March 2017, the patient was vaccinated with the improperly stored dose of PROQUAD (dose, route and anatomical location were not reported) (lot # M029595 and expiration date 10-DEC-2017) for prophylaxis.  Additionally, a propped stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported) was used to reconstitute the vaccine. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 480 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004456: US-009507513-1704USA004454: US-009507513-1704USA004455: US-009507513-1704USA004452: US-009507513-1704USA004453.
Extreme itching, knot at site of injection, red/hot injection site, 2 inch wide by 4 inch long red streak, pain - These side effects are still present as of today, Oct 8th, 2012.
couldn't eat; nauseated; Vomit; sick to the stomach; bitter taste on the mouth; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to the stomach), DYSGEUSIA (bitter taste on the mouth), FEEDING DISORDER (couldn't eat), NAUSEA (nauseated) and VOMITING (Vomit) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Pain (the Shingles vaccine in august and that still has pain) since an unknown date. Previously administered products included for an unreported indication: SHINGRIX and vaccine.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to the stomach) and DYSGEUSIA (bitter taste on the mouth). On an unknown date, the patient experienced FEEDING DISORDER (couldn't eat), NAUSEA (nauseated) and VOMITING (Vomit). On 27-Jan-2021, DYSGEUSIA (bitter taste on the mouth) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (sick to the stomach), FEEDING DISORDER (couldn't eat), NAUSEA (nauseated) and VOMITING (Vomit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Possible cause: In a subsequent physical exam on the above date, platelet count was very low, 48.  I have scheduled an appointment with a hematologist on Feb 23 to determine treatment.
Information has been received from a physician concerning a 78-year-old female patient, with no pertinent medical history, who was vaccinated on 11-JAN-2007 intramuscularly (previously reported as subcutaneously) with a 0.5 ml dose of Varivax instead of Zostavax. No adverse event was reported. No additional information to report. There was no product quality complaint involved. Follow-up information was received from a physician on 25-JAN-2007 indicating that the reason for the medication error was her office's "check out sheet" and an inexperienced nurse. The office has now implemented changes to reduce errors, has reeducated the administering nurse, and the check-out sheet has been amended (now grouped by pediatric and adult vaccines). The physician stated there was no confusion due to the vaccine's packaging. The patient will be vaccinated with Zostavax in the next month. At the time of this report, the patient has not had any issues since vaccination.
Redness, swelling and itchiness at site. Swollen area is 2 cm x 3 cm.
Diarrhea; Soreness at vaccination site of left arm; This is a spontaneous report from a contactable consumer, the parent. A 12-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 04Sep2021 at 14:30 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and allergy to peanuts. It was also reported that the patient could have had COVID-19 in Jan/Feb2021 as family members had it, but the patient was not tested. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included over the counter cetirizine hydrochloride (WAL ZYR) taken for allergies from an unknown date and unknown if ongoing. On 06Sep2021 at 08:00 in the morning, the patient experienced diarrhea which lasted all day and soreness at vaccination site of left arm. On 07Sep2021 in the morning, the patient still had diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness at vaccination site of left arm and diarrhea were not resolved at the time of this report.
1. Abdominal pain and vomiting about 52 hours post vaccine (lasted 45 mins, then cleared) 2. Stuffy, runny nose coupled with cough from +/- 52 hours post vaccine until present (treating with OTC medications) 3. Low grade fever 52 hours post vaccine (cleared overnight with 1 dose of Motrin)
Patient complains of extended experience of pain, swelling, and redness in left unilateral axilla. Pain is significant enough to cause loss of sleep and significant alteration in daily lifestyle. Pain is described as most significant at site of axilla.
This case was reported by a healthcare professional and described the occurrence of miscarriage in a 17-year old female subject who was vaccinated with Boostrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date the subject received n unspecified dose of Boostrix (unknown). The subject participated in an observational study, 100454. On an unspecified date, an unspecified time after vaccination with Boostrix, the subject became pregnant. This was her first pregnancy. The subject was seen in the emergency room for vaginal bleeding and abdominal pain at approximately seven weeks of pregnancy. Per the reporter, "this would indicate that she was vaccinated approximately 13 days prior to the last menstrual period prior to her pregnancy". On an unspecified date, an unspecified time after vaccination with Boostrix, the subject had a miscarriage. This case was assessed as medically serious by manufacturer. At the time of reporting the outcome of the events were was unspecified.
Very bad night sweats after receiving the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Very bad night sweats after receiving the booster dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 NIGHT SWEATS (Very bad night sweats after receiving the booster dose). At the time of the report, NIGHT SWEATS (Very bad night sweats after receiving the booster dose) was resolving.            No concomitant medication were reported.   Patient received the booster dose on January 2022 or beginning of February 2022, the reporter did not remember the precise date. Patient started having very bad night sweats after receiving the booster dose. Patient explained that they have gotten better, but were still ongoing.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-526693 (Patient Link).
Patient received PREVNAR on 9/20/16 on left arm. She claims that it was painful during the injection. She noticed a rectangular red patch on left deltoid 1-2 days later and was still sore. There was swelling around injection site and she noticed an indentation about 1 week later but less sore. Indentation continued to worsen 1 week later and the soreness returned. Patient went to see her doctor 1 week later when her put her on 1 week of prednisone.  There was no improvement and she will be going back to the doctor today 10/31/16.
Patient received 2nd dose of Moderna vaccination on 5/18/21.    Today he contacted the pharmacy stating that he had knee and ankle pain.
Severe weakness and dizziness.  Blood pressure spiked the first night to 164/112.  Spent 3 days in bed not able to do much at all.
Severe pain in my legs starting from the groins , fever with chills and profuse seating.
Received Rabies immunology & vaccine. Right side of face red & swollen. Cold compress & told to take BENADRYL I was told mild reaction continue on with vaccine, received 2nd dose on 6/12/15 went to ER 6/14/15 neck stiffness & complete left side had little swelling was prescribed prednisone, oxycodone, & Flexeril. 6/15/2015 back to ER severe pain, neck, face & hand & legs very swollen. Admitted to Hospital. Stay was 2 days. Back to  Hospital 3 days discharged. Back to Hospital on 6/20/2015 swelling & bruising. Readmitted to Hospital for four days, discharged to Rehabilitation.
Pt recv vax on 1/14/99; 12 hr post vax  pt exp insomnia, motor restlessness, tremor & palpitations >7 day
Headache, Arthralgia, Fever & NauseaVomiting Narrative:
Brought pt to office 3/24/04 right thigh was very swollen. Firm and warm to touch. Measures thigh at 35 cm, mid thigh 33.5cm and 28.5 cm at knee. When compared to left thigh 31.5 cm, mid thigh 29 cm at knee 24cm. Pt walks with limp. Won't bear full weight. Instructs to give Tylenol for temp. 100.4 yesterday if temp recurres. Ice to right thigh today and rest. Returned to office if s/s worsen or increased pain.
Approximately 8 hours after vaccination, the patient was laying in bed and noticed a wet fluid running down her arm. Upon inspection, she noticed that a blister had formed directly over the site of injection, and had popped. The drainage was clear. The blister continued to ooze for approximately 72 hours. She did not seek medical treatment, and the wound has healed on it's own. Upon further questioning, the only other adverse effect she experiences was a sore arm, with redness in the area of injection.
Patient reports sore arm spreading into back, states that it feels hot but not itchy. Began around 5 days ago, has not gotten worse but is not getting better either.
Pain and burning when given the vaccine, pain and swelling from the shoulder to my elbow, diarrhea, chills, headache, very tired, nausea, muscle aches, fever.
6 year old male presented for second dose of Covid-19 vaccine and was given the Pfizer 12 and older formulation (30mcg dose) instead of the Pfizer 5-11 formulation (10mcg dose).  Nurse recognized the error when documenting the dose and immediately notified Dr. who was seeing the patient that day.  The physician discussed the error with the family, symptoms to watch for and reasons to call for evaluation.  On follow-up with the family over the next 2 days the parents reported that the patient had been vomiting for 48 hours after vaccination, had headache, fever and chills and a swollen and sore left arm.  By second day symptoms were subsiding and child was doing much better.  Patient did not need to be evaluated in person but was followed via phone by the physician.
Pt was given shot on 08/18/09 in Left deltoid IM. He was sitting in a chair. Approx 1-2 minutes after injection his left arm was flexed toward body his legs went straight out and his head was flexed backwards and his face became red and he seemend not to be aware.  Apperaing to be a focal seizure lasting like 10-15 seconds maybe more but not more than a minute.  He then awoke was okay than like 30sec-1 minute later he became pale and listless place pateint from chair to floor. His mouth was clamped shut could not access airway, felt for pulse. He had one. I laid on side then approx 20-30 seconds later he was aroused and became aware stating all was okay. He was still very pale. Pulse 64 BP 108/60 laying down. Complaining that he was hot placed fan on him.  911 was already called.  He then wanted to sit up in chair was able to stand and sit in chair.  Fire rescue arriving to scene with him in chair AAOx3.  He was taken to Hospital ER via EMS.  He ambulated out of clinic.  He was discharged from Hospital same day with diagnosis of Vasal-Vagal as per family member Aunt.
Large area of redness & swelling lt arm-also crusty like rash around inject site; pt given Epi;
Syncopal event. Patient was laughing with her sister, and felt fine about 1-2 minutes after the shot. Stood up and continued to joke with her sister. Suddenly felt faint, and collapsed to the floor, hitting the side of her head on the sink. Had brief twitching of upper extremities, and then regained consciousness after <1 minute. Immediately endorsed feeling fine, and no longer light-headed with no headache or nausea. No neurological findings and normal neuro exam. BP immediately after event 80s/50s. Patient was moved to a chair and observed for 15 minutes. Continued to deny any confusion, light-headedness, headache, nausea. Repeat BP 110/67. Patient was given strict return precautions.
4 year old female patient administered dose of expired Quadracel, no AE; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a four year old female patient who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 19-Nov-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5532AA and expiry date: 09-Oct-2020) via an intramuscular route in the right leg for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  Product used: Used  First time product used: Yes  Still using product: No  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 vaccinated with Recombivax developed fever of 104F at 4:50Pm irritable no vomitting, given Tylenol, temp at 5:50PM down to 100.4 next day temp 101. Rechecked on 20SEP90.