chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9/25 EXTREME FUSSINESS WITH CONSISTANT CRYING. 9/26 THROUGH CURRENT DATE - BEGAN PRODUCING EXCESSIVE LOOSE STOOLS - MORE THAN 8 PER DAY AT TIMES - I HAVE BEEN IN CONTACT WITH THE ON CALL DOCTOR FOR MY CONCERNS AND HAVE BEEN INSTRUCTED WHAT TO WATCH FOR WITH PATIENT - OTHER THAN THE BOWEL COMPLICATION, PATIENT IS OTHERWISE DOING FINE ASIDE FROM THE SECONDARY DIAPER RASH.
Severe diarrhea, chills, severe nausea but no vomiting, headache, mild fever.  No appetite for 3 days.  Injection site began to hurt today (8 days later), is hard, itches and is warm to the touch.
About 3 hours after flu shot, developed fatigue, achiness, light-headedness and sharp, stabbing headache. Also developed shivering and numbness in fingers and toes of about 12:00am. The shivering and numbness abated after 3 hours. 23 hours later, still feels tired, with headache.  No other symptoms. No fever.
Rapid back and forth eye movements causing vertigo like symptoms. Feeling unbalanced and dizzy at times. I feel better when I lay down. I am not sure if it is caused by the vaccine, but it is the only change in my life currently.
I received my flu shot at pharmacy Friday and that evening started feeling off. I get these every year with no issues. It's Monday and I've had the following symptoms all weekend. Pressure headache, aching back muscles and rib cage, no fever, coughing, coughing up flem, cold skin, some side pain, and diarrhea.  Sorry, it's not severe enough to warrant the risk of going to the doctor. Paperwork says quadrivalent fluzone ndc 49281-420-88 / (L) UJ427AC / (E) 30Jun21/ Sanofi.
Patient stated that he had an itchy throat after vaccination and has a history of allergic reactions (severe with food). Patient was able to communicate and was not having any trouble breathing, although he did state he wished he had his inhaler with him. Administered 50 mg oral benadryl to pt and continued to monitor. Benadryl helped and the patient was able to leave on own accord after 45 minutes.
L arm size of dime swelling, itches every day. Today area red, raised, pt c/o itchy, arm felt numb on day of flu shot, unknown date of vaccine and which flu shot (2nd).
Needle retracted during vaccine administration and some spillage occurred. It is estimated that this person received about half the prescribed dose.
Inconsolable crying for 5 hours after administration of Predvarix (DTAP/Hep B/IpV) Hib; PCV7, and Rotarvirus vaccine.  Administered vaccine at 10:30 am.  Explosive diarrhea 1 time after Rotavirus vaccine.
pt states the evening after getting the vaccine her left arm started hurting around the injection site and down towards the elbow on the inside of her arm. She applied a heating pad to help with the pain. The next day she had developed a red raised swollen rash on the upper inside of the right arm around the elbow.  It was incredibly itchy and was tingling  with a frostbite sensation. This intense pain and itching lasted a couple of days before it started to subside. She feels like it was more intense than usual due to having all of her covid vaccines prior to getting the flu vaccine.
Spotting for two to three days since Nov 16, 2021 while taking birth control. Never had an issue till getting this poison in my arm.
Vaccine was given after vial was left out ~ < 24hrs. Reached out to manufacturer for information about how to proceed, and was given information about (off-label) safety data from Pfizer about involuntary temperature excursions. Per manufacturer, post-puncture safety window at room temperature(45-86F) is 24hr (12hr after label time), and cumulative room-temperature  time for the vial is up to 36hrs. The patient did not have a reaction noted, but the error was noted within the hour. The patient was not re-vaccinated as the timestamp was not more than 24 hours after the vial's puncture.
A non-serious report of administration of expired product has been received from a registered nurse concerning a four-year-old male who received FLUMIST on 15-Nov-2008. FLUMIST expired on 12-Nov-2008. Medical history and concomitant medications were not reported. There was no adverse event reported with this medication error; therefore, treatment and reporter/sponsor causality assessment's are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. 01/05/09 On 05-Jan-2009, the reporting nurse confirmed that there were no late-occurring adverse events reported. 01/05/09 Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information received on 20-Mar-2009 included Product Complaint Investigation results.
I tested positive for the flu on 12/2/22. I had to go to the ER and had to stay overnight. I was prescribed metoprolol to slow down my heart because it was very rapid at the time. I also had low blood pressure and oxygen. I had a sore throat, fever, body aches, cough, and fatigue. I am starting to feel better, but not completely better.
Patient verbalized to vaccinator she was feeling shortness of breath immediately after receiving 1st dose of Pfizer vaccination. Patient became diaphoretic. Vital signs monitored, EMS activated by site lead, patient remained safe, husband contacted and came into facility to retrieve patients belongings. EMS arrived and assessed patients vitals. Patient transferred to Hospital for further evaluation. Vital signs upon transfer B/P 134/75, HR 76, O2 saturation 100%
Donor stated he had a headache and nausea after prior injections. He also reported he had a headache and was nauseated after 1st and 2nd injections but declining to tell anyone during his last visits. These symptoms resolved themselves with medical intervention.
The vaccine expired on 17-Apr-2022 was administered on 04-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 04-May-2022) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 04-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 17-Apr-2022 was administered on 04-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient received booster dose. Date the vial was initially stored in the refrigerator was on 04-May-2022. The vial did not undergo any temperature excursion.  No treatment medications were provided.
Extreme fatigue- persistent, preceded by respiratory viral symptoms started 2 weeks after MENACTRA.
This spontaneous report was received from a healthcare worker concerning an adult patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. In September 2015, the patient was inadvertently administered a pediatric dose of VAQTA (route, lot # and expiration date not provided). No adverse effect was reported. Additional information has been requested.
Sore throat, congestion, and cough. Treatment: Robitussin, Halls Throat Drops, and Hot Tea.
Large red splotch on my skin at the injection site, four inches wide and three inches tall, warm to the touch, very tender, and itchy. It also feels swollen or tense. It hurts. It appeared the day after my vaccine and is still there, with the same amount of visibility and pain, at this point (8 days after the vaccine).
Post donation and 32 minutes post vaccine at 12:13 in center parking lot, developed dizziness, nausea, headache, pallor with hyperventilation.  Also had numbness and tingling in lips and arms/finger.  Transported to nursing office via wheelchair.  Continued intermittent hyperventilation for approximately 30 min. Reassured and coached on slow deep breaths.  Refused use of paper bag to control breathing.   Given beverage after nausea subsided and breathing regulated and tolerated well.  At time of release BP 107/71 Pulse 76 and breathing regulated.  Ambulated without assistance upon discharge from facility in satisfactory condition with only residual mild headache.
Great deal of redness and swelling at the site; Great deal of redness and swelling at the site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Great deal of redness and swelling at the site) and VACCINATION SITE SWELLING (Great deal of redness and swelling at the site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Great deal of redness and swelling at the site) and VACCINATION SITE SWELLING (Great deal of redness and swelling at the site). At the time of the report, VACCINATION SITE ERYTHEMA (Great deal of redness and swelling at the site) and VACCINATION SITE SWELLING (Great deal of redness and swelling at the site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient received FLUZONE HD on right arm and PNEUMOVAX 23 on left arm on 10/12/18 by another pharmacist. She called on 10/14/18 saying that on the night of the vaccination her left arm (where she received PNEUMOVAX 23) started to hurt a lot, and the next day it became red and hot to the touch with swelling. On 10/14/18 it still hurts a bit and the redness has traveled downward towards the elbow. She has no wound near the injection site, no discharge. I reviewed the patient's file and assured her that she received the appropriate vaccination (received PREVNAR 13 from us in 2016). I advised the patient to take BENADRYL for the redness and swelling, use an ice pack for the warm sensation, and TYLENOL or ibuprofen if desired for pain. She said she will try the BENADRYL and ice pack, and if it still does get better she will try to go to urgent care.
Parent reported that patient had discoloration of thigh at site of vaccine adminstration.  Mother returned for follow-up appointment on 4/29/10. At this time it was noted that antero-lateral aspect of (R) upper thigh had a hyperpigmented macule measuring 6cm x 5cm and gradually fading out by 12cm. There was no tenderness, no limitation to movement.  No treatment was advised other than observation.  Patient was requested to return for a follow-up visit. I spoke with mother on 6/3/10 and she stated that patient was better but that discoloration was still present. Parent was offered an appointment on 6/5/10 but declined stating that she would call back.  I attempted to contact parents on 6/15/10 and am awaiting a call back.
Patient tested positive for COVID 4/6/21. Completed COVID vaccine series 1/19/21. Asymptomatic.
Received vaccine at 1103, 1110 noted decreased responsiveness, color became blue. Lowered to floor chest compression given and airway opened. Began to respond, did vomit, was diaphoretic. Was taken to ER, responsive at that time states last he remembers was feeling lightheaded and dizzy like he was going to pass out. Upon arrival to the ER he was diaphoretic, gray in color. C/O L) arm pain where received shot, felt like Charlie horse pain. Cardiologist consulted  and ordered patient to be transferred to higher level of care. Was transferred via ambulance on 3/17/21
a pediatric nurse in error, administered quadracel intramuscularly and instead of going into the deltoid muscle, it went below the deltoid musclewith no reported adverse event; Initial information received on 29-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 4 years old male patient who was administered quadracel intramuscularly and instead of going into the deltoid muscle, it went below the deltoid muscle with no reported adverse event while receiving vaccine Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Jun-2022, the patient received a 0.5 ml (total) dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine frequency: once [strength, formulation and expiry date unknown] lot C5970AA via intramuscular route in the right arm for prophylactic vaccination (immunization).  On 28-JUN-2022 the patient developed a non-serious event a pediatric nurse in error, administered quadracel intramuscularly and instead of going into the deltoid muscle, it went below the deltoid muscle with no reported adverse event (incorrect route of product administration) latency: same day following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (incorrect route of product administration).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event incorrect route of product administration.    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 guidelines. 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.
fever and malaise 1st couple of days after her COVID vaccine.; fever and malaise 1st couple of days after her COVID vaccine.; On day 3-10, experienced 'paresthesia felt like polyneuropathy in hand, right foot, muscles, felt like shooting electric shocks in both hands. It felt like she had been applying 'pressure on nerves'; On day 3-10, experienced 'paresthesia felt like polyneuropathy in hand, right foot, muscles, felt like shooting electric shocks in both hands. It felt like she had been applying 'pressure on nerves'; This is a spontaneous report from a contactable Physician reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included COVID-19 from Feb2020. The patient's concomitant medications were not reported. The patient reported fever and malaise 1st couple of days after her COVID vaccine. On day 3-10, she experienced 'paresthesia, felt like polyneuropathy in her hand, right foot, muscles, felt like shooting electric shocks in both hands. It felt like she had been applying 'pressure on nerves'. Has since resolved completely. She has seen a neurologist who performed a general physical exam and it appeared normal. Also, she notified or asked Nursing occupational health. She had a history of COVID last Feb2020. She was asking if there are any recommendation if she should get the 2nd dose of the COVID vaccine. The events had resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event polyneuropathy cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Patient stated: Received shot at 1230pm 10/22. At around 6pm her airways seemed to constrict and heart raced. She then vomited and was shaky until about 830pm. She then felt better and never called for help.
fever and chills; fever and chills; This is a spontaneous report from a non-contactable consumer (husband).  A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Husband reported that his wife received vaccine yesterday (18Jan2021) and developed fever and chills in Jan2021. Can she use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine? Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Rash started on 10/17. Patient seen in office with hives on 10/23 that extend from left knee to hip.
2 days after receiving his scheduled 2 month shots, DTaP, Hep B, Hib, Polio, and Prevnar, patient began having seizures.  After numerous tests, blood work, genetics testing, spinal tap, etc, the doctors still have not been able to diagnose the problem.
Immediately following the injection there was a severe pain in the arm when raised/elevated. This has persisteded until present. If arm is stretched or raised for extended period of time arm feels a combination of pain and numbness. Pain can extend from shoulder down to wrist. Loss of strength in the arm makes simple tasks like a pushup not possible. Treatment has been stretches and attempts to flex the arm.
Resident developed scattered, raised, reddish, irregular shapes rashes in the neck/chest area and right upper arm around the injection site approximately 5 minutes after vaccine administration of Tdap, Hep A and Varizella on the right arm. Patient was assessed, vital signs taken T:98.2 P:79, BP sitting:111/84, O2 sat RA: 99% Pain 4/10, Pt Stated, "I'm scared", rash itchy, non-painful, patient breathing without difficulty, conversant, answering and responding to questions asked with the interpreter. Reassessment 10-15 minutes after vaccination: alert, orientedX3, walking, moving around without any limitations. Instructions to mother provided: to continue to monitor rashes, advice nurse # given and to call if there are further questions, call EMS or bring patient to ER  if difficulty breathing. Patient left the clinic with mother and 2 other siblings, alert, oriented, walkinf without any limitations, breathing freely, with out any distress , denied pain, no itchiness
She denies further adverse event; received PROQUAD that expired; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.   On 14-APR-2021, the patient was inadvertently vaccinated with one dose of expired Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (albumin status recombinant Human albumin (rHA)) (dose: 0.5 milliliter, lot number: S031882, expiration date: 07-APR-2021, strength and route were not reported) for prophylaxis. No additional adverse events reported.
STAFF GAVE PATIENT A HIB VACCINE THAT HAD EPIRED ON 02.11.2023.
tiredness; bit light headed; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced tiredness and light headedness. On an unknown date, the outcome of the tiredness was not recovered/not resolved and the outcome of the light headedness was unknown.   It was unknown if the reporter considered the tiredness and light headedness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but as per indication of the vaccine age group was captured as adult. On Friday from the date of reporting, the patient received a dose of Shingrix. The patient was a bit light headed and very tired.  The reporter asked how long did the tiredness last. The patient was tired at the time of reporting.
This spontaneous report from a pharmacist refers to a patient of unknown age. On 27-FEB-2014, the patient was vaccinated with an expired dose of PNEUMOVAX 23 0.5 ml, intramuscular (lot number was reported as 1417AA expiry date 22-JUN-2013). No adverse effect was reported. Additional information has been requested.
1/2 hour after having the Pfizer vaccine, she had nausea that is lasting until today and it doesn?t go away
Covid vaccine given, 4 days later infected with Covid; This is a spontaneous report from a contactable Physician. A male patient of an unspecified age received bnt162b2 (BNT162B2) first dose, via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history  and concomitant medications were not reported. The patient experienced covid vaccine given, 4 days later infected with covid on an unspecified date with outcome of unknown.Reported Question: Covid vaccine given, 4 days later infected with Covid. He was treated with Bamlanivimab 1 week after vaccine. Should this patient got both doses of vaccine in 3 months?  Information about Lot/ Batch has been requested.
FEVER TO 105, PAIN IN JOINTS AND VOMITING LASTIN 3 DAYS AFTER RECEIVING DTP/OPV/HIB-V(CONNAUGHT) IMMUNIZATION.
Patient received booster dose( moderna) on 11/18/2021.  Symptoms of headache, feeling  being cold, stabbing pain of needles  in throat and difficulty of swallowing
This spontaneous report was received from a registered nurse referring to multiple unspecified adult patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patients were vaccinated with the pediatric/adolescent dose of VAQTA for prophylaxis (dose, route of administration, lot number and expiration date were not reported) as their initial dose. Nevertheless, no adverse effects were reported.