chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 14NOV96 & on 15NOV96 pt exp nausea, diarrhea, joint aches & a dec appetite;It was also reported that pt was otherwise never ill;
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe
Prefilled syringe from 16Jun2021 injected into another employee; Prefilled syringe from the same vial of the first dose used for second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Prefilled syringe from 16Jun2021 injected into another employee) and EXPIRED PRODUCT ADMINISTERED (Prefilled syringe from the same vial of the first dose used for second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Prefilled syringe from 16Jun2021 injected into another employee) and EXPIRED PRODUCT ADMINISTERED (Prefilled syringe from the same vial of the first dose used for second dose). On 14-Jul-2021, PRODUCT ADMINISTRATION ERROR (Prefilled syringe from 16Jun2021 injected into another employee) and EXPIRED PRODUCT ADMINISTERED (Prefilled syringe from the same vial of the first dose used for second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication  was reported.   This case was linked to MOD-2021-256700 (Parent-Child Link).   See case MOD-2021-256700 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-Significant Follow-up appended to AER
Narrative: Patient reported dry/scratchy throat following administration of 2nd dose of pfizer covid vaccine. Patient was able to depart without any intervention.
Fever approximately 100 degrees. Red and inflamed down arm. Numb/pain down to fingers. Cannot raise arm. Very hot on arm/fever in arm.
felt a bit of soreness; soreness on right side where she got vaccine; felt tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "felt a bit of soreness"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness on right side where she got vaccine"; FATIGUE (non-serious), outcome "unknown", described as "felt tired". Therapeutic measures were taken as a result of pain, vaccination site pain, fatigue include two Tylenol.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. developed fever up to 101 on 06/26/15 then rash developed on arm at injection site on 06/27/15.
Onset at 0530 am 4/11/02-irregular breathing, pain in sternum and back with inhalation "deep breath impossible due to pain" to emergency room at 0730 am. No fever vs normal No rash "whelp' at site of YF vaccine. D/C from Emergency at approximately 16:00 pm- provisional diagnosis. Pt saw chiropractor immediately after D/C from Emergency. Had "adjustment".
Last week, had rash on right arm, light red, circular in nature; sore arm  felt like someone beating my arm in a fight; ingers on both hands felt numb and tingling for couple of minutes; stomach was off; absolutely had no energy; felt pretty lousy after the first dose; headachy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm  felt like someone beating my arm in a fight), HYPOAESTHESIA (ingers on both hands felt numb and tingling for couple of minutes), ABDOMINAL DISCOMFORT (stomach was off), ASTHENIA (absolutely had no energy) and FATIGUE (felt pretty lousy after the first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sjogren's syndrome, Hashimoto's disease, Joint inflammation, Osteoporosis and Osteoarthritis. Concomitant products included COLECALCIFEROL (vitamin D), FOLIC ACID, vitamin c and folic acid and CALCIUM CITRATE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm  felt like someone beating my arm in a fight), HYPOAESTHESIA (ingers on both hands felt numb and tingling for couple of minutes), ABDOMINAL DISCOMFORT (stomach was off), ASTHENIA (absolutely had no energy), FATIGUE (felt pretty lousy after the first dose) and HEADACHE (headachy). On an unknown date, the patient experienced RASH (Last week, had rash on right arm, light red, circular in nature). On 27-Feb-2021, HYPOAESTHESIA (ingers on both hands felt numb and tingling for couple of minutes) had resolved. On 01-Mar-2021, PAIN IN EXTREMITY (sore arm  felt like someone beating my arm in a fight), ABDOMINAL DISCOMFORT (stomach was off), ASTHENIA (absolutely had no energy), FATIGUE (felt pretty lousy after the first dose) and HEADACHE (headachy) had resolved. At the time of the report, RASH (Last week, had rash on right arm, light red, circular in nature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details was reported.   This case was linked to MOD-2021-060899 (Patient Link).
Patient exposed by his mother on 12/23/21, they live in the same home. Mother went into isolation. Patient became symptomatic with sore throat and cough on 12/24/21 and symptoms worsended the following day with congestion, runny/stuffy nose. Positive covid test on 12/24/21. He went into isolation. End of isolation is on 1/3/22, aware he has to callback for f/u.
MMRV was given by medical assistant in place of MMR. Patient also received a dose of Varicella vaccine. No adverse effect occurred.
Developed pain in the left breast 4 days after the vaccine, followed by an area of swelling and redness by day 6. Provider was seen on 3/3/23. Mastitis was suspected and I was placed on antibiotics. Symptoms began to resolve after a few days of taking antibiotics. Please note that I was not lactating or breastfeeding, and have never had any prior health issues with my breasts.
Moderna COVID 19 Vaccine EUA:  Patient reports about 30 minutes after receiving vaccine he experienced chest pain, heart palpitations and extreme body aches.  Patient did not see medical attention at this time.  He states he laid down and fell asleep for the remainder of the night .  Upon waking the following day, he experienced a severe migraine headache, continued body aches and then developed a cough lasting several days.  Patient  followed up with PCP Tuesday, Feb. 2nd.   Patient denies any fever.  He states he has continued to have a "strange feeling in my heart" at night depending on the position he is lying in.  Patient denies any history of heart problems.
5/11/21 Welts on hands and hands and arms.   5/12/21  Swollen lips
mom called said pt broke out in whelps all over body;no fever, real fussy;was seen in office same day 19JUN96;PE-alert & active;pink spots all over body;no resp distress
pt recv vax 13AUG98 & c/o feeling achy all next day;around 4PM on 14AUG98 c/o red, flushed face w/swelling, welts & SOB;Sent to ER for tx;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose and route not reported, lot # L012035, 07-APR-2017; L016126, 06-MAY-2017; L005299, 17-FEB-2017; L019127, 27-MAY-2017; L021210, 10-JUN-2017). Information regarding concomitant medications was not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Wound infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EL9269) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st , Time: 1 PM, Site and Route of injection:, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL3247), administration date: 14Jan2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: WOUND INFECTION (non-serious) with onset 27Sep2021, outcome "recovered" (06Oct2021), described as "Wound infection". Therapeutic measures were taken as a result of wound infection. No follow-up attempts are possible. No further information is expected.  Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.  Additional information: treatment drug: Cephalexin
From telephone contact on 7/2/02 and additional faxed information received on 10/9/02, it was reported that a 31 year old adult female was vaccinated with TD ADS ADULT, lot # U0527AA, on 6/28/02 at 12:00 PM. On 6/28/02 at 12:15 PM< she experienced pain, swelling, and head at the injection site (arm), along with low grade fever and arm weakness. Patient recovered. The case is closed.
PERSISTENT FEVER WITH RASH THAT CAME AND WENT. WAS TAKEN TO ER THEN RETURNED TO ER WITH MILD SEIZURE & LOW FEVER LATER THAT WEEK. WAS ADMITTED WITH LOW NEU COUNT, INCREASED BASO, WBC LOW BUT ABOVE 2.5. HAD SWOLLEN RIGHT TESTICLE, REOCCURING DISAPPEARING RASH (HOSPITALIST SAW ALL OVER) STARTED ON FACE MOUTH & NECK AREA WITH FLUSH FROM FEVER WOULD COME & GO WITH FEVER, SWOLLEN LYMPH NODES ON BOTH SIDES BACK OF HEAD, SWOLLEN FACE & CHEEKS, & SWOLLEN NECK, RUBBING AT LEFT EYE. OVERALL FATIGUE.
mom reports marked redness & swelling lt leg p/inject; excessive crying x approx 7 hrs; low grade temp;
Pruritic morbilliform eruption also with few scattered punctate pustules with predilection for intertriginous sites and groin that developed 24 hours after Pfizer mRNA COVID vaccine without other identifiable trigger and spread over next week. - Antifungal cream - ineffective - single dose of prednisone 60 mg - improved pruritus and swelling - Started on topical corticosteroid and oral H1 antihistamine today
Burning sensation all over body / Palms of hands and bottoms of feed were burning; Felt like they had blistered; This case was reported by a nurse via call center representative and described the occurrence of burning sensation in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 9277N, expiry date 27th June 2021) for prophylaxis.   Concurrent medical conditions included parkinsonism.   On 16th September 2019, the patient received Shingrix (intramuscular). On 16th September 2019, less than a day after receiving Shingrix, the patient experienced burning sensation and blister. On an unknown date, the outcome of the burning sensation and blister were recovered/resolved.   It was unknown if the reporter considered the burning sensation and blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and in the middle of the night he woke up with a burning sensation all over his body.  The palms of his hands and bottoms of his feed were burning so badly it felt like they had blistered.  The symptoms resolved after about 4 hours.
Sores in mouth (?mouth ulcers?)/ inflammation primarily on the left side of the roof of mouth and left side of upper gumline. One major sore that feels almost like a pimple. Very painful and makes it difficult to chew food, drink, floss, & brush teeth. First noticed upon waking the morning after the dose was received. Still ongoing the next day. No treatment sought yet.
hot with no fever; dizzy; achy and the vaccine is kicking his butt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot with no fever), DIZZINESS (dizzy) and MYALGIA (achy and the vaccine is kicking his butt) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0363B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot with no fever), DIZZINESS (dizzy) and MYALGIA (achy and the vaccine is kicking his butt). At the time of the report, FEELING HOT (hot with no fever), DIZZINESS (dizzy) and MYALGIA (achy and the vaccine is kicking his butt) outcome was unknown.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-may-2021 and no significant information was provided
On August 9th, I received the tdap vaccine at University in order to fulfill the health requirements to attend school there part-time. I collapsed after having the shot, which the nurses told me was a vasovagal response, and not to worry. I was dizzy the rest of the evening, and the next day did not feel well, but went to work, assuming the symptoms were due to the shot and would pass. That week I began to experience severe fatigue, severe nausea, a feeling of wanting to jump out of my skin, hot flashes running from my neck into my shoulders, anxiety, low grade fever, inability to walk, dehydration, trouble breathing, debilitating headaches, dizziness, a feeling of being off balance, severe muscle weakness, rapid heart rate, and fullness in my ears that would not clear. This lasted over 2 years.
Initial report received from another manufacturer on 21 November 2008 who received the information from a consumer. An anonymous female patient (age not reported) received a flu vaccine (trade name, manufacturer, lot number not reported) two years in a row in the right arm. This year she noticed a lump on her arm in the same spot the vaccines were given and she had the lump removed. The patient had just learned that the lump was a squamous cell "canceroma". No further information was provided. Documents held by sender: None.
Was exiting building when fell to floor. Mom at side. Pt was pale, diaphoretic and alert by the time nurse arrived minute later. Pt observed in clinic for 30 minutes. Given juice, cold wet towels applied to neck & forehead, reclined. No further reaction noted in clinic.
pt felt like he was doing to pass out- was pale and diaphoretic, legs heavy and fingers tingling.  Patient was given Epi and Benadryl.  Patient was sent home from ER on the evening of the event.
I was having chest pains the week or so prior to going to the clinic on April 22. I was also having shortness of breath. They did an INR blood test and an MRI. The INR test showed elevated levels and so I was ordered to have an MRI which confirmed the blood clots. I was placed on enoxaparin sodium injections for about 2 weeks and then I was prescribed warfarin. I am not sure if its help as I still experience the chest pains and shortness of breath. I am not sure if the blood clots are still there or not.
Rapidly appearing 4inch diameter raised red rash at vaccination site with some scattered smaller red spots down the arm near the vaccination site. Itching, nausea, headache and dizziness set in about 2 hours prior to appearance of rash.
patient was inadverently given 0.6mL of the Pfizer-Biontech Covid19 vaccine, instead of the recommended 0.3mL; the recipients experienced more local reactions with very painful arms being reported; the recipients experienced more local reactions with very painful arms being reported; This is a spontaneous report from a contactable Pharmacist. This pharmacist reported for a 25-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via unspecified route of administration on unspecified date (Batch/Lot number: Not reported) as single dose for COVID-19 Immunisation. The patient's medical history and concomitant medication was not reported. Patient was inadvertently given 0.6mL of the PFIZER-BIONTECH COVID-19 VACCINE, instead of the recommended 0.3mL the recipients experienced more local reactions with very painful arms being reported. The clinical outcome of the events was unknown.  it was also reported that "If a person is given more than the recommended dose, they should be monitored and treated for any symptoms as required. The second dose of vaccine should still be given as per the recommended schedule "  Information on the lot/batch number has been requested.
After getting 2nd does the 1st injection site became swollen and inflamed.  About a 3" x  1.5" area at injection site has been affected.
Pt is a 3 1/2 year old male who presents today for symptoms of urticaria. He received a varicella vaccination during a visit to the office on 5/15/01. He broke out in urticarial rash later that afternoon and this has become gradually worse over time. Mother has not given him anything yet for this. He has not been exposed to any other medications. He is not on any OTC or RX medications. He is on no alternative medication. Pt has had no previous immunization reactions. He is not allergic to medications. Has not had any hospitalizations. Pt had the injection administered in the right anterior thigh. Exam: NAD. He said that his rash "tickles". Urticaria reaction with wheal and flare response over the extremities and buttocks. Very little involvement of the trunk or the face. Lungs are clear. No crackles or wheezes. Pharynx is nml. Neck supple. Lungs and heart are clear. Abdomen is soft without tenderness. Dx: acute Urticarial reaction. Suspect reaction to varicella vaccine. Will use Benadryl and/or Atarax as needed for urticarial reaction. I have advised mom to try and keep him cool. Use Tylenol for minor itching. If he should become worse a follow-up visit is indicated. Otherwise, careful exposure to eggs and egg based vaccines in the future.
Only one component of the vaccine was given to patient, the solution component which as the Tdap/ no AE; Based on information previously received on 21-Jan-2021, the following information [case classification from Non-Valid to Valid Agency with no AE and update in narrative accordingly; company drug code Pentacel from 242 to 520 updated and latency as one day in the field and update in narrative accordingly] have been amended.  Initial information was received on 21-Jan-2021 regarding an unsolicited valid non-serious case via Agency (Reference number- 00439658) from a pharmacist.  This case involves a patient of unknown age and gender who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] however, only one component of the vaccine was given, the solution component which as the Tdap (product preparation issue) via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency was on same day).  At the time of reporting, no adverse event reported.  The reporter said that whether they can reconstitute the powder portion of the vaccine and was it safe to give another dose to patient.  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.  There will be no information available on batch number for this case.
expired ACT HIB vaccine was administered with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 months old female patient for whom expired HIB (PRP/T) vaccine [ACT-HIB] vaccine was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Aug-2023, the patient received an expired dose of 0.5 ml (Frequency = once) suspect HIB (PRP/T) VACCINE powder and solvent for solution for injection (lot: UJ787AA) via intramuscular route in the left thigh for Immunisation with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) as dose 2,single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (1st Dose of COVID-19 Vaccine), for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 15Apr2021, outcome "unknown", described as "headache".  Additional Information: Yesterday patient received the second dose of the Pfizer Covid 19 vaccine. Is it normal to have a headache today? Patient is 39-years-old.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.