chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse for the Pregnancy Registry for GARDASIL vaccine (yeast) concerning a 22 year old female with sulfonamide allergy who on 04-DEC-2007 was vaccinated IM with the first 0.5 ml dose of GARDASIL vaccine (yeast) (Lot # not reported). On an unspecified date the patient was vaccinated with a second dose (Lot # not reported). On 05-JUN-2008, the patient was vaccinated with the third dose of GARDASIL vaccine (yeast) (Lot # not reported) then the office discovered that she was pregnant (LXP: 08-MAY-2008). The office performed a pregnancy test prior to the administration of the vaccine that demonstrated a "weak positive". Then after the vaccination a second pregnancy test was performed that displayed a positive result. No adverse effects reported. Concomitant therapy included hormonal contraceptives (unspecified). Unknown medication attention was sought in the office. The outcome was not reported. Additional information has been requested.
pt recvd vax; at 8:30pm pt was shaking; uncontrollable; went away when supine; worst at 10pm; sxs gone at mid nite; no fever; no pain;
Cellulitis with blisters at vaccine site. (L) arm (diagnosed as "spider bite").
injection site soreness; 101.5 degree fever; headache; joint pain; muscle pain; fatigue; A report was received from a consumer concerning a patient, 22 years old, male and experienced multiple events of injection site soreness, 101.5 F fever, headache, joint pain, muscle pain and fatigue.  The patient's medical history was not provided. No Concomitant medications were reported.  On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 026L20A).   On 27 Dec 2020, the patient experienced injection site soreness, 101.5 F fever, headache, joint pain, muscle pain and fatigue. No treatment information was reported. On the same day, the body temperature of the patient was 101.5 degrees Fahrenheit.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, injection site soreness, 101.5 F fever, headache, joint pain, muscle pain and fatigue was unknown.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 22-years-old male patient, who experienced a non-serious expected event of injection site pain, pyrexia, headache, arthralgia, myalgia, and fatigue. The events occurred 2 days after first dose of mRNA-1273, lot # 026L20A.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
This case was reported by a physician (allergist) and described the occurrence of anaphylaxis in a 4-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline), MMR II (Merck) and Varivax (Merck) for prophylaxis.  On 25 January 2008 at 12:00 the subject received 2nd dose of Havrix at 0.5 ml in the left arm.  On 25 January 2008 the subject also received unspecified dose of MMR II (the subject had at least one previous dose) and 1st dose of Varivax.  At an unspecified time after vaccination with Havrix, MMR II and Varivax, the subject experienced anaphylaxis, a systemic reaction.  The physician considered the events were life threatening and clinically significant (or requiring intervention).  The subject was treated with Epinephrine, 2 doses), Benadryl, oxygen and prednisone.  Once stabilized, he was sent to the emergency room for observation, but was not admitted.  He required no further treatment.  The child had no reaction to the first dose of Havrix.  In 2008, the events were resolved.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 29-MAY-2012 the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). On 24-SEP-2012, the patient was vaccinated with dose 2, GARDASIL (lot#, expiration date and route not reported). On 19-NOV-2012, the patient was vaccinated with dose 3, GARDASIL (lot#, expiration date and route not reported). No adverse effects reported. Additional information is not expected.
Client is a 10 year old female. Client received a Pfizer pediatric covid-19 vaccine @1550. 1552 this nurse was called over to the vehicle. Client was reclined in the passenger seat. Client was pale and diaphoretic but responded appropriately to verbal stimuli. Pulse oximeter placed on client's right index finger. Pulse 68, O2 sat 98%. Client given an ammonia ampule to smell @. Client offered water and goldfish crackers 1558. Client drank some water and put goldfish unopened on her lap but indicated that she would eat them if she "needed to".  Client's color improved and diaphoresis decreased. Client stated that she was "feeling better".         Client's mother advised us to wait in the "recovery area" for observation for at least 15 minutes and the client felt well enough to go home.
Large swollen lymph node to the left of my left breast.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number EK8734) via unspecified route of administration in the left arm on 27Mar2021 at 10:00 (at the age 56-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no known allergies to medications, food and other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EN6200) via unspecified route of administration in the left arm on 06Mar2021 at 10:00 (at the age 56-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 29Mar2021 at 20:00, the patient experienced large swollen lymph node to the left of left breast, was not quite under the arm and lymph node was painful. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of painful lymphadenopathy was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient received Moderna COVID vaccine bivalent booster on 1/6/23. On 3/19/23, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure due to COVID-19 pneumonia (patient with 3 weeks of respiratory symptoms that have been progressive in the setting of COVID-19 positivity on 2/27/23) and SIRS/sepsis (POA) secondary to pneumonia. As of today (3/22/23), patient is still admitted in the med/surg unit.
No adverse effects  being reported to pharmacy. Parents falsified age of patient (child) to get adult strength dose administered
Edema, erythema at injection site. Onset several hours after injection. No treatment necessary.
admin wrong moderna bivalent, outreached to patient. schedule for 06/03/2023 for right vaccination
Patient had a positive HCG. Patient's last LMP was 17 July 2013 and received vaccination on 12 Aug 2013. Patient's positive pregnancy test was on 9 September 2013.
Pain in upper arm and shoulder  within 30 minutes of injection.  Continued for 3 weeks and became swollen and bruised. Pain continues at present, 2 months later. Injection site was higher and nearer to shoulder joint than any injection I have previously received.
I had the shot and still put the shingles/suspected vaccination failure; shingles; still having pain; I got another shingle shot; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said that shingles vaccine did not help because he/she had the shingles shot and still got the shingles. The 2 years later, the patient got another shingle shot, which led to extra dose administered. The patient would see how long it takes to get shingles this time and he/she still had the pain from the shingles and the patient was just did not quit as they said it could last for years and years. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. Note: As per the narrative, the pain occurred due to past shingles, hence pain was linked with the 1st suspect of shingle vaccine.
Dizziness; Bad sinus problem; Pressure felling over both eyes but more towards right eye; Pressure symptom over the nostrils.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), SINUSITIS (Bad sinus problem), OCULAR DISCOMFORT (Pressure felling over both eyes but more towards right eye) and NASAL DISCOMFORT (Pressure symptom over the nostrils.) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Sinus infection since an unknown date.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (Dizziness), SINUSITIS (Bad sinus problem), OCULAR DISCOMFORT (Pressure felling over both eyes but more towards right eye) and NASAL DISCOMFORT (Pressure symptom over the nostrils.). At the time of the report, DIZZINESS (Dizziness), SINUSITIS (Bad sinus problem), OCULAR DISCOMFORT (Pressure felling over both eyes but more towards right eye) and NASAL DISCOMFORT (Pressure symptom over the nostrils.) outcome was unknown.        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.   Treatment was OTC Qu pill. Concomitant medication was not provided.
Employee states numbness and tingling to tongue and getting worse, going down throat.  Epi pen 3mg administered sub cutaneous per Dr. standing orders.
Itchy, red rash from injection site down arm toward elbow crease. Warm and sore to touch. Used Benadryl cream 3x day from 2/3/21 to current date.
Uncomplicated Cellulitis - Patient states that the site was not wiped down with alcohol swab before injection, site became "red, warm, and swollen" a day after injection. Symptoms worsened over the next days, patient estimates that affected area was up to 3x5 inches at its worst point. Reaction treated with over-the-counter topical antibiotics (Neosporin) for 2 weeks until symptoms improved.
This spontaneous report was received from a registered nurse (also reported as a licensed practical nurse) refers to unspecified patients of unknown age and gender. No medical history or concurrent condition were reported. On unknown dates, the patients were vaccinated with (Oka/Merck) VARIVAX, injection (dose, frequency, strength and lot number were not provided). Co-suspect or concomitant therapies were not provided. The VARIVAX vaccines administered to the patients underwent a supported temperature excursion. No adverse experiences reported. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Onset of menstral cycle - 4 days following shot 5 days prior to normal start.  Heavy and clotting.
It became raised and puffy with a red ring around the blotch; itchiness and pain is gone, the original blotch remains and is now a purplish color; Still itchy and a dull ache deep within my arm remained.; It was hot to the touch, itchy, burning; Itchy; Burning; I developed a red blotch about two inches below the injection site; Mild flu-like symptoms for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild flu-like symptoms for 24 hours), RASH MACULAR (I developed a red blotch about two inches below the injection site), VACCINATION SITE WARMTH (It was hot to the touch, itchy, burning), VACCINATION SITE PRURITUS (Itchy) and SKIN BURNING SENSATION (Burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Mild flu-like symptoms for 24 hours). On 04-Apr-2021, the patient experienced RASH MACULAR (I developed a red blotch about two inches below the injection site). On 05-Apr-2021, the patient experienced VACCINATION SITE WARMTH (It was hot to the touch, itchy, burning), VACCINATION SITE PRURITUS (Itchy) and SKIN BURNING SENSATION (Burning). On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Still itchy and a dull ache deep within my arm remained.). On an unknown date, the patient experienced SWELLING (It became raised and puffy with a red ring around the blotch) and SKIN DISCOLOURATION (itchiness and pain is gone, the original blotch remains and is now a purplish color). At the time of the report, INFLUENZA LIKE ILLNESS (Mild flu-like symptoms for 24 hours), RASH MACULAR (I developed a red blotch about two inches below the injection site), VACCINATION SITE WARMTH (It was hot to the touch, itchy, burning), VACCINATION SITE PRURITUS (Itchy), SKIN BURNING SENSATION (Burning), SWELLING (It became raised and puffy with a red ring around the blotch), SKIN DISCOLOURATION (itchiness and pain is gone, the original blotch remains and is now a purplish color) and PAIN IN EXTREMITY (Still itchy and a dull ache deep within my arm remained.) outcome was unknown. Not Provided
24 hour headache Painful joints for about 2 days Fatigue about 2 days Insomnia for two nights  Took Tylenol and that helped a bit
Very mild papular rash upper torso and scalp. No other complaints. Began 10 hours after injection. No other changes in household or dietary anomalies. She was in no distress.
~22 hours after her vaccination, she got a 102 fever - it lasted a couple hours ~36 hours after her vaccination, she had nausea and threw up two times all symptoms cleared about 42 hours after her vaccination
syncopal episode;c/o nausea, lower extremity, weakness & generalized achiness 2hr p/vax;vitals @ time of syncopal episode BP 90/50, HR 50;p/ 750cc nl saline BP 128/70, HR 80;
Sunday 3/28 around 4:40 pm we had given one of our extra doses of COVID-19 given to a patient. Approximately 10 minutes later, patient alerted us to feeling funny ( throat felt large, no trouble breathing, slightly dizzy, and coughing excessively, itchy). She stated she usually has her inhaler ( COPD/Asthma patient) with her, but didn't this day. We went ahead and dosed her with diphenhydramine 25 mg, and got her a albuterol inhaler from her profile, and water ) After taking 2 inhalations of her inhaler, the coughing subsided and was feeling much better.. Afterward, recommended follow-up with her primary with-in 24 hours and if it progressed to go into ER. She denied wanting to go see provider, but will inform them of her reaction, also denied us to call emergency services as she felt ok and was not having trouble breathing. I did do a follow-up call before we closed at 5:55 pm and she said she was doing well, and will use another puff of her albuterol soon, but didn't think she needed to go in and that she was fine.
arm is sore; can't lift arm; achy; fatigue; throwing up not keeping any food down; diarrhea; cold sweat; headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (throwing up not keeping any food down), DIARRHOEA (diarrhea), COLD SWEAT (cold sweat), HEADACHE (headache) and PAIN IN EXTREMITY (arm is sore) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included Diabetes.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VOMITING (throwing up not keeping any food down), DIARRHOEA (diarrhea), COLD SWEAT (cold sweat) and HEADACHE (headache). On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is sore), LIMB DISCOMFORT (can't lift arm), PAIN (achy) and FATIGUE (fatigue). On 26-Mar-2021, VOMITING (throwing up not keeping any food down), DIARRHOEA (diarrhea), COLD SWEAT (cold sweat) and HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (arm is sore), LIMB DISCOMFORT (can't lift arm), PAIN (achy) and FATIGUE (fatigue) outcome was unknown.
Approximately 30 minutes post vax injection pt developed fine rash around injection site extending to upper trunk.
Information has been received a registered nurse concerning two patients of unknown age. On 03-AUG-2017, the patients were vaccinated with PROQUAD (lot # M006107, expiratory date: 01-AUG-2017; dose and route were not reported) as prophylaxis. No adverse effects were reported. No additional information was available. All telephone attempts on 01-SEP-2017 to obtain follow-up information had been unsuccessful. Follow up information has been received from the registered nurse concerning one 5 years old male patient on 06-OCT-2017. In approximately December 2016 (also reported as eight months before the vaccination), the patient suffered from seizure following unknown vaccine. There was no seizure after that. On 03-AUG-2017 at 14:00, the patient was vaccinated at public health clinic with the second dose of PROQUAD subcutaneously at left arm. So, the vaccine was given 2 days after the expiration date. No further treatment was stated. No re-vaccination was needed. This is one of two reports received from the same reporter.
5 year old patient was given Pentacel, no AE; Initial and follow up information received on 09-Dec-2019 and 11-Dec-2019  regarding an unsolicited valid non-serious case received from a nurse.  This case involves a five years old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ083AAA, Exp. Date 11-Oct-2020) via intramuscular route in the right thigh on 04-Nov-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no side effects were noted.  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 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.
Vaccine was given exp date of 9/30/22.....was not thrown out on that night, dose was given in am on 10/01.....vaccine was later extended exp date until 10/19 so no harm etc just reporting as a potential event
Patient called and complained of her arm being red for over a quarter of the arm and complained of soreness.
Pain, swelling at injection site, swelling started to reduce around day 3 and was gone by day 6;  Multiple Lymph Nodes around left collar bone began to enlarge day 3 and are still enlarged as I write this 2/2/2021. Some soreness if touched.  No other symptoms.
patient started her period the day of the vaccination and has not stopped bleeding since; This is a spontaneous report from a non-contactable consumer, reporting for herself. A 32-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2), via an unspecified route of administration in the left arm on 09Apr2021 at 16:00 at a single dose for covid-19 immunisation. The patient received the vaccine in the hospital. The medical history was not reported. Concomitant medications included ergocalciferol/retinol palmitate (VITAMINS A & D) taken for an unspecified indication from 09Apr2021 to an unspecified stop date; cetirizine hydrochloride (ZYRTEC R) taken for an unspecified indication from 09Apr2021 to an unspecified stop date; rhamnus cathartica/rhamnus purshiana/senna spp. (HERBAL) taken for an unspecified indication start and stop date were not reported. No other vaccinations received in the last four weeks. On an unspecified date, the patient started her period the day of the vaccination and has not stopped bleeding since. It has been 18 days now. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Dizziness and disorientation after shot.   Continuous and daily ear ringing, headaches, dizzyness, mental fogginess, and chest pains throughout the day and every day since day of shot.  Over 1 month now.
still isn't feeling well; headache; fatigue/tired; dizzy; cough; body aches/really painful; but feels like something in her chest; This is a spontaneous report from a contactable consumer (Patient). This 46-years-old female consumer reported herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 05Mar2021 as dose 2 single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunisation. The caller got her second dose 05Mar2021 (Friday) and since then, she had her 7th day of not feeling well. The caller was tired/fatigued, had a headache, was dizzy sometimes, and had a little cough, not a lot, but felt like something in her chest. The caller's body aches was still there, could not get out of the bed, somehow had made it to work the past few days but she still felt very tired. The caller wanted to know how long it would last, was it normal, and what she should she regarding the AE. Also, she wanted to know whether others have had prolonged side effects. The caller mentioned that it had gotten better, her husband was fine but its just in her case that it was really painful. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.