chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This is a spontaneous report received from a non-contactable consumer (patient) via Medical Information Team. An 80-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; Solution for injection in pre-filled syringe), via an unspecified route of administration on Sep2020 at single dose for immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient received a dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) on Sep2020 after her physician recommended her to be immunized with the vaccine after the risk of Pneumonia and COVID-19 concomitantly. The patient developed a headache on an unspecified date after the administration of the vaccine pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and that persists up to this day. The patient reports that her Physician had studied her medical conditions with tests, and MRI and different medications but it has not taken away the headaches. The outcome of the event was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
This is a spontaneous report received from contactable reporter(s) (Physician) for a Pfizer sponsored program (004756). The reporter is the patient. A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2021 (Lot number: EK4176) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1), administration date: Dec2020, when the patient was 51 years old, for COVID-19 immunization.The following information was reported: ALOPECIA AREATA (non-serious) with onset Mar2021, outcome "not recovered", described as "Alopecia areata"; ALOPECIA (non-serious) with onset Mar2021, outcome "not recovered", described as "Alopecia"; MADAROSIS (non-serious), outcome "unknown", described as "She has lost all her hair including her eye brows and eye lashes"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in the arm". The events "alopecia areata", "alopecia" and "she has lost all her hair including her eye brows and eye lashes" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of alopecia areata, alopecia.
Patients received 0.25ml of Moderna bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided. It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received, updated I narrative.
nursing my infant and he developed fever for 3 days without any other symptoms following my vaccination; nursing my infant and he developed fever for 3 days without any other symptoms following my vaccination; This is a spontaneous report from contactable other HCP. (mother) This other HCP reported information for both mother and baby. This is the baby report. An infant male patient started to received  the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EK5730,   transmammary route of administration, on 22Dec2020 18:15 as a SINGLE DOSE for COVID-19 immunization. Medical history was not reported. Concomitant medication included levothyroxine (LEVOTHYROXINE), biotin (BIOTIN), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), ergocalciferol (VIT D) and lactobacillus acidophilus (PROBIO).   The patient experienced vaccine exposure via breastmilk on 22Dec2020.  The mother reported nursing my infant and he developed fever for 3 days without any other symptoms on unspecified date following my vaccination. Outcome of the nursing my infant and he developed fever for 3 days without any other symptoms following my vaccination was unknown.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021098666 Infant case (dose 1)
Information has been received from a physician concerning a 6 year old male patient who on 19-JAN-2005 was vaccinated with the first dose of MMR II. On 16-OCT-2007 the patient was vaccinated with the second dose of MMR II. On 16-JAN-2010 the patient experienced right parotitis, swelling under the right ear and a fever of 101-102 degree F. It was unknown if the patient experienced orchitis. There was no other symptom. It was unknown if the patient had exposure to others with mumps. The patient had blood work performed on 18-JAN-2010. On 18-JAN-2010, the patient was diagnosed with mumps. At the time of the report, the patient's outcome was unknown. No further information is available.
Rash; Itches like crazy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itches like crazy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itches like crazy). At the time of the report, VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itches like crazy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Benadryl
This spontaneous report was received from a physician and refers to a currently 11 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # R002516, expiry date 13-SEP-2018, oral for prophylaxis. It was reported that the vaccines were stored at temperature 9 - 25 degrees Celsius for 12.5 hours. Temperature excursion was detected by digital data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA005223: US-009507513-1812USA006406.
This spontaneous report as received from a physician refers to a female patient of an unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX 0,65 ml for prophylaxis. On an unknown date, the patient experienced shingles primarily around her "forehead" area approximately 3 years after she was administered ZOSTAVAX. The outcome of herpes zoster was unknown. The causality assessment was not provided.
Case number PHEH2012US017119 is an initial spontaneous report received from a nurse on 29 Aug 2012. This report refers to a 12-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11052, and expiry date: Mar 2014) 0.5 ml intramuscularly on 27 Aug 2012. On unspecified date the patient had injection site reaction. The injection site was raised, hard, sore, red and swollen. The outcome was not reported.
This is a spontaneous report from two contactable consumers (patient and patient's child) and from a contactable physician. A 72 years old female patient of an unspecified age and ethnicity received PREVNAR13, lot J50612) via intramuscular route of administration, in left deltoid muscle, on 21NOV2014 at 17:00, at 0.5 ml single. Medical history include  arterial hypertension since 28FEB2003, latent hypothyreose since 23NOV2007, chronic venous insufficiency. TSH in AUG2014 was 0.00765 IU/ml. Concomitant medication included METOHEXAL 95) at 1 DF daily, for arterial hypertension. The patient had local pain while injection since 21NOV2014 at 17:00 for  2 weeks. On 22NOV2014 at 06:00 the patient experienced painful to pressure, immediate  and visible swelling of the muscle for 2 weeks, with subsequent redness. The involved area was 15 cm in diameter oval. Redness lasted until 03DEC2014. There were nor hematoma discoloration, nether fever. After the pain subsided, a two weeks persistent itching developed, which stretched itself to the elbow and responded well to FENISTIL cream. The patient had itching  from 25NOV2014 (approximately at 06:00) to 06DEC2014. The immediate pain upon injection was only very short and was not documented as anything special by the physician. The adjective "painful upon palpation" referred to the redness and swelling which set in 12 hours after the injection". Since unknown date the patient had a hot hand-size area. The patient was treated with dimentidene cream for redness, itching, hot hand-size area. The patient also experienced an allergic reaction (substantial reatogenicity around the injection site) for 2 weeks. The patient was not hospitalized. At the time of report the patient was completely free of symptoms. Follow-up (15DEC2014): New information reported from the patient includes: updated patient date of birth, patient age, events details, events outcome, information that patient was not hospitalized. Follow-up (09JAN2015): New information from the contactable physician includes: vaccination details, medical history, concomitant medication, lab data, events clinical course, details and outcome. Follow-up (06MAR2015): Follow-up attempts completed. No further information expected. Follow-up (12MAR2015): New information from the contactable physician includes confirmation of events description and clinical course. Follow-up attempts completed. No further information expected.
states his 30 minute wait was over and noticed that his cheeks hurt, removed mask and has bright red rash on both cheeks about 3 inches diameter. States that it burns. No rash on arms, chest, back. States throat feels fine and has no difficulty swallowing.  O2 99% on r/a, HR 86; BP 138/88 3:35 gave patient 25mg benadryl tablet by mouth - continues to deny throat itching or swelling. Gave patient ice for comfort to hold on cheeks. States" that feels so good. " 3:55 HR 82; O2 97%; BP 122/88 4:00 states he is feeling better that the burning sensation is gone, rash not as red on cheeks. Left ambulatory to personal vehicle.
Coughing; chills; she is feeling like a headache, might be from all the coughing; she threw up a yellow stuff, I think the yellow mucous or acid; Fever; This is a spontaneous report from a contactable consumer (patient's spouse) via a Pfizer-Sponsored Program, Pfizer First Connect. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EL1284) via an unspecified route of administration on 04Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history was reported as "none". Concomitant medications were not reported. The patient experienced "coughing", "chills", "she is feeling like a headache, might be from all the coughing", "she threw up a yellow stuff, I think the yellow mucous or acid" and "fever", all on unspecified dates. It was reported that "the reporter called concerned about his wife who got the Pfizer BioNTech COVID-19 vaccine "yesterday" and then she started coughing and experienced a fever." The reporter stated "she was coughing a lot and she threw up a yellow stuff, I think the yellow mucous or acid or whatever. She had a fever that peaked till 100. I gave her Aspirin, it dropped down to 98 at the moment, but she was still having chills." The reported stated that "I just gave Aspirin for the fever. She said at the back of her neck you know she said that she is feeling like a headache, might be from all the coughing." The patient underwent lab tests reported as "got blood work for allergies and stuff like that". When inquired regarding the indication, the reporter stated, "she was caring for my uncle who is 65 and older". The reported stated "I feel that it is recovering, it's getting better".  The clinical outcome of the event "chills" was not recovered/not resolved whereas the clinical outcomes of the events "coughing", "she is feeling like a headache, might be from all the coughing", "she threw up a yellow stuff, I think the yellow mucous or acid" and "fever" were all unknown.
Patient stated that she did not feel well and seconds later fainted/had seizure, including rigid body and eyes rolled back. Fell face down on the floor, turned white, discolored, and unresponsive.
Information has been received from a 64-year-old female consumer with penicillin and nitrofurantoin (Macrobid) allergy and a history of surgery in June of 2007, who on 11-Sep-2007 was vaccinated with a dose of Zostavax.  Concomitant therapy included "vaginal cream".  At the end of the day on 11-Sep-2007 the patient experienced "dry eyes, colds and swelling at the injection site".  No medical attention was sought.  The outcome was reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Beyond a mild headache and very loud tinnitus that started about 45 minutes after the shot and only lasted about 1 hour, I developed severe chest pain at approximately 7 hours after  the shot that awoke me from a sound sleep.   Pain rated at 8 1/2-9 on 1-10 scale.  It continued for 2+ weeks.  Exponentially  worse with any increase in heart rate.  Diagnosed via email with cardiologist as probable pericarditis and instructed to take OTC NSAIDs until symptoms resolved.  At 3 weeks out I still feel mild chest pain, but pain no longer increases with an increase in heart rate.  IgG titers pulled 3/5/21 and I will get the second dose depending on my immune response to the first dose.
vial of Moderna Covid-19 Vaccine that stayed out of the refrigerator for more than 12 hours; a vial of Moderna Covid-19 Vaccine that stayed out of the refrigerator for more than 12 hours was administered to 3 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vial of Moderna Covid-19 Vaccine that stayed out of the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (a vial of Moderna Covid-19 Vaccine that stayed out of the refrigerator for more than 12 hours was administered to 3 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (vial of Moderna Covid-19 Vaccine that stayed out of the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (a vial of Moderna Covid-19 Vaccine that stayed out of the refrigerator for more than 12 hours was administered to 3 patients). On 29-Jul-2021, PRODUCT STORAGE ERROR (vial of Moderna Covid-19 Vaccine that stayed out of the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (a vial of Moderna Covid-19 Vaccine that stayed out of the refrigerator for more than 12 hours was administered to 3 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
fever for hours,then chills for hours and fever for  hours. Day three after 2nd shot lesion on the roof of my mouth and eye infection in left eye. Antibiotic 500 mg for 10 days.They helped some. Then Amoxilillin  500 mg . After 8th day mouth cleared up. Left eye , I hot packed.
Hives that are spontaneously appearing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of URTICARIA (Hives that are spontaneously appearing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives that are spontaneously appearing). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at a dose of daily. At the time of the report, URTICARIA (Hives that are spontaneously appearing) had not resolved.            No concomitant medications were reported.  The patient got his booster and approximately 10 days later is having the same concern with hives that are spontaneously appearing only to be controlled by daily Zyrtec. If not taken, they continue to reappear to this day.   This case was linked to MOD-2022-437335 (Patient Link).
expired dose of shingrix was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 15th May 2022) for prophylaxis.   On 9th June 2022, the patient received Shingrix. On 9th June 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-JUN-2022  Reporter's comment: Health care professional (HCP) reported an expired dose of Shingrix was administered to a patient.  The reporter consented to follow up. Additional supportive information: On 9th June 2022, patient received dose of Shingrix that was already got expired on 15th May 2022, which led to expired vaccine used.
mom reports pt started c/o not feeling well around 6PM went to bed early around 7PM started throwing up around 3AM dry heaves; t102.6 ax;
Back pain; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (Back pain), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, BACK PAIN (Back pain), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  On unknown dates, the patient experienced chills after getting second Covid vaccine, fever after getting second Covid vaccine and body aches after getting second Covid vaccine.  No treatment information was provided.  The reporter's causality with Humira for the events of chills, back pain, fever and body aches was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Very painful when administered. Stiff and sore in the evening. Could hardly lift arm. Applied ice.
Information has been received from a 69 year old female patient with auto immune disease/overactive immune system, who also suffered from narcolepsy and acid reflux. She had drug reactions/allergies to unspecified medications. The physician advised the patient to get a booster Pneumonia vaccination. The patient did not know if she was previously vaccinated with the PNEUMOVAX 23 or not. On 11-NOV-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 for vaccination (dose, dose #, lot #, route and application site were not reported). Concomitant therapies included aspirin, beta blocker, narcolepsy and acid reflux medications. On 11-NOV-2015, after receiving the PNEUMOVAX 23 vaccination the patient had an adverse experience. The vaccine burned as she received the vaccination The patient suffered from injection site reaction and tightness in her chest. The patient's second toe on her right foot turned black and blue on the back and is now spreading around to the front of the toe. No treatment was given for events. The patient had scheduled an appointment with physician. The outcome of events was reported as not recovered/not resolved by the time of this report. The causality was not reported. Additional information has been requested.
Roughly two weeks in, my equilibrium was off. I started leaning to the right and having to work hard to keep myself upright. This turned into extreme dizziness and nausea. I was unable to drive distances for this reason. Nor walk straight. It subsided slightly right before my second dose.
Gave another Prevnar 20 vaccine and patient already had it on 9/13/2022
- Chest Pain, Abnormal EKG Reading, Nausea, Dizziness, Persistent Chest Pressure, Tiredness