chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 days after receiving Fluogen employee starting getting fine erythemic rash on anterior and lateral aspects of thighs and lower back/c/o itchiness but no other sx.
Pfizer-BioNTech Covid 19 vaccine EUA- About 15 minutes after receiving the vaccine I had chills go up the back of my head. Severe HA started about 1600, body aches in joints and muscles began that night. Returned to work 2/3/21 as day progressed my HA became so bad I was nauseous, after 2 hors at work I had to go home. Fever of 100 that went to 101.7 the following day. HA was not relieved with Tylenol or ibuprofen . Arm was moderately sore no redness or swelling.
Fever 103 axillary, frontal headache, muscle ache arms, rash on torso.
Diarrhea; feeling weak; slept over half the week; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9261; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 28Jan2021 (at the age of 55-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease) diagnosed years ago. There were no concomitant medications. On 01Feb2021 the patient reported of feeling weak and on 02Feb2021 she had diarrhea. Reporter stated she had the first Pfizer shot on 28Jan2021, states all week she has felt weak and the last few days she has had the runs in the morning. Reporter stated that she had diarrhea in the morning only since Tuesday. Stated she started feeling weak on Monday, had slept over half the week on an unspecified date in Feb 2021, stated she never had to call out of work. At the time of report, outcome for events feeling weak and diarrhea were not resolved and slept over half the week was unknown.   Follow-up attempts are completed. No further information is expected.
Left supraclavicular lymphadenopathy noted 9/1/21 -  significantly enlarged and very tender lymph node x1
severe h/a, became flushed & warm, lightheaded, felt like had prickly heat although no rash present lasting 2-3 rhs; took ASA;
Patient came in with family to receive flu and COVID vaccine.  Discovered after the vaccine had been administered the patient was only 11 years old.  Received the adult vaccine and dosage.
C/o sore throat, body aches, vomiting, difficulty breathing 2 hours after rec flu shot. 10/20/10 feeling better.
Non-sexually acquired genital ulcers developed on Vulva with Persistent erythema, pain, extreme itching.  Clobetasol Propionate cream prescribed to reduce inflammation, applied every day for 7 days and ulcers completely healed. Non-sexually acquired genital ulcers have continued to developed in ?flares? since first incident.  Scarring has developed on Vulva.
This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 25Mar2021 at 15:30 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), dexlansoprazole (DEXILANT), hydrocodone bitartrate, paracetamol (NORCO), potassium chloride (KLOR CON), and progesterone (PROMETRIUM). Additional concomitant medications were reported as: AM. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, fatigue, injection site severe pain, and hard knot at injection site on 26Mar2021 at 12:00. The patient did not receive any treatment as a result of the events. The clinical outcome of headache, fatigue, injection site severe pain, and hard knot at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
2days p/vax pt devel ? fever, hot to touch, swollen arm x1week. tx: ice, tylenol, warm compress
The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023; No adverse event; 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 12-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 12-Apr-2023).    Concomitant medication details not reported by the reporter. Dosage text was reported as Unknown. Batch number was reported as 069H22a and AS7173B. Vial with batch number 069H22a was initially stored in refrigerator on 18-APR-2023 and vial with batch number AS7173B initially stored in refrigerator on 06-MAR-2023. Vial did not undergo temperature excursion. Treatment details was not reported by the reporter. This case contains information of 8th patient out of 10 patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case Patient no-1
pt recv vax & devel a palm sized welt @ the inj site;a 2 inch area of redness surrounded the welt;
This spontaneous report was received from a nurse concerning a 15 year old female patient. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of PROQUAD (dose number, lot number, expiration date and route were not reported), 0.5 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The nurse reported that a patient received PROQUAD at 15 years of age. The nurse stated that the patient had received her first dose of M-M-R and VARIVAX (Merck) previously as separate vaccines. No adverse effects reported. Additional information has been reported.
Client received 1 vaccine, DTAP. R arm. Mom reports he complained about pain that evening but she did not observe the arm. Next day school nurse called clinic stating redness, swelling and heat from elbow to top of shoulder. Temp 100.4. Mom brought patient to clinic. R arm had redness, heat and swelling elbow to shoulder size of baseball at top on thin arms. Applied ice packs, advised intermittent timing, TYLENOL or MOTRIN. If difficulty breathing or worse, take to ER.
Patient states she got to school and walked into a wall, then went into class and starting "saying things" but she didn't think she was talking. She kept falling asleep in class, got home and didn't want to eat and then slept from 4pm until the next morning. She went to school on 1/25/2013 and said she felt better but still very sleepy and kept falling asleep in class.
Immunization administered at school. Parent previously sent signed consent but came to the school and asked that her children's forms be pulled because they had already been vaccinated. The form was not pulled; child re vaccinated after 4 days.
Information has been received from a physician concerning an 11 year old female who on 27-MAR-2008 was vaccinated with GARDASIL (659964/1978U). Concomitant therapy included HAVRIX (lot# not reported). On 27-MAR-2008 the patient experienced wooziness and began crying. Subsequently, the patient recovered from the wooziness and crying. The patient's sister had the same AE after receiving GARDASIL. See SR# 1-2774239749. Additional information has been requested.
Throat little itchy immediately after vaccine; Lip swollen; Hived lip; Elevated heart beat; Low grade fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Throat little itchy immediately after vaccine), LIP SWELLING (Lip swollen), URTICARIA (Hived lip), TACHYCARDIA (Elevated heart beat) and PYREXIA (Low grade fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (NSAIDS).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced THROAT IRRITATION (Throat little itchy immediately after vaccine), LIP SWELLING (Lip swollen), URTICARIA (Hived lip), TACHYCARDIA (Elevated heart beat), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (Sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Apr-2021, THROAT IRRITATION (Throat little itchy immediately after vaccine), LIP SWELLING (Lip swollen), URTICARIA (Hived lip), TACHYCARDIA (Elevated heart beat) and PYREXIA (Low grade fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient visited emergency room. No concomitant medication reported. Treatment  also included steroid.
pt recvd vax & had urticarial ring & few scattered papules on R fore arm w/ hives on LL & RA;
First, extreme pain at the injection site (left upper arm) as if someone punched me hard in the arm. I could not sleep because the pain was so intense. The next morning, I could not lift my arm above shoulder height and the pain radiated down my arm to about my elbow, both inner and outer arm. Several hours later, I took my temperature and it was 100. There was slight bruising under the skin in a radius about 5 inches around the injection site and some redness, but no red streaking. I was concerned so called the pharmacy that administered the vaccination. Said my reaction was atypical. It took 4 days to feel any relief from the pain. Mild fever lasted for 2 days.
This is a spontaneous case, initially received on 24-Jan-2018, was reported by a nurse and concerns a 04-year-old female child. The patient's medical history and concomitant medications were not reported. On an unspecified date in Dec-2017, the vaccine underwent first temperature excursion. It was reported that, FLUCELVAX QUADRIVALENT PFS had been out of range for 80 hours, and reached at the highest temperature of 9.1 Celsius (explicitly considered as incorrect product storage). On 04-Dec-2017, the patient was administered with FLUCELVAX QIV (dose 0.5 ml, route of administration: intramuscular, anatomical location: left/right deltoid, batch number: 195228, expiry date: 31-May-2018) (explicitly considered as drug administration error). The patient had no adverse event following the vaccination. The reporter assessed the events as non-serious.
Allergic reaction consisting of skin rash in face, neck, chest, arms. Difficulty swallowing/ throat inflammation Treated with Benadryl
Patient inadvertently received FLUMIST during clinic at school on 10/6/2011. No immediate symptoms. Mother reported to school health office 4 days later that patient was ill after receiving FLUMIST.
p/vax woke up w/itching all over body;itching cont through 11/6/99;on 11/7/99 itching improved but noticed a sl reddened rash on upper chest & mottled appearing skin on both arms;11/8//99 s/s almost gone;11/9/99 s/s gone;took DPH;
Patient said that night of shot he ran a fever and arm turned red and swelled up. Today he no longer had a fever but arm was still swollen and red, he said it had started to go down.
Very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Very sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Very sore arm). At the time of the report, MYALGIA (Very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided. No Treatment Medications were provided.
After the vaccination I have presented problems in the menstrual cycle, less quantity in the menstrual flow and constant joint pain that radiates towards the extremities as muscular fatigue and tingling, my vaccination was on November 10 and since then I have presented the changes in my body.
Severe headaches - still occurring as of 5/15 - medication prescribed to manage pain started in April and other medication intended to prevent headaches from occurring started on 5/13 Muscle pain - less severe after 4 weeks and ongoing massage therapy Chills - frequent for about 3 weeks, occasional now Fatigue - still occurring as of 5/15
Patient got her second dose of Pfizer COVID vaccine 16 days after her first dose of Pfizer COVID vaccine.  Patient has no problems and has tolerated both vaccines alright.
Patient reported that she couldn't walk for 24 hours. She said her legs weren't working. It wasn't a numbness and it only last for the day of the vaccine. The next day it was fine.
Narrative: also mild tight upper chest - sxs resolved with benadryl 25 mg ivp, 500 ml saline and observation
No adverse reaction to date, however two TDAP vaccines administered within a one week period of time on 10/18 and 10/23/11, both in right deltoid
was a little tired.; very hard to walk; went to sit on the toilet, I slid right off, fell on the floor; so weak; groggy; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (very hard to walk), FALL (went to sit on the toilet, I slid right off, fell on the floor), ASTHENIA (so weak), SOMNOLENCE (groggy) and FATIGUE (was a little tired.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031m21a and 040a21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (ambicillin (ampicillin) allergy) and Drug allergy (zanax Xanax) allergy). Concomitant products included LORAZEPAM (ATIVAN) from 13-Aug-2012 to an unknown date, GABAPENTIN from 13-May-2012 to an unknown date and QUETIAPINE from 04-Apr-2018 to an unknown date for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) from 05-Dec-2000 to an unknown date for Cholesterol.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced GAIT DISTURBANCE (very hard to walk), FALL (went to sit on the toilet, I slid right off, fell on the floor), ASTHENIA (so weak) and SOMNOLENCE (groggy). On 05-Mar-2021, the patient experienced FATIGUE (was a little tired.). On 05-Mar-2021, GAIT DISTURBANCE (very hard to walk), FALL (went to sit on the toilet, I slid right off, fell on the floor), ASTHENIA (so weak) and SOMNOLENCE (groggy) had resolved. At the time of the report, FATIGUE (was a little tired.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by reporter.   This case was linked to MOD-2021-162197 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: ADR form uploaded. Added patient demographics, race, ethnicity, medical history, concomitant medications and a new event (fatigue).
second dose was given 11 months after the first; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient was the reporter.  The age at vaccination was not reported. The patient received 2nd dose of Shingrix, 11months after the 1st dose, which led to lengthening of vaccination schedule. The reporter enquired if the 3rd dose was required for Shingrix.
Information has been received from a physician concerning a female "in her later 70's" who in January 2008, was vaccinated with 0.65 ml "one dose" of ZOSTAVAX.  Two weeks post vaccination, in approximately January 2008, the patient developed a "mild case of shingles" on opposite arm and not on the arm of the injection.  The physician noted that the patient did not have any pain, nor did they have a history of shingles.  Unspecified medical attention was sought.  There was no product quality complaint.  At the time of reporting the patient was recovered (date unspecified).  Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender, who in 18-JAN-2013 (also reported as 18-JAN-2012), was vaccinated intramuscularly (IM) with a expired dose of 0.5 PNEUMOVAX 23 (lot number reported as 0595AA, expiration date: 30-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. At the time of the report, the patient's outcome for the adverse event was unknown. Additional information has been requested.
This spontaneous case was reported by a nursing assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient expired Moderna dose/2 patients expired Moderna dose) and NO ADVERSE EVENT (No adverse event) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 25-Jan-2022 at 2:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Jan-2022 at 2:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient expired Moderna dose/2 patients expired Moderna dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient expired Moderna dose/2 patients expired Moderna dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (1 patient expired Moderna dose/2 patients expired Moderna dose) to have an unknown relationship. It was unknown whether patient took over the counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event. It was unknown whether the patient ever been diagnosed with tested/positive for Covid-19. It was unknown whether the patient had acute illnesses at the time of vaccination and up to one month before. It was unknown whether the patient had chronic or long standing health conditions. The event did not cause the patient to seek medical care. It was unknown whether the patient had any other potential cause. It was unknown whether the patient experienced a similar event in the past. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2022-635425, US-MODERNATX, INC.-MOD-2022-635428 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2022: Significant follow-up received included updated report type, reporter details added, patient details added, dosage information updated, event onset date added, narrative updated. Sender's Comments: US-MODERNATX, INC.-MOD-2022-635425:88 year old male. US-MODERNATX, INC.-MOD-2022-635428.
Presents for SOB, fever, headache, body aches. RA O2 sat "high 80s". Admit for COVID & hypoxia. Tx: O2 via NC, steroids, remdesivir, abx. DC to home on RA, abx, & steroids.
1st dose, none Second dose administered 02/18/2021,  11:00 AM 1st 10 days: lymph node swelling of left breast and later, right breast,  First evening required a hot pack to reduce pain. Left shoulder was rehabbed from torn rotator cuff over a year ago, now joint pain for 3 weeks, varying in severity Brain fog, fatigue, irritability 3 1/2 weeks Changes in taste but not smell, last 7 days, continuing today 03/29/2021
Chills; Nausea; Vomiting; Heavy chest; Restlessness; Ache; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01May2021 at 11:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included PCOS (polycystic ovarian syndrome), vulvodynia and COVID-19. Concomitant medications included paracetamol (TYLENOL), ibuprofen (MOTRIN), loratadine (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL); for unknown indications and from an unknown date. Past drug history included any protein pump inhibitor, latex, cinnamon, coconut and berberine (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was 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 four weeks prior to the COVID-19 vaccine. On 01May2021, the patient experienced chills, nausea, vomiting, heavy chest, restlessness and ache. The clinical outcomes of the events chills, nausea, vomiting, heavy chest, restlessness and ache were not recovered at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.