chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via a sales representative and described the occurrence of swelling in a subject of unspecified age and gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced severe swelling. At the time of reporting the outcome of the event was unspecified. The physician considered the event was probably related to vaccination with INFANRIX. This event occurred in four different subjects. The reporter indicated that they narrowed the events down to the same lot number for all cases. The lot number was not provided at the time of reporting. Case A0722975A serves as the master case. The other case numbers are A0722979, A0722980A and A0722981A. Follow-up information was received on 25 April 2008, via physician , who reported the 4-year-old male subject was vaccinated with INFANRIX, (GlaxoSmithKline). On 19 March 2008 the subject received 5th dose of INFANRIX (unknown, unknown gluteal). On 19 March 2008, as a result of vaccination with INFANRIX, in the "buttock", the subject experienced vaccine administered at inappropriate site. On 20 March 2008, 1 day after vaccination with INFANRIX, the subject experienced swelling in considered the events were probably related to vaccination with INFANRIX. Follow-up information was received on 25 April 2008, via sales representative who reported an additional event of fever. It was stated the physician saw in increased incidence of excessive swelling with INFANRIX. At the time of this report, the physician considered the fever probably related to vaccination with INFANRIX. Follow-up information was received on 01 May 2008, via physician, who believed there was a problem with this particular lot of INFANRIX.
Severe immunologic reaction to tetanus vaccine. Awoke on 7/16/2011 with severe pain, muscle stiffness and pain, breakthrough fever after taking Ibuprofen and TYLENOL. Reported to primary doctor on Mon July 18, 2011.
she was talking to a friend at 8:00AM, as she was trying to talk, she could not get the words out. There was confusion. She reports feeling "funny" and went to lay down, she dozed on and off for 2 hours, she could not remember names, her sister's husband and boyfriend's family. "funny" feeling is described as not thinking right.        Afterwards she was tired and slow for the rest of the day. Has not had episode in the past or since. 2 weeks following she went somewhere else, she reports she could walk 2 miles, used to be able to walk 3-4 miles. She complains of apathy and excessive napping.        She denies dizziness, balance difficulties, headache, visual changes, head trauma, concussion, medication change, bug bites. 2nd COVID dose was April 15th.        She complains of lack of motivation. She has a history of insomnia. She reports memory has been consistent. She complains of short attention span and lack of patience. She denies history of stroke and seizue, tobacco and alcohol use.        She can fall asleep very easily now.
a sore arm for a day; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 77-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN), lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history and concomitant medications were not reported. The patient experienced sore arm for a day on an unspecified date. Clinical outcome of the event was unknown.   Information related to lot/batch has been requested.
Pt developed swollen left lateral thigh with localized heat, induration and redness about 3-4". It was not painful.
1/21 after vaccine, NO problems until a headache began about 10am.   Worked a night shift and experienced a steady moderate headache and increasing general fatigue, muscle aches.  1/22 ~9am started with chills (lasted the off and on the next 1012hours then less frequently the following 12 hours), joint aches (especially all finger joints (on fire) but subsided after 2-3 hours, muscle and intermittent mild-moderate head aches the rest of the day. 1/22  Worked night shift and by 11pm the symptoms were all becoming less severe.   1/23   By 8am felt fairly normal.  Slept normally and have recovered just fine.
severe choking cough, rash progressed from neck to trunk & limbs;swelling of eyelids to entire face;ambulance to hosp ER, IV meds given;
small local reaction near injection site on R thigh followed by a systemic outbreak of hives 12 hours later  tx: topical cortizone cream
Chills, low-grade fever, headache, muscle aches, fatigue/weakness, nausea. Symptoms started about 18 hours after injection and lasting for 24 hours.
2 episodes of superficial thrombophlebitis left lower extremity in person without previous history of clots.
Received booster instead of full 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received booster instead of full 3rd dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced ACCIDENTAL UNDERDOSE (Received booster instead of full 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Received booster instead of full 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported patient was immunocompromised and wants a fourth shot.
Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night with fever, chills, bad headache and body aches head to toe. Took Tylenol. Woke in the morning with fever (101.8), chills, bad headache, body aches head to toe, joint aches and nausea. Took Tylenol. Too sick to get up all of Saturday. Saturday afternoon vomited. Saturday evening fever broke and began feeling a little better. Sunday still had a bad headache, body aches and joint aches. Today, Monday, feeling better but still have a mild headache, body aches and joint aches. I also feel really week and tired.
Patient was diagnosed with COVID-19 on 4/14/2021 after receiving his first dose of Moderna COVID-19 vaccine on 3/23/2021
About 11 hours after receiving my second dose I could feel I had a sore arm. I was also getting pretty tired (but it was a long day filled with other activities so I wasn't sure of it was vaccine related). About 9pm (12 hours after vaccine) I was chilled. Temperature was elevated about 3 degrees above normal for me. Went to bed, did not sleep well was hot and cold off and on all night, also became really sore. All of my joints were sore leading to not sleeping well. The whole following day I was sore with chills, slept on and off. Also had a raging headache which started sometime during the night. By 9:00pm the day after the vaccine I was feeling less sore with a less intense headache. Woke up the next day and felt great, still had a sore arm but the body aches were gone.
Fever of up to 104.3 for 7 days, home visit for fever and headache, 2 ER visits to Medical Center, 3 days in hospital on IV fluids, morphine, antibiotics (Azithromycin, SEPTRA and CEFDINIR,  KENALOG cream for rash, TYLENOL and ibuprofen. I had a constant severe headache, fever, chills, severe night sweats, muscle aches, rash on stomach and back, and pneumonia. I felt like I was poisoned. I have never been so sick in my life. I was healthy prior to the vaccine. My new rheumatology RN did not consider my immune compromised status. I should never have been prescribed this shot. I missed 9 days of work and feel like I will not bounce back from this.
Reported tachycardia, hot, flushed face, increase in blood pressure, high anxiety.  Treated in ER and released..  Follow up after reveals no further adverse reactions.
Covid Vaccine was administered at 11:52 AM. At 11:57 AM patient began experiencing right arm numbness, loss of vision, experiencing hot flashes and shortness of breath. Vitals were taken : Temp:: 97.8 BP: 90/60 mmHg Pulse : 48 Spo2: 81 % Glucose: 89 Notified provider Fenny Lin, FNP   Provided Nasal Ammonia inhalant and Oxygen was provided to patient at 2 Liter per minute for 20 Minutes. Stabilized patient Provided Gatorade for hydration  Observed patient for an additional 30 Minutes per provider.  After 30 Minutes of observation Vitals were taken at 12:37 PM Temp: 97.9 Spo2: 100% Pulse:51 to 57  BP: 92/62 mmHg. Symptoms resolved and patient was advised to follow up with his PCP for additional assistance. Also notified if symptoms returned must go to nearest emergency room for further evaluation.  He may also contact our office for any further concerns. Per provider okay to release patient.
Nausea, facial swelling, and neck discomfort 30 minutes after injection. Shortness of breath with treatment in ER 3 hours later.
Pt noticed sl. swelling 10/24. On 10/25 large area of swelling, red, hot to touch. Advised ice. 10/26 area now swollen shoulder to elbow, but cool and pink. Itching. Advised BENADRYL 10/27 some improvement noted.
Arm joint area where vaccine needle given weakened and sore - almost unable to use.  Pain in knees-going from one knee to the other where I was unable to walk far.  Body seems weak and I am very fatigue.  Another doctor was recommended.
Symptoms: headache, fatigue, abdominal pain the first 10 days,  loss of smell and dry cough
Local numbness, arthralgia, myalgia (shoulders, elbows, wrists, fingers) one day of receiving vaccine. Symptoms recurred 4 days later. Pruritis around injection site.
Pt recv vax on 2/16/99; on same day pt exp seizure; tx=Depakote
cold like symptoms starting 12/19/21. Several family members tested positive this past week for Covid
Breakthrough case admission after 3 vaccines Moderna 3/4/21 lot# 040A21A;  Moderna 4/2/21 lot# 026B21A; Moderna 7/22/22 lot# 060A22A
mentions that she got all of her vaccines and boosters from Pfizer/ on Paxlovid; mentions that she got all of her vaccines and boosters from Pfizer/ on Paxlovid; 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 92-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pain related to her broken arm" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; AVAPRO; BABY ASPIRIN; PRILOSEC [OMEPRAZOLE]; FISH OIL; LIPITOR; CALCIUM; VITAMIN D3; BIOTIN; MONTELUKAST; LOSARTAN; MAGNESIUM; TYLENOL taken for pain; TRAMADOL taken for pain.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "mentions that she got all of her vaccines and boosters from Pfizer/ on Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she got all of her vaccines and boosters from Pfizer and then still got Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID arm; very very itchy, 3.5 inches diameter; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (COVID arm) and PRURITUS (very very itchy, 3.5 inches diameter) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 immunisation.     No Medical History information was reported.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DERMATITIS ALLERGIC (COVID arm) and PRURITUS (very very itchy, 3.5 inches diameter). At the time of the report, DERMATITIS ALLERGIC (COVID arm) and PRURITUS (very very itchy, 3.5 inches diameter) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug information was not provided. Treatment information was not provided.
Rash on legs, fever, twitching to left. No fever with tick spells. Jerks 3-4 x hour happened with focusing on something. Referred to neurologist. Observation was only treatment done. Patient is better with ticks present.  1/26/07 Received neuro consult report which reveals patient seen on 12/7 for EEG & 12/8 for complete neuro eval.  Neuro exam was WNL. A video tape of the patients jerking movements was reviewed.  She rapidly twisted her head to the left & then returned back to neutral position.  No LOC, no facial expression change or any other associated movements.  No loss of eye contatct or focus & is developmentally on target. FINAL DX: Motor tic disorder; noted to be highly unusual for child of this age & probably better described as movement disorder.
Lump at injection site; Itchiness at injection site; Redness at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment details were not provided.
Case number PHEH2013US019704 is an intimal spontaneous report from the pharmacist received on 18 Sep 2013 with a follow up information received from a pharmacist on 03 Dec 2013. This report refers to a 26-year-old female patient. She was vaccinated with MENVEO (batch number: M11041) at a dose of 0.5 ml intramuscularly in the left deltoid on 13 Sep 2013. On 14 Sep 2013, she had headache. The patient recovered from the event headache on 15 Sep 2013. She felt chills on an unknown date (reported as on all the weekend). It was reported that she had headache and chills within 24-48 hours after vaccination. She took TYLENOL or ibuprofen and had sweating when she woke up and she no longer had a fever. On 17 Sep 2013, 4 days after vaccination, she experienced itching at the injection site, from which she recovered on 18 Sep 2013, but there was 2x3 cm redness around the injection site. The redness went away 6 to 7 days after vaccination. It was reported that the patient has not seen her physician. The event was reported as non-serious. The causality of the events was not reported. Follow up information received from a pharmacist on 03 Dec 2013: Dose and site of vaccination, outcome of redness and reported seriousness of the events updated.
Pt. described having vomiting for 3 days at the end of August,'05.  Was admitted to the hosp. for vomiting and dehydration.  Was given IVF, and multiple tests performed, including UPT, which was neg.  Pt. dc'd after 3 days, without a specific diagnosis.  No complications.
Injection site and area surrounding the site red & swollen. Patient also saying area is painful. The patient was prescribed steroids by her doctor.
Left clinic after 15 minutes 3 minutes later had taste of gasoline in my mouth followed by extreme dizziness then lips mouth tongue throat numbness for approx 5 minutes then tingling for 10 minutes. Followed by episodes of extreme dizziness tight chest and racing heart. Went to emergency had blood work and monitoring said bad reaction but ok to leave. Had side effects almost daily throughout the next week including brain tingling and extreme pins and needles in brain and left arm along with throat lips tongue and face numbness and chest tighness and really cold feelings running through my left arm. Went to  emergency room again the following Monday. May  10th 2021.
This spontaneous report as received from a medical assistant regarding a multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored GARDASIL lot # K010215, expiration date- 05-MAY-2017, (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021 at 2:17 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 43.67.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Developed high fever, chills, body aches, fatigue, headache, shortness of breath, chest pain
sore arm; blood in urine; urine was dark; Weak; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HAEMATURIA (blood in urine), CHROMATURIA (urine was dark), ASTHENIA (Weak) and HEADACHE (headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included VITAMINS NOS and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HAEMATURIA (blood in urine), CHROMATURIA (urine was dark), ASTHENIA (Weak), HEADACHE (headache) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (sore arm), CHROMATURIA (urine was dark), ASTHENIA (Weak), HEADACHE (headache) and PYREXIA (Fever) outcome was unknown and HAEMATURIA (blood in urine) had resolved.            N o treatment details were reported.  No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-095574 (Patient Link).
In June 1997, the pt was dx with multiple sclerosis. The pt sought unspecified medical treatment.
Extreme itching and hives all over both arms and hands about 6 hours after shot. Few spots on legs and abdomen.  Extreme lethargy the next day.