chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient started feeling lightheaded, dizzy, SOB, hot a few minutes after vaccination then fainted.  A couple of minutes later she felt fine and after staying in the pharmacy for 30 minutes left.
NO record of vaccine in chart, patient reports he received both vaccines in March 2021. Brand not in medical record.   Patient reports to the ED with c/o cough, chest pain, shortness of breath, and weakness since yesterday morning. Patient reports that he has a "compromised immune system" and so he called the nurse line and was told to report to the ED. Patient denies fevers but reports some chills. Patient in no obvious distress, airway intact.
Experienced COVID; Carpal tunnel syndrome; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Experienced COVID) and CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Experienced COVID) and CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome). At the time of the report, COVID-19 (Experienced COVID) had resolved and CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) was resolving. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a Covid-19 vaccine trial. The reporters causality for the events carpal tunnel syndrome and Covid with Humira (ADALIMUMAB) solution for injection in pre-filled pen was no reasonable possibility.   No concomitant medication were reported.   No treatment drug were reported.  Company Comment: This spontaneous case concerns an elderly, female patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unspecified interval after receiving an unknown dose number of mRNA-1273 vaccine. The clinical course, diagnostic evaluation including COVID-19 test and treatment details were not reported in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly, female patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unspecified interval after receiving an unknown dose number of mRNA-1273 vaccine. The clinical course, diagnostic evaluation including COVID-19 test and treatment details were not reported in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I still kind of sore; Chills; Joint pain; I am shivering; I am cold; I am really high and my head hurts and is heavy; 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. Other Case identifier(s): US-PFIZER INC-202101766634 (Pfizer).  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 07Dec2021 14:28 (Lot number: FJ620) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 1, Lot: FF2593), administration date: 24Nov2021, when the patient was 18 years old, for COVID-19 immunization.  The following information was reported: PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "I still kind of sore"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "Joint pain"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "I am shivering"; NASOPHARYNGITIS (non-serious) with onset Dec2021, outcome "unknown", described as "I am cold"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "I am really high and my head hurts and is heavy".  No follow-up attempts are possible. No further information is expected.
Information has been received from an office manager concerning a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 22-JUL-2015, the patient was inadvertently vaccinated with an expired dose of M-M-R II (0.5 ml, subcutaneous, lot # J006994 and expiration date: 14-JUN-2015). No adverse effects reported. Additional information has been requested.
Symptoms included pain and weakness in the tongue while eating similar to what is described by the disease myasthenia gravis.
Information has been received from a registered pharmacist concerning an 80 year old female with arthritis and sulfa allergy who on 02-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck) (lot number 663174/1552X), subcutaneously (site not reported). The patient experienced stiff neck and developed a large red spot at the site of injection after receiving the vaccine. Patient not recovered. Additional information was received from a licensed practical nurse who reported that the 80 year old female patient was vaccinated with a first dose of ZOSTAVAX (Oka/Merck) (lot number also reported as 663672/1709X, route not reported) into her right deltoid arm. The patient was vaccinated at the local pharmacy. There was no illness at time of vaccination. The patient developed 7-8cm redness area at injection site the day post vaccination. The nurse also reported that the patient developed stiff neck but has a history of arthritis. The patient was not sure if the pain in neck was related to injection. The patient recovered within 2 weeks. Additional information is not expected.
On Monday, November 1, 2021, at 2:34 pm, I was given Moderna booster. Next morning around 9:30 am, I noticed my head was hurting. I never have headaches. The headache was strong enough that it required something for relief. I took 2 Tylenol tablets, which provided some relief. The headache did not go away completely; but subsided enough to provide some temporary relief. There was soreness at the injection site, and I had fatigue.
Besides from the low grade headache,  i started to have chills, then fever for 5 days, joint pains and generalized body malaise, observed " petechiae rash" on my face
RAISED LESION ON CALF; NON RAISED LESION ON CALF; FATIGUE; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's past medical history included hypothyroid, and hx of hyperthyroid, and concurrent conditions included seasonal tobacco allergy, does not consume alcohol, and does not smoke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced fatigue. On 23-MAR-2021, the subject experienced raised lesion on calf. On 23-MAR-2021, the subject experienced non raised lesion on calf. Treatment medications (dates unspecified) included: bacitracin zinc/polymyxin b sulfate, povidone-iodine, and hydrogen peroxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from raised lesion on calf, non raised lesion on calf, and fatigue. This report was non-serious.
Patient's daughter reported that the day after vaccination, patient had facial droop, some slurred speech, and her legs hurt/were week. This resolved on it's own, and it does not sound like they sought treatment for this.
He had a sore right arm after each dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He had a sore right arm after each dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (he is a cancer survivor). Concurrent medical conditions included Immunocompromised. Concomitant products included PALBOCICLIB (IBRANCE) and ANASTROZOLE (Anastrazole) for Cancer.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PAIN IN EXTREMITY (He had a sore right arm after each dose). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (He had a sore right arm after each dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.   This case was linked to MOD-2021-358000, MOD-2021-357979 (Patient Link).
About 2 hours after receiving the vaccine, patient reports having experienced swelling and pain of the right wrist, left arm, and left hand, making use of her arms difficult.  She also experienced a headache.  The following morning 5/25, she woke up with these symptoms still occurring, only "worse" and states it is hard to/painful to hold the phone.  Patient does not plan to seek medical attention at this point, she plans to wait and see if the swelling/pain/headache get better over the course of the day.
We received the following information from the above mentioned literature article on 06 OCT 2008: During the 2004-2007 influenza seasons, influenza-associated pediatric deaths were analysed. Of 90 children who were recommended for influenza vaccination, only 5 (6%) were fully vaccinated. 18 children were at least partially vaccinated more than or equal 14 days before illness onset per season, respectively. One child who was partially vaccinated did not have either an age related or ACIP defined high-risk condition recommended for vaccination. The reason for death was not reported for individual cases. Influenza-associated pediatric mortality and/or bacterial coinfection were suspected. The author will be contacted for details. Children with high risk condition (asthma, seizure disorder, neuro/vesicular disorder). One child without any risk conditions. Causality not related. Causes of death for individual cases not identifiable, complications of influenza and bacterial coinfections were mentioned.  Expectedness assessment according to product information: Partial vaccination is unexpected.  Vaccination failure is expected.  Bacterial coinfections and influenza complications are unexpected after vaccination with FLUVIRIN, BEGRIVAC, FLUAD and AGRIPPAL.  On a case level, the case is considered unexpected.  No change in benefit-risk-ratio.  No measures necessary.
Ordering physician  exited patient room and RN at nurses station and told nurse stated to please give patient the second pfizer covid dose in the series. RN went to other RN running shot clinic and requested COVID shot. Bivalent booster dose pulled from COVID shot clinic vaccine basket. RN went to patient room to administer vaccine. Vaccine administered to patient. RN then went back to COVID clinic station to scan vaccination. Vaccination that was administered to patient was scanned into system. Error message appeared that the scanned medication did not match the ordered medication.  At this time RN administering vaccine immediately went to supervising RN and MD to let them know what had happened. Bivalent booster was administered to patient when the second monovalent vaccine was ordered. Parents called by Dr. Mother aware of vaccine administration error.
I received dose #1 of Pfizer vaccine on 12/22/2020 at the Hospital.  I received my second dose of the Pfizer vaccine on 1/12/2021 at the same hospital.  I then had a positive covid test on 2/20/2021.    Lot: EK5730, expiration of vial: 3/201
This spontaneous report as received from a licensed practical nurse refers to an adult patient of unknown age and gender. On an unknown date, the patient was vaccinated with the third dose of adult formulation of RECOMBIVAX HB (route and lot # not reported). On an unknown date, the patient did not have any titer levels for hepatitis B that were able to be measured. At the time of the report, the patient's outcome was unknown.
Booster; Slight headache; chills; sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, (booster) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Manufacturer unknown), for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; HEADACHE (non-serious), outcome "unknown", described as "Slight headache"; CHILLS (non-serious), outcome "unknown", described as "chills"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweats".  The lot number for bnt162b2 was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a patient's grandmother refers to an approximately 13 month old male patient. No medical history and concomitant therapy was reported. On 30-MAR-2015, the patient was vaccinated with a dose of PROQUAD (Merck) (dose and route not provided) by a local nurse with the local health department. On 06-APR-2015, the patient experienced a fever of 104, a runny nose, a rash and a bruise at the injection site. The patient sought medical attention and visited emergency room. The patient was treated with TYLENOL. The outcome of the events was reported as recovering. No product quality issue was involved. Additional information has been requested.
Delayed menstruation for 7 days Skin dryness on exterior of hand on same side of injection
7 days after receiving the first dose on 1/6/2021 in my left arm, the injection site became swollen, erythematous, itchy, and painful. The symptoms lasted for 7 days. The lot number for the first vaccine was 025J20-2A.   2 days after receiving the second dose on 2/3/2021 in my right arm, the injection site became swollen, erythematous, itchy, and painful. The symptoms lasted are still ongoing. The lot number for the second dose was 010M20A.
-pt reported that she had this prevnar + shingrix and resulted in hair loss, started off as rash and went to her scalp, got into both feet (trying to dry up now), white scaly, under the arms/elbows/armpits -pt stated she called the nurse about 1 month ago, the nurse consulted her to give it time it will go away -Pt saw MD on 11/03/2020 and MD told pt she should not have received 2 shots at the same time, MD consulted pt to take benadryl
fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A child patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever". It was unknown if therapeutic measures were taken as a result of pyrexia.  Additional information: I was in a meeting with (Pfizer colleague) today and she said that her child had a fever a few days after receiving the childhood vaccine for under 5s (5 years).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she contracted COVID 3 days after getting the 1st dose; This is a spontaneous report from a contactable consumer (Patient's mother) via Medical information Team. A female patient (daughter) of an unspecified age (Age: 27; Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she contracted covid 3 days after getting the 1st dose (non-serious) on an unspecified date. Patient's mother called to ask if her daughter can take the 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE since she contracted COVID 3 days after getting the 1st dose - She is now fully recovered and ready for the 2nd shot on 11Feb2021. The outcome was recovered on an unspecified date.  Information on the Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Approximately 5 minutes post vaccination patient had numbness from shoulder to hand.  Numbness improved approximately 15 minutes post vaccination.
PATIENT HAD A SORE ARM ON THURSDAY.  ON SATURDAY MORNING SHE WOKE UP WITH A SWOLLEN, RASH AREA AROUND THE SITE OF THE INJECTION.  ON SUNDAY THE AREA WAS LESS SWOLLEN.  ON MONDAY SHE CAME IN TO SHOW ME THE RASH. IT WAS A STRAIGHT HORIZONTAL LINE WITH RED PETECHIAE AROUND THE LINE, EXTENDING TO THE REAR ARM PIT AREA.
This spontaneous case was reported by a nurse and describes the occurrence of CONDITION AGGRAVATED (Seizure disorder worse since May 30 2021) and ACCIDENTAL UNDERDOSE (nurse administered 0.3 ml amount of vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 003A21A) for COVID-19 vaccination. Concurrent medical conditions included Seizure (Worse since May 30 2021) since 09-Nov-2001, Arthritis (pain in colder weather) since 01-Jan-2001, Depression, Herpes NOS, Stress, Pain and Sulfonamide allergy. Concomitant products included ARIPIPRAZOLE (ABILIFY) from 01-Jan-2021 to an unknown date and ESCITALOPRAM OXALATE from 01-Jan-2021 to an unknown date for Depression, ACICLOVIR (ACYLOVIR) from 01-Jan-2021 to an unknown date for Herpes NOS, METHOCARBAMOL from 01-Jan-2021 to an unknown date for Muscle relaxation, MORPHINE SULFATE from 01-Jan-2021 to an unknown date for Pain, ALPRAZOLAM (XANAX) from 01-Jan-2021 to an unknown date and LAMOTRIGINE (LAMICTAL XR) from 01-Jan-2021 to an unknown date for Seizure. On 14-Apr-2021 at 10:06 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .3 milliliter. On 12-May-2021 at 10:03 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021 at 9:00 AM, the patient experienced ACCIDENTAL UNDERDOSE (nurse administered 0.3 ml amount of vaccine). On 30-May-2021, the patient experienced CONDITION AGGRAVATED (Seizure disorder worse since May 30 2021). On 12-May-2021 at 9:00 AM, ACCIDENTAL UNDERDOSE (nurse administered 0.3 ml amount of vaccine) had resolved. At the time of the report, CONDITION AGGRAVATED (Seizure disorder worse since May 30 2021) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received updated medical history and concomitant medications , event start/stop dates, patient details. On 28-Jul-2021: Follow-up received, contains non-significant information.
Severe, sharp headache approximately 18 hours after vaccination until 29 hours after vaccination.
Itchy site of injection; Swollen site of injection; Redness site of injection; bad headache; Pain at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Pain at the site of injection), INJECTION SITE PRURITUS (Itchy site of injection), INJECTION SITE SWELLING (Swollen site of injection), INJECTION SITE ERYTHEMA (Redness site of injection) and HEADACHE (bad headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   The patient's past medical history included No adverse event (No medical history provided).   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at the site of injection). On 11-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchy site of injection), INJECTION SITE SWELLING (Swollen site of injection), INJECTION SITE ERYTHEMA (Redness site of injection) and HEADACHE (bad headache). At the time of the report, INJECTION SITE PAIN (Pain at the site of injection), INJECTION SITE PRURITUS (Itchy site of injection), INJECTION SITE SWELLING (Swollen site of injection), INJECTION SITE ERYTHEMA (Redness site of injection) and HEADACHE (bad headache) had not resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Information has been received from a Certified Medical Assistant concerning a 9 year old female who on 08-NOV-2010 was vaccinated with a first dose of GARDASIL (Lot # not provided). Concomitant therapy included influenza virus vaccine (unspecified) (Lot # not provided) given on the same day. It was reported that the patient complained of a headache within 15 minutes of administration of her first dose of GARDASIL. The patient was monitored in the office and was able to leave the office fully recovered without requiring treatment. The medical assistant added that the patient "had a thin build". She also reported that "she had seen this reaction more commonly in younger patients". Additional information has been requested.
Pain/hurting; Burning so bad; This is a spontaneous report from a contactable consumer (Patient) or other non-health care professional via. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration in Apr2021 as dose 1, single for covid-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. The patient experienced pain/hurting and burning so bad on an unspecified date. Patient reported that since she got the shot, she can't do the insulin injection all because it was hurting and burning so bad. she got the second shot she was started feeling better, but she was still can't do her injections because she said it hurts and feels so bad and she has recently bad nose with shingles and she says she had believed that it was because of the Covid vaccine and she was calling to report those events. The outcome of the events was unknown. Information on the lot/batch number has been requested.