chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nerve damage in her arms and legs.; Nerve pain in her arms and legs; Hands start cramping up; COVID arm; She reported her arm was inflamed really bad; This spontaneous case was reported by a patient and describes the occurrence of NERVE INJURY (Nerve damage in her arms and legs.), NEURALGIA (Nerve pain in her arms and legs), MUSCLE SPASMS (Hands start cramping up), VACCINATION SITE REACTION (COVID arm) and INFLAMMATION (She reported her arm was inflamed really bad) in an adult female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NERVE INJURY (Nerve damage in her arms and legs.), NEURALGIA (Nerve pain in her arms and legs), MUSCLE SPASMS (Hands start cramping up), VACCINATION SITE REACTION (COVID arm) and INFLAMMATION (She reported her arm was inflamed really bad). At the time of the report, NERVE INJURY (Nerve damage in her arms and legs.), NEURALGIA (Nerve pain in her arms and legs) and MUSCLE SPASMS (Hands start cramping up) had not resolved and VACCINATION SITE REACTION (COVID arm) and INFLAMMATION (She reported her arm was inflamed really bad) had resolved.            No concomitant medication was provided by the reporter.  Patient received intramuscular 0.25ml of booster dose. Patient reported that after receiving the first Moderna primary series dose, patient did pretty good. Patient reported that sometime after receiving the second Moderna primary series dose, patient began experiencing nerve damage in arms and legs, the nerve pain does not occur every day, but patient could feel the nerve pain in arms and legs. Patient also reported that sometimes patient's hands start cramping up. No history or allergies were reported. It was not reported that patient had been diagnosed with/ tested positive for COVID-19. No acute illnesses at the time of vaccination and up to one month before was reported. Further in follow up its was reported that some folks went though a lot of misery after receiving their Moderna COVID-19 vaccination. No Consent was given for Safety follow-up.  No treatment medication was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received and narrative updated.
Patient came for 2 mo well and Hib was not mixed patient only received the Diluent. Parents were advised and reschedule to give vaccine. No adverse reactions.
Anaphylaxis, SkinRash, Rash & UrticariaPruritus Narrative: Delayed allergic reaction following mornings to 1st dose of Moderna: hives, itchiness at the injection site, and throat swelling requiring an epipen. Saw allergist: results negative for allergy to vaccine , cleared to receive 2nd dose
Developed itchy bumps, rednesss, and blisters  around chest and midsection.
left arm to be a bit sore; tiny little headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), on 16Mar2021 at 13:00, after lunch (at the age of 76-years-old) at 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was in good health for age 76, as reported. The patient played semi pro sports. The patient received the first dose of BNT162b2 (lot number: EN6200) on 23Feb2021, at the age of 76-years-old, for COVID-19 immunisation. The patient experienced his left arm to be a bit sore and just one tiny little headache in Mar2021. He had no fever or other possible side effects. Patient asked if drinking alcohol had any effect a few hours later the vaccine. He clarified he was not drunk; only for a couple of glasses of wine/beers. The patient clarified that he had a couple of glasses of wine with dinner and had no reaction. He was speaking about having a couple of glasses of wine with dinner and the pharmacist told him that he was pretty sure that would be fine to do. Patient stated he had a lady friend coming over the night of the report and she was getting her 2nd Pfizer vaccine on that day and he was convinced that a glass of wine would not hurt. The patient asked when after the shot you would have the highest level of protection and how long after the 2nd booster of BNT162b2 he would be best protected and if it would be in another week or 2 weeks before full protection occurred. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
103 temp, sweats, chills, slept 72 hours, no taste, no appetite and black stools for 6 days.
Stomach discomfort and diarrhea started at 9pm, followed by vomiting at about 10:45pm. Both continued once to twice an hour until 4am the following day (4/1/21). Low grade fever noted at 6am, 100 degrees.  Noted again at 10am at 99 degrees, on 4/1. Slight diarrhea continued throughout the day on 4/1...and zero appetite until 4/2.  Fatigued until 4/3 and feeling back to normal on 4/4, with bouts of tiredness.
8/29/02 Baby very tired and  a little fussy, slept alot. 10/02/2002 Found hard lump (induration) 5mm on right thigh. Office uncertain if it was Hib or DTaP that caused it. Mother concerned because she herself had a sarcoma in deltoid.
Begin with just a small rash on my neck the day after the shot that went away 2 days later.  Then little bug bite looking bumps started to appear on my back and stomach which was 5 days after receiving the shot.  Now 9 days after receiving the shot alot more bumps are popping and and the dry red rash is back on my neck.
The patient received his first dose of Pfizer COVID vaccine 6/9/21 at pharmacy. He was then admitted 6/20/21 at hospital with abdominal pain, sepsis and a suspected aspiration event and expired on 6/23/21. This was felt by the treating physicians to be most likely not related to or associated with the vaccine, but given the close proximity it was asked that this be reported.
headache; muscle ache; dizziness; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Apr2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 08Apr2021, the patient experienced headache, muscle ache, dizziness. The patient took Tylenol as treatment after the first dose. The outcome of the events was unknown.  Information about batch/lot number has been requested.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with GARDASIL lot # K023423, expiration date 18-JUN-2016 (dose was not reported). The patient received a dose of GARDASIL that was stored improperly. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
she got COVID shot and flu shot; she got COVID shot and flu shot; feel tired; cough; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 57-year-old female patient received BNT162b2 (BNT162B2 NOS), on 05Jan2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), till 09Jan2023 at 11 mg; influenza vaccine (FLU VACCINE VII), on 05Jan2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 05Jan2023, outcome "unknown" and all described as "she got COVID shot and flu shot"; COUGH (non-serious) with onset Jan2023, outcome "unknown"; FATIGUE (non-serious) with onset Jan2023, outcome "unknown", described as "feel tired". The action taken for tofacitinib citrate was dosage permanently withdrawn on 09Jan2023.  Additional information: the patient was taking medication regularly. However, she got COVID shot and flu shot on 05Jan2023, and she started to feel tired along with experiencing cough.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial report received on 10 March 2010 from a health care professional. A 19-year-old female patient had a dose of H1N1 vaccine on an unknown date. The trade name, manufacturer name, lot number, route and site of administration of the vaccine was unknown. At an unspecified amount of time later, the patient experienced an unspecified reaction, and was hospitalized. The dates of hospitalization were not reported. The Centers for Disease Control and Prevention had contacted the reporter's facility for further information regarding the conversation. The patient is a current patient at the caller's facility; however the caller's facility did not administer the H1N1 vaccine to the patient. It was unknown, if the patient had received any other vaccinations within 4 weeks prior to receiving the H1N1 vaccine. At the time of this report, it was unknown if the patient had recovered. Documents held by sender: None.
This spontaneous report as received from a female physician of unknown age reporting on herself via company representative. Medical history and concurrent conditions were not reported. When the physician was over the age of 26 (unspecified date), was self-vaccinated with the first dose of GARDASIL (dose, route, lot number and expiry date were not reported). No adverse reported. There was no concomitant medication provided. This is one of two reports received from the same reporter. Additional information is not expected, because the reporter refused additional contact.
2/4/12 - Red, raised blisters scattered over torso & back & on face. No drainage. 2/6/12 - MD Rx: Silvadene cream to blisters on chest & back at 9A & 9p x 14 days.
Redness, swelling, warmth at shot site, mild headache, now redness has moved down from shot site to elbow, and swelling is around elbow.
Vaccine expired on 3 Oct 2021 ,vaccine placed in refridgerator 17 Nov 2021; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 3 Oct 2021 ,vaccine placed in refridgerator 17 Nov 2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 3 Oct 2021 ,vaccine placed in refridgerator 17 Nov 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 3 Oct 2021 ,vaccine placed in refridgerator 17 Nov 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 17 Nov 2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Pt. had hand red and swollen. Also pt felt dizzy after the 48 hrs of the vaccine.
01/28/2021 Covid and strep test came back negative. APRN gave me antibiotics because my lymph nodes were swollen. After a few days I felt better.
Patient was given a Pentacel vaccine, but did not receive the HIB portion of the vaccine.
CHILLS CANNOT GET WARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: D10523P) dose was not reported, vaccinated at right arm, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced chills cannot get warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills cannot get warm was not reported. This report was non-serious.
Immediately after vaccine was administered, needle was pulled out of arm and a moderate amount of blood came out of the site and was running down patients arm. Within seconds, a half dollar size welt formed at the site and started swelling upwards off of the arm.
Delayed cutaneous hypersensitivity reaction starting 7 days after vaccine; itching, red, raised, hot area 3 inches in diameter on upper left arm where vaccine was received. Symptoms slowly went away over 48 hours.
About 24 hours after injection, joint and body aches that lasted about 36 hours.  Experienced similar with first injection, but second was much elevated.
Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  Additional therapy given at the same time, in the opposite arm included a dose of influenza virus vaccine, "flu vaccine".  The reporter indicated the patient had a reaction to the pneumococcal vaccine 23 polyvalent, which was described as a "silver dollar size" raised red area at the injection site, and injection site soreness, rated "4" on a pain scale.  It was noted the raised red area lasted 72 hours.  The reporter requested a lot check.  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Unspecified medical attention was sought.  Additional information has been requested.  The health professional mentioned 13 other patients who also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES #'s: 0210USA01524, 0210USA01734, 0211USA02240, 0211USA02242, 0211USA02243, 0211USA02244, 0211USA02245, 0211USA02246, 0211USA02247, 0211USA02248, 0211USA02249, 0211USA02250, 0211USA02251).
injection site rash; feels different; injection site pain; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (injection site rash), FEELING ABNORMAL (feels different), INJECTION SITE PAIN (injection site pain) and INJECTION SITE SWELLING (injection site swelling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Lactose intolerance. Concurrent medical conditions included Diabetes, Hypercholesteremia, Drug allergy (fosamax) and Drug allergy (some cholesterol medicine).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced BURNING SENSATION (injection site rash), FEELING ABNORMAL (feels different), INJECTION SITE PAIN (injection site pain) and INJECTION SITE SWELLING (injection site swelling). At the time of the report, BURNING SENSATION (injection site rash), FEELING ABNORMAL (feels different), INJECTION SITE PAIN (injection site pain) and INJECTION SITE SWELLING (injection site swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
This spontaneous case reported by a physician, describes the occurrence of administered expired product (expired COVID-19 vaccine) and product administration error (error resulting in administration of expired COVID-19 vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 038B21A) for COVID-19 immunization. No medical history reported. On Nov 9, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 9, 2021, patient administered expired product (expired COVID-19 vaccine) and product administration error (error resulting in administration of expired COVID-19 vaccine). On Nov 9, 2021, administered expired product (expired COVID-19 vaccine) and product administration error (error resulting in administration of expired COVID-19 vaccine) resolved. Per reporter, there were no symptoms or quality issue to report. The reporter did not provide any causality assessments, concomitant medication or treatment information.
sore and tender arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore and tender arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure abnormal and Leukemia. Concomitant products included AMRUBICIN for an unknown indication.    On 15-Mar-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 PAIN (sore and tender arm). At the time of the report, VACCINATION SITE PAIN (sore and tender arm) outcome was unknown.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient regularly took a blood pressure pill and medications for diabetes. Lot number or expiration date information were not available. No treatment information was provided by the reporter. This case was linked to MOD-2021-406930, MOD-2021-406936 (Patient Link).
Headache, dizziness, severe stomach pain, knee pain and knee weakness, nausea.
Her motion sickness (within normal was a rare event for her) has gotten worse since the 2nd dose; Her motion sickness (within normal was a rare event for her) has gotten worse since the 2nd dose; nausea; threw up 10 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Jan2022 10:00 (Lot number: FL0007) at the age of 6 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, Time: 1000, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: Pfizer FK5618), administration date: 04Jan2022, when the patient was 6 years old, for COVID-19 immunization, reaction(s): "threw up once"; Bnt162b2 (DOSE 1, Time: 1000, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: Pfizer FK5618), administration date: 04Jan2022, for COVID-19 immunization, reaction(s): "motion sickness". The following information was reported: NAUSEA (disability) with onset 26Jan2022, outcome "recovered with sequelae" (27Jan2022), described as "nausea"; VOMITING (disability) with onset 26Jan2022, outcome "recovered with sequelae" (27Jan2022), described as "threw up 10 times"; MOTION SICKNESS (disability), CONDITION AGGRAVATED (disability), outcome "unknown" and all described as "Her motion sickness (within normal was a rare event for her) has gotten worse since the 2nd dose". The events "nausea" and "threw up 10 times" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea, vomiting. The clinical course was reported as follows: The reporter informed that after patient's first dose on 04Jan2022, she threw up once 2 minutes after the vaccine was administered. It was in the waiting room of the vaccine clinic. The patient (her daughter) received her second Pfizer dose at step pediatrics on 25Jan2022 around 10:00 AM. On 26Jan2022 around noon, she complained of nausea and threw up. For the next 12 hours, she threw up 10 times, she could not even keep water down. She was traumatized from her nausea and vomiting. On 27Jan2022, based on the pediatrician's advice, they gave her Zofran 4 mg orally at 11:00 am. She managed to keep liquids down after the Zofran. They gave her 2 doses of Zofran 4mg each on 27Jan2022. She started soft food diet on 28Jan2022. Her motion sickness (within normal was a rare event for her) has gotten worse since the second dose. The vaccine was administered in a doctor's office/urgent care and not at military facility. The patient had no prior vaccinations, no relevant family medical history, and no relevant tests. The reporter considered the BNT162B2 had a causal effect to the adverse events.  Follow-up attempts are completed. No further information is expected.
Lightness in the head like dizziness; Ear pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 27Aug2021 11:00 (Lot number: FC3182, Expiration Date: 31Oct2021) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Lot number: FC3180, Time: 10:30 am, expiration date is 31Oct2021, Anatomical location: Arm), administration date: 06Aug2021, when the patient was 13 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 30Aug2021, outcome "unknown", described as "Lightness in the head like dizziness"; EAR PAIN (non-serious) with onset 30Aug2021, outcome "unknown", described as "Ear pain". Therapeutic measures were not taken as a result of dizziness, ear pain.  Additional information: NDC number and UPC number  of COVID 19 Vaccine was unknown. No other Products. Patient not received treatment for the adverse event. Reporter stated we took a blood test recently. it was like 2 weeks ago or may be more than that like may be like 9 or 10Aug. Reporter stated we didn't get any test result. It was just like it was a check up thing that is required. No prior vaccination. Family medical history was reporter stated mother had a heart disease.  No follow-up attempts are possible. No further information is expected.
Pt vaccinated with Influenza Vaccine became itchy in area lt arm; hard in area; sl swollen, red & warm started evening 1NOV90 has continued stated less red & swollen today 3NOV90.