chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sharp pain and it's going down his neck; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELI1284 or ELI284 [pending clarification], Expiration Date: Apr2021), intramuscular, on 31Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included hypertension. The patient's concomitant medication included losartan for hypertension. On 31Dec2020, the patient had the COVID vaccine and he kept getting a sharp pain and it's going down his neck; it is at the opposite side where the shot was injected. The patient didn't know if it's a side effect. No treatment was administered for the event. The outcome of the event was unknown.    Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
child recv vax & pt (mom) exp chickenpox like rash w/a couple of lesions d/t secondary transmission from vax child;11/6/98 pt had mult lesions on lower extremities & 1 lesion  on forearm;pt sought unspecified medical attention;
Concerning accelerated heart rate for several hours (10 hours), excessive sweating (40 hours),  severe headache, and the least significant was a sore arm (injection site),  I have never had an accelerated heart rate before until I started getting the Pfizer COVID-19 vaccinations ? dose 1, dose 2, and now booster.  All the literature you read says cardiomyopathy is the only risk factor.  I do not agree it is the ONLY one.  It affects heart rate and rhythm.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-357792 (Patient Link).
left brest sore; Lympho nodes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (left brest sore) and LYMPH NODE PAIN (Lympho nodes) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (left brest sore) and LYMPH NODE PAIN (Lympho nodes). At the time of the report, BREAST PAIN (left brest sore) and LYMPH NODE PAIN (Lympho nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
tingling and numbness in arms and legs; Severe headaches; swollen face; tingling and numbness in arms and legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Aug2021 15:15 (Lot number: FC3183) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL. Past drug history included: Codine, reaction(s): "Drug allergy", notes: known allergies: Codine. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 23Aug2021 06:00, outcome "not recovered" and all described as "tingling and numbness in arms and legs"; HEADACHE (non-serious) with onset 23Aug2021 06:00, outcome "not recovered", described as "Severe headaches"; SWELLING FACE (non-serious) with onset 23Aug2021 06:00, outcome "not recovered", described as "swollen face". Therapeutic measures were not taken as a result of hypoaesthesia, headache, swelling face, paraesthesia.  Additional information: Patient did not receive any other vaccine in four weeks. Other medication in two weeks was Estradiol. Patient did not have covid prior vaccination. Patient did not tested covid post vaccination. Facility type vaccine: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
evening of 9/28/21 just tired;  9/29/21 felt like a head cold and tired 9/30/21 got dizzy, very tired, disoriented, went into afib, and almost passed out at work.  Coworkers had to call ambulance to take me to hospital.  Tests were ran, everything came back normal except me having the vaccine on the evening of 9/28/21, was discharged same day 10/1/21 still a little dizzy, a little disoriented,  tired, chills and headache 10/2/21  still a little dizzy, a little disoriented, tired and chills 10/3/21 still not feeling like myself and tired 10/4/21 finally starting  to feel like myself
Low blood oxygen as measured with wearable pulse Ox device.  Starting at approximately 13 hours after second dose, blood oxygen stayed in the 80-89% range.  The following day, daytime pulse ox was measured at 85% (never that low during the day).  I feel fine, but I have never seen low blood ox as a side effect.
R arm swelling, numbness, cold sensation and discoloration, starting in R hand and radiating up to elbow
Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:49 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Non significant follow up received includes reporters address updated and email address confirmed.
One day later, had pink skin, mild warmth, swelling just distal to biceps of same arm. Encouraged ice, acetaminophen for some stiffness and elevation if any sysx of infection return. If itchy, antihistamine.
Began with redness around injection site 6 days after injection.  Continued to grow to cover upper arm and began to experience swelling around elbow and forearm.  Went to urgent care clinic six days after onset of symptoms.  Diagnosed as cellulitis infection, prescribed antibiotic. One week after starting antibiotics,  symptoms 95% gone.
body aches/aches all over her body like a fever; nausea; Pfizer COVID 19 vaccine; first dose 17Dec2020; second dose 05Jan2021; dizziness; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration in the right arm on 05Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included heart attack three years ago which predates treatment with the Pfizer COVID 19 vaccine. The patient's concomitant medications were not reported. The patient previous received the first dose of the Pfizer COVID 19 vaccine (first dose lot= EH9899) on 17Dec2020 at 17:30 PM in the right arm and reported no reactions to the vaccine. The patient experienced dizziness on 05Jan2021, body aches/aches all over her body like a fever, nausea on 06Jan2021. Consumer calling regarding the Pfizer COVID 19 vaccine. States she never had side effects with the first shot but the second was killing her. Clarified she received the first dose of the Pfizer COVID 19 vaccine 17Dec2020 at 17:30 PM in the right arm. She didn't have any effects after that dose. Reports she received the second dose of the Pfizer COVID 19 vaccine 05Jan2021 at 17:30 PM in the right arm. She noticed about 20 minutes after the injection on the way home, she felt dizzy had to pull over. The next morning, she continued to experience a little dizziness with nausea but states she never threw up and she had aches all over her whole body, like a really bad fever but she didn't have a fever. She was still feeling the body aches but when she gets up and walks it gets worse, like if she went to work so she stayed home today and she can still feel it a little but it is less since she is relaxing. From her vaccine card she provides the lot number for the first dose and the lot number for the second dose EK9231; does not see NDC or expiration date. The outcome of events for dizziness, nausea was resolved on 06Jan2021, for body aches/aches all over her body like a fever was not resolved. The adverse event didn't require a visit to physician office nor emergency room. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to adverse event was none. Relevant tests were none. Vaccination Facility Type: Hospital. Vaccine Administered at Facility: No.
Head is spinning, vertigo at night when changing positions. Since monday 4:30 am.
client was given pediatric dose instead of 12+ dose- no adverse reactions noted.  Guardian choosing to wait 8 weeks to get correct dose
NOSEBLEED THIS AM FROM 0700 - 0715H.  ONE EPISODE; HEADACHE - FRONT OF HEAD CONSTANT TODAY; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included kidney stones, and on birth control, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient did not had no known drug allergies and did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced headache - front of head constant today. On an unspecified date, the subject experienced nosebleed this am from 0700 - 0715h. one episode. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache - front of head constant today, and the outcome of nosebleed this am from 0700 - 0715h. one episode was not reported. This report was non-serious.
toothache; sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (toothache), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and COPD. Concomitant products included UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO) for COPD, LISINOPRIL for Hypertension.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced TOOTHACHE (toothache), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, TOOTHACHE (toothache), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information was not provided.
Rash, swelling, redness and itching an inch below vaccination site. 8 days after receiving vaccine.
Spoke with patient's mother at approximately 2:30pm the following day after the immunizations. Mom reports that the patient screamed as she was getting the vaccines and didn't stop crying for hours, and this is not typical at all for the patient with vaccines. Mom reports that last evening she had a low grade fever (did not have specific #), and kept complaining of pain in the site of the MMRV. Mom reports localized 2 inch area of redness around the MMRV injection site. More concerning patient slept until 1pm today, only urinated once in almost 18 hr period. Patient has fever of 104.5F, reduced with Tylenol 1 hr after administration and currently at 100F. Patient also complaining of neck pain. Hurts to tilt neck back to drink small dose cup of Tylenol. No appetite, not wanting to drink. Low energy.
Severe local reaction - erythema, swelling entire upper arm, moderate fever 101 - 102 degree generalized systemic symptoms lasted 7-10 days.
a 38 years old patient received a dose of Fluzone High Dose with no AE; a 38 years old patient received an expired dose of Fluzone High Dose by mistake with no AE; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist via Medical Information (Reference number: 00315664) .  This case involves a 38 years old male patient who received an expired 0.5 mL dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] by mistake (lot: UJ268AA, expiry date: 10-May-2020), via intramuscular route in left deltoid on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age) and (expired product administered).  The patient's medical treatments, vaccinations and family history were not provided.   The patient's medical history included transplant.  No Concomitant medications were given.  It was a case of an actual medication error due to the expired vaccine used and inappropriate age at vaccine administration (latency same day on the day of vaccination).   Reporter wants to know if there are any known adverse effects. The Fluzone High Dose that was give was the 2019-2020 formula. They have already given the patient Fluad.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and general body pain. On an unknown date, the outcome of the influenza-like symptoms and general body pain were unknown. It was unknown if the reporter considered the influenza-like symptoms and general body pain to be related to SHINGRIX. Additional details reported as follows: When asked for more specific information reporter stated her mother was in bed for full day following her SHINGRIX doses. This case has been linked with US2018GSK155286, reported by same reporter.
Heartburn; Dose Number:1, Date of start of drug: 18Dec2020; Dose Number:2, Date of start of drug: 07Jan2021; Dose Number:1, Date of start of drug: 18Dec2020; Dose Number:2, Date of start of drug: 07Jan2021; This is a spontaneous report from a contactable physician (patient himself). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 07Jan2021 08:30 in right arm at single dose for covid-19 immunisation. Other medical history included hypertension. The patient was known allergies: latex. Other medications in two weeks included nebivolol hydrochloride (BYSTOLIC). The patient previously took the first dose of BNT162B2 (lot# EJ1685) on 18Dec2020 03:00 PM in left arm for COVID-19 immunization. Facility type vaccine was in hospital. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient experienced heartburn on 08Jan2021 with outcome of not recovered. No treatment was received for heartburn.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 5G7A7, expiry date 18th May 2021) for prophylaxis.   On 1st April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist on the line reported that the patient experienced shingles. The vaccine was given in the upper arm, which arm was unknown. Another pharmacist at the site was the one who spoke with the patient.
Fever, sweats; hospitalized in S. Africa 15NOV-22NOV; dx pneumonia; no cough;
Inadvertently gave a booster dose (0.25mL) of Moderna for her second dose of the primary series instead of a full dose (0.5mL). With guidance from CDC, client returned to the clinic the same day and received a second booster dose (0.25mL) to complete the full dosage amount of her second dose of the Moderna primary series. No adverse effects were reported by the client.
17.5 year old received vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17.5 year old received vaccine) in a 17-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17.5 year old received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17.5 year old received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.   Reporter did not allow further contact
3in diameter swelling and redness surrounding injection site, joint pain noted to left shoulder directly above injection, radiating infection noted toward shoulder and elbow, clindamycin given for highly probable staph infection
Patient started out feeling good on August 4.  By 5 PM she felt achy and started to have diarrhea.  She went home and went to bed.  She was up every 2 hours with diarrhea.  Thursday, August 5th, continued aches with decreased appetite.  Thursday evening she had more stomach problems with diarrhea.  On Friday, August 6th,  around 1:30 in the morning she woke up with diarrhea, sweating profusely and she was in the locked position on the floor.  Her hands were locked.  She called for her husband and they took her to the emergency room.  The ambulance was unable to get blood out of her finger for a glucose check.  They gave her Imodium, IV fluids.  Sunday night, August 8th, she then had diarrhea and numbness in her legs, hands but they did not lock up.  Sunday evening she had diarrhea again.  Monday, August 9th, she was feeling better.   No more aching. She still felt weak and not like herself. I have not had any further update since I spoke with her on 8/9/21.
No additional adverse effects reported; The patient was inadvertently administered an expired dose of properly stored MMR II; This spontaneous report was received from a medical assistant referring to a 41 year old female patient. Information on the patient's medical history and concurrent conditions were not reported. On 28-JAN-2020, the patient was inadvertently administered an expired dose of properly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin)(M-M-R II) (strength, dose details, route, indication and anatomical location were not reported) of lot # N027782 and expiration date:16-AUG-2019 (expired product administered) which was reconstituted with properly stored sterile diluent (manufacturer unknown). The patient did not experience any additional adverse effects.
Systemic: PATIENT STATES HEART RATE 117. TOOK AGAIN AND 124. PT ALSO FEELS "WOOZY"-Mild, Systemic: Nausea-Mild, Additional Details: PT REPORTED HR @117 &FELT "WOOZY." CALLED FROM STORE WHILE SHOPPING.CALLED PTLATER TO CHECK ON HIM.STATED RESTING/SLIGHTLY NAUSEOUS(NO VOMITING).HR 124.ENCOURAGED TO GO TO NEAREST URGENT CARE IF AT ALL WORRIED.TOLD HIM THAT HR IS NORMALLY @70-100 WHILE RESTING. PT TO CONT W/FLUIDS &MONITOR BP. MAY TAKE APAP IF OK MEDICALLY.INFORMED PT ABOUT VAERS.ASKED HIM IF HE WAS GETTING BETTER, AND HE STATED YES JUST SLOWLY. GOING TO "TAKE IT EASY TODAY." TOLD PATIENT TO CALL US ANYTIME WITH ADDITIONAL QUES
Within 1 hour of injection, site began swelling & painful. Called 11/3 a.m., was told to ice site. Decrease in swelling. F/u 11/8 pm., red, swelling & warmth from injection site, downward. Local reaction, resolving.
About 5 days after initial vaccination, I developed a very swollen and sore armpit. I saw my physician who ordered a diagnostic mammogram and ultrasound. The radiologist reported a couple of lymph nodes. The swelling has decreased a little, but it's not gone. And it's still quite painful at times. Approximately 8 hours after my 2nd dose, I developed a fever of 103, chills, muscle and joint aches. This lasted a day and a half.
I received my vaccine on 04/05/2022. On July 13/2022 I started feeling ill during the day. Persistent cough and sneezing.  on 07/17/2022 I went to the doctor after testing positive for Covid-19. I was prescribed Paxlovid. Started feeling better same day after taking medication.
I have a half golf ball sized lump in my arm at the injection site since September 26th and its November 13th. Its tender and feverish still.  It is also kinda scabbed over because it is itchy. It is slightly red still too.
8/2/18: 8:45 PM (time of administration) reports arm immediately felt like it was "on fire" and whole arm ached like it had been punched. Pt reported it felt like poison was injected into her arm. Went home after. 8/3/18: 1:30 AM Pt woke up in bed feeling extremely hot and feverish (did not use thermometer for temperature reading), complained that left side of head, neck, and shoulder felt paralyzed and unable to move. Pt stated she shifted in bed, but did not get out of bed. 8/4/18: 10 AM Began taking ibuprofen 400 mg and diphenhydramine 25 mg PO every 6 hours, "per package instructions" following advice from a friend who had previously worked at FDA and stated she should use this after immunization. Also began pushing fluid intake. 8/4/18: noon saw chiropractor, who reported she physically "felt hot" head to toe, later in the day her massage therapist would not work on her due to her physical temperature. 24-48 hours following the vaccine, pt reports she started to feel more normal, but continued to feel hot despite the scheduled ibuprofen dosing.
The patient presented with neck swelling, right-sided neck rash, complaining of shortness of breath, and feeling lightheaded