chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Joint aches; particularly in neck, wrists, hands, knee, ankles, and feet. Tired, generally 'not feeling well'.  Took ibuprofen and improved for short duration. Notable Dizziness / vertigo throughout day.
Pain from the day of the shot persisted for 2 days until follow up. On day 2 at follow up in addition to the pain, swelling at injection site on L shoulder. Swelling is tender to palpation and warm.  Patient can move her shoulder normally even if she has some pain.  L shoulder: swelling localized around injection site. redness and warmth 2 inches diameter. pain at palpation of deltoid muscle around injection site. no abscess felt or pus oozing. No fever, no axillary Lympadenopathy.
Clinician prepared vial with 1.3ml Normal Saline diluent rather than 1.8ml Normal Saline. Pt reported having fever & headache for 2 days after vaccination.No further clinical concerns were reported
Redness, heat, pain at RL day after vaccination. Extending aroung entire upper leg with induration. Better with cold.
Day1-2 could not raise my arm above my right shoulder; My right arm from shoulder to elbow was quite sore for 4 days post injection; woke me at Day 1; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the right arm on 18Oct2021 at 13:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, anxiety and seasonal allergies. The patient had no other known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), unspecified inhaler, unspecified over the counter (OTC) allergy and unspecified multivitamin; all taken for unknown indications from an unknown date and unknown if ongoing. On 18Oct2021 at 17:00, her right arm from shoulder to elbow was quite sore for 4 days post-injection and woke her at day 1 and day1-2 could not raise her arm above her right shoulder. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events day1-2 could not raise her arm above her right shoulder was resolved on 19Oct2021 while her right arm from shoulder to elbow was quite sore for 4 days post injection and woke her at day 1 was resolved on 21Oct2021.  No follow-up attempts are possible. No further information is expected.
"Pfizer-BioNTech COVID-19 Vaccine EUA" - received first dose 2/25/2021 and second dose 3/18/2021 Patient wint intermittent persistent occipital headache for 2-3 days.  Pain was rated 8/10.  Also with bilateral lower extremity rash without itchiness persisting for 2 days.  no vision change, no photophobia. Denied any fever, chills, SOB, cough, loss of smell or taste, myalgia, nausea, vomiting, diarrhea, weakness or any focal neurological deficit.    Admitted for ITP (also with epistaxis and severe low platelets, hyponatremia, acute cystitis without hematuria.  No chest pain, no GI bleed.Treatments included 2 units PRBC transfusion (4/6), plateletpheresis (4/6), dexamethasone IV (changed to prednisone oral on 4/7), IVIG infusion from 4/5 to 4/7, and B12 replacement.    Discharge home with prednisone oral, folic acid, cyanocobalamin
Received dose 1 on 10-feb-2021, she forgot to get dose 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th February 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter asked if it was safe to get 2nd dose at the time of reporting.  The reporter consented to follow up.
Information has been received from a consumer concerning a 9 month old female who in August 2007, was vaccinated with a first dose of PedvaxHIB, and in November 2007 with her second dose. It was reported that the patient developed legs swollen, vomiting, diarrhea and chronic rash all over the body after getting the first and second doses of PedvaxHIB. Unspecified medical attention was sought. The patient had not recovered at the time of the report. No further information is available.
Was preparing vaccines for this child and accidently gave him the 12+ Moderna vaccine instead of the 6m-11y. No adverse reactions, Parent's were notified, MD notified. Child is fine.
Abdominal pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 939676) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN (Abdominal pain). At the time of the report, ABDOMINAL PAIN (Abdominal pain) outcome was unknown.            It's been 72 hours, and patient was still having some abdominal pain on 09Aug2021. It felt like appendicitis, then moved to his kidneys.  No concomitant medication was reported. The treatment information was unknown.
Itchy swollen knees with a bright red rash concentrated at the knees first noted approximately 5 minutes after showering. The rash slightly spread up and down both legs but was paler than at the knees. Rash, swelling, and itching increased then ultimately subsided within 2 hours.
Diarrhea; Severe shaking; Tight muscles; This case was reported by a consumer via interactive digital media and described the occurrence of diarrhea in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th November 2022 18:30, the patient received the 2nd dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced diarrhea, tremor and muscle tightness. On an unknown date, the outcome of the diarrhea, tremor and muscle tightness were not recovered/not resolved.   It was unknown if the reporter considered the diarrhea, tremor and muscle tightness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that yesterday (day before reporting) he/she received second dose of Shingles vaccine. Now he/she had diarrhea and more problems like some severe shaking and tight muscles. The patient wanted to know what he/she could do. Additional supportive information: Follow-up would not possible as no contact details were available.
1st dose / in December 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2018, batch number C7B9P, expiry date 27th February 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Headache; Itchy area on the abdomen / felt itchy on the abdomen like a shingles; Felt sick; achy; felt itchy on the abdomen like a shingles; chills; like a bite; This case was reported by a nurse via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2020, the patient received the 1st dose of Shingrix. On 1st July 2020, immediately after receiving Shingrix, the patient experienced headache, pruritus, malaise, pain, vesicular rash, chills and scratch. On an unknown date, the outcome of the headache, pruritus, malaise, pain, vesicular rash, chills and scratch were unknown.   It was unknown if the reporter considered the headache, pruritus, malaise, pain, vesicular rash, chills and scratch to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix about 1 week ago and right after the administration she experienced headache, felt sick and an itchy area on the abdomen. The patient also experienced felt itchy on the abdomen like a bite like shingles. She also reported that she felt sick, achy, and had chills. The reporter did not consent to follow up.
Information has been received from a consumer concerning his 82 year old wife who has had shingles all her life and was scheduled for back surgery on 25-JUL-2007 who on 11-APR-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  The reason for vaccination was to lessen the pain she has each time she gets shingles, not to prevent shingles.  On approximately 12-JUN-2007 the patient developed mild shingles. On 12-JUL-2007 the patient developed shingles with severe pain in the small of the back.  Medical attention was not sought.  She began to use a LIDODERM patch and LYRICA.  At the time of this report the patient had not recovered.  No further information was provided. There was no product quality complaint involved.  Additional information has been requested.
A non-serious spontaneous report of received expired vaccine was received from a health professional concerning an 11-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received the expired FLUMIST on 29-Nov-2011. The patient received a repeat dose of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. The reporter stated that the patient did not experience any late occurring adverse events.
5/15/06 Physical and immunizations given. On 5/16/06, 01:00 AM, temperature 103.6-104.1. Tylenol every 4 hrs. Seen by doctor. Pharyngitis influenza. Treated with IM/Rocephin.
Employee received vaccine at about 4:40pm on 12/17/2020.  Later that night, employee started experiencing sharp chest pains. The following morning, donor woke up with hives, tender to touch arm, at site,  and a sore throat. Donor did not take any medication but took a hot shower to calm s/s of hives. Employee states she did not seek any outside care for evaluation.
Information has been received from a physician concerning an 85 year old female with a history of "lung cancer surgery" who on 08-FEB-2008 was vaccinated with ZOSTAVAX (Merck) SQ (lot#659326/1824U). Concomitant therapy included NORITATE, LIPITOR and MSD. On 07-FEB-2009 the patient developed a case of the shingles. The physician reported that the patient was prescribed VALTREX for treatment. Unspecified medical attention was sought. Follow-up information from a registered nurse indicated that the Patient with no allergy and a history of chickenpox when 8 years old received her first dose of ZOSTAVAX vaccine live (Merck) SQ, 0.5ml (lot#659326/1824U) into the left upper arm. The patient had no recent exposure to chickenpox or herpes zoster. On 02-FEB-2009 (also reported by the same nurse as 09-FEB-2009), the patient developed zoster vesicular eruption with 8-10 lesions on right trunk for 3 weeks. No rash occurred at the site of injection or elsewhere within 42 days of the vaccination. Other systemic symptoms included 3/10 pain. There was no direct fluorescent antibody done and no specimen was collected. The patient was treated with oral VALTREX 1gm TID for one week. Subsequently, the patient recovered. The reporter considered shingles to be an other important medical event. Additional information is not expected.
At time of vaccination 4/29/2022, red rash noted at site of injection. Resolved within 5 days. About two months later, on 6/24,2022 hives covering abdomen, back, upper thighs and arms noted. Have persisted and not resolved.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter.
She developed swelling in her right arm from the elbow to shoulder, hours after the immunization. She than had redness, warmth and pain in that area and was seen in Urgent Care 2 days after getting the shot.  She was put on Cephalexin 500mg, 4 times daily for 10 days. She was seen in follow up 4 days later and only had mild residual tenderness and swelling.
Developed diarrhea evening of shot date-continued x 3 wks 02/11/2010 Information has been received from a physician and registered nurse concerning a 2 month old male with gastroesophageal reflux who on 14-AUG-2007 was vaccinated with his first oral dose of ROTATEQ (lot# 657522/07690). Concomitant vaccinations administered on that day included the first dose of ACTHIB (lot# UF204AE; in the left thigh; the first dose of TRIPEDIA (lot# C2606AA) in the left thigh, the first dose of IPOL (lot# Z0547) in the right thigh and the first dose of PREVENAR (lot# C47442X) in the right thigh. On that same day, the patient developed diarrhea occurring about 4 times a day which continued for 3 weeks. Medical attention was sought through a pediatiric gastroenterologist. Cultures for rotavirus and "C. dif" were prerformed. The patient was treated with PREVACID (TAP) and then switched the patient to NUTRAMIGEN. On approximately 04-SEP-2007 the patient was recovered. There was no product quality complaint. Additional information has been requested.
Pt's friend notified staff that pt c/o dizziness. 2 RN attended pt, placed head down, removed mask & transferred. BP 102/62; HR 50-60; RR 18. Assessed by MD. Pt reported he did not eat breakfast. Water, crackers given. Pt reported feeling much better. Pt stable & released from vaccination site
Patient called our office on 10/26/12 to obtain the vaccine name and lot number to give to her physician. She reported having severe joint pain and swelling of the fingers.
patient received dose after beyond use date (exp 1/24/23). Supply had not been pulled from fridge and RA thought the date needed to be updated to today. No reactions that we can tell, provider and family notified of incident. No sign/symptoms noted.
Pain in left arm where injection was done lasted about 4-5 days. Starting 5/18/21 I got a cold sore and it has progressively gotten worse and still present today. It is now on moth the top and bottom lips in the corners. Right side is more severe than left side. Worst cold sore outbreak I have ever had. First time it has spread to the skin above my lip. Also first time one of my cold sores has been pus-filled. I received prescription of generic valtrex 1 gram yesterday, 5/22/21. And took two pills, upon waking this morning there is no improvement and today is when I first noticed one of the sores being pus-filled. I started using abreva as soon as the tingle started. These medications used to help significantly and keep the sores from spreading. It has only been getting worse. I believe this could be related to receiving my first Moderna vaccine shot, as this is unlike any other outbreak I have had. I received the valtrex prescription from a doctor over telehealth appointment.
Breakthrough case admission after 3 vaccines Pfizer 2/4/21 Lot# EL3248;  Pfizer 2/25/21 lot# EN6200;  Pfizer 11/19/21 lot# FH8030
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 24-MAR-2014, the patient was vaccinated with GARDASIL, dose 1 and on 17-JUN-2014 the patient was vaccinated with the second dose (strength, route of administration, site of administration, lot number and expiration dates were not reported). There were no concomitant medications reported. On 14-JUL-2014, a blood work was done which revealed an increase in liver enzymes. The healthcare worker discussed the report with physician, however, the physician did not want to provide any further information. It was unspecified whether the patient had sought any medical attention. There was no product quality complaint  involved. The outcome of increased in liver enzymes was unknown. The causality of the event increase liver enzymes was unknown. Additional information is not expected.
Constipation; Vomiting; stomach felt inflamed; pain; there was air inside; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), VOMITING (Vomiting), GASTRITIS (stomach felt inflamed), PAIN (pain) and ABDOMINAL DISCOMFORT (there was air inside) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CONSTIPATION (Constipation), VOMITING (Vomiting), GASTRITIS (stomach felt inflamed), PAIN (pain) and ABDOMINAL DISCOMFORT (there was air inside). The patient was treated with MILK OF MAGNESIA at an unspecified dose and frequency and HYOSCINE BUTYLBROMIDE (BUSCAPINA) at an unspecified dose and frequency. On 10-Apr-2021, CONSTIPATION (Constipation), VOMITING (Vomiting), GASTRITIS (stomach felt inflamed), PAIN (pain) and ABDOMINAL DISCOMFORT (there was air inside) had resolved. Not Provided          This case was linked to MOD-2021-079201 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: case; Sender's Comments:  MOD-2021-079201:1st dose
Mom called to clinic & states patient has progressive swelling, redness & itching on rt. arm, both below & above injection site. Warm to touch. No s/s infection at inject site. Took Ibuprofen, starting 11/18/99. Referred to MD.
Chills; High Fever; Cough; Muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 (Lot number: 30130BA) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing), notes: Verbatim: High Blood pressure. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for hypertension; ABILIFY. The following information was reported: PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "High Fever"; COUGH (non-serious) with onset Oct2021, outcome "not recovered", described as "Cough"; MYALGIA (non-serious) with onset Oct2021, outcome "not recovered", described as "Muscle ache"; CHILLS (non-serious) with onset 15Oct2021, outcome "recovered" (20Oct2021), described as "Chills". The events "high fever", "cough", "muscle ache" and "chills" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, cough, myalgia, chills.  Additional Information: NDC number, UPC number and Expiry Date for suspect were Unknown. The patient took no prior vaccination (within 4 weeks). When probed for the concern, consumer stated he got the (first dose) Pfizer Vaccine on 15Oct (further not clarified) 2021 and wanted to report adverse reaction to this. Patient had high fever and still have like cough, muscle ache, had chills and it lasted about 5 days. consumer's (patient) height and weight, consumer stated, "My weight is, I think like 299 I believe probably." When probed for any concomitant medication, consumer stated, "patient took "Abilify" (further not clarified, hence not captured in the tab). When probed for any laboratory test, consumer stated, "It was long ago. When probed for any treatment for the event, consumer stated, "No, he didn't take. He went to the urgent care. Consumer stated, there was a question. Should he even take the second dose vaccine, was it safe to do so.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant concerning a patient who on 25-AUG-2009 was vaccinated with VARIVAX (Merck) (lot# not reported), instead of with ZOSTAVAX (Merck) due to human error. No adverse effect reported. Additional information has been requested.
Severe joint pain, decreased mobility feet, knees, hands. Prednisone. Approximately 1 month till recovered completely.
severe GI upset (patient initially suspected food poisoning), then later developed a sore, red, hot arm at the injection site.  GI effects lasted 8/9, arm turned red, swollen, and hot on 8/10/19
On 09/10/2022 I received my Covid-19 vaccine. On 03/02/2023 I started having a sore throat, slight fever, cough, and felt tired. Three days later symptoms were getting worse, and I tested negative for Covid-19 multiple times. After reaching out to clinic I tested positive for strep throat. I was prescribed Amoxicillin . Symptoms lasted approx. 4 days.