chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included etanercept (Enbrel).  On 31st May 2018, the patient received the 1st dose of SHINGRIX. On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain and bone pain. On 1st June 2018, the patient experienced feeling bad. On an unknown date, the outcome of the muscle pain, bone pain and feeling bad were recovered/resolved. It was unknown if the reporter considered the muscle pain, bone pain and feeling bad to be related to SHINGRIX. Additional details reported as follows: The patient received the vacine in the left arm. The patient reported same day as first SHINGRIX dose she had soreness but by the 2nd day she felt like she had been beaten, the soreness was worse and she in general felt bad. She reported the soreness was muscle and felt like bone also. She stated the events resolved within 36 hours in 2018. The healthcare professional was not asked.
Musculoskeletal discomfort; pain started in chest, moves to sides and back. Painful to cough, and painful to bend over, and twist; getting in and out of a chair difficult. Peripheral edema; swelling in ankles and feet. Coughing up phlegm/muscus All tests came back normal; regiment of ibuprofen and acetaminophen recommended for the pain. All symptoms persisted.
After receiving the second dose, I started to notice that I was having pains in my joints and muscles. The pain has increased over time and I've been having a lot of trouble walking. I received medication to help with the pain, but it didn't really help. As of today, it has been 6 months since I've received my second dose and I'm still having the aches and pains.
She noted itching immediately on injection and when she looked at her arm 15 minutes later noted localized redness and hardness of the skin
Developed hives 6 hours, patient received both flu and pneumonia vaccine. Patient was informed of continuing with have and itching to refer to his Dr.
@ the inject site a shiny, white depressed area 1 cm in diameter devel It was sl itchy & tender when touched; The itchiness & tenderness has stopped;
Family arrived for withdrawal of life support. Will stop all heroic measures when they are  ready. Patient passed away on the 11th September 2023 at 2:22 AM while on comfort care measures
Vaccine was administered to the patient after beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after beyond use date) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after beyond use date). On 02-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine was administered to the patient after the beyond use date of the vial. The vial was received on 23-APR-2021 and stored in the fridge and the vaccine was administered after 30 days. No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
also suffers from Narcolepsy; fatigue; moderate body aches; This is a spontaneous report from a contactable consumer reported for self. This 23-year-old female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. She experienced fatigue and moderate body aches. She also suffers from Narcolepsy and takes Xywav nightly. Outcome of the events was unknown.  Information on lot/batch number has been requested.
COVID positive diagnosis on 5/22/22, history of pseudomonal colonization/pneumonia,
Death  5/2/2021 Causes of death listed on death certificate: 1) Small-bowel obstruction  2) Carcinoma of small-bowel
Dosage administered was incorrect. Received 0.5mL instead of indicated 0.25mL booster.
No adverse event; Caller reported GARDASIL 9 was involved in this possible excursion, and caller stated the GARDASIL 9 was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-FEB-2022, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, 0.5 milliliter, lot #U007667, expiration date: 23-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided) after a potential temperature excursion occurred. The data logger stopped recording for 24 hours, however, there were no specific temperatures to evaluate. The vaccine did not undergo previous temperature excursion. The patient did not experience any adverse event.
This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the left arm on 30Sep2021 (at the age of 67-year-old), as a single dose for COVID-19 immunisation. Medical history included depression and high blood pressure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 23Feb2021 (at the age of 67-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 67-year-old), both as single dose for COVID-19 immunisation. On 01Oct2021, the patient experienced some swelling and redness at the injection site for about 5 to 7 days and had no pain. The event did not result in doctor or other healthcare professional office/clinic, 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 some swelling and redness at the injection site was resolved on unknown date in Oct2021.
This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a elderly male patient who received SHINGRIX. Concomitant products included CARDIZEM CD, vitamin E and danazol. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovered/resolved. The reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Concomitant products included Vitamins. The reporter was the physician who received vaccine. The patient received vaccine on left deltoid. The next day after receiving the SHINGRIX, he experienced injection site tenderness which lasted for 3 or 4 days then resolved. The reporter stated that his doctor changed jobs and took 1 month off so he should be available at this phone number and facility after 1st June 2018.
Moderna COVID-19 Vaccine EUA Itching along with red area about 2 inches in diameter in middle of upper arm near injection site started on 2/8/2021, subsides for a few days, started itching again on 2/12/2021 and continues with a larger red area about 3 inches in diameter that is warm to the touch.
she got really sick with all three of the vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "she got really sick with all three of the vaccines". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she got really sick with all three of the vaccines".  Additional information: Daughter was 44 and she got really sick with all three of the vaccines. Daughter never said that to her before. Thinks a lot of people just don't say anything and don't report it. Will talk to her daughter about calling and filing a report. Thought she was feeling better. Its wearing off. Doesn't know how the symptoms work through the system exactly. Starting to feel a little bit better. Doesn't know that she will make it to her appt Wednesday though. She can't shower to get out of house. She walks and rides a bike everyday. So this has really put her our. Doesn't get sick very often at all.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201369512 same reporter/patient/event, different doses.;US-PFIZER INC-202201353127 same reporter/patient/event, different doses.;
Initial case received on 18 January 2010 from a health care professional. A 42 year old female patient received a left forearm intradermal injection of IPOL (lot number D0304-2) on 12 January 2010 instead of TUBERSOL for PPD skin testing. On 13 January the patient experienced "arm itching." She was advised to use a cold compress. The patient was seen in the physician's office two days after administration of IPOL intradermally and continued to experience itching of left forearm and redness of site. No further reactions were reported. The patient's history included hypertension and an allergy to VICODIN. Concomitant medications included Amlodipine Besylate. Follow up information was received on 09 February 2010 from a health care professional. On 01 February 2010 the patient received a dose of PPD in the right forearm (manufacturer and lot not reported). At this time, the patient was seen for follow up and did not have any problems. The results for the PPD test were negative. The patient was reported as recovered. Follow-up information was received on 19 March 2010 from a health care professional. No treatment was required for this patient. The PPD received on 01 February 2010 was TUBERSOL, Lot # C3266AA to the right forearm intradermally. The results read on 04 February 2010 were negative. The patient did not have any symptoms or problems associated. Documents held by sender: None.
About 15-20 minutes after receiving the flumist I felt very drowsy and could barely stay awake.  I also was very disoriented and literally walked into a wall after going through a doorway.  A few minutes after that I rose from sitting and nearly fell over.  I felt similar to if I was very inebriated for several hours and was afraid to drive until much later that evening.
Face, neck, and ears became flushed within 5 minutes of the injection. Remained red for approximately one hour.
Information has been received from a pharmacist concerning an unspecified age female with unspecified drug reactions/allergies and medical history, who was vaccinated "3 years ago" with all three doses of GARDASIL (started in approximately in JUL-2006) (dates, routes and lot numbers unspecified). There was no concomitant medication reported. The pharmacist reported that the patient tested positive for Human Papilloma Virus (HPV) on a Pap Test. At the time of the report the outcome of the patient was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Twitching in hands, arms, back, legs and face, even while sleeping.  Pain in thighs and calves, tingling numbness on left side of face
Information has been received from a nurse concerning a 23 weeks male child with no pertinent medical history and drug allergies, who on 24-NOV-2010 was vaccinated with the first dose of ROTATEQ (lot # unknown), and on 31-JAN-2011 was vaccinated with the second dose of ROTATEQ (6690691/1645Z). There was no concomitant medication. On 08-MAR-2011, the patient experienced abdominal distention, maroon stool, and one episode of non-bilious vomiting followed by one episode of bilious vomiting. On the same day, the patient was examined in the Emergency Room. Abdominal scan showed intussusception. The patient was admitted and treated nonsurgically with air enema. The NP added that there were no pre-disposing factors; the patient was born at 39 weeks, 1 day; and weighed 4025 grams (8.87 pounds). On 09-MAR-2011, the patient was recovered and went back home. On 21-MAR-2011, the patient visited the office and the baby was 17pounds 12oz. No further information is available.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 015M20A and 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) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: No new information appended.
This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain), ODYNOPHAGIA (hurts when he swallows), LYMPHADENOPATHY (Swollen lymph nodes on his neck) and LYMPHADENOPATHY (Swollen lymph gland) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced EAR PAIN (Ear pain), ODYNOPHAGIA (hurts when he swallows), LYMPHADENOPATHY (Swollen lymph nodes on his neck) and LYMPHADENOPATHY (Swollen lymph gland). The patient was treated with AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. At the time of the report, EAR PAIN (Ear pain), ODYNOPHAGIA (hurts when he swallows), LYMPHADENOPATHY (Swollen lymph nodes on his neck) and LYMPHADENOPATHY (Swollen lymph gland) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pain day received vaccine and since, 10/13 swelling and increased pain, 10/16 red blotches, heat. Triamcincolone cream, Prednisone, Zofran, OTC - Benadry; Zyrtec; Famotidine, Tylenol. Referred to allergist for allergy testing.
Off-Label Use: Vaccine Given to patient under 18 by accident. Healthcare professional did not realize patient was 17.
Sweating in middle of night when it began, pain and tenderness and swelling in arm , severe swelling, could not raise arm It has started to improve today 8/27/19 when she notified us
Little soreness in arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced little soreness in arm. It was reported that while calling about her husband, the caller mentions that they both had a little soreness in their arm after the vaccine. Caller declined to complete full report. The clinical outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient received an expired first-dose of DTaP-IPV/Hib with no reported adverse event; Initial information received on 23-Dec-2021 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 2 months old male patient who received an expired first-dose of dtap-ipv/hib with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  On 08-Nov-2021, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at first dose of 0.5 mL 1X(once) via intramuscular route (lot UJ384AA, 09-Oct-2021) followed by second dose with (unknown administration site, strength) for prophylactic vaccination .  On 08-NOV-2021 the patient developed a non-serious event "patient received an expired first-dose of dtap-ipv/hib with no reported adverse event" (expired product administered) (latency-Same day)following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was reported "Caller states that a two month old patient received an expired first-dose of DTaP-IPV/Hib that was manufactured by Sanofi in the office on 08NOV2021 and asked if the dose needed to be repeated. Caller states that the patient has received a second dose on 24NOV2021. Caller states that she does not have the brand name of the vaccine, only that it was manufactured by Sanofi and that her records show it as DTaP-IPV/Hib".  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event patient received an expired first-dose of dtap-ipv/hib with no reported adverse event.  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 the 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.
pt received vaccine at age 11 instead of 12 the parent filled form for 11/202008 instead of 11/20/2009
Immediate reaction to vaccine: fever, body aches, headache and joint pain and fatigue; Those lasted about 48 hours. In April, I had blood in my urine. I had cystoscopy and they found bladder tumors that were cancerous. They removed them on May 28th. They were able to get them removed. Before the surgery, I had a bladder infection, and I went to an urgent care; antibiotics to treat that.
Miscarriage at 13 weeks gestation due to fetal cystic hygroma; Miscarriage at 13 weeks gestation due to fetal cystic hygroma; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) was exposed to bnt162b2 (BNT162B2), transplacental, administration details for the mother: on 18Dec2020 at 10:00 as dose 1, single (Lot number: EK5730) and on 08Jan2021 at 10:00 as dose 2, single (Lot number: EL3246) for covid-19 immunisation. The mother of the patient was 32 years old. The mother was 13 weeks pregnant at the event onset. The mother's relevant medical history and concomitant medications were not reported. The mother was vaccinated at a hospital.  The following information was reported: FOETAL CYSTIC HYGROMA (death, medically significant), EXPOSURE DURING PREGNANCY (death, medically significant), outcome "fatal" and all described as "Miscarriage at 13 weeks gestation due to fetal cystic hygroma". Therapeutic measures were taken as a result of foetal cystic hygroma. The patient date of death was 03Mar2021. Reported cause of death: "Miscarriage at 13 weeks gestation due to fetal cystic hygroma". No autopsy was performed. Additional information: On 03Mar2021, the mother experienced a miscarriage at 13 weeks gestation due to fetal cystic hygroma.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (10Oct2023): This is a follow-up report to notify that this case 2021288616 was submitted to the Agency trading partners with the 2020516672 of case 202300324023. Case 202300324023 is going to be resubmitted to confirm information and case 2021288616 is considered invalid and corresponding information is re-entered under this new manufacturer report number 202300324023.; Sender's Comments: Based on the information provided,  a causal association between reported events and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2020516672 Mother case;; Reported Cause(s) of Death: Miscarriage at 13 weeks gestation due to fetal cystic hygroma; Miscarriage at 13 weeks gestation due to fetal cystic hygroma
17 days after shot resident presented with Cellulitis to right arm.  Red, swollen, warm to touch. No pain reported or assessed.  Arm is completely cleared.
immed felt hot all over, nauseated, became light-headed-states usually feels this way to some extent d/t fear of shots;vomited small amount then went to ER;
Hives (splotchy and itchy rash on shoulder, chest and face). Also experienced chills, fever and headache.
Information has been received from a 23 year old female who on 04-MAR-2009 was vaccinated with with second dose of GARDASIL.  The patient had no medical history.  It was reported that the patient had her period was right after getting the second dose of GARDASIL. On 07-MAY-2009, the patient reported that her period was 3 days late.  The patient didn't know if she was pregnant and didn't do any pregnancy test yet.  The patient did not seek medical attention.  At the time of reporting, the patient had not recovered.  No further information is available.