chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.    This case had been linked with US2021AMR151371, reported for the reporter's husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151371:Same reporter
Pt recvd series of 3 Engerix-B on 22JAN91, 22FEB91 & 19JUL91 & SEP91 exp onset of inc liver enzymes;
by the time the second dose is due, patient already turned 12 and therefore needing the adult vaccine instead  of the 5-11. Patient received 5-11 vaccine as his second dose instead of the adult 12+. patient is 12 years old at time of second vaccination. No adverse reactions noted.
Information has been received from a physician concerning a female who on 11/14/1996 was vaccinated once with 0.5 ml subcutaneous dose of varicella virus vaccine live. On 5/26/2005 the patient experienced breakthrough chickenpox, described as a mild case with less than 50 lesions. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Left deltoid induration, swelling about 4cm by 4cm with moderate tenderness. No redness.
Pruritic red, raised rash on face, bilateral arms, anterior posterior chest, back, abdomen and perineal area and buttocks. Seen at Medical Center around 11:30pm.
Mother states he seemed fine the day of shots.  However the next day 112/14/2001, throughout morning and afternoon was fussy with intemittent crying.  Then at approximately 20:30, began crying continuously.  Nothing consoled him.  Cry was high-pitched.  Finally stopped crying around 23:00, and slept as usual throughout the night.  Denies fever/seizure act.  Limpness or paleness was given Tylenol every 4 hours as directed.  No irritation at injection site.  Did not call MD the next day was much better.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Client presented stating she felt like her heart was racing. Initial pulse 120 S/R. Talked for a few minutes and client stated no itching or shortness of breath. After 5 minutes pulse 86 S/R. After 10 minutes pulse 78 S/R. Client stated normal resting heart rate of 65. She takes 12.5mg HCTZ PO daily.
Headache, Arthralgia, FATIGUE, FACIAL SWELLING, CHILLS, PAIN/SWELLING INJ SITE Narrative:
Red arm, redness was growing and it hurts at the injection site, redness has gone down but is also itchy. Advised her to contact her healthcare provider for further evaluation.
Severe pain in hands and fingers.  Began on Feb 4, 2021 and are essentially gone by Feb 16, 2021
Within 1 hour of vaccine started having prickly like feeling in hands, arms, legs, spreading to enter body. Itching then raised red rash covering arms more then entire body. Started Benadryl 25mg every 4-6 hours. Became slightly SOB 11/9/2002. Continue to take Benadryl 25mg every 4-6 hours. Has not called to see MD. 11-15-02 talked with client - saw Dr.; gave rx for Medrol park still complained of prickly sensation, rash present as then before.
Within 15 minutes of receipt of vaccine, developed swelling, redness, itching at immunization site. Took 50mgs Benadryl with good response. Repeated Benadryl dose the next day.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 20 year old female with no medical history or drug allergies who on 17-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included NUVARING.  Subsequently the patient felt weird, the patient then became pale and fainted.  The reporter stated that the patient's eyes rolled back, she was unresponsive and her arms and legs were shaking. The patient was sent to the emergency room but it was unknown what the patient was diagnosed with.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer (patient's daughter) reported for 70-year-old patient that: A 70-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and expiration date were unknown), via unspecified route, on 14Apr2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was tested positive the week after, they are now getting out from the disease, The reporter would like to know the appropriate amount of time when to receive the second dose. The Customer and/or medical inquiry forwarded or referred to MI. The outcome of the event was recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Shortly after receiving the shot she had seizure like motion extension of legs eyes rolled back, mild guttural noises.  No loss of bowel/urine.
My left eye started twitching 5/20 a couple hours after I received my 2nd COVID vaccine. It's been several days and my eye is still twitching. Sometimes it twitches several times an hour and sometimes I go a few hours without twitching. No other symptoms and only my right eye has the twitch. I do not have a history of eye twitching.
Joint pains; 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 ARTHRALGIA (Joint pains) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pains). At the time of the report, ARTHRALGIA (Joint pains) outcome was unknown.            Concomitant medications were not reported.  No treatment details were provided.
soreness (arm); redness at the injection site; first dose 4 years ago, second dose this week; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 5j27j, expiry date 6th May 2023) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (4 year ago patient received 1st dose of Shingrix for tolerance refer case US2022AMR104136).   In July 2022, the patient received the 2nd dose of Shingrix (intramuscular). In July 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site redness and drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site redness were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain and injection site redness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR104136   Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's Comments: The patient who received her second dose of SHINGRIX this week. She states that she received her first dose of SHINGRIX 4 years ago.  The patient states that after her first dose of SHINGRIX, she experienced soreness and redness at the injection site which eventually resolved.  The patient received shingrix in left arm and she experienced the same soreness and redness at the injection site within 48 hours of the second dose.  The soreness and redness at the injection site has not yet resolved after the second dose. The reporter did not gave consent to follow up. Additional supportive Information: The patient received 2nd dose of SHINGRIX 4 years after 1st dose which leads to lengthening of vaccination schedule; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104136:same report, 1st dose
Can't bring arm away from her body / can't get dressed; Arm was painful / Crying in pain / Pounding pain; Crying in pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2020, the patient received the 1st dose of Shingrix. On 29th August 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and crying. On 31st August 2020, the patient experienced mobility decreased. The patient was treated with ibuprofen (Advil) and acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the pain in arm, crying and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm, crying and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and arm was painful and after a few hours she was crying in pain.  It remained painful throughout the day and when she went to sleep then there was pounding pain.  The patient took Asprin and Advil but had a horrible night.  The patient arm was very painful, but she slept better.  The patient can lift arm, but she cannot bring arm away from her body and cannot get dressed. The reporter did not consent to follow up.
low grade fever; chills; muscle weakness; First dose received on 19Dec2020 second dose received on 08Jan2021; First dose received on 19Dec2020 second dose received on 08Jan2021; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient not pregnant received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 08Jan2021 (unapproved schedule) as a single dose for COVID-19 immunization, lot number: EL3302. Medical history was reported as none. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 Intramuscular Left arm, lot number: EK5730. On 09Jan2021 patient experienced low grade fever, chills, muscle weakness. No treatment received for the events. Patient was tested for Covid post vaccination with Nasal Swab on 06Jan2021 result was negative. Patient was recovering from the events, at the time of the report.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Erythematous and induration about 15cm X 20cm on left upper arm.
Mom called to report 5 in x 3 in red, hot, swollen and tender area to left deltoid that appeared on 11-15-16. Pt. received flu shot to left deltoid on 11-14-16. Mother instructed to apply warm compresses and give MOTRIN PRN.
The pt developed pain, swelling, red, warm to touch are on upper left arm. Client came into the office on 01/14/2002. Erythematous, swollen, warm to touch and painful to palpitation. Given Benadryl and applied warm moist heat on the area.
sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). On 31-Jan-2021, VACCINATION SITE PAIN (sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were blood pressure pills.  No Treatment information for the event was provided. Patient reported that Patient has scheduled a steroid injection for his shoulder on 25Feb2021.   This case was linked to MOD21-035602 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). On 31-Jan-2021, VACCINATION SITE PAIN (sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were blood pressure pills.  No Treatment information for the event was provided. Patient reported that Patient has scheduled a steroid injection for his shoulder on 25Feb2021.   This case was linked to MOD21-035602 (E2B Linked Report).; Sender's Comments:  MOD21-035602:
Patient came in to receive 2nd Moderna vaccine.   Was given Janssen 0.5ml instead.  Patient says he has been having dry heaves.
This spontaneous report was received from a pharmacist regarding a 57 year old female patient with no pertinent medical history reported. On 01-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # J000429, expiration date 10-APR-2014) (0.65 ml, subcutaneous, anatomical location not provided). No other suspect therapies or concomitant medications were reported. Approximately on 06-MAY-2013 (reported as 7 days ago) the patient experienced mouth soreness after administration of ZOSTAVAX. The pharmacist stated the patient described the reaction and said "it felt like a cold sore, it was not visible but it was moving around her mouth" The pharmacist also stated that the patient rate the pain at 5 on a 0-10 scale. The outcome for mouth soreness was unknown at the time of the report. The patient was given treatment with unspecified "over the counter remedies". The patient did not seek medical attention. The reporting pharmacist did not assess the relatedness between ZOSTAVAX and mouth soreness. Additional information has been requested.
headache; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect from a contactable consumer reporting on herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number /expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On the same date that evening, the patient experienced headache. The patient received treatment for the event which included 2 aceteminophen (TYLENOL). The outcome of the event headache was unknown.   Information on the Lot/Batch number has been requested
Sneezing, coughing, wheezing, lethargic, increased heart rate & pale 5 minutes after shot. ALBUTROL breathing treatment/ Nebs. Epi jr. pen injection X 1 BENADRYL 12.5 mg IM, MULIPRED- 15 mg PO.  Improved & sent home 3:56 PM 7-14-09
Vaccine exposure during pregnancy; Soreness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN (Soreness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On 11-Jan-2021 at 2:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Mar-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN (Soreness). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 11-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were  reported. No treatment information was provided.  Company comment:This is a case of product exposure during pregnancy with the associated event of Pain for this female patient. Based on the current available information and temporal association between the use of the product and the start date of the event (Pain), a causal relationship cannot be excluded. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with the associated event of Pain for this female patient. Based on the current available information and temporal association between the use of the product and the start date of the event (Pain), a causal relationship cannot be excluded. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient is going to take Ibuprofen and Tylenol.
At 13:45 pt notified COVID-19 drive-thru vaccine station patient monitor that she was having facial flushing. Dr. and RN responded to patient in parking lot to assess. Patient reported that she had a reaction after her first dose of vaccine, she "felt it in her body," and lightheaded, and it took 3 hours for it to feel better. She also said that when clinical staff assessed her last time, she did not take her mask off, so they didn't know that her face was flushed and swollen. She said that she had talked to her PCP who recommended that she bring Benadryl to take after the vaccine if she had the same reaction. Pt states that while in line for vaccine, someone told her she should take the Benadryl before the vaccination, so she took 50mg.    VS:  BP 128/82, HR 56, RR 20, SpO2 98%. Heart sounds regular, lungs clear to auscultation. Pt denies nausea. No rash visible. Clinical staff stayed with patient. Pt also said that she had history of anaphylaxis to eggs. At 15 minutes, symptoms not progressing, but also not lessening. At 14:12, because patient had taken Benadryl and staff was unable to tell if allergic symptoms were lessened by the Benadryl, they contacted EMS to come assess the patient. EMS arrived at 14:20, report was given. EMS assessed pt in ambulance. AT 14:44, EMS released pt to home. She reported that she felt better and thanked clinical staff.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) and rash (all over the body) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 03B21A) for COVID-19 vaccination. Concomitant products included Trileptal (oxcarbazepine), Klonopin (clonazepam), naproxen and omeprazole for an unknown indication. On Apr 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore arm) and rash (all over the body). At the time of the report, pain in extremity (sore arm) and rash (all over the body) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments or treatment medication.
I was in bed trying to fall  asleep. I started getting a heavy feeling and buzzy feeling in my legs. Then right away they shake. It?s starts off light in my knees and then gets more intense as it gets to my stomach and chest. Then it would start the cycle all over. Knees to chest with my whole body shaking. This went on for about 30 mins. It was so intense I had a hard time catching my breathe. My quad muscles hurt so bad because of the tremors.  This has never happened to me before so it was very scary. Then it happened again on Thursday, June 10th around 11:30pm. Except this time it lasted an hour. It was so painful having those tremors. I had no control of them.  It was hard to breathe at times. I thought I was going to have to go the hospital.