chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age (gender unspecified). On an unknown date in November 2011, the patient was vaccinated with first dose of GARDASIL (lot number, expiration date and route was not reported). No concomitant medications were reported. The nurse reported that the patient was in the office on 07-DEC-2012, to receive 2nd dose of GARDASIL. No adverse event was reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Patient states that injection site hurt to touch, was red and swollen, and patient felt sick. All symptoms occurred 1 day after injection and continued for about 3 days.
Estimated start time of 10:00am?injection site soreness, muscle soreness, joint pain, and migraine, nausea, chills, and heat flashes. Estimated start time of 9:00pm?chest pain and sensation of burning lungs. Aspirin taken at 10:00pm. All symptoms except for injection site soreness were gone by 11:00pm.
Approximately 6 days after immunization nerve pain, sore trunk, organs. Pain in joints. Patient reported on 5/27/14.
Clinical Summary The patient is a 77 year old  female with a history of Cognitive Impairment due to PML, MGUS, and PE who presented on 10/31/22 with fevers/abdominal pain x 7 days PTA, Abdominal pain. Found to have COVID, choledocholithiasis, possible UTI, Cr 1.5, AST 501, ALT 292, T bili 0.5, WBC 2.2, and Hgb  9. Transferred to hospital 11/1/2022 for further management.  Discharged home.   1. Sepsis with Leukopenia: secondary to COVID. Blood/urine cultures negative.  Resolved. 2. COVID PNA: Vaccinated x 4 (last 10/1/22, likely non-responder given MGUS) symptom onset 10/24/22, (+)test 10/31/22. Admit CXR with atelectasis in LLL.  Given Decadron while inpatient, discontinued at discharge.  Isolation no longer required. 3. Acute Hypoxic Respiratory Failure: secondary to  COVID-19 infection. Required 2L NC on admit.  4. Elevated Liver Enzymes: Per GI, likely multifactorial from COVID, DILI from Keflex/Tylenol, and underlying fatty liver disease.  Patient took 3 Tylenol tabs every 4 hours x3 days PTA.  Admit AST 501, ALT 292.  Hepatitis panel unremarkable.  Showed CT Abdomen/Pelvis  10/31/22: GB sludge with cholelithiasis.  RUQ US showed cholelithiasis.  Held lipitor.  General Surgery followed.  GI followed, recommended CMP weekly x 4 weeks. 5. AKI: Baseline Cr 0.8, Cr 1.5 on admit due to sepsis.  Resolved.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Information on patient's pertinent medical history and concurrent condition was not reported. On 22-APR-2016, the patient was vaccinated with one improperly stored dose of VARIVAX (Merck) (lot # L049532, expiry 08-DEC-2017) (dose and route not reported). No adverse effects were reported. The data loggers were used. On unspecified date, the temperature was 6.5 Fahrenheit (F) for a time frame of 13 minutes and was back in range. A previous temperature excursion on unspecified date was reported to the same lot number, previously exposed to 6.7 F for 13 minutes. The total cumulative time out of range was 26 minutes. No additional information was provided. This case is one of the two reports received from same reporter. Additional information has been requested.
At injection site in right arm, bruising developed, and redness appeared approximately 3 inches below injection site. It was a large red area about size of a small apple. The raised area was red and warm.  Fever 102.9 Nausea Dizziness Bladder control dysfunction - once  Persistent headache.
Swelling, redness around the injection site of MENACTRA few hours after the vaccine. 2 days later pt reported nausea and itching.
shingles; itchy spots on her head; itchy spots on her eyebrows; itchy spots became painful; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), RASH PRURITIC (itchy spots on her head), RASH PRURITIC (itchy spots on her eyebrows) and PAIN (itchy spots became painful) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles), RASH PRURITIC (itchy spots on her head), RASH PRURITIC (itchy spots on her eyebrows) and PAIN (itchy spots became painful). At the time of the report, HERPES ZOSTER (shingles), RASH PRURITIC (itchy spots on her head), RASH PRURITIC (itchy spots on her eyebrows) and PAIN (itchy spots became painful) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-089287 (E2B Linked Report). This case was linked to MOD21-081347, MOD21-081381 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089287:
He had no reactions. The vial was expired due to error of invalid expiration date on packing
This spontaneous report as received from a medical assistant refers to a 12 years old patient (unknown age and gender), who on 19-APR-2011 was vaccinated with a dose of GARDASIL (dose, route and lot number were not reported) and on 22-AUG-2011, was vaccinated with a dose of GARDASIL (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect had been observed or reported. At the time of the report, the patient's outcome for the adverse event was unknown. This is one of two reports from the same report. Additional information has been requested.
This spontaneous report was received from a healthcare professional and refers to a currently 12 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 16-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
PAIN AFTER VACCINATION; This spontaneous report received from a patient via other company concerned a 6 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced pain after vaccination. The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable. The outcome of pain after vaccination was not reported. This report was non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on her right upper limb), FATIGUE (Tired), HEADACHE (Headache) and ARTHRALGIA (Pain on right shoulder blade) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-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) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain on her right upper limb), FATIGUE (Tired) and HEADACHE (Headache). 23-Feb-2021, the patient experienced ARTHRALGIA (Pain on right shoulder blade). At the time of the report, VACCINATION SITE PAIN (Pain on her right upper limb), FATIGUE (Tired), HEADACHE (Headache) and ARTHRALGIA (Pain on right shoulder blade) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.
ear ache; achy; diarrhea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear ache), PAIN (achy), DIARRHOEA (diarrhea) and VOMITING (throwing up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LANSOPRAZOLE (PREVACID), LEVOTHYROXINE and TRIAMTERENE for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced EAR PAIN (ear ache), PAIN (achy), DIARRHOEA (diarrhea) and VOMITING (throwing up). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, EAR PAIN (ear ache), PAIN (achy), DIARRHOEA (diarrhea) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Mother called this date 05/12/2020. Stating that her child has developed a rash on torso, now upward to  the rest the body. No to the following: SOB, Temp, Swelling, Redness to injection sites,  No to change in diet, No to change in laundry soap, No to any carpeting . Child did well after the injections with no complaints from child till 05/10/2020 per Mother. Advised mother to call the nearest E.R. for phone evaluation due to CoVid19. If advised to go to ER for evaluation of rash to body to do so as soon as possible. Mother states understanding.
irregular heartbeat ( ATRIAL FIBRILLATION) went to emergency room  They admitted me (24 hrs) then heart went back to regular rythm.
Blisters/One blister was kind of longer than the other at about 7mm; was given COVID-19 Vaccine too high and almost on the very top of the shoulder; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old female patient received her second dose of bnt162b2 (BNT162B2 also reported COVID-19 Vaccine by Pfizer, lot EL1284, expiry 30Apr2021), intramuscularly on 08Jan2021 10:10 at 0.3 mL, single for Covid-19 immunisation since she was an essential worker. She had her first dose of vaccine on 21Dec2021 (lot EK5730, expiry date 31Mar2021) via IM route at 0.3ml single dose for Covid-19 immunisation. Medical history included seasonal allergy. The patient's concomitant medications were not reported. The patient reported that COVID Vaccine which was given on the very top of her shoulder on 08Jan2021. Because of the location of the injection, the patient experienced a cluster of blisters at the injection site on 09Jan2021 now reported as a big scab. One blister was kind of longer than the other at about 7mm's. She took ibuprofen and has been guarding her shoulder. The outcome of Vaccination site blister was recovering.
my joints felt like, the same symptoms; feeling sleepy; my body was burning; my nostrils were hurting; This is a spontaneous report received from a contactable consumer (patient). A 25-year-old male received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EW0175) via unspecified route of administration, administered in left arm on 05Jan2021 (age at the time of vaccination was 25-year-old) as a single dose for COVID-19 immunization. Medical history included HIV since an unspecified date in Aug2021. I was recently diagnosed with HIV. So, that was why I got my first shot. Concomitant Medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration, in left arm on Dec2020 (age at the time of vaccination was 24-year-old) as a single dose for COVID-19 immunization experienced a little bit fever and was like sleepy. On an unspecified date, the patient experienced my joints felt like, the same symptoms, feeling sleepy, my body was burning, and my nostrils were hurting. It was reported that Consumer stated, The first shot, let me think about it. So, the first shot. It was in December and I started having, I remember being, I think the symptoms were kind of same. I take the vaccine; I was off for two days after and I was like sleepy and I have just a little bit of fever and stuff like that. It was like the same that I am having right now. But not bad. The second dose, three hours after I got it, I was feeling sleepy. I slept, I believe like 20 hours. But like symptoms were like I would sleep that much. But then I was like waking up. I normally play in a video game & I was feeling like that something was happening and also like my body was burning, my nostrils were hurting, my joints felt like, the same symptoms and I was like waking up, just drinking water and going to the bathroom. Drinking water going to the bathroom, drinking water going to the bathroom and then just like sleeping. At the same time sleeping water bathroom. The patient underwent lab test and medical procedure which included Blood test on an unspecified date, which result was unknown and Urine analysis which result was unknown on an unspecified date. The clinical outcome of all the events was unknown.  Information on the lot batch number has been requested.
The patient was unable to receive his Imovax vaccination today because it was not in stock with no adverse event; Initial information was received on 27-May-2021 regarding an unsolicited valid non-serious case from a pharmacist (Inquiry number: 00618801).  It was reported that 20 years old male patient was unable to receive his RABIES (HDC) VACCINE [IMOVAX RABIES] (Suspension For Injection) today because it was not in stock on an unknown date for prophylactic vaccination (Product dose omission issue).  It was a case of potential medication error due to missed dose.  Pharmacist states that a patient, the patient was supposed to receive an Imovax vaccination on 27May2021. His last vaccination was received on 20May2021. The patient was unable to receive his Imovax vaccination today because it was not in stock. The pharmacist states that the Imovax will be in stock tomorrow and the patient will be able to receive it then.  At the time of report, no adverse event 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.  There will be no information available on batch number for this case.
Developed flu like symptom (after second dose); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Developed flu like symptom (after second dose)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Patient considered immunocompromised as she receives a Pegasys injection every two weeks.). Concomitant products included PEGINTERFERON ALFA-2A (PEGASYS) for Immunocompromised, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM and PROGESTERONE for an unknown indication.    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 INFLUENZA LIKE ILLNESS (Developed flu like symptom (after second dose)). At the time of the report, INFLUENZA LIKE ILLNESS (Developed flu like symptom (after second dose)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antibody test: high (High) titers were high.         No treatment information was provided by the reporter.  Patient received a full dose and not half, and patient was a classic example of someone who is small. It's been 6 months since patient received the second dose. Before receiving third dose, patient asked doctor to test again for antibody, but doctor said they didn't believe in Ab testing. Patient is considered immunocompromised as patient takes Pegasys injection every two weeks. Last time received it was on 8Sep2021.   This case was linked to MOD-2021-320389 (Patient Link).
COULD NOT SLEEP; CHEST PAIN THAT WAS SORE BUT WAS MORE CENTRALIZED IN HEART MUSCLES; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure (under control), alcohol use (very little and rarely), and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 203A21A) dose was not reported, 1 total, administered on 06-JUL-2021 at left arm for prophylactic vaccination. The patient did not experience any adverse event after the first dose and reported that he was fine (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D214, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 28-JAN-2022 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 29-JAN-2022, next day after receiving the booster shot patient went to the gym and run on a treadmill with no shortness of breath, then he went into the locker room and felt a chest pain, patient described it like angina pain squeezing his heart. Patient drank water and reported that it got better. On 30-JAN-2022, patient experienced chest pain that was sore but was more centralized in heart muscles. Patient drank water and reported that it got better. On 31-JAN-2022 around 2:00 am patient woke up with chest pain and stated that he could not sleep. He drank water and it helped. On 31-JAN-2022, all the symptoms resolved and patient has been to the gym since then and stated that it has not happened again. Patient reported that he has not consulted his primary care physician (Dose number in series 2). Laboratory data (dates unspecified) included: Cholesterol (NR: not provided) fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain that was sore but was more centralized in heart muscles, and could not sleep on 31-JAN-2022. This report was non-serious. Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Worsening bronchitis that consumer had before injection; Pain at injection; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Worsening bronchitis that consumer had before injection) and VACCINATION SITE PAIN (Pain at injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Bronchitis. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), PROGESTERONE, ESTRADIOL and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CONDITION AGGRAVATED (Worsening bronchitis that consumer had before injection) and VACCINATION SITE PAIN (Pain at injection). On 27-Mar-2021, VACCINATION SITE PAIN (Pain at injection) had resolved. At the time of the report, CONDITION AGGRAVATED (Worsening bronchitis that consumer had before injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-072514 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-Jun-2021 contain no significant information.
8 months and 11 days old child was administered a dose of Rotarix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 7RT75F, expiry date 19-SEP-2024) for prophylaxis.   On 23-JUN-2023, the patient received the 2nd dose of Rotarix lyophilized formulation. On 23-JUN-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: 8 months and 11 days old child was administered a dose of Rotarix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-JUN-2023 The physician reported a patient aged 8 months and 11 days was administered a dose of Rotarix (national drug code number 58160-854-52), which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.