chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 patients, were inadvertently administered vaccines, deemed to be nonviable from excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV  (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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-17-MAY-2022 Reporters comment- The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371. Registered nurse manager called in to inquire about the time interval for repeat dose and if it was safe. The reporter was unable to provide any vaccine or patient details. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371, which led to incorrect storage of drug. This was one of 17 linked cases reported by the same reporter.
tingling of tongue, ear felt weird, Benadryl administered and some improvement but not completely and 911 called after started to go further in mouth
Admission note on 10/28/21: Pt is a 75 year old female with hx significant for DM2, HTN, familial tremor, gout, HLD, osteoporosis, OSA on home BiPAP, and GERD. Pt presented to urgent care after generally feeling unwell for a week. Pt admits to runny nose, cough, sneezing, and fever at home of 102.  In urgent care, she was noted to be hypoxic and transferred to ER.  Pt's SpO2 was 70% on RA and required 5L to maintain SpO2 in 90s.  Rapid Ag test for COVID was positive.  Pt was vaccinated in January for COVID and believed she had a cold, did not suspect COVID.  She sates she did see a neighbor who had a cold a little over a week ago and suspects that is how she contracted COVID.   Transferred to hospital as there were no beds available.  On arrival to hospital she required 4L O2 via NC.  Pt denied shortness of breath, body aches, HA, N/V/D Patient discharged 11/1/2021
Within several hours after receiving vaccine pt felt like she "was hit by truck". Seen 3 wks later due to persistent myalgia, weakness, wt gain. Labs ordered, referred to rheumatologist, seen 2 wks later, dx'ed with polymyalgia rheumatica. Symptoms were: severe joint pain in hips, knees, shoulders & generalized widespread muscle pain. Sed rate and C-reactive protein blood tests were both elevated, indicating an inflammatory reaction. Patient was started on Prednisone, requiring a dose of 60 mg to control symptoms. Pt was referred to the rheumatology clinic. It was a concern that the pt. might also have Giant Cell Temporal Arteritis. So she was referred to a surgeon who performed a (R) temporal artery biopsy. This was negative. Pt. started a slow taper of the prednisone, reaching a dose of 17.5 mg on Feb. 8, 2013. Symptoms returned then and blood tests again were elevated. Dosage of prednisone was again increased and it was also decided to add methotrexate. Pt has complained of headaches and jaw pain, as well as some vision changes. Again it was a concern that the pt may have temporal arteritis, and she was hospitalized 03-28-13 to 03-30-13 for further testing. CTA of entire vascular system was negative. Blood work was stable. Discharged on Prednisone 60 mg qd and methotrexate 12.5 mg/weekly. Follow up at rheumatology on 04-18-13.
About 6 hours into my second dose I developed a severe symptoms from the vaccine. Hot painful arm, Muscle pain, headache, nausea, dizziness, fever, chills etc. Despite being on round the clock Tylenol I was awoken at 2am to severe chills and fever. I got my mom who tried to help me get through it. I noticed since waking my heart felt very fast. My mom monitored me on my smart watch and pulse ox. My heart rate was up in the 120's for no reason while resting. I have anxiety but I was not anxious at the time and actually went to bed around 5am. My mom monitored me while sleeping. My heart did not go down all night and morning. It remained in the 120's. I got an appointment with a doctor to where I was told it was most likely my immune system (I did have low vitamin D) and that it could be from the fever despite my fever being broken already. She called it Tachycardia. She advised if it does not go down then to come in. Thankfully my heart rate went down close to the evening time. I did not however feel back to normal. I felt strange from the days after. A couple days later I was awoken to my heart at 180. It was extremely scary at that point I felt like something was wrong. I got every test done and even went to the emergency room. I lost numerous weight for no reason in about a month or so fairly fast. I was 128 and fell to 110. However all tests say I am healthy. Despite vitamin D being low. My Iron was borderline. D-Dimer was oddly high. And blood sugar would fall every now and then for strange reasons. My doctor left and I couldn't see her anymore so with that I took it as anxiety. I have been in treatment for anxiety ever since this incident. I am sure it is anxiety. However nothing can explain the high heart rate that never went down for hours when I did get the shot. My periods have never been the same either. They are heavy painful and never on time. I feel like I developed PMDD but again could be just anxiety. I was supposed to go back for tests and Etc. however I never did because I gave up at that point and just decided it was best to believe its anxiety and I have been going to therapy once a week for. I do want to be clear I had a lot of anxiety about the pandemic itself this has been extremely hard. Apart of me believes that maybe my body panic after getting my last dose and was almost like a relief. However It has been hard. I have been unable to leave the house when before the vaccine I was out of course with a mask but I was doing stuff. Now I get scared leaving. I don't like having my heart race like the way it did and its been hard. Did I experience an adverse reaction? I don't know. Maybe that first night. But I do know I haven't been able to get the booster because I am so petrified. I cant even leave my neighborhood.
Late dose two; Shingles like lesions; Pain; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 5592T, expiry date 12-OCT-2023) for prophylaxis.   On 04-OCT-2023, the patient received the 2nd dose of Shingrix (unknown arm). On 27-FEB-2023, the patient received the 1st dose of Shingrix. On 28-FEB-2023, not applicable after receiving Shingrix and 1 days after receiving Shingrix, the patient experienced vesicular rash (Verbatim: Shingles like lesions) and pain (Verbatim: Pain). On 04-OCT-2023, the patient experienced drug dose administration interval too long (Verbatim: Late dose two).  The outcome of the vesicular rash and pain were resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the vesicular rash and pain to be related to Shingrix.     It was unknown if the company considered the vesicular rash and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-OCT-2023 The pharmacist reported that the patient experienced lesions after dose one of Shingrix and received dose two 8 months after dose one. Pharmacist described lesions as shingles like and located on the interior of the arm that received the vaccination. The lesions appeared the day after she received the first dose of Shingrix. The lesions dried like vesicles and completely went away with no residual pain. Lot number and expiration date for dose two of Shingrix were not provided. Pharmacist noted the patient did not experience any reaction on the day after dose two. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The reporter consented to follow up.
Nerves in my face were jumping; Teeth occasionally chatter; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Nerves in my face were jumping) and CHILLS (Teeth occasionally chatter) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ROSUVASTATIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MUSCLE TWITCHING (Nerves in my face were jumping) and CHILLS (Teeth occasionally chatter). On 28-Jan-2021, MUSCLE TWITCHING (Nerves in my face were jumping) had resolved. At the time of the report, CHILLS (Teeth occasionally chatter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Patient states started with itching the evening after injection, started with stomach problems.  Pain loose bowel, 30 minutes after injection started with hives the evening after injection or the next day.  Has been taking allergy medication.  States shot caused yeast infection, treated with diflucan.
Neuropathy from the bottom of her feet to her bra line / Admitted into the ICU for three days; Fatigue; Pain; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In September 2015, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. In September 2015, 1 day after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced neuropathy (serious criteria hospitalization and GSK medically significant), fatigue (serious criteria hospitalization) and pain (serious criteria hospitalization). The patient was treated with morphine iv drip and pregabalin (Lyrica). On an unknown date, the outcome of the neuropathy, fatigue and pain were unknown.   It was unknown if the reporter considered the neuropathy, fatigue and pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. On Friday, the patient received Boostrix and by Saturday, fatigue had started and by Tuesday, she had Neuropathy from the bottom of her feet to her bra line. The patient was admitted into the ICU for three days. The patient was in such Pain, Morphine IV did not help. She was then prescribed Lyrica, and within three hours, she was able to be discharged. All information was not available. The reporter did not consent to follow-up.
Cellulitic induration around 10-15cm circumference around injection site. Rt arm > Lt arm.
This case was reported by a physician via call center representative and described the occurrence of rhabdomyolysis in a 21-year-old male patient who received ENGERIX B adult (batch number UNK, expiry date unknown). Concomitant products included dTpa vaccine. On 2nd December 2016, the patient received the 1st dose of ENGERIX B adult 1 ml. On an unknown date, the dose was an unknown dose. On 2nd December 2016, less than a day after receiving ENGERIX B adult, the patient experienced rhabdomyolysis (serious criteria hospitalization and GSK medically significant), myositis (serious criteria hospitalization) and generalized muscle aches (serious criteria hospitalization). On 4th December 2016, the patient experienced urine discoloration (serious criteria hospitalization). On 10th January 2017, the outcome of the rhabdomyolysis was recovered/resolved. On an unknown date, the outcome of myositis, generalized muscle aches and urine discoloration were recovered/resolved. It was unknown if the reporter considered the rhabdomyolysis, myositis, generalized muscle aches and urine discoloration to be related to ENGERIX B adult. Additional details were reported as follows: On 2nd December 2016, the patient received ENGERIX B and Tdap (brand unknown) vaccinations. On that day, the patient was also engaged in exercise including leg lifts and push-ups for approximately 20 minutes and was also involved in moving some furniture. The patient noted mild generalized muscle soreness over 2nd to 3rd December 2016. On 4th December 2016, the patient noted pink urine. By 5th December 2016, the patient described that his urine was having the appearance of motor oil. The patient presented to a hospital and was admitted and subsequently and diagnosed with rhabdomyolysis and myositis. The patient was having elevated blood creatine phosphokinase (159, 180), aspartate aminotransferase (1701), alanine aminotransferase (434) and white blood cell count (16,000). The patient was treated with fluids and standard care. The patient was discharged on 9th December 2016 with blood creatine phosphokinase (11,000), aspartate aminotransferase (368), and alanine aminotransferase (278). He was noted to be recuperated with no sequelae. According to the follow-up of 10th January 2017 the patient was cleared for full activity. The physician was unable to provide the lot number and expiration date of the ENGERIX B and the brand of Tdap administered or the details of the administration.
Info has been received from a health professional concerning a female pt who was vaccinated with a 1st dose pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given at the same time in the opposite arm, included a dose of influenza virus vaccine, "flu vaccine". Subsequently in approx Oct 2002, the pt developed a sore arm, and pain under right armpit. It was noted she could not lay on that side for a couple of days. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history or concomitants medications were reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot# L007225, expiration date 03-MAR-2017; lot # K006137, expiration date 29-APR-2016) (dosage schedules were not reported). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I have a fever of 100.5, general malaise, tired and want to go back to bed.
Severe redness, swelling, and itchiness in inner folds of left arm (from armpit to below her elbow) (not injection site). Patient went to ER and hospital in 2 separate visits. No bacterial infection was found in bloodwork. Antibiotics, antihistamines, anti-inflammatory and pain meds were given. Swelling and redness have gone down but patient will see primary doctor 10/12/18 to follow up. Both vaccines were given 1 inch apart on same  left deltoid as patient requested.
Chest pain; nose bleed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain) and EPISTAXIS (nose bleed) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included CARTHAMUS TINCTORIUS OIL, HYALURONIC ACID, NICOTINAMIDE (CERAVE ECZEMA CREAMY OIL), ASPIRIN [ACETYLSALICYLIC ACID], FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), MONTELUKAST, LOSARTAN, METOPROLOL and talopram for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain) and EPISTAXIS (nose bleed). At the time of the report, CHEST PAIN (Chest pain) and EPISTAXIS (nose bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to emergency room. Treatment details included Prednisone.
fever; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches) had resolved.            No concomitant medication information provided. No treatment medication information provided.   This case was linked to MOD-2021-019146 (Patient Link).
Initial and follow up information has been received via the Merck pregnancy registry, from a consumer concerning her 16 year old daughter who on 22-DEC-2006 was vaccinated with the first dose Gardasil (Lot #654885/1424F). Concomitant therapy included PROZAC. The date of the patient's LMP was approximately 11-JAN-2007 ("approximately 16 weeks pregnant"), though the patient was not aware that she was pregnant, and on 28-FEB-2007, she was vaccinated with the second dose of Gardasil. The estimated date of delivery was 18-OCT-2007. Follow up information from a healthcare professional (HCP), indicated that on 12-JUN-2007, an ultrasound was performed and was normal. The HCP noted that during the pregnancy, the patient had experienced multiple urinary tract infections that were treated with MACROBID (12-JUL-2007 and 04-OCT-2007), as well as preeclampsia (details not provided). On 03-AUG-2007, therapy with ZOLOFT was initiated for depression. On 27-OCT-2007, at 39 weeks after the LMP, a normal, female infant (weight not provided) was born. Following the delivery (time duration not specified), the infant had a seizure, and was sent to tertiary care center to evaluate if she had a seizure disorder. No etiology was found, and the infant had no recurrence of symptoms. No treatment was required. Upon internal review, seizure was considered to be serious as an other important medical event. Additional information is not expected.
pt called pharmacy on 080821 stating that a whelp or red swollen spot came up about 10 days after moderna vaccine--she has been treating with Zyrtec and seems to be better--also states her mother had a similar reaction but did not receive from us  --she will talk to her dr at her regularly scheduled appt  before getting second shot
fever to 102.8; This is a spontaneous report from a contactable (patient).  This 32-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 18Dec2020 at single dose for COVID-19 immunisation. The patient was vaccinated at Pharmacy or Drug Store. Age at vaccination was 32-years-old. No other vaccine was received in four weeks. Medical history and concomitant medications were unknown. About 20 hours after the first vaccine (Dec2020), the patient ran a fever to 102.8, lasted about 12 hours. Information on the Lot/Batch number has been requested.
Right arm above elbow red, warm and swollen since 10-3-13. Advised pt to alternate heat and cold compresses to affected area.
Baby delivered via emergency C Section at 32 weeks 5 days. Showing low heart rhythms and function. Born needing oxygen. Also born with cleft soft palette and bifurcated uvula.
Pain, swelling, itching and raised hives/welts on left upper thigh at injection site; Fever over 100.0 for 24+ hours.
My whole body, all my muscles and joints started hurting. painful to bend fingers, bend knees, walk and move. some swelling in my fingers. Charlie horses or muscle cramps that last a few minuets and make my body extremely sore  and painful for days after. Pharmacist said this is a side affect but should have been gone by now.  He told me to report to you.
A few hours after the injection I began to have fatigue which got increasingly worse throughout the day, at around 7 pm the night of my injection I had body aches and began feeling chilled. Around 9 pm I checked my temperature and had a 99.3 degree fever. Throughout the night my fever increased to 101.8 and stayed within 100-101.8 for the next 8 hours. The next day I discovered I had a full body rash. It appeared like leopard spots. It did not have any raised bumps and did not itch but was hot to the touch. The rash persisted for another 24 hours.