chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has not received second dose and more than 42 days have passed; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received second dose and more than 42 days have passed) 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 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received second dose and more than 42 days have passed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received second dose and more than 42 days have passed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
I RECEIVED THE FLU VACINATION AND A PNUEMONIA VACINCATION IN THE LEFT SHOULDER AT THE SAME TIME. AROUND 1:30PM ON 10/27/06. ABOUT 2 HOURS AFTER THE SHOTS MY ARM BECAME INCREASINGLY SORE.  THE SORENESS STARTED IN THE SHOULDER BUT OVER THE COURSE OF THE EVENING SPREAD TO THE ENTIRE LEFT ARM, ARMPIT, LEFT SIDE OF TORSO AND LEFT SIDE OF NECK UP TO BELOW THE LEFT EAR. I HAD LOW FEVER ON THE EVENING OF THE SHOT AND THE FOLLOWING MORNING AND NAUSEA (HOWEVER NO VOMITING).  I HAVE NOT HAD MUCH OF AN APPETITE FOR THE LAST 3 DAYS BUT THE OTHER SYMTOMS HAVE IMPROVED. SHOTS WERE GIVEN BY VISITING NURSES - PAID FOR BY MY EMPLOYER.
Patient states she woke up to go to bathroom @ about 4am and fell down, her right side gave out on her, she was having a very bad headache and then was having difficutly using right arm and leg.  She was taken to hospital and currenly in hospital.  She is told she had a stroke.  Today she is saying she is now having double vision, which is new.  She is planning on going Rehab.
Heat, rash, and swelling of face, tongue sensitivity, throat swelling and difficulty swallowing, fever, abdominal pain, pupil dilation.
[Casirivimab/indevimab] treatment under Emergency Use Authorization(EUA): Infusion started at 9:45 and was stopped at 11:00. At 11:30 Patient developed SOB and drop in Sat from >96% to 88%. Patient had a large cough and expectorated a quarter size of brown phlegm. Code blue was activated, patient placed on NRB 180/81, 72, 24, 91%. Patient was AAOx3 and talking during this time. Patient transferred to the ER gurney and transported to ER for further evaluation. From H&P: tested positive for COVID-19 outside facility on 1/22 w/onset of covid sxs on 1/18 after returning from hunting trip with son on 1/17. Patient s/p Moderna vaccine #1 on 1/14/2021. Initially symptoms were just fatigue, cough, and chills and then spiked low grade fever on 1/20. Patient began to experience weakness and difficulty walking on 1/24 and fell from standing on 1/25 and possibly hit his head but without LOC. Patient presented to ED complaining of SOB that began after receiving monolconal antibodies about an hour PTA. Patient states that prior to the infusion, he was not feeling overly short of breath. After the transfusion, a code blue was called in the parking lot due to the patient becoming light-headed and short of breath - he never lost pulses. Upon arrival to the ED, he was in obvious respiratory distress and O2 sats were 92% on 15L NRB and patient switched to BIPAP. Patient given dose of epinephrine injection,after which he states he began feeling better.
Fever & chills started 12 hrs after injection.  Temp to 102.5 degrees F.  Taking TYLENOL & ADVIL.  Headache.  Flushed on face.  Arm warm to touch & slightly pinkish.
Pt had reaction to PNEUMOVAX vaccine given. Contacted office on 7/25/14. Pt states she went out to town the morning following appointment. Noticed pain, lump and redness around 7pm the evening of the vaccine. Next day pt states arm was red down to elbow, hot, swollen and she was unable to raise. Patient was out of town and instructed to go to ER. States she was treated with BENADRYL and given a regimen of Clindamycin. States arm is improving as of 7/25/14. Follow up appointment given for 7/29/14 at 11:45 AM with PCP.
Went in for my booster dose (3rd vaccine) of Pfizer. Jab went in arm around 11:00am on 01/05/2022. First and second in series were moderna. 2nd moderna I got was back on 03/30/2021. Waited 30 minutes felt fine. As soon as I got home 10 minutes later I felt a lot of acid build up in my stomach. I had a full breakfast 2 hours before the vaccine. However acid build up made me strangely and unusually hungry. Was like that every 3 hours or so which I?ve NEVER had stomach acid before or been this hungry. I have never smoked pot or cigarettes. That?s all until around hour 12 at around 11:00pm I started to develop a low grade fever and extreme body pain from head to toe that woke me up and kept me up. Tylenol relieved some what but not completely. Next morning around 8am on the 6th still in excruciating body pain all over even my thighs butt and legs like pain I?ve never felt. Tylenol helped. Took 2 extra strength Tylenol maybe once every 5 - 8 hours since 11pm on the 5th. However morning of the 6th I developed a weird single cough that would happen once every 10 minutes or so. Other than body pain I felt fine otherwise. Started feeling I?ll around 2:30pm took a hot bath and was fine  helped body aches. All body aches were gone everything was completely back to normal at Around 5:30pm on January 6 with still occasional low grade fever that went back to normal with Tylenol but also still had that single weird one cough. At 1:30am on January 7th I woke up  with a 100.3 low grade fever. Previous to that I just had around 99.9 on average.  Took Tylenol didn?t really help. Cough got worse acid in stomach got worse started hacking up yellow mucus occasionally making it feel like I had throw up. Tylenol kicked in around 5:30am went back to sleep. Same cough and acid but fine until 11:30pm on January 7th where I no longer feel hungry turned off by food and actually ended up feeling nauseous and throwing it up. Currently super  tired probably from lack of sleep
No Adverse effects noted. Resident administered expired Moderna vaccine, expired on 10/13/2021.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 13-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Fever, chills,diarrhea, extreme soreness at site of vaccine, painful joint aches,headache, loss of appetite, fatigue.
Hive like rash , onset 7/7, waxing and waning, persistent as of 7/10/2021
C/O Few seconds L chest sensation, lightheaded.  "I thought it was a muscle flutter" 1 hour after receiving HPV # 3.  Today, 1 day later, C/O "my heart is racing.  Pulse 105 and regular.
Information rec'd reports pt noted vaccine made my body turn against my spinal cord and it started swelling and I am lucky to be able to walk and talk again. almost died from the reaction.
Information has been received that indicated the patient developed varicella lesions beginning with a few and increasing to 25. On 09/01/2000 the patient developed a rash on his right arm. Over the next several days, the rash continued to develop and spread. On 09/04/2000, the patient was seen by a physician who reported that the patient had vesicular and scabbed lesions on his face, scalp, inside his mouth and throat including 1 lesion on his left anterior tonsil, right arm, trunk, and penis. The patient's fever was reported to be as high as 104F on approximately 09/03/2000. The patient has no other signs or symptoms. The physician indicated that the patient's mother and brother have both been recently diagnosed with hepatitis A. The patient was also currently in the process of being evaluated for hepatitis A with test results pending. Subsequently, the patient recovered. Additional information has been requested.
Redness, swelling, not itching, very sore, ripple around red area.
Stroke, severe cramps in legs and hands, imbalance, back pain, loss of movement left hand. Stroke.
Patient spoke to pharmacist 11.24.17. She woke up on 11.12.17 and could not walk due to extreme weakness in both legs, fine tremors, tingling at base of spine. Patient has always walked with walker since onset of multiple sclerosis. She states she has not had an attack since 1997, and has been getting seasonal influenza vaccines since about age 60 years old. Since 11/12/2017, she states her walking and standing is slowing improving, and fine tremor, pressure at spine is not as intense. Per conversation with pharmacist 11/24.17. Patient has not seen her PMD, states he cannot resolve the adverse event. States symptoms have been resolving since 11.12.2017.
Serve soreness in the shot location, pain radiates to my left side neck, chills, fatigue, body aches, mild headache
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 20May2023, outcome "recovering"; DRUG INEFFECTIVE (medically significant) with onset 20May2023, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The individual tested positive for COVID (first time) on 20May2023, and noted sore throat, head and joint pain, and flu-like symptoms The individual has taken NSAIDs (eg: Aleve) for pain, but not Paxlovid. Patient did not had covid prior vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199240 same patient/drug, different dose/event;
Sore arm; almost fainted; headache about 18 hours after shot; Currently Pregnant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Nov2021 14:30 (Lot number: FH 3527) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 26Aug2021. The patient was 11 weeks pregnant at the time of exposure to BNT162B2; 9 weeks pregnant to influenza vaccine. The patient was 11 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 02Jun2022. Concomitant medication(s) included: FLU taken for immunisation, administration date 03Nov2021; MAGNESIUM; VITAMIN D [VITAMIN D NOS]; VITAMIN B6. Vaccination history included: Bnt162b2 (Dose 1, Lot number: ER 8730, Administration time: 07:30PM, Vaccine location: Left arm), administration date: 26Mar2021, when the patient was 30 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, Lot number: 8734 ER, Administration time: 07:30PM, Vaccine location: Left arm), administration date: 16Apr2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 16Nov2021 08:30, outcome "recovering", described as "headache about 18 hours after shot"; PAIN IN EXTREMITY (non-serious) with onset 16Nov2021 14:45, outcome "recovering", described as "Sore arm"; PRESYNCOPE (non-serious) with onset 16Nov2021 14:45, outcome "recovering", described as "almost fainted"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 15Nov2021 14:30, outcome "unknown", described as "Currently Pregnant". Therapeutic measures were not taken as a result of headache, pain in extremity, presyncope. Additional information: The patient is currently pregnant and taking prenatal vitamin. Allergies were unknown. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 post vaccination.
Information was received on 30-JUN-2017 from a pharmacist regarding a male patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. The patient was administered three doses of ZOSTAVAX. The first dose was given on 17-OCT-2014 (lot # K009769, unspecified expiration date); the second dose was given 24-SEP-2015 (lot # L015417, expiration date 01-AUG-2016); and the third dose was given on 04-JAN-2017 (lot # M035695, expiration date 07-NOV-2017). No adverse effects were reported. The outcome of the events were unknown. No further information was provided. Additional information has been requested.
like by day 5 I'm dying or getting close to it; tired/exhausted/disabling fatigue; joint pain; heat; fevers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing), notes: I've had this disease for 18 years but I'm working full time I'm so grateful for Xeljanz. The patient's concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "like by day 5 I'm dying or getting close to it"; FATIGUE (non-serious), outcome "unknown", described as "tired/exhausted/disabling fatigue"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; FEELING HOT (non-serious), outcome "unknown", described as "heat"; PYREXIA (non-serious), outcome "unknown", described as "fevers". Clinical course: A 64-year-old RA patient that had this disease for 18 years but working full time. Every time she got a vaccine, she had to go 8 without Xeljanz and methotrexate and all the other stuff. So, she knew like by day 5 she was dying or getting close to it, like she was feeling it. She really can't. She was really tired, exhausted. She had disabling fatigue. She had joint, she don't had deformities. She had joint pain. She had (inaudible) nodes, heat and fevers.  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-202201151993 Same patient, different drug/ event;US-PFIZER INC-PV202300118874 Same patient, different drug/ event;
Received Hepatitis B vaccine Friday afternoon. When awoke Saturday am, had a raised flesh-colored rash over lower extremities. C/o itching rash now on shoulders, chest and neck. Some relief with Benadryl,
Admitted to hospital for GI bleed and tested for COVID on 5/4/22 prior to transfer to another hospital- Tested positive for COVID and has been coughing. Treatment includes: Paxlovid.
gallbladder attack; This is a spontaneous report received from a contactable reporter (Physician).  A 73-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 23Feb2021 16:20 (Lot number: EM6203) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "sulfa" (unspecified if ongoing); "hypertension" (ongoing); "TIA" (ongoing); "Diabetes Mellitus Type 2" (ongoing); "allergic rhinitis" (ongoing); "Type 2 HSV infection" (unspecified if ongoing). Family history included: "breast cancer" (unspecified if ongoing). Concomitant medications included: ATORVASTATIN CALCIUM, start date: 09Jun2018; IBUPROFEN; NYSTATIN POWDER, start date: 08Mar2021; PANTOPRAZOLE; VALTREX; LISINOPRIL; AMLODIPINE; METOPROLOL; JANUVIA [SITAGLIPTIN PHOSPHATE], start date: 11Sep2020; METFORMIN. Vaccination history included: Bnt162b2 (Dose 1, single; Date and Time: 02Feb2021 16:20; Site and Route of Injection: Left Deltoid, Intramuscular; Batch/Lot No- EM9810), administration date: 02Feb2021, when the patient was 73 years old, for COVID-19 Immunisation, reaction: "Lump under left Armpit". The following information was reported: GALLBLADDER DISORDER (non-serious) with onset 23Feb2021, outcome "recovered" (2021), described as "gallbladder attack". Therapeutic measures were not taken as a result of gallbladder disorder.  The reporter considered "gallbladder attack" not related to bnt162b2.  Additional Information: Vaccination Facility Type was reported as "Other". The event gallbladder attack was reported as non-serious. The patient provided information to the reporter regarding the reported adverse event with the use of the product. The reporter considered the Pfizer Product had no causal effect to the adverse event. The patient received no prior vaccinations and had no relevant tests done.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The event gallbladder disorder considered as intercurrent condition and unrelated to product bnt162b2 (BNT162B2).,Linked Report(s) : US-PFIZER INC-2021123466 Same patient and product; Different dose and event.
4/13/21  - 7pm Developed confusion and amnesia noted by husband. Taken to local ER where tests showed small acute stroke left temporal lobe and previous (3-4 weeks prior) small stroke right temporal lobe. Hospitalized for 2 days.  No neurological deficits.  No previous signs or symptoms of stroke prior to 4/13.  Wt. 137 lbs,  ht  5"7;  normal sinus rhythm.
This is a spontaneous report from a contactable pharmacist. A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, at single dose, on unknown date. Relevant medical history was not reported. Concomitant medication included a shot of Flu vaccine, via an unspecified route of administration, administered the same day of PREVNAR 13. The year before the patient received PREVNAR 13 and Flu vaccine and her arm popped up a little bit. The patient experienced vision changes, and blurry vision the next morning of vaccination, on an unspecified date. Outcome of events was unknown. Follow-up (12Dec2014, 15Dec2014): New information received from a contactable pharmacist includes: patient's gender, event blurred vision detail, concomitant influenza vaccine added, previous vaccination. Follow-up (06Feb2015): Follow-up attempts completed. No further information expected.
Felt a little nauseated, tired, and her arm was sore. She slept in. She also reported and rash that seemed to be around the vaccination site. No complaints of swelling of the face/tongue/airway. No reaction to previous vaccinations in the past.
Blurry vision; Arm pain; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), PAIN IN EXTREMITY (Arm pain), MYALGIA (Body aches) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurry vision), PAIN IN EXTREMITY (Arm pain), MYALGIA (Body aches) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Blurry vision), PAIN IN EXTREMITY (Arm pain), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.            Concomitants were not reported.   Reporter did not allow further contact
unknown amount of patients may have received doses of vials of the Moderna COVID19 vaccine after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (unknown amount of patients may have received doses of vials of the Moderna COVID19 vaccine after 30-day Use By Date) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (unknown amount of patients may have received doses of vials of the Moderna COVID19 vaccine after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (unknown amount of patients may have received doses of vials of the Moderna COVID19 vaccine after 30-day Use By Date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants and treatment drugs are provided.