chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second dose of the Moderna Covid-19 Vaccine potentially on the 46th day; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose of the Moderna Covid-19 Vaccine potentially on the 46th day) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose of the Moderna Covid-19 Vaccine potentially on the 46th day). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose of the Moderna Covid-19 Vaccine potentially on the 46th day) outcome was unknown.        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 medication were provided. No treatment medication were provided. No lab data has been provided by the reporter.
Severe lowerback and kidney pain. Felt like I was freezing cold. Very Tired. Ibuprofen, Aleve, Tylenol.
I developed chronic urticaria/the hives got significantly worse.; I developed chronic urticaria/the hives got significantly worse.; I have also developed angioedema; This is a spontaneous report from a contactable consumer. This 31-year old female (no pregnant) consumer (patient) received 2nd dose of BNT162B2 (at the age of 31 years old) on an unspecific date at single dose for COVID-19 immunization. Medical history was Hypothyroid. No known allergies. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. Historical vaccine was 1st dose of BNT162B2 (Lot number=En6204), on 10Mar2021 04:00 AM in Left arm for covid-19 immunization. She developed chronic urticaria after first shot. It started appearing after 1 week (17Mar2021 02:00 PM) and after 10 days was there every single day (AER# 2021702659). By the time of the second shot I was on prednisone to control the hives, but stopped the day before to get the second shot. After the second shot, the hives got significantly worse. It has been 3 months and nothing is helping to stop the hives. She had also developed angioedema and now need to carry an epinephrine (EPIPEN). She had never had hives in her life and have never had any allergies. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). She had been on many medications to try and reduce. Outcome of the event was Not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information about lot/batch number has been requested.
bad case of shingles. Has had it three times now; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's roommate. The age at vaccination as not reported. After receiving 1st dose of shingles vaccine, the patient had a bad case of shingles a week after.  The reporter told the patient not to get the shots after seeing all the lawsuits and much study about it. The reporter further stated that the patient didn't listen and got shingles about a week after. Till the time of reporting, the patient had shingles three times.
Information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a baby whose mother was vaccinated with a first dose of GARDASIL (Lot# 660553/0070X) on 21-JUL-2009 and on 18-SEP-2008 was vaccinated with a second dose of GARDASIL (660616/0570X). The baby's mother LMP was on 20-AUG-2008. It was reported that the baby was born via c-section on 09-JUN-2009 (WAES# 0810USA02706). The baby's birth weight was 6 lbs 11oz. The nurse indicated that the baby had "intolerance to the labor" and problems with gastroesophageal reflux disease but otherwise "was a well baby, no congenital anomalies". At the time of this report, the outcome of the baby was unknown. Upon internal review intolerance to labor was considered to be an other important medical event. Additional information is not expected.
she cut the thumb of her right hand on the broken glass of a pre-filled GARDASIL 9 syringe; she cut the thumb of her right hand on the broken glass of a pre-filled GARDASIL 9 syringe; cut the thumb of her right hand on the broken glass; she bled a few drops of blood from the wound; This spontaneous report was received from a 51-year-old non-pregnant female nurse referring to herself. No information regarding her pertinent medical history and concomitant therapies was provided. No drug reactions or allergies were reported. On 27-JUN-2019, the patient cut her thumb of her right hand on the broken glass of a pre-filled hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1602283, expiration date: 18-AUG-2021 (also reported as 16-AUG-2021). No liquid got into the wound. She bled a few drops of blood from the wound and she washed out the wound with an unspecified antiseptic and then put a bandage on it. The patient did not seek medical attention and no laboratory diagnostics were performed. The finger flange itself was broken into 2 large pieces and multiple tiny shards, but he liquid was still inside the syringe. The defect was noticed while the syringe was still in the tray, there was broken glass, the finger and no liquid in the tray. There was a measurable amount of liquid remaining in the syringe. No crack was reported. The finger flange was reported as broken off. It was reported the syringe tip/needle attachment was not affected and the syringe tip or luer lock was not loose nor broken off. The syringe tip cap was attached properly prior to use, the syringe tray and the cellophane cover of the syringe tray were intact and the syringe carton was not damaged. The outcome of product quality issue and syringe issue was unknown. The outcome of events of skin laceration and wound haemorrhage was reported as not recovered. The relatedness between the events and the vaccine was not reported.
Three hours after the vaccine until ten days after the shot. I felt pain from the middle of my back on up to my neck. It was like whip lash. I did have an injury from a car accident about ten years ago. I had muscle pain around my shoulder area and my whole upper back 11pm the night of the shot I had a fever. I still had joint pain but I had to leave work with a headache joint pain and a low grade fever. After two days the headaches were less severe. I had joint pain that was mainly in my hands like arthritis all the way down to my fingers. My fingers were also swollen. Tylenol seemed to keep the pain under control. This lasted for ten days after it slowly went away.
Information has been received from a nurse practitioner concerning a 60 year old male patient with a history of Human immunodeficiency virus exposure 20 years ago and no drug reactions or allergies who on 02-Jan-2009 was vaccinated SC with one dose of ZOSTAVAX (Oka/Merck) (Lot#662859 / 1561X) . Concomitant therapy included acyclovir. Subsequently the patient had developed shingles. The Nurse practitioner was notified on 13-Jan-2009 that the patient had developed a rash and had gone to see the Dermatologist who diagnosed him. There were no Laboratory Diagnostic Studies performed. At the time on the report on 14-Jan-2008 the patient was not recovered. The patient sought medical attention with an office visit to a dermatologist. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a Nurse Practitoner concerning a 60 year old male patient with a history of Human immunodeficiency virus exposure 20 years ago and no drug reactions or allergies who on 02-JAN-2009 was vaccinated SC with one dose of ZOSTAVAX (Merck) (Lot # 662859/1561X).  Concomitant therapy included ACYCLOVIR.  Subsequently the patient had developed shingles.  The Nurse Practitioner was notified on 13-JAN-2009 that the patient had developed a rash and had gone to see the Dermatologist who diagnosed him.  There were no Laboratory Diagnostics Studies performed.  At the time of the report on 14-JAN-2008 the patient was not recovered.  The patient sought medical attention with an office visit to a Dermatologist.  Additional information is not expected.  Attempts to obtain follow-up information have been unsuccessful.
Lightheaded/Dizziness within a few minutes of injection; This is spontaneous report from a contactable healthcare professional. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EN6205, unknown expiration), intramuscular in right arm on 26Feb2021 12:00 PM at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced lightheaded/dizziness within a few minutes of injection on 26Feb2021 at 12:00 PM.  The event resulted in emergency room/department or urgent care visit. The patient received unspecified treatment for the event following evaluation/transport to hospital. It was unknown if the patient received other vaccine in four weeks. It was unknown if patient had COVID prior to vaccination and if tested for COVID post vaccination. Outcome of the event was unknown. The event was assessed as serious (hospitalization).   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event dizziness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This is a spontaneous report by a contactable pharmacist via a Pfizer Sales Representative reported on behalf of a female pharmacist in regards to PREVNAR 13. This pharmacist mentioned that on 29Oct2012 "10 doses of PREVNAR 13 were stored in freezer instead of refrigerator". At the time of report PREVNAR 13 was not used by the patient, hence no patient involved. Follow Up (19Nov2012): This is a follow up spontaneous report from a contactable reporter who was calling on behalf of the Pharmacist. This follow up report is a result of a letter received by the Pharmacist from Pfizer. New information: No new adverse event was reported. The reporter wanted to know why they have received this letter from Pfizer. Follow Up (26Nov2012): New information received from a contactable other HCP on behalf of the Pharmacist included: product never left the store. Never used never dispensed. The PREVNAR 13 was received into the store and by accident was placed in the Freezer. The product was never used/never dispensed. Lot # F45119 Exp: Feb2014. Follow-up attempts completed. No further information expected.
This case was reported by a physician and described the occurrence of erythematous rash in unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO at an unknown dose. On an unknown date, several days after receiving BEXSERO, the patients experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the erythematous rash to be related to BEXSERO. Additional details were provided as follows: The reported stated about several reports of bilateral erythematous rash presenting on both upper deltoids of an unspecified number of patients within days after vaccination with BEXSERO. This case has been linked to case US2016GSK019838.
First night (February 23, 2021) had severe pain in left arm. A red rash/welt/lump 2 inches in diameter appeared. I began antihistamine on Day 2 and saw a halt to the growth of the reaction. Over the next few days I continued the antihistamine and saw a slow reduction in symptoms. Then on March 1 an itchy rash appeared in the same 2in diameter area. This looked different in that instead of a smooth reddish appearance, there were lots of red bumps. Resumed antihistamines and added hydrocortisone cream, but the rash did not respond and has since grown to 3 inches in diameter.
Body ache; Headache; Fatigue; A spontaneous report was received from a nurse who was an 51-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches, headache and fatigue.  The patient's medical history included history of autoimmune disorder. No concomitant medications were reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On the same night, the patient experienced body aches, headache and fatigue.  On 06 Jan 2021, it was reported that the symptoms became severe. Treatment for the events included Tylenol.  She was due for the second shot of the vaccine in the first week of February.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, body aches, headache and fatigue was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Patient received the Pfizer COVID-19 vaccine on 3/8/21 (first dose) in the left arm.  She woke next morning with blisters on the left hand, then developed widespread pruritis that only involved the left side of the body.  Had swelling around left eye.  No frank hives, no SOB or dyspnea.  Treated in ER with oral Benadryl.  Now 1 week later, she still has itching throughout the entire left side, from scalp down to feet. Still taking Benadryl once daily now.  Wondering about whether to get the second vaccine.
Uncontrollable crying, unconsolable, swollen leg, and very warm to the touch.
Initial information received on 14-Sep-2014 regarding an unsolicited valid serious case received from a nurse via phone. This case involves a 73 years old male patient who experienced diagnosed as having a UTI and treated with intravascular (iv) leviquin and admitted to the hospital, while he received vaccine FLUZONE HIGH DOSE. It was reported that patient had the same flu shot last year without issues. The patient's other past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1995AA, expiry day 01 April 2019, via intramuscular route in the right deltoid. On an unspecified date, next day post vaccination complaint fever (pyrexia), nausea, vomiting, body ache (pain) and later patient went to emergency room and was diagnosed as UTI (Urinary tract infection). On an unspecified date, patient was hospitalized for this events. Lab data not reported. Final diagnosis was diagnosed as having a UTI. The patient was treated with LEVOFLOXACIN (LEVAQUIN). The event outcome was reported as unknown.; Sender's Comments: This case concerns an elderly patient who was diagnosed with Urinary Tract Infection on an unknown date after vaccination with FLUZONE High Dose vaccine. Considering the unknown latency, age of the patient and the nature of the event, the role of the vaccine is unlikely.
patient received the vaccine. patient was just fine for like 10-15 mins or so. When it was about time for them to leave, he stood up and thats when his mother called for help that he wasnt feeling well. he laid down on the floor for a little bit but then sat back up and sat back on the chair and said he was feeling better. i asked if they wanted us to call 911 and the mom said no. then, the patient said he had to vomit so we asked where he would like to vomit the bathroom is right next to him. patient chose to walk to bathroom and threw up a couple times. patient felt more dizzy/faint in the bathroom so the mother said please call 911 so we did. we sat with patient sitting on a chair for a couple mins and offered little cup of water. tried to talk to the patient and see if he was conscious. patient was responding to questions mom asked in another language. then, the paramedics arrived and put patient on a stretcher and said he seemed ok but was going to take him to hospital just in case. patient was breathing fine and not shaking.
strong metal taste in mouth and throat; dizzy; miserable for 3 weeks; nauseas; extreme tiredness; vaccine was very cold and she could feel it going in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE COLDNESS (vaccine was very cold and she could feel it going in), DYSGEUSIA (strong metal taste in mouth and throat), DIZZINESS (dizzy), FEELING ABNORMAL (miserable for 3 weeks) and NAUSEA (nauseas) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE COLDNESS (vaccine was very cold and she could feel it going in). On an unknown date, the patient experienced DYSGEUSIA (strong metal taste in mouth and throat), DIZZINESS (dizzy), FEELING ABNORMAL (miserable for 3 weeks), NAUSEA (nauseas) and FATIGUE (extreme tiredness). At the time of the report, VACCINATION SITE COLDNESS (vaccine was very cold and she could feel it going in), DYSGEUSIA (strong metal taste in mouth and throat), DIZZINESS (dizzy), FEELING ABNORMAL (miserable for 3 weeks), NAUSEA (nauseas) and FATIGUE (extreme tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Left ear keeps plugging up and interfering with my hearing. Right ear isn't as bad as the left one.n/
Chills; Fever; Body aches; pounding horrible headache; Unable to sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: FP6955) via an unspecified route of administration on 22Mar2021 at 11:30, (at the age of 44- years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, eczema, seasonal allergies. The patient was allergic to Brazil nuts. The concomitant medication included ibuprofen (MANUFRATURER UNKNOWN) as needed, but not on the day of (unspecified). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 22Mar2021 at 23.30 (12 hours after jab), the patient experienced chills alternating with fever, body aches, pounding horrible headache, unable to sleep (waking every hour) which lasted until 36 hours after jab. The patient did not receive any treatment for reported events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of chills, fever, headache, body aches and unable to sleep was resolved on 24Mar2021.   No follow-up attempts are possible. No further information is expected.
Headache and body aches beginning about 18 hours after vaccination and lasting approximately 36 hours.
Pt received PENTACEL and PCV-13 on left leg, non stop crying, swelling and redness noted from knee to mid thigh.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 22-JUL-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reproter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reproter. Additional information has been requested.
Shot administered pt looked at needle as shot was being given after child stiffened up, wouldn't talk et eyes appeared unfocused. The event lasted approximately 15-20 secs then child refocused his eyes et sat on mom's lap answered questions appropriately was pale et a little sleepy. Cool, wet washcloth to forehead, ambulated ok denied any c/o's. Was not incontinent.
On Day 11 after the MMR shot, my neck lymph nodes got enlarged and painful. Shortly after, I got a mild rash. This didn't concern me too much. However, since 05/01/2010 - currently, I've been experiencing severe arthritis issues in all joints (fingers, wrists, feet, knees). I was given prednisone by my PCP for 10 days which helped, however, I have fluids accumulated in my joints (especially my left knee), it's still swollen. I've been limping for the past 3 weeks, due to swelling and pain / discomfort, not able to bend my knee or do much of any activities. There has not been any injury of any kind. I understand that especially women often have these side effects (painful and swollen joints - rubella part of the vaccine), based on the research I did.
pt recv vax & w/in 24hr pt exp acute bilateral parotitis;w/in the next hr pt exp excruciating epigastric pain that radiated through to the back & was assoc w/inc elevation of pancreatic amylase & lipase;dx acute pancreatitis;
Red, swollen, itchy, hot welts at the injection site and the area around the injection site. muscular paine.  fever. headache.  nausea.