chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two patients were given temp excursion vaccine vial; 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 PRODUCT STORAGE ERROR (Two patients were given temp excursion vaccine vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 PRODUCT STORAGE ERROR (Two patients were given temp excursion vaccine vial). At the time of the report, PRODUCT STORAGE ERROR (Two patients were given temp excursion vaccine vial) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   2 patients were given each a dose of excursion vials.  No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-156255 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-156255:
Fever; couldn't get out of the bed; aches and chills; chills; didn't eat anything for two days; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 03Mar2021 at 12:00 (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as dose 2, single (at the age of 74-years-old) for Covid-19 immunisation. Medical history included triple bypass at least 10 years, Penicillin allergy and has had the allergy since 2000 (he does not have NDC, lot, and expiry to provide for Penicillin), rotator cuff problems on both shoulders, and Parkinson's with no investigation assessment. Concomitant medications included a bunch of stuff (takes 14 different medication) and a list is in his wallet in his car in the garage. He doesn't have his list with him to provide medication names. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the right arm on 02Feb2021 (Batch/Lot Number: EL9266; Expiration Date: May2021) as dose 1, single (at the age of 74-years-old) for Covid-19 immunisation. The patient wanted to complain about the shot he got. It was the second COVID-19 vaccine. He got the shot on a Wednesday at noonish. He couldn't get out of the bed on Thursday (04Mar2021). He had fever of 100 to 101 around 6AM. He had aches and chills and he didn't eat anything for two days. He didn't eat anything much for two days. It was on Saturday before he felt like he could get up and then Monday before he was feeling better. By 08Mar2021, everything had resolved. He is not sure if he lost weight or not, weighs between 176 and 177 pounds. The patient underwent lab tests and procedures which included body temperature: fever of 100 to 101 on 04Mar2021. The patient recovered from the events on 08Mar2021.  No follow-up attempts are possible. No further information is expected.
I was given number 1of2 SHINGRIX Vaccine at about 11AM. (I have NOT taken the 2nd shot; nor will I take it). I experienced a some itching at the site of the shot but later I woke up from sleeping with really bad itching and red lumps/bumps on my left arm, hands, back and neck. I took some BENADRYL. The BENADRYL helped a little bit. The following morning I called my doctor, and he called in a 5-day prescription of prednisone and told me to use a CORTIZONE cream. While taking the prednisone the itching subsided but the lumps and bumps did not go away. After I finished the prednisone the itching came back and more fresh lumps and bumps on arm, back, neck, ear, eye, face and head; bumps are painful and very itchy. Again, I called and got an appointment with Dr and he gave 5 more days of prednisone and a prescription CORTIZONE cream. Same results, while on the pills I was fine but after the pills, more itching. I then went to a minor emergency clinic and he examined me, gave me 9 day prescription of prednisone, a stronger cream and recommended XYZAL. He also recommended I go to a Dermatologist. I was fine while on the prednisone; however after prednisone was finished the itching returned within a day; new lumps and bumps all over. Dr recommended I take ALLEGRA during the day and BENADRYL at night. Dr. did a biopsy. He said the results showed it was a reaction to the SHINGRIX shot. Dr said maybe some of the medicines that I was on did not agree with the SHINGRIX shot so he took me off the Pravastatin and replaces with Ezetimibe. He also replaced the Lisinopril with Bisoprolol. He told me to continue the ALLEGRA/ZYRTEC and BENADRYL. Dr. gave me another prescription for a Clobetasol Propionate Emollient cream. He referred me to an allergy doctor. The bumps and lumps were still there. When I was able to get in to Dr., he did blood work to see if something else was going on, he said the results showed that all lab results were normal. Dr. recommended I see a dermatologist, Dr. She said it looked like bites to her, however she did another biopsy on a couple of the bumps/lumps. When I went back to see Dr., she said the pathologist wrote in bold letters "This is a reaction to the SHINGRIX Shot". She suggested I continue with the ALLEGRA/ZYRTEC and BENADRYL and the cream until they could figure out what to do next. She said she would call Drs. to see what to do next. Nothing really helps. The itching and breaking out with lumps and bumps still happen and it is quite annoying. What can we do to make it stop? It has been 4 months now. When will it go away?
This spontaneous report was received form a certified medical assistant refers to an approximately 5 years old female patient with no drug reactions or allergies who on 25-MAR-1996, was vaccinated with the first dose of MMR II and on 21-AUG-2000, was vaccinated with the second dose of MMR II (doses, routes and lot numbers not reported), No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that on an unknown date, the patient showed no immunity for measles after completing the two doses of MMR II. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The relatedness for patient showed no immunity for measles after completing two doses of MMR was unknown for MMR II. Additional information has been requested.
Combined initial and follow up report received from consumer (patient's daughter) on 05 Jul 2010 and 06 Jul 2010: This patient with a medical history of heart failure since 10 years received H1N1 influenza virus vaccine (unknown manufacturer and batch number) on 30 Apr 2010. The reporter believed that the patient also received seasonal influenza vaccine (unknown manufacturer and batch number) on 30 Apr 2010. The patient received both vaccines in public health center. On 03 May 2010, the patient presented with symptoms of strong flu described as body pain, a lot of dry cough and heavy lung. The reporter described heavy lung as difficult to breath and without secretion. According to reporter, the symptoms experienced by patient got worse until 08 Jun 2010. On 08 Jun 2010, the patient presented with ear infection which was treated with an antibiotic (unspecified). On 10 Jun 2010, the patient experienced lung infection and had used ciprofloxacin (unknown manufacturer) two tablets a day for one week. On 11 Jun 2010, the patient was hospitalized due to ear infection and on 14 Jun 2010, he was discharged. On 14 Jun 2010, the patient did not present with cough or heavy lung. On 21 Jun 2010, the patient did not experience ear infection or lung infection, anymore. The body pain remained but the reporter did not know whether this pain was due to vaccine or state of weakness of the patient and the patient also presented with walking difficulty. On 02 Jul 2010, the patient was hospitalized due to labyrinthitis. The patient used diazepam (unknown manufacturer) to treat labyrinthitis. The patient lost 7 kg weight, approximately. On 04 Jul 2010 in the morning, the patient presented with an infarction which was confirmed through exams done on 04 Jul 2010 at night. According to physicians, the symptoms presented by patient were not associated with vaccine. The patient was discharged on 05 Jul 2010. The reporter did not remember of name and contact of the physicians who attended the patient. On 06 Jul 2010, the patient was recovering from infarction and the physician informed that he would be recovered from labyrinthitis till 16 Jul 2010.
This spontaneous report as received from a physician refers to multiple patients (age and gender not specified). Concurrent conditions, medical history and concomitant medication use were not provided. The physician reported that on 07-JUL-2016, 11-JUL-2016, 12-JUL-2016 and 13-JUL-2016 an unspecified number patients were vaccinated with M-M-R II (lot # L032044, expiration date 24-AUG-2017) that was improperly stored. No adverse effects were reported. No further information was provided. Additional information is not expected.
Information has been received from a physician concerning a 14 year old female patient who on approximately 06-FEB-2008 (reported as "sometime last week") was vaccinated with a dose of GARDASIL (lot # not reported).  The physician reported that patient who received the GARDASIL injection had "walked outside of the office and passed out a couple of times."  She was taken to the emergency room (ER).  The patient recovered on an unspecified day.  No further information was provided.  Additional information has been requested.
I started get chills and sweating around 6pm when I woke up from a nap. I was still tired so I went back to sleep after a hour or two.  I woke up again in a few hours with worse chills, minor headache, and minor joint pain. I took over the counter medication, felt a little better and went back to sleep after a few hours. I woke up around 4am to use the bathroom and still had the worse chills, sweats, minor headache and was very dizzy. I decided to lay down on a rug rather than try to make it back to my bed and laid awake for a few hours again I woke up again in a few hours a little better and repeated everything until Sunday night when all my symptoms were very mild. I eat and drank water regularly and took over the counter acetaminophen a few times.
At 10 PM parents reported increased screaming;  fever 102 degrees with diff. reading temp.;  shaking;  taken to Hospital Dx vaccine reaction.
Follow-up information received 01/26/10. No Adverse Events. Pt simply got a second seasonal flu vacc. Vaccine was given 12-2-09 at about 10:15 am.
Bad headache, can?t stand my leg are wobbly, shivering, sleeping all day Fatigue
Around 8 o?clock the evening of my second Moderna vaccine I began to shake, felt like vomiting, my temperature went up to 101.9, my heart rate was 93 and my blood pressure was 150/93. Called Doctor after hours number and they told me to drink lots of water and take Tylenol.  This lasted till the next morning when I was able to take a Tylenol and woke up with 100 degree fever. Kept taking Tylenol was able to eat a bit and couldn?t move that day.  Still is experiencing diarrhea and weight loss Along with brain fog.
March 1, 12:30 Vaccination -  March 3 Severe Exhaustion - Spacy and slight headaches for about two hours.  Joint pains.  additional and more severe pain in right hand joins. March 4- Exhaustion March 5 - tired March 6 - Severe Exhaustion and mid-day became vomiting and upset stomach for one hour - severe exhaustion after
Patient received his first dose of Pfizer COVID-19 vaccine and about ten minutes after, he reported light-headedness and felt cold. Shortly after, he started throwing up. He felt better after throwing up and had paramedics check him before he was safely released to go home from the pharmacy.
Information has been received from a medical assistant concerning a (approx.) 13 year old female who was not taking concomitant medications and was vaccinated (date, route and site not reported) with the 1st dose of GARDASIL (lot# not reported). On an unspecified date, the patient experienced abnormal periods. The patient's mother stated that after the 1st dose was received the patient periods became irregular. The patient did not receive medical attention via hospitalization nor an office visit. Additional information has been requested.
Previously gave flushot on 9/8/17. While giving flushots at physician Friday meeting Dr. got a flushot - not remembering she had already had a flushot.
Patient received the second dose of Moderna vaccine on 4/1/21. Approximately 5 days afterwards he began to have a headache. This lingered and progressed to the point that presented to the emergency room. A CT head revealed cerebral venous sinus thrombosis. No evidence of thrombocytopenia but notably, the patient's platelets clump.
Approximately 4-5 minutes after receiving Fluzone vaccine, client fell and hit head on floor.  Client appeared to exhibit seizure-like activity (eyes rolling back of head, p?) for approximately 20 seconds.  After 20 seconds, client tried to focus eyes but could not.  EMS called and arrived in 5 minutes.  Speak coherently for 1-2 minutes.  Pulse 100, Respiratory 20.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date these patients were vaccinated with improperly stored (trade name reported as PEDVAXHIB) (dose, frequency, route, lot number and expiration were not reported). No adverse effects were reported. Additional information has been requested.
Client came to the on 3-22-21 with complaints of bruising after her Moderna vaccine on 3-10-21. On assessment the anterior shoulder to the deltoid was black and blue with yellow coloration measuring 3 inches wide and 6 inches long.  She states that the injection site hurt immediately located in the middle of the Deltoid about an inch posteriorly and above the bruising. The client states that the area was red and swollen the next morning and then turning black and blue. She saw her provider and not orders were given. She denies any chronic conditions reporting lab work done in November.
Information has been received from a nurse concerning a 35 month old male with no pre-existing allergies, birth defects, or medical conditions who on 5/23/03 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot # 644569/1158M). There was no illness at the time of vaccination. On 4/11/05 at 8:45 AM, at almost 3 years old, the patient developed a severe case of shingles involving the whole right upper and lower arm, also involving the thumb, index finger, and half of the ring finger. It was noted that the child had a rash for 3 days before presenting to the office on 4/11/05. The rash was described as multiple vesicles and papules along a strip from the right shoulder and down the right arm all the way, involving the thumb and index finger. The pediatrician had a culture done and it was positive for VZV. The pediatrician prescribed acyclovir. No additional information was reported. The outcome was reported as not recovered. There was no product quality complaint. Follow up information received from a registered nurse indicated that the patient had recovered on 4/18/05. No additional information is expected.
This spontaneous prospective pregnancy report as received from a healthcare worker refers to a 17 year old female patient. On 09-SEP-2014, the patient was vaccinated with the second dose of GARDASIL, injection, 0.5 ml, intramuscularly (lot # and expired date were not reported). Concomitant therapy was not reported. The patient's mother informed an unspecified staff member, that the patient might be pregnant. Patient's last menstrual period had been the last week of July 2013 and home pregnancy tests had been positive. Patient was scheduled to follow-up with a physician on an unspecified date. No adverse effects were reported. There was no treatment was given for adverse event. The outcome of pregnant was unknown. Additional information has been requested.
rash; low grade temperature of 99.5; itchy rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH PRURITIC (non-serious) with onset May2022, outcome "unknown", described as "itchy rash"; PYREXIA (non-serious) with onset May2022, outcome "unknown", described as "low grade temperature of 99.5"; RASH (non-serious) with onset 26May2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received Paxlovid. Reporter stated, the keys that they had, they have had got reporter the paperwork for the box, so reporter didn't get out of the car that now. Expiry Date of Paxlovid: Unknown. Reporter had 5-year-old child had the shot Thursday he developed a rash; he was got an itchy rash now running a low-grade temperature of 99.5 and reporter wanted to know if reporter should give anything for the Itch or if reporter can take him to the ER.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke up feeling really nauseous and my whole body was sore. Really dizzy and had a horrible headache. My arm also got a huge knot in it. Lasted about two days. My arm is still killing me though and still has a knot in it.
some of it squirted out during administration; the patient only received part of the dose; The syringe was cracked at the top; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from agency.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 27Apr2023 as dose number unknown, single (Lot number: GM9410, Expiration Date: 20Aug2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious) with onset 27Apr2023, described as "The syringe was cracked at the top"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious) with onset 27Apr2023, described as "some of it squirted out during administration"; INCORRECT DOSE ADMINISTERED BY PRODUCT (non-serious) with onset 27Apr2023, described as "the patient only received part of the dose". Additional information: A nurse administered Prevnar 20 to the patient.  No follow-up attempts are possible. No further information is expected.
Brought on flair-up of fibromyalgia, symptoms include: muscle weakness and ache in neck, shoulders, upper arms, and back. Also headaches and sleeplessness. This has also set off back and leg problems-the symptom of the spinal stenosis. I have had an epidural for the back and leg issues, but unless I take TYLENOL 4 times a day I am in a lot of pain. Medication has been increased for the fibromyalgia.
This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. In June 2016 (reported as "this past week"), the patient was vaccinated with an unknown dose of PNEUMOVAX 23 (site and route of administration, lot # and expiry date were not reported). Concomitant medications were not reported. On 24-JUN-2016, the patient sought medical attention at an Urgent Care and he was diagnosed with cellulitis. It was unknown if the treatment was given for the event. The outcome of the event was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. Additional information has been requested.
Information has been received from a registered nurse (R.N.) concerning a 10 year old patient who was vaccinated with a dose of VARIVAX (Merck) and had a chickenpox breakthrough. At the time of report, it was unknown if the patient recovered or not.
Low graded fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low graded fever) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02F21A, 015M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced HEADACHE (Headache). On 30-Aug-2021, the patient experienced PYREXIA (Low graded fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 tylenol, around midnight. At the time of the report, PYREXIA (Low graded fever) and HEADACHE (Headache) had not resolved.            The concomitant medications were not reported.
Severe pain in all extremities, especially after any physical movement such as a walk. Severe shortness of breath after walking up any incline. Basically, if I do anything for a short period of time I have to rest for up to two days, longer if I do anything for an extended period of time.
This spontaneous report was received from a licensed practical nurse regarding a 12 months old patient of an unknown gender. On 27-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # N013270, expiry date: 25-OCT-2018, lot # N014947 expiry date: 11-NOV-2018) (dose, route and anatomical location not reported) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK INJ) (lot#, expiration, route, dose and anatomical location not reported). The vaccine was stored at a temperature of 32 degree Fahrenheit (F) for unknown period of time (reported as "ongoing excursion") (Incorrect product storage). The previous temperature excursion included multiple 6 degree Fahrenheit (F) to 14 degree Fahrenheit (F) for a total of 6.5 hours. The call was because of the data logger. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000128: US-009507513-1708USA010196: US-009507513-1710USA011199: US-009507513-1710USA011202: US-009507513-1710USA011201:
Patient came in with her daughter today, 7/27/23. Daughter says mom received the boostrix vaccine on 3/27/23 and was experiencing left arm discomfort/general pain. She has difficulty raising it above her shoulder, reaching behind her back, and discomfort sleeping on the arm. Daughter says mom started experiencing a sore arm around DAY 3 after the vaccination. When I asked where, the daughter and the mom kept touching the middle of the arm (distance from shoulder to the elbow). I stressed the fact that the vaccine is given on the upper arm. Mom did not wince as the daughter and herself kept pressing on the site. Daughter claims no redness. When touching the arm to determine swelling, the daughter wasn't sure (she was also pressing down the other arm for comparison).