chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 adult patients received Monovalent vaccine 1 day after MFG expiration date; no adverse event; 4 adult patients received Monovalent vaccine 1 day after MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 1 day after MFG expiration date), PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 1 day after MFG expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 1 day after MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 1 day after MFG expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 1 day after MFG expiration date), PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 1 day after MFG expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received Monovalent vaccine 1 day after MFG expiration date) and PRODUCT STORAGE ERROR (4 adult patients received Monovalent vaccine 1 day after MFG expiration date).    Pharmacist is calling to report that 8 adult patients received Moderna COVID-19 vaccine Beyond manufacture Expiration Date.  No concomitant medications were reported.  MFG Expiration date was 20May2022 (agent checked, it has not been extended).  It was unbroken cartons.  Vial size was reported as 5.5 ml.  The vial was initially stored in the refrigerator on 20MAY2022 and 28MMAY2022  4 adult patients on 21MAY2022 and 4 more adult patients on 29MAY2022  The vial did not undergo any temperature excursions.  No concomitant medications were reported.  This case contains information for the 1st of 8 adult patients described by the reporter.
pt recv vax 22JAN96-30JAN96 fever 104 ax;31JAN96 cont febrile-dark pink mac-papular rash began-buttocks,back,trunk-spreading to face,extremities,eyes red & photophobic;no palms & soles;sl cough;to MD 2FEB95-rash cont
PATIENT REPORTS FATIGUE AND MUSCLE ACHES WHICH LASTED APPROXIMATELY 32 HOURS; PATIENTS DENIES TAKING ANY OTC PAIN MEDICATION
Poor quality product administered; series of temperature excursions; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (series of temperature excursions) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (series of temperature excursions) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (series of temperature excursions) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (series of temperature excursions).    No concomitant product reported by reporter.  It was reported that series of temperature excursion occurred  over the past 5 months since 10-Aug-2022. There were 4 instances where temperatures were out of range which included both the Monovalent adult and Bivalent booster for adults. Excursion details for monovalent vaccine were reported as follow. First excursion occurred on 10-Aug-2022 with maximum temperature of 8.5 degrees Celsius for 34 minutes and vaccine was taken out of the freezer to refrigerator when it was used on 10-Aug-2022. Second excursion occurred on 07-Oct-2022 with maximum temperature of 12.3 degrees Celsius for 90 minutes and vaccine was taken out of the freezer to refrigerator when it was used on 07-Oct-2022. Third excursion occurred on 09-Nov-2022 with maximum temperature of 8.6 degrees Celsius for 29 minutes and vaccine was taken out of the freezer to refrigerator when it was used on 09-Nov-2022. Fourth excursion occurred on 11-Nov-2022 with maximum temperature of 8.6 degrees Celsius for 29 minutes and vaccine was taken out of the freezer to refrigerator when it was used on 11-Nov-2022. Storage condition at the time of the excursion was refrigerated storage and vial size was 5.5 ml. No visual changes were observed in the vial. Reporter was not sure exactly how many patients received doses from these vials following the temperature excursions but does believe the doses have been administered.  No treatment medication reported by reporter.   Reporter did not allow further contact
I had a case of breakthrough Shingles. Breakthrough because I'd been taking Valacyclovir for a few years to prevent Shingles. The symptom was extreme soreness on the top right of my scalp. Tender only to touch, but not pressure. I never did get the rash, fortunately. I was prescribed a heavier dose of Valacyclovir (1 gram 3x/day for 10 days), and the pain gradually went away. I don't believe there is any connection to the vaccine. I'd been extremely stressed for a few weeks and attribute the breakout to that. I'm only reporting this because someone at the CDC told me I should after I mentioned it on my V-Safe check-in.
Pt developed a red hive-like area around injection site. The site was slightly itchy and warm. Size of hive was comparable to a half dollar. Area was hard and extremely tender. Hive developed 48 hours after receiving vaccine.
Complete loss of hearing in Left ear.  No other symptoms such as pressure, fullness, etc.
Very sore top of Deltoid, can't move without sharp pain or extreme weakness across body, backwards, or laterally up in left shoulder. Can't sleep on left side. Very sore all the time always feels like it needs to be messaged.
The site of the vaccine became red, hot, tender, and swollen.  The swelling was more than expected for a localized site reaction. She later developed nausea, dizziness and a headache which had not resolved by 7/27/16.
Extreme exhaustion (ongoing), difficulty keeping eyes open while driving (~1 week), dizziness (~1 week), headache (~2 weeks), unable to take care of kids due to overwhelming exhaustion (~ 1 week), feeling like I had the flu except no fever (~1 week), pain/tingling/throbbling in forearms/hands/lower legs/feet (ongoing). The pain/tingling/throbbing has affected everyday life as well as created an inability to sleep.
Local reactions at vaccine site: itching, 6" x 4" red area, warm, hard, swollen.
I had fatigue, headaches, SOB, dizziness. I had a routine check up already scheduled and was seen at that appointment. My blood pressure was elevated; 148/106 at the time of my appointment. I was sent to Labor and Delivery to be seen, I had my blood pressure continued to be high so my OB admitted me. I was induced without complication. My baby was born early but is healthy and home. I had a normal pregnancy up until Dose 2 of the vaccine. I had an estimated date of 03/17/2021 but delivered on 02/26/2021.
As I was driving home shortly after my shot, I felt unusually tired, so much so that I wanted to fall asleep at the wheel. When I got home, I had a lie-down and fell fast asleep. Later, I was awoken from my sleep by pain and the injection site. I put an ice pack on it, and the pain intensified. The pain was such that I was in and out of sleep all night long; I couldn't get a sound sleep on account of the pain. The following day when I woke up, I found it excruciatingly painful to raise my left arm. I took two Tylenol and then noticed that the muscles in my legs were extremely sore. I found it painful to walk. My legs felt like they had run a marathon! I ended up using a walker for about 2 1/2 weeks. I had already dealt with chronic pain, but this wasn't normal for me, so I called the doctor. She told me to wait a few more days and to come to the clinic if it didn't subside. Ultimately, I didn't go to the clinic. About 3 weeks after the leg pain began, the pain finally began to subside. During these three weeks, not only did I have leg pain and a sore injection site, but I also felt extreme malaise and weakness. I also experienced great anxiety, for which my doctor prescribed a 3-day supply of the lowest dose of lorazepam.   During the time that I received the vaccine, I was already taking methylprednisolone to treat my RA and fibromyalgia. The inflammation in my body was also high. I now wonder if the interaction of the vaccine and methylprednisolone exacerbated the inflammation.
Patient reported that 2 days after getting ADACEL vaccine her face and cheeks felt hot and were beet red.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
This spontaneous report was received from a certified medical assistant referring to unspecified patients of unknown age and gender. The Patient's concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL lot # L010596, expiration date on 05-MAY-2017 (route, dose and anatomical location were not reported) which were stored in a temperature of 31F during 60 hours. Concomitant therapies were not provided. No adverse events were reported. No product quality complaint was involved. This is one of several reports coming from the same source. Additional information has been requested.
Information has been received from a physician concerning a 77 year old female with hypertension who on 30-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 mL subcutaneously in the upper arm (Lot #659267/1836U). Concomitant therapy included losartan potassium-HCTZ (MSD), ACTONEL, calcium (unspecified) and INDERAL. On 02-MAY-2008, the patient was seen in the physician's office because she had developed a swollen arm, with a 2 X 2 area at the injection site which was warm to the touch and hard. The patient was treated with over the counter TYLENOL and comfort measures as needed. At the time of this report, the patient had not recovered. Additional information was requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician and a medical assistance concerning a 77 year old female with hypertension who on 30-APR-2008 was vaccinated with ZOSTAVAX 0.65 ml. subcutaneously in the upper arm (Lot #659267/1836U). Concomitant therapy included losartan potassium-HCTZ (MSD), ACTONEL, calcium (unspecified) and INDERAL. On 01-MAY-2008, the next day, the patient was aware of a swollen area, 2 x 2, red and warm. On 02-MAY-2008 the patient was seen in the physician's office because she had developed a swollen arm, with a 2 x 2 area at the injection site which was warm to the touch and hard. The patient was treated with over the counter TYLENOL, ice and comfort measures as needed. On 14-MAY-2008 the physician noted the swelling decreased area was still slightly pink (physician also noted the redness, swollen, warm area lasted a duration of 10 days). As of 21-MAY-2008 the physician noted the patient was no longer being treated. Additional information is not expected.
myocarditis; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team.  A child female patient received bnt162b2 (COMIRNATY) (Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis". Reporter was fully vaccinated. Reporter's daughter received all the booster everything Pfizer she was in her 40 they were all fine. Reporter's question was about the booster for the 5-11 years old, and the reason that, and reporter wanted to find out if there was, now reporter understand that 5 million children received this Pfizer vaccine reporter didn't know how many, if that was the right number but on the news, reporter was just assuming. Since the schools were mandating many of the private schools were mandating the vaccine by 15Feb2021. Reporter was concerned about myocarditis, had there been any myocarditis case, caused reporter knew one family that who child (patient) got it like a few days ago, that was why was worried about reporter's grandchildren getting it. Patient was a girl, reporter's daughter just told. Reporter's grandchildren would be vaccinated, so reporter asked if there had been any adverse effects from children ages 5-11. Reporter asked if there had been like one or two or there had been a lot of people with myocarditis who are ages 5-11.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
Patient presented with a rash and went to primary care's office; MD said that pt is most likely allergic to preservative in vaccine as she has had the influenza vaccine in years past.
A 43 year old female has complained of severe headache for three hours after being treated each time with three dosed of Rabavert. The headache did not subside following the use of ibuprofen or other over-the-counter medications used for headaches. The headache eventually went away three days following the dose. She was pre-medicated with Benadryl before her fourth dose on 7/22/99 and did not experienced headaches. She plans to be pre-medicated prior to her fifth dose. Follow up information is pending. Information from follow-up report states: Follow-up report was received on 23 Nov 1999. The subject received RabAvert on 09 Jul 1999, 12 Jul 1999, 15 Jul 1999, and 22 Jul 1999. She also received human rabies immune globulin (HRIG) on 09 Jul 1999. She experienced headaces 3 hours after each RabAvert injection. She also experienced diarrhea which was very severe by the third vaccination and an "achy feeling like flu in body" which lessened after each repearted dose. She was treated with Imodium, and the headaches resolved on 23 Jul 1999 after taking over the counter Benadryl.
Felt a little headachy; Tiny fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Felt a little headachy) and PYREXIA (Tiny fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Ventricular contractions premature (Patient had Pre ventricular contractions) and Hormone replacement therapy (low dose bioidentical hormone replacement, since their late 40s.).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HEADACHE (Felt a little headachy) and PYREXIA (Tiny fever). At the time of the report, HEADACHE (Felt a little headachy) and PYREXIA (Tiny fever) 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 Concomitant medication was reported.  No treatment medications were reported.   This case was linked to MOD-2021-362429 (Patient Link).
This case was reported by a physician via call center representative and described the occurrence of nausea in a adult female patient who received FLUARIX (batch number AFLUA550AA, expiry date unknown). On an unknown date, the patient received FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced nausea, vomiting and dizziness. On an unknown date, the outcome of the nausea, vomiting and dizziness were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting and dizziness to be related to FLUARIX. Additional details were provided as follows: This case was reported by a physician, who herself was the patient. The age at vaccination was not reported. The patient received FLUARIX vaccine back in year 2010 and after vaccination she experienced nausea, vomiting and dizziness, which were lasted for about 1 to 2 months. No further information was reported regarding the event.
The next day I felt ill, vomiting, arm pain, muscle aches and joint pain.  All have decreased except I still have moderate to severe joint pain throughout the day and night
Adult PFIZER vaccine formulation given to 11 year old patient in error.  Patient's mother listed patient age as 12yo on registration form.
Greater than 12 cm, erythemic, and warm to touch, radiated up left upper extremity and down past left elbow.
Patient became flushed, chest tightness and felt winded. BP was 130/70 and 02 saturation was 100%. Patient had not tongue swelling, previous reaction to a vaccine, medication or food and no shortness of breath. Patient was placed on gurney for 30 minutes and had no further symptoms after this time.
After the first and 2nd shot, patient did not feel good; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (After the first and 2nd shot, patient did not feel good) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 007B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis (22 years ago).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (After the first and 2nd shot, patient did not feel good). At the time of the report, FEELING ABNORMAL (After the first and 2nd shot, patient did not feel good) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported patient did not had any other vaccine at the same time as the DEC-2022 COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2023-721293 (Patient Link).
Guillain Barre; Trouble walking; Felt strange; Initial information was received on 30-Oct-2021 regarding an unsolicited valid social media serious case via a consumer/non-health care professional (under reference number: US-SA-SAC20211103000621).  This case involves an elderly patient (in seventies) with an unknown gender who experienced Guillain barre (Guillain-Barre syndrome), trouble walking (gait disturbance) and felt strange (feeling abnormal) after receiving INFLUENZA VACCINE.  At the time of the event, the patient was an ongoing Insulin dependent diabetic. The patient's, other medical treatments, vaccinations and family history were not provided.  The patient had no other risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site prophylactic vaccination.  On an unknown date the patient developed a serious Guillain barre (Guillain-Barre syndrome) trouble walking (gait disturbance), felt strange (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.   The patient was hospitalized for these events.  The patient reported that he/she had bad reaction to the flu shot. After that he/ she never took another flu shot and never had flu.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  The patient was treated with IMMUNOGLOBULIN G HUMAN (GAMMA GLOBULIN) for Guillain-Barre syndrome for five days by neurologist.  After treatment the patient went home and spent another three weeks recovering and then went back to work.  At time of reporting, the patient was recovering from the events.; Sender's Comments: This case involves an elderly patient (in seventies) with an unknown gender who experienced Guillain-Barre syndrome, gait disturbance and feeling abnormal after receiving INFLUENZA VACCINE. The patient was an ongoing Insulin dependent diabetic. The time to onset is unknown for the events. Relevant lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (shingrix) for prophylaxis. Previously administered products included shingrix with an associated reaction of pain (received first dose of shingrix on 18th November 2019, for tolerance refer case US2022AMR007322). On 24th September 2021, the patient received the 2nd dose of shingrix (intramuscular) .5 ml. In September 2021, 12 hrs after receiving shingrix, the patient experienced injection site pain and general body pain. On 24th September 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the injection site pain, general body pain and drug dose administration interval too long were recovered/resolved. The reporter considered the injection site pain and general body pain to be related to shingrix. Linked case(s) involving the same patient: US2022AMR007322; Additional details were reported as follows: The patient self-reported this case. The patient received a dose of shingrix and about 12 hours later experienced injection site pain and body aches which resolved 3 days later. The patient's two doses were greater than 6 months apart, which led to lengthening of vaccination schedule. The patient asked if he should restart the series. The patient did not provide consent to follow up. This case has been linked to US2022006705, reported by same patient for his wife.; Sender's Comments: US-GLAXOSMITHKLINE-US2022006705:Same reporter.
fever & abnormal behavior reported by parents-acting dazed, glassy eyes, shivering & chills; seen in ER by MD, t102;
Rash and hives all over her body, eyes red and puffy, rash and hives on face around neck, arms, thighs where shots were given and around, and head, crying for 2 days, agitated, could not be soothed, irritable, hurting and itchy all over. Gave TYLENOL and BENADRYL and a lot of extra love and affection.