chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in the refrigerator on 31-Jan-2022 and administered on 09-Mar-2022; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 31-Jan-2022 and administered on 09-Mar-2022) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 31-Jan-2022 and administered on 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 31-Jan-2022 and administered on 09-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. The vial was initially stored in the refrigerator on 31-Jan-2022. Treatment information was not provided.   This case was linked to MOD-2022-525860 (Patient Link).
If you had a severe allergic reaction after getting the first dose of an mRNA COVID-19 vaccine,  experienced severe allergic reactions?also known as anaphylaxis?after getting a COVID-19 vaccine.  I experienced difficulty breathing and had blue on my cheeks and around my mouth.  Reported it to my primary care and was told this.... an allergic reaction is considered severe when a person needs to be treated with epinephrine or EpiPen© or if they must go to the hospital.  I should have gone to hospital.
When patient woke up we changed his diaper and noticed hives starting on his bottom and it continuted to spread across his whole body throughout the day. Benadryl helped but didn't completely remove the hives. No fever was present with hives and hives continued on and off until 03/03/2012.
This spontaneous report as received from a registered nurse refers to a 50 years old patient. The patient was vaccinated with VARIVAX (Merck) (lot# was unknown) instead of ZOSTAVAX on 24-OCT-2012. No adverse symptoms reported. Additional information has been requested.
A female pt with exposure to rabies through a dog bite, developed pain in the right and left hip after vaccination with RabAvert. Concomitant medications included Elavil and Diovan. The pt described taking a rabies vaccine which may have been RabAvert about one and a half years ago for exposure to rabies through a dog bite. She was treated with five shots the first day and then received at least four more over approx a month. The end of the course was Jul02. In Aug02, she began to notice pain in both of her hips, which lasted about four to five months and spontaneously remitted. Also around Aug02, she developed an extremely salty taste and a feeling of dripping into her throat. The pt had seen a dentist, periodontist, primary care physician, neurologist and ear, nose and throat specialists. She has had a brain MRI, sinus scans, salivary gland biopsy and kidney tests all of which were normal or negative. The pt also complained of intermittent tingling of legs and feet that lasts a few minutes.  Follow up received 24May04: The pt is a 55 year old female with a past medical history of hypertension and allergy to penicillin, tetracycline, Minocin, Ampicillin and tetanus. The pt received a dog bite on 24Jun02. On 24Jun02, she was administered RabAvert with immunoglobulin and prescribed erythromycin. Subsequent vaccination dates were administered on 27Jun02, 01Jul03, 08Jul02 and 22Jul02. On 08Jul02, the subject received 0.5ml RabAvert IM and on all other dates a 1 mL injection was administered IM. On 01Jul02 no adverse reactions had been reported but it was noted the pt's right calf was bruised. On 08Jul02, the pt's leg wound seemed better with less bruising. She complained of stomach upset with erythromycin. Approx two to three weeks later after the last dose, she noted arthritic symptoms in the joints which were more prominent on the hip area. Work up results for Lyme's disease and Sjogrens disease were negative. Laboratory results for thyroid and urinalysis and MRI of the hip were negative. About four months later, the arthritic symptoms in the hip abated but the salty taste remained.
Positive side effects of the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021 at 12:00(at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic depression, anxiety, asthma and morbidly obese. The patient had probably known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications included progesterone (PROGESTIN) from an unknown date taken for birth control as implant.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 29Mar2021 at 14:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation.On 19Apr2021 at 15:00, it was reported that the patient  honestly wanted to report a positive side effect. After the second dose, the patient felt great, like really great. The patient felt as if recieved an injection of six months of healthy diet and exercise that took hold all at once and lasted 36 hours, and felt like being on steroids and stimulants and antidepressants all at once. The patient was morbidly obese, but felt like could run for miles. The patient  was extremely peppy and productive at work. The patient  knows positive side effects probably don't get reported often, but had not known if it's a potentially risky side effect or medication interaction, and would leave that to the professionals. The patient thought that these things should be tracked and reported. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events positive side effects reported for the vaccine was resolved at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administered Varicella vaccine to patient who had chickenpox as a child. Patient had no reaction was made aware of incident.
COVID vaccine breakthrough case. Pfizer 1/29/21 EN5318, 2/19/21 EN6201, 8/19/21 FC3181. 4/2/22 FL3198 and Pfizer bivalent 9/28/22 DJ5342
Had pain in my shoulder (and  neck on my left side) as soon as the shot went in. At roughly three hours after the shot, I felt I was slurring my speech (I had to make a very concerted effort to make proper sentences and not slur) and was very dizzy. I also was having a hard time with lights. For example, I was unable to look in the mirror in my bathroom as the lights above the mirror were too bright for me. At three hours after the shot, I had severe pain in my left shoulder. Overall, I felt as I had been sedated or drugged. I tried walking to the nearest convenience store to get some food and I felt I was experiencing vertigo. Several days after the vaccine I had a slight cough and sore throat. I am still experiencing a slight cough on some day sand a slight sore throat.   I had a subtle red patch in the left shoulder area a couple days after the shot. Eight or nine days after the shot, I had covid arm and had a very visible red patch on my left shoulder. I have pictures of this.  I have been feeling very tired and dizzy ever since the first shot. My glands in my neck under my jaw line are also swollen. I do not know if it is either  wise or safe for me to get the second shot, which is scheduled for this Friday as it seems that I still have not recovered from the first shot. Can my immune system really take another round of this?  There are a couple other things that I have noticed. I don't seem to be thinking very clearly and I have noticed a remarkable number of type-os and poor syntax in emails that I send at work; this is not normal for me.   Finally, after the shot, I noticed that my muscles, when doing a little exertion such as pushups, would build lactic acid quicker and more blood seemed to be delivered to my working muscles. I still have not regained my strength and tire more easierly when playing tennis or hitting against the tennis wall, for example. This is also not normal and not how I felt before the first injection.
UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient via company representative through social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received pfizer covid-19 vaccine (tozinameran) (dose number in series 1) (form, route of administration, batch number, dose were not reported, expiry: unknown) for prophylactic vaccination.  No adverse events were reported following vaccination with pfizer covid-19 vaccine (dose number in series 1). The patient additionally received booster dose covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, according to the patient, covid smell loss was fixed by the vaccine (coded as unexpected therapeutic benefit) (dose number in series 2).  Patient reported that, "I got your vaccine (as a booster after my Pfizer vaccine) and I truly believe it fixed my COVID smell loss". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Patient fainted after vaccination.   He came to after about 40-60 seconds and drank some orange juice. He still felt dizzy and sat for about 30 minutes until he felt better. Patient did not want to call EMS.
This spontaneous report was received from a medical assistant concerning multiple unknown patients of unknown age and gender. On unknown dates, the patient were vaccinated with improperly stored ROTATEQ, lot#: M017514, expiry: 07-NOV-2017 and Lot#: L033694, expiry: 16-JUN-2017. There were no previous temperature excursion. Information on current excursions were as follows: Time/temperature for high excursion: 40 hours at highest 55.2 F (Fahrenheit). Time/temperature for low excursion: 456 hours at lowest 26.2 F. No adverse effects reported. No further information provided. This is one of two reports received from the same source. Additional information has been requested.
Fever, facial hives, rash on legs and arms, tongue itching w/swelling.
lack of response - Information has been received from a doctor of pharmacy concerning a female patient who in February and April 1999 was vacicnated with a first and second dose, respectively, of varicella virus vaccine live.  Subsequently on approximately 07 mar 2000 the patient was tested for antibodies and an undetectable lever was found.  Unspecified medical attention was sought.
Patient complained of left shoulder and neck pain starting the evening after receiving the flu vaccine.  Patient describes the pain as a constant ache and having difficulties turning neck to the side.
SORE MUSCLES, ACHES   STARTED APROX 6 TO 8 HRS AFTER SHOT AT 11;30 A.,M.   I STARTED TAKING TYLENOL EVERY 3 HRS  THRU THE NIGHT AND THE NEXT DAY EVERY 4 HRS.  THE SORE MUSCLES SOON STARTED TO SUBSIDE APPRPOX 2 DAYS  AND I THEN NOTICED MY INJECTION SITE WAS ANGRY AND RED. IT WAS TENDER  AND FEVERISH BUT NOT BAD.   THAT STAYED WITH ME UNTIL  MONDAY   AUGUST 30.  FINALLY IT SUBSIDED.
Itching for several days; Experienced an allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple allergies.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pruritus and allergic reaction. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the pruritus and allergic reaction were recovered/resolved.   It was unknown if the reporter considered the pruritus and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The reporter reported for herself. The age at vaccination was not reported but it could be 74 or 75 years. The reporter stated that, after vaccination with 1st dose, experienced an allergic reaction, had itching for several days. The patient took steroid medication for few days.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021008415:Same reporter. Duplicate case - deleted.
Redness and mild swelling around vaccination administration site persisting approximately one week after vaccine was administered.
Fainting (2x), extreme dizziness/ vertigo, extensive onset of sweating, sensation of 100?s  of bugs crawling on neck, excruciating headache and internal pain like a steamroller had run over me.  Came on very fast and without warning.
I have been experiencing soreness in my back over the past weekend as if I may have pulled a muscle.   Over the last 48 hours I have developed a rash around my torso in where the soreness is located.  After doing some research, I believe I have a case of shingles.  I scheduled an appointment with my doctor for tomorrow to get checked out and receive treatment.   My rash looks just like pictures of shingles that are on the internet.  I also read that the covid vaccination can trigger shingles in certain recipients.
We administer Pfizer booster dose to a patient 13 years old, 6 months after the second dose. The patient does not present any adverse effects at this moment. The patient mother was notified of the wrong administration the same day of administration.
diarrhea; gastrointestinal distress; fatigue; headache; a sore arm, quite sore; This is a spontaneous report from a contactable consumer (patient).  A 67-years-old female patient received fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at SINGLE DOSE for COVID-19 vaccination.  The patient's medical history and concomitant medications were not reported. The patient experienced the typical side effects within 2 days of the COVID-19 vaccine (1st dose): The first day (14Jan2021) she experienced a sore arm, quite sore, the day after (15Jan2021) she noticed fatigue and headache. The patient had diarrhea on an unspecified date. These symptoms improved by the end of the 2nd day, but she was not 100% (better) yet. The patient experienced gastrointestinal distress on 18Jan2021. The outcome of the event gastrointestinal distress was unknown, of events sore arm, quite sore, fatigue, headache and diarrhea was recovering. Information on the Batch/Lot number has been requested.
Beginning a few days after the vaccination, I experienced diplacusis. I could not hear music correctly with my right ear (or both ears together). It is flat in pitch, dissonant, tinny, distorted. Some pitches and ranges, some instruments are worse than others. Spoken voices, too, are somewhat distorted, sound lispy or hissy, particularly female voices. Other symptoms include tinnitus (new to my right ear) and an occasional feeling of fullness or clogging in my right ear and Eustachian tube, especially after lying on my right side. I tried treating/flushing both ears, but that produced no loosening of any wax. There has been some fluctuation day to day, but symptoms have never disappeared. My primary care doctor confirmed I had some wax on June 30, but said it wouldn?t be enough to cause the changes. Just that week I began noticing some similar problems with my left ear (with already present tinnitus and some hearing loss prior to vaccination), though much less severe. In the last week of July, there was some improvement in overall symptoms, though music is still intolerable. The ENT, , removed wax on August 3 with no immediate improvement in symptoms noted. Some further improvement noted approximately ten days later.
Information has been received from a 22 year old female healthcare worker who on 26-JAN-2007 was vaccinated with HPV vaccine.  The patient stated that the "HPV stung a lot as it was being administered." Unspecified medical attention was sought.  The patient recovered. Additional information has been requested.
Patient felt dizziness, shaking and light headed few minutes after getting the shot, forehead was hot to touch but temperature was 97F, upper lip was sweating and hands were turning blue, and patient reported temporary loss of vison, patient was conscious the entire time called 911 and patient  was taken to Emergency Room,  Patient was  later discharged and   4 hours later patient came to the pharmacy to pickup the car and drove home.
L arm injection site, warm and swollen 6 1/2cm X 6 1/2cm.
Dose 1 Moderna 03/23/2021 lot 044A21A currently has covid 19
Started out yesterday, 8 days after the vaccine on 2/25/21 the arm was itchy, then got a real hard knot underneath the skin, which has been warm and hard since that time.   He took an Aleve for that and muscle aches.
only 1 vial administered, given with sterile diluent; only 1 vial administered, given with sterile diluent; This non-serious case was reported by a other health professional via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: only 1 vial administered, given with sterile diluent) and inappropriate dose of vaccine administered (Verbatim: only 1 vial administered, given with sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 02-MAY-2023 The reporter enquired, if only 1 vial of Menveo was inadvertently administered versus mixing the 2 vials of Menveo together prior to administration, what is the next step? Would patient need to be recalled for revaccination? If so, what is the interval between partial doses?  Would only the missing component be administered the next time or the fully reconstituted dose?  The reporter wanted to know when patient could get Menveo readministered. No further information shared in webform for adverse event (AE). Callback placed to HCP and voicemail left requesting callback. The reporter consented to follow up. The patient received Menveo with sterile diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
I had smashed my elbow into a door jam about a month to month in a half before the injection and the pain had mostly gone away. About a week after the first injection the pain returned full force and continues to this day unless I take adoring twice a day.  In the past few weeks I have noticed pain in the first joint of all my fingers.
Realized that after administration and patient left that the vaccine had expired 6/30/2021.  Contacted our pharmacist, who did some research, and was notified that it was fine and that he should received the current vaccination.  Called patient and he is scheduled to come in today for the correct vaccination.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced an unspecified (localized) injection site reaction. At the time of reporting the outcome of the event was unspecified. The reporter stated this event occurred in as many as 10 subjects. Other vaccines given at this facility include ADACEL (Sanofi), MMR and VARIVAX. The site was trying to rule out the source. No concurrent vaccines were mentioned in this report.
Patient experienced severe pain in her upper arms near injection site, high fever and shaking and both arms swollen.
Elevated temperature of 100.4 degrees. Some chest discomfort and nasal congestion. Took aspirin or acetaminophen until temperature returned to normal (approximately 36 hours later).
This spontaneous report was received from a medical assistant referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates since 21-JUL-2017, these patients were administered improperly stored PEDVAXHIB (lot# reported as N002913 with expiration date 23-FEB-2019, lot# reported as N003702 with expiration date 08-NOV-2019, lot# reported as N009802 with expiration date 19-DEC-2019, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 47 to 77 Fahrenheit (F) for 43 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA007735: US-009507513-1709USA004621: US-009507513-1709USA004622: US-009507513-1709USA004619: US-009507513-1709USA004620.
First day within 24 hours numbness and tingling in vaccinated arm and hand, few days later fatigue, weakness, chest pain, now today 9/29 numbness tingling on entire left side of body, dry mouth extreme fatigue
vomiting, diarrhea, dizziness, unable to stand, weak starting the night of vaccine leading to  dehydration did an ECHO  next day by Dr and found blockages which were taken care of that day by MD, and then episodes of decreased blood pressure, severe headaches
Extremely high fever, 103.5. Bone chattering shakes, vomiting, inability to sleep, overwhelming thirst. Tylenol reduced the fever to a manageable 100. Symptoms persisted for 18 hours. Once the fever reduced, the ability to function slowly resumed. Normal function resumed after 60 hours.