chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired Moderna vaccine administered past 12 hours puncture time; expired Moderna vaccine administered past 12 hours puncture time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered past 12 hours puncture time) and PRODUCT STORAGE ERROR (expired Moderna vaccine administered past 12 hours puncture time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 2nd booster dose. Date the vial was initially stored in the refrigerator: 4-APR-2022 Date(s) and time(S) vial was first punctured: 4-APR-2022 at 1:55 PM Date(s) and time(s) of administration of vaccine: 5-APR-2022 at 9:00 AM - 1:40 PM EST How was the vial stored post puncture RT/fridge: Refrigerator Did the vial undergo any temperature excursions: No  No concomitant medications was provided. No treatment medications was provided.
Symptoms started 10-26-15 - date vaccine. Fever, arthralgia, myalgia, sore throat, itchy eyes, dry cough.
Information has been received from an M.S. concerning a 4 year old Asian male who on 17 APR 1997 was vaccinated with one dose of varicella virus vaccine live. On 21 NOV 2000 the patient experienced breakthrough varicella. On 27 NOV 2000 the patient recovered from breakthrough varicella. Other patients were reported with similar symptoms following varicella virus live (WAES01072609; 01072611-01072617; 01030289; 01072717; 01072719). No further information is available.
The day after the vaccine, she had an episode of syncope while in the bathroom. She does not remember the event, but was at a friend's house and was found in the bathroom after they heard a bang and was noted to be shaking. She then passed out again and continued shaking. She texted her mom and was given a cold rag on her forehead but has no recollection of any of that. Afterwards, she returned to normal.
Slight fever (<101.4); chills; shortness of breath (spO2 <90); lower backache; large joint aches; pronounced headache; fatigue.
Woke up with hives on her arms. Then they proceeded to spread on her legs. They were raised and warm. Brought her to Doctor and they advised me to give her Benadryl. This lasted for 48 hours.
Pt. was monitored for 15 minutes after receiving the first dose of the COVID-19 vaccine, Pfizer. Complained of chest discomfort, tightness, diaphoresis, and syncope when attempting to stand.  HR was 166 at initial presentation, BP was 117/75, SPO2 98% on room air, R 18 equal and unlabored.
pt recv vax & 2wk contracted 14 day measles, fever 102, irritable;
1-5-2021 was light headed after getting vaccine, and periodically was light headed for 48 hours after vaccine. Also had feeling of warmth throughout my body (with no fever present), also lasting 48 hours. 1-11-2021 began having few hives on my back, below both ears and on my arms, those areas with hives itch a lot. I put Benadryl/cortisone cream on the areas. Hives are few in number, it goes away but still up until now, come back.
The pt was given Moderna as a booster instead of  Pfizer which she requested. Pt reported no adverse reaction to the vaccination and none were observed. Pt was observed for 30 mins after receiving shot.
Moderna COVID-19 Vaccine EUA. First dose sore arm and major headache lasted one day.  Second dose, sore arm, nausea/vomiting, body aches, chills, headache, fatigue, lasted 2 days.
Arm Soreness and stiffness, Headache (the patient took Tylenol)
mom called & stated next AM p/vax pt arm @ DTAP site was fiery red & swollen & had a rash;mom did not notify MD @ that time;later reported to PHN as pt allergic to tetanus;
17OCT95 24hrs p/inj redness, swelling to lt arm;eventually p/72 hrs entire lt shoulder & upper arm red, swollen & painful for 5-6 days;resolved w/APAP & DPH
Triangle raise red mark; Hurting very slightly at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Triangle raise red mark) and INJECTION SITE PAIN (Hurting very slightly at injection site) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Triangle raise red mark) and INJECTION SITE PAIN (Hurting very slightly at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Triangle raise red mark) and INJECTION SITE PAIN (Hurting very slightly at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I developed a swollen lymphnode in my left breast which was confirmed by ultrasound and mammogram, and in the same month the lymphnode became swollen I developed psoriasis, which I had never had symptoms of prior to the vaccine. In that same month  I also developed severe congestion, which in March 2022 was confirmed to be nasal polyps via endoscopy.
After the administration of the Rotavirus Vaccine patient became very fussy and lost her appetite. She refused to take her bottle or binky.  Our daughter developed a mid grade fever that evening, running 99.6 we administered the proper dose of Infant TYLENOL. She then developed a fever again around 4:30 AM of 100.3, every time we would try to feed her she would immediately throwing-up all that was consumed. Patient has been seen for possible GI issues with digesting her food and has already had an issue with throwing up vigorously, the handout given to my wife and I stated that if the infant had moderately or severe throwing up then this vaccine shouldn't be administered at this given point and time. We've went back to the physicians office several times, they advised us to go to the hospital because she was becoming dehydrated. The only thing she can consume at this point is Pedialyte mixed with water. This is going on the 4th day without being able to hold down anything besides water/Pedialyte.
Patient tested positive for Covid-19 on 01/13/2022.  Patient admitted to hospital on 02/26/2022 with c/o SOB and was found to have hypothermia along with AKI/CKD.  Patient was placed on antibiotics and found to have E. Coli UTI with chronic indwelling foley and had issues with dysphagia, eventually suffering from aspiration PNA with worsening oxygen requirements requiring PAP support.  Patients work of breathing continued to increase and palliative measures were introduced, he developed shock which worsening despite vasopressor support and decision was made to transition to comfort measures only.  Patient expired on 03/04/2022.
Achy for the day after first dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy for the day after first dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history information was reported.  Concomitant products included APIXABAN (ELIQUIS) and CLONIDINE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achy for the day after first dose). At the time of the report, MYALGIA (Achy for the day after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication were provided.    This case was linked to MOD-2021-285702 (Patient Link).
On Friday, February 19,2021 patient called and reported a "large redness "around site of vaccination. She had just noticed it in the mirror. It did not bother her at all all-no pain or anything. She would not have known of the redness had she not seen it in the mirror. Initially she has normal side effect of soreness and slight swelling for a few days after vaccination. Daughter took pictures on the patient's arm. and sent them to pharmacist. Estimated redness measured 4 inches by 3 inches
A consumer report has been received. The report concerns a patient born on 19-Dec-2006, Female consumer who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 16-Jan-2015. The patient experienced ACUTE GASTROENTERITIS. At the time of reporting, the event of ACUTE GASTROENTERITIS was ongoing. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/Med Immune 20-Mar-2015 by consumer. New event acute gastroenteritis added. Events diarrhea (on and off for three weeks since receiving FLUMIST), vomiting (on and off for three weeks since receiving FLUMIST, abdominal pain (on an off for three weeks since receiving FLUMIST), light fever (on and off for three weeks since receiving FLUMIST) deleted. Form completed date updated. Start date for suspect drug updated on 16-Jan-2015 and lot number added. Narrative updated.
Just a few hours after receiving them, blood curdling non stop screaming lasting longer than 3 hours,  she acted like she was bothered by light movement and sound
Uncontrollable shivering, total body muscle aches, headache, nausea, loose stools, fever
Pain to neck, shoulder joint, front snd back of arm. Severely limited range of motion and unable to Lift arm.
Diarrhea; his arm was a little sore; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER BIONTECH COVID-19 VACCINE; lot number: EL3247; expiration date: unknown) at the vaccination age of 82-year-old intramuscularly in the left arm on 25Jan2021 14:00 at a single dose for COVID-19 vaccination (COVID-19 immunization). The patient's medical history and concomitant medications were none. The patient did not received other vaccine within 4 weeks prior to vaccination. The wife reported that her husband got the first dose of the Covid-19 Vaccine on 25Jan2021 about 14:00 and did not have any reaction except his arm was a little sore on 25Jan2021 18:00. It is sore if he rubs the area, but has gotten better She said that last night, he developed diarrhea at about 22:30 26Jan2021. She inquired if this is a coincidence, he got the diarrhea or is it a side effect from the shot. She added that the diarrhea started about 36 hours after he got the first dose. He had the diarrhea at 22:30 26Jan2021, he had it again at 02:00 27Jan2021, and again at 07:00 27Jan2021 and he has not had it since. She said that her husband was saying he thinks it was getting better. She mentioned that after he received the vaccine, they waited for 15 minutes to make sure there was no reaction. She added that the vaccination facility type was health department drive through vaccination. The adverse events did not require emergency room or physician office visit. The outcome of the event was recovering.
Post vax, the patient presented on 12/20/2000 with 20-25 vesicular lesions scattered mostly on her trunk with a few on her face. There were no other symptoms. In follow up, the patient was seen in the physician's office on 12/20/2000 with a 1 day history of an itching rash which began 12/20/2000, low grade temperature in the AM was noted and 25 + veiscles scattered over the body. The patient subsequently recovered from her experiences. No additional information is available.
After the first dose in March of 2021, my hair began to come out more than usual, like a comb full. After the second dose it continued falling out. After the booster, in October, it really started coming out, like a palm full, every time I washed my hair (every other day, too scared to comb or wash more than that as would lose more hair each time).  I probably lost about 1/3 of my hair.  Went to the dermatologist and she said she'd seen a lot of this.  My hair began to regrow in 2022 and is now about 1.5" -2" long where it had fallen out.  It is no longer coming out in large quantities and is back to normal.  I will not get a booster.  The booster REALLY made it fall out.
started 2 weeks after 2nd shot, shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, 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 Shingrix.     Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that he/she had shingles which started occurring 2 weeks after receiving his/her 2nd Shingrix shot. He/She did not want to get shingles. The follow-up could not be possible as no contact details were available. Additional Supportive Information: Follow-up would not possible as no contact details were available.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer, the mother of a now 3 year old male patient who received a fourth dose of Prevnar on an unspecified date. In January 2004, the child was diagnosed with pervasive developmental disorder. The reporter stated the patient had no serious medical conditions or history. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (IM). Additional suspect vaccine included Hib-Titer vaccine administered on an unspecified date. Patient was not taking any concomitant therapy. On unspecified dates, the child received a series of 4 injections of Prevnar, which completed his primary series. In January 2004, the child was diagnosed with pervasive developmental disorder. As of 4/25/05, the child had not recovered. It has been determined that HQWYE420328APR05 is a duplicate report of HQWYE420728APR05. Therefore, the reports are being consolidated into HQWYE420728APR05, which will remain the official case of record. No additional information was available at the time of this report.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 18-JUL-2011 the patient was vaccinated with GARDASIL (lot # not reported) (intramuscularly, dose one, total daily dose not reported). It was reported that the patient would be receiving dose two of GARDASIL (lot # not reported) on the reporting day, 17-DEC-2013. The outcome was unknown. Additional information has been requested.
Neck pressure; Ache left side of back and lower left side; Slightly dizzy; Head ache left side of brain; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 09:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 15Apr2021 at 16:00, the patient experienced head ache on left side of the brain and neck pressure, ache on left side of back and lower left side and was still slightly dizzy at the time of report, but not as bad as on the first day. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events head ache left side of brain, neck pressure, ache left side of back and lower left side were recovered with sequelae (also reported as recovered with lasting effects) on an unknown date in Apr2021, while that of slightly dizzy was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
cysts on his hand and wrist; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: CYST (non-serious), outcome "unknown", described as "cysts on his hand and wrist".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My 1st Covid shot on 2/28/2021, I was fine.  My 2nd Covid shot on 3/21/2021, I experienced dizziness, headaches and generally felt sluggish for about 3-4 days.  However after my 3rd Covid shot on 10/11/2021, i have been experiencing low grade headaches EVERY day from 10/12/2021 up to the present day (11/09/2021)  Generally speaking, these are low grade headaches that I treat with a single Execedrin, but on occasion the headaches are much stronger and I can't identify any pattern as to why they are mild one day and more severe the next day. Yesterday, 11/08/2021 was a bad day where I was bedriden for most of the day.  My hope was that these headaches would decline in intensity and frequency but that doesn't appear to be the case.
bad nauseas (which are "driving her crazy"); body aches; Body aches and head aches since Saturday morning; Bad chills since Saturday morning; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (bad nauseas (which are "driving her crazy")), MYALGIA (body aches), HEADACHE (Body aches and head aches since Saturday morning) and CHILLS (Bad chills since Saturday morning) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 16-Jan-2021, the patient experienced NAUSEA (bad nauseas (which are "driving her crazy")), MYALGIA (body aches), HEADACHE (Body aches and head aches since Saturday morning) and CHILLS (Bad chills since Saturday morning). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NAUSEA (bad nauseas (which are "driving her crazy")), MYALGIA (body aches), HEADACHE (Body aches and head aches since Saturday morning) and CHILLS (Bad chills since Saturday morning) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient took medications to treat nausea.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: NNI On 07-Jun-2021: Event outcome updated and patient declined for further FU.
A report has been received from a Health Professional concerning a 12 year old, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. Administration of expired product to two patients was reported by the health professional which started on 04-Feb-2015. The outcome of the event of ADMINISTRATION OF EXPIRED PRODUCT TO TWO PATIENTS is unknown. The report was considered to be non-serious.
Eczema at injection sites on both legs. Now has Immunological Hypersensitivity reactivity to milk, eggs & possibly more.
Light dizziness to begin with for a few days off and on with headache, by 9/24 vertigo started antivert 25 tid, some relief then by 9/27 sustained vertigo and went to Dr. recieved 4mg Decadron and started steroid dose pack. Vertigo continues on 2nd day of dose pack.  Missing work unable to drive. Very concerned that I am not getting better, interfering with work. Took the Fluarix Quad 0.5.
my chest started hurting; I couldn't breathe; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 16:00 (lot number: not reported) as single dose for COVID-19 immunisation. Medical history included mild asthma. The patient is not pregnant. Concomitant medications included lisinopril; fexofenadine hydrochloride (ALLEGRA); and estradiol. The patient previously took morphine, tramadol, and nickel and all had known allergies. The patient experienced her chest started hurting and she couldn't breathe the next day (29Dec2020). She slept for 2 days. Symptoms progressed and got worse and she had been to the emergency room (ER) five times. She also had many Doctor (Dr) appointments and symptoms had not improved. The events assessed as serious with disability and hospitalization of one day. Treatment received for these events included dexamethasone, duo neb, lorazepam, and hydromorphone. No COVID prior to vaccination and COVID tested post vaccine (unspecified date): unknown results. No other vaccines received in four weeks. The outcome of the events was not recovered.  Information on about lot /batch number has been requested.; Sender's Comments: Drug causality for suspect drug  in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product.    The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Client and family came by to receive the Bi-valent booster made by Moderna. They received the mono-valent booster in error. The family has been notified, and advised about potential adverse reactions such as a sore arm in the morning. The family was also advised to wait 2 months before getting the bivalent booster in accordance with current recommendations. The family members seemed frustrated, but understanding and appreciative of the pharmacy?s openness with them regarding the situation. Contributing factors include high volume, similarities between the two packages, improper workflow by the pharmacist, and storage of the two similar medications directly next to each other.
Positive Erythema to both thighs Right thigh: 9 x 7 cm, Left thigh: 1 X 2 cm
Per pt H1N1 vaccine received 2 weeks prior to her baby's birth, at 37 wks, 3 days. Baby born C-section for decreased fetal movement. Babe born in respiratory distress, with hypoglycemia, hyperbilirubinemia. Has hypotonia and abnormal MRI showing hypoxic/ischemic injury and intraparechymal hemorrhage.