chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 1:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 1:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 72.13  Concomitant products were not provided.  On 07-Jan-2021 vials were moved to clinic. On 05-Jan-2021 the vaccines were moved to fridge. On 07-Jan-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 34 and at 10 AM temperature was 34  The vaccine beyond use date was reported as 27-Jan-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
She got her vaccine, her arm hurt and did not have any appetite.  Her head hurt, her 98.7 and normal 97.1 and also had chills.   When she gets a fever she gets strange thoughts.   She did not feel like she wanted to vomit, she just did not want to eat.  She had to force herself to drink water as she did not want to, but knew that she had to.  She did not eat for the whole day or night, but on Thursday was drinking some.  She has had coffee today, still not hungry but feeling better.  Her arm is getting better, but not as bad as it did.  Her head has cleared and not fuzzy feeling like it was.    She had called the ER at where she got the vaccination, they told her that they could not help her with her side effects and to go to a satellite office or the ER.  Her arm was warm when she called them, but not necessarily swollen.
Patient said she started experiencing itching at vaccine site on right arm at 7:30 am on 11/28/2017, then by 11/29/2017 she noticed the vaccine site had swollen. She stated that she applied ice and also took ibuprofen, but no improvement in symptoms. I advised patient to take BENADRYL. Advised patient to call her doctor's office to schedule a visit. Patient's primary care physician contacted by phone but unavailable, and no option to leave a voicemail. Will still follow up with patient.
patient could receive a possible third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th September 2020) and Shingrix (2nd dose received on 21st December 2020).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient claimed that she had not received the 2nd dose of Shingrix yet, but the pharmacist stated that the facility had a record that the patient got the 1st and 2nd dose of Shingrix. The health care professional wondered if there was information about giving a 3rd dose of Shingrix to a patient since the patient could receive a possible 3rd dose of Shingrix, which led to extra dose administered. The health care professional called to request information about giving a 3rd dose to the patient. The reporter did not consent to follow up. Note: This case was conservatively kept valid with event extra dose administered as it was not clear if the patient had received the 3rd dose or not.
diffuse muscle pain; shivering / chills; back pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020 on unknown date) and Covid-19 vaccine (1st dose received on unknown date). Concomitant products included covid-19 vaccine.   On 14th April 2021, the patient received the 2nd dose of Shingrix. On 14th April 2021, 8 hrs after receiving Shingrix, the patient experienced muscle pain, shivering and back pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the muscle pain and back pain were not recovered/not resolved and the outcome of the shivering was recovered/resolved.   It was unknown if the reporter considered the muscle pain, shivering and back pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received 2nd dose of covid-19 vaccine in end of February 2021 concomitantly. The patient received the dose of Shingrix on left arm at her physician's office and 8 hours after the vaccination patient had diffuse muscle pain, shivering, chills and back pain. The patient received the 2nd dose of Shingrix later than recommended schedule. On 14th April 2021 the patient received Tylenol for treatment. The muscle pain and back pain was not resolved whereas the chill and shivering was recovered. The reporter stated that the 1st Shingrix vaccination received in 2020 but did not remember the exact date, but knew that it has been longer than 6 months. It was stated that the patient was told by her physician to delay her second dose of Shingrix so she could receive her 2 doses of Covid vaccine. The reporter consented to follow up.
Mother had called on 10/5/20 to report a local reaction at the injection site following administration of Flulaval to her son on 10/3/20; it was first noticed10/4/20.   Reaction described as quarter sized, swollen/ firm area that was tender to the touch.  No redness at the site; no other complaints reported.  Mother continued to monitor the site and noted that the reaction  began to resolve the day she called to report (10/5/20).  Mother was encouraged to notify child's pediatrician.  GSK was notified as well as Health Dept. medical director.
About 1 min after administration, patient started to look pale and clammy, offered her a seat. 1 min later she said she was going to sit down and sat directly on the floor. Her breathing became a little ragged and unsteady.  Her head dipper to her chest and she passed out, but did not stop breathing. Gentle shake of her shoulder and calling her name, she responded after about 5-10 seconds. Gave her some water, and had her sit on floor for about 30 minutes after this event, watching closely. No further recurrence or symptoms. Breathing returned to normal after about a minute or 2, clamminess ended after about 5, color was starting to return at about 20 minutes.
No additional AE reported. No PQC reported; HCP reports patient was accidently administered an expired dose of PNEUMOVAX 23 on Oct 21, 2022; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-OCT-2022, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, lot #U003306, expiration date: 15-OCT-2022 (strength, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.
Red rash that is a 1 inch 1/2 wide; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Red rash that is a 1 inch 1/2 wide) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 INJECTION SITE RASH (Red rash that is a 1 inch 1/2 wide). At the time of the report, INJECTION SITE RASH (Red rash that is a 1 inch 1/2 wide) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
My daughter had a peanut butter sandwich at 1145. She has never had a reaction to peanuts before. She had her four year old well check at 130, and they administered the MMRV and the DTaP vaccines at 145. At 2PM, we left the clinic. She started sneezing uncontrollably and her nose was running clear. She began complaining anxiously about her ears hurting. On the drive home, she started a dry repetitive cough. When we got home (220), she complained of something hurting on her foot. She had a hive. I took off her clothes and saw two more hives. She was crying a lot and then she started itching her eyes and ears like crazy, while more hives began appearing. I drove her to the ER. On the way to the ER, her ear and lip began swelling and she was trying to fall asleep (losing consciousness). I was shouting at her and she was responding when I yelled. When we got to the ER, they said her throat was swelling. They administered an epipen, benadryl, and 1-2 other antihistamines. She began resolving quickly with the administration of medicine. She had no other subsequent issues. Since then, we have tested her for peanuts, and she has 15.5 kU/L. We are going to do further testing for vaccine ingredients and a food challenge to see if she reacts to peanuts now.
On 10/24/2001 injection site from flu shot red, slightly raised, itches. Pharmacist informed same day. Took Tylenol. Site was marked around area of swelling, redness. Next day, all the symptoms resolved.
Pt received the vaccine on 3/24/21. On 4/12/21 pt died of cardiac arrest
Rash began 5-25-11. Consists of erythematous macules, almost confluent, most notable on chest, entire neck, up hairline, low back, groin region, axillary regions but also to arms & legs. Tx: Loratadine 10mg QD, Ranitidine 150 BID, MEDROL dose pak.
I95.9 HYPOTENSION 4/24/2023 OSTEOARTHRITIS OF LEFT KNEE
Narrative:  Right elbow swelling after second COVID vaccine on July 7. Had  rash on his back after second vaccine. Rash comes and goes since that time. Rash does itch Referred to dermatology Right hand tender with motion and left hand multiple ares of small areas of rash on back small area on stomach
The patient received the ZOSTAVAX vaccine on 3/16/2010 in the left deltoid. Two days later she returned, complaining of a large -2 cm- local reaction at the site of the injection. Over the next few days she developed a new rash on the right foot, ankle, and both legs and arms with severe pain in the fingers and a sensation of heat in her palms. There were no oral erosions. On physical examination there were multiple urticarial wheals on the arms and legs. On the right foot there was purpuric semicircular patch that spread between the inner aspect of the great toe and second toe. My diagnosis was serum sickness-like reaction possibly due to ZOSTAVAX. Confounding the history however, she had also taken a course of trimethropim-sulfamethoxasole on 3/19/10. It seems possible that BACTRIM was the cause of the entire picture. She was treated with prednisone -40 mg tapering over 12 days-and fexofenadine with excellent results.
No additional AEs; improperly stored vaccines; improperly stored vaccines; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-NOV-2021 and on 13-DEC-2021, the patient was vaccinated with an improper stored varicella virus vaccine live (oka/merck) (VARIVAX) vaccine subcutaneous injection, (lot # U010399, expiration date 01-APR-2023) (strength, dose and route were not provided) for prophylaxis. Temperature was recorded as 10 Farenheit (F), time duration was 350 hours and there was no previous temperature excursion. No further information was provided. No other adverse events was reported (no adverse event).
Drowsiness; aches and pains; normal headache; She gets migraines; She didn't go to work because it made her nervous; tongue has been numb; side of face numb; This is a spontaneous report from a contactable consumer (patient herself).   A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6200, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Age at vaccination 41-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included high cholesterol from an unknown date and unknown if ongoing she is not medicated because it is not at that point. The patient concomitant medications were not reported. The patient did not receive any other products. Caller confirmed product as COVID19 Vaccine. She was an educator. On an unspecified date, the patient had her Pfizer first vaccination yesterday afternoon. She had typical side effects such as, drowsiness and aches and pains. Her tongue had been numb since yesterday. She gets migraines and had numbness of the tongue and face, but the tongue and side of her face had remained numb since getting the vaccine. It is not as bad as yesterday, but it was still there this morning when she woke up. She didn't go to work because it made her nervous. With the side effects her coworkers had she wasn't sure if she needed to report it. No further details provided. The caller declined to provide HCP information. It was crazy at the site yesterday and she had been holding for a long time. She was sure it is crazy everywhere. After the vaccine she waited for 15 minutes. When she got in the car she noticed her tongue and side of her face were numb. She would say that was about 20 minutes after the vaccine. It was at 15:30 on 17Feb2021. Yesterday it was more of the right side of her face and today it is more so the left lower side of face that it numbs. Yesterday and today, it is the entire tongue that is numb. Numbness of tongue and face is normal for her with migraines, but usually it goes away. She had a normal headache, but not a migraine since getting the vaccine. There is a number on the card, but she was not sure what that is for. It was just weird that the numbness didn't go away. No. The only thing was in her 20's she had a positive TB test result. No further details provided. Prior Vaccinations, the patient had not received any other vaccine within 4 weeks. The patient underwent lab tests and procedures which included mycobacterium tuberculosis complex test: positive on an unspecified date the only thing was in her 20's she had a positive TB test result. The outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Light headed, Nausea, Elvated BP, irregurlar heart beat, arm tenderness lasting up to 3 days.
Right upper arm very sore at the injection site.  Nausea, headache, chills, shaking started Saturday night.  Work up Sunday,  November 8 with a temperature of 101.4,  extreme muscle aches, fatigue, weakness, headache, chills, nausea feeling.  Took aspirin and sudafed during the day every 4 to six hours.  Started to feel better at 9:00 pm Sunday night
"10mins post vaccination, pt c/o dizziness and the pt had a near syncopal event. Vitals: BP 92/66, HR 63, RR 16, SpO2 96% -- > 145/65, 73, 16, 99% -- > 110/72, 80, 16, 100%.  Pt stable and released from vaccination site. No known allergies or medications. PMH significant for Gallbladder Surgery in 2012 and a positive PPD s/p treatment in 2015.  More recent PMH unavailable to this writer."
mom gives hx of a fussy baby who did not sleep well or eat well the pass 16hr but pt nursed well @ office;mom noticed rash 5AUG AM diffuse, red macular rash from scalp to soles-including torso, extremities;
On the first day I woke up and threw up and had diarrhea,  that last for about 15 minutes.  I started experiencing chills, fatigue. and I called the physician and received Paxlovid and those symptoms lasted a few days and one the 16 th I tested again and was negative and once the Paxlovid was done I had rebound symptoms on the 17th and I had a sore throat and started feeling bad again.  I called the doctor and they said I was having rebound symptoms and I needed to isolate again.
I've been really dizzy, hard to breathe, chest pains, weird sensation going through my body and head. I've been to the e..r. twice in a week. My whole body aches.
About three days after getting the vaccine, I developed shortness of breath, sore muscles, low fever of around 100, and general fatigue. I took day quill and NyQuil on and off to  counter the fever. It?s been almost 3 weeks now and the symptoms are still the same. I heard of an enlarged heart that can come from this so it?s my biggest concern.
This spontaneous report was received from a registered nurse and refers to a 8 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 11-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L037559 with expiration date of 29-SEP-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 106 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1705USA014053:
Inadvertently administered the Menveo diluent component without the powder component to a patient; Inadvertently administered the Menveo diluent component without the powder component to a patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA641A, expiry date 30th June 2023) for prophylaxis.   On 21st June 2022, the patient received Menveo. On 21st June 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-JUNE-2022 This case was reported by the other healthcare professional. Reporter reported patient was inadvertently administered the Menveo diluent component without the powder component. Additional supportive information: As administered the Menveo diluent component without the powder component to a patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
soreness in the her right arm at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the her right arm at the site of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VACCINATION SITE PAIN (soreness in the her right arm at the site of the injection). At the time of the report, VACCINATION SITE PAIN (soreness in the her right arm at the site of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient had mild seizure like activity eyes rolled back of head, body was stiff. Pt says she heard music episode lasted about 30 mins.
He got his vaccine, he was fine at first during that hour, later on the next day he started to feel whelps on his back on the side.  He looked further and there was a red mark that was a little swollen and he felt a little pain.  He decided to call his doctor on that Monday, went to see him and said that he had shingles.  He was prescribed pills for a week, 3 times a day which kind of subsided.  His left side is now swollen, larger than the other.  He has slight discomfort and pain, not itching that much.  The middle of his back is kind of itchy every other day, and has some cream that he is applying that goes away and then comes back.  It has erupted some type of eczema in him, and cannot believe he has shingles. His doctor told him to probably not take the 2nd one, and he is not going to take it.  He took Valacyclovir for a week.  He hopes that this clears up and hopes he is not affected for the rest of his life.
Case number PHEH2014US022451 is an initial spontaneous report from the consumer received on 07 Nov 2014. This report refers to a 62-year-old female patient. She was vaccinated with FLUVIRIN (batch number: not reported) on 23 Sep 2014. On 07 Nov 2014, she was inadvertently vaccination with FLUVIRIN (batch number: 146501) instead of pneumonia shot. No adverse event reported following these medication errors.