chrisvoncsefalvay/vaers-outcomes huggingface dataset:
receive a second dose for shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21st September 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: receive a second dose for shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-MAR-2023 The pharmacist called to report a late second dose of Shingrix The health care professional (HCP) firstly reported patient had not received a second dose, later on in the same call reported, that this patient did receive a second dose for Shingrix but date for the second dose was unknown. Information about lot number and expiration date was asked and hcp look in their system but it was not registered, so it was declined. The reporter consented to follow up via email. This case was linked with US2023043217 reported by the same reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2023AMR043623:Same reporter
Pt was given injection at 15:30 on Friday. Saturday at 16:00, injection site was the size of a baseball, red, hot and itching. He was given 2 tsp Benadryl and inflammation was gone the next morning.
Child with red, warm swollen R thigh at injection site. Area is 11 cm wide and 10 cm long. R thigh is 35.5 cm in circumference and L thigh is 34.5 cm. No swollen glands or other s/s at this time.
This spontaneous report as received from a 63 years old female registered nurse reporting on herself with chronic fatigue syndrome, fibromyalgia, bone spurs in knees, lumbar, unspecified thoracic and cervical disk problems, penicillin allergy, cephalosporin allergy and serious dermatitis allergy to mycin. On either 24-JUL-2013 or 25-JUL-2013, the patient was vaccinated with ZOSTAVAX (lot number, dose and route were not reported). Concomitant therapy was not reported. In July 2013 40 hours after administration, the patient developed cellulitis in the arm where ZOSTAVAX was administered, a headache, hives and itching on her arms, ringing in her ears, itching around her mouth and a slight swollen tongue. The patient took BENADRYL immediately and the adverse symptoms did not get worse. The nurse reported that she was still breaking out in hives on her arms and on unspecified dates recently she developed a few additional hives on her legs, feet, earlobe and shoulder. There were no hives on the nurse's trunk area. The nurse declined the VZVIP packet because she stated the adverse reaction was definitely hives and was not varicella-like. The nurse stated that since ZOSTAVAX was administered she had gone to an unspecified urgent care facility two times on unspecified dates and to the emergency room two times on unspecified dates. During those visits the nurse was treated with ATARAX and unspecified steroids. The nurse reported that these adverse symptoms had improved slightly. The nurse also reported that recently on an unspecified date she developed an unspecified respiratory allergy and needed to use oxygen therapy. Relationship between the events and ZOSTAVAX was not reported. The nurse considered respiratory allergy and needed to use oxygen therapy medically significant because oxygen therapy was used to prevent serious criteria. Additional information has been requested.
Patient began having lots of abdominal and side pain.  Went to the ER to rule out appendicitis.  ER sent pt home.  He continues to have pain in side, abdomen and now  pain in back and front of legs, also has fatigue, very winded and sort of short of breath and also dizzy.
Patient had fainted about 5 minutes after the vaccine was give. Patient was pale and non-coherent before fainting.  Patient was placed on the floor, her feet were raised and chest compressions were started for 15 seconds before patient came too. EMS was called and arrived shortly after the patient came too EMS checked the patients vitals and gave the okay that there was no need for a hospital visit and the patient was fine. The EMS concluded that it was nothing more than a vagal response to the shot.
Information has been received from a health professional concerning a 19 yr old female, with no pertinent medical history and no known allergies, who was vaccinated with first and second 0.5ml SC doses of varicella virus vaccine live on 18May05 and 15Jun05 respectively. Concomitant therapy included hormonal contraceptives (unspecified). It was reported that an antibody titer was drawn 2 weeks after the second dose of varicella virus vaccine live, on approx 29Jun05, with the results of some conversion, not enough. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Broke out in rash within 24 hours of receiving vaccines, rash on trunk and face.
sudden hearing loss; This is a spontaneous report from a contactable consumer (patient's son) via medical information team. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number: not provided, expiry date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sudden hearing loss (medically significant). Patient got treated immediately and got his hearing back, it was not as good as it was before. Patient did not have any hearing issues like reporter does. The outcome of the event was recovering.  The lot number for the vaccine was not provided and will be requested during follow up.
Constant ringing in both ears, tinnitus.  Onset two days after second dose.  Ringing remains constant, not getting worse or better.
arm swollen, febrile-reported to clinic 26AUG93, recvd shot 18AUG93;
Expired vaccine was stored and then administered; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that vaccine did not undergo any temperature excursion and patient did not experienced any adverse event and the date vaccine placed in refrigerator was on 26-Oct-2021.
18JAN2023 I woke up and felt something was wrong not normal I had a lot of congestion in my nose and throat over the next several days it got worse I was able to cough up a lot of mucous out of my throat it was clear as was the mucous in my nose I had no fever but I was very tired an weak and did not have a normal appetite but made my self eat. These symptoms continued then today 30JAN2023 I tested negative for the first time. I am still bringing up mucous from my throat and nasal passages and still feel tired.
member presents for discussion regarding COVID 19 vaccine reaction. he had the first dose on Nov 9, 2021 Pfizer , administered at the 177MDG . He developed chills several hours  later , as well as  bad headache, and fatigue in his legs.  then the following day developed facial swelling, lip dropped, ( ? bells palsy) wrist swelling and numbness of the arms and legs, Went the ER for evaluation, Lyme and mono  were negative on lab testing .CT scan of the brain was normal . He  was released to home .  He then saw his PCP and was dx with possible bell's palsy, still had fatigue, facial swelling and limb numbness. On  14 Nov went to the ER for chest pain, had EKG with minor abnormalities.  Evaluated and released . Chest pain lased about 24 hrs . Did not have an echo. Other than the random welts ( HIVES) which are continuing  the other  symptoms resolved .
This nurse removed opened vial of Moderna from storage, 2-8 C. Placed in cooler with ice packs along with two other unopened vials of Moderna. This nurse then transported and gave the three vials to the agency nurse. Agency nurse administered open vial of Moderna to persons who had signed up for the Booster vaccination of the Moderna Vaccination 0.25ml. Once completed updated Manager that the bottle given to her was open and was going to open another vial. This nurse confirmed with the manager that the bottle had been opened previously, 1/19/2022. This nurse had mis read the storage information regarding Moderna to be stored unopened and unused for 30 days. This nurse made telephone call to each person affected by this opened vial. Per Medical Director Dr., offered everyone a dose of 0.25ml out of the new unopened vial. RN
administration of expired dose; 15 month old received boostrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9BC23, expiry date 30th January 2022) for prophylaxis.   On 11th February 2022, the patient received Boostrix. On 11th February 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: Medical assistant reported that an expired dose of Boostrix administered to a 15 months old patient, which led to expired vaccine used and inappropriate age at vaccine administration. The reporter consented to follow-up.
Right leg swollen two times its size. Positive erythema and warmth all over leg.
On 2nd day following vaccine I woke with a really hard jaw pain  Its hard to eat, chew  or even open mouth. Now on 2/26/21 it still hurts however it is better, there is a slight swelling at the bottom of my right ear. The bone.( It seems) Question is:  is this a known reaction? About 10 minutes following the vaccine my upper left lip became numb ,but only a few seconds then disappeared.
sore arm; buzzing (like static from a tv) in both his ears; really tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), TINNITUS (buzzing (like static from a tv) in both his ears) and FATIGUE (really tired) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002b21a and 024m20a) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included HYDROCHLOROTHIAZIDE, TELMISARTAN (MICARDIS HCT), DILTIAZEM (CARDIZEM [DILTIAZEM]), ZOLPIDEM, CINNAMON [CINNAMOMUM VERUM], TEA, GREEN, VITAMIN D3, FISH OIL, MULTIVITAMIN [VITAMINS NOS], CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, MANGANESE ASCORBATE (COSAMIN), VITAMIN B6, VITAMIN B3, VITAMIN B12 NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), TINNITUS (buzzing (like static from a tv) in both his ears) and FATIGUE (really tired). On 16-Mar-2021, FATIGUE (really tired) had resolved. On 17-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, TINNITUS (buzzing (like static from a tv) in both his ears) had not resolved. Not Provided          No treatment information was provided. The patient has an appointment with health care provider scheduled for 01-May-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-073700 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073700:1st dose events
He feels like he is coughing like when he had pneumonia; She stated he is short of breath; tired; This is a spontaneous report from a contactable hcp (LPN and patient's girlfriend).   A 54-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in left arm, on 25Aug2021 (Batch/Lot Number: F3180) as a single dose, for covid-19 immunisation. Medical history included pneumonia. Concomitant medications were not reported.  The caller stated she wanted to find out if the reaction or side effects that that her boyfriend is having are normal. She stated they are not really on the list but she is not sure if it could still be potentially from the vaccine. She stated it is related to breathing issues. She stated he is short of breath on 29Aug2021. He feels like he was coughing like when he had pneumonia, but he was cold then and he is not cold now. She stated he was coughing and is tired. She stated the shortness of breath was not that prevalent but the coughing is making him feel short of breath. She stated he still went to work today and was really run down but he did alright at work. She stated this could be something new after he got back from traveling. He received the vaccine on "the 25Aug2021" but didn't have symptoms until last night and this morning. She stated she was not sure if those go under shortness of breath like an allergic reaction or whether this is normal. His cough was worsening, and its like he was more tired, it takes him more time, like a minute or 2, to get back to normal, he's winded and  he doesn't feel right, he said it feels like back when he had pneumonia before, but that was when the weather was cold. Caller states that she has tried to hear him and she cant hear anything, it feels like he needs to expel something, caller clarified she tried to hear her boyfriend with a stethoscope and she was not able to hear anything, she listening while he was doing normal breathing. She did not hear anything wet.  The outcome of the events was unknown.          .
a rash "shaped like 25 cents" which burns, on her left arm, surrounding where she received the vaccine/ got a rash on her skin that started to burn; a rash "shaped like 25 cents" which burns, on her left arm, surrounding where she received the vaccine/ got a rash on her skin that started to burn; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Apr2021 09:11 (Batch/Lot number was not reported) as single dose at left arm for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced after she left, she developed a rash "shaped like 25 cents" which burns, on her left arm, surrounding where she received the vaccine. She's got a rash on her skin that started to burn. Outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Symptoms started 13 hrs after shot-felt like throwing up for about 2 hrs had very severe body aches all over-which lasted 12 hours.
(09/23/16) PT DESCRIBED SORENESS AT SITE OF INJECTION AND BRUISING 5 DAYS AFTER INJECTION WITH FLUZONE HD. OBSERVED FOR A FEW MORE WEEKS, PAIN ALLEVIATED BUT SLIGHT DISCOLORATION UNDER SKIN. PT CONCERNED THAT THE LIGHT BROWN DISCOLORATION UNDER SKIN MAY POSSIBLY LEAVE A SCAR OR A MARK. HAS NOT SOUGHT MEDICAL ATTENTION.
red blotches; itching (fire ants); arm swelled a little; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches), PRURITUS (itching (fire ants)) and PERIPHERAL SWELLING (arm swelled a little) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergies to several medications but not severe).    On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (red blotches), PRURITUS (itching (fire ants)) and PERIPHERAL SWELLING (arm swelled a little). At the time of the report, RASH MACULAR (red blotches), PRURITUS (itching (fire ants)) and PERIPHERAL SWELLING (arm swelled a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that pharmacist did go over his medication. Patient took b  No relevant concomitant medications were reported.
on set ~6/21/21  moderate/sever weakness and fatigue. Went o hospital on 7/10/21 Dx Acute Kidney Injury
I have not received my period since getting the vaccine/ Period has been regular for 15+ years.; This is a spontaneous report from a contactable consumer or Other-HCP (patient). A 37-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0153), via an unspecified route of administration in Arm Left on an unspecified date Apr2021 10:00 AM (age at the time of vaccination 37-years-old), as a single dose for COVID-9 immunization. The patient's medical history included Migraine. Patient had no known allergies. The patient's concomitant medication includes Topamax, Maxalt, Amitriptyline, and Multivitamin. No prior Vaccinations within 4 weeks. No covid prior vaccination. No covid tested post vaccination. On 09Apr2021, the patient experienced I have not received my period since getting the vaccine/ Period has been regular for 15+ years. On an unspecified date, the patient underwent lab tests and procedures which included pregnancy test: negative, I have confirmed negative blood pregnancy test from physician. Patient received Medroxyprogesterone 10mg as a treatment for adverse event. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered.  No Follow-up attempts are needed. No further information is expected.
Sore Arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.            No concomitant medications were reported. Treatment information not provided.   This case was linked to MOD-2021-216918 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: TCR-patient declined having ever called in to report any events.; Sender's Comments: Verified speaking with initial reporter/ patient. Patient declined having ever called in to report any events. She declined FU attempt and disconnected the call.
pt tested positive for COVID on 7/9/21 s/p 2 doses of Pfizer (2/27/21 & 3/20/21); pt was treated with Regeneron on 7/13/21
Patient complained of dizziness. Patient's blood pressure taken. Patient given water and snack and felt better.
HCP calling to report an infant spit up after receiving first dose of ROTATEQ.  HCP reports the mother had just fed the infant and burped them, and this occurred right after administration of ROTATEQ.; accidental underdose; This spontaneous report was received from a registered nurse and refers to a 2 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), first dose, orally (lot #, expiration date, dose and frequency were not reported) for prophylaxis.      On an unknown date, after receiving the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), the patient spit up. The reporter mentioned that the mother had just fed the infant and burped them, and this occurred right after administration of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).   At the reporting time, the outcome of the event infantile spitting up was not reported.The reporter did not provide a causality assessment between the event and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).
Chills, joint aching, sore gums, tired, pain at in jecrion site, delay rash, itchy, red raised.
@3:52pm pt c/o headache, dizziness and nausea. Pt. placed in gurney to restwith HOB elevated. V/S monitored.  Vitals: 102/63 BP, P-62, RR-17, o2 - 98% RA  Patient had sips of water with relief of nausea noted.  Vitals monitored   @4:18pm vitals BP: 100/70 , P-73, RR-17, o2 -99% RA  @4:20pm - pt. verbalized recovered from symptoms. Pt. sent home. Advised to notify primary MD of recent COVID-19 S/E.     #21: pt. stable and sent home
Pt recvd Hep B vax & on 23MAY91 pt devel a rash; no further details were provided;
She stated a girl in her orthopedic office also dealt Joint pain this for 6 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "She stated a girl in her orthopedic office also dealt Joint pain this for 6 months".  Additional information: Reporter knows for a fact she was not the only person that was dealing with the joint pain. She stated a girl in her orthopedic office also dealt with it for 6 months and it went away for her.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300156123 same reporter/drug, different patient/event;
Red rash around vaccine site 12 days post vaccine.  Warm to the touch and itchy.