chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 014F21A, 031M20A and 011L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medications were reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Swelling of lips, tongue, cheeks took benadryl continuously for 2 weeks ,  gradually was able to decrease, now just an occasional issue
Felt chills and aches next morning. Left work to rest and slept until 3pm. Visited physician. Body aches, stomach aches. Physician advised pt she had "stomach virus". Pt reports fever. Went to ER. Had diarrhea. Advised to take Tylenol and liquids.
migraine; vomiting; fever; chills; fatigue; joint pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 30Mar2021 at 10:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 15:00, the patient experienced migraine, vomiting, fever, chills, fatigue and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events migraine vomiting, fever, chills, fatigue and joint pain was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
3x3 cm red, firm area on right upper thigh, 2 hours to where Immunization was given.
This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored (Temperature -15.5C to -10.2C; from 01-JAN-2016 to 22-MAR-2016) dose of (Oka-Merck) PROQUAD lot # l040411 expiration date 13-APR-2017, (administration routes were not reported). No concomitant therapies were reported. The Pharmacist stated that he had no knowledge if adverse events were reported or not. This is one of several reports from the same reporter. Additional information is not expected, since there was no consent to contact the reporter to follow up.
Pt mentioned she was very afraid of needles/shot & usually passed out. After receiving the shot, pt seemed fine. But about 30 secs later pt said that she's scared & began to shake & had convulsion like symptoms. Pt experienced involuntary incontinence sxs. Pt's mother was holding her & comforting her & pt recovered. Pt rested for about 5-10 min, had some water & left the pharmacy. Called pt's home at 3:20pm. Mom states pt is fine.
This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. On 21-MAR-2013 the patient was vaccinated with the first dose of RECOMBIVAX (10 Microgram, route not reported) and then received a second dose of RECOMBIVAX HB (10 Microgram, route not reported) on 17-JUN-2013. Concomitant therapy was not reported. No adverse symptoms were reported. Additional information has been requested.
Five to ten minutes after the vaccine I got red, head itched/sweaty and face was tingly as well as hands. My heart rate went up to 186 I became Tachycardia. I t came in all of a sudden.  I ended up going to the E. They gave me IV fluids, Benadryl thru the IV. They also did a CT scan on my brain.   After three hours they discharged me . I felt  Tachycardia for about two days after. After the 2-3 day I felt better.  I had another Tachycardia episode  on January 25,2021- I was scheduled to get my second dose but didn't get it done.  It just hit me and my heart rate went up, it has not gone away and have been dealing with it for about two weeks. I have a heart monitor on me.  I saw a Gastrologist and they want to do an EGD to rule out ulcers.  I'm not able to eat without feeling a hot rush and my heart rate going up.  I have lost 12lbs since the 20th.
Chills, nausea, dizziness - onset 12 1/2 hrs after vaccination.  Continued for 24 hrs. Bruise about size of nickel at injection site, though I did not feel the injection.  Injection spot  has 1/4 inch red spot with 1/8 inch raised area in middle that looks similar to start of a pimple.  Rash below and in front of injection site -- size of a quarter.  All visible 60 hrs after injection with no change.
Severe headache 7-8/10, global, pulsatile.  Not improved with Tylenol.  Unable to perform normal activities.  Missed work due to pain.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 20-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Atopic dermatitis also known as Eczema  that persisted 10 years afterwards.
This spontaneous prospective pregnancy report has received from 22 years old female patient, for VARIVAX (Merck), a Pregnancy Registry Product, concerning herself with no pertinent medication attention or drug allergy. The patient was vaccinated with a dose of VARIVAX (Merck) on 03-JUN-2012. The patient stated she found out she was pregnant after getting the vaccine. Pregnancy test was performed. The patient sought medical attention by office visit. Follow-up information received. The lot number 0471AE of VARIVAX (Merck) involved, was verified as a valid lot. Additional information has been requested.
This spontaneous report as received from a consumer refers to an adult (currently 39 year old) patient of unknown gender. The patient's medical history was not reported. In 2009 (exact dates were not reported), the patient was vaccinated with the first two doses of GARDASIL (lot #, dose, route and site of administration were not reported). In approximately 2015 (reported as "this past week"), the patient was vaccinated with a dose of GARDASIL. No adverse effects were reported. Additional information has been requested.
Pt recvd 1st dose of Recomb in approx JAN91 & approx 1 wk post vax devel pain & swelling of the lt ankle which required a visit to ER; Uric acid & x-ray were nl; pt tx meds & ice packs;
10:01amMember had a Vaccine reaction on 1st dose of Covid vaccine with lip and facial numbness and tongue swelling with lip twitching and shortness of breath. Member did not inform staff on second vaccine that she had an allergic reaction. Member answered no to all covid vaccines questions. Member left vaccine table after getting vaccine and came to side table with admin staff to inform that she was having a reaction. At that time member informed staff that she had a reaction to 1st dose of covid vaccine. Noted member upper lip twitching. Member stated that her tongue felt like it was swelling and her lips are numb. Medicated with Epi pen .3mg SQ right thigh and Benadryl 50 mg IM. Paramedics called to transport.
Child started breaking out on 9/13/02 in am. Red dots all over child's body (>100 spots). Pt brought in and dx: with chicken pox.
Pain concentrated in lower back making it painful to stand; by Tuesday moved to back of both knees; by Thursday concentrated only in left leg causing throbbing in leg.  Still some pins and needles in outside of left foot
same leg of the injection site of the thigh to swell to double its size that night; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 7 years old male patient who experienced same leg of the injection site of the thigh to swell to double its size that night (swelling), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included Fluzone Quadrivalent with no reaction.  The patient's past medical history, medical treatment(s) and family history were not provided.    On 10-Nov-2018, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6262LA via intramuscular route in the thigh nos.  On 10-Nov-2018, the patient developed a non-serious same leg of the injection site of the thigh to swell to double its size that night (swelling) on same day at night following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was same leg of the injection site of the thigh to swell to double its size that night.  the consumer was taken to the emergency room on the same day of the injection; that the exact treatments were not known by the caller but possible Benadryl, that the consumer was advised not to get the Fluzone Quadrivalent again.  The father of the consumer, a physician as well, is contemplating the nasal mist influenza immunization.  The patient outcome is reported as Unknown for same leg of the injection site of the thigh to swell to double its size that night.
received a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7GM34, expiry date 10th February 2023) for prophylaxis.   Previously administered products included shingrix (1st and 2nd dose received on an unknown date).   On 29th October 2021, the patient received the 3rd dose of Shingrix. On 29th October 2021, 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 pharmacist reported that, the patient accidentally received third dose of Shingrix, which led to an extra dose administered. The reporter consented to follow up.
Headache; Nausea; Tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Lot number: Unknown), for Covid-19 Immunization, reaction(s): "Headache", "Nausea"; Covid-19 vaccine (DOSE 2, SINGLE; Lot number: Unknown), for Covid-19 Immunization, reaction(s): "Headache", "Nausea"; Covid-19 vaccine (DOSE 3, SINGLE; Lot number: Unknown), for Covid-19 Immunization, reaction(s): "Headache", "Nausea"; Covid-19 vaccine (DOSE 4, SINGLE; Lot number: Unknown), for Covid-19 Immunization, reaction(s): "Headache", "Nausea". The following information was reported: HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Caller was inquiring about the Pfizer Covid-19 vaccine bivalent booster. They just received it with her husband and they are elderly. She wants to know long the bivalent booster will last and they will get another one. It was reported that the patient had the first, second, third and fourth doses of the COVID 19 vaccine. Now we received this new Omicron BA4/BA5 dose. When the information was shared, caller mentioned she  had a little bit of a headache and nausea, but we the previous vaccinations the patient  had similar effects that last 1 day or 2, so patient was not worried about it. She also mentioned that they got COVID in Jul, but that it was very mild. She mentioned she still had some tiredness, but that she was old. Caller declined to be transferred and mentioned that she will call and report it in a couple of days in case these do not go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
loss of taste and smell; loss of taste and smell; he has difficulty breathing through his nose; inflammation in his nose; congestion in his nose; he has congestion in his chest and head; he has congestion in his chest and head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Lot number: GH9697) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing). Concomitant medication(s) included: AMLODIPINE oral taken for hypertension (ongoing); LOSARTAN oral taken for hypertension (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Site of injection: left arm , Route of Administration: Intramuscular, Batch/Lot number: EL9267), administration date: 11Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Anatomical Site of injection: left arm, Route of Administration: Intramuscular, Batch/Lot number: EN6205), administration date: 04Mar2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical Site of injection: left arm , Route of Administration: Intramuscular, Batch/Lot number: F31611), administration date: 24Nov2021, when the patient was 72-year-old, for COVID-19 Immunization.  The following information was reported: UPPER RESPIRATORY TRACT CONGESTION (non-serious), RESPIRATORY TRACT CONGESTION (non-serious) all with onset Oct2022, outcome "unknown" and all described as "he has congestion in his chest and head"; NASAL CONGESTION (non-serious) with onset 28Oct2022 at 20:00, outcome "not recovered", described as "congestion in his nose"; DYSPNOEA (non-serious) with onset 30Oct2022, outcome "not recovered", described as "he has difficulty breathing through his nose"; NASAL INFLAMMATION (non-serious) with onset 30Oct2022, outcome "not recovered", described as "inflammation in his nose"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 30Oct2022, outcome "not recovered" and all described as "loss of taste and smell". Therapeutic measures were not taken as a result of nasal congestion, ageusia, anosmia, dyspnoea, nasal inflammation, upper respiratory tract congestion, respiratory tract congestion.  Additional information: The reporter stated that  he had difficulty breathing through his nose. Clarified as congestion in his nose, inflammation in his nose from using a tissue. he had congestion in his chest and head and loss of taste and smell.
wihin 2hrs of second dose develped severe headache. 16hrs later developed same adverse reaction as had with Losartan . Listed as "rare" had severe stabbing pain from bilateral foot to  calves, started as  Losartan reached theraputic level and worsened, so stopped med.  2 yrs later was still having occasional episodes of this pain. Had not had an episode in over 6 months and then BAM! 16hrs after 2nd dose hit with avengence and was sporatic. It is waning now but felt still felt it needed to be reported, not sure what the connection is.
Pt has her 2nd dose of her COVID shot on Sunday October 17th 2021. Monday-Tuesday morning she noticed dizzy and could not walk. Pt thought she might had a fever due to being hot and sweating but never assed her self for a fever. Pt stayed in be on Monday and did not eat because she was not hungry and was afraid to fall. Pt lives by herself.
About 15 minutes after the patient had the shot, she said her hands were shaky. I asked her to sit a little longer and I offered her some water. About 5 mins later I asked how she was feeling and she said she still felt shaky and thought her hands felt numb. I asked her to continue to sit down and relax. I quickly called our local EMT paramedic service. About 5 minutes later, 2 paramedics showed up, spoke to her, and took her to their mobile service. I called the patient on the next day i.e. 4/25/21 and spoke to her father, who had brought her in for her shot the previous day. He said the paramedics said her blood pressure and oxygen saturation were fine, so they opted to go home instead of to the ER. He said she was doing better at home on 4/25 but still had some cold and flu like symptoms. I asked him to keep us updated and to also inform her primary care provider, so that a decision can be made whether she should continue the Moderna vaccine series or otherwise.
Chills, body aches(especially in hips) sore arm where shot was given, minor headache. Symptoms last about 13 hours Treatment was Ibuprofen and rest. Symptoms were bad enough that I couldn?t go to work.
intradermal inject of  vax 3 - area of redness & swelling; No systemic sx;
A few days after receiving vaccines, her left arm began to turn red. It slowly blistered and she went to the hospital. Hospitalist diagnosed her with cellulitis.
Chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in 2022 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: CHILLS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt presented to the ED on 2/10 with CC of altered mental status. Pt was noted to be more confused for the past 3 days. She  tested positive for COVID-19 infection.  She was treated with Remdesivir for 5 days.  She was not started on Decadron as she was not hypoxic.  CXR showed no pneumonia. Patient's mental status slowly improved and suspected to be due to COVID-19.
dry mouth, heart palpitations, inc BP, inc pulse rate; light headedness; weak legs;
3 days later she got COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (3 days later she got COVID) 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 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced COVID-19 (3 days later she got COVID) (seriousness criterion hospitalization). The patient was hospitalized on sometime in August 2021 due to COVID-19. At the time of the report, COVID-19 (3 days later she got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment of the event included antiviral drugs.  3 days later the patient got covid. While the patient was in the hospital she was tested positive for covid and got antiviral on 11 AUG 2021 and she quarantined for 10 days. The patient is now due for her 2nd dose.  Company comment- Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Sudden onset dizziness and syncope while sitting in vehicle. Event occurred within 2 minutes following vaccine. Pt unresponsive for 30 seconds, pale, diaphoretic. Once awake, groggy but oriented. Unable to obtain blood pressure due to hypotension, pulse 40 and thready. After approximately 5 minutes, patient's color improved however blood pressure remained low. EMS called. Pt evaluated and was advised to seek further medical care.
HEADACHE, DIZZY FAINT FEELING, STOMACH PAINS, FEVER, BODY ACHE, NAUSEOUS, SLEEPIESS.
Information has been received from a physician concerning an 8-year-old white female who on 15-JAN-1999 was vaccinated with a dose of Varivax. The physician reported that on 16-OCT-2006, the patient developed varicella characterized by five lesions on her chest and abdomen. It was unknown if medical attention was sought. No laboratory/diagnostic tests were performed. At the time of this report, the outcome was unknown. Additional information has been requested.
Recieved Menquadfi on 8/8/23 in R arm, now with significant redness & swelling in R arm. No fever. Large area of erythema, warm and swelling on R arm. Cellulitis of right upper extremity. Cephalexin 500mg capsule - 1 capsule by mouth 3 times a day for 10 days. Diphenhydramine 25mg capsule - 1 capsule every 6 hours as needed for up to 10 days