chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used, 7 days from first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used, 7 days from first puncture) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used, 7 days from first puncture). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used, 7 days from first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received is Non-significant.
Nausea followed by syncope night of 10/20/2008 which resulted in a head injury requiring 8 stitches from ER. Had another severe dizzy spell with nausea and sweating morning of 10/22/08.  12/31/08 Reviewed ER records of 10/21/2008 & 10/22. FINAL DX: syncopal episode & scalp laceration closed w/8 staples.  Lightheaded & vertigo. Records reveal patient experienced nausea & when got up from bed to walk to bathroom fell hitting her head.  Minimal LOC.  D/C to home.  Returned to ER next day w/dizziness & vertigo.  Found to have orthostatic changes, UTI & dehydration.   Tx w/IV fluids & d/c to home on oral antibiotics.
'sickness' in his stomach'; This case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced stomach discomfort. On an unknown date, the outcome of the stomach discomfort was recovered/resolved.   It was unknown if the reporter considered the stomach discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received but did not know which arm her husband received his, and that he only had the sickness in his stomach but was fine at the time of reporting. The reporter did not consent to follow up. The caller stated she did not had any HCP contact information. This case linked with US2020AMR149422, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR149422:same repoter
Experienced dizziness and vertigo for 2-3 days. Broke out in hives day after vaccination which continued for 3 days.  Body aches, headache and fatigue.
This case was considered medically important. Information regarding PREVNAR 7 was received from a nurse regarding a 28-month-old male patient who experienced Streptococcal pneumoniae bacteremia - serotype 19A, and invasive pneumococcal disease Serotype 19A -  drug ineffective. The patient received the fourth dose in Feb-2008. The patient experienced Streptococcal pneumoniae bacteremia - serotype 19A in Apr-2009. The patient was taken to the Emergency Room due to a high fever. Diagostic test were performed (see test results) and the patient was admitted to the hospital. Treatments were not reported. The patient was discharged from the hospital after about one week. Streptococcal pneumoniae bacteremia and pneumococcal infection resolved. No additional information was available at the time of this report.
This spontaneous report as received from a pharmacist refers to a 77 year old male patient. The patient's medical history included: difficulty sleeping and high blood pressure. The patient was vaccinated with 0.5 ml PNEUMOVAX 23 once in the deltoid region of his right arm on 25-OCT-2012. Lot number H010916; expiry date 15-FEB-2014. Earlier the same day the patient received a flu shot (not otherwise specified) in his left arm. A shingles vaccine (not specified) was administered one month before in 2012. Concomitantly the patient took AMBIEN, tramadol hydrochloride, aspirin (81 mg daily) and amlodipine besylate, LOTREL 5/20. On 25-OCT-2012 the patient experienced aching all over and his right arm was twice the normal size, really hot, and hurting. The patient was advised by the pharmacist to take BENADRYL and TYLENOL. No laboratory testing was performed. At time of the call the patient reported that the achiness was better, he was using an ice pack on his right arm. The patient reported that he could not lift his right arm above his shoulder without excruciating pain. The pharmacist was planning to notify the patient's physician regarding the events. The outcome of the events swollen right arm and pain while lifting his right arm were not provided. The relatedness for the events for PNEUNOMOVAX 23 was not provided. Additional information has been requested.
slept for 2-3 days; Body was Sore; First Dose: Diarrhea; worn out; Arm was sore; This is a spontaneous report received from a contactable consumer (patient's husband). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Jan2021 13:45 at 61 years old (Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included ongoing seizure, seizures began when she was 5 years old, minor seizures. Seizures were under control in 1984, possibility configuration it is the right cocktail; Nerve injury; swelling on the wound leg; Blood pressure abnormal. Family history was none, states her Dad died last year, he was old, died of old age and natural causes. As people get older their body falls apart, nothing that is cancerous. States her Mother died of her heart, something to do with the heart and that was before they got married in 1984, he never met her mom. Concomitant medications included ongoing gabapentin taken for Nerves, she has been taking that for the last 7 years, states she has a wound on her left leg and that was being treated by a wound doctor for the last 7 years, states he got tired of what the wound doctor was doing so he drove her to (withheld) to be treated. Caller states the wound doctor at (withheld) made a suggestion on how to bandage it up and medicate it and it went from 8Jan2021 length was 7.5mm by 10mm and with (withheld) suggestion yesterday it was 1mm by 0.7 mm, so half the size of a penny, states he anticipated within the next week or two weeks that it will be healed; ongoing valproate semisodium (DIVALPROEX) taken for seizure, states she has been taking for at least 20 years; ongoing furosemide taken for Water Pill, states she takes it to reduce swelling on the wound leg; states he gives it to her on the odd day of the month; ongoing metoprolol taken for Blood pressure abnormal, start and stop date were not reported; ongoing zinc taken for an unspecified indication, start and stop date were not reported; ongoing acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported; ongoing pramipexole taken for seizure, start and stop date were not reported, states she takes it at 6pm, because it makes her drowsy and so the best time is at night time when she goes to bed; ongoing Vitamin C taken for an unspecified indication. No other vaccines were administered on same Date of the Pfizer Suspect, every year they get the flu shot and everything is normal. Caller states his wife got her first shot on 09Jan2021. States the effects started immediately, her arm was sore and then the next day (10Jan2021) her body was sore and she had diarrhea for 2-3 days and she also slept for 2-3 days, she was worn out. On the 3rd or 5th day she said she feels good, lets go. Caller states, then they were okay. The outcome of the events was recovered on 12Jan2021.
This spontaneous report was received from a physician and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown date in 1991, the patient was vaccinated with a dose of RECOMBIVAX HB 10/1.0 mcrg/ml injection, intramuscularly in her hip for prophylaxis (dose, lot# and expiration date were not reported).  On an unknown date, the patient had unspecified immunity testing for hepatitis B virus performed, with a negative result. Product quality complain was not reported.      The outcome of of the event was not reported. The relatedness between the event and RECOMBIVAX HB was not reported.  Additional information has been requested.
Patient awoke on Tuesday morning with a rash covering entire body with severe itching and hives on back.
Mouth inside cheeks inside lip area., raw thicker,, slight burning on left side corner of the lips and inside left side to upper.  Worst started April 30 with immediate swelling including change in throat. Took Hydroxizine. The throat got better aware of inside mouth swollen.
Starting in August 2021, I started having irregular and heavy menstrual cycles. I have been on the birth control pill after giving birth in 2017. I have always taken the pill at the exact same time each day and every day. I have always had a very light period that only lasted about 2 days each month. This was consistent every month while on birth control. I have never had a heavy period. Each month after August 2021, I continued to have a more heavy period with blood clots and had a period almost 20 days out of 30-31 days. I called my doctor 3 times and they increased my birth control to prevent the constant bleeding. November 4th, 2021, I got an IUD inserted and my OBGYN also noticed many blood clots in my cervix while she was inserting it during the procedure. I have also felt more fatigued and bloated lately, all during this constant menstrual cycle over the past few months.  I have also had 5 urinary tract infections since getting my 2nd dose of the vaccine causing  physical pain each time. It took longer than usual for my antibiotics and pain medicine prescribed to me for my urinary tract infections to take affect.
DTaP and IPV were administered at left deltoid location on 5/11/2005.  The next day the left upper arm developed swelling.  Swelling increased and became erythematous over the next day.  Patient was assessed at the office 5/13/2005 and had a 10 X 10 cm swollen, erythematous, warm area over the left deltoid and upper to mid triceps area of the left arm.
Myalgias, fatigue, falling asleep during the day while at work. Sx lasted for three weeks.
Symptoms:  Leg & Body Aches;  Temp. 100.1;   Heart Rate above 110's;  Headache;   weakness,  lasting 2 days.
Sore arm at injection site within two hours of shot.  Then by 6 p.m. or so that night, body aches, headache, chills and fever.  Feeling like I had been hit by a truck.  Difficulty sleeping as it was painful to roll over.  Arm at the injection site is bruised today.
Tinnitus presented 8 days following first dose (2/22/2021) and has persisted since with concomitant high frequency hearing loss.
Medication Came Out and Dribbled on Patient's Arm; Initial Report Received on 18-Aug-2021 and 20-Aug-2021  A pharmacist reported that a 43 year-old male (race and ethnicity not provided) during administration of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, a small amount of medication dribbled on the patient's arm.  No relevant medical history was reported other than allergies to sulfa antibiotics.  No relevant concomitant medications were reported.    On 18-Aug-2021, the patient received a dose of HEPLISAV-B (Lot # 934598, expiration date 25-Feb-2022 and NDC # 4 3528-0003-05) in the right deltoid from a pharmacy intern. During administration of the injection, the patient flinched. A small amount of medication came out and dribbled on the patient's arm.  No additional information was reported. No quality investigation was conducted as it was not specified where the small amount of drug came out from nor were any other details provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
her 2nd Shingrix, as it has been more than 6 months since her first.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than 6 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: her 2nd Shingrix, as it has been more than 6 months since her first.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-NOV-2023 The patient called about getting her 2nd Shingrix, as it had been more than 6 months since her first. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination.
Pt received seasonal flu shot and H1N1 FLUMIST on 12-17-09 around 10:30 AM. She developed hives and temp of 103 around 8 AM on 12-18-09. Pt given BENADRYL 50 mg PO by school nurse. When seen in Dr. office, temp normal at 98.5, but hives. Prescribed prednisone 60 mg PO daily x 5 days.
Wet/Productive Cough, Muscle Aches, Lost Taste and Smell, Diarrhea, Other  Chest congestion.
The adverse event took place after the patient's 2nd Shingrix vaccine.  This was a little over 2 months after her 1st dose (3/15/19) where she reported no issues. Patient said she experienced mild-moderate swelling of the left arm (at the place of immunization) as well as redness. She described the area as slightly painful and warm. After speaking to her physician, she took Tylenol and ice her arm for a couple of days. She noted it took about 2 weeks for the swelling to go down and the redness to fade. To date 6/13/19, she came into the pharmacy and her arm appeared to still be slightly red at the spot of injection.
This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in unspecified number of patients who received FLUARIX quadrivalent. In 2015, the patients received FLUARIX quadrivalent. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patients experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to FLUARIX quadrivalent. Additional details were provided as follows: This case was reported by a nurse practitioner. The reporter that unspecified number of patients received FLUARIX QIV and they experienced multiple adverse events after the vaccination. The reporter did not have details regarding the initials, date of birth, demographics of the patients and adverse events (side effects) experienced with each of her patients. The reporter did not have details regarding the date of vaccinations, when the side effects occurred, batch number and expiration date of the vaccines.
the patient developed a rash on right arm that went from injection site to elbow, unsure if area was warm. rash resolved by day 3
Swelling, rash, warmth to touch that progressively worsened x 3 days. Currently diagnosed as Herpes without complication and cellulitis. Treatment - Amoxicillin-Pot.Claulanate 875-125mg PO BID X 10 days, Valacyclovir HCL 1g PO TID X 7days.
area turned purple and looked necrotic; Red arm below injection site; arm thick below injection site; Warm arm below injection site; area turned purple; looks like sunburn across bicep and tricep; This case was reported by a nurse via call center representative and described the occurrence of necrosis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced necrosis (serious criteria GSK medically significant), erythema of extremities, induration, skin warm, skin discoloration and sunburn. On an unknown date, the outcome of the necrosis, erythema of extremities, induration, skin warm and skin discoloration were recovered/resolved and the outcome of the sunburn was not recovered/not resolved.   It was unknown if the reporter considered the necrosis, erythema of extremities, induration, skin warm, skin discoloration and sunburn to be related to Shingrix.  Additional details were provided as follows: The patient was a nurse and reported for herself.  The patient received Shingrix in an unknown arm. On day 2 or 3, after receiving Shingrix, the patient's arm was red, thick and warm below the injection site. This lasted a while but resolved. She reported that, later the area turned purple and looked necrotic but had resolved at the time of reporting, it was unsure when this occurred and how long it lasted and when the event resolved.  At the time of reporting, it had been 8 weeks since the patient received the Shingrix and she reported that, the area looked like a band of sunburn across her bicep and triceps, unknown date when this started.  The patient inquired if this had been reported and wanted further information beyond the information given from the PI (Package insert).  She also inquired about the ingredients in the Shingrix vaccine.  The reporter consented to follow-up. The patient reported that, the pharmacist who administered the vaccine, his father experienced the same adverse events but did not have patient identifiers, refer linked case US2021AMR223501.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR223501:Same reporter
After receiving Covid vaccine Moderna first dose, patient felt very warm, threw up, felt sick in stomach, turned pale, and was dizzy. She became normal within 10 minutes. We gave her a cup of water to drink and told her to rest up once she gets home.
pt recvd Td 16JUL92 redness & swelling started 12JUN92 & c/o itching but tender to touch; appears to be an allergic reaction-raised, but not to a point; urticaria; rx advil, DPH, hot/cold;
Possible vaccine failure. Onset 12/10/04. Hospitalized for 18 days (01/01/05 to 01/18/05). Meningitis and Pneumonia. Discharge Summary received on 2/07/2005 states fever, lethargy, seizure, hypoxia and tachycardia. Discharge Summary received on 3/07/2005 confirms symptoms from Summary received on 2/07/2005.
Urine turned dark brown.  After drinking large amount of water, it cleared up in one day.
DIZZY; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizzy, and headache. This report was non-serious.
Patient and caregiver report redness 7" x 4" around site, hardness, heat to left deltoid with tenderness that developed 3/18 accompanied with low appetite, muscle weakness, and fatigue. Arm symptoms were reported on 3/22 and improving by 3/23. Other symptoms reported on 3/23. They report that on 3/23 symptoms were still present but starting to improve.
First 24 hours patient experienced flu like symptoms, and since then for about two weeks patient has been experiencing muscle and joint pain with intermittent flare ups.
No adverse event; First Moderna Dose : 21-Jan-2021 and Second Moderna dose: 8-Feb-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Dose : 21-Jan-2021 and Second Moderna dose: 8-Feb-2021) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A, 029K20A, 93990S and 005M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma and Drug allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Dose : 21-Jan-2021 and Second Moderna dose: 8-Feb-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna Dose : 21-Jan-2021 and Second Moderna dose: 8-Feb-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication included Vitamin supplements from 01-Jan-2023. Patient received dose 5 of Moderna on 16-Oct-2022. Batch/Lot No: AS7169B Location of injection: Arm Left. patient received Pfizer Paxlovid from 20-Mar-2023 to 25-Mar-2023 for treatment of COVID-19. On 29-Mar-2023, patient had Paxlovid rebound which was reported as recovering. Treatment medication was not reported.
FATIGUE; HEADACHE; MUSCLE ACHES; RINGING IN THE EARS; SLIGHT FEVER; This spontaneous report received from a health care professional concerned a 6 decade white and non Hispanic or Latino male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, (dose Number in series: 2) 1 total administered on 18-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After receiving booster dose, On NOV-2021 the patient experienced fatigue, headache, muscle aches, ringing in the ears, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the experiencing fatigue, headache, muscle aches, ringing in the ears and slight fever was not reported. This report was non-serious.
Moderate Stroke in front of brain - unable to speak, disoriented. Went to ER. Treated and observed in the hospital for 2 days.  Outcome - mild aphasia