chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore at site of injection immediately. Body aches began around 9 pm and progressively intensified until muscles of legs, back, arms, buttocks, and feet became very tender and painful.  Patient worked night shift at hospital and had difficulty walking and working due to pain. At 7:30 am on 10/23/15, took 400 mg of ibuprofen, 500 mg of Vit C, 5000 iu of vitamin D, and Zoloft 25 mg, and then went to sleep. Muscle aches had disappeared upon awakening at noon on 10/23/15.
EXPIRED VACCINE WAS GIVEN; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 07-SEP-2021) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-SEP-2021, the patient experienced expired vaccine was given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine was given was not reported. This report was non-serious.
15 patients received an expired Moderna dose/gave Moderna vaccines from a vial with an expiration date of 10/15/21; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (15 patients received an expired Moderna dose/gave Moderna vaccines from a vial with an expiration date of 10/15/21) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (15 patients received an expired Moderna dose/gave Moderna vaccines from a vial with an expiration date of 10/15/21). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (15 patients received an expired Moderna dose/gave Moderna vaccines from a vial with an expiration date of 10/15/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided The Moderna vial (10 dose, 0.5ml) was removed from the freezer to the refrigerator on 10-11-2021 without any temperature variations in the transfer from the freezer. The solution was off white in color.  No variation in color from all the other previously used vials. 16 patients received 0.25 ml booster dose. 3 patients received 0.5 ml full dose. Event onset time was given 01:18pm Vaccination facility information is reported as Doctors office, and the address is 4360 Chamblee-Dunwoody Rd, Suite 370 with clinical name Arbor / Haven OBGYN.   This case was linked to US-MODERNATX, INC.-MOD-2021-362642, US-MODERNATX, INC.-MOD-2021-362750 (E2B Linked Report). This case was linked to MOD-2021-362017, MOD-2021-362031, MOD-2021-361987, MOD-2021-362064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow-up received on 18-oct-2021 and contains NNI. On 24-Oct-2021: Patient initials ,narrative updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-362750:cluster master file MOD-2021-355973 US-MODERNATX, INC.-MOD-2021-362642:
This spontaneous report as received from a 60 year old female consumer reported on herself with low thyroid. The patient's medical history included that she went into a coma and almost died on an unknown date of 2010. On 02-AUG-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous, dose reported as 1 injection (strength, frequency, lot number and expiration date were not reported). Concomitant therapies included lithium, Synthroid, Ticlodone, Xanax and hydroxyzine pamoate. On 02-AUG-2014, the patient experienced injection site swelling and a really "hard knot" at the injection site of ZOSTAVAX. On 13-AUG-2014 (also reported as last night), the patient noticed an outbreak of itchy red bumps on each of her ankles. The outcome of the events were not reported. No treatment was given for the adverse events. Patient did not seek medical attention. Additional information has been requested.
On 12/23/09 noticed hardness in right upper arm around injection site where seasonal Flu vaccine was administered, developed soreness painful movement. Symptoms have not improved, actually have increased. Has applied ice and little heat.
The parent was present with his son during his entire visit to our pharmacy for the vaccine.  On the Covid-19 vaccine questionnaire, the date of birth was listed .  My pharmacy technician,  greeted the patient and his father.  She confirmed the date of birth 3 separate times that the patient verbally confirmed.  My vaccinating pharmacy technician, , reviewed information with the patient and his father by verbally confirming the date of birth again just before vaccination.  At the end of the day, we processed the claim thru to the patient's insurance who rejected the claim, stating that we had the wrong date of birth.  The insurance stated that the patient's date of birth according to their records was .  We called the parent to see if they could confirm that the insurance had their records wrong.  The parent admitted to pharmacist, , RPh on 4/28/21 at 11:30 am that he falsified the document and knowingly used the wrong date of birth so he could get the vaccine for his son.
A 40 year old female patient with no known history of low white blood cell count, born on 1/7/1963, received a post exposure series with RabAvert (batch # 309011) after a raccoon bite. She received the following vaccinations: first vaccination on 12/22/02 and the last vaccination on 1/19/03 (vaccination dates of probably three interim vaccinations not provided). Approximately one month after the end of series patient began experiencing low white count (last value 4.0) and axillary lymphadenopathy which is persisting. She also showed episodic high blood pressure, lost hair and also some fibrocystic breast stuff (started 4/15/03). Seriousness criterion: possible permanent disability. Causality: unrelated. The reported symptoms are unexpected after vaccination with RabAvert. No change in benefit-risk-ratio. No measures necessary. Despite request; no other information was received.
very hard heart palpitations/She had her oximeter thing that she places on her finger and her pulse was 177.; very hard heart palpitations/She had her oximeter thing that she places on her finger and her pulse was 177.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: before any of the Pfizer shots. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1; Lot: EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for COVID-19 Immunization; bnt162b2 (Dose 2; Lot: EW0172), administration date: 06May2021, when the patient was 73-year-old, for COVID-19 Immunization; bnt162b2 (Dose 3; Lot: FE35 then it looks like a percent sign after so she is not sure of the lot number for this dose), administration date: 12Nov2021, when the patient was 73-year-old, for COVID-19 Immunization; bnt162b2 (Dose 4; Lot: FM7553), administration date: 13Jun2022, when the patient was 74-year-old, for COVID-19 Immunization; bnt162b2;bnt162b2 omi ba.4-5 (Dose 5; Lot: GJ5342), administration date: 21Sep2022, when the patient was 74-year-old, for COVID-19 Immunization; Flu shot, administration date: Sep2023, for Immunization (she had the flu shot (it is the one for older citizens), had this flu shot a week before the most recent covid shot, clarified as she got the flu shot on 28Sep2023 or 29Sep2023). The following information was reported: PALPITATIONS (medically significant), HEART RATE INCREASED (medically significant) all with onset 04Oct2023, outcome "recovering" and all described as "very hard heart palpitations/She had her oximeter thing that she places on her finger and her pulse was 177.". Clinical course: She had a Pfizer covid shot on Tuesday, she called it a booster but it is the new current covid shot that is out. She is having a fairly strong reaction. She has reacted to all the Pfizer shots she has had. She also had covid before any of the Pfizer shots. Her reaction this time was different than other times, describes her reaction as having very hard heart palpitations. She had her oximeter thing that she places on her finger and her pulse was 177. The patient underwent the following laboratory tests and procedures: Heart rate: (04Oct2023) 177, notes: Result: 177; Unit: Not Provided.  The information on the batch/lot number for bnt162b2 omi xbb.1.5, bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Expired Bexsero Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 15-year-old female patient who received Men B NVS (Bexsero) (expiry date 28-FEB-2023) for prophylaxis.   On 14-MAR-2023, the patient received Bexsero. On 14-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero Administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-Mar-2023 No further details such as lot number of the vaccine or patient´s details were available at the moment of the call. The reporter consented to follow-up by email. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Mid-afternoon that day after receiving the vaccine I developed a headache which was odd because I usually don't get headaches. The headaches started to get worse and worse over the course of three weeks which made me go to the ER last week on 10/29/2021. They put a Lidocaine patch on my neck. Then went to the doctor on 10/28/2021 when they injected me with Kenalog 10mg and 2 ML of 1% Mepivacaine into the back of my neck and head. Then the headache went away that night. I haven't been able to breath good, and I have been having fatigue that has gotten worse especially since receiving the 3rd dose. I don't have a diagnosis for it yet.
Raised, spotty rashes in specific locations (currently on day 4 of rashes): Elbows Hands and fingers Ankles Feet and toes
Patient presented with SOB, pain in back, difficulty breathing within minutes after vaccine administered. Called 911 and administered one dose of epipen. Patient had all symptoms resolved after epipen administration and even requested ambulance to be cancelled. Vitals were normal.  Patient had never had any reactions to vaccines in the past. Followed up with patient next day.  No adverse reactions / side effects reported. Patient PCP was notified.
Temp 100.6, headache/body ache  Left deltoid induration 4mmx4-5mm
Severe vestibular issues including non spinning vertigo 24/7,  balance issues, visual disturbances, smell sensitivity, vestibular headaches, increased anxiety with severe panic attacks and severe disabling brain fog.
Tingly/itchy face especially around thelips and tongue; Tingly/itchy face especially around the lips and tongue.; Tingly/itchy face especially around the lips and tongue.; This is a spontaneous report received from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the one dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; EN6208) via an unspecified route of administration in Left arm on 13Mar2021 at 10:30 am (at the age of 38-year) as a single dose for COVID-19 Immunization. The patient's medical history was not reported. Allergies to medications, food, or other product reported towards Peaches (any fuzzy fruit). 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 14Mar2021 at 09:00 am, the patient experienced Tingly/itchy face especially around the lips and tongue (Lip itching, Oral pruritus and Tingling mouth). The patient did not receive any treatment for the events. The clinical outcomes for Tingly/itchy face especially around the lips and tongue was not recovered. No follow-up attempts are needed. No further information is expected.
Tdap given few days ago into deltoid region, LR arm.  Developed red, itchy painful area below site of shot; that area has been progressively getting bigger and itching, until today when it's itching less than yesterday.  Had chills and malaise one day.  Recalls having childhood pertussis.  She has already made notification to VAERS.
Very sore upper right arm at site of innoculation.  By 01.25 pain had resolved. 01.25.2021, 12 Noon, Very sore jaw, right side.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 81-year-old female patient who received SHINGRIX. On 26th April 2018, the patient received SHINGRIX. On 27th April 2018, 1 days receiving SHINGRIX, the patient experienced injection site erythema. On 28th April 2018, the patient experienced injection site induration and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site itching were recovering/resolving. The reporter considered the injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injection site induration and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included vitamins. At 11:00, the patient received SHINGRIX on the left arm. The patient noticed a red spot at the injection site on her left arm the morning following the vaccination. It was the size of fifty cent coin and it increased to the size of a palm the next day and it felt hard to the touch. It was also a little itchy when her clothes brushed against it. It had faded but still felt a little but hard in morning of the reporting day. The patient had denied permission to contact their physician. The patient stated her pharmacist might had already reported the event.
Pt started with significant arm and axillary swelling 2 days after the injection 1/13/21. No redness/induration at injection site. No itching. Reported facial and b/l hand swelling, but not noted on day of evaluation 1/15/21 Reports ongoing cough, intermittent temps of 99 and nasal congestion additionally
This was my booster. I opted to switch-up and get Moderna instead of Pfizer. These symptoms were worse than my first two Pfizer injections. After my booster, I felt intense body aches and pain about 4 hours after injection. This pain intensified throughout the night and continued the next day for about 30+ hours. Mostly felt in spine and left arm (injection site). I'm now only experiencing minor pain approaching 48 hours of injection.
Pt recv vax on 10/30/98; on same day pt exp cough,nausea, leg cramp, chills, fever, aches, night sweats, weakness, sore stomach, tired x2 day
Information has been received from a female who in 1994 or 1995 was vaccinated with RECOMBIVAX HB (manufacturer unknown). In 1994 or 1995, the patient experienced an anaphylactic reaction. No further information is available.
Information has been received from a Licensed Vocational Nurse referring to a adult male patient of unknown age. There was no medical history or drug reaction/allergies reported. On 20-FEB-2015, the patient received his first dose in the hepatitis B vaccination series with a dose of TWINRIX (dose, route, lot# and expired date were unknown). Then he received a pediatric dose of RECOMBIVAX HB (strength: 5 microgram/0.5 ml, dose, lot#, expired date and route were unknown) on 20-MAR-2015 as his second dose and then another dose of TWINRIX on 20-AUG-2015, as his third dose. No concomitant medication was provided. No adverse effect was reported. Additional information has been requested.
Lump under my left arm pit  sticks out tight sore and it hurts when I try to raise my arm up.
Headache, Myalgia, Arthralgia,  Fatigue Narrative: Pain at injection site immediately following  injection. Patient spread to back, hips, and legs.
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 03-JAN-2019, the patient was vaccinated with improperly stored VAQTA (lot # R013858, expiration date: 12-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments:  US-009507513-1901USA004786.
redness, swelling half way down to his wrist, itching and warm to the touch on the injection arm; redness, swelling half way down to his wrist, itching and warm to the touch on the injection arm; redness, swelling half way down to his wrist, itching and warm to the touch on the injection arm; warm to the touch on the injection arm; This is a spontaneous report from a contactable consumer (patient's partner). An 81-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9267), on 11Feb2021 (at the age of 81-years-old) at 2nd dose, single, administered in arm, for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included he took medications daily but nothing the reporter thought would be relevant. The patient previously received the first dose of BNT162b2 (lot number: EL8982) on 21Jan2021 (at the age of 81-years-old) at 1st dose, single for COVID-19 immunisation at grocery store. The patient was experiencing redness, swelling half way down to his wrist, itching and warm to the touch on the injection arm for one week, on 13Feb2021, after the second dose of the vaccine. The reporter wanted to know if this was associated with the vaccine because of the duration of the symptoms. He was having some kind of reaction for about a week. They wanted to report it, where he got the shot on that arm it went down the arm just past the elbow, it was red swollen and itching. Reporter confirmed they were seeking information about this reaction, if it was associated with the product to go on this long. It was about 2 days after the dose that he noticed the redness swelling and itching. It was pretty puffy, reporter thought it had worsened since it began. No investigation assessment was performed. The patient had not recovered from the events.   No follow-up attempts are possible. No further information is expected.
- approx 2 minutes post-vaccination: syncope, racing pulse, uncontrollable crying
Received Novavax 18-NOV-2022; tested positive for COVID-19; Diagnosed with COVID; tested positive for COVID; Night sweats; Loss of appetite; Migraine; Nasal congestion; Chills; Fever; Fatigue; Malaise; On 25-OCT-2023, this serious, initial spontaneous safety report was received from a consumer via a pharmaceutical company, and was received by Novavax on 07-NOV-2023.  An individual of an unspecified race, age, and sex was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted 10 ug/mL suspect COVID-19 vaccine dose 1 (dose 3 of COVID-19 vaccine) in the left arm on 18-NOV-2022.  Medical history included Systemic lupus erythematosus, which was in remission until the individual was vaccinated with Moderna COVID-19 vaccine (elasomeran) dose 1 on 10-FEB-2021 and dose 2 on 12-MAR-2021. Additional medical history included Migraine, Osteoporosis, and Drug hypersensitivity to sulfonamide and codeine.  Concomitant medications included Plaquenil (hydroxychloroquine sulfate) 200 mg (last dose taken on 18-OCT-2023) and Fosamax (alendronate sodium) 70 mg.  On an unreported date in OCT-2023, after vaccination, the individual experienced night sweats (PT: Night sweats), chills (PT: Chills), fever (PT: Pyrexia), loss of appetite (PT: Decreased appetite), fatigue (PT: Fatigue), malaise (PT: Malaise), migraine (PT: Migraine), and nasal congestion (PT: Nasal congestion). On 07-OCT-2023, the individual was diagnosed with COVID-19 at an urgent care facility, resulting in vaccination failure (PT: Vaccination failure) (Serious: Medically Significant) on 18-NOV-2022. Treatment of COVID-19 included Paxlovid (nirmatrelvir, ritonavir) from 09-OCT-2023 to 14-OCT-2023. The individual's symptoms improved 2 days after completing treatment. On 18-OCT-2023, the individual experienced the exact same symptoms that they had when they were diagnosed with COVID-19 at the urgent care facility. On an unreported day in OCT-2023, the individual tested for COVID-19 and was positive, and re-tested again 3 days later, and was still positive.  Relevant lab tests included a positive SARS-CoV-2 test on 07-OCT-2023, an unreported day in OCT-2023, and 3 days later on an unreported day in OCT-2023.  On 18-NOV-2022, the event of Vaccination failure was recovered/resolved.-On an unreported day in OCT-2023, the event outcomes of Pyrexia and Chills were recovered/resolved. At the time of reporting, the event outcomes of Night sweats, Decreased appetite, Fatigue, Malaise, Migraine, and Nasal congestion were recovering/resolving.; Sender's Comments: This individual of an unspecified age and sex experienced: Vaccination failure, COVID-19, Chills, Decreased appetite, Fatigue, Malaise, Migraine, Nasal congestion, Night sweats and Pyrexia after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Vaccination failure was assessed as serious. The events COVID-19, Chills, Decreased appetite, Fatigue, Malaise, Migraine, Nasal congestion, Night sweats and Pyrexia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Fever; chills; achiness; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EN6206), dose 2 intramuscular, administered in left arm on 16Mar2021 (at the age of 50-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL8982) as dose 1, single intramuscular, administered in left arm on 23Feb2021 at 11:00AM for COVID-19 immunization. Patient experienced wheezy. The patient medical and concomitant medication history were reported. No prior vaccination within 4 weeks. Patient had an allergic reaction to both doses-with 2 hours of vaccine. Vaccine facility type at hospital. On 06Mar2021, the patient experienced fever, chills and achiness on an unspecified date for 36 hours. Seriousness criteria-not serious. Patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 08Feb2021. The event require the initiation of new medication/other treatment/procedure reported as no. The outcome of the events were recovered on 2021.  No follow-up attempts are needed. No further information is expected.