chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). O     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported. It was reported a temperature excursion that occurred several days ago in the Freezer. It was found that vaccines were viable. The patient received the booster dose. No treatment medications were reported.
Two others have blood clots; This is a spontaneous report from a contactable consumer. A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date: not reported), via an unknown route of administration on an unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have Covid-19. On an unspecified date in 2021, the patient had blood clots. Therefore, the patient had Regular visits to hospital and was told to be treated for life. The patient apparently developed life-changing condition shortly after the vaccine. Event was assessed serious (Medically significant). Outcome of event was not recovered.   No follow-up attempts are needed. No further information is expected.
Area of painful redness started under vaccine, 1 day after administration and still present 4 days later.
Stated as a bump that would not go away,  became infected June 1, 2022- w/puss.
30 minutes following, experienced a warm and flushed feeling  36 hours following injection until 72 hours: low grade fever (100.4), headache, chills  24 hours until 1.5 weeks following injection: very large swollen welt, warm to touch, painful....upon reduction of swelling looked like a bee sting as the point of puncture was still visible
pt recv vax 7AUG95 & 10NOV96 pt devel chicken pox w/20 lesions;f/u from a nurse indicated that pt recovered;
red rash and soreness on right side of upper arm about even from the injection site to the elbow
Within 1/2 hour, post vax, had diffuse urticaria followed by breathing difficulty. Treated with 6.25mg Diphenhydramine po; albuterol 0.5/2.5u NS Nebulizer; 7.5mg prednisone po; O2 via face mask. Took to children's medical center and observed X 2 hours.
had all the shingles vaccines, and still had them/ suspected vaccination failure; had them six times/ had them 4 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (2 times before vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had got all the shingles vaccines, and still had them 4 times after vaccination. The patient stated that it was no fun. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient went to bed early the day of the vaccine. The next day she was very weak with extreme fatigue and felt real light headed . The fatigue is still ongoing. She stated that the DR. have run all kinds of text. No one can find anything wrong with her, Patient stated that something is wrong with her she is having extreme muscle pain. It takes her 2 days to go to work up the nerve t o go to the store because she knows she will be extremely weak. Muscle pain is in the patients arm.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), on 26Feb2021 as dose 2, single (Lot number: EMU198) and on 26Sep2021 as dose 3 (booster), single (Lot number: FC31E2) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing). Concomitant medication(s) included: GLUMETZA, start date: Nov2020, stop date: May2022; BYDUREON BCISE, start date: Jul2018, stop date: May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Clinical course: Anti-Viral Details: Brand=Paxlovid, Treatment Start Date=14Apr2022, Treatment Stop Date=18Apr2022, Indication=Treatment of COVID-19}].  No follow-up attempts are possible. No further information is expected.
a lump on the shoulder where the injection was is considered normal or not; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Dec2022 as dose number unknown (booster), single (Lot number: GJ6739) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV positive" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (Dose 3 (booster), single, manufacturer unknown), for covid-19 immunization.  The following information was reported: VACCINATION SITE MASS (non-serious) with onset 29Dec2022, outcome "unknown", described as "a lump on the shoulder where the injection was is considered normal or not".  Additional Information: Caller asked about the Pfizer Covid19 booster shot, and if getting a lump on the shoulder where the injection was considered normal or not. Caller noted that he just got his shot yesterday and that was his 5th time and that has never happened before. Consumer stated, "Yesterday, he got his second booster shot (Clarified as COVID-19 Vaccine) and this morning he found that he had a lump on his shoulder. His arm bump being a little larger than normal. Wants to know if that is normal or not.
RN alerted lead RN  of a 12 year old male, client, received Pfizer (for 5 through 11 years of age, Lot # FK5127) at 10:50am. Client should have received Pfizer for 12 years of age and older. Lead RN informed mother of client that client will receive Pfizer for 12 years of age and older for second dose per clinical lead RN, mother of client verbalized understanding.
Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant and treatment details were provided.   This case was linked to MOD-2021-114930 (Patient Link).
Blisters on roof of mouth paralysis in legs passing out, bad headaches in back of her head, not being able to eat much food or drink felt overly full onset of Guillain Barre syndrome, still passing out and feeling dizzy after 2 months heavieness in legs sleeping excessivly feeling fatigued alot. 1/18/08-records received for DOS 1/11/08-ER visit for syncopal episode. Previously hospitalized for diffuse neurologic complaints. Guillain-Barre syndrome ruled out with negative MRI. Continues to have syncopal episodes, occasional fatigue, stomach upset, decreased oral intake. Tachycardia, anxiety, rapid respirations and syncope. No memory loss. Referred to outpatient neurology and pediatric psychiatry. DX: Persistent syncopal episodes. Per information received from annual follow up, it has been almost 5 mos, she still passes out, she gets dizzy on a daily basis. she now has to wear glasses from the seizures and passing out. And has a hard time keeping food down. Has lost 25 lbs and always tired, very fatigued. Many stays in the Hosp. and many tests. My daughters only got one shot out of 3. I would like more answers, is this ever going to stop-and if you could recommend any immunization attorneys that would be great. 1/19/2010 Last time she had a seizure was 2 months ago it seems to be backing off accept for all last year.
Anaphylactic reaction: throat and ears itching; eyelid edema; eyes tearing; nausea; vomiting; heart racing.
felt icky; headache and feverish; headache and feverish; shingles; A spontaneous report was received from a consumer concerning a 59-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  shingles/herpes zoster, headache and feverish, felt icky/sticky skin.  The patient's medical history was not provided. Concomitant medications reported were aspirin, vitamin D for drug use for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 20 Feb 2021, the patient experienced the event,  shingles. On 21 Feb 2021, the patient experienced the events,  headache and feverish, felt icky.  Treatment details included Valacyclovir..  The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events, shingles, headache and feverish, felt icky was unknown.
pt recv vax 945AM & states around 12PM began to have SOB & states chest felt a little tight;pt given 02;taken to hosp & given DPH;ER MD felt was the brand of hep b that was given to pt;
59 y/o female experienced right distal arm and hand paresthesias about 10-15 minutes after receiving the Moderna Covid-19 vaccine in the same arm.  She stated that this was atingling and burning sensation and indicated the dorsal hand, middle three fingers with some lesser extension on he palmar side of same.  After a few minutes more she noted this in a circular palmar zone and along the radial aspect of the wrist, extending about 3 inches up the radial aspect of the arm from the wrist.  She laater on questioning of other symptoms stated that she had a mild pain in the mid right abdomen and a mild pain under the left eye / lower lid.  She was monitored for an hour. No "treatment" was given.  She was allowed to proceed home and was instructed to inform her primary care provider.
I took niquil before any symptoms has started. I felt fine until the 5th hour. I was hit with chills and then I couldn?t see or hear, it felt like I was underwater and I began to throw up a lot. I also experienced body aches, head aches, and the sweats. I could barely walk to the bathroom and back to my bed.
No other AE reported; We inadvertently gave an MMR II intramuscularly today instead of subcutaneous; This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-MAR-2021, the patient was inadvertently vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot number: S022754, expiration date: 22-JUL-2021) 0.5 ml intramuscularly (inappropriate route of vaccination). No adverse event was reported.
Prolonged crying (over 24 hours) onset within one hour of vaccine. Fever-onset in less than 24 hrs.
No additional AE reported; Vaccine had been administered since the excursion.; This spontaneous report was received from a medical assisstant and refers to a 6 month old patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 02-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot # 1691307, expiration date 25-NOV-2021 (dose and frequency were not provided) for prophylaxis.       Temperature: 47.0lF Time frame: 1 minute 30 seconds Previous temperature excursion? No Was call because of a "data logger"? Y
Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: pt's tongue felt funny, then her throat felt tingly, progressed to throat beginning to close. given 50mg benedryl and 20mg pepcid at pharmacy and she went by ambulance to ER. she will undergo further testing this week at allergist to see if she is allergic to polysorbate and peg.
(R) thigh vaccines given at approx 2:40 pm, when patient was checking out with dad at approx 2:45 pm he noted a large circular area that was red, blotchy, & itchy. Provider looked at area & dad was instructed to wait in office with patient so we could monitor area. 10 minutes later area was less red & in 20 minutes area had decreased in size considerably. Patient was fine otherwise & left clinic with father.
Patient tested positive for COVID-19 after completing the full Pfizer vaccine series, 61 days after 2nd dose.   Patient received 2nd dose of COVID vaccine on 1/27/21 .   Tested positive on 3/29/21.   NOT hospitalized. Likely a family member who had common cold symptoms the week before mine. "Symptoms reported: chills, runny nose, fatigue, severe headache; Symptom onset date: 3/28/21"
I started having stabbing chest pains and I was really nervous I was having a heart attack. I also had shoulder pain and indescribable feeling in the left arm - it wasn't pain but it didn't feel good. The week or so before, I had a cramp in my leg. After consulting with an ER doctor several times, they decided it wasn't an heart attack.  Muscular Skeletal pain from not sitting from working at home: diagnosis - Phone visit appt with the doctor She prescribed Yoga and setting my desk more Ergonomically. I'm still having the symptoms.
5 days after second dose of vaccine I broke out in hives on random areas of my body. This went on for the next five days and then seemed to resolve itself.
Patient reports shoulder pain and radiating pain of chest continuously day after administration to today. Patient is also having pain while moving shoulder and she aslo reports shortness of breath especially when her chest pain is severe. Patient also reports that on day 5 she had severe vertigo where she had to stay in bed the whole day.
Bell's palsy; A spontaneous report was received from consumer concerning male patient of unknown age, who developed Bell's Palsy (Facial paralysis).   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On an unknown date, the patient received his first planned vaccine doses of mRNA-1273 (Batch number: unknown), intramuscularly, for prophylaxis of COVID-19 infection.    On 15 Mar 2021, the reporter stated that the patient experienced Bell's Palsy shortly after receiving the vaccine. Treatment for the event was not known.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event, Bell's Palsy, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
SON was given 12+ Pfizer Bivalent Shot (gray cap) when it was supposed to be pediatrics dose (orange cap)
A short time after having received the vaccine, patient complained of lightheadedness, palpitations and was noted to have sustained high BP readings. Transported to ER via personal vehicle, refused transport. On follow up, patient reports having been started on new med for BP but otherwise recovered.
4/15/03 - Onset of fever, anorexia, rash on body. 4/18/03 - seen in office - febrile, cranky, confluent hive-type lesions on both arms/legs/face/buttocks. Bilateral otitis media. Rx Amoxicillin, Tylenol, Benadryl. 5/2/03 - all symptoms resolving.
FEVER, ACHES, DIZZINESS, PRESSURE,  TIREDNESS NOT AFFECTING DAILY LIFE, ABLE TO RUN ETC.  HOWEVER STILL HAVING SOME DIZZINESS AND TIREDNESS. RECOMMENDED CHECKING WITH MD
Very bad chills; low fever; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves adult patient (unknown gender) who experienced very bad chills (chills) and low fever (pyrexia), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious very bad chills (chills) and low fever (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory, data not reported.   It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
Administrative deviation only; no adverse event resulted from this deviation. This patient received a mixed series of COVID-19 vaccine (one dose of Moderna and one dose of Pfizer- box #4 reflects the date on the second dose). The decision to administer a mixed series to the patient was due to an "exceptional circumstance" stemming from the unavailability of the first vaccine product (Moderna) at the time the second dose was due. We understand that although CDC provides considerations for a mixed series in exceptional circumstances (such as a vaccine shortage, which was the case here), a mixed series is still considered an administration deviation that requires VAERS reporting. Note second vaccination date is listed.
Experienced foggy brain (hard to thing and form sentences), general milaise, all joints extremely achy and painful, extreem chills, skin over entire body hurts to the touch, muscle soreness, tired and sleepy, toghtness in chest, hard pounding of heart, cough and congestion, headache.
pt recvd vax;devel fever & local rxn of soreness, swelling & rash at inject site;
Pt recvd 1st vax & "felt bad";  Given 2nd vax, devel OM & a ruptured ear drum & hospitalized 4 or 5 days; p/3rd dose vax pt devel weakness, pain in lower extremities, pain in liver, resp distress, allerg  react, fatigue, lymphadenopathy;
Narrative: Other Relevant Hx: Symptoms:  Myalgia, Diarrhea & Pain and swelling at injection site Treatment:
This spontaneous report was received from a mother's patient concerning to her daughter a 17 year old female patient. The patient's concurrent conditions included allergy to amoxicilin. The patient's concomitant medications included an unspecified pill for birth control. On 08-MAY-2017, the patient received her second dose of GARDASIL 9(strength, dosage schedule, indication, lot number and expiration date were not reported) for prevention of hpv and immediately, the patient experienced pain at the site of injection. The mother also reported that her daughter "continued to experience pain and 10 days after receiving the dose she experienced an egg sized lump at the site of injection". She took her daughter to the physician who recommended applying warm compresses to the site. The mother stated that "the compresses had not helped and her daughter continued to experience the pain and lump". No further information was provided. There was no product quality complaint (PQC) involved. The reporter did not assess the causality between the events and GARDASIL 9. Additional information has been requested.
The early hours of the 16th later in the day and into the 17th I experienced fever (between 100 and 101), chills, fatigue, body aches, stuffy nose, rash over the area around the vaccine site and pain around vaccine site. On the 18th most of the symptoms had subsided but rash moved into horseshoe shape below vaccination site and fatigue continued slightly.
rash all over body;puffiness around mouth;vomiting;tx DPH;
This spontaneous report was received from a registered nurse who was also an administrator and refers to a patient of unknown age (reported as over the age of 18) and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. Approximately in January 2017 (reported as "within the last month"), the patient was vaccinated with a dose of PROQUAD injection (exact dose, route of administration, lot # and expiry date were not reported) instead of separate doses of VARIVAX and M-M-R II. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
FEVER BLISTER ON LIP; This spontaneous report received from a patient concerned a male 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) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced fever blister on lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever blister on lip was not reported. This report was non-serious.
Hyporesponsive episode. Deep sleep shortly after vaccine. Baby in deep sleep. Mom could not arouse him until after 10 minutes. No color change. Pulse present.
Pain numbness loss of use entire left arm extending to upper back adversely affecting balance/ordinate forking. Then went to right arm with effect. Elbows and both wrists felt sprained. Seemed to travel on both arms