chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within seconds after receiving the Arexvy vaccine, patient reported a sensation in her throat.  We prepared for anaphylactic reaction as we watched and waited.  Patient's blood pressure was monitored and was higher than her expected normal at 134/82, hr 88. She continued to swallow and noted something going on in her throat. Over the next 15 minutes she noted being foggy, having a headache, and pain along her spine.  Over the next 30-45 minutes most symptoms resolved, but still felt a little foggy.  Contracted patient the following day and other than sore arm, felt fine.
Pt had high pitched non-consolable cry for 2 hrs; the pts' MD order pt to recvd DT only in the future;
SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a female 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: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient received the vaccine and noticed some drip down her arm and was concerned that she did not receive the full dose (inappropriate dose of vaccine administered). On an unspecified date the patient had an antibody test (COVID-19 antibody test) which showed negative for antibodies (suspected immunological vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccination failure and inappropriate dose of vaccine administered was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000190571.; Sender's Comments: V0.20210845363-covid-19 vaccine ad26.cov2.s -suspected immunological vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
cold; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (Patient's mother) reported for a unknown female patient that: This case is for reporter's 1st of other two daughters. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 21May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 immunization. The patient previously took historical vaccine BNT162B2 as Dose 1, single for Covid-19 Immunization. The patient's concomitant medications were not reported. The patient experienced cold on an unspecified date. The outcome of event was unknown  Information about lot/Batch number requested.
Severe hives about a week after his vaccination; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Severe hives about a week after his vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Severe hives about a week after his vaccination). At the time of the report, URTICARIA (Severe hives about a week after his vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.   Reporter did not allow further contact
Immediate:  body flushing, racing heart (about 40-50 bpm higher than normal), and lightheaded/dizzy Same day: tongue felt funny/slightly swollen Same day evening & next day: hives on upper and lower torso
Immediately following administration, patient's eyes rolled backward, slumped in chair, and began convulsing. About 20 seconds later, she regained consciousness.
Pt states to have entire aches, even her skin, hands are cold, to the point where finger tips numb, fever like symptoms...taking Ibuprofen helps.
This case was reported by a physician (also the mother of the subject) and described the occurrence of stuttering in a 2-year-old female subject who was vaccinated with Flu vaccine (manufacture unspecified). In September 2008 the subject received unspecified dose of Flu vaccine (unknown). In September 2008, 3 to 4 days after vaccination with Flu vaccine, the subject started stuttering on and off for the past year. The reporter was not sure of the association between the stuttering and receiving flu vaccine. At the time of reporting the outcome of the event was unspecified.
"Moderna COVID-19 vaccine EUA" Patient received 0.5ml instead of 0.25ml.  COVID booster vaccine.
8/31/09 VARIVAX vaccine given (L) arm SC - 9/1/09 Facial swelling, cheeks, nose, orbital swelling, unable to open eyes. Rash - neck.
Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022; Patient was inadvertently administed the vaccine 11 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administed the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A and 071F21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Primary series.) and Pfizer (Primary series.). Past adverse reactions to the above products included No adverse reaction with Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (Benadryl).   On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administed the vaccine 11 days after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administed the vaccine 11 days after expiration date) and PRODUCT STORAGE ERROR (Patient was inadvertently administed with the 11 days of expired vaccine that was initially stored in the refrigerator on 27 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was unknown whether the patient had been diagnosed with/ tested positive for COVID 19. Acute and Chronic illness at the time of vaccination and up to one month before was reported as none.  On 03-Nov-2021, patient received first booster dose of Moderna vaccine. On 31-May-2022, patient received second booster dose of Moderna vaccine (batch no. 033K21-2A) after expiration date. Number of doses/vials administered were reported as one vial. It was reported that the vial was initially stored in the refrigerator on 27May2022 and vial  did not undergo any temperature excursions. It was unknown if AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). Unknown if patient experienced a similar event in the past.  No treatment medications were reported.
8th day after receiving the Pfizer vaccine i have a golf ball size raised (swollen) rash around the injection site.
When I got the shot I had some expected local pain which seemed to widen in area over the next day or so to include my arm pit area.  After a couple days the area shrank in size and is now just in the front of the arm joint.  From the time the pain shrank in area it has remained to this day. I have a sharp burning pain in the shoulder joint area.
Information has been received from a nurse practitioner concerning a 24 year old female who on an unspecified date was vaccinated with the first dose of Gardasil (lot number unknown). On an unspecified date, the patient was vaccinated with her second dose of Gardasil and developed genital warts. Medical attention was sought. At the time of reporting the patient was recovering. Additional information has been requested.
Seen 4/25 for 12 mo WCC and vaccines.  3-4 days later developed red dots on torso, not itchy.  Spots would last 1-2 days and then fade a reappear elsewhere.  No fevers.  Mildly fussy and fighting sleep more.  3 days ago developed redness and swelling on L thigh with raised bumps on it.  Also not itching, but has grown slightly since first appeared.  Twin sister with same rashes for same time.
Sore Arm after first dose of the vaccine; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced sore arm after first dose of the vaccine in 2021. With the first one she had a sore arm, but was otherwise fine. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sinus drainage, asthma type cough, itching, welt fever like blister, skin peeling, redness, sore. Dr's report attached. It has not gotten better from Oct 5th to Jan 28th 2013 saw Dr on Jan 28th on same again.
Pt devel erythema & induration surrounding the inject site p/receiving Typhoid vax; This ADR previously reported to FDA by the reporter;
March 31st I began feeling like everything was moving quickly and off balance.  Within a few hours, everything appeared to be spinning and I was nauseous.  Could not balance, walk unassisted, or tolerate light.  I was given a prescription for Meclazine to take as needed - I have recovered about 80%, I am still unable to drive or track fast moving objects
1225: 25 min after Covid vaccine pt started experiencing  itching to her neck, waist and arms. Her left arm where the injection was given felt heavy and fingers were tingling. She also felt like her top lip was swollen.  Pt was given PO famotidine and 25mg of Benadryl. Spoke with physician and he also wanted her to have 25mg IM Benadryl.  1236: IM Benadryl given 1245: Feeling better. Itching improved. Lip doesn't feel as swollen. 1250: Dr in room. Continues to get better-itching still improving. Lip no longer feels swollen. 1255: Pt able to return to work at the hospital. Advised to go to the ER immediately if she begins to feel worse.
1 day after -  chills,  nauseated, fatigue  5 days later -  lump in arm arm at vaccine site,  itchy, warm
Per mother of child, patient felt faint and dizzy upon leaving clinic. That evening around 5:00 pm, patient fainted when with Uncle. Family did not seek medical attention and states patient was fine after fainting. Mother noticed on 8/11/10 that patient had a knot on right tricep at injection site with some swelling. Applied heat pack to site. Bicep and tricep continued to swell and red band appeared around bicep and tricep on 8/12/10. Red rash around injection site on right tricep appears to be size of silver dollar per mother of child as of 8/12/10. Mother states patient had low-grade fever on 8/11/10 and treated with Tylenol. Mother of child states the injection site is not have pus or drainage and only appears to have swelling and redness. Instructed mother of child to follow up with doctor.
Patient vaccinated with 3 doses of Pfizer. (6/11/21, 7/2/21.  8/28/21.   Admitted to hospital with COVID-19 positive labs on 12/7/21
No additional adverse events.; on 2/4/2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a 18-year-old patient of unknown gender. The patient's pertinent medical history, historical drug, concurrent conditions, and drug reactions or allergies were not provided.      On 04-FEB-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot number S006018, which has been verified to be valid, expiration date reported and validated as 27-FEB-2021 (strength, dosage schedule, vaccination scheme, anatomical location and route of administration were not provided), for prophylaxis (product storage error); the vaccine was reconstitued with a properly stored sterile diluent (MERCK STERILE DILUENT). Additionaly, it was stated that the vaccine was exposed to a temperature between 15 degrees Fahrenheit (F) to 46 degrees F (36.86 F) for a time frame of 9 hours and 49 minutes. Furthermore, there was a previous temperature excursion reported at a temperature of 15 degrees F to 46 degrees F (19.13 F) for a time frame of 1 hour and 30 minutes. There was no digital data logger involved. No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA002222:
No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0 and 48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
RED ITCHY RASH ON ARMS,  UPPER CHEST, LEGS LASTING FOR APPROXIMATELY 1 HOUR
There was no adverse event with this patient. However, on this day, other nurse's were completing inventory and were in the room where the freezer is located, making it congested. When the vaccine was replaced (post inventory), the two vaccines on this shelf were switched from their normal location. I reached in to grab the varicella from its normal location and instead grabbed the MMRV and gave it to the patient. I did call the parent to make her aware of the fact that her child had received both the MMR and the MMRV on this day. During the call, I made her aware of the need to watch her for increased temperature and reminded her of the possibility of the rash in that 5-12 day period. The mother voiced an understanding and thanked me for the phone call. The vaccine was also re-positioned on this day to its normal location in the freezer. To our knowledge, no physician visit was required.
It was reported that a 5 year old female patient received an IPOl and a Tripedia vaccination in September 2000, (dosage, route, site and lot information was not reported). The patient developed a "severe site reaction to the Tripedia dose". The patient's mother sought medical attention for her daughter's experience.
Facial swelling on forehead and periorbital area. 2 hours after MMR and Hep B, mother advised to give Benadryl and follow up in am. I was first called at 9am on 7/30/02. Mother did not call again tun 4/15pm 7/31/02. We gave Allegra D and sent to ER.
patient with large local reaction- redness of arm > 8 cm diameter requiring steroid treatment; also had fatigue and mild fever of 100.6 which have resolved
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 377MK, expiry date 25th September 2021) for prophylaxis.   On 18th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional detaikls were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist staed that, the patient had 2 epiosde of shingles after vaccination. The reporter unsure when the first case was, but they came in and said they develop shingles this weekend and it was ongoing. The reporter consented to follow up.
The following day began the process of acute bronchitis which ultimately went into adrenal fatigue Working now to g
Had shot on 10/1/07 (L) arm, became very swollen, red, site warm, had fever. Size per Dr (L) arm 4.7, (R) 6x8.
Initial report received from a consumer on 27 Jul 2010: This patient was vaccinated with MENVEO (batch number and dose unknown) on an unspecified date. It was reported that, the patient received multiple doses of MENVEO (might be 02 doses on the same day). The patient experienced knee pain, neck pain and dizziness on an unspecified date. The outcome of the events was not reported.
Adult patient received Kinrix instead of Boostrix.  Patient aware, no adverse effects noted.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored MMR II (lot # K024038 and expiration date 26-NOV-2016) (dose and route were not reported). No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
High grade fever, multi hour severe migraine, light sensitivity, sharp abdominal pain, confusion, coordination/balance problems and severe flu like symptoms.    Treatment was self administered and comprised fluids and bed rest.
patient received an intramuscular dose of MMR II instead of subcutaneously; No adverse effect reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, albumin status of rHA (recombinant human albumin) (M-M-R II) for prophylaxis, lot # N027781, expiration date 08-AUG-2019 (formulation, strength, frequency were not provided). The patient received an intramuscular dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) instead of subcutaneously. There was no adverse effect reported.
This case was reported by a physician via sales rep and described the occurrence of injection site induration in a adult patient who received SHINGRIX for prophylaxis. On 11th October 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site induration and injection site swelling. On an unknown date, the outcome of the injection site induration and injection site swelling were unknown. It was unknown if the reporter considered the injection site induration and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received SHINGRIX on unknown arm. Area was indurated and raised about half a centimeter. About a centimeter in diameter. The reporter had not seen this type of reaction before. Always been a generalized redness with mild diffuse swelling of deltoid area. The reporter agreed to be contacted for follow up from GlaxoSmithKline.
Approximately 24 hours after receiving TD (Sun afternoon or evening) developed increased pain left upper arm, shaky chills and felt feverish. Severe symptoms continue 4-8 hours. Took 2 Tylenol and finally slept after 2 hours. Awakened am improved but with cont. h/a & weakness. By midday felt nearly normal. Seen @ U.W. urgent care and reported symptoms to them 12/10/01 f/u wound care
one of four pt to devel fever of 101-102 deg F, uncontrollable irritability, and a local rxn post vax
aches; nausea; Low grade Fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches), NAUSEA (nausea), PYREXIA (Low grade Fever) and FATIGUE (fatigue) 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 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 MYALGIA (aches), NAUSEA (nausea), PYREXIA (Low grade Fever) and FATIGUE (fatigue). At the time of the report, MYALGIA (aches), NAUSEA (nausea), PYREXIA (Low grade Fever) and FATIGUE (fatigue) outcome was unknown.