chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client stated on 4/11 in the morning, he woke up with a headache and "malaise". He also noticed "tender tissue" under the "crook of right armpit". He denied any discoloration, but reported "severe swelling". Client went to go see primary care provider. Was told there was not lymph node enlargement and was given KEFLEX. Client stated that on 4/12 he felt neck stiffness that was more prominent on the right side. The pain was localized to the "base of the neck." He also stated that on 4/11 he felt "shooting pains" and a "weak sensation" down his right arm but that it had resolved by 4/12. Client stated the headaches he feels are one of the "worst headaches" he has felt before.
pt recv vax 31MAY96 & pt devel chickenpox that consisted of approx 6 lesions;
Received Flumist 29Ssep2010, the following day he began experiencing shortness of breath, fevers, and myalgias.  Also non-productive cough, vomiting, and diarrhea.  CHR positive for pneumonia; blood pressure dropped while in ER to 77/64, and was at 87% saturation on 4L and pt was sent to ICU.
Vaccine administration error. There was an error discovered that the Pediatric Covid vaccine was mistakenly not diluted prior to administration of vaccine to child resulting in higher than authorized dose (0.2 mL of undiluted vaccine administered).  Upon discovery of error, management consulted Health Department pharmacist, Medical Director, Administration, and Pfizer. Parent was notified on 03/22/22 of error and given guidance based on CDC and manufacturer's recommendation to not repeat dose and inform recipient of the potential for local and systemic adverse events.  Mother states  the patient woke up in the night coughing and complained that her chest was hurting and mom gave her Tylenol. Mom states she also gave Tylenol again before school,  and at that time said her arm was sore. The mom reports that she has been giving both children allergy medications. Both children have been at school all day (call took place at 1:30) and the mother has not been contacted with any issues. The mother states that she will call their Pediatrician for an appointment if the daughter has chest pain when she gets out of school.   Questions answered.  Informed mother to contact the health department and the child's pediatrician and/or seek medical care if the child has any concerning side effects.  Health Department to follow-up with family over the next days and week.
Patient fainted a few minutes after getting the vaccine. After the follow-up with the mother she said it was not related to the vaccine and he might have been nervous because of receiving the vaccine. He is doing OK and no follow up needed.
Low grade fever with chills Body aches Redness/itchiness/firmness at injection site beginning 5 days after injection
He was sick due to covid injection; Indication: Other chronic pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-AMGEN-USASP2022227143.  This non-serious spontaneous report (USASP2022227143) was reported to agency on 30/DEC/2022 by a consumer and involves a male patient who was sick due to covid injection [PT: illness] while receiving Enbrel with Single Dose Prefilled Syringe. Off label use was reported. No historical medical condition was reported. The patient's current medical condition included other chronic pain. No concomitant medications were provided. The patient's co-suspect medications included Covid-19 vaccine. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date. It was reported that, the patient was taking Enbrel for other chronic pain, which was an off label use. The patient missed dose which was advised by doctor because he was sick after taking Covid (Coronavirus disease 2019) injection. No treatment information was received. The outcome of the event illness was reported as recovered/resolved. The event illness was resolved on an unknown date. Action taken with Enbrel and Single Dose Prefilled Syringe was temporarily withheld for the event illness. The consumer reported that the event illness was possibly related to Enbrel. The causal relationship between the event illness and Single Dose Prefilled Syringe was not provided by the consumer. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected.  Enbrel is under agreement with the agency.  No follow-up attempts are possible. No further information is expected.
Inadvertently gave 6 month-35 month dose to a 17 year old. Spoke with Public Health Nurse and an additional dose of the same vaccine given to make it equivalent to correct dose.
Narrative: Pt is an 80 yo M with PMH of OA, CHF, CAD, HLD, aortic valve stenosis, T2DM, HTN, hyperthyroidism. neuropathy, osteoporosis who received the 2nd dose of COVID-19 vaccination on 2/26. Per the coroner, the patient was expired in front of his home while power washing his driveway.
HCP calling to report improperly stored vaccine was administer prior to temperature excursion evaluation.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 14-OCT-2020, the patient was administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number S028919, expiration date 16-SEP-2021 (route of administration was not provided) for prophylaxis.         The vaccine had a temperature excursion ranging from 6 Fahrenheit degrees (°F) to 14 °F with an average of 13.1 °F for 5 hours and 32 minutes. The vaccine had been exposed to previous temperature excursions. The call was due to digital data logger.
Fever (Tmax 102.8), chills, joint and muscle aches, fatigue, headache, injection site tenderness. I've taken Tylenol for fever and pain control. Symptoms resolving but not entirely gone, now 3 days after booster dose.
Sectoral episcleritis, severe dryness and redness, and pain/foreign body sensation in left eye starting ~1 week after first dose and worsening gradually  over the next 5 weeks.  Unresponsive to all attempted at-home treatments started 2 weeks post symptom onset, including artificial tears 4x/day, warm compresses, oral NSAIDs, and fluticasone nasal spray.  Dose 2 taken as planned on 6/16/21.   Saw optometrist on 7/10 who prescribed Prednisolone Acetate 1%  eye drops for 2 weeks.  Redness and pain disappeared completely within 2 days of drops.  Reevaluated on 7/17 and told to taper drops over the next week as symptoms had significantly improved.  Last drop was taken on 7/25 - symptoms immediately returned the next morning, have gradually worsened since then, and are once again not responding to at-home treatments (currently artificial tears 4x/day).  Was told by optometrist that this may be an indefinitely recurring condition.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The reporter was reporting 2 doses of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017) (dosage, strength and route unknown), that had been improperly stored (temperature and time frame: 34 degree F for 3 hours 24 minutes and 47 degree F for 6 minutes), were inadvertently administered to the unspecified patients on unspecified dates. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed red, irritated left eye 6 d post-vaccination.  Associated SS include viral prodrome of pharyngitis, nasal congestion. No fever, constitutional systems.  Excellent site care (reviewed) and no sick contacts.  PMHx of HTN, Hyperlipidemia, GERD, no eye surgerys, medications. Seen in ED yesterday evening and dx'ed (ID consulted) with conjunctivitis.  This morning developed redness around eye, some swelling. No photophobia, H/A, purulent d/c, but copious clear d/c.  PE shows him to be afebrile, no LN, looks well, conjunctival erythema w/ clear mucoid d/c.  PERRLA, normal fundus, no corneal lesions.  Exam by Ophthalmologist pending. Cultures taken.  Patient placed on medical restrictions. Take check for 1/7 pending.
Pt was seen in office on 09/19/18 with c/o red and swollen left arm. She received PNEUMOVAX 9/18/18. Site was red, warm to touch and tender. Seen by Dr, dx with vaccine reaction. Instructed to put cool compress on site and call if worsens in 24 hours. Pt verbalized an understanding of instructions.
Mild case of shingles; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 09:15 (at the age of 45-years-old) as single dose for COVID-19 immunisation. The medical history of the patient included ulcerative colitis. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks prior to the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 09:45 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccination. On 09Apr2021, the patient experienced a mild case of shingles 2 weeks after the second vaccine. The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild case of shingles was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 hours after 2nd vaccination I found that all of my standard routines were effortless, and I could add 20-30 lbs of added resistance before they felt normal.; This is a spontaneous report from a contactable consumer (patient himself).  This 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN 6201), via an unknown route in the left arm, on 13Feb2021 09:45 (at the age of 73-year-old) at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in the left arm on 23Jan2021 for COVID-19 immunisation. No other vaccine was received in four weeks. The patient did not have a relevant medical history. Relevant concomitant medications included cefalexin (CEPHALEXINE). The patient stated ''I've been going to gym 3x weekly for over 10 years doing the exact same resistance machine routine; 3 hours after 2nd vaccination I found that all of my standard routines were effortless, and I could add 20-30 lbs of added resistance before they felt normal; I'm wondering if the vaccine stimulates adrenaline production (at least short term); I've never had this happen before; even doing free chin-ups I normally struggle to do one, but 3 hrs after vaccine, I could do 4 with little effort''. The patient was not treated for the event. The outcome of the event was unknown.
Tinnitus -- high-pitched clicking in right ear every 10-30 seconds  Symptoms began 2am following injection #2 the previous morning Amplitude high enough to prevent sound sleep nights 1 and 2 after injection; now decreasing very slowly over following nights 3-6 Otherwise recovered in one day from expected mild muscle soreness, mild fatigue/malaise, slight fever
2 hours after vaccines, eyes got red, itchy, rash below cheeks - pruritic, flat; blanching - no fever or other signs/sx illness (viral syndrome vs vaccine reaction)
patient received dose of Moderna vaccine post excursion; patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (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 (patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received dose of Moderna vaccine post excursion).    This case contains information for the 3rd out of 19 patients described by the reporter.  Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19 (Master case)
suspected vaccination failure; I have had the shingles they were bad; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient reported that, they were bad. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided.
local inflammation 14cm x 11cm;tx w/DPH & Ibuprofen;
Information has been received from a physician concerning a female who was on an unspecified date was vaccinated subcutaneously with 0.65 ml of ZOSTAVAX.  The physician reported that "the patient developed a rash after receiving ZOSTAVAX".  Unspecified medical attention was sought.  It was noted that the patient was due to return to the office for follow-up after which any additional information would be reported.  There was no product quality complaint.  There were no lab diagnostic studies performed.  At the time of reporting the patient's status was unknown.  Additional information has been requested.
severe pain in upper left back and neck. severe pain in left elbow, numbness and tingling from left shoulder down to tip of pinky finger on left side, wrist pain, nausea  still occurring after 6 days
This spontaneous report as received from a pharmacist refers to a patient of unknown age who on 27-JAN-2015, was vaccinated with a dose of PNEUNOVAX 23 (Lot No. J005068, exp. 18-JAN-2015), 0.5 ml, intramuscular. The pharmacist reported that the patient received an expired dose of PNEUMOVAX 23. No adverse effect reported. Additional information has been requested.
weak; out of breath; aches; chills; headaches; pain; A spontaneous report was received on 8 Feb 2021, from a consumer concerning a 87-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events aches, chills, headaches, pain, weak, out of breath.  The patient's medical history was not provided. Concomitant medications reported were amlodipine for drug use for unknown indication.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 103K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the event(s) aches, chills, headaches, pain. On 8 Feb 2021, the patient experienced the event(s) weak, out of breath.  Treatment details included Tylenol, YSayegh8Feb2021.  Action taken with mRNA-1273 in response to the events was not reported.  On 1 Feb 2021 the outcome of event(s), aches, chills, headaches was resolved. The outcome of event(s), pain, weak, out of breath was unknown.
Had a  golf ball Sized sore spot at injection site. Eventually moved from my shoulder to my elbow and I felt sick for two days and it's still sore.
Within a few hours of receiving the shot, my armpit was swollen, tender, and sore. I went to the doctor and an ultrasound was completed due to family history of cancer. Results were normal and I took Tylenol for the pain. It took a month for the swelling and pain to go away.
Syncope and dehydration. Pt was light headed following vaccination. Had pt sit in the lobby for 20 minutes following the shot. Called EMS to ensure he did not need medical attention. Blood pressure was fine, EMS stated that pt was dehydrated. Gave pt a bottle of water and he sat in lobby for an additional 20 minutes. Pt signed a waiver from EMS stating that he did not need medical treatment. He felt better and went home.
lightheadedness; some tingling in her left arm; BP improved; This is a spontaneous report from a non-contactable other hcp. A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205) via an unspecified route of administration, at the age of 38-year-old, on 22Mar2021, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On 22Mar2021, during her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She also had some tingling in her left arm.  She denied rash, hives, difficulty breathing and difficulty swallowing. She admits to eating lunch around noon and drinking lots of water today. Treatment included water. Follow up response to treatment was good. Lightheadedness resolved prior to discharge. BP improved. She was escorted out of the building and denied symptoms while ambulating out. Patient discharge: Stable to go home and follow up with PCP. Outcome of lightheadedness was recovered in Mar2021, some tingling in her left arm was unknown, while BP improved was recovering at the time of the report.  No follow-up attempts needed. No further information is expected.
remained anti-HBs-nonreactive; This literature market report refers to an adult patient with unknown age and gender who was a heart transplant recipient. Information about concurrent condition and concomitant therapy was unknown.  On unknown dates, the patient received 3 doses of hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. The patient had post-vaccination completion hepatitis B surface antibody (anti-HBs) checked and the patient remained anti-HBs-nonreactive. The outcome of the event was unknown. The reporter considered the event to be related to hepatitis b vaccine (recombinant) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.   This is one of three reports received from the same literature.; Sender's Comments:  US-009507513-2011USA008579: US-009507513-2011USA008580:
Difficulty in walking; Fatigue aggravated; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficulty in walking) and FATIGUE (Fatigue aggravated) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced GAIT DISTURBANCE (Difficulty in walking) and FATIGUE (Fatigue aggravated). At the time of the report, GAIT DISTURBANCE (Difficulty in walking) and FATIGUE (Fatigue aggravated) had not resolved.            No concomitant medication was given.  The events patient experienced after first dose aggravated after second dose.  No treatment  was given for the events.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-122469 (Patient Link).
chest pain; left side "spleen" pain; neck pain; Pain in breasts; pain in underarms; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), ABDOMINAL PAIN (left side "spleen" pain), NECK PAIN (neck pain), BREAST PAIN (Pain in breasts) and AXILLARY PAIN (pain in underarms) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced CHEST PAIN (chest pain), ABDOMINAL PAIN (left side "spleen" pain), NECK PAIN (neck pain), BREAST PAIN (Pain in breasts) and AXILLARY PAIN (pain in underarms). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and METHYLPREDNISOLONE for Adverse event, at a dose of UNK dosage form. On 10-Feb-2021, CHEST PAIN (chest pain) had resolved. On 17-Feb-2021, ABDOMINAL PAIN (left side "spleen" pain) had resolved. At the time of the report, NECK PAIN (neck pain) had not resolved and BREAST PAIN (Pain in breasts) and AXILLARY PAIN (pain in underarms) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient received the second shot on right arm on 09-Mar-2021. Lot number (014M20A). The patient visited physician and received steroid shot for the events as treatment.   This case was linked to US-MODERNATX, INC.-MOD-2021-069815 (2nd dose case) (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: new events of breast pain and pain in underarms added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069815 (2nd dose case):