chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; first dose was a Bivalent Booster dose/bivalent booster dose administered as primary series dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (first dose was a Bivalent Booster dose/bivalent booster dose administered as primary series dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (first dose was a Bivalent Booster dose/bivalent booster dose administered as primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (first dose was a Bivalent Booster dose/bivalent booster dose administered as primary series dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    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 assessment was provided for WRONG PRODUCT ADMINISTERED (first dose was a Bivalent Booster dose/bivalent booster dose administered as primary series dose). No concomitant drug was reported. Reporter stated that a patient came over to receive the second dose in the primary series, but they realized that the first dose was a Bivalent Booster dose. No treatment drug was reported.
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX lot # M045204, expiration date 11-NOV-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the VARIVAX underwent a temperature excursion between 15 to 46 Fahrenheit degrees for 24 hours. The temperature excursion was captured using a digital data logger. No previous temperature excursion was reported. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source.; Sender's Comments: US-009507513-1705USA013050:
redness at injection site; induration at injection site; stiff neck; headache; fever; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABX751AA, expiry date 29th February 2020) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On 20th April 2019, 1 days after receiving Bexsero, the patient experienced injection site erythema, injection site induration, stiff neck, headache and fever. On an unknown date, the outcome of the injection site erythema, injection site induration, stiff neck, headache and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site induration, stiff neck, headache and fever to be related to Bexsero.  Additional case details were reported as follows: The patient received vaccine on unknown arm. The day after the patient received the vaccine, the patient experienced redness and induration at the injection site, stiff neck, headache, and fever. The reporter did not provide any additional information. The reporter consented to follow up.
Swollen tongue, lip,  gum soreness, tender jaw, joint pain, swollen finger joints and nail beds feel itchy and some hives.
Adverse event reporting:  testicular pain (left testicle).  He has never had this type of pain before.  It mainly hurts when he moves. He also had chills, mild fever (101.5), aches.  We knew to expect those but did want to report the testicular soreness since it?s not a listed side effect.  It may not be related and just coincidental but wanted to report in case there is a connection.
Patient called the pharmacy and stated that their entire upper arm was red and swollen. Advised the patient to seek medical treatment due to the severity of the swelling.
CHILD RECEIVED ADULT VACCINE DUE TO THE PROXIMITY OF HIS  #12 BIRTHDAY. MOTHER OF THE CHILD AGREED WITH THE TYPE OF VACCINE HE RECEIVED.
hard time breathing  swallow throat ras non stop scratching chest arms legs nauaea redness pain mscle
they administered the shot it felt like a quick pin prick; This is a spontaneous report from a Pfizer-sponsored program. A contactable female Other HCP reported that:  A female patent of unspecified age  is a Physical therapist received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number and expiration date were not reported) via an unspecified route of administration, on 28Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Jan2021 (same day of vaccination), when they administered the shot it felt like a quick pin prick but did not feel the injection. The outcome of event was unknown.  Caller asks, "is there a test to verify that I got the injection or should I just assume I got it, because my arm isn't hurting". Caller reports concern that her arm did not become sore after receiving the vaccine and now questions if she actually received the vaccine and if so, will it be effective.   E-transmitting for AE. Caller reports concern that the vaccination did not cause arm soreness. Offered caller warm transfer, offer declined.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Expired VAQTA administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.   On 10-NOV-2020, the patient was accidently vaccinated with expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 milliliter, lot # S032055 was confirmed to be valid, expiration date 09-NOV-2020 (route and site of administration were not provided), for prophylaxis. The product was supported per post expiry memo for 3 months post expiration date. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032055; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Blurred vision, rapid heart beat, numbness in legs, nausea , severe headaches and body aches.
4 pts were given doses from bottle; 2 of the 4 pts devel very high temp following inject; reporter is quite concerned because the doses were given from the same bottle & this react does not occur frequently;
I was feeling achy, had a cough, and fatigued, it felt like  had a mild head cold. I took a home COVID-19 test it came positive and was unable to connect with my doctor until Monday. Once I had my telehealth visit my doctor prescribed LAGEVRIO that I started taking Monday evening. I still feel tired, slight cough and congestion but getting better.
no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 4 month old patient who was vaccinated on 07-DEC-2022 with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023, orally (PO). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
pt recvd 1 dose of Engerix-B on 4JUL92 & devel diarrhea, fever, weakness & felt achy; resolved; 6JUL92 felt like having a gall bladder attack; abdo pain & an enlarged liver devel on 8JUL92;
arm pain; injection site warmth; localized reaction; This case was reported by a nurse via sales rep and described the occurrence of local reaction in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, less than a day after receiving Bexsero, the patient experienced local reaction, pain in arm and skin warm. On an unknown date, the outcome of the local reaction was recovered/resolved and the outcome of the pain in arm and skin warm were recovering/resolving.   It was unknown if the reporter considered the local reaction, pain in arm and skin warm to be related to Bexsero.  Additional details were provided as follows: This case was reported by the registered nurse (RN). The age at vaccination was not reported. For the first 24 to 48 hours after vaccination, the patient experienced a severe localized reaction that lasted a full week. The patient's arm was sore and warm to touch. Her arm was getting better each day. The reporter did not agree to follow up from GlaxoSmithKline (GSK). This case had been linked with case US2019AMR113752, reported by the same reporter.
pt recvd flu vax & devel sl swelling @ the inject site which lasted for 2 to 3 days;
UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a consumer concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Patient experienced itching, swelling, redness, tenderness, and pain hours after vaccination (8/8/17 am).
Fever, Involuntary movements in lower extremities and spasming of the whole body.
The patient, arrived to vaccine clinic with two para-educators. Verbal consent and screening checklist completed over the phone with patient's mother. Mother reported a history of patient fainting following the patient's second Covid vaccine, and mother reported that patient improved after drinking apple juice. Mother also reported that patient has Down Syndrome. Plan was made by clinic staff to provide patient with apple juice and pretzels while at the vaccination table, to have an area nearby for patient to lie down if needed, and for patient to wait her 15 minutes at the vaccination table, so that she would not have to walk to another area following vaccination. Patient arrived at vaccination table with two para-educators and began sipping on apple juice and snacking on pretzels. Patient received Pfizer vaccine without issue. Patient continued sipping apple juice and snacking on pretzels while waiting her 15 minutes and talked with vaccinators and para-educators. After 13 minutes had passed, patient stated that she began to feel dizzy, so patient lied down on the floor with her feet up, with the assistance of the clinic staff. Patient's skin appeared pink, and patient was able to open eyes and talk with clinic staff. Para-educator stated that "this might be an attention-seeking behavior." Patient lied on floor for approximately 5 minutes with clinic staff attending to her. After 5 minutes, patient reported that she was feeling better, and not dizzy anymore. Patient was sat up slowly by clinic staff and sat on the floor for approximately 5 minutes, with observation from clinic staff. Patient then was moved to a chair with the assistance of two clinic staff. Patient sat in chair for an additional 2-3 minutes, without issue. Patient was then walked across the room to sit in another chair, with the assistance of two clinic staff. Patient reported feeling fine. At that time, para-educators assumed care of the patient, and patient left the clinic reportedly feeling "better."
No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 23-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000973: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001003: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000: US-009507513-2108USA001007:
Terrible loud ringing in ears and buzzing in head, hearing loss (high frequency ),  fatigue, insomnia, fever, chills, brain fog
pt w/ 3wk of posterior neck pain and headache after second dose that did not improve with OTC meds. on 4/10/21 @ 6pm pt noticed that he could not swallow and was drooling, His L face and body was numb so he presented to the Ed. Pt was worked up for angioedema at first . then symptoms progressed to  R sided facial weakness and CODE stroke was activated. Found to have R vertebral artery occlusion, R PICA occlusion secondary to distal vertebral artery dissection and pt was given TPA. Neuro exam slowly improving.
VACCINATED ON 03/01/03, WOKE WITH 1CM X 3 CM AREA OF ERYTHEMA, NO INDURATION, WARM TO TOUCH AREA ON L UPPER ARM ON 03/02/07, TX'D WITH BENEDRYL AND ACETAMINOPHEN, PROGRESS REPORT ON 03/05 - DOING MUCH BETTER, AREA RESOLVED.
Pt called the office 24 hours after the injection. c/o pain at site of injection and chills last PM. Seen in office skin at site of inj right deltoid area and around arm is pink, warm to touch and swollen. Temp 97.4.
Cough, fatigue, sore throat, wheezing, slight muscle spasms in right thigh, runny nose
Patient was given FLULAVAL 11/02/2017 and 11/24/2017 on mistake. Patient was supposed to be given TDAP at this point in her pregnancy (28 weeks) but was given FLULAVAL, again, instead. Patient will receive TDAP at next appt.
Lab Asst obtained this year's flu vaccine in her left arm at 0830. About 15 minutes later patient noticed throat swelling, nose swelling, pt was unable to breathe, and had severe nausea. Pt reported to her PMD at the clinic and received an EPIPREN. At about 1300 pt noticed recurrence of symptoms with no relief from oral BENADRYL. Pt experienced nausea, vomiting, throat swelled shut, upper lip swelled, eyes were also puffy. Pt reported to her PMD at the clinic and got another EPIPEN injection as well as a dose of prednisone. At 2030 pt experienced yet another reoccurrence of these symptoms, more severe than the last episode with no relief of oral medication. Symptoms were so unrelenting that pt reported to ED. She was admitted to ED from 9/15/17 and discharged 9/16/17 -pt has NEVER reacted to flu vaccine before at all in any fashion.
1/2 inch red, itchy, hard rash at site of injection - right underside of arm.
increased urinary incontinence; had a bad fall/fell on his back; fever; chills; balance issues/difficulty with balance; joint pain; has been complaining of not feeling well; This spontaneous report was received from a consumer referring to her husband of unknown age. The patient's concurrent conditions included urinary incontinence. On 02-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route and lot # not provided). Concomitant medications were not reported.        The patient's wife reported that in May 2019 "over the last few days", the patient had been complaining or not feeling well, joint pain, chills and having difficulty with balance. On 10-MAY-2019, the patient had mild fever of 37.6 °C. On the same date, the patient fell on his back in the bathroom and it was difficult for his wife to get him up. When she got the patient to his bed there was evidence of worsened urinary incontinence. The patient visited an urgent care clinic on 11-MAY-2019 and the doctor did not see the patient advising him to go to the emergency room. The reporter stated that the patient was still not steady on his feet. The outcome for increased urinary incontinence, not feeling well, chills and joint pain was reported as not recovered. The outcome for fever and fell on his back was unknown.
I have not taken the second injection; After 1st dose, sick with flu like symptoms; sick; This case was reported by a other health professional and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In February 2022, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms and sickness. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 02 DEC 2022 Reporter's comment: The reporter stated that patient took first injection of Shingrix in February 2022. The patient immediately got sick with flu like symptoms that lasted for 3 weeks. The patient had not taken the second dose of Shingrix also considering for getting second dose. Patient asked that whether he/she waited to long or would get it. Additional supportive information: Till the time of reporting the patient did not received the second dose of Shingrix which led to incomplete course of vaccination.
discolored; arm still has redness; a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (discolored), ERYTHEMA (arm still has redness) and PERIPHERAL SWELLING (a little swollen) in a female 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (discolored), ERYTHEMA (arm still has redness) and PERIPHERAL SWELLING (a little swollen). At the time of the report, SKIN DISCOLOURATION (discolored), ERYTHEMA (arm still has redness) and PERIPHERAL SWELLING (a little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   No treatment medication information were provided.     Reporter did not allow further contact
I contacted the medical team and spoke with a medical team member. Information given to patient (lot#, exp date, date administered). Confirmed that there were no temperature excursions in refrigerator since expiration date of 3/14/2021. Per patient in-house data supports the potency of the vaccine administered. Merck does not make any recommendations about re-administering this vaccine. The clinician must make the final decision.? Event Case # 01892274 Stability Information Case # 01892275.
8SEP98 10min p/vax devel runny nose, expiratory wheeze, c/o pounding heart, puffy eyes;
Severe pain and numbness to left arm (arm injection given in), head ache, neck ache, tight throat.
Patient's mom called and said her son was given the vaccine by our pharmacist, and has now developed a bruise and complaining of arm soreness. She was concerned that the vaccine was given too high up. I explained to her that bruising and soreness was normal and I couldn't determine if it was too high without seeing it. Mom brought the patient in for observation on 6/9/22. Based on the bruising, it does appear that the vaccine was given too high up (about 1/2 inch from top of shoulder). Patient was still able to have full range of motion with his arm. I advised the mom to keep an eye on him and to take him to the doctor if it gets worse or he loses any range of motion.
exacerbation of MS;pt recv vax & some time p/vax exp exacerbation of prev existing mult sclerosis;prior to this exp the pt condition was considered stable;pt bitten by monkey in Mexico;