chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client was given the influenza vaccine on 2/5/07 to left deltoid. 3-4 days after the shot, client experienced pain in arm and limited range of motion. Client never went to a doctor and only notified clinic who administered vaccine on 6-26-07. The nurse assessed the arm w/no signs of swelling, redness or infection. Pain has continued since approx. 2-8-07.
High Blood Pressure headache low grade fever  heart palpitations extreme Chest pain blurred vision extreme shoulder pain extreme neck pain back pain calf pain
Temp 102 degrees oral 10/4/03-normal at present. Red, raised pruritic spots on trunk, face, extremities. Exposed to c. pox 1 wk ago, few vesicles.
Pt ached all over for several weeks then aches settled in upper back and shoulders. Didn't feel well, very tired. Saw MD on 1/11/00 and he offered the idea it was from the Hep B vaccine. Treated with Nuprin, aches were gone on 1/18/00.
I was fine until exactly a week later. I started having itchiness  and swelling in my ears, face and throat. I took Albuterol and Benadryl at home. Then I went to the ER and they have me a steroid and  Pepcid. I went home, and I was still very itchy. Then I went to urgent care and they repeated the treatment and I was fine by the 3rd day. I went to see my allergist and he wasn't sure if it was due to the vaccine. I was instructed to take the 2nd dose, but to take meds first. I took antihistamines before 2nd dose and I was fine.
Redness, swelling, heat and pain at injection site x 4 days - still slightly reddened at 6 days post-vaccination Body aches, headaches, low grade fever, chest congestion x 3 days
I received my vaccine yesterday and had complications after the vaccine and could not work today .  I had swelling of the extremity all the way to finger tips with 8/10 pain . Which was unrelieved by ice and warm packs and taking Tylenol.  I did contact my md last night as the pain was enough for me to question if I should be going to the emergency room. She believes it might have been an allergic reaction to the vaccine.
Pt felt short of breath immediately (5-10 seconds) after administration. He began clearing his throat but did not immediately say anything to the medical assistant who was administering the vaccine, so she then gave him the influenza vaccination in the other arm (right). He continued to clear his throat and then said that he felt short of breath, hot, dizzy, nauseated, and like he might pass out. Vital signs were immediately checked and found to be normal, a portable pulse oximeter was left on his finger and O2 sats were always >98% throughout the episode. He was given a nebulizer treatment as he stated it felt like his asthma usually presents, but that did not affect his symptoms. After one hour of monitoring the patient and consistently normal vital signs he stated that he felt better and wished to return to work.  He was placed on prednisone 10 mg taper, instructed to use his albuterol MDI as directed prn and strict ER precautions were reviewed with the patient. I personally checked on him later that day, the next day, and one week later, and he reported no further issues.
convulsing; Hallucinating; Fever of 104 degrees; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsing) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced SEIZURE (convulsing) (seriousness criterion medically significant), HALLUCINATION (Hallucinating) and PYREXIA (Fever of 104 degrees). At the time of the report, SEIZURE (convulsing), HALLUCINATION (Hallucinating) and PYREXIA (Fever of 104 degrees) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included Paracetamol.  Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Fever is consistent with event safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Fever is consistent with event safety profile.
Had 1st dose of Moderna vaccine on 5/2. Had mild arm soreness and developed a round erythematous macule on arm about 5 days after vaccine. Otherwise tolerated well. Had salpingectomy 5/13. Took Miralax the next day. Had an anaphylactic reaction (full body itching, throat tightness), abd cramping, dizziness. Was taken to ER via ambulance. Given epi, steroid, benadryl. Returned to ER the next day for hand swelling. Feeling better now, just run down. Has taken oral PEG in the past without incident (colonoscopy prep a few years ago).
chills for 6 hours, exhausted for 8 hours joint pain 8 hrs next day chills for 2 hrs and tired. difficulty breathing used inhaler
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Caller declined providing medical history. Caller reports they tested positive before back in September 2022.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE and Influenza (at doctor's office). Past adverse reactions to the above products included No adverse event with Influenza and PFIZER BIONTECH COVID-19 VACCINE.    On 06-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: Positive. On 12-Jan-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported. Patient's all other vaccines were Pfizer. Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. On 11-Jan-2023, patient started having cold symptoms. On 12-Jan-2023, she experienced extreme body pain, fatigue and chills. She tested herself and was positive for COVID on 12-Jan-2023. No treatment information was reported.
It's reported client developed right-sided facial swelling while in observation area after receiving vaccine. Patient was administered 50mg IM, but unable to start IV. Client transported to Emergency room for further assessment.
Tenderness for a couple of days; This case was reported by a consumer via call center representative and described the occurrence of tenderness in a adult female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced tenderness. On an unknown date, the outcome of the tenderness was recovered/resolved.   It was unknown if the reporter considered the tenderness to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by patient's parent. The age at vaccination was not reported The patient had received Bexsero vaccine and had tenderness for a couple of days and got recovered on 10th March 2022. The reporter attempted to call consumer back to gather additional details for adverse event reporting, left message for consumer.  The adverse event was left on the afterhours VM in Medical Information and reported in its entirety based on the VM message.  No additional details regarding adverse event. The reporter consented to follow up.
Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrible headache) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Terrible headache). At the time of the report, HEADACHE (Terrible headache) outcome was unknown.            Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Mom requested MMR vaccine.  MMRV was given.  No known adverse affects. Parent notified of error.
tested positive for Covid 19 disease; tested positive for Covid 19 disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (ongoing). Concomitant medication(s) included: COSENTYX taken for psoriasis (ongoing). Vaccination history included: Flu vaccine, administration date: Oct2021, when the patient was 71 years old, for immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "recovered" (13Jan2022) and all described as "tested positive for Covid 19 disease". The event "tested positive for covid 19 disease" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (01Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Developed chills with aching long bones (thighs, low back, upper arms) early evening after injection. Profound malaise and fatigue with same pain and chills next day and continuing until 2/1/2021.
pt went to MD for PE & recvd vax 19AUG92 then exp reddened area 6 by 8 cm w/white hard center site of inject, size of hazel nut; MD wondered if lyme disease;
PFIZER VACCINE WAS PLACED IN FREEZER 05062021 AND DUE TO BE MOVED TO REFRIGERATOR 05192021.  VACCINE WAS LEFT IN FREEZER UNTIL 05212021 THEN MOVED TO REFRIGERATOR. PROGRAM WAS NOTIFIED OF ISSUE ON 05252021 AND SENT EMAIL STATING  VACCINE AS SAFE TO USE .   05272021 EMAILED  VACCINE WAS NOT SAFE TO USE AND TO DESTROY THE VACCINE.  THEN EMAILED 05282021 THAT PFIZER HAD DEEMED VACCINE STABLE AND IT WAS SAFE TO USE SO DOSES GIVEN 05252021 WERE GOOD.
Breakthrough COVID  First vax 1/15/2021 second lot number could be EN5318 instead of GN5318.  65-year-old male presents to the ER for sudden onset fever, chills, night sweats.  It happened for only 1 day.  His temperature was a 101° F at home.  He felt very weak and lethargic and could not get up to walk.
SINUS PRESSURE BEHIND EYES WHICH WAS MOVING TO THE FOREHEAD; HEADACHE; FEVER OF 99.9F; This spontaneous report received from a patient concerned a 54 year old female. 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, batch number: Unk) dose was not reported, administered on 18-MAR-2021 11:30:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced sinus pressure behind eyes which was moving to the forehead. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever of 99.9f. Laboratory data included: Body temperature (NR: not provided) 99.9 F. The batch number was not reported and has been requested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sinus pressure behind eyes which was moving to the forehead, headache, and fever of 99.9f. This report was non-serious.
Patient was given expired vaccine on 07/26/2022. COVID vaccine expired on 06/30/22 no symptoms reported
Severe facial flushing (redness and burning warmth) radiating to ears and neck beginning suddenly about 48h after receipt of vaccine and has continued without relief for 10 hours. Tylenol  and ASA taken after symptom started did not relieve the flushing or burning discomfort. Not accompanied by any other symptoms. No rash present. Felt fine up until the flushing onset at about 48h mark.  Feels as how I?ve heard patients describe niacin flushing (I have personally not ever taken niacin).
rash around site of injection; patient complains of itching outside and inside the arm; large area of rash on arm
Felt like they gave the vaccine subcutaneously; A spontaneous report was received from a consumer who was also a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and she felt like they gave the vaccine subcutaneously (incorrect route of product administration).  The patient's medical history was not reported.  Concomitant product use was not provided.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) for prophylaxis of COVID-19 infection.  During administration, the patient felt like they gave her the vaccine subcutaneously.   Action taken with mRNA-1273 in response to the event was not applicable.   The event of felt like they gave the vaccine subcutaneously was considered resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # 007M20A) with no associated AEs reported.
Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.; Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (Caller reported that a patient was given a dose of Moderna vaccine from a vial that had undergone a 2 and a half-hour temperature excursion.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that vail stored at -10Deg C.  No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: The recent follow up received on 24-MAR-2022.
Patient came into the pharmacy on 7/26/23 to get a second vaccine and it wasn't until then that the patient stated that 4-5 hours after getting the vaccine she developed hives/rash on her trunk and back and said it was so bad that she had to go to the ER. I advised her that she should have mentioned this when the event occurred and advised her that she should not get the 2nd dose until consulting with her physician.
Leg very sore; slept alot; vomited twice cranky; no fever; when awoke screaming; APAP given-seen in office by MD on 22NOV91;
@1245PM CLIENT VERBALIZED FEELING LIGHTHEADED, UPON ASSESSMENT, BP 170/92, RR24, PR 107, AFEBRILE. DENIES ANY PAIN , NO INDICATORS OF PAIN PRESENT. NO S.SX OF ANY RESPIRATORY DISTRESS. 02SAT=98% ROOM AIR. FSBS 331MG/DL VERBEALIZED THAT SHE TOOK ALL HER DM MEDS THIS AM.  @1:05PM CLIENT VERABLIZED THAT SHE FEELS BETTER AND APPEASRS TO BE LESS ANXIOUS. BP 167/90, RR18, PR 92 AFBERILE.
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. The healthcare worker reported that doses of GARDASIL (lot # K006124, expiry date 02-FEB-2017 and lot # K011325, expiry date 08-APR-2017) (dosage, strength and route were not reported), which were exposed to temperatures outside of the recommended range, had been administered to unspecified patients on unspecified dates since 15-SEP-2015. At the time of the report, no adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting
Circumstance or information capable of leading to medication error; patient might receive a possible third dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose in March 2022, batch number:DE9LR) and Shingrix (received 1st dose in September 2021 and batch number:C54P9).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error) and extra dose administered (Verbatim: patient might receive a possible third dose). The outcome of the circumstance or information capable of leading to medication error and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 The reporter reported that a patient might receive a possible third dose of Shingrix.  The partial information about patient, vaccine and event was given. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The reporter reported that a patient might receive a possible third dose of Shingrix, which led to extra dose administered and circumstance or information capable of leading to medication error .
Approximately around 10 days after my booster shot I experienced the following symptoms: Hives (Different parts of my body), Itchiness. I have taken some Benadryl to try ease the symptoms but it did not do anything to improve the situation. I called my doctor and had a Telehealth appointment and was prescribed with Prednisone and some other medication and it did help ease the itchiness. When I stopped taking the medications I would start to have some small flare up from different parts of my body even up to this day (03/31/2022). I saw a dermatologist and prescribed me with Montelukast, Allegra and Zyrtec.
Immediate raction noted 1 min after vac. moderate erythema & swelling at inject site.  Size of small orange; dr notified, ice applied X 30 min, Tylenol given, observed X45 min.  Also had same rxn to R leg - HIB same tx.
Intense sharp pain on the side of the foot; Aching, soreness; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Intense sharp pain on the side of the foot), PAIN (Aching, soreness), HEADACHE (Headache) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 020(X)21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Intense sharp pain on the side of the foot), PAIN (Aching, soreness), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Intense sharp pain on the side of the foot), PAIN (Aching, soreness), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details not provided.   This case was linked to MOD-2021-066082 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.