chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen injection arm; rash in 3 different areas of injection arm; rash in 3 different areas of injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swollen injection arm), INJECTION SITE RASH (rash in 3 different areas of injection arm) and RASH (rash in 3 different areas of injection arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain in arm (patient stated a week ago their arm was hurting.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (swollen injection arm), INJECTION SITE RASH (rash in 3 different areas of injection arm) and RASH (rash in 3 different areas of injection arm). At the time of the report, INJECTION SITE SWELLING (swollen injection arm), INJECTION SITE RASH (rash in 3 different areas of injection arm) and RASH (rash in 3 different areas of injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no medication report were provided no treatment medications were reported.
2-3" AREA AROUND INJECTION SITE. WARM, RED, AND HARD. NOT TENDER.
Site: Pain at Injection Site-Mild, Additional Details: A vaccine was administered to a patient that had been left at room temperature for greater than 24 hours. The vial was not punctured until this vaccine was given. The patient was called but she did not answer. A voicemail was left for her to contact us back. The District Leader is looking into if the vaccine must be readministered or not.
Headache, HYPERtension, slurred speech, arm felt heavy, code blue called and transported to hospital Narrative:  slurred speech, arm felt heavy, code blue called and transported to hospital
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 37-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot#), at the age of 37, in left arm, on Mar 23, 2021, at 16:45, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient had a headache/headache after the first shot lasted the entire day, with outcome of recovered. No therapeutic measures taken as a result of headache. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19, nor tested for COVID-19 since vaccination. Other medical history reported as none. The patient received the 2nd dose on Apr 13, 2021, at 16:45, in left arm. No other vaccine in four weeks and no other medications in two weeks. No follow-up attempts possible. No further information expected.
Case number PHEH2014US017383 is an initial spontaneous report received from a nurse on 27 Aug 2014. this report refers to a 13 year old female patient. Past medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: M14024), intramuscularly reconstituted with a sterile diluent instead of MenCYW-135 liquid component on 07 Aug 2014. Reporter stated that, they have scheduled patient for revaccination tomorrow. No adverse reaction reported following this administration error.
Caller asked if it is okay that he is taking amoxicillin after taking first dose of covid-19 vaccine; This is a spontaneous report from a contactable male consumer (patient) received from a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication) included amoxicillin (AMOXICILLIN) taken for an unspecified indication, start and stop date were not reported. The patient reported caller asked if it is okay that he is taking amoxicillin after taking first dose of covid-19 on an unspecified date. The outcome of event was unknown.  Information on the lot/batch number has been requested Follow-up attempts are completed. No further information is expected.
Right thigh swollen to knee, normal gait complained of leg pain with no erythema or tenderness.  Given acetaminophen 1.5 tsp, and ibuprofen 1.5 tsp.
Developed fever 102.5 at 1 AM and had a seizure lasting under 1 min. Otherwise doing well.
the burning pain in legs; Pain at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (the burning pain in legs) and VACCINATION SITE PAIN (Pain at the site of injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) 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) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site of injection). On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BURNING SENSATION (the burning pain in legs). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (the burning pain in legs) and VACCINATION SITE PAIN (Pain at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-116618 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021 contains Reporter demographics added, Adverse Event updated, treatment information was updated.
had the vaccine and still got them / Suspected vaccination failure; Shingles attack on eye; Retina to unattached; Shingles on head; shingles attack on mouth; Lost 2 teeth; Pain on top of head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the vaccine and still got them / Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles attack on eye) (serious criteria GSK medically significant), retinal detachment (Verbatim: Retina to unattached) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on head), oral herpes zoster (Verbatim: shingles attack on mouth), tooth lost (Verbatim: Lost 2 teeth) and headache (Verbatim: Pain on top of head).  The patient was treated with non-drug therapy (Surgery). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles, oral herpes zoster, tooth lost and headache were not reported and the outcome of the retinal detachment was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, retinal detachment, shingles, oral herpes zoster, tooth lost and headache to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, retinal detachment, shingles, oral herpes zoster, tooth lost and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that shingles was awful. The patient reported that the shingles attacked on his/her eye caused his/her retina to unattached and had surgery to fix the retina. The shingles attacked on the top of his/her head and mouth and he/she lost 2 teeth and he/she had constant pain on top of his/her head. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Pt. was vaccinated w/varicella and MMR on 2/11/14.  Per mom, left arm became swollen, red, and tender to touch in am on 2/12/14.  Pt. also developed hives starting on 2/12 in am. Varicella was administered in left arm.  Pt. followed up with HCP and Benadryl given by mom.
Arrived in the ED with total body hive (red, raised welts); swollen tongue & lips and angioedema with itchiness
Patient received immunization at 0730 after filling out a VAR. At 0910 patient returned to immunization station to report a "funny feeling" in  his ears. He stated that they were feeling full and that he felt a little lightheaded. He further stated that he had Meniere's disease and that he had just taken 50mgs of ANTIVERT. He had no other symptoms but still felt uncomfortable and I suggested we call 911. They came and all vitals were in normal range. Still feeling uncomfortable he requested that they take him to the ER.
VERTIGO; TINGLING IN LEGS; This spontaneous report received from a patient via other manufacturer (Abbvie) concerned a 54 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: vertigo which resolved in 2016. The patient was previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. Age at time of vaccination 53 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 13-JAN-2022 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 54 years old. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26. cov2.s (dose number in series 2). No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received additional dose of spikevax (elasomeran) (dose number in series 3), (form of administration not reported, Route of Admin was intramuscular, batch number: unknown, expiry: unknown) dose and was not reported, 1 total, administered on an unspecified date in 2022 for prophylactic vaccination.  On an unspecified date in 2022, the patient experienced tingling in legs (dose number in series 3). On an unspecified date in MAY-2022, the patient experienced vertigo (dose number in series 3). The action taken with elasomeran (spikevax) was not applicable. The outcome of the vertigo and tingling in legs was not reported. This report was non-serious.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 13-SEP-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777 and expiry date 07-JUN-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
The day after the injection - 10/2/19, i developed severe fatigue and body aches from head to toe.  Approximately 24 hours after vaccination, I developed (2) areas approximately 3 inches by 2 inches, that were firm red and warm, 3 inches below the injection in the left arm and a similar area on the right shoulder. I took Benadryl 10/2/19.  By the next morning 10/3/19, the aches have subsided and the area on the opposite shoulder has started to subside but the area beneath the injection site is still firm, warm and red.  I took Loratidine this morning.  No other treatment sought.  My Doctor was notified.
This spontaneous report was received from a medical assistant referring to a 23 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAY-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # N003997 and expiration date 20-OCT-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA011654
Vomiting, constriction of chest muscles continued for 12 hours. Bruising on chest and breasts for the violent squeezing of chest muscles.
it looks like cellulitis or something from the shot; arm got really sore and it was pretty painful/inflammation/not the injection site, behind his arm and elbow/ It was really red and swollen.; he can hardly move his arm; he touches the inflamed area it turns white; allergic reaction; This spontaneous report was received from a 49-year-old male consumer, who was also a patient, via Pfizer (Mfr Control No 2020263644). The patient's medical history included right arm surgery (on 10-JUN-2020). Concomitant therapies included acetaminophen (TYLENOL) for pain due to the surgery.  On 06-JUL-2020 at 07.30 in the morning, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) prefilled syringe, in the left arm, between the shoulder and elbow, (strength, dose, route of administration, lot number and expiry date were not provided) for vaccination.  On 06-JUL-2020, as the day progressed, the patient's arm got really sore and it was pretty painful. The patient could hardly move his arm and due to the event he could not get out of bed on 07-JUL-2020 (however, he also stated the vaccine was given in his good arm and he could not use the other arm, because of the surgery he had on it before vaccination - discrepant information). He was taking acetaminophen (TYLENOL) to help with inflammation. He stated the inflammation was not at the injection site, but behind his arm and elbow. On 08-JUL-2020, it was really red and swollen. The patient was icing it to get the swelling to go down. Moreover, he stated it looked like cellulitis "or something" from the shot. On an unknown date in July 2020, when he touched the inflamed area, it turned white. Additionally, he thought he might have an allergic reaction. He also asked if he should go to the emergency room. He stated he did not think "he was going to die or anything" and that he was not trying to complain; he was just trying to get information about side effects. The outcome of the event of "the patient could hardly move his arm" was reported as recovering/resolving. The outcome of the other events was unknown (however it was also reported as ongoing and as recovering - discrepant information).  The reporter considered the event of cellulitis to be related to the suspect vaccine (reported as "from the shot"). The causal relationship between other events and the suspect vaccine was not reported.  Upon internal review, the event of cellulitis was determined to be medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Patient arrived at the pod to receive her vaccine. Nurse  asked pharmacist for a larger IM needle due to the patient having a larger arm.  Pharmacy re-drew the vaccine, however this was a different syringe used.  Initial dose given to patient was 0.03 ml instead of 0.3 ml.  Pharmacist caught the med dose error approximately 10 minutes after the patient had received her initial vaccine.  Patient called back from lobby and given a second dose to make this a full dose.  Dr. notified of event as well as lead Pharmacist.  Patient did receive the appropriate dose at the end.   Patient monitored for an additional 15 minutes after receiving the second dose. No adverse reactions to patient noted.
Left arm swollen, red, and hot to touch (full length of arm). Pt has had fever, light headed, has been in bed since Wednesday. (day of shot)
Pt started to feel dizzy, unable to see, and having a difficult time breathing. Pharmacist assessed her and administered an 0.3mg of epi. Pt started to feel better. When EMS arrived pt still conscious and aware. SO2 was 97. They took her to continue care.
Woke up with a high fever, sweating, and severe chills. Swollen, red, hot arm at injection site.
Severe chills and feeling of cold for 6 hours. 7 blankets applied and TYLENOL taken. Severe pain in arm/inability to loft arm. Vomiting after 36 hours w/severe pain.
According to the mother, child was vaccinated in the morning and in the evening she came down with a fever.  Just as she was about to take the temperature, child had a full tonic clonic febrile seizure that lasted 2 minutes. Mom immediately called 911 and the ambulance to the child to Medical Center.  Child was examined and Tylenol administered.  Child was released after 3 hours. Follow up at PMD today for assessment.
37 YOF walked to observation area. Told staff she "felt like her throat was closing  up". Moved by wheel chair to EVAL w/o incident. Upon EVAL pt had hives from lower neck down breast. Pt obviously anxious, shaking and Hx of anxiety. Pt given 25 mg Benadryl X2.(1307/1315). Hives began to resolve after 2nd. dose of Benadryl. Pt still anxious and stated throat felt like it was still closing  up. Ambulance was called for transport to hospital.
Itching arm at the site of the shot. Red and circular. Itching began about 8-9 days after vaccine.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 17-MAY-2017, the patient was vaccinated with an expired dose of ZOSTAVAX vial 19400 plaque-forming unit (PFU), with expiry date in February 2016 (exact dose, site, route of administration and lot # were not reported). Concomitant medications included sterile diluent (DILUENT MRK INJ). No adverse event was reported. Additional information has been requested.
Pain in arm, fever, extreme dizziness on day following vaccination (to the point of almost fainting a few times)
Information has been received from a pharmacist concerning her 18 year old daughter with no pertinent medical history who on 21-JUN-2007 was vaccinated intramuscularly with the first dose of the Gardasil. There were no concomitant medications. On the evening of 24-JUN-2007, the patient developed a fever of an unknown temperature. Medical attention was sought and the patient was treated with Motrin. The patient's fever persisted. There were no laboratory or diagnostic tests performed. Additional information is not expected.
pt recvd vax NOV95 & 1wk p/vax devel muscle weakness;pt was hospitalized for 1 wk;testing was performed;sxs persist;MD does not believe that the pt has GBS;This case was reported by pharmacist
Mouth ulcers; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (Mouth ulcers) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 031M20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included BLOOD CELLS, PACKED HUMAN, DEXAMETHASONE ACETATE (PLAVEX), RANOLAZINE (RANEXA) and OMEPRAZOLE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MOUTH ULCERATION (Mouth ulcers). At the time of the report, MOUTH ULCERATION (Mouth ulcers) outcome was unknown.            No treatment was provided..   This case was linked to MOD-2021-044632 (Patient Link).