chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt stated that the afternoon of the day she received the vaccine, pt c/o fever, chills. The next day, area was slightly swelled, area  kept increasingly swelled through out the day. Pt came in to office on day 3 of swelling, area was warm to touch, red, and swelled. Pt was given at visit rx for prednisone 10 mg ; 10 mg tablet, 1 tab(s) orally twice for 2 days then once daily for 3 days. Also pt received  rx for triamcinolone topical 0.5% cream, 1 app applied topically 2 times a day. Advised pt to follow up in 2-3 days.
Woke up at 2:35 next morning with 100.8F fever, chills, and uncontrollable tremors.  Still had 99.5F fever in the morning and was fatigued with a severe headache and slept most of the day.  Next day, 3/27, fever was reduced but still fatigued.  Only started feeling better on 3/28.
Within 5 minutes of receiving vaccine, dizziness, warm all over body from head to foot, unbalanced, unfocused.   Started having tingling and leg pain. The pain would subside through the day, leg cramps in both legs and numbness. I had a few terrible migraines within the next week. as of now the pain has lessened greatly and so has the tingling but I am still having some issues.
Approximately 5 hours after injection I experienced muscle aches, fatigue, dizziness and malaise.  After a while, left upper arm pain.
Fever, joint pain, headache, dizziness, tiredness, cough, throat congestion
Patient received vaccine on 10/28/14, called 2 wks later complaining of arm pain. Told to call MD about complaint. Pt called 11/22/14 saying MD says a tendon may have been "hit" during vaccination.
CLIENT EXPERIENCED REDNESS AND TENDERNESS AT INJECTION SITE WHICH HAS DEVELOPED INTO A NODULE IN THE LEFT VASTUS LATERALIS WHERE THE VACCINE WAS ADMINISTERED.
Nurse documented Hepatitis A Adult formulation given when a pediatric/adolescent dose should have been administered.
Arm sore; Joints (hips, knees & back) stiff and achy; Joints (hips, knees & back) stiff and achy; This is a spontaneous report from a non-contactable consumer (patient). A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; expiry date-unknown; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:30 (at the age of 71-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, high blood pressure and known allergies: Certain fruits. Concomitant medications included montelukast 10 mg; enalapril maleate 20mg 2x daily Am. No covid prior to vaccination. The patient experienced arm sore, joints (hips, knees & back) stiff and achy on 10Mar2021 18:30. No covid tested post vaccination. It was reported that Arm was still sore on the 2nd day. Joints (hips, knees & back) stiff and achy which started 6 or 7pm yesterday evening and continue to be achy today. No treatment received. The clinical outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient told immunizer she has cancer
Itching started first on the evening of April 11, 2021. The next morning my arm was very warm to the touch, red round rash and itching. I also had a slight pain at the point of inoculation.  It lasted until about April 17, 2021. During the week, it dissipated and finally disappeared.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site erythema (1st dose received in 2018, for tolerance refer case: US2019015631). On an unknown date, the patient received the 2nd dose of SHINGRIX (subcutaneous). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site pain, injected limb mobility decreased and intramuscular formulation administered by other route. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site pain and injected limb mobility decreased were resolved with sequelae and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Before getting the 2nd dose of the SHINGRIX, the administering pharmacist told the patient that she would administer the vaccine subcutaneously and had a short needle attached to the syringe. The reporter told the pharmacist that the product should be administered intramuscularly. The pharmacist said she would administer it intramuscularly but did not change the needle. The reporter felt that the product was administered subcutaneously on the left arm because she did not get any systemic effects like she did with the first dose but experienced significant issues at the injection site. She woke up the next day and she could barely lift her arm. The injection site was red, sore, and hot which measured 3 inches across horizontally and 3.5 inches vertically. It took 5 to 6 days to resolve. The call was transferred to Medical Information.
This Resident received the two Moderna vaccinations prior to today.  At clinic on the unit, this Resident received the Pfizer booster.  No noted advers reactions.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S019435; expirationdate: 23-AUG-2020; 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; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
2 days after I got the vaccine I had to go to the hospital for a headache. They gave me a large NSAID shot. Then the headache went away but it came back and I am still having headaches 3 weeks later. I also have burning pain in my hands. It is an almost constant and excruciatingly painful burning sensation. This started happening 6 days after I received the vaccine. I now take 900 mg of Neurontin a day for the pain. I am talking to my doctor later today and asking her to test me for diabetes. I am very thin and never previously had diabetes. I hadn?t been tested for it to see the cause of the burning in my hands. It is worth noting that I had an MRI with contrast 5 days after the vaccination. My doctor said already she doesn?t think it?s diabetes due to my low weight but I can?t possibly understand why I would have sudden burning in my hands. Adverse agent: burning pain in hands. Treatment: Neurontin 300 mg 3x a day. I don?t know when this pain will stop, it?s been 3 weeks.
Massive head ache for 12 hours / felt like someone was slamming symbols against my head After massive head ache subsided I had a fever, chills, aches and pains basically cold or flu symptoms for 12 hours
This spontaneous report as received from a physician refers to a patient of unknown demographics. On an unknown date in September 2012, the patient received dose one of GARDASIL intramuscular injection, dose and frequency unspecified. On 13-MAR-2014, the patient was in office to receive dose two of GARDASIL. Concomitant medication was unspecified. No product quality compliant involved. No adverse effects reported. No further information was provided. Additional information has been requested.
At 16 mo visit on 1/23/09, child had single words and could point to indicate wants. No animal names or noises. Rec. increased reading to child. MMR/Varicella/PREVENAR/Flu given. After this visit, the child's language regressed and he began hand flapping and would not follow directions.   9/8/09 VAERS report received with MR attached.  WCC 1/23/09 with normal exam except abnormal weight gain.  Saying 3 words at this time.  Vax given.  Returned 3/20/09 with parental concerns for speech regression over past few months as well as flapping his hands when excited.  Does maintain eye contact however clear regression of speech noted by MD. Sent for genetic, neuro and developmental testing. Evals (+) for developmental delays, macrocephaly, toe walking. sx c/w autism.
swollen lips/swelling of my lips; severely chapped; burning lips; itching lips; painful lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips/swelling of my lips), CHAPPED LIPS (severely chapped), ORAL DISCOMFORT (burning lips), LIP PRURITUS (itching lips) and LIP PAIN (painful lips) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swollen lips/swelling of my lips), CHAPPED LIPS (severely chapped), ORAL DISCOMFORT (burning lips), LIP PRURITUS (itching lips) and LIP PAIN (painful lips). At the time of the report, LIP SWELLING (swollen lips/swelling of my lips), CHAPPED LIPS (severely chapped), ORAL DISCOMFORT (burning lips), LIP PRURITUS (itching lips) and LIP PAIN (painful lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
2 days after the vaccine patient woke up with a racing heart that lasted 2 hours. considering her heart condition her primary doctor advised not to get a second dose.
injection site reaction, cherry red circle size of a half dollar; Injection site reaction is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site reaction, cherry red circle size of a half dollar) and VACCINATION SITE PRURITUS (Injection site reaction is itchy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.    Co-suspect product included non-company product DIAZEPAM for an unknown indication.    The patient's past medical history included No adverse event. Concomitant products included INSULIN LISPRO (HUMALOG), INSULIN and BACILLUS LICHENFORMIS (ENTERAC).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient started DIAZEPAM (unknown route) at an unspecified dose. On 15-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site reaction, cherry red circle size of a half dollar) and VACCINATION SITE PRURITUS (Injection site reaction is itchy). At the time of the report, VACCINATION SITE ERYTHEMA (injection site reaction, cherry red circle size of a half dollar) and VACCINATION SITE PRURITUS (Injection site reaction is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The patient experienced a sore arm 3 hours after she took the shot.  She came in to work to get the vaccine, but had a high fever and chills, and took Tylenol to feel better.  She called out from work at 3PM because she was not feeling well.  She felt drained and dehydrated the next day.
Vaccination Saturday 10/15/05 at 12:35 PM. Next day, left arm was swollen and red. Legs and back pain, tired all day. Monday, 10/17/05, arm still swollen, no redness. Back a little sore.
Pt. was in his dorm, stood up and stated he could breathe, then went unresponsive.  A medical response was called and staff arrived to the dorm within 2 minutes. Pt. took a couple of agonal breaths and stopped breathing, no pulse was found and CPR was initiated.  Staff and EMTs administered 45 minutes of CPR, narcan and cardiac medications. He was pronounced dead by EMT at 10:45 am.
Patient was vaccinated on 4/19/2022 with a beyond used date Pfizer vaccine. Pfizer clinical team was consulted and they could not confirm the viability of the beyond used date product. Patient was informed on 5-6-22 about the error and was advised to get re-vaccinated with Pfizer#4  on 5-6-2022. Patient did not report any adverse events and did not come back for vaccination yet
Patient says she had severe pain in both legs the day after her flu vaccine. She said it lasted only one day.
1/19/21, achy all over, felt nauseous, bad headache that lasted all day.  As the day progressed had shaking chills.  Started feeling sicker and sicker, and then started feeling chills/hot at the same time, exhaustion.  Fell asleep and when woke up had fever of 100.7.  Just fell back to sleep, took Tylenol and that helped break the fever, but still feeling extremely tired and achy all over.  Feels like the flu.  Just now today, 1/20/21 body pain is starting to ease up, still feeling tired but fever has resolved.
The patient felt faint and hot within a few minutes after the injection.  He was seated in our waiting area and walked over the one of the pharmacy windows to let us know.  I immediately had him sit down.  I applied a cold, wet cloth to his forehead and alternated with the back of his neck.  He stated that his arms felt numb.  I reviewed the injection site in his left deltoid which was appropriate.  I also fanned him with paper.  He began to feel better and I asked him to move his arms a little to try to get rid of the numb feeling.  He called his mom for a ride home.  He left with his mom 30 minutes after receiving the vaccine and was feeling much better.
It's not safe and affective; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "It's not safe and affective".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1st dose 3 years ago, 2nd received now; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix approximately 3 years ago right before covid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient just got Shingrix again but was not sure if this considered his/her second dose. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot# L016429 with and expiration date 09-AUG-2017; lot# L037339 with an expiration date 09-FEB-2018; lot# K005881 with and expiration date 14-JAN-2017; lot# L018351 with and expiration date 11-AUG-2017; dose, anatomical location and route of administration were not reported). The vaccines were exposed to 4 hours 30 minutes at 47.5 Fahrenheit (F) on the fifth of April (year unspecified), 1 hour 30 minutes at 51.3 F, 2 hours at 56.3 F on the seventh of April (year unspecified), 1 hour and 30 minutes at 48.9 F on the fifth of May (year unspecified) and 1 hours at 51.6 F on the sixth of May (year unspecified). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A report from a pharmacist concerns a 5 year old male. No relevant medical history or concomitant medications were reported. The patient received nasal FLUMIST on 21-Jan-2014. Pediatrician administered FLUMIST to a child and after routine blood test one week ago (approx 3 weeks after receiving FLUMIST) child was found to have a low neutrophil count. The outcome of the low neutrophil count was unknown. The company physician considered the low neutrophil count to be serious as an important medical event.
AFib; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "AFib".  Clinical course: Caller said she received an email saying about another booster shot for the Pfizer covid vaccine. Caller says she got 2 of the original doses and got a booster dose back on 21Sep2022. Caller was asking if Pfizer has another booster shot available. Caller says the email mentioned it being the BA4/BA5 variant for the omicron virus. Caller says she has Afib and was 76 years old and that if she were to take it this would be her 2nd booster dose or 4th dose of the Pfizer covid vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "treated for chronic Lyme disease" (unspecified if ongoing). There were no concomitant medications. The patient did not have any known allergies. The patient received vaccine. The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 12Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) positive, notes: 12Jun and tested positive for Covid at an urgent care clinic out of state; (21Jun2022) negative, notes: I felt well but did the 10 day quarantine followed with 2 negative Covid tests on 21Jun and 22Jun; (22Jun2022) negative, notes: I felt well but did the 10 day quarantine followed with 2 negative Covid tests on 21Jun and 22Jun; (23Jun2022) positive, notes: In the evening of 22Jun I began having the same symptoms return and tested positive on 23Jun; (26Jun2022) Positive, notes: My symptoms continue, but improving, and I tested positive today, 26Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: I began having symptoms of headache, sinus, and ear congestion, and diarrhea on 12Jun and tested positive for Covid at an urgent care clinic out of state. I was ordered Paxlovid and had total relief of symptoms in about 48 hours. I felt well but did the 10-day quarantine followed with 2 negative Covid tests on 21Jun and 22Jun. In the evening of 22Jun I began having the same symptoms return and tested positive on 23Jun. My symptoms continue, but improving, and I tested positive today, 26Jun. Adverse event start date: 21Jun2022, Adverse event start time: 08:00 PM, if patient recovered was recovering, if treatment ae was no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After vaccination LPN called me into room, pt had unassisted fall to the floor, NP arrived to room and pt was left lateral position of the floor, vitals instantly grabbed at 1620 pt BP was 98/56 with a HR of 62, pt was pale and clammy, pt states no LOS, pt talking to us the whole time, pt and significant other denies any BS issues, BS taken was 109, pt then starting to have color return to the face, BP now 1625 104/60 HR 84, pt able to stand up and denies hitting head, on examination nothing seen, per significant other and pt this is the first vaccine he has received since pediatric vaccination, at this time appears to be vasovagal response, pt is ambulating and talking to significant other in waiting room, neurologically intact, PERRLA on both eyes, strength equal in all extremities, no bony tenderness on spine, neck supple no sign of injury, head is atraumatic and free from injury, pt vitals WNL and can go home, education gave on syncopal episodes.
Random swelling around elbow and inflammation spreading up the forearm and its painful and tender to the touch. Rash/swelling only on arms. No fever no itchiness just swelling and pain.