chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injected arm sore within 2 hours, Intense headache approximately 4 hours after injection lasted approximately 12 hours after injection low grade fever, overall body aches and pains with continued headache and added symptoms of loose stool and gastrointestinal discomfort and swelling armpit injected arm and tender area 24 hours after injection
After administering FLUZONE High Dose and PNEUMOVAX in right arm, she later called to report swollen, hot, sore arm that lingered at least 4 days. Some diarrhea too.
soreness at the injection site; This is a spontaneous report received from a non-contactable reporter (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Mar2021 (Lot number: EN6204)  at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "tree nut allergy" (unspecified if ongoing). The patient has not had COVID prior to vaccination. Concomitant medications included: VITAMIN C [ASCORBIC ACID]; MELATONIN; IBUPROFEN; TYLENOL; VITAMIN D [COLECALCIFEROL]. The patient did not receive any other vaccine in four weeks. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "soreness at the injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: The patient was not tested for COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Nausea, head ache, fever, body aches, burning sensation from head to toe, sore arm at injection site
COVID 19 Treatment; COVID 19 Treatment; 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 02Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14Mar2022 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 was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: symptoms and positive test; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Anti-viral details product: COVID 19 Treatment. brand: Paxlovid. treatment start date:22Aug2022. treatment stop date:28Aug2022. Other medication in 2weeks was No. Known allergies was No. Other medical history was Nothing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came in as a Nursing visit. I looked at previous well child visit for vaccination orders. I also checked with Provider to double check the orders were correct. Pt was given Dtap (PEDIARIX) instead of Dtap (INFANRIX).
Died recently; This is a spontaneous report from a non-contactable other HCP. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced died recently on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died recently
Fever, face was swollen, she believes baby's tongue was swollen as well. Baby at that time was "limp" facial swelling and not interacting with mother. Gradually sx improved.
Symptoms from first dose of HPV9 continued - see Box 18. By November severe leg cramping started in both legs and numbness. Called doctor for phone consultation who recommended heat/ice packs and massages which helped a little bit but it was just temporary relief. Doctor said it was growing pains.
Patient received COVID-19 vaccine from outside on 11/5/2021, c/o rash and itchiness on the trunk, armpits and inguinal area lateral side, also on back of legs and on butt on 11/6/21. Patient started on benadryl q6h on 11/6/2021, rash developes to face and whole body, went to UC at night, s/p prednisone, then patient felt better on 11/7/2021, rash resolving.
1 week and 1 day later it was noted while showering that there was a 2 in red raised mark surrounding the injection site that was itchy. 2 days prior to red mark appearing I was experiencing extreme headaches, fatigue, sore throat, and swollen lymph nodes. At this time on 2/28/2021, I still have the raised red mark on my area but it has lightened and it is still itching. My lymph nodes are still swollen and a headache is still present as well as fatigue but the sore throat has mostly resolved.
Pt presented to the clinic for a flu shot and the immunization was given without issue. The patient returned to the clinic 2 days later with signs of infection around the injection site, including redness, warmth, swelling, and tenderness. The patient was treated for cellulitis.
The client reported that a "few hours" after receiving the first dose of COVID vaccine Pfizer, they developed dizziness. The dizziness lasted for about 3 days and occurred intermittently. The client did not take any medications for the dizziness. The client did eat prior to receiving the first dose of COVID vaccine Pfizer and did eat today. The client reports a history of vertigo controlled with over the counter medications as needed. The client has a history of diabetes controlled with metformin and glipizide and a history of myofascial dysplasia and degenerative disc disease managed with naproxen as needed. The client reports a history of shaking after taking septrin.
Narrative: COVID infection following COVID vaccine series 01/13, MODERNA, dose #1 02/11, MODERNA, dose #2 08/16 pt cc: chills, cough, diarrhea, fatigue, fever, headache, myalgias, rhinorrhea, sore throat exposure: unknown 08/16 COVID swab, result: detected 08/17 SARS-COV-2 Variant Sequencing result: pending
Pt reports he received SHINGRIX vaccine from Pharmacy staff. The injection hurt immediately and the left shoulder has had pain and stiffness since injection. He reports he developed a large bruise over the upper shoulder. He reports he used ice and NSAIDS, TYLENOL no relief. He was seen in physical therapy as he could not lift the arm above the shoulder height and they used heat, ice and stretching and told him to see his PCP for follow up (he was being treated or a right shoulder problem and they assisted him during same time).
This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a female patient who received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site wheal and injection site pain. On an unknown date, the outcome of the injection site wheal and injection site pain were unknown. It was unknown if the reporter considered the injection site wheal and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a painful 4 inches raised welt on arm just below the injection site. The reporter was asking if that was an allergic reaction. The reporter was leery about having a second dose since reaction to the first was more severe than expected. The reporter was asking the effective rate of 1 dose of verses the other doses.
Bell's palsy; Tingling on right side of the tongue; Numbness on the right side of the tongue; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006N20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), PARAESTHESIA ORAL (Tingling on right side of the tongue) and HYPOAESTHESIA ORAL (Numbness on the right side of the tongue). At the time of the report, BELL'S PALSY (Bell's palsy), PARAESTHESIA ORAL (Tingling on right side of the tongue) and HYPOAESTHESIA ORAL (Numbness on the right side of the tongue) was resolving.            Prednisone was prescribed but patient did not take the prescribed medication. Patient declined to provide the list of her maintenance medications. Company Comment : 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.; 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.
I became light headed, then passed out, then woke up and started vomiting, vomited/dry heaved about a dozen times, then had severe chills and could not feel my feet and hands for about 2 hours. I have had vasovagal events in the past and this was exactly like them, only normally they are triggered by an event, and there was no event so I assume it was the vaccine. After sleeping it off under multiple blankets for a couple hours I seem to be recovered and just have a headache.
redness generalized, swelling (Face & eyes);hives generalized, DPH given;went to Er no tx there just observation;
unbearable pain up into shoulder & down into hand for 3 days;shot on 29SEp cant even pick up an object;also c/o stomach cramps;one episode of pain (like menstrual cramps);no lump or nodule, no redness;not febrile, no nausea;
diffuse erythematous papular lesions all over body, silvery red lesions on scalp, hair loss
Vaccine was good to use. /No adverse event; temperature excursion occurred and that doses have been administered.; PROQUAD on 15-JUN-2021, VARIVAX on 26-JUL-2021; This spontaneous report was received from a Medical assistant concerning a 5-year-old female patient (birth weight 47LB). No concurrent condition, medical history, or concomitant therapy was reported.  On 15-JUN-2021, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were unknown; lot # T021301 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 19-DEC-2021) for prophylaxis. On 21-JUN-2021, there was a temperature excursion for varicella virus vaccine live (oka/merck)(VARIVAX). Temperature were 14.1 Fahrenheit (F). The time frame was reported as 1 hour 30 minutes. There was no previous temperature excursion. The temperature excursion occurred as a result of a reading from a Digital Data Logger. On 26-JUL-2021, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength and route were unknown; lot # T024285 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 15-JUL-2022) 0.5 milliliter for prophylaxis (product storage error and inappropriate schedule of product administration). The operator was trained. The vaccines were used according to the instruction leaflet and were available for return/evaluation. The current location of the vaccines was laboratory. The vaccines were good to use. There was no adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003384:
Cellulitis developed at the injection site. Treatment Drugs Used: 1 - CEPHALEXIN Dose: 500 Units: MG Freq: BID Route: PO.
Prior to vaccination the patient reported that in the past he had passed out after giving blood. About a minute after administering the COVID-19 vaccine the patient reported feeling dizzy. He then passed out in the chair. We safely moved the patient to the floor. Then within approximately 15 seconds the patient sat up and then stood up on his own. We asked the patient to then be seated in the chair while he recovered. We called 911 as soon as he passed out. Patient was somewhat confused initially but quickly regained his bearings. He began sweating and said he was very hot. We checked his blood pressure and it was 100/80. Patient continued to recover and said he was feeling better. We had him wait until EMTs arrived. He told them he did not need any care. We took his blood pressure again and it was now 110/75. He said he felt well to go to the EMTs and pharmacist.
I received the second dose of Pfizer on 8/4/21. I have been feeling LEFT-sided CHEST pain and Shortness of breath for the past month. Today's date is 9/16/21 and Left-sided chest pain is still present.
short of breath; I got dizzy; I got itchy; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm Left on 10Mar2021 11:30 (at the age of 57 years) as 1st DOSE, SINGLE for covid-19 immunisation (57years old when vaccinated). Medical history included asthma allergies, hypertension. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), valsartan, amoxicillin, Montelukast sodium (SINGULAIR). Patient did have known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 10Mar2021 06:30 the patient got dizzy and itchy followed by short of breath around 23:30, so patient took a Benadryl and fell asleep and woke up without those symptoms. Reporter assessed the event as non-serious. The outcome of the events were resolved on 11Mar2021.  No follow up attempts are possible. No further information is expected.
Low grade fever, chills, arm pain, body aches, swollen lymph node, and rash over abdomen, back and sides,
Initial report received from a health care professional on 11 October 2010 and follow-up on 12 October 2010. A 54-year-old female patient with a history of hypertension, had received an intramuscular injection of ADACEL, lot number U3082AA (lot number C3314), in the right deltoid on 01 October 2010. Eight days later, on 09 October 2010, the patient complained of flu-like symptoms, was achy, and had a fever. In addition, he developed numbness in his legs from the foot to the thighs bilaterally and had a hard time walking. The patient was seen by a physician. It was not reported whether any laboratory testing was completed or whether the patient required any treatment for his symptoms. At the time of this report the patient had not recovered. Upon follow-up on 12 October 2010, it was reported by the physician that he had not seen the patient since the vaccination two weeks prior. The patient had called from home complaining of myalgia, fever, paresthesia in the lower extremities, and difficulty walking (possible ataxia). A neurological evaluation had been requested, but the reporting physician did not have the details of the examination at the time of this report. List of documents held by sender: none.
Headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that after received Shingles vaccine he/she experienced headache.
Upper arm developed circular area of erythema, edema, heat and pain.  Approximately 2 inches in diameter.  Mom noticed reddened area when putting child to bed.  Reports she has administered Ibuprofen and Benadryl.
3-4 hours of severe physical tics accompanied by non-stop coprolalia, head banging and screaming. Complaining of ringing in ears and aural sensitivity. Episode receded, but significant tics occurred the next day as well.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-SEP-2011, the patient was vaccinated at a hospital with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 27-JAN-2016 , the patient was treated at a hospital for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed  hydrocodone acetaminophen for the management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Headache, NauseaVomiting, HEADACHES, SORE LEFT ARM (SHOT ARM), UPSET STOMACH, AND EXTREME FATIGUE, MINOR SWELLING IN SHOT ARM. Narrative:
pt recv vax 6JUN95 & 9JUN95 devel fever of 102 & was hospitalized to r/o sepsis; tx w/Cefotaxime & Ampicillin while a septic w/u was conducted; pt devel hepatomegaly; 12JUN95 tender abd; 13JUN95 pt devel elevated liver enzyme; LDH 2076;
8-3-21, 7:00 pm, flu -like symptoms,  extremely tired.  8-04-21  - , diarrhea,  fever, chills, sweating. lost sense of taste., glands under arms swollen  Fever and chills -- chills - sweating soaking clothing and bed sheets for two nights. Diarrhea continued unit 8-7-21 Sense of taste gradually returned on 8-6-21 Glands swollen for about 10 days.
This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received ENGERIX B adult (batch number AHBVC207AB, expiry date 28th February 2015). On an unknown date, the patient received ENGERIX B adult. On an unknown date, an unknown time after receiving ENGERIX B adult, the patient experienced inappropriate age at vaccine administration and accidental overdose. On an unkonwn date, the outcome of the inappropriate age at vaccine administration and accidental overdose were unknown. Additional information: An adult dose of ENGERIX-B was inadvertently given to a pediatric patient. Reporter refused to provide DOB but did say the patient was 14 years old.
A little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 06-FEB-2023, the patient received the 2nd dose of Shingles vaccine. In FEB-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: A little sore). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient just had shingles vaccine the day before reporting. The patient experienced a little sore but not bad. The follow up would not possible as no contact details were available.
pain at site of injection; fever; headache; chills; nausea; Sore throat; Body Aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 16-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2022 15:00 (Batch/Lot number: unknown) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "OCD" (unspecified if ongoing); "migraine" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; FLUVOXAMINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 04Jun2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: May2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "pain at site of injection"; PYREXIA (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "headache"; CHILLS (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "nausea"; OROPHARYNGEAL PAIN (non-serious) with onset 03Feb2022 22:00, outcome "recovering", described as "Sore throat"; PAIN (non-serious) with onset 03Feb2022, outcome "recovering", described as "Body Aches"; FATIGUE (non-serious) with onset 02Feb2022 22:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, headache, chills, nausea, oropharyngeal pain, pain, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.