chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; Tinnitus; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and tinnitus. On an unknown date, the outcome of the injection site pain and tinnitus were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and tinnitus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced injection site pain and tinnitus. HCP noted it had been several weeks since the vaccine was given, and the patient continued to experience both events.  HCP noted the patient experienced tinnitus in the right ear. The patient had an upcoming appointment with an ENT provider to evaluate the tinnitus. The reporter consented to follow up.
Red dots/ rash across my chest that did not itch or hurt or cause any discomfort but was noticeable and visible. Persisted for 2 days.
Pt had a convuls about 1 1/2 hrs p/receiving vax;, t102.3 in ER & exp apnea & cyanosis in arms & legs; lt thigh was swollen for 1 day & temp lasted 2.5 days; MD dx pertussis vax rxn;
Information has been received from a nurse practitioner concerning a 77-year-old female who on 21-DEC-2006 was vaccinated subcutaneous with a single dose of ZOSTAVAX.  On 19-NOV-2007 the patient developed a mild case of shingles on one side of her body.  On 26-NOV-2007 the patient developed another mild case of shingles on the opposite side of her body.  The patient was treated with famciclovir (FAMVIR) antiviral medication.  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Additional information has been requested.
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 04-months-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 16-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
The patient is 11 years old and recieve the COVID19 Pfizer vaccine for ages 12 years old >  No adverse event was observed during observation after vaccination and no adverse reaction was reported when followed up with patient and caregiver.
HA, fever, pain/stiffness in neck. Discharge summary states viral meningitis, photophobia. msv
no additional AE; inadvertently administered an expired dose of MMRII to a patient on 5/26/2021 that had a labeled expiry of 5/23/2021; This spontaneous report has been received from a medical assistant referring to a 12-month-old patient of unknown gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 26-MAY-2021, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin (rHA)) (M-M-R II) 0.5 mL for prophylaxis (lot# S015962, expiration date was reported and validated as 23-MAY-2021; strength and route were not reported) (expired product administered). There were no temperature excursions involved. No additional adverse event was reported.
Patient came in with his mother on 9/10 to receive his vaccines. I gave all the need paperwork to his mother on the vaccines he was given and then gave him his shot. When I went to put the information into our EMR that's when I seen the err that I made. I told my office manger what I did which was. I made a mistake in gave patient the  Dtap  vaccine but he was do to get the Tdap.
Ended up testing positive for COVID-19/showing no symptoms; Ended up testing positive for COVID-19/showing no symptoms; This is a spontaneous report received from a contactable male consumer. A patient of an unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), at an unspecified dosage via unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. On an unspecified date, the reporter stated that he was around someone who ended up testing positive for COVID-19 on saturday. He mentions that this person had their shots already but because his wife had it, he wanted to get tested as well, despite showing no symptoms. The caller also reports that he himself has gotten tested but has not gotten his results yet. The caller would like to know if he is still okay to receive his second dose following this exposure to COVID-19. The outcome of event was unknown. Information on the lot/batch number has been requested
Dose 1,2,3 Pfizer BioNTech / dose 4 Moderna, 5 Moderna bivalent; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: En6203), in left arm, on 19Mar2021 as dose 2, single (Lot number: Er8727), in left arm and on 20Sep2021 as dose 3 (booster), single (Lot number: Ew0217) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Apr2022 as dose 4 (booster), single (Lot number: 057m21a), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 08Oct2022 at 13:15 as dose 5 (booster), single (Lot number: 053022a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "thyroid" (unspecified if ongoing), notes: thyroid; "HBP" (unspecified if ongoing), notes: HBP; "COPD" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: contrast dye" (unspecified if ongoing), notes: Known allergies: contrast dye; "Known allergies: molds" (unspecified if ongoing), notes: Known allergies: molds; "Known allergies: pollens" (unspecified if ongoing), notes: Known allergies: pollens. Concomitant medication(s) included: LANTUS, start date: 01Dec2019; OZEMPIC, start date: 13Oct2021; METFORMIN, start date: 01Jan2004; SYNTHROID, start date: 05Aug2019. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Apr2022, outcome "unknown", described as "Dose 1,2,3 Pfizer BioNTech / dose 4 Moderna, 5 Moderna bivalent"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. From 19Dec2022 to 24Dec2022, patient received Paxlovid as treatment of COVID-19.
Outbreak of cold sore on lips; Body aches; Nausea; Headaches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Outbreak of cold sore on lips), PAIN (Body aches), NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Body aches), NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Fatigue). On 04-Feb-2021, the patient experienced ORAL HERPES (Outbreak of cold sore on lips). The patient was treated with ACETAMINOPHEN for Adverse event following immunisation, at an unspecified dose and frequency and DOCOSANOL (ABREVA) for Cold sores lip, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Outbreak of cold sore on lips), PAIN (Body aches), NAUSEA (Nausea), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Patient received 4th dose of covid vaccine (pfizer) on 7/7/22. On 7/20/22 she woke up up with left sided facial numbness, left facial drooping and unable to raise left eyebrow. Patient went to ED and diagnosed with cerebral palsy. Of note, patient received her 3rd dose (booster)  Moderna on 11/24/21.  Her first two covid vaccines were Pfizer on 3/17/21 and 4/10/21.
71yr old male who presents ambulatory to ED with complaints of dizziness, lightheadedness, and vomiting. Patient states he started throwing up this morning around 0800 and vomited about seven times, which stopped at 1100. Patient states he became nauseous and vomited after turning his head quickly and when he opened his eyes suddenly. Patient states he took some ibuprofen around 1100. Patient called clinic and they advised him to come into ED. Patient rates pain 5/10 to his tooth upon arrival.    DIAGNOSIS 1. New onset a-fib    2. Dizziness        ASSESSMENT/PLAN/DECISION MAKING: 1. New onset a-fib    2. Dizziness      -1715:  Assessed patient, placed order for labs/ekg - labs pending, EKG shows new-onset atrial fibrillation.  Patient denies cardiac history besides hypertension. Prior EKG studies on hand (2016) do not show a-fib.  - 1800: Turned over care of patient to oncoming ER provider  Differential diagnosis includes benign positional vertigo although testing is negative, labyrinthitis.  CT scan will rule out any intracranial abnormalities. His D-dimer was elevated and he has atrial fibrillation and that is why we will obtain a CTA to rule out pulmonary embolism.  His atrial fibrillation appears to be newly diagnosed.  We are not sure how long he has been having this condition.  He is rate controlled and he is on a beta-blocker.   CTA  "1. No acute pulmonary embolism identified.  2. Extensive pleural thickening and pleural nodularity left greater than right lungs. Although this could represent asbestosis, mesothelioma or pleural-based metastases are not excluded. I would recommend PET/CT for further evaluation.  2. A few scattered pulmonary nodules are present. Largest is a triangular 9 mm nodule along the minor fissure most likely representing a fissural lymph node but warrants attention on follow-up imaging. There is also a 4.5 mm subpleural nodule right lung base.  4. Severe cardiomegaly.  5. Mild subpleural reticulation suggestive of scarring/fibrosis.  6. Soft tissue right tracheal lumen at the thoracic inlet potentially representing secretions although a soft tissue nodules not excluded. Attention on follow-up imaging is recommended.
Sore arm 11 am- several days Fever 2pm- 7pm Welt at injection site 4pm- over a week  Fatigue 12pm-next day  Shingles 2-10-21
In a large area (size of a bagel but not round)around the injection site was bright red and fevered, leg was swollen 1 1/2 times.  Child became dehydrated quickly. 11/13/09 Medical records received for DOS 10/16/09-10/17-09. Final DX:  Dehydration, Viral infection, Otitis Media, Angioneurotic Edema, Abnormal reaction in procedure.  Seen in ED for R thigh swelling. DX w/L OM and clinical dehydration. S/P 2-3 days vaccine. WBC increased.  Abx therapy.  Viral illness. Localized rxn. Resolved.  Normal PE.  D/C to home.  ICD9 Codes: 276.51, 079.99, 382.9, 995.1, E879.8.
Started menstruation four days early; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), spironolactone (MANUFACTURER UNKNOWN) and mirtazapine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received fluconazole (DIFLUCAN) and experienced allergy. On 11Apr2021 at 15:00, after receiving vaccine, the menstruation started four days early. Therapeutic measures were not taken as a result of the event. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event menstruation started four days early was resolved on an unknown date in Apr2021.   No follow-up attempts are required; information about lot number cannot be obtained. No further information is expected.
I cannot urinate although I feel I need to / painful and no urine; I cannot urinate although I feel I need to / painful and no urine; This is a spontaneous report from a contactable consumer (patient himself). A 56-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported) via an unspecified route of administration in right arm on 25Mar2021 13:30 as a single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. He did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications (unspecified) within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient stated "I cannot urinate although I feel I need to. Very painful and no urine" on 26Mar2021 14:00. No treatment was received for the events. Outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
After the immunization he sat there for about 2 minutes then he got up and came to the register. He had syncope fainted and fell down hitting his head on the floor. He immediately regained consciousness but was pale and clammy. He had a bump on the back of his head and he was very dizzy and nauseated and vomited several times. We called the EMS and they checked his vitals and blood sugar. His mother drove him to the ER.
A report was received from a health care professional on 12/8/03 concerning a 10 month old male vaccinee who inadvertently received Fluvirin on 12/6/03. On 12/6/03, the vaccinee inadvertently received Fluvirin. No adverse symptoms had been reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Long-covid-like symptoms. Started with a very strong lymphatic reaction that I also had with my second shot. I was sick for almost two weeks after my second shot. After this shot, I was not as sick, but my lymphatic/immune reaction and tired feeling in my back lasted several weeks. As it was ending, I experienced an incredibly painful pain in my upper right back. This lasted for several weeks. I also experienced systemic dysfunction across my body. I now suffer from chronic tinnitus. I have experienced arthritis and arthritic reactions after working out or even minor activity. I have experienced chest pains and palpitation. I have experienced brain fog, anxiety, and depression. I have had issues with bladder control. I have been having nerve or fibromyalgia-type pain. I have been having circulation issues. I had a pseudo-chillblain. I had increased sensitivity to cold. I have had eye focus issues. I have had involuntary contracts and muscle spasms in my head and elsewhere. I have had kidney and groin-area pain.
DOSE GIVEN AT 1020, EXPERIENCED TINGLING IN HANDS AND FLUSH ALL OVER BODY.  1036 C/O THROAT CLOSING.   ELEVATED HR, BP.   EPI ADMINISTERED AT 1036, TRANSPORTED TO ER
During the patients 15 minute observation he appeared to be have a seizure, Patient was placed on floor by his father,  patient was unresponsive, BP 85/52, HR 96, SpO2 100%, RR 16-18.  When child awoke he was confused and did not know what had happened, water was offered, states "I'm sleepy".  911 was and care was transferred.
Her friend also had the 1st 2 doses and was tested positive; Her friend also had the 1st 2 doses and was tested positive; This is a spontaneous report from a non-contactable consumer or other non hcp via a program. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single and second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date a consumer friend experienced that friend also had the 1st 2 doses and was tested positive. She wanted to know ask if she got the booster shot, would it be different from the 1st doses, and how soon can she get it. Consumer asked In the original statement the protection of the vaccine was for at least 6 months, asked if it was true, and asked if the booster was the same medication as the first 2 doses. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. The outcome of events was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning several females who on unspecified dates were vaccinated with Gardasil 0.5 ml by injection. Subsequently, several patients fainted after receiving Gardasil and several patients experienced pain and swelling at the injection site. Medical attention was sought. The outcome of the events was unspecified. No additional information is available.
receiving a dose from a vial that was opened more than 12hs before vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving a dose from a vial that was opened more than 12hs before vaccination) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving a dose from a vial that was opened more than 12hs before vaccination). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (receiving a dose from a vial that was opened more than 12hs before vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took unknown medication as concomitant drug.  No treatment drug information was provided by reporter.  Medical Assistant called as 4 patients received doses from 1 vial between 1 to 2pm on the 06Aug2021, which was first opened on 05Aug2021 at 9:20 am.
Felt woozy/dizzy, the head ache started , then nausea without vomiting.  BP  180/84, BP 170/82 Supervisor was called and let her know that patient would not be able to work today.  Patient stayed for 2 hours and symptoms subsided. EMS checked her out. She then drove home.
Pt recvd 2 doses of Hep B vax in 1985 p/recvd 2nd dose pt exp a severe skin rxn; later pt recovered & was advised not to recvd any more vax w/Hep B vax;
Redness and swelling at sight of injection spreading down arm lasting approximately one week. Palpitations, mild shortness of breath at night. Severe itching not responsive to antihistamines. No wheezing or choking.
Information has been received from a nurse practitioner concerning a female who on 18-SEP-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced injection site reaction. The patient sought unspecified medical attention. Injection site reaction persists. Additional information has been requested.
fever, tired, aches, h/a, runny nose, t102-103 lasted 5 days;
it was the booster; Achiness; Tiredness; Headache; little bit of injection site pain; This is a spontaneous report from a contactable consumer or other non hcp.    A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, The patient experienced it was the  achiness, tiredness, headache, little bit of injection site pain, booster dose on an unspecified date with outcome of unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
No wheal formed on the 1st dose attempt; 2nd dose given and wheal formed