chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large red/rash at injection site similar to what I have seen referred to as Covid arm. It was elevated and hot to the touch, slightly itchy but not painful. I applied a topical over the counter cortisone cream and took Benadryl before bed twice, 2 nights. It all completely went away after 3 days.
pt had a fever of 104 @ 415PM & was seen by MD & rx was given for APAP;
Hearing loss; This is a literature report.  A 86 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), for COVID-19 immunisation. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss". The event "hearing loss" was evaluated at the physician office visit.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt. c/o redness/swelling at injection site quarter size. Apply ice pack to area prn BENADRYL 50mg Q 6 hr. TYLENOL/MOTRIN around clock for 24hr.
I woke up at 0300  extremely SOB. Sat up and tried to breathe through it. I was then nauseous, but did not vomit. I also had arm pain, felt like someone hit my arm with a bat.  As the morning progressed I felt worse, started feeling like an elephant on my chest, headache, and then fever/chills. I took my temperature which ranged from 99.0 - 101.0  from about 0930 to 1300hrs. I took Tylenol and drank a lot of water.  Finally about 1400hrs I started feeling better, and back to normal.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 4-year-old male. Neither the patient's medical history nor the concomitant medications were reported. The reporter indicated that she was not sure whether the patient received FLUMIST IV or not. The product expired on 05-Dec-2011. On 26-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 04-Apr-2012: the reporter stated that the patient did not experience any late occurring adverse events.
This case was reported by a nurse and described the occurrence of cellulitis in an 18 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On 03Mar04, the pt received the fourth dose of Infanrix. Approximately one day following the administration of Infanrix, on 04Mar04, the pt experienced cellulitis, redness, erythema, swelling and was warm to touch. The pt was see at a physician's office. The events were unresolved. The reporting nurse considered the events to probably be related to vaccination with Infanrix and due to something with the lot number.
This child had a local reaction, 6 cm diameter, erythematous, macular rash at the injection site (right ant thigh) with slight tenderness; 24 hours after injection of IPV. Treated with ice and Benadryl, follow up if not resolved.
Charlie horses in his feet and calves; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Charlie horses in his feet and calves) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Charlie horses in his feet and calves). At the time of the report, MUSCLE SPASMS (Charlie horses in his feet and calves) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication provided.
Achy; No appetite; Mild dizziness; Feeling flushed; Soreness at the vaccine site; Fever; MILD JOINT PAIN; Chills; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included liver disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 10:45 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced mild joint pain. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 05-MAR-2021 11:00, the subject experienced mild dizziness. On 05-MAR-2021 11:00, the subject experienced feeling flushed. On 05-MAR-2021 11:00, the subject experienced soreness at the vaccine site. On 06-MAR-2021, the subject experienced achy. On 06-MAR-2021, the subject experienced no appetite. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 (high fever). On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild joint pain, and fever, had not recovered from soreness at the vaccine site, and the outcome of mild dizziness, feeling flushed, chills, achy and no appetite was not reported. This report was non-serious.
Patient was traveling and got mildly ill, tested positive for COVID19 two weeks after getting first shot
Pt had smallpox vaccination on 12/14/06, and began to have left shoulder joint pain with spreading erythema from inoculation site down the anterior surface of the shoulder and axillary region with painful, swollen lymph node in left axilla.  Pt complained of feverish symptoms and itching at the site.
pt recvd vax & noted lt-sided weakness especially facial muscles, sweating, felt febrile;
The next morning, I woke up with a high pitched noise in my left ear. It has gotten worse in the last few day. I went to urgent care for it. They did a physical exam and looked in my ears. They diagnosed me with tinnitus.
Later in evening I had intense muscle pain in legs and chills.  It progressed later in that day to a piercing headache and 100 degree fever.  Ibuprofin helped to lessen the pain.  The following day the pain was greatly improved but I was very lethargic and tired.
Dizziness and weakness approximately 38 hours after vaccination. Possibly mild to severe allergic reaction. No other symptoms or side effects.
Mom noted new bruises both knees on 21DEC91 took to pts orthopedic hosp for eval; Plt ct 11.8 adm for IVIG; dx ITP; discharge 23DEC91 PH 104;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2016, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Vaccine was administered at 9:20 AM by public health at the Community Center; patient was observed for 30 minutes without problems; patient reports she left after 30 minutes of observation and was on her way home when she started to feel itchy and scratched under her chin; around 10:15 AM she had more itching and redness to her skin and was flushed in her cheeks so she took a dose of over the counter Benadryl. by mouth; she continued to have itching throughout the day and reports she took another dose of Benadryl at 4:00 p.m. and again at around 2:00 a.m..
She has a lump on one of her arms; eating up with osteo arthritis; Neuropathy in both legs since the shot; edema; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy in both legs since the shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy in both legs since the shot) (seriousness criterion medically significant) and OEDEMA (edema). On an unknown date, the patient experienced NODULE (She has a lump on one of her arms) and OSTEOARTHRITIS (eating up with osteo arthritis). The patient was treated with Surgery for Neuropathy peripheral. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy in both legs since the shot) and OEDEMA (edema) had not resolved and NODULE (She has a lump on one of her arms) and OSTEOARTHRITIS (eating up with osteo arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient stated they did not have any previous history or conditions before receiving the vaccine. No concomitant medication was reported.  Patient stated she need help figuring out if Autoimmune disorder has been seen with the vaccine. She had 10 MRI. She has been to a Cardiologist, Brain specialist and foot doctor. She had edema ever since. She stated, she could feel it moving up. She had 5 surgery and 2 knee replacement. Patient also stated she has blood test that she can provide the result. No treatment information was reported. The patient had undergone a Hip replacement.  Company Comment: This is a spontaneous case concerning a 50 year-old, female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of neuropathy peripheral, which occurred the same day after the first dose of mRNA-1273 vaccine. The outcome was reported as not recovered. Additionally, non-serious events of osteoarthritis, oedema and nodule were reported in the case. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
fever 103 4 hrs p/vax; vomiting began same as fever & lasted 24-48 hrs;
Arm at immunization site was sore and tender. He woke up 2 days after immunization with a rash that is warm to the touch at immunization site. Rash is still warm and red even 2 days after in initialy showed up.
2/15/22 Vaccine Error: 11 year, 4 month female given 12+ Pfizer 2nd dose. LPN states mother and child approached the vaccination table where LPN verbally verified name, age, date of 1st Pfizer dose. LPN states vaccination card listed "Pfizer and lot number only" and did not specify 5-11 or 12+. LPN states she asked mom, who confirmed the child received 1st 12+ dose. LPN states she had to rewrite vaccine card because she had written "Pfizer 5-11 and lot number" on first card. LPN states she verified dose and amount medication with RN at drawing table. Child sat in observation and 10 minutes in, I hear mom state, "Oh, she's 11, not 12." LPN explained significance of this statement to me and provided me with statement below:  "In clinic today, a parent waited until the child was in the observation area to say her child is not 12 but 11. Before the child was given the vaccine I checked with mom on the name, age and the dose. I had to rewrite the card because I had put the lot number for the 5-11 Pfizer dose on the card instead of the 12 year old dose- mom said it was fine no worries . Mom was not able to get the girls to cooperate. At mom's request, other staff members had to come to hold but kids in order to give the injection. After about ten minutes of waiting in observation, mom then says oh she is not 12 she is 11 and she knew she should have corrected me earlier. I immediately alerted my team lead and explained what happened."  Child states she is feeling well and mom stated she was going to call the pediatrician. Mom states the pediatrician reported it's "no big deal and she might feel a bit more crumby than normal tomorrow." Mom stated she wasn't that worried after speaking with the doctor and "will keep the ibuprofen on hand tomorrow." I gave her VAERS information if the child should have any other reactions. I reviewed red flags that would warrant immediate medical attention. Mom stated she understands and agrees with the plan. All questions answered in an apparently satisfactory manner.
patient complained of racy heart rate and feeling unwell. She complained that she was tired and lightheaded. patient did state she took 2 benadryls and anti-anxiety medications prior to vaccination per drs orders. I took her blood pressure--first reading was 120/99 and HR was 88bpm-- 2nd reading was 112/82 HR unknown-- and third reading blood pressure was 128/32 HR 163 and fourth reading was. 134/90 and hr 91. Patient stated she hadnt eaten all day--gave her cookies and water. Patient stated she was starting to feel better-counseled her on what to do if her symptoms come back and/or get worse. Walked her to the door with her husband.
peripheral neuropathy; This is a spontaneous report from a contactable physician. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 68-years-old, via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021, as dose 1, single for COVID-19 immunization. Post vaccination he experienced peripheral neuropathy on an unspecified date in 2021. He did not explain detailed specifics or if this has resolved. Soon after he developed peripheral neuropathy and it may or may not be related. He has been to a few neurologists and been evaluated and has been told it could be related. He would like to know if this has been reported and if Pfizer has any information. The outcome of the event was unknown.; Sender's Comments: Based on the information available and temporal relationship, a causal association between BNT162B2 and the reported peripheral neuropathy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Patient received a 3rd dose of Moderna. 1st dose on 2/9/21, 2nd dose on 3/9/21, and 3rd dose on 6/28/21.
pt recv vax between 24OCT96 & 1NOV96;w/in 24hr p/vax pt devel an inj site rxn between 6-15cm in diameter w/redness, swelling & itching;this is 1 of 3 pt;
Patient called and stated that he had been having a shooting pain from his neck all the way down the arm of the arm he was vaccinated in. He said that he did not have anything like this previously and was that normal. I told him that it was not and to report it to the CDC v-safe program, I also notified my manager, district manager and clinical market manager to confirm that they hadn't heard of anything like this. I asked for him to follow back up with us & for him to let us know if it resolves itself.
Mom reports rash on abdomen/trunk, face, hairline, behind ears.  Patient seemed asymptomatic otherwise no px, no itching, no shortness of breath, not distressed.  Rash lasted around 4 hours and resolved on own.
45 minutes after receiving flu shot pt developed hives - upper chest, face, neck and some chest heaviness. Pt has numerous food allergies and had eaten at Wendy's after injection. Treatment: Benadryl 50 mg IM, Zyrtec 10 mg PO suspension and Diprosone 0.05% cream.
full blown tinnitus; some ringing in my ear on and off; not much sleep; ear felt full; sore, painful glands neck & base of skull; woke with night sweats; mild arm soreness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 79-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration, in arm right on 26Feb2021 at 17:30 (at the age of 79-years-old) as dose 2, single for covid-19 immunisation. The medical history of the patient included High blood pressure - controlled (hypertension) from an unknown date and unknown if ongoing. The concomitant medications of the patient included levothyroxine sodium (SYNTHROID), losartan, verapamil, colecalciferol (D3) taken for an unspecified indication, start and stop dates were not reported and tumeric. The past drug history of the patient included allergy to penicillin. The patient previously received first dose of BNT162B2(solution for injection, Batch/Lot number: EL9269), via an unspecified route of administration, in arm right on 03Feb2021 at 06:45 PM (at the age of 79-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient experienced mild arm soreness on 27Feb2021 at 21:30, woke with night sweats and sore, painful glands neck & base of skull on 10Mar2021 at 21:30, ear felt full on 12Mar2021 at 21:30, some ringing in my ear on and off and not much sleep on 14Mar2021 at 21:30 and full blown tinnitus on 15Mar2021 at 21:30. The reporter stated that she called her doctor she said there was nothing to be done for it and also stated that tinnitus 24/7; glands sore; ear still wonky (technical term). The events did not result in death or Life threatening or caused/prolonged hospitalization or disabling/incapacitating or congenital anomaly/birth defect. The events are reported as non-serious by the reporter. No treatment was received. The outcome of the events was reported as not resolved.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
NO KNOWN ADVERSE EVENT. PATIENT INCORRECTLY RECEIVED ADULT DOSE INDICATED FOR 19 YEARS AND OLDER. WE HAVE BEEN UNABLE TO MAKE CONTACT WITH THE PATIENT'S PARENT/GUARDIAN DESPITE SEVERAL ATTEMPTS.
This spontaneous report as received from a healthcare worker refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with (Merck) PROQUAD reported lot # K020747, expiration date: 30-APR-2016 and reported lot # K023861, expiration date: 25-MAY-2016 (dose and route were not reported), after they were exposed to temperature excursion of 25 Fahrenheit (F) for 41 hours. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a certified medical assistant (CMA) refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and concomitant therapies were not reported. In approximately 2015 (reported as on unspecified dates since 18-AUG-2015), the patients were vaccinated with improperly stored does of GARDASIL (lot #L001442, expiration date 04-NOV-2016, dose and route of administration were not reported). No adverse reactions were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Pregnancy; Initial Report Received on 15-Dec-2022 (Safety received 14-Mar-2023)   A patient reported to the Registry that she (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization within 28 days of her last menstrual period (LMP). The patient asked if she could register.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) within 28 days The route and site was not provided.   A copy was emailed to the patient. She requested time to read and a return call. Several attempts were made by the pregnancy registry on 15-Dec, 22-Dec and 29-Dec-2022 to follow-up with the patient to confirm if she reviewed the consent and to discuss participation. Voice messages were left requesting a return call with registry hotline number and hours provided. On 05-Jan-2023, a final email was sent. Permission was not provided for Dynavax to follow-up with the patient.   No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Muscle pain in arm, neck, shoulder; stomachache, headache and loss of appetite.
Client received a dose of Janssen &Janssen COVID vaccine on 8/30/21 at 2:45 PM that had frozen in transport and experienced a temperature excursion. RN called and informed client. Client denies any issues. APRN reached out to Johnson and Johnson in regards to the temperature excursion and dose being administered from vial that experienced excursion. Johnson and Johnson have conducted an investigation and determined that there is no harm in administering a dose of Janssen & Janssen COVID vaccine that has experienced a temperature excursion like documented in this case, but stated the dose administered may not be as effective due to the excursion. Johnson and Johnson stated that nursing staff may use clinical judgement to determine if a second dose is needed. After speaking with the client the client declined wanting and additional dose.