chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and refers to a 15-year-old female patient with no pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter mentioned that on 14-MAY-2018, the patient was supposed to receive a dose of tuberculin purified protein derivative (PPD); however, instead of that, she received mistakenly a dose of GARDASIL 9 intradermal instead of intramuscularly (strength, dose, frequency, anatomical location, lot number, and expiration date were not reported) for an unspecified reason. On the same date, the patient began to have a "local reaction" which was described as an 1 centimeter area of induration surrounded by a 4x4 area of inflammation on the left forearm at the administration site; additionally, the patient mentioned that the local reaction was also painful. It was reported that the patient sought for medical attention but laboratory tests or diagnostic procedures were not performed. The patient was treated with cephalexin (KEFLEX) and consequently, on an unknown date, the patient recovered from the adverse events.
About 5 minutes after vaccination, patient started to feel lightheaded, tongue/lip was tingling/becoming numb and her right hand was feeling weird. I called 911 for an EMT who then came right away (5 min from phone call) and they assessed her and gave 1 dose of BENADRYL and water. Patient then started to feel better and walked out of store with husband and EMT (~15-20 min).
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 22-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 10 September 2014, the subject received a dose of BOOSTRIX (intramuscular, administration site unknown). Her last menstrual period was on 12 February 2014 and estimated date of delivery on 19 November 2014. The subject was exposed to the vaccine during the third trimester. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 06 October 2014 from nurse: The VAERS details were provided. This was a normal conception. Some of the patient's details were provided.
inadvertently received PROQUAD, instead of M-M-R II; inadvertently received PROQUAD, instead of M-M-R II; An adult inadvertently received PROQUAD, instead of M-M-R II; No adverse effects were reported; This spontaneous report was received from a nurse refers to an adult patient of an unknown age and gender. The patient's concurrent conditions, drug allergies, medical history and concomitant medications were not reported. On 20-MAY-2019, the patient was inadvertently received with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) )(0.5 milliliter, lot # R022564 and expiry date 04-FEB-2020) route via subcutaneous for prophylaxis instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R-II (interchange of vaccine products, wrong product administered and product administered to patient of inappropriate age). Other suspect therapies included sterile diluent(lot N035969 and expiry date 18-APR-2020). No adverse effects reported(No adverse event).
pt devel pain @ inj site approx 2 days p/vax;pain was described as mild to moderate for 1.5 wk, & then became more intense;pt exp inc pain when lifting lt arm, & when reaching out & front;exp some relief p/Ibuprofen;seen by MD;
10 days after injection 2 sores that 1 scabbed over and the other.
Recurrence of some BPPV; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 31Mar2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: FORTEO taken for osteoporosis, start date: 06Jan2022. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed., Unknown Manufacturer), for COVID-19 Immunization; Bnt162b2 (Dose: 03), for COVID-19 Immunization, reaction(s): "a tooth broke out", "BPPV began in Dec2021". The following information was reported: VERTIGO POSITIONAL (non-serious) with onset 2022, outcome "not recovered", described as "Recurrence of some BPPV". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that tried submitting this through your website form, but I had trouble using your form. When I tried to put in my list of medications on your form, that's where the trouble started, so I did not submit the information through your web page, and I am sending you this letter instead. Here is the information regarding my second booster shot was had second Booster shot of the Pfizer vaccine at 5:00 PM on 31Mar2022, and it triggered a recurrence of some BPPV I had a few times over the past few months. BPPV history: The BPPV began in Dec2021 after a visit to the dentist where a tooth broke out and he had to rebuild a tooth for about an hour. The symptoms would be "a little room spinning for a short time in the morning and then I would be fine the rest of the day. It would go away after a few days. I don't recall the start of the second episode of BPPV. The 3rd episode of BPPV started after an MRI exam where they put ear plugs in ears. And now after the second booster shot, it started again. Had checked on the web and Yes, patients have reported vertigo after the Pfizer shot. I will let you know if the BPPV continues or gets worse. I have also been taking a daily injection of Forteo for Osteoporosis, since 06Jan2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous consumer report (initial receipt 27-OCT-2014) concerns a 62 year-old female patient. On an unspecified date in 2013, the patient received flu vaccination (manufacturer and batch number not reported). On an unspecified date in 2013, the patient started experiencing headaches and felt achy. She felt like she has a head cold. Other symptoms included neck ache, tossing and turning and she could not sleep. These symptoms lasted for approximately 2 weeks. Outcome was reported as recovered. Linked case: 2014046047 (same patient).
10/12/2006 had febrile seizure 10:30am saw ER Dr at hospital that Dr called another Dr. Dr thought it was more likely to be from the ear infection. instead of the MMRV.
interested in getting her pneumonia and flu shot yesterday 10/11/21.  She stated on the  form she had a pneumonia shot in the past but when MCIR checked she has not received a pneumonia vaccine before.  She was given PCV 13 and a high dose flu vaccine based on her age.    She tolerated well at time of injection and VIS sheets were given.  She called today 10/12 at approximately 1330.  She stated later yesterday she started to develop a bad headache and was not feeling well.  She ended up calling her local ED last evening as she was concerned.  She states they instructed her to take otc acetaminophen and use ice.  She states she did.  She slept and today is feeling much better.  I encouraged her to drink fluids and monitor for further symptoms and go to ED symptoms return.
Patient received vaccine at 10:30 am and waited for approximately 15 minutes before leaving pharmacy.  He reports he felt well at this time.  At 2pm, he started to feel unwell and by 5pm, it "hit him hard."  He complains of fatigue, feeling unwell, unable to concentrate and blurred vision with a white haze around it.  It says he considered going to the emergency room but could not drive in his condition.  By noon the next day, he surprisingly felt better and returned to work.
Information has been received from a physician concerning a 15 month old female with no known allergies or medical history who on 5/2/2005 at 14:00 was vaccianted SC in the left arm with a first dose of varicella virus vaccine live (lot 648554/0584P) Illness at the time of vaccination included otitis media. Ten days later the patient developed a varicella rash with no complications. Unspecified medical attention was sought. At the time of the report, the patient was recovering. A product quality complaint was not involved. Follow up information was received from a registered nurse who reported that in the am of 5/13/2005, the patient developed a fever of 101 degrees for two days. A rash started in the am of 5/13/2005. The patient was not in day care. There were no known exposures to chickenpox. The patient had scattered vesicular lesions on the head, trunk and extremities. It was noted that he had no adverse events following prior vaccination. The patient recovered on 5/16/2005.
Pt stated she felt foggy and had difficulty thinking straight. Pt was assisted to the floor and took Benadryl 25 mg orally from her own supply that she came with. Pt provided water and was monitored. Pts husband also present. Pt was asked to rest and after feeling  bit better she sat up, then was moved to a chair and monitored for an additional timeframe. Before leaving pt stated she was feeling well.
Pt has a erythema around injection site (about 1.5" - 2" in diameter).  Pt reports itchiness, swelling, redness, and tenderness at the injection site. No fever.
Patient called on 9/15/22 at 8pm to say that he had read up side effects of Zostavax that said it could cause blurred vision and blindness.  I explained to him he did not get Zostavax (a live vaccine)  but Shingrix but he insisted that he had double vision since the vaccination. He added that he did see the eye doctor and called his physician. When asked what the optometrist find, he replied that she said everything was normal and could not find anything wrong in his eyes and suggested for him to use artificial tears just in case his eyes are dry.  When asked what the doctor said to him, he also replied that the doctor did not find anything wrong either but told him not to get the second dose.  I told him to use artificial tears as advised by the eye doctor and give it a couple days to see if there is any improvements and notify us later if there is any issue.
On 11 SEP 2007 a product liability litigation was received from a lawyer. The following information was provided: A female patient who is the plaintiff received three doses of RabAvert on 13 SEP 2005, 20 SEP 2005 and on 4 OCT 2005. It was reported that as a direct and proximate result of the vaccinations the patient sustained permanent and disabling personal injuries (interval unknown) including, but not limited to, swelling of the brain, numbness, nerve damage and was thereby caused to sustain serious, permanent, and debilitating body injuries. She developed severe and irreversible damage to her nerves and nervous system, she was caused to suffer from severe and permanent muscular and neurological damage and the use, function and movement of portions of her body have been permanently impaired. She had severe discomfort, pain, and mental anguish. As a direct result of her injuries the patient's ability to work, labor, earn wages, and enjoy the ordinary pursuits of life has been seriously and permanently impaired or destroyed. The patient had to undergo necessary extensive hospitalization and therapeutic are and treatment. Defendants are the manufacturer for failure to adequately warn prescribers, administrators and all other health care providers of the risk of permanent side effects caused by RabAvert and the registered nurse who administered the vaccines for medical malpractice. Causality: not related. Although only limited information is provided and exact diagnosis of the patient's disease and onset latency are not provided causality has been excluded. Swelling of brain is a serious, immediate medical intervention requiring disease of different aetiology. It has never been observed in association with use of inactivated vaccines and there is no plausible pathomechanism that could explain this disease as result of vaccination.
1130 Pain started in arm .. increased the mobility of arm  to loosen muscles  1:30 I could not move arm at all without it hurting  By the evening I attempted to move my arm but couldn't  I had to use my right arm to help move the left arm Next morning I could move arm but still ached  next morning pain was gone 12/21/2020 Light Ache
This spontaneous report as received from a consumer's mother refers to her son, between 14-17 years of age: male patient of unknown age with sulfa drug and penicillin allergy. No pertinent medical history reported. On an unknown date, between 1995-1999, the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route and lot # were not provided). There was no concomitant medication. There was no concomitant medication. On an unknown date, the patient developed severe systemic hives (when he was between the ages 14-17 years of age). Reporter stated that the reaction started right away either on the day of vaccination or the day following vaccination (between 1995-1999). Patient sought medical attention (office visit at the time of the event). Unspecified treatment was given for adverse event. No laboratory tests were performed. Therapy with RECOMBIVAX HB was discontinued (series was not completed). The outcome of severe systemic hives was reported as recovered/resolved on unknown date (at least 1 week after onset date). Causality was not reported. The relationship between severe systemic hives and RECOMBIVAX HB was not reported. Additional information has been requested.
Patient received her first Moderna COVID-19 vaccination on 03/11/2021. She did not have any ill effects directly afterwards. However, starting on 03/27/2021, she began complaining of left arm pain in the area of the injection. She continued to complain of pain in the injection site on 03/28/2021. On 03/29/2021, her roommate found her deceased on her bed due to a probable cardiac event.
I was really really ill; "I have no appetite, had no real meal since Thursday"(8Apr2021); Arm is still very sore; Very high fever, 103; "I just feel tired"/just washed out, just laid out"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was really really ill), DECREASED APPETITE ("I have no appetite, had no real meal since Thursday"(8Apr2021)), PAIN IN EXTREMITY (Arm is still very sore), PYREXIA (Very high fever, 103) and FATIGUE ("I just feel tired"/just washed out, just laid out") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE BESILATE (NORVAS), LEVOTHYROXINE SODIUM (SYNTHROID) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ILLNESS (I was really really ill), DECREASED APPETITE ("I have no appetite, had no real meal since Thursday"(8Apr2021)), PAIN IN EXTREMITY (Arm is still very sore), PYREXIA (Very high fever, 103) and FATIGUE ("I just feel tired"/just washed out, just laid out"). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ILLNESS (I was really really ill), DECREASED APPETITE ("I have no appetite, had no real meal since Thursday"(8Apr2021)), PAIN IN EXTREMITY (Arm is still very sore), PYREXIA (Very high fever, 103) and FATIGUE ("I just feel tired"/just washed out, just laid out") had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Influenza virus test: negative (Negative) Tested negative for the Flu. On 08-Apr-2021, Body temperature: 103 (High) High Fever of 103.         The patient experienced very high fever, 103 and it knocked her to the knees. She stated that After three days she had only made it from the bed to the couch and the side effects are ongoing.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-073884 (E2B Linked Report).; Sender's Comments:  MOD-2021-073884:First dose case
Patient had 1st Pfizer Covid vaccine on 04/22/2021 at clinic and came back one week early  on 5/6/21 requested for the second shot. Pharmacist did not catch the early time interval and provided the shot at 2 weeks apart.
After the second dose my period was irregular for two cycles.; After the second dose my period was irregular for two cycles. Now after the second dose Im very late; I am unable to get pregnant.; This is a spontaneous report from a contactable nurse, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 14Jan2021 at 12:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 24Dec2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 17Feb2021, after the second dose, the patient's period was irregular for two cycles, now after the second dose she was very late. The patient was unable to get pregnant. It did get more regular after a few months; she would still take the shot but wanted to report it as it has happened twice now and the patient was usually regular. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period was irregular for two cycles, now after the second dose she was very late and she was unable to get pregnant was resolving at the time of this report. The patient also received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 27Sep2021 at 14:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Developed irregularly round erythematous, warm, slightly firm ~5in in diameter area on R upper arm with top point being at site of HPV injection. No fluctuance, drainage, minimal tenderness. Pruritic. Tx: ibuprofen, ice, BENADRYL, monitoring. Patient seen today so unsure of how long reaction will continue.
Dentist consider her Covid-19 positive; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Dentist consider her Covid-19 positive) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced COVID-19 (Dentist consider her Covid-19 positive). At the time of the report, COVID-19 (Dentist consider her Covid-19 positive) outcome was unknown.        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.   As patient experience Covid-19 and dentist denied to treat and had a appointment for a PCR test.  On an unknown date, Blood immunoglobulin G: positive (Positive) Positive. On an unknown date, Blood immunoglobulin M: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.  No relevant concomitant medications were provided. No treatment information was provided.
11-15-07 1553 Client received flu shot at 1553 Sanofi Lot U2502AA in left deltoid IM.  11-19-07 Mom came into office in afternoon and told clerical the patient had to go to the Dr. on Saturday November 17, 2007 because the spot where he got the flu shot was all red.  The Dr. told her it was an infection.  11-20-07 1120 Left message at client's house for mom to return my call and let me know details of what happened. 11-20-07  Saw client's mom in evening at flu clinic and she reported details to me.  She stated on Friday November 16 her son (client) told her that his arm itched.  On Saturday November 17 her son was getting dressed and felt a bump on his arm.  He went to show his mom and she stated it was red, warm and sore.  No fever was present.  Mom felt the redness was the size of an orange or a grapefruit.  She took him to acute care in the am and he saw a PA.  He was given an antibiotic.  Mom is unsure of the name but knew it started with a 'C'.  He was prescribed 10 days worth for three times a day.  She gave him two doses on Saturday and by Sunday the redness was the size of a dime.
At 1645 client she was feeling tingling in her nose, cheeks and legs. Client denied any allergies to medication/food/environment and denied any pertinent medical history or regular medication use. Client denied any shortness of breath (SOB), difficulty breathing, headache (HA), chest pain (CP), or numbness and tingling in mouth, lips or throat. Client ambulated to zero gravity chair without assistance or incidence. At 1647 a first set of vitals taken: BP 118/80, HR 88, RR 20, skin warm, dry and normal color for ethnicity, A&Ox4. Lead RN visualized client's oropharyngeal area and noted no swelling or redness,  capillary refill <2 seconds. Client stated the numbness and tingling in her legs was resolving and stated she could, "swallow ok".  At 1650 client stated tingling in her legs had subsided, she reported a decrease in the tingling of her nose and cheeks, stated the feeling was "minor" and rated it a 1/10. Client continued to deny SOB, CP, HA, dizziness and numbness or swelling of mouth, lips or throat. At 1655 vitals taken: BP 118/78, HR 78, RR 18, client states she, "feels better". At 1705 vitals taken: 118/76, HR: 76, RR 18, client stated tingling of legs, cheeks and nose had resolved. She denied any SOB, difficulty swallowing or breathing, denied CP, HA, and numbness of mouth, throat or lips. At 1710 client educated on ED precautions. Client verbalized understanding and ambulated away from the observation site on her own accord and with a steady gait.
Pt received vaccine on 4/6, on 4/18 started to develop paresthesias in legs, numbness, hyperesthesia, blurry vision and difficulty urinating. She was admitted on 4/23 and MRI of brain/C-spine/T-spine/L-spine showing widespread demyelinating lesions mostly in T-spine. ADEM was primary consideration. LP showed lymphocytic predominance with about 130 WBC, elevated protein and normal glucose. Viral PCR of CSF and nasal swab were negative. Culture negative. She had acute urinary retention requiring foley catheter. She will be discharged today 4/25 with plans to follow outpatient for final MS serologies and neuro/optho follow up for final diagnosis.
Patient had received 2 prior doses of Pfizer vaccine and requested the booster be Moderna. I failed to note that Moderna was not approved  yet at  Patients age. Patient is fine and had no adverse effects.
Rash, fever 3 days after vaccine. Urticarial rash on right leg.
Large 3 inch by 8 inch rash on my back just above waist level. Has lasted about one month and is mostly remitted.  I am not prone to rashes and have no skin conditions that would explain the rash.