chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a 47yo female who presents with an urticarial all-over body rash after the Johnson and Johnson vaccine. She had her vaccine on Friday and started to notice the rash on Saturday. It has progressively spread out since then. Denies fevers, n/v, diarrhea.  She has taken a total of 2 benadryl tablets - one on saturday and one on sunday with some relief, however the rash would come back.  Prescribed cetrizine 10 mg tablet: 1 tab po bid 60 tablet(s), 1 refill; Famotidine 20 mg tablet: Take 1 tablet twice a day by oral route.  60 tablets, 1 refill;
2/21/2023  I thought I had a sinus infection. I had head congestion and sinus pressure. On 2/22/23 I took an at home COVID test that was negative. I also took one on 2/23/23 that was negative.  The night of 2/25/23 I got a really bad sinus headache. The next day I had an awful headache.  My sinuses were so swollen, I could not breathe and was unable to open my sinuses up.  That day, 2/26/23, I went to urgent care. I was tested for Flu and COVID. Flu was negative and COVID was positive.  The doctor prescribed Paxlovid which I started taking that day.  Within about 8 hours, my headache was gone.  I took the Paxlovid for 5 days. After that , I felt like I was recovered.  I took an at home COVID test on 3/7/23 and it was negative.  Around 3/10/23 I began having congestion again. I tested positive for COVID on an at home COVID test.  It was very mild sinus issues, not at all like the first time.  I have recovered.
Developed a sore arm around 10pm, woke up with severe 7/10 body aches that quickly worsened leading to almost fainting, and sick to stomach along with mild headache.
Pt received Moderna COVID vaccine. Approx. 20 mins later, she began to feel dizzy, shaky, swollen tongue, scratchy throat. Overhead page for code A.  Patient was lying on the floor with her feet elevated and RN staff was obtaining vitals. Oxygen was 100% on nasal cannula, heart rate in the 70s, and systolic blood pressure in the 110s which patient reported was normal for her.  She was alert oriented and talkative.  Reports feeling dizzy, shaky, and a feeling of a scratchy or slightly enlarged tongue.  Benadryl was ordered 50 mg p.o.  Patient was easily able to swallow medication.  Heart and lung examination or performed which were within normal limits.  Patient moved from conference room to observation in primary care.  IV access obtained and fluids started.  Oral examination performed and no objective erythema or edema of the oropharynx or tongue.  3099 was called and discussed case with ED physician.  Agreed with current management.  She continued to be monitored.  Some improvement in symptoms of dizziness and lightheadedness.  No worsening symptoms of tongue swelling. Recheck: improved symptoms. Feeling better. Will d/c home with driver and instructions to follow up with PCP about next dose.
This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (as a patient received 1 dose of the Pfizer COVID19 vaccine and a second dose of the Moderna COVID19 vaccine), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066h21a) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 06-Aug-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (as a patient received 1 dose of the Pfizer COVID19 vaccine and a second dose of the Moderna COVID19 vaccine) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine).    No concomitant medication information was provided.  No treatment medications were provided.
tired; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; This is a spontaneous report from a contactable consumer (patient herself).  A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included anxiety (needed to calm down), blood pressure abnormal, blood cholesterol abnormal, rheumatism, and osteopenia; all were ongoing. Concomitant medications included losartan potassium for blood pressure abnormal, atorvastatin blood cholesterol abnormal, sulindac for rheumatism, carvedilol for blood pressure abnormal, alendronate sodium for osteopenia, and venlafaxine; all were ongoing. On 12Jan2021, the patient experienced strong pain on her shoulder, upper arm, breast and neck area. On an unspecified date, the patient was also tired. Clinical outcome of event tired was unknown while for the other events was recovered on 13Jan2021.
Mild soreness initially. 24h later became a deeper pain. Didn't think much of it, but it initially but it has persisted. Tender.   Pain limits movement of the  L arm in any activity where my arm is Abducted. Even brushing teeth burns at the top of the deltoid.   It sometimes is difficult to find a comfortable position to sleep.  Home trials of NSAIDs/Rest/ICE have not worked.  Finally decided to see my primary care doctor on  6/11.   At that appointment, I received a steroid injection into the shoulder joint and a referral for physical therapy.   The steroid seems to be helping significantly so far and I am hopeful that PT will resolve the rest of the pain.
headache; lethargy; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administrated in right arm on 02Mar2021 14:00 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had known allergies to animal dander/urine; pollen, dust, etc. On 02Mar2021, the patient experienced headache, and lethargy. On 11Aug2021, the patient underwent lab tests and procedures which included NAAT/RT-PCR nucleic acid, SARS-CoV-2 test: Negative. The treatment was received as a result of adverse events which included 125 mg amoxicillin every 12 hours for 7 days. 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 been has tested for COVID-19. The outcome for all the events was recovered on an unspecified date Mar2021.  No follow-up attempts are possible. No further information is expected.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
PATIENT WAS ADMITTED TO HOSPITAL WITH HEADACHE AND VISUAL IMPAIRMENT, ULTIMATELY DIAGNOSED WITH CEREBRAL VENOUS THROMBOSIS
Pt devel pneumonia following 1st & 2nd dose of pneumoccal vax; No further details were provided;
This case was reported by a consumer via call center representative and described the occurrence of headache in an adult female patient who received 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 headache, general body pain and injection site pain. On an unknown date, the outcome of the headache, general body pain and injection site pain were recovered/resolved. It was unknown if the reporter considered the headache, general body pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's sister. The age at vaccination was not reported. Recently the patient received a dose of SHINGRIX but the exact date was not known. The headache and body aches lasted for a day and the sore arm was for a few days. The reporter did not consent to follow-up. This case has been linked with US2019034291, reported by same reporter for the patient's sister.
Janssen COVID-19 Vaccine EUA It is at the injection site and the symptoms are redness of the skin, pain, and a little swelling
Administered with 0.3 ml of the vaccine.; A spontaneous report was received from a pharmacist concerning sixty-seven patients who received Moderna's COVID-19 vaccine (mRNA-1273) and were administered with 0.3 ml of the vaccine.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patients received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. While administering the vaccine, the reporter stated that the patients received less than the 0.5 ml dose of the Moderna COVID-19 vaccine. The reporter also mentioned that the syringe was set to 0.3 ml instead of 0.5 ml. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The event, administered with 0.3 ml of the vaccine, was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of Underdose for mRNA-1273. There were no reported AEs associated with this case.
Severe headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Right arm on 26Jan2021 at 03:30 PM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history was reported as none. Patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 27Jan2021 patient experienced severe headache and chills. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient recovered from the events on unknown date.
This infant's right thigh had 2 distinct areas of 1 cm induration and redness.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 14-JAN-2013 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-APR-2015, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 22-APR-2015, the patient sought subsequent treatment from a physician for ongoing and worsening symptoms of shingles infections, and was also d iagnosed with post-herpetic neuralgia a chronic condition of nerve damage and pain secondary to zoster outbreaks. The patient has been prescribed valacyclovir (VALTREX) and pregabalin (LYRICA) for 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.
AMENORHEA SINCE DECEMBER '08. PREGNANCY TEST NEG. MOTHER REPORTS NEVER HAD A PROBLEM BEFORE GETTING THE GARDASIL VACCINE.
A physician reported that a pt received Acel-Imune and subsequently developed an injection site reaction characterized by a coin sized area of redness, warmth and swelling.
no additional AE reported; Caller reports receiving a dose of GARDASIL 9 on an unspecified date last week and his physician is advising that he restart the vaccination schedule; This spontaneous report was received from an adult patient of unknown age and gender who referred to herself/himself. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date in 2016, the 23-year-old patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The patient was unsure which Merck hpv vaccine was administered. The patient reported never receiving the remaining doses.  On an unspecified date in January 2021 (reported as an unspecified date last week), the patient was vaccinated with dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) and the physician was advising that he restart the vaccination schedule. No additional adverse event was reported.
pt claims to have been sick nearly everyday since recv vax;also claims to have had three bouts w/the flu since recv the shot;
I had been having symptoms for a while. I was unable to focus, unable to sit still, and had bad verbal processing. I was diagnosed with ADHD. I was prescribed Adderall extended release. I was also diagnosed with sensory processing disorder. I will be dealing with this the rest of my life.
High fever, severe headache, body aches, nausea, vomiting, sinus (nose) burning.
low blood pressure of 82/57, patient appeared dizzy, nausea and vomiting symptoms, pale, cold to touch and sweating. blood oxygen saturation declined suddenly to 75% was alert, patient's  blood glucose reader showed 140mg./dL . EMT arrived quickly she was taken out of facility and inside the ambulance for further evaluation. patient decided to not go to the hospital with EMT and left with her own car.
Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. On 04-APR-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt given KINRIX at 4 months of age. Parents did not report any signs and symptoms. MD called & requested return call - received none.
Information has been received from an RN concerning a pt (demographics unknown) who on an unspecified date was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (from either lot 641532/1353L or 641130/1161L). Subsequently, the pt developed an injection site reaction. The reaction involved the "entire upper arm from the elbow to the shoulder" and was characterized by redness, warmth and fever. The pt sought unspecified medical attention and was treated with an antibiotic. The reporter expressed a concern with the lots. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: She was seen in the physician's office on 05/31/2002. At that time, she stated that she could not raise her arm above her head "one day ago". She had circumferential erythema, described as pink, circumscribed from the top of the deltoid to 4 cm below the elbow. Her arm was very warm to the touch and tender. She had good range of motion and pulses. Her temperature was 99.7 degrees. The pt was treated with an antibiotic. On 06/18/2002, the pt complained of mild discomfort in the right axillary area. No adenopathy was noted and pt had normal use of muscles. On 09/09/2002, it was reported that there was "no notation of problems in following office visits". The reporter expressed a concern with the lot. It was noted that she had previously been vaccinated with pneumococcal vaccine 23 polyvalent in 1995. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further info is expected.
Pt says the area has itched for about 3 days and today she noticed a red area on her left deltoid that is 2.75 inches wide by 3.5 inches long.  She says she had the same type reaction to a flu shot in Jan 2013.
Started with A small area on my upper wrist was itching now spread to my right arm and legs, reminds me of poison ivy the way it itches especially when I shower, also I had a few area spots of red looking sores but those are looking much better..I put Benadryl cream and also took oral Benadryl, I went to the dermatologist and the dermatologist wasn?t sure what I have, took a biopsy of an area on my right leg, prescribed kenelog cream and told me to use cerave lotion on my skin, also I did go to urgent care and the Dr didn?t know what I have either, asked if I have used anything different such as laundry detergent or eating and no I haven?t, prescribed a steroid, I finished my last dose and it didn?t help..it?s been about 2 weeks a little improvement..I go back to the dermatologist 3/11 for results from the biopsy and anything else I can find out and I did let the dermatologist know I got the covid vaccine.
Patients states that same day of vaccine injection felt "terrible", achy, fever, chills. Client went to ER. Did not call.
Pt became dizzy, PB dropped, Sat remained 99% in R/A. Lungs clear, no wheezing noticed. Recovered in 10 min. Vital sign normal prior to discharge. Refused to go to ER.
A nurse administered tetanus toxoid 0.5mL IM into the left deltoid and prepared Kefzol 1g in 100 mL NS and upon administration, patient became pale, eyes rolled back, and tonic/clonic seizures started. Kefzol stopped, lorazepam and diazepam given. Patient also found to have diffuse red flat patches on arms, legs, and trunks. The patient was admitted for several days due to this and was put on Dilantin. 60-day follow up on 12/05/2003: "Vaccine recipient has recovered from the adverse events that were reported for this vaccination.  Yes, reaction not thought to be due to vaccine!"
feel like being on airplane; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "feel like being on airplane".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Regarding The VSIR for the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
Information has been received from a physician concerning a 23 year old female who on 17-OCT-2007, was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 659435/1265U) in the left deltoid, on 19-DEC-2007, was vaccinated with the second 0.5 ml dose of GARDASIL (lot # 659439/1267U) in the left deltoid and on 15-APR-2008, was vaccinated with the third 0.5 ml dose of GARDASIL (lot # 659182/1757U) in the left deltoid. Concomitant therapy included LO OVRAL. In December 2007, the patient experienced severe psoriasis over face, neck, hands, feet and entire scalp causing hair loss. On an unspecified date, the patient was seen by a Dermatologist who performed a "work up". AT the time of reporting, the patient did not recover. Follow-up information on 19-NOV-2008 was received from a physician who reported that she was not able to add much more to her initial report. She stated that the patient's chart did not reflect when the adverse event occurred in December 2007. It was unknown if the onset was before or after the second GARDASIL dose on 19-DEC-2007. The doctor did report that there was no pertinent medical history and no concurrent conditions. She confirmed that the events were disabling and important medical events. The patient was currently taking HUMIRA and using a special shampoo. Dermatology reported that the events were an immune response to the vaccine.  Current outcome was not recovered. The physician would not be seeing this patient again until October 2009. The physician considered severe psoriasis and hair loss to be disabling and other important medical event. Additional information has been requested.  12/3/08 Dermatology consults received beginning 6/5/08 with DX: Sebopsoriasis. Pt presented with 6-8 month hx of facial, scalp and hand scaly patches.  F/u 7/7/08 with Dx: Seborrheic dermatitis.  Psoriasis.  Tinea versicolor. PE (+) for erythematous scaly patches on face, extremities and scalp. Started on Humira. Reported severe sores in mouth. Dx: aphthous ulcers. Herpes simplex virus. Humira d/c.
Information has been received from a consumer concerning a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies, concurrent conditions or concomitant therapies were reported. On 20-SEP-2016, the patient was vaccinated with an unspecified dose of PNEUMOVAX 23 (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported) and at the same time was vaccinated with an unspecified dose of influenza virus vaccine (unspecified) (reported as "a flu vaccination") (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). On an unspecified date in September 2016, after the vaccination with PNEUMOVAX 23, the patient experienced joint pain (arthralgia), fatigue, chills without fever, pyrexia and muscle weakness. No product quality complaint was involved. At the time of reporting, the outcome of arthralgia, fatigue, chills, pyrexia and muscle weakness was unknown .The relatedness between the events and therapy with PNEUMOVAX 23 was not reported. Additional information has been requested.
Swelling, heat, itchiness, and redness of upper arm on the side of the injection