chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient.  A 22-year-old non-pregnant female patient received the second dose  of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration in the left arm on 25Jan2021 (at the age of 22-years-old) as a single dose for COVID-19 immunization.  Medical history included sulfa allergy, depression, and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included duloxetine (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN), and ibuprofen (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 on 08Jan2021 (at the age of 21-years-old; Lot Number: EK9231) for COVID-19 immunization in the left arm. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines (except the first dose) within four weeks prior to the vaccination.  On 25Jan2021, hours after the second dose, the patient had severe full body flu like aches, lingering joint pain/some joint, dizziness, exhaustion, and weakness. On 26Jan2021, the patient had soreness at injection sight red and swollen. The patient did not receive any treatment for the events.  The clinical outcomes of the full body flu like aches, lingering joint pain/some joint, dizziness, exhaustion, weakness, and soreness injection sight red and swollen were recovering.
7cm x 7cm erythematous, warm, raised, local rxn, inc pain, swelling;
Patient developed intractable vomiting during the night after receiving the Moderna COVID vaccine and 102 oral temperature. The vomiting continued until post vaccination day #2, and patient was referred to urgent care facility where she received IV phenergan and IL of IV fluids for dehydration. Patients was sent home on pedialyte and odansetron.
patient had a baby and was breast feeding; This spontaneous report as received from a registered nurse refers to a 15 year old female patient with no pertinent medical history or drug reactions or allergies. On 11-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S021740 exp date 25-MAR-2021) intramuscularly for a scheduled spleen surgery that she would have on an unspecified date. Her surgeon wanted her to receive the vaccine. Concomitant therapies included influenza virus vaccine (unspecified).  The nurse reported that the patient had a baby in December 2019 "2 months ago" and was now breastfeeding. The patient's current status was "fine".
Approximately one hour after receiving the injection, I had pain around the injection site. This continued to worsen, and stayed very sore until 36 hours after receiving the injection.  At 2 1/2 hours s/p injection, I began with a headache and mild dizziness. The headache  was relived with Tylenol. When the Tylenol wore off, the headache did persist until 24 hours after injection.  Around 4-5 hours after injection, I began feeling very tired, and this did continue for approximately 48 hours.  I received the injection on Friday, and the entire day Saturday, I did not feel well overall.
Felt light headed when going to the restroom; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt light headed when going to the restroom) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced DIZZINESS (Felt light headed when going to the restroom). At the time of the report, DIZZINESS (Felt light headed when going to the restroom) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
1 of 4 pts vaxed from the same lot# during the month of MAY95 who exp fever & inj site rxn w/in 24-48hrs p/vax;recovered;
Information has been received from a healthcare professional concerning a 7-year-old white female with an allergy to ibuprofen who on 06-NOV-2007 at 10:15 am was vaccinated in the right arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 658425/1182U). On 08-NOV-2007 the patient experienced right lateral/posterior arm with redness, 8x10 cm with central induration and warmth with tenderness. The patient sought unspecified medical attention and was treated with antibiotic therapy ("ABT"). No diagnostic labs were performed. On an unspecified date the patient recovered. Additional information is not expected.
12JUN91 pt exp 2 hr sz; Taken to ER from 330-1130PM; mom describes pt crying for 2 hrs even p/APAP given; then fell asleep & began to shake, & slobber @ the mouth;
Patient presented post-seizure. Reported 1 week of headache prior to presentation. Found to have cerebral venous sinus thrombosis, small areas of hemorrhage in the right frontal lobe, and bilateral pulmonary emboli, as well as thrombocytopenia (previously had normal platelet count).  Per MD "Clinical picture is entirely consistent with VITT.  See no other obvious explanation for this constellation of clinical findings. "
64 yr old male presents with c/o having a flu and pneumonia injections 2 weeks ago and now has soreness, redness, and skin  peeling. He states that originally the red was approx 8 1/2 inches from top area to bottom area. The area was tender to touch and his temp got up to 102. A. Pt has hardness approx 3cm in diameter that is lt pink with darker pink in middle.  No peeling visible now. P. Pt instructed to take Motrin or Tylenol for the pain and inflammation.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 52-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 1st May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, injection site erythema and influenza-like symptoms were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. This case was initially reported via voice message. The pharmacy was called back for additional details. The patient experienced injection site reaction consisting of a swollen arm, round red circle at the injection site, and flu like symptoms, which were not delineated. The patient stated that, it was not cellulitis, but as erythema.
I was very sick with COVID-19 for six weeks starting the week of Thanksgiving 2020. After each dose of the vaccine I was very sick for a full week each time.  After the third dose of the vaccine, I lost my sense of taste. I felt like I had COVID-19 again. It has been four weeks and it has still not returned. I felt terrible within six hours I had all over body and it lasted for a week. After four weeks the swelling and pain in my hands and feet is excruciating. I developed Neuromas on the bottom of my feet. I have been prescribed steroids to help my symptoms. I also experienced feelings of dizziness and disorientation for up to ten days. I did not feel confident to drive. I never had a fever but I did feel flushed sometimes.
Mom states that patient noticed that her was sore and looked at it and it was turning red and was warm to touch and has gradually become worse over the course of the night and day today.  Pt in the clinic today 10/4 and redness and swelling measured 5x5cm and was warm to touch and painful per patient.
Information has been received from a physician concerning a patient who on an unspecified date was inadvertently vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). No adverse effect reported. Follow up information was received from a physician who indicated that the patient did not experience an adverse reaction. He stated that the error was caused by a novice medical assistant who was unfamiliar with the practices. The physician also provided the Lot # for VARIVAX (Merck) (Lot # 663323/0645Y). Follow up information was received from a physician concerning a 61 year old self-employed female patient with no known drug allergies/drug reactions who on 08-SEP-2009, at 10:00 am, was vaccinated with the first dose of VARIVAX (Merck) (Lot # 663323/0645Y) into her left deltoid. There were no illnesses at time of vaccination. It was reported that the patient received the wrong immunization. There was no adverse reaction. This is one of two cases from the same source. Additional information is not expected.
Attending Physician:  DO Specialty:Internal Medicine Date of H&P: 3/7/2022    HPI: Patient is a 69y.o. female PMH of arthritis, cva, left hemiparisis fall, gerd, hepatitis C htn. Presents to ed due to waxing and waning lightheadedness since Saturday. Presents with daughter who is primary care giver. Also complaints of generalized weakness and some confusion over the past couple days. She was in a 2nd degree type two heart block on admission.  When asked she says the dizziness she had the past few days was similar to the dizziness she experienced prior to her CVA in 2020. She also has complaints of an occipital headache which is new for her. She reports her headache a 3/1-10 scale. She denies vision changes, nausea, vomiting, fever chills. She occasionally uses alcohol and reports NO illicit drug use and NO  prescription drug misuse. Patient is a 69y.o. female PMH of arthritis, cva, left hemiparisis fall, gerd, hepatitis C htn. Presents to ed due to waxing and waning lightheadedness since Saturday. Presents with daughter who is primary care giver. Also complaints of generalized weakness and some confusion over the past couple days. She was in a 2nd degree type two heart block on admission.  When asked she says the dizziness she had the past few days was similar to the dizziness she experienced prior to her CVA in 2020. She also has complaints of an occipital headache which is new for her. She reports her headache a 3/1-10 scale. She denies vision changes, nausea, vomiting, fever chills. She occasionally uses alcohol and reports NO illicit drug use and NO  prescription drug misuse.    Patient is well known to me. Seen in my office with her Dtr. Challenged with mobility/ ready for structured rehab/ disc'd with Dr.  Will monitor on database and have cardio eval. Med program reviewed. No neg chronotropic agents.  Compliant with home Rx.
full body urticaria, treated with Prednisone, Benedryl, Pepcid, unknown outcome at this time
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 07-APR-2021, the patient experienced adverse reaction at vaccination site. On an unspecified date, the patient experienced trouble breathing, and throat like closing up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the adverse reaction at vaccination site, trouble breathing and throat like closing up was not reported. This report was non-serious.
The day after I received the shot I woke up, my arm had 3 areas of redness, heat and pain. The first area was immediately around the injection site which was 4 inches wide and 4 inches long. The second red blotch about an inch below the injection site was 2 inches high 4 inches wide. The third splotch was an the inside lateral aspect of my injection arm and it is 2 inches wide 4 inches long. I took Benadryl 25mg by mouth before my shot and another 25mg later on the day of the injection. I have taken Benadryl 25mg three times a day since then to help with the inflammation and itching. Today on Feb 28th, there is still slight redness but all spots are looking less inflamed.
This spontaneous report was received from a health professional and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L018503, expiration date: 16-MAR-2017, dose and route were not reported) that was improperly stored (temperature: 50F, time frame: 20 hours). There was no previous excursion. No adverse effect reported. Additional information has been requested.
Information has been received from a physician concerning a patient who may have been vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed breakthrough chicken pox. It was noted that the patient was sent to the emergency room. There was no product quality complaint. The reporter indicated that the patient's cousin also developed breakthrough varicella (WAES0407USA02452). It was also noted that there were 40 other cases of breakthrough varicella (WAES0408USA0172). Additional information has been requested.
Pt states 1 week post vaccination MMR and TD he reported to clinic complaining of temp, vomiting, diarrhea and rash for 3 days. Pt noted moderate rashes with redness on back and chest. Pt stated experiencing muscle and joint pain all over his body. Pt stated last vomiting and diarrhea ends this 4am, Feb 5, checked temp 96.9 once.
3x4cm red, tender, itchy area around (L) inferior deltoid area. Some warmth, induration. Treated with oral Benadryl and Keflex Rx given in case of no improvement.
Pt recv vax on 3/10/98; post vax pt exp sx of lupus
Information has been received from a nurse in a physician's office concerning a pediatric patient who may have been vaccinated with a dose of Varivax (lot# not reported). Subsequently the patient developed a mild case of chicken pox, 8-15 lesions. The patient's outcome was not reported. Additional information has been requested.
Got the shot on Thursday evening. On Friday, my left arm up to my neck hurt. I felt like I was getting sick with a cold. On Saturday, I felt worse and worse on Sunday. On Monday, my hands and joints hurt me so bad. I felt weak, heavy and a ton of pain all over. On Tuesday, I missed work due to feeling so bad. I ached in different areas mostly in my chest. I went to the emergency room that evening. I went home with no outcome. I took over the counter ibuprofen which helped with the pain. On Wednesday, I experience shortness of breath and pain in my chest around 3:00 pm lasting about an hour. My symptoms seem to be slowly improving.
Fever; Nausea; Diarrhea; Muscle soreness; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ein9210) via unspecified route of administration in left arm on 08Feb2021 at 16:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and metoprolol tartrate (LOPRESSOR); both from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ein9810) via unspecified route of administration in left arm on an unknown date as a single dose for COVID-19 immunisation and Penicillin on an unknown date for unspecified indication and experienced a Penicillin allergy. 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 was not tested for COVID-19. On 09Feb2021 at 00:00, the patient experienced fever, nausea, diarrhea, muscle soreness and sore throat. The patient had not received any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events fever, nausea, diarrhea, muscle soreness and sore throat was recovered on an unknown date in Feb2021.  No follow-up attempts are needed. No further information expected.
expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given.  The vaccines were stored in freezer and took out one to two vials and placed in fridge each day as needed
It was so restless I was afraid for my heart/got restless/ restlessness increased; Was so restless that he was afraid to go to sleep; Became hyper; Felt nervous; Felt insecure; Very fast in my thinking; Shivering and couldn't stop it; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (It was so restless I was afraid for my heart/got restless/ restlessness increased), SLEEP DISORDER (Was so restless that he was afraid to go to sleep), PSYCHOMOTOR HYPERACTIVITY (Became hyper), NERVOUSNESS (Felt nervous) and DISCOMFORT (Felt insecure) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESTLESSNESS (It was so restless I was afraid for my heart/got restless/ restlessness increased), SLEEP DISORDER (Was so restless that he was afraid to go to sleep), PSYCHOMOTOR HYPERACTIVITY (Became hyper), NERVOUSNESS (Felt nervous), DISCOMFORT (Felt insecure), THINKING ABNORMAL (Very fast in my thinking) and CHILLS (Shivering and couldn't stop it). At the time of the report, RESTLESSNESS (It was so restless I was afraid for my heart/got restless/ restlessness increased), SLEEP DISORDER (Was so restless that he was afraid to go to sleep), PSYCHOMOTOR HYPERACTIVITY (Became hyper), NERVOUSNESS (Felt nervous), DISCOMFORT (Felt insecure), THINKING ABNORMAL (Very fast in my thinking) and CHILLS (Shivering and couldn't stop it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient experienced shivering, he meditated, and it slowed down and fell asleep. During the episode, he felt nervous; was walking from one room to another and couldn't stop talking. He also stated that the things that were unusual were extensive walking and couldn't stand still.  No relevant concomitant medications were reported. No treatment information was provided.
ear infection; A regulatory authority report was received from a consumer concerning a unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ear infection. The patient's medical history, as provided by the reporter, included ear infection. Concomitant medications were not reported.  On 25 Feb 2021, approximately one days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, prior to receiving mRNA-1273, the patient felt ear infection with medically significant. Treatment for the events included steroids shots.  Action taken with mRNA-1273 in response to the events was not reported.   The event, ear infection was considered unknown outcome event on 26 Feb 2021.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
This form is being completed by parent who is a physician. 16 yo female with 2 y h/o JRA, stable on 20 mg piroxicam q day.  H/O only 3 mild flares.  Pt received 3 vaccines at regular healthy child visit on 8/23/07: first dose ever of MCV4, Hep A, and HPV.  On 11/13/07 she received 2nd dose of HPV. In mid December (specific time to onset unknown) she developed multiple, scattered, small painful pustules on her toes filled with clear liquid and two swollen and painful toes. Over the following weeks her wrists, multiple toes and joints of her fingers swelled and became quite painful with reduced range of motion. She visited her pediatric rheumatologist for a regularly scheduled visit on Jan 2. "low dose" Methotrexate q week and folic acid were initiated. Little improvement in symptoms at this time.
Fever, dirrhea, sweating Narrative:  Took OTC Tylenol  Other Relevant History:
After Injection  pain,  swelling (hardness) in arm; Sunday side effects  joint pain; Monday  fatigue , awaken in sweat, dizziness, nausea and vomiting  for 10minutes; No fever; Tuesday fatigue, No fever 96.6; little dizziness and nausea.
Late on the day of second shot I began to feel warm and tired. Upon waking on 2/18 I was unable to do normal activities. My temperature was 100.8 mid morning. I slept on and off most of the day, had little appetite, aches, stiff neck and a headache on my forehead.  About 2:00 in the afternoon my symptoms declined. By evening I was almost back to my normal. On 2/19 I was able to resume regular activities.
Pt developed wheezing and scratchy "tight" throat about 10 min into obs period.  throat felt like it was closing, voice hoarse. MD present and pt given 50 mg Benadryl per MD order with relief of symptoms within 5 mins.  Pt continued to be monitored in obs area, no further distress after an additional 30 min observation.
pt recvd vax 25oct94; 27oct94 called & c/o red, swollen, painful Lt arm from inject site to elbow; started 26oct94; plan of tx , DPH for itching; ice pack to dec swelling; apap for pain;
severe headache, abdominal pain,  or shortness of breath and patient states they were consistent for 2 weeks and now they have passed
(L) upper thigh cellulitis. (L) inguinal lymphadenopathy, Warm soaks. Tx cephalexin 250mg/5 ml x 10 days.
Severe right arm pain from the infection site to the fingers. Right hand swelling with some numbness and weakness.