chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. An 82-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. Medical history included cancer survivor. The patient's concomitant medications were not reported. The patient experienced heart problems and memory problems on an unspecified date with outcome of unknown.  But, the reporter did not specify these events as occurring prior to or after the patient received the vaccine.
Information has been received from a registered nurse concerning a 20 month old (previously reported as 6-month-old) female, with no pertinent medical history or allergies who on 19-OCT-2007 was vaccinated in the right thigh with her first dose of varicella virus vaccine live (Oka/Merck) (lot # 659115/1326U) and a first dose of measles-mumps-rubella vaccine (lot # 656527/0285U). The vaccines were given on the same day, but separate locations. The patient had a recent upper respiratory infection (URI) on 04-OCT-2007 at the time of vaccination. On 05-NOV-2007, the patient returned to the doctor's office with swollen lymph nodes (groin nodes) on the same sides as where the vaccine was given and fever. It was noted multiple nodes palpated in groin areas approximately 14 days post vaccination ("R>L"). No diagnostic laboratory test performed. At the time of the report the patient's status was unknown. Follow-up information received on 26-FEB-2008 indicated the patient recovered "Mid December". Additional information is not expected.
Patient has localized swelling, redness and warm to touch. Entire upper arm where she received the vaccination.  Patient was seen on 03/02/21 by PCP. Patient was recommended to use ice for swelling as well as tylenol /ibuprofen and to call with an update on 03/05/21 or sooner if becomes worse. PCP also used marker to outline to monitor if the redness or swelling increases.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 10-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Follow-up of right leg pain.  She received her second HPV vaccine on March 18.  She was a little bit sore in the shot area after the vaccine.  The following day she developed more pain in the upper leg and knee area on the right side.  It progressively worsened and I saw her in March 22.  We decided for symptomatic measures and monitoring since she is otherwise asymptomatic and history was benign.     Since then she feels pain has worsened.  Pain is localized to lower lateral right leg just above ankle.  Last night she was really warm and slept with her window open.  No known fevers.  She is currently taking tylenol and ibuprofen which doesn't seem to help.  Pain never completely goes away but there are positions that don't hurt as much. Pain seems more superficial than previously when she described it as more in the bone. She is waking in the middle of night with position changes due to pain. When she is walking she "feels like something will tear".  More painful with walking. Mother states she tries to avoid walking.  Limps when walking.
Dtap given in left deltoid on 2/9/05. Pt returned on 2/10/05 c/o redness and swelling. Physician dx cellulitis and gave Keflex.
There was no adverse effect for patient his provider was informed and she  agreed that there would be no issues
Disclaimer: I have had issues with eating food for many years, so this is not a completely new condition in any way related to the vaccine. For at least 10 years, I have had severe heartburn, indigestion, and painful hiccups when I eat. Certain foods (e.g. red meat & bread) cause worse/more predictable reactions. I believe my possible adverse event is related to this preexisting condition, but the date in which it became debilitating correlate with my vaccination date.  Around 08/25/2021, I was eating a sandwich that I often eat, and I noticed it was a lot harder to get it down my esophagus. I didn't choke, as I was able to drink water and push it down, but I did notice it got a little stuck. On 08/30/2021, I was eating a steak slowly and in small bites as I'm used to doing to prevent my hiccups, when I felt a strange pressure in my chest. I tried taking a sip of water, but it felt like my body couldn't drink. I told my husband, who saw this happening and became alarmed, not to worry, that I could breathe. After a few failed attempts to drink, I told him I thought I may be choking. My mouth and nose both started to pour saliva/snot and I realized the steak was stuck in my esophagus. I kept trying to sit up straight and swallow as much water as possible, and finally after about a minute it went down.   A few days later, I was eating a cheeseburger, and the same thing happened. This time, however, I couldn't get the food to go down. I kept trying to drink my Sprite, but every sip I took came immediately back up along with a tiny bit of food. It took me at least 20 minutes of doing this repeatedly for me to clear my esophagus and get relief from the choking sensation.  I have had issues swallowing food since and have been limiting myself to soft & wet foods to avoid anything getting stuck.  I have never experienced food getting stuck in my esophagus until that date 08/25/2021, though I did have preexisting related issues with eating. It was like a switch flipped and suddenly I couldn't swallow normal food anymore. I received a phone call from the CDC today advising me to file this report in case it is related to the vaccine I received about a week prior to the start of this issue.
I broke out with shingles on the left side of my neck, along the left jawbone, behind and in my left ear.
Woke up next morning with huge red lump in arm. Size of palm of hand.  Hurts to touch. Headache, muscle aches, chills too.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "IIH" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Covid symptoms ended on Day 10; Positive, notes: On Day 14, new symptoms began again, and new positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID-19 treatment from 05Jul2022 to 09Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in the arm were received the injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. Post vaccination the patient experienced pain in the arm for about two months. The reporter did not consent to follow up.
Vax fog, joint pain, nasal congestion,  ear infection  right ear, cough, fever, red itchy painful bumps, sore throat
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 01Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "htn" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: COVID 19 Treatment with Paxlovid on 08Jun2022 to 13Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
12 days after booster, developed generalized widespread urticaria and redness over bilateral wrists, neck, face, and chest. On day 7 of adverse event and condition is still present and not improving despite steroid taper, daily allegra, and daily pepcid. Urticaria spreading to lower parts of the body now.  Similar to dermatographia.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa. No Medical History information was reported. On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 23-Sep-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This is a spontaneous case reported by a consumer, concerning a 42-year-old female patient with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19 approximately 2 months after receiving the second dose of mRNA-1273 Vaccine in the Covid 19 vaccination series. Patient previously received the 1 dose  of mRNA1273 vaccine on an unknown date. The patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose for Hidradenitis suppurativa, Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of Covid 19 was resolving. Ongoing Covid 19 pandemia and use of Adalimumab could be considered as confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case reported by a consumer, concerning a 42-year-old female patient with no medical history reported, who experienced the unexpected, non serious AESI event of COVID 19 approximately 2 months after receiving the second dose of mRNA-1273 Vaccine in the Covid 19 vaccination series. Patient previously received the 1 dose  of mRNA1273 vaccine on an unknown date. The patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose for Hidradenitis suppurativa, Details of risk factors, co morbidities, clinical course, concomitant medications and treatment details were not reported. The outcome of Covid 19 was resolving. Ongoing Covid 19 pandemia and use of Adalimumab could be considered as confounder to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Moderate pain elbow to shoulder. Slight pain elbow to wrist. No treatment at this time.
left shoulder with warm, red swollen bump around 2 inches in diameter, mildly tender to touch at our exam but markedly increased in the ER on the night prior. Patient had been Keflex in the ER
Severe erythema, swelling and urticaria at and around injection site, down to elbow. (RU extremity) 2 days post vaccination
Based on location in the upper extremity and needle size of 5/8" parent reported potential SQ administration
Baby screamed for over 3 hours, was told to monitor her breathing and keep an eye on her. 2 days later experienced what was later diagnosed as "muscle spasms".
10-12hrs after... 30min of aches and chills that subsided with Tylenol and nap  1 week later -  current: redness at injection site that is spreading and slightly feverish on spot
11/18/2016 runny nose, wheezing, coughing, fever. One week later ear infection RX-antibiotic, bronchiolitis, wheezing, breathing difficulty. Eczema RX-Creams. RX-Oral steroid with albuterol neb with steroid in neb. Lymphadenopathy neck and head. GERD, severe atopic dermatitis, yeast infections of skin neck and groin/bottom RX-Nystatin, kept returning. FAILURE TO THRIVE 12/15/16. Food/milk intolerance. Sent to multiple different asthma and allergy specialists. No answers. Multiple hypo-allergenic formulas no improvement. Sent to the Dermatology. Topical steroids used. Dermatologist admitted us immediately for severe eczema and very poor weight gain after treatments not improving condition on 1/31/16 - 2/3/16. Admitted again on 3/6/17 for the treatments given were not improving. MRSA Colonization positive during hospital stay. No diagnosis found.
Pt recvd 3 doses Hep B vax 2JAN91, 4FEB91, & 2JUL91 & on 4JUL91 pt noticed red, blotchy rash w/itching @ inject site; pt also noted a peculiar rush, burning-type sensation that went from inject site over the rash area; poss hypersensitive
Initial information received from a consumer (the patient) on October 2013. A patient (demographics unknown) had received a dose of FLUZONE, (batch number: UH926AA, dose number, route and site of administration not reported) on 03 October 2013 at 10 hours. The patient was not sick prior to the vaccination. On 04 October 2013 at 5:30 hours, the patient experienced headache, dizziness, vomiting, sweating when she stood up and had slight low back pain without fever. These symptoms lasted and were severe all day. The patient was concerned because the patient had received flu vaccine for over 10 years and have never had a reaction like this. Laboratory details and corrective treatments were not reported. At the time of this report, the outcome was unknown. Documents held by sender: None.
Five weeks after receiving the 2nd dose of the Pfizer COVID-19 Vaccine while on a business trip, I went to the hospital to be checked because I was having some digestive issues after arriving. At the hospital, the doctor measured my blood glucose and it measured more the 650mg/dL. I was immediately hospitalized and ended up in a coma and several near death situations. When I woke up ICU several days later, I was roughly 60% of my pre-hospitalization weight. The doctors informed me that had a perforated appendix and several large abscesses in my abdomen. The treatment required several surgical procedure sand two months of continuous anti-biotics to reduce the infections. Additionally, I was diagnosed as Type-1 diabetic despite no previous history of diabetes nor pre-diabeties. In total, I spent more than one week in the ICU, 44 days total in the hospital, and 9 weeks under Doctor care.
First day tired. No appetite. Sore arm. Day 2 injection site 4 inch diameter lump with redness, swelling, tenderness and heat. Massive headache equal to migraine in intensity and effects. Chills. Vomiting. Lethargic. Diarrhea. Shingles outbreak by end of second day. It's now the morning of Day 3 ... arm hasn't changed. Able to keep down crackers and water. Dying for a cup of coffee. Living on tylenol. Headache lurking. Taking medication for shingles. Slept for 14 hours.
Pt soon developed 2 wks of mod-severe pain at site of injection after injection. Area red and hot to touch per pt.
Abdominal cramping, vomiting, and later diarrhea for approx 1 week. After receiving the flu-mist. Pt states he felt it run down the back of his throat and he swallowed some. Follow up: "Seen on 12/15/03, abd soft/ increased bowel sounds.  Had complained he could taste the Flumist for a week in his throat."
Fever, chills dizziness, headaches the next day. Headaches daily until October 7th when I ended up in the emergency room with a Stroke.
Itchy Injection Site; Red 4" X 2" near Injection Site; Swollen Injection Site; Little Spot on the Left Arm First day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Little Spot on the Left Arm First day), VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red 4" X 2" near Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION (Little Spot on the Left Arm First day). On 13-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red 4" X 2" near Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site). On 12-Feb-2021, VACCINATION SITE REACTION (Little Spot on the Left Arm First day) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red 4" X 2" near Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included anti-itch lotion. concomitant medication was not provided.
Pain redness and swelling at injection site still spreading as of 2/3/2021, Headache, Nausea
This spontaneous report was received from an other referring to a 4 year old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 30-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Patient arrived for early flu vaccine, inadvertently administered Pediarix. No signs and symptoms, family to be notified today.
March 14 2021 - 2 days after first vaccine shot, leg pain, 1-3 days later diagnosed with superficial blood clot in left leg via ultrasound, treated with baby aspirin for 3 days and heat pad, symptoms slowly lessened till 2nd dose of vaccine on April 2nd, after second dose symptoms worsened again, both legs still fatigue very quickly to this day (April 15 2021) when I'm sitting down on chairs, seats etc.  April 8 2021, 12:30pm - heart pain for 30 minutes, felt very weak, similar to light heart attack, ER visit later that day couldn't find any explanation
My menstrual cycle has not happened.  I  am a week and a half late.  I am not pregnant.
Parotitis; Information has been received from a registered nurse concerning a child who on 09-Jun-2000 was vaccinated with the second dose of measles virus vaccine live (+) mumps virus vaccine ive (+) rubella virus vaccine live (second generation). On 13-Jun-2000 the patient developed parotiditis. The patient sought unspecified medical attention. Additional information has been requested.