chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions in a clinic. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future  The outcome of the event of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Vaccine error: Higher dose of COVID vaccine (Orange Pfizer COVID vaccine for age 5-11yo) was given to a 2yo patient at approximately 13:50 on 7/6/23 during well child visit with PCP.  During monitoring period of >15 min post-vaccination, child was playful in the room and overall well appearing. Notified parent/guardian of administration error. Per CDC guidance, recommended that patient continue vaccination series as scheduled with appropriate age-based dose (Maroon Pfizer COVID vaccine for 6mo-4yo) with next dose in 3 weeks.  However, may deviate/delay from recommended schedule should patient experience prolonged side effects or adverse reactions from high dose received today.  Parent/guardian verbalized understanding.
Dose came from a vial that was more than 30 days on the fridge; Dose came from a vial that was more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose came from a vial that was more than 30 days on the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose came from a vial that was more than 30 days on the fridge) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021 at 1:18 PM, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Dose came from a vial that was more than 30 days on the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose came from a vial that was more than 30 days on the fridge). On 21-Sep-2021, PRODUCT STORAGE ERROR (Dose came from a vial that was more than 30 days on the fridge) and EXPIRED PRODUCT ADMINISTERED (Dose came from a vial that was more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drug details were provided.   This case was linked to MOD-2021-326226, MOD-2021-326432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow-up received included :Patient demographics updated(Race & Ethnicity).
This was very first flu vaccination recieved. Caused Bad vertigo, Nausea, Low-grade fever, Trembling, Anxiety.  These symptoms have persisted to this present day (1/4/2012). 12/21/2011 went to urgent care suspecting inner ear infection, they saw nothing wrong. 12/30/2011 went to ear/nose/throat specialist, said patient's immune system was over-reacting to the flu shot, come back in two weeks if symptome persist. 1/2/2012 went to emergency room.  Did bloodwork and CAT scan...all results came back normal, referred back to ear/nose/throat specialists.
Patient said he had red warm patch around injection site and it went kind of down his arm until elbow. He didn't notice it until someone told him on about the 5th day (Thursday) when they noticed his arm was red and warm to the touch. He said initially shot was sore for about 6 days but pain went away. Red patch also went away, it wasn't sore, and there wasn't any rash (at least he didn't notice any). Patient only came in today (11-11-2018) to report it. That would be about 2 weeks later since the shot. Today his arm was clear and not sore. He did not let his doctor know because it (pain and redness) all went away. He didn't take anything for the pain or the redness on arm.
Itching and flushing of upper chest noted 30 minutes after flu vaccine. Within 1 hour of vaccine had red, raised rash on chest, back of neck. Saw nurse practitioner in work area and NP told her to take CLARITIN. Itching resolved in 30 minutes. Following morning rash resolved.
Swollen, tingling, slightly numb tongue 20 mins after injection; tingling and numbness disappeared by morning but swollen sensation lasted until 2 days post injection.  Slight fever/feeling warm and flush beginning 2 hours after injection and carrying over into morning after injection.  Extreme lethargy and feeling as if dehydrated evening of injection and still present as of today (4 days post injection).  Dizziness present when turning head too quickly in certain direction (left/right, up/down); present first day post injection lasting through until 3 days post injection.  Slightly swollen and sore left arm at site of injection; swelling disappeared by first day post injection but soreness still present until 3 days post injection.  Diarrhea beginning morning after injection and still present as of today (day 4 post injection). Sore throat began 2 days post injection and was accompanied with major sinus pressure and sensation of ears being pressurized; sore throat disappeared day 3 post injection but was replaced with dry cough that is still present as of today (4 days post injection)
Hospitalized for abdominal pain and fevers in a type 1 diabetic with pancreas transplant and immunosuppressive therapy
Diffuse papular/macular erythematous rash and fever X 2days.
Extreme chapped lips. Started out very dry, tight, red, and sore. Then they were very dry around the outside of the lips and the center of the lips that touch was sticky. When you smile, you feel as if your lips are going to split.  This has lasted for two months and is still continuing. I am using a steroid cream twice a day on my lips. Using a combination of coconut oil and lavender essential oil in between to keep my lips soft. This has helped but it seems as if it gets worse if I stop treatment.
Patient was given full dose of moderna 0.5mg instead of booster dose of 0.25mg. No adverse reaction or side effects noted during observation time of 15 minutes.
Pt was given his first anthrax vaccine on 14 Mar 07. He stated he noticed a red rash on his back across his shoulder the next morning. Slight itching, with redness. No treatment was done. Pt was going to take OTC Benadryl and OTC cortisone cream if the itching got worse.
Case number PHEH2016US029318, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 25 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX QUADRIVALENT at 52F for 1 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 26 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Large hematoma at injection site with axilla pain and pain in location of brachial artery from day 1. Persistent fatigue and headache. At day 14 (today) experiencing piercing nerve pain and mild swelling in L hand (thumb mainly).
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 07-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.  ; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX. On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st May 2018, less than an hour after receiving SHINGRIX, the patient experienced pain in arm. On 2nd May 2018, the patient experienced headache. On an unknown date, the outcome of the pain in arm and headache were not recovered/not resolved. The reporter considered the pain in arm and headache to be related to SHINGRIX. Additional information was received as follows: The patient did not have any concomitant medications. The reporter stated that she got a dose of SHINGRIX, the day before the reporting date in left arm. The patient was expected to have the soreness, which she got within an hour of the shot. But in morning, on the day of reporting (1 day after vaccination), the patient woke up with a terrible headache and added she didn't get headaches usually. The patient was provided the information from the prescribing information and referred to her physician.
high temp off & on, taken to hosp w/high temp;given shot, allowed to go home, went to hosp, not nl, returned to hosp 7.5wk, no dx;MD states brain damage, cannot walk, crawl, sit up, talk or feed self;
died after 4hours of receiving it; This is a spontaneous report from a Pfizer sponsored program received from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter mentioned that a family member (the patient) who received the Pfizer Covid-19 vaccine died after 4hours of receiving it. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died after 4hours of receiving it
Second Dose was given early  on day 13 ,instead of the 21 day interval,  The vaccine was administered before confirmation was established the date of the first dose Parent notified and to keep patient under observation and seek medical help as needed
Upper Respiratory Infection and GERD attack.  Recovered from upper respiratory infection but still recovering from GERD attack
No adverse reactions reported after receiving inadvertently the adult formulation as the second dose, as patient had received the pediatric formulation as the first dose.
awoke in AM (day p/shot) w/face swollen & rash on face-itching;went to ER-given DPH & anti-itch med took for several days;rash still present;2MAY96 swelling is down;
Information has been received concerning a 19 year old female who on 07-NOV-2007 was vaccinated intramuscularly with the first dose of 0.5mL of Gardasil (lot # reported as "12660"). Concomitant therapy included duloxetine hydrochloride (CYMBALTA) and topiramate (TOPAMAX). On 09-NOV-2007 the patient experienced redness at the injection site, swelling at the injection site and nausea. The patient received the Menactra several weeks ago and had the same reaction. Additional information has been requested.
Stomach 'pain' and hypersensitivity to area under both breasts.  Gradually the hypersensitivity went to the waist area.  Many pain killers and nerve drugs used which didn't help.  I used Ibuprofen with some relief.  Pain level ~2-3 usually and would lead to nausea if irritant didn't stop.
02-26-2021  I woke up at 3:30 am and had dizziness, then woke up at 8 am and had dizziness, headache, fatigued, very  sore and swelling  at injection site,  loss of appetite, body aches, later afternoon I developed chills, extreme fatigue, worsening headache, all over body aches that hurt to the touch. could not sleep during the night and 02-27-2021 I had horrible teeth pain and body aches that were horrible,  headache and chills subsided but the sweats started slept all day with all other symptoms mentioned. on 02-28-2020 most symptoms subsided except loss of appetite, extreme fatigue and then I ate a little bit and within 30 minutes I had a normal BM and then diarrhea started and happened a few times throughout the day after I would try and eat a little something. Today 03/01/2021 I am still fatigued, have another headache and no appetite and feel just kinda yucky.
High fever with rash, was dazed/unresponsive during fever (no seizure activity) but improved with treatment of fever.
I had my first dose of the Moderna vaccine in my left arm on Feb. 17, 2021. On Feb. 25, 2021, my left arm was itching, and I noticed a red, round spot at the site of the injection, about 2-3" in diameter, warm and firm to the touch. An online search found that this has happened to others and called it "COVID arm" and suggested taking an antihistamine for the itching, which I did for two days. The itching was much better and, over the next week, the redness started to fade; but it's now two weeks post injection and the redness, although faded, is still there and seems to be moving down the arm. There is some itching from time to time, but not nearly as intense as it was the first time. I have no underlying conditions and have had no other side effects that I'm aware of.
Redness of skin, especially on face; itching of head and arms; some swelling in feet; This is a spontaneous report from a contactable nurse (patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EH9899), intramuscular at arm left on 21Dec2020 at 12:30 at a single dose for COVID-19 immunization. The patient received COVID-19 vaccine in a hospital facility. The patient has allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient is receiving unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 at 01:00 PM, the patient experienced redness of skin, especially on face, itching of head and arms, some swelling in feet. The patient received Benadryl 50 mg PO as treatment. The outcome of the events was recovering.
triggered something in her body to cause an autoimmune disease; terrible itchy rash/it is on my arms and legs and extremely itchy; rash on her shin, calf and ankle and arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AUTOIMMUNE DISORDER (triggered something in her body to cause an autoimmune disease) in a 48-year-old female 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (triggered something in her body to cause an autoimmune disease) (seriousness criterion medically significant), RASH PRURITIC (terrible itchy rash/it is on my arms and legs and extremely itchy) and RASH (rash on her shin, calf and ankle and arm). At the time of the report, AUTOIMMUNE DISORDER (triggered something in her body to cause an autoimmune disease), RASH PRURITIC (terrible itchy rash/it is on my arms and legs and extremely itchy) and RASH (rash on her shin, calf and ankle and arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment included for the events were antihistamine which did not help and topical steroid which helped a little bit for the event rash. The patient had been to a general practitioner, an allergist and a dermatologist and she was having an appointment with a demonologist to follow up.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Initial_Additional1 Follow-up received: updated patient details, added new event and reporter details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
How did shot yesterday. Woke up this morning with pain to the injection site but no visible remarks or swelling.  I do have a swollen lymph node to my left armpit. With pain. I also have pain to my left inguinal lymph node I only have pain there upon palpation It is curious to note that this is on the same side of the injection site
Patient was very nervous about getting the covid vaccine. She sat for 15 minutes and after about 8 minutes she said she thought she was having a panic attack and felt hot. Tech administered vaccine and sat with her the whole wait time since she was nervous. Held an ice pack on her neck when she stated she felt hot. The 15 minute timer went off and she still felt nervous so she continued to sit. Rph also was present once the ice pack was given.  She had a dry heave at about 12 minutes. After 20 minutes we moved her to the floor she said she was seeing light flashes.  She was sweaty and hot. BP was taken at 420pm 162/109 and 98 pulse. Asked pt if we could call an ambulance, she felt she didn't need one. We got lead from Division 1, also suggested an ambulance and this time pt said ok.  Now BP taken was 157/109 and pulse 108.  Patient felt a dry heave and we put her on her side.  Ambulance arrived and put pt on a stretcher.
fever (100-102 F) 12/6-12/9, then developed rash on body 12/10
headaches, body aching pretty much all over, high fever,chills,shivering,cold,nausea,, loss of appetite,diarrhea,very week,disn?t care about anything, could barely move, uncontrollable loud with moaning fast heavy breathing  all onset approzimately 7.75 hrs after the injection and sum lasted for very approximately five hours, some lasted very approximately 14.75 hours abd some lasted very approximately 18.75 hours
Menstrual cycle began a month after covid vaccine and has not stopped since vaccine.  Flow has never stopped completely.  On September 7, 2021, I began flowing severely heavy with many large blood clots and has lasted for 3 full days with no slowing to date. I visited Doctor M and she did an exam of my cervix and uterus and removed another large clot. Also did a biopsy of uterus cells. She prescribed 2.5mg of Premarin 4 times a day for 7 days to stop the bleeding with no slowing of flow after a 6 doses of medication.
Right after the vaccine administration the patient started to feel dizzy. He placed his head down on his mother's arms to rest. Patient's mother revealed after vaccination that he had experienced this before after received a prior vaccination. Patient was alert and oriented the entire time. At no time did he ever lose consciousness. There were no other signs and symptoms that would indicate an allergy. He did not require any medical interventions. He kept reclined for about 15 minutes with his mom and family, while his dizziness improved. After about 15 minutes he felt better and he and his family left feeling better.
Hives inside [her] forearm; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown, via an unspecified route of administration on 06Feb2021 as a single dose for COVID-19 immunization.  The patient had the first dose of BNT162B2 as COVID-19 immunisation on unspecified date, and lot number.  Medical history and concomitant medication were not reported.  On 06Feb2021 the patient experienced hives on opposite arm of injection arm.  She said she had not realized up until 1 hour after the injection that she had "hives inside [her] forearm". She added the hives got "more and more and are spreading from the interior of [her] forearm to her elbow, shoulder blade, and the tip of [her] finger".  Treatment included Benadryl for two days and "it doesn't help" and therefore, she stopped taking.  It's been 9 days now. It is still spreading.  The outcome of hives was not recovered.  Information on the lot/batch number has been requested.
Son unable to walk about 30 minutes after vaccination (after removing from car seat), extremely irritability and crying with fever. Injection site red with a huge knot. All symptoms persisted for 3 days approximately, including the inability to walk. I would put him down to get him to stand and he would cry. Attempted to give MOTRIN for fever and pain. Little relief but still marked fussiness, pain tender to palpation and refusing to walk.