chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; HCP called to report administration of MMR II reconstituted with MENACTRA vaccine instead of MRK STERILE DILUENT; HCP called to report administration of MMR II reconstituted with MENACTRA vaccine instead of MRK STERILE DILUENT; This spontaneous report was received from a pharmacist and refers to an 11-year-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-AUG-2022, the patient was vaccinated with measles, mumps, and rubella virus vaccine, live (M-M-R II)0.5 ml, frequency reported as once (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis. The measles, mumps, and rubella virus vaccine, live (M-M-R II) vaccine was reconstituted with meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) vaccine (strength, dosage regimen, lot #, expiry date,  and route of administration were not provided) as prophylaxis, instead of sterile diluent (Vaccine incorrect diluent used, wrong drug administered). No adverse event was reported.
Fatigue, fever, chills, joint pain. Day 2 post vaccine October 15, I woke up with left under arm pain and swelling. Tylenol and Ibuprofen (ibuprofen 6hrs at least after injection) helped with the fever, chills, and joint pain. Those resolved by end of post vaccine day 1.  Left under arm pain and swelling entire second day. This did not happen with the first or second doses.
Passed Quickly; Severe Dizziness; very weak; Arm Hurt; Chills; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date not reported) via an unspecified route of administration on an unspecified date (at 49-years of age) for Covid-19 immunization. Patients medical history and concomitant medications were not reported. She had an allergic reaction to CAT scan contrast dye in the past. It was reported that after the first dose of the vaccine, within several minutes, she felt dizzy and it passed quickly. 4-5 hours later patient got severe dizziness and her family had to walk her to her bed. She was very weak and very dizzy so she laid down. She was dizzy in the morning and then was only mildly dizzy for a number of days. She also had chills and her arm hurt. She stated she saw dizziness at the bottom of the sheet as a more serious reaction and wanted to know if she should get the next dose of the vaccine? Patient also stated she heard that one dose of the vaccine is over 80% effective. No PQC was present. It was reported that patient did a report. Patient was guided to read form PI section 4. Read from Fact sheet under "WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE?" regarding the description of serious allergic reactions. Referred to HCP for further discussion. PI: LAB-1457-7.0/ Revised: 06Apr2021 Fact sheet: LAB-1451-4.0/ Revised: 06Apr2021. The patient has a question if she is still considered vaccinated with just one dose? Is it 80% effective? Patient was asked to read from attached document. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1:00  received Vaccine 4:00   ate  meal 7:00    vomited 3 times in succession                felt better with NO other symptoms Slept for 10 hours
This case was reported by a consumer via call center representative and described the occurrence of paralysis legs in a 69-year-old female patient who received SHINGRIX. On 16th March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced paralysis legs (serious criteria GSK medically significant), chills, mobility decreased and fever. On an unknown date, the outcome of the paralysis legs, chills, mobility decreased and fever were recovered/resolved. The reporter considered the paralysis legs, chills, mobility decreased and fever to be related to SHINGRIX. Additional details were provided as follows: The reporter was friend of patient. The reporter called to report side effects for his wife as well as friend of them, who also had a side effect. The chills described as extreme. Six hours after chills, the patient could not move her limbs.
diarrhea; feeling unwell; weakness; sickness; stomach pain; throat irritation; nauseated; she can't catch her breath/ difficulty breathing and shortness of breath; joint pain; muscle pain; feels tired; feels like her whole body was shutting down/ felt awful; dizziness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 03Feb2021 for COVID-19 immunisation and had no side effects. On 24Feb2021, the patient received the second dose of the vaccine and stated that she was still feeling unwell from the vaccine. The patient mentioned that she was experiencing weakness, sickness and feels like her whole body was shutting down on an unspecified date. The patient was also having stomach pain, throat irritation and diarrhea. The patient went to the ER last friday (05Mar2021) and went to the doctor on 09Mar2021. The patient was given pain medicine, nausea medicine and two antibiotics. The patient then inquired on how long does the side effects usually last and if there was anything that she could do. The patient then stated that she was having all the side effects and had been to the ER and to the doctor. Sometimes on unspecified dates, she can't catch her breath. She was having joint pain, muscle pain, and felt tired. The patient stated that she didn't feel like this until she got the second vaccine and now, she felt like everything fell apart. The patient went to the emergency room and they didn't do anything for her. She felt nauseated, had dizziness, weakness, difficulty breathing and shortness of breath. The patient had been trying to do all she can, she was just so weak. The patient then inquired if there was anything that can get rid of the side effects, how long they will last and if she will be normal again. The patient was not getting any better and felt awful. The patient then stated that they do anything for her in the ER and added that she only saw the nurses and not the doctor. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
On the evening of the eighth day after the vaccine was administered, I noticed that my arm was feeling sore and stiff around the injection site. Upon looking in the mirror, I saw that the skin surrounding that site was red, roughly two inches in diameter. Using the internet, I did see that this was a possible side effect of the Moderna vaccine. Waking up on the ninth day, my arm is still sore and stiff around the site and slightly down my arm. The redness around the vaccination site has not seemed to grow. the conditions are the same on the afternoon of the ninth day.
4 and 1/2 hours or so after the bivalent booster in my right arm, I experienced tingly numbness in my right wrist and upper left portion of my right hand. The tingliness was topical. That right side of my wrist is sore as well. I experienced tingly numbness up the right tendon portion of my neck from my collarbone up, and through the skin of my jaw and into my right side of my chin and bottom lip, right side. This numbness or tingliness was all very topical, almost as if I was coming out of numbing from the dentist office, but it was strictly limited to my skin/topical areas. It came and went as well. Currently at 10:12pm CT, it has eased off somewhat, so hopefully it will subside.
I started my symptoms on October 26, 2022 I experienced cough, phlegm; I wasn't prescribed any medications at the time of my Dr. visit.
Redness, Very sore arm, slight fever (< 101) - saw Dr on Demand due to concerns about return to work in the COVID era - Dr said typical symptoms and prescribed ibuprofen for as needed use. Dr also recommended "icing" on the local reaction.
tight muscles; Temperature; Headache; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 14Jan2021 (Lot number: EL3248) at the age of 64 years as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOPHEN taken for analgesic therapy, start date: 05Feb2021, stop date: 06Feb2021; L-THYROXINE [LEVOTHYROXINE SODIUM], start date: 1978 (ongoing); OMEPRAZOLE (ongoing); PROPANOLOL HYDROCHLORIDE (ongoing); LISINOPRIL/HCTZ (ongoing); SIMVASTATIN +PHARMA (ongoing). The following information was reported: MUSCLE TIGHTNESS (non-serious), outcome "unknown", described as "tight muscles"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Temperature"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  No follow-up attempts are possible. No further information is expected.
The pt experienced excruciating pain for 4 days, severe pain for 50 days, mild pain and burning for 8 days and still occurring.
2nd dose 11 months after 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 03-OCT-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received his/her 2nd dose of Shingrix 11 months after the first. The patient asked as about the revaccination. Additional Supportive Information: The patient received 2nd dose of Shingrix 11 months after the first, which led to lengthening of vaccination schedule. The follow up would not possible as no contact details were available.
I have gotten every single Moderna vaccine, plus one Pfizer booster (in past) and the most current Pfizer updated Covid-19 vaccine. I got the vaccine in my left arm, flu shot in right, after waiting a week post-RSV vaccine in left arm. About 3.5 days post, my tongue blistered up in one place and became painful. Another small blister formed on the left side of my tongue. I took diphenhydramine (2) and went to bed that night. When I woke up, my tongue was covered in these blisters, and several were moderately painful. My throat also felt sore. I swished Listerine in my mouth for a good long while, and these eased the discomfort. Now, 7 hours post-waking, some of the blistering is subsiding, but the original larger blister on my tongue is still uncomfortable. I have not contacted my doctor, hoping this will settle down on its own. I decided to contact you after reading Chun, et al. on the NIH website.
Rapid heart beat- on -going continuing up to now- Feb. 13.  Varies- Mostly at night- during night. Higher blood pressure than normal. Diarrhea- frequent need to go. Gas. Nightmares. Trouble sleeping. Called doctor- did not go in. Took extra ativan and blood pressure meds. Will see doctor next week
on 4/2/2021 I had blood work and my white blood cell count was over1100.  My oncologist did more blood work and a cat scan since I'm in remission from late-stage cancer.  Dr. suspected the vaccine was the cause of the high white blood cell count.
Allergic reactions; A spontaneous report was received from pharmacist concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine and experienced allergic reactions.   The patient's medical history included two reported allergic reactions. Concomitant product use was unknown by the reporter.    On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: A25L20A) for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced allergic reactions. Treatment information was unknown.   Action taken with mRNA-1273 in response to the event was unknown.   The event outcome for the event allergic reactions was unknown.   The reporter did not provide an assessment for the event allergic reactions.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time, however a causal relationship cannot be excluded.  Further information has been requested.
I had Kenalog shot 80 milligrams, Toradol, I had it 1sep2021, I had the same shots before and had no problems and this time it didn't work. I had it in Jul and Dec2020. I saw my doctor on 1 sep2021.
Small red welt at actual injection site. Starting there and then traveling below that is hot, red, very hard circular welt. In the middle of that is a cluster of small, wheepy blisters. The red area takes up most of her upper arm area. It's approximately 4-5 inches in diameter. She has never had a vaccine reaction. She's had no fever, no other symptoms aside from a sore, itchy arm.
7P started feeling bad, 7:30P blurred vision. 11/13 had trouble sleeping & 7A found cluster of 3 knots behind rt ear. 12N knots larger, had ridge from rt ear up to head-pain. 3P went to ER and given Keflex & pain med. 11/14 am, knot behind
cold; Sneezing; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold) and SNEEZING (Sneezing) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced NASOPHARYNGITIS (cold) and SNEEZING (Sneezing). At the time of the report, NASOPHARYNGITIS (cold) and SNEEZING (Sneezing) outcome was unknown. Not Provided          No concomitant medications were reported.  Treatment information was not provided.
Severe widespread joint pain including sudden tears in both knees' meniscuses leaving me unable to function normally the past 5 weeks, constant headache, sudden dizzy spells, lightheadedness, fatigue, sense of impending doom, severe anxiety, feeling of breathlessness or not getting enough oxygen, inability to soundly sleep
10/9/12 - 10AM headache and myalgia -> Rx with OTC pain med. 10/12/12 - Vertiginous, fevers, headache - bedrest and OTC nausea meds and TYLENOL. 10/14/12 - Erythema multiforme involving skin; (R) buccal cavity.
Pt recv vax on 12/14/98; on 12/16/98 pt exp LA knot, sore, warm, red, inflamed; tx=cool compress, Ibuprofen/Acetaminophen
This solicited report was received from a 44 year old female patient enrolled in a Market Research Program. The patient's concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date, the patient received pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (also reported as flu shot). Dose, route, lot #, expiration date and anatomical location were not reported. It was reported that after vaccination the patient had an allergic reaction. The patient stated she did not feel comfortable due to the allergic reaction with that last vaccination. The outcome of the event was unknown. At the time of reporting, the causality assessment between the event and the suspect therapy was not reported. Additional information is not expected as the reporter did not consent for further follow up.
Left arm at injection site, red and tender with appearance of cellulitis. Prescribed cephalexin 500mg X 10 days and Benadryl. Follow-up visit on 4/1/00 shows area slightly larger and more tender, no abscess noted. Instructed to return PRN.
Patient's mother reports that he went to sleep about 5 minutes after vaccines were given. When he woke up she noticed that his drooling has increased and that he now has "jerks" and "shaking all over". Reports he has done this 1-2 times a day since receiving vaccines on 1-29-2019.
I received the shot at 11:00 am May 6th, by 1:35 pm I was in full respiratory arrest.  Spent two days in ICU where a blood clot was found in my lung.  Followed up with PCP and suggested I NOT take second dose.
First fatigue, starting five hours post-shot. Then 11 hours post-shot, incredible chills lasting until around hour 23. Achey joints until hour 23-24. Malaise. Mild nausea lasting through hour 32.  Sore arm.
intrauterine Growth Retardation; cyanotic; drug exposure in utero; Initial information received on 13 November 2019 regarding a solicited valid serious case received from a consumer/non-hcp, in the scope of post-marketing sponsored study.  Patient ID: unknown;   This case is linked to case 2019SA318338 (Mother).  This case involves a male patient who had intrauterine growth retardation (Foetal growth restriction) and was cyanotic (Cyanosis) after birth, whose mother received FLUZONE QIV vaccine and received Benzyl Alcohol. The mother's age at the time of report was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant therapy included Benzyl Alcohol.  On an unknown date, the patient's mother received a dose of suspect FLUZONE QIV lot number not reported via unknown route. It was case of drug exposure in utero. On unknown date, the patient developed a serious event of intrauterine growth retardation (Before Birth) (foetal growth restriction), following administration of FLUZONE QIV to patient's mother. It was reported that the patient's mother stated that she went to 39 weeks and 1 day and then physician inducted her because the fetus was having intrauterine Growth Retardation (IUGR).  On unknown date, the patient developed a serious event of cyanotic (cyanosis) (After birth) following the administration of FLUZONE QIV to patient's mother.  The baby was born healthy an Apgar of 09, approximately 1 hour lately when the baby was attempting to breastfeed, he turned cyanotic and had to be watched in the nursery for the next 48 hours. The HCP attributed the cyanotic episode to an allergy to Benzyl alcohol. At the time f report the child in now 3 years old and seems to be doing well.  As per company, based IME list both the event considers as medically significant.  Final diagnosis was cyanotic, intrauterine growth retardation and drug exposure in utero. The Lab data not reported. It was not reported if the patient received a corrective treatment. The event outcome of intrauterine growth retardation and cyanotic was not reported. Relationship to investigational product according to reporter: not reported, The HCP attributed the cyanotic episode to an allergy to Benzyl alcohol. The child in now 3 and seems to be doing well. Relationship to investigational product according to company: reportable.; Sender's Comments: A neonate of adult female, who received a dose of study product during pregnancy, was diagnosed with intrauterine growth retardation and cyanotic. Which occurred after mother received a dose of study vaccine. Company causality taken as reportable for reporting purpose. The event cyanosis was assessed as related to Benzyl alcohol allergy. Additional information on IUGR and past medical history, previous pregnancies, family history, concomitant medications is require to assess company causality for IUGR.
thyroid storm cancer; lose her hearing, eyesight; lose her hearing; lost her appetite; gained over 75 pounds in 7 months; hair falling out; eye lashes gone; tongue got thick; would get lost; fatigue; constantly thirsty; depression; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included allergic to all antibiotics including penicillin. Concomitant medications were unknown. The patient stated "Even the brochures do not tell you how often to get it." The patient stated she was allergic to all antibiotics. She told them and they would write a prescription with penicillin or other things she was allergic to. She would take it to the pharmacy and they caught the mistake. Suddenly, she lost her appetite, gained over 75 pounds in 7 months, hair falling out, eye lashes gone, tongue got thick, would get lost, fatigue, she was constantly thirsty. She would lose her hearing, eyesight, potty on herself. She got depression. Finally figured out that she had thyroid storm cancer. Outcome of all events was unknown.   Information on the batch/lot number has been requested.
Two incidences of cold induced uticaria with symptoms of sever pruritis and sensation of skin prickling for 30minutes after being outside.  First incident on 1/22/2021 after an hour long hike over bilateral thighs.  Lasted 20minutes.  Associated with dermatographia.  Second incident on 1/29/21 with walking to mailbox without socks.  Cold induced hives appeared over b/l ankles.  same symptoms, but resolved after 15min.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (Sleepiness) in a 78-year-old female patient 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 PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (Sleepiness). At the time of the report, PAIN IN EXTREMITY (sore arm) and SOMNOLENCE (Sleepiness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-015824.
I had a breakthrough case of Covid started getting migraines and had a lingering cough as well.
Redness, swelling, itching on day 8. Warm to the touch. Today is day 10. Swelling is down, itching is less.
Vaccine was administered on 11/1/16. Pt states onset of symptoms of left arm tender was 11/2/16. Pt seen at health center today 11/3/16 for redness, swelling, tenderness and warm on left upper arm. Injection site WNL. S/S below injection site on left upper arm. Pt seen in office and placed on KEFLEX antibiotic with care instructions.
Modern a COVID-19 Vaccine. Swelling in the right eye lid. Muscle pain. Headache. Injection site throbbing in pain. Labored breathing (with burning discomfort). Fatigued.
Sweating, temp, hives on left arm, very sore and tender. Took Benadryl for pain as needed. Went to Urgent care given a Z-pac.
Severe Meniere's episode including vertigo, intense vomiting, diarrhea for several hours.  Normally when I have an episode it will go away after several hours and about 12 - 18 hours of sleep and does not return for at least a month or more.  However, this episode was followed by 3 days repeating the above.  Since the episodes have stopped I stay in an intense brain fog and the feeling that I must be very careful so as not to trigger another episode.  I have read reports from a Meniere's Disease support group that I am part of and there are many others that have experienced this same result after their second dose of the Pfizer or the Moderna vaccine.