chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, NDC number and Expiry date are not provided), via an unspecified route of administration on 09Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included a history of severe acid reflux it is all up in her throat, inflamed vocal cords and lots of mucous production from unspecified date, which she had both before and after receiving the vaccine. She states she is also dealing with her sinuses from unspecified date. The patient's concomitant medications were not reported. The patient previously took sulfa, Macrobid medications and experienced allergy on unspecified date. She is allergic to sulfur and Macrobid and the reaction to that is anaphylaxis on an unspecified date. The patient previously took sulfur and states that she has had a bad reaction from the sulfur that had her burning and swelling and the itching and anaphylaxis on an unspecified date. The patient previously took Macrobid (clarithromycin, NDC number and Expiry date are not provided) and she had Burning, swelling, itching, flushed, and anaphylaxis to Macrobid on an unspecified date. She wanted to know if that would cause her to have a reaction to the vaccine? Stated it is not a good reaction such as feeling flushed, burning and itching all over and a rash. She clarified that she did not have a reaction to the first COVID-19 Vaccine. She had these reactions before to the sulfur and Macrobid. She states that the events mentioned above did not come from the vaccine. She states that she already had these symptoms before she took the first vaccine. She is already on medication for that stuff for the allergies, severe acid reflux, and the inflamed mucus in her vocals. She states that before she has the second one, she wanted to know if those medications are in the second vaccine? On an unspecified date in 2021, the patient experienced headache after the first dose of the vaccine. The reporter was calling about the Pfizer COVID-19 Vaccine. She wants to find out information about the vaccine. She states she took the first vaccine. She wants to know if it's safe for her to get the second dose of the vaccine with her ongoing symptoms. She asked, Would the second vaccine cause any problems, or would she have any serious reaction from the second shot due to the fact that she already has these symptoms? The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Student reported "being sick, sleepy, dizzy, nauseated, headache" after receiving influenza vaccine on 12/13/13. Symptoms began, per student, in the afternoon after receiving the immunization. Lasted "until Sunday 12/15/13".
Information has been received from a nurse practitioner concerning a "10 1/2 year old" female patient, who on 19-NOV-2007 was vaccinated with a dose of VARIVAX (Merck) (route, dose and Lot # not reported) in her right arm and a dose of GARDASIL (route, dose and Lot # not reported) in her left arm. The nurse stated that she did not find out it until 18-NOV-2010 when the patient was at a doctor's appointment. The nurse stated that on 19-NOV-2007 (also reported as 21-NOV-2010), once the patient was given both the GARDASIL and VARIVAX (Merck) vaccinations, the patient had developed swelling and blisters and went to the emergency room. The patient was treated for cellulitis at the hospital and discharged on an antihistamine and BACTRIM. At the time of the report, the patient had recovered. Follow up information has been received via telephone call from a Licensed Practical Nurse concerning the female patient. He stated that the patient was not admitted to the hospital and that the event was not emergent but the Emergency Room (ER) was the easiest place for the patient to get to at that time. There were no serious criteria reported to him by the nurse practitioner. The patient or her mother had not even report the event to the doctor's office. The only way they found out was that the patient was seen at a recent well visit and they told the nurse at that time. The cellulitis was diagnosed in the left arm in which GARDASIL (Lot# not reported) was given. It was reported that the patient will receive not the second dose of GARDASIL. He stated that the nurse was asking about the patient perhaps now receiving a dose of CERVARIX. Additional information has been requested.
Left deltoid hypersensitivity reaction (Arthus reaction) Treatment observation, antihistamine
This vaccine was used BUD.  However, parent  did not report any adverse reaction  from the vaccine.
This non-serious unpublished literature report was received by the company on 25 September 2011 from a physician. The following is from the report: Background: Individuals with HIV infection have decreased responses to influenza vaccine. Current guidelines for HIV infected adults recommend the use of a 15 mcg dose of the trivalent flu vaccine. There is no information about the immunogenicity of higher doses of this vaccine in HIV infected adults. Methods: A randomized, double blinded study comparing the immunogenicity of FLUZONE SD (15 mcg) versus FLUZONE High-Dose (60 mcg) was conducted in HIV infected adults attending a single clinic. Antibody titers were measured using hemagglutination-inhibition assay against the H1N1, H3N2 and flu B/Brisbane/60/2008. Results: Total participants were 195, and 190 completed the 3-week follow-up visit (93 FLUZONE SD, 97 FLUZONE HD). Seventy-one percent were male, and 68% were of a certain race. Median age was 45 years of age (range was 20-78 years of age). Eighty-nine percent of them on HAART, with a median current CD4 of 452 (IQR 293-629) cells/mm^3, and a nadir CD4 of 180 (IGR 53-318) cells/mm. The HIV RNA viral load was less than 400 copies/mL in 90% and less than 200 copies/mL in 89% of the subjects receiving treatment. Approximately half of the patients had protective titers at baseline. By week 3, a higher percentage of individuals receiving FLUZONE HD had protective HAI titers (H1N1 97% vs 88%, H3N2 96% vs 92% and FluB 92 vs 80%). Both vaccines were well tolerated, with 165 adverse events (77 FLUZONE SD vs 88 FLUZONE HD, p=NS). Grade 1 myalgia (19%), malaise (14%), local pain (10%), local tenderness (10%) and headache (9%) were the most frequent adverse events. There were no serious adverse events. Conclusions: HIV infected patients reached higher levels of protection when vaccinated with single dose FLUZONE HD vs standard dose trivalent vaccine. High dose antigen vaccines may be used when vaccinating individuals with HIV infection against seasonal flu. Documents held by sender: None.
Swelling in axillary lymph node. Swelling was noticed next evening after vaccine give. Swollen lymph node is on same side vaccine was given. Lymph node is tender to the touch an approximately the size of a large, firm grape.
Have a lump in my arm from the shot; Have a small bump in my arm we're I got the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Have a lump in my arm from the shot) and VACCINATION SITE MASS (Have a small bump in my arm we're I got the shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (Have a lump in my arm from the shot) and VACCINATION SITE MASS (Have a small bump in my arm we're I got the shot). At the time of the report, SKIN MASS (Have a lump in my arm from the shot) and VACCINATION SITE MASS (Have a small bump in my arm we're I got the shot) outcome was unknown.            No concomitant medications were reported Treatment medications were  not reported.
minimal change disease; Nephrotic syndrome; kidney disease; tubular damage to her kidneys; This is a spontaneous report received from a contactable consumer and from a Pfizer-sponsored program. A 70-year-old female consumer received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced minimal change disease, nephrotic syndrome, kidney disease/"tubular damage" to her kidneys in 2021.  The patient received her 2nd Pfizer vaccine dose on 28Jan21. She was then hospitalized for 12 days. Her diagnosis was minimal change disease/ Nephrotic syndrome/ kidney disease. She has had tubular damage to her kidneys. Reporter is asking if there is any information/data on this particular side effect, how often has this happened to other people. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 in 03/2023 while on vacation on a cruise.  I went to the clinic on the boat.  I had coughing, weeing, fatigue and I lost the since of taste. This time it's taking longer to feel better. I also tested positive for COVID-19 in 09/2022 while out-of-state.
Rash two days after vaccines. Observed in creases of elbows and knees. No fever.
Varicella - Information has been received from a registered nurse concerning a 4 year old mael patient who on 19 May 1997 was vaccinated with a first dose of varicella virus vaccine live sc in the right thigh.  On 20 mar 2000 the patient developed chicken pox.  The reporter stated that the child developed chicken pox on his face and ears but does not have a fever or malaise.  The physican office has not yet seen the child follow up information from a registered nurse indicated that the patient subsequently recovered.  Follow up information from a registered nurse indicated the the patient had no further work up or visit.
Information has been received from a nurse concerning a female who was vaccinated with a dose of GARDASIL injection, and subsequently experienced a strong feeling of depression. The patient's outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
woke for nap screaming; mom checked pt found staring, drooling; pt taken to ER; ? post ictal;
Not been able to get her second vaccine due to Covid 19; Influenza A/flu; fever; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of influenza a virus infection in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 5th March 2020, between 3 and 5 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza a virus infection, fever and diarrhea. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the influenza a virus infection, fever, diarrhea and social problem were unknown.   It was unknown if the reporter considered the influenza a virus infection, fever and diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient came down with Influenza A. The patient experienced fever and diarrhea and tested positive for the flu but was negative for Covid 19. The patient had not been able to get her 2nd vaccine due to Covid 19.  The patient was now scheduled to receive her second shingrix vaccine day after the date of reporting. The reporter did not consent to follow-up.
Vesicles noted, then pustules scabbed over, on face, 2 papules with erythema on hand.
Arm pain; Pain is mostly with movement; Pain is through the upper left arm and into the shoulder; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Arm pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Pain is mostly with movement) and ARTHRALGIA (Pain is through the upper left arm and into the shoulder) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029l20a and 012m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Pain is mostly with movement) and ARTHRALGIA (Pain is through the upper left arm and into the shoulder). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm pain), VACCINATION SITE MOVEMENT IMPAIRMENT (Pain is mostly with movement) and ARTHRALGIA (Pain is through the upper left arm and into the shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-033893 (Patient Link).
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and TRIGLYCERIDES.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was given Sleeping Pill as concomitant medication.   This case was linked to MOD-2021-079363 (Patient Link).
Injection site, upper left arm: swollen, sore, reddened, pain in movement. General: chills, fever (up to 101.6), fatigue. Symptoms began within 6 hrs of receiving the vaccine on 07/23/2018. Symptoms continued until 07/28/2018. Symptoms were held in check with ibuprofen until symptoms subsided 07/28/2018. Contacted prescribing doctor via online practice portal, doctor phoned in prescription for antibiotics, in case the symptoms were as a result of cellulitis.
Pain in her body, more so on the left side where she had the injection; Nerves running down the side on left and right hand; Bad headache; every night her entire left side of body feels like all bones are cracking, like she has two different bodies; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date was not reported) on 06Jan2021 and second dose on 27Jan2021 both via an unspecified route of administration, both as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started experiencing pain in her body, more so on the left side where she had the injection, nerves running down the side on left and right hand, bad headache and entire left side of body feels like all bones are cracking, like she has two different bodies. The bad headache went away. The outcome of the bad headache was recovered and was unknown for the rest of the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
4/26 mom called as vomiting/diarrhea on off since vaccinations.  Started on CULTURELLE 1/2 daily, PEDIALYTE x12 hrs advance slowly.  No fever and good urine output.
Hives, itching, swelling, non stop, and continues today (11/4/2018) day 5. 20 mg Dexamethasone PO 11/1/2018 AM. 20 mg Dexamethasone PO 11/2/2018 Late night. Daily: taking BENADRYL, ZANTAC, and started ZYRTEC BID 11/3/2018. Nothing is helping with hives except for 24 hours after steroid.
got the flu anyway; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 03-Dec-2020.  This case involves an unidentifiable patient who got the flu anyway (influenza) while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient got the flu anyway (influenza) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
not adverse. just recieved additional Bi-Valent moderna,  last Bi-valent was 10/21/22.
Became almost stuck in mental lapse.  Seizure activity.  Blank stare.  Lip twitching.  Body stiff.  Lasted approximately 1-2 minutes.  Stopped breathing or it was so light undetectable.  Skin would turn grey.  Once it was over his head would be burning up and sweating as well as body.  Would become very tired.  We had EEG done approximately 1 month after onset which didn't show anything (Dr said this happens a lot even if seizures are present).  No course of treatment at this time as no more seizures after a run of approx 20 in 10 days and discontinuation of vaccines.
Breakthrough case admission after 5 vaccines Pfizer 3/10/21 Lot# EN6199;  Pfizer 3/31/20 Lot# Er8733;  Pfizer 10/26/21 Lot# 301258A;  Pfizer 6/13/22 Lot# FP7135;  Pfizer 9/22/22 Lot# GH9703
On May 21/2021 I got my first dose of Moderna. My adverse event started the next day 05/22/2021 When I woke up with irritation on both of my eyes. As the day went by around my eyes rashes formed. It was itching and sore. I went to the urgent care, they prescribed me with steroids for 6 days. Then I went to my primary care doctor for an evaluation he said that many people got this kind of reaction after Moderna. He has seen a lot of cases. He recommended that I should go to an allergist and the allergist told me that I should not get Moderna for dose 2 and told me to get Johnson & Johnson. The adverse event last around 6 months after my first does of Moderna.
Within 2 hours of the shot, my right deltoid began to hurt. About 1900, I began to have chills. My fever started about 2030, and when I checked my temp at 2300, it was 100.5F temporally. My fever broke about 0100 today, but chills continued for another hour. Between 0200-0500, I was able to get some sleep but tossed and turned due to lower chest discomfort. I woke up about 0515 with bilateral lower chest (under my breasts and stopped at the bottom of my ribs) pain and some shortness of breath but attributed it to my continued muscle weakness and fatigue. But by 0600, it became painful to lay down in any position. I noticed when I would stand up, after a few minutes, the chest pain would subside and my shortness of breath would ease. I experienced some sweating with the episodes of chest pain and anxiousness. My heart rate stayed in the upper 60s - lower 70s, which is normal for me. I took 400mg of Ibuprofen about 0600 and considered going to the hospital to be checked out, but decided against it. I was able to sit down on the couch about 0730 without having chest pain or discomfort. And by 0800, I was able to lay down on the couch with just my head raised and sleep. It is now almost 1200 and I do not currently have any shortness of breath or chest pains.
Pt with macular rash on trunk - antihistamine - steroid injection  40mg DEPOMEDROL - 2mg DECADRON IM
Initial report received from nurse on 16 Feb 2010: This patient received one dose of Sanofi H1N1 vaccine on 28 Nov 2009. He inadvertently received a second dose of FLUVIRIN, 0.5 ml, on 28 Jan 2010. No adverse events were noted after administration of both vaccines.
Having severe pain in my left shoulder. I can't even lift my arm or use my arm at all. I already took 625 mg TYLENOL and an anti-inflammatory.
Polymyalgia rheumatica; Numbness; This case was reported by a consumer and described the occurrence of polymyalgia rheumatica in a 7-decade-old female 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 polymyalgia rheumatica (serious criteria GSK medically significant) and numbness. On an unknown date, the outcome of the polymyalgia rheumatica and numbness were unknown.   It was unknown if the reporter considered the polymyalgia rheumatica and numbness to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: The case was reported by the patient's friend who was the epidemiologist. The reporter did not consent to follow up.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient had rash/swelling below the injection area. Itchy and red, but not hot to the touch.  She has tried using benadryl which has helped.  Rash has not gotten worse or better since it showed up.
On February 16th, 2021 and March 16th, 2021 I received my two Moderna Covid-19 vaccinations. After receiving those vaccinations I started to rapidly lose weight, to the tune of almost 10 pounds per month. I was shedding weight so rapidly and without appropriate cause that my wife and I began to become concerned. I was having daily nausea and vomiting and just could not get an appetite to save my life. I contacted your offices and requested a GI work up, which is still technically incomplete as of right now, but also completely inconclusive at this time. As of now my entire GI work up has been negative, pending an upper endoscopy. Literally the only thing in my life that changed at the time that I started to shed the weight was the fact that I received the Moderna Covid-19 vaccination. A vaccine that was still under EUA and had no viable information on its long term effects on a human being
2/1/20 14:24 Influenza vaccine given left deltoid, pneumonia vaccine given right deltoid. 2/2/20 17:24 Hep A vaccine given right deltoid.  2/3/20 in the A.M. on doctors rounds (9-11am usually) it was noted that pt had 10cm area left deltoid that was reddish, warm, with erythema.  Afebrile. Dx was infection of the skin. Keflex 250mg po qid x 20 doses ordered along with cold compressed & elevate as tolerated.  2/4/20 on MD rounds the nurse practitioner noted infection significantly improved, continue with Keflex. Encouraged to f/u outpatient if infection gets worse.  Pt discharged routinely.
stomach bug; This is a spontaneous report from a Pfizer-sponsored program, COVAX US Support. A contactable consumer reported a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after receiving the vaccine, the patient got sick with a "stomach bug". The outcome of the reported event was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow-up.