chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of passed out in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was recovered/resolved. It was unknown if the reporter considered the passed out to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter was a friend of the patient. The reporter reported that the patient passed out after receiving a dose of SHINGRIX vaccine, which was a 2 part series. The patient would not receive the 2nd dose of SHINGRIX vaccine. The reporter provided limited information. The reporter disconnected call before further questions could be addressed regarding the adverse events of the patient. This case was linked with case US2018GSK136348, reported by the same reporter.
pt recvd vax & w/in 4hrs p/inj pt exp severe abd pain;tx heating pad;pain lasted 6-7hrs & subsided;
Woke up with red blotchy rash on arm near injection site. Did not hurt or itch but occasionally it will itch a little.  My shoulder would ache on and off.   The rash got larger the next day. I put aloe gel, calamine lotion, triple antibiotic cream , hydrocortisone cream and iced it.  Warm to the touch.  Very concerned about this.  No change.
first dose of Shingrix on September 20th 2020 and the second dose on June 3rd 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 44DX9, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 20th September 2020).   On 3rd June 2021, the patient received the 2nd dose of Shingrix. On 3rd June 2021, 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 details were provided as follows: The patient received 2nd dose, more than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
I can't smell but I can taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (I can't smell but I can taste) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L207) for COVID-19 vaccination.     The patient's past medical history included Hypertension and Seasonal allergy.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced ANOSMIA (I can't smell but I can taste). At the time of the report, ANOSMIA (I can't smell but I can taste) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported No treatment medications were reported.
Arm got really red and swollen. Developed a ball under the skin. Felt flu like symptoms 4 days after the shot and went to urgent care on day 5 because of flu symptoms/ body aches. Got a different antibiotic for my arm due to the infection but it would not get smaller. Went back and had the abcess from the shot drained. I am back at urgent care over 1 week later because there is still a smaller ball under my skin where the shot was administered
Acute disseminate encephalomyelitis symptoms. Pain behind eyes, dizziness, shooting pain in lower extremities, urinary retention, bowel impaction, numbness lower extremities, loss of hot/cold sensation in lower legs, muscular weakness in legs, double vision, duration 18 days, treatment: IVIG and ACYCLOVIR. 9/3/09-Clinic progress note of 1/16/09 seen for GI dysfunction, constipation. On-going leg spasms R>L during sleep. Light sensitivity.
I received the COVID vaccine on Monday Dec. 21, 2020 at 14:30.  By 17:00 I was not feeling well.  I was tired, had a headache, muscle aches, nausea and a fever of 101 F.   The headache, low grade fever and significant malaise continued through Tues Dec 22 and Wed Dec 23.   On Thursday morning Dec 24 at 2:30 AM, I woke from sleep with the urge to use the bathroom.   I suddenly felt light-headed and dizzy and had a diaphoresis that soaked my hair and PJs.   Fortunately my husband who is a nurse anesthetist helped me through the episode safely and was able to get me back to bed.   I am not sure if that event was related to the vaccine or if I happened to be a little dehydrated and had a vaso-vagal event.  I did not take any medications because I was allowing my body to have a natural response to the vaccine.
My COVID-19 infection symptoms started on 03/31/2023  in the afternoon.  I had fever, chills, vomiting , congestions, cough, diarrhea, and nausea. On 04/11/2023 I lost my  sense of smell  but, within the few days it came back. I did a home test on 04/02/2023  which was positive. I called my doctor's office on the following Monday and did a telehealth. He prescribe me Paxlovid ( 5 days),  Bromfed DM, and Ondansetron.  I also took Tylenol for fever. As  of now I  have congestions and lingering cough.  I tested negative on 04/10/2023.
Swollen arm; red; Itchy really bad; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itchy really bad) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20/2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itchy really bad). At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itchy really bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
cramps when moving the fingers; she began having left hand pain & cramps when moving the fingers; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps when moving the fingers) and VACCINATION SITE PAIN (she began having left hand pain & cramps when moving the fingers) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 013M2VA or 013M2UA and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced MUSCLE SPASMS (cramps when moving the fingers) and VACCINATION SITE PAIN (she began having left hand pain & cramps when moving the fingers). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (cramps when moving the fingers) and VACCINATION SITE PAIN (she began having left hand pain & cramps when moving the fingers) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
slight neuropathy; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a adult female patient who received Flu Seasonal TIV Quebec (FluLaval 2012-13 season) (batch number AFLLA733AA, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval 2012-13 season. On an unknown date, unknown after receiving FluLaval 2012-13 season, the patient experienced neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the neuropathy was unknown.   It was unknown if the reporter considered the neuropathy to be related to FluLaval 2012-13 season.  Additional details were provided as follows: Age at vaccination was not reported but it could be 53 years or 54 years. The patient experienced slight neuropathy after receiving the Flulaval in 2012. The batch number of FluLaval  was reported as ASLLA733AA was corrected to AFLLA733AA as per sales data sheet. The reporter did not consent to follow-up.
looked like pancreatitis; developed increased LFTs; This is a spontaneous report from a contactable physician (patient). A 53-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, saoluion ), via an unspecified route of administration on the left arm on 07Jan2021 at 08:00 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia and benign prostatic hyperplasia (BPH). The patient has no known drug allergy (NKDA) and no known food allergy (NKFA). Concomitant medications included duloxetine hydrochloride (CYMBALTA), acetylsalicylic acid (ASPIRIN 81), diphenhydramine hydrochloride (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]), multivitamins [vitamins NOS] (MULTIVITAMINS [VITAMINS NOS]). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number: eh9899, expiration date: unknown), at the age of 53 years old, on the left arm on 17Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed increased liver function tests (LFTs) that looked like pancreatitis on 08Jan2021 at 12:00. Treatment received for the adverse event include addition of PPI. The events resolved with sequel.   Information on the lot/batch number has been requested.
Caller said it has worsened into vertigo; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Feb2021 (Lot number: EN6200) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 24Feb2021, outcome "unknown", described as "dizziness"; VERTIGO (non-serious), outcome "unknown", described as "Caller said it has worsened into vertigo".  Additional Information: Patient never had medical history relevant to AE(s) personally or anyone in his family, Caller stated that the vertigo happens at various times. Several times a day. From the time he wakes up until he goes to sleep. Caller stated the same thing for the dizziness. The reason is calling is to get help and he has done research. And a lot of people get vertigo after getting the vaccine. Asked caller if he would like to complete an additional safety report on behalf of the people that he researched getting vertigo after the vaccine. Caller stated he does not want to file anymore reports that he wants to talk with someone about how he is having side effects and that something needs to be done.  No follow-up attempts are possible. No further information is expected.
Pt came in and got her 1st dose of Moderna from Health on 04/21/2021. Pt went to on 05/19/2021 and the staff there administered a Pfizer vaccine. Pt came to  Health to speak to her primary about it. I spoke with public health and  and there was a mistake made giving the patient the wrong vaccine.
Cough , wheezing breath 10 days Azithromycin 500 mg, Dexamehasone 4 mg. Followed by inhaler Breztri budesonide, glycopyrrolate and formoterol fumarate 28 puffs over 7 Days with no relief
Initial and follow-up information has been received from a health professional concerning a 19 year old female with no known allergies and a history of cervical intraepithelial neoplasia and loop electrosurgical excision procedures in May 2005, April 2006, and April 2007, who on 03-APR-2007 was vaccinated with the second dose of Gardasil (Lot #0212U). On  06-AUG-2007, the patient was vaccinated with the third dose of Gardasil (Lot #0212U). Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING). Prior to the third vaccination, the patient's method of birth control, ethinyl estradiol (+) etonogestrel had been discontinued and the patient was going to change to drospirenone (+) ethinyl estradiol (YAZ). The patient was instructed to take precautionary measures until that was started. On 04-SEP-2007, the patient was seen in the clinic and tested positive for pregnancy. An internal exam was performed and a urine pregnancy test was positive. An ultrasound showed that that fetus was less than five weeks. On 10-SEP-2007, a serum HCG was 4379. The patient's estimated was approximately 14-JUL-2007 (previously reported as 23-JUL-2007); estimated EDC 28-APR-2008. Follow-up information indicated that the patient had a spontaneous abortion (miscarriage) on 13-OCT-2007. Additional information has been requested.
After receiving Flu, Spikevax and Adacel vaccine, Patient felt light Headache and Sweating. Patient was asked to lay down on his back with elevated legs. Patient was feeling good within 5 mins.
Headache and stiff neck across my shoulders and couldn't turn my head. I developed a fever and cough 12 days after the shot 101-102 degrees. I was sent for Covid -19 test but the PCR test was negative. I was given an Augmentin and took Tylenol  and probiotics. I recovered and had no fever after three days but I still felt congested and I had a cough. I restarted my Methotrexate about the same time I recovered.
p/vax pt devel an inj site rxn characterized by an area of redness, warmth, pain & swelling measuring 3 inches in diameter;pt died of causes unrelated to vax;
Pt had a light red rash upper back of arm around injection site.  She said it was warm to touch and hard nodule under skin.  She came to the pharmacy on 5-26-16 and said it was looking much better and not as warm any longer.  I informed her if the redness spread, became more warm or looked worse to go to the doctor.  I also told her to put a cold pack or frozen veggies on the site to help with the warmth.
This spontaneous report as received from a medical assistant (healthcare worker) refers to a 18 year old male patient. On 12-NOV-2013 the patient was vaccinated with ZOSTAVAX, 0.5 ml, via subcutaneous route. Lot and expiry date was not reported. The patient was intended to receive his second dose of VARIVAX, was inadvertently administered ZOSTAVAX. No adverse effects reported. Additional information has been requested.
first dose on 2019, due to the pandemic, received dose 2 today; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number Z4427, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 03rd September 2019, batch number 249DB).   On 12th October 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Due to the pandemic, the patient did not return for 2nd dose of Shingrix and received vaccine on the date of reporting The reporter consented to follow up via email. No further details were provided via call.
Information has been received from a published article, title as stated above, from a physician concerning a 3 year old male (case patient 5) with acute lymphoblastic leukemia who was vaccinated with VARIVAX (Merck). This report was part of a post-marketing surveillance program describing the outbreak of varicella with likely breakthrough disease in a population of pediatric cancer patients receiving cancer treatment in a healthcare setting with an affiliated group housing facility. In October 2004, approximately 7 days after identification of the index subject, the subject presented with vesicular, crusted lesions on his scalp and shoulders. His lesions tested positive for VZV by fluorescent antibody test. The subject was exposed to varicella through the index subject who had been living in the same housing facility. Subsequently, the subject was admitted to the hospital and given acyclovir therapy. It was reported that the subject had documented VZV antibody titer prior to exposure, considering likely breakthrough disease (defined as varicella with onset at least 42 days after vaccination). The subject did not experience medical complications related to varicella. At this time, relationship of breakthrough varicella to study therapy is unknown. Results of the study revealed that in approximately 16 days, varicella had been detected in 7 children (the index case, 5 secondary cases and 1 tertiary case). Of the 7 identified cases, 4 appeared to be cases of breakthrough disease in previously vaccinated children. The outbreak resulted in the exposure of 82 families at a pediatric group housing facility, 28 children at the schoolroom and 77 patients, 150 family members, and 9 staff members at 3 outpatient clinics. The study highlights the important role that breakthrough varicella can play in healthcare centers with affiliated group housing. Formal recommendations on the management of exposed individuals who have been vaccinated should be made aware in such settings, especially if immunocompromised hosts are present. This article also discussed the experience of a 4-year old female, a female child and a 7-year old boy while on therapy with VARIVAX (Merck) (WAES # 0812USA00618, 0812USA01704 and 0812USA01705). This is one of several reports from the same source. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Soreness at the puncture site; slight fever lasting 1 hour; This is a spontaneous report from a contactable consumer (patient).   An unspecified age and gender of patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EW0161) via an unspecified route of administration on 14Apr2021 at 10:30 as a single dose for COVID-19 immunization. Past vaccination includes first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via unspecified route of administration on 24Mar2021 at 10:30 AM as a single dose for COVID-19 immunization and side effect was a throbbing of left arm for approx.24 hours. The patient medical history was not reported. Concomitant medication included arnica montana (ARNICA (PLANTA TOTA) "WELEDA") (MANUFACTURER UNKNOWN).  Patient chose to take Arnica on tues prior (with the ok from patient's primary care and RN at the vaccination clinic (withheld). On an unspecified date, that time, patient's symptoms were soreness at the puncture site (only when the patient accidentally touched) and a slight fever lasting 1 hour. On Friday, patient was feeling fine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 59 year-old female patient. On 24-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 Fahrenheit) for no more than 24 hours. The outcome was not reported.
This case was reported by a other health professional via sales rep and described the occurrence of dysesthesia in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced dysesthesia, purpura and pain. On an unknown date, the outcome of the dysesthesia, purpura and pain were unknown. It was unknown if the reporter considered the dysesthesia, purpura and pain to be related to SHINGRIX. Additional information was received as follows: The physician reported that the patient was seen today another physician and he diagnosed with purpuric, painful and dysesthesia. The reporter would like to know if the patient's physician needs to fill out a form documenting reaction regarding SHINGRIX. The reporter didn't received any information when he reached to reporter additional information.
Patient was given the incorrect vaccines, the provider was informed and the parent was informed. No reactions or adverse events were reported.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 19-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 828 hours with the lowest recorded temperature of -3 Celsius. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
No symptoms reported. Combo Vaccine was given to child of 2 years of age and recommended for ages 4-6 years of age.
Fever beginning the afternoon of the injection, spiked to over 101 degrees that evening. The second day fever varied up and down from a "normal" temperature to just under 100 degrees. No fever on day 3. Extreme arm soreness that lessened over time.
Information has been received from a Registered Nurse concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergies who in July 2008, was vaccinated with first dose of GARDASIL (Lot # not provided) 0.5 ml, intramuscularly and at the end of August 2008 the patient received second dose of GARDASIL (Lot # not provided) 0.5ml, intramuscularly. There was no concomitant medication. After 2 days the patient received first dose of GARDASIL she experienced mild nausea. The nausea resolved within 2 days without treatment. The patient experienced moderately severe nausea starting 2 days after receiving her second dose. The nausea lasted 4-5 days and resolved without requiring treatment. The patient did not experience vomiting. There were no Laboratory Diagnostic performed. The patient sought medical attention by phone. No further information is available.