chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient became diaphoretic, "felt funny", pupils dilated, says she felt like she was going to "black out", left arm "numb and tingly", pale
About 2 weeks after the shot, I started to have a Psoriasis flareup on both of my legs.  mainly on the inside of the thigh and down onto the front of the shins.  The flareup is still occurring 3 months later.
patient experienced bleeding and a alteration in her menstrual cycle within the same month the vaccine was administered. The caller stated that the mentioned stated that the patient's friend experienced similar reactions to the first dose; patient experienced bleeding and a alteration in her menstrual cycle within the same month the vaccine was administered. The caller stated that the mentioned stated that the patient's friend experienced similar reactions to the first dose; This spontaneous report was received from a consumer, referring to her daughter's friend, a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.      On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot/batch # and expiration date were not reported) for prophylaxis.       On an unknown date, the patient experienced bleeding and an alteration in her menstrual cycle within the same month the vaccine was administered. The outcome of the events was unknown.      The causality assessment between the events and the suspect vaccine was not provided.  Upon internal review, the event of bleeding was considered to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA009246:
A report was received from a health professional on 1/30/02 regarding an 18 year old male patient who experienced nodules on legs and bottom of feet after receiving a Fluvirin vaccine on 11/20/01. The patient had a previous flu vaccine in 2000. On 11/20/01 the patient received a Fluvirin vaccine and on 11/27/01 the patient experienced severe pain in both legs and feet, he also started to have painful nodules on legs and bottom of feet. The patient was admitted to hospital where he remained for four days. The patient was treated with Diazepam, Prednisolone and Paracetamol. Hepatitis B and Meningitis vaccines were given approximately 2 weeks after the event. It is not known if the patient had recovered at the time of reporting the event. There was insufficient information to determine the reporter's causality assessment.
Firm, swollen, tender, itchy around the injection site. Did not begin having this system until one week after the injection. It seems it is ?COVID arm.? Other than that, I have had no symptoms besides a sore arm the day after the injection.
Initial unsolicited report received from a nurse via other company representative (Pfizer) on 17 August 2016. Manufacturer Report Number: 2016384510 This case involves a 18-year-old female patient who was vaccinated with a dose of MENACTRA and with an injection of dose of TRUMENBA (batch number: M68769) expiry date, dose, dose in series, route and site of administration were not reported) intramuscularly on 25 July 2016 around 09:30 AM. The patient's medical history and Concomitant medications were not reported. On 25 July 2016, around 13:30 hours, same day 04 hours following the vaccination, the patient's legs felt like jelly, she was nauseated and was unable to drive. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
joint pain, burning sensation on clavical and feet, breast sensitivity,  swollen lymph nodes under arm and neck(same side as injection) some breathing issues
Generalized rash over head, neck and both arms with pruritis. Treatment: Adrenaline 0.15ml subcutaneous dose 1.
no adverse effects; a 6 month old patient received the first dose of ROTATEQ; This spontaneous report was received from a licensed practical nurse and refers to a 6 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 09-MAY-2019 (in the age of 6 months), the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, lot # and expiration date were not reported) for prophylaxis (it was considered as inappropriate schedule of vaccine administered). No adverse effects were reported.
Information has been received from a licensed practical nurse concerning a male patient with asthma and a allergy to DEMEROL who on approximately 15-JUN-2007 "within the last two weeks", was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included ADVAIR. On approximately 15-JUN-2007, the patient developed itching all over the body. Unspecified medical attention was sought. The patient was given ZYRTEC 10 mg twice a day with resolution of symptoms. No laboratory diagnostics studies were performed. Follow up information indicated that the PNEUMOVAX 23 was not administered by this office. No product quality complaint was involved. Additional information is not expected.
Patient reported feeling swelling in her tongue and itchiness in her throat. No rash, shortness of breath, noticeable swelling.  Administered oral diphenhydramine 50mg and monitored 30 min. Patient reported feeling drowsy, but that symptoms had lessened significantly. Patient was driven home.
Mild headache  Informed patient to monitor self, hydration, rest, and inform medical services if new sxs other than fever, chills, HA, fatigue experienced. Advised patient to go to ER if develops CP, SOB, generalized rash. Advise patient to contact medical services if side effect prolong and not resolve with OTC meds.
1st dose 29Oct2022, no 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who did not receive HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose (batch number 2KE55 and expiry date 22nd September 2023) on 9th October 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after not receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 29Oct2022, no 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-APR-2023 The vaccine administration facility was same as primary reporter. The details was reported for 1st dose. The reporter consented to follow up via email. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
fever of 102 p/vax instructed parent to alternate Motrin & APAP & call if any changes in sx;fever cont
Patients mother took patient to ER 2 days after vaccine administration.  Patient was diagnosed with Cellulitis and given Keflex.  Skin to right arm slightly swollen and discolored today.
3PM fussy; 7PM warm to touch-(3rd dose of APAP given); 8PM t103 R; seen by MD; pt broke out w/red blotches on stomach & rt arm;
Sore arm for 1 week starting immediately after vaccine./ Nausea and exhaustion on second day lasting approximately 24 hours./ No treatment except sleeping extra for exhaustion.
This spontaneous report has been received from a license practical nurse concerning a 13 year old patient (gender unknown) who was vaccinated on 13-AUG-2014 with a dose of GARDASIL (Lot # J006850, exp. date 31-MAR-2016) (dose and route not specified). It was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
A non-serious, spontaneous report of four-year-old asthmatic received FLUMIST two weeks after flushot was received from a registered Pharmacist concerning a four-year-old of unknown gender. The patient's medical history included asthma and twin birth. The patient had received a flu shot two weeks before FLUMIST vaccination. On 28-Oct-2010, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
immediate injection site (LUE) pain with administration; 5 minutes status post injection, new onset LUE numbness, light headedness, bilateral hand tremors, nausea; numbness from injection site to anticubital (LUE) x45 minutes with decreasing light headedness; status post 45 minutes, continued numbness at injection site; other adverse symptoms resolved
Inection site redness; Injection site feverish; muscle soreness; This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th October 2019, less than a day after receiving Shingrix, the patient experienced muscle soreness. On 1st November 2019, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the muscle soreness was resolved with sequelae and the outcome of the injection site erythema and injection site warmth were recovering/resolving.   It was unknown if the reporter considered the muscle soreness, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient experienced muscle soreness on the day of the injection. The patient had the site became red and feverish to the touch in an area about the size of a fist. The reporter stated that it was growing and down to his elbow.
Day of vaccination - red around site. Next day - swelling from above injection site down to elbow. Swollen, warm, red, itchy, hard. Has used warm and cool compresses. As of 11/10/14 - improving but still red and swollen.
5 hours after initial dose mild fever 99.4, and a headache. Headache lasted 2 days. 3 days later a hives rash developed on my thighs. on the 4th day after vaccine I still have the hives.
Case number PHEH2014US024949, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 99 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 13 Nov 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursion lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
Severe itchiness at the site, entire upper swollen with large soft ball sized raised hive and bruising
Violently vomiting, severe stomach cramping, fever, rash on upper arm where vaccine was administered.
Patient reported itching, swelling, and redness at injection site the evening of receiving the vaccine and still there 2 days later.
On December 13, about 12 days after receiving the Moderna booster I woke up with the back of my scalp super itchy. The next few days it was spreading everywhere. After about a week and a half of it being super uncomfortable and my ears getting hot and red, it turned more to just being able to write on my skin. Anytime I touch anywhere my skin will turn red. I?ve been taking zyrtec everyday and it doesn?t seem to really help. I went to the doctor and they didn?t really know why this happened or if it was from the booster but I?ve never been allergic to anything and had not eaten or done any daily tasks differently.
Swollen , painful lymph nodes with reddening at node location. Body aches. Raised heart rate. Headache. Muscle pain.  Injection site rash.
This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 18-MAR-2016, the patient was vaccinated with a dose of MMR II (lot # L032181, expiration date: 25-AUG-2017, dose and route were not reported), that was improperly stored (temperature and time frame were unknown at the time of reporting). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient had syncope and a headache. Patient threw-up. We asked him to lie on the floor and put his feet up on the chair. After 15 minutes, he was okay and returned to normal.
4-16-13- Tdap and MMR Vaccine- Lt. delt. area 4-21-13- c/o itching, swollen at inj. site. red patches and feels hot.- no pain.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   Unable to get hold of patient to inform him of adverse event.
Information has been received from a doctor of pharmacy concerning a 70 year old female patient with no medical history and no drug reactions/allergies, who on 28-OCT-2010 was vaccinated with a dose of influenza vaccine (manufacturer unspecified) and in the morning of 12-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665924/0930Z) IM. Pharmacist reported that by the afternoon on 12-NOV-2010 the patient experienced a dull, achy pain in her right arm. In the morning of 15-NOV-2010 she was still experiencing this pain. She said ibuprofen had not helped. There were no Lab diagnostics/studies performed. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Follow up information was received from a nurse of physician's office indicating that this patient was not a patient who had received any medical care at this physician's office. Additional information has been requested.
Shot allegedly given to high on arm,. Patient currently has had pain since shot for 5 weeks
Mild pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: PAIN (non-serious), outcome "recovered", described as "Mild pain". Therapeutic measures were not taken as a result of pain. Additional information: The patient reported that he got mild pain for 2 to 3 days and went away on an unspecified date but has returned (reported as reversed) after 13-14 days (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was administered a third dose of the Shingrix vaccine. Per records, patient had previously received her first dose on 2/9/23 and her second dose on 5/11/23.
Chills; Rash in upper extremity; fever; Body aches; This case was reported by a nurse and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 7447A, expiry date 25th April 2020) for prophylaxis.   The patient's past medical history included allergic rhinitis. Concurrent medical conditions included drug allergy (allergy to cefotan).   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th June 2019, 1 days after receiving Shingrix, the patient experienced chills, red rash, fever and general body pain. On an unknown date, the outcome of the chills, red rash, fever and general body pain were recovered/resolved.   The reporter considered the chills, red rash, fever and general body pain to be probably related to Shingrix.  Additional information received were as follows: The patient experienced red rash to her upper arm associated with chills, fever and body ache. The events were self resolved in 3 days.
I am a T1D of 46 years duration, on a Medtronic insulin pump. Since receiving my 2nd dose of the vaccine 4 days ago, my blood sugars have gone high and stayed high, regardless of the amount of insulin I take. I have basically stopped eating, because it causes my bg to rise into the 400 - 500mg/dl range, even when bolusing 2 0r 3 times the amount I regularly take with meals. My last A1C, taken less than a week ago was 6.8, so I am normally well-controlled.
within 1/2 hour of shot, had chest tightness, generalized weakness, soreness/achey in neck, shoulders, back. Fullness feeling in neck and under eyes. lightheadedness, overall weakness when I arrived home. went directly to er, treated with Benadryl and observed. STILL have same symptoms and had to spend money for er, doctor, massage
2 cm area of erythema and induration of both thighs at site of vaccine. Rx: TYLENOL 80 mg po Q6 hrs prn pain/fever.
WEAKNESS; CHILLS (COULDN'T STOP SHAKING); FEVER (DELIRIOUS); HEADACHE; RED CHEEKS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced red cheeks. On 11-MAR-2021, the subject experienced fever (delirious). On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021 21:00, the subject experienced chills (couldn't stop shaking). On 12-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills (couldn't stop shaking), and headache, was recovering from fever (delirious), and had not recovered from weakness, and red cheeks. This report was non-serious.
Patient received Covid vaccine BUD. Vaccine expired on 7/7/22 and was given to pt on 7/9/22
This spontaneous report was received from a nurse and refers to a 12 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, reported as when the patient was 11 years old, the patient was vaccinated with a dose of GARDASIL intramuscularly (dose, route of administration, lot# and expiration date were not reported). On 13-NOV-2015, when the patient was 12 years old, the patient was vaccinated with GARDASIL 9 intramuscularly, lot # L028083, expiration date 03-JUL-2017 (dose and route of administration were not reported). No adverse effect was reported. Additional information has been requested.
Warm, red welt at injection site on right arm. On 10/11, 10/12 2 days post injection, using BENADRYL cream. Resolved by 10-16-12.
Fever on 17-19th. Spots on face/chest afternoon of 1/20. Spots all over him Fri, 21st. Blisters on lips noticed Fri am 1/21. On rest of body as well began Saturday early am. Took to urgent care on Saturday 130pm, confirmed as chicken pox. Still has chickenpox, most have scabbed. A few blisters remain.
Employee administered Fluzone "high dose" Quadrivalent flu vaccine by 11-7 Supervisor on 10/5/21. Employee under 65years of age. Currently, doesn't report any adverse reactions.
Upon administration, hurt more upon initial injection than previous. Site has continued to be extremely sore, resolved some, but now has become worse. When rotates arm has shooting pain down upper arm. Popping started 9/17.
rash, from her butt down to the back part of her legs; headaches; body aches; fever; bad migraines; itching; This is a spontaneous report from a contactable nurse (reported for herself). A female patient of an unspecified age (age: 33; Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included preexisting condition: lupus. The patient's concomitant medications were not reported. The patient reported that on Friday she received her first dose and just now this morning (25Jan2021), she woke up with a rash, from her butt down to the back part of her legs. This morning it was bad, warts. She worked at a dialysis center and they gave her Benadryl, and Benadryl cream. She wanted to make sure because she had a preexisting condition: lupus. They had the patient wait for 30 minutes after the vaccine. The patient had bad headaches, body aches, fever, bad migraines and this itching had been incredible on 22Jan2021. Caller wanted to know if there was any information regarding this and what to do about the second dose. The events were non-serious per the reporter. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Profuse itching to hands on 6/6 which moved to feet on 6/10, moving to entire body on 6/11. Seen by primary MD  on 6/21 who previously ordered labs  on 6/17 all WNL, prescribed Zyrtec. Positive for dermatographia.  Referred to dermatologist. Saw dermatologist on 6/29. Positive for dermatographia. Switched to Allegra one tab daily, but can take 2 if no relief. Started 2 Allegra on 6/30. Continue with medication to date. Updated MD office today. No changes to treatment as of yet. I?ve never had dermatographia or any other chronic skin condition.
administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose) on 26-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE (Second dose) on 27-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) 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 information was reported.  It was reported that, on 06-Jan-2022 the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.