chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with shingles; diagnosed with shingles / actually had shingles on my back in my early 30s; mild teeth pain on right side; mild ear pain on right side; This is a spontaneous report from a non-contactable consumer or other non hcp (patient himself). A male patient of an unspecified age (reported as age 63) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 19Mar2021 as first dose, single for COVID-19 immunisation. Medical history included ongoing HIV test positive (reported as for 30 plus years), varicella (reported as I did have chicken pox as a kid), and ongoing herpes zoster (reported as I actually had shingles on my back in my early 30s).  The patient's concomitant medications were not reported. On 21Mar2021, patient felt some swelling in right cheek and neck and stuffiness in his ear. Over the next two days, patient had some mild tingling on right side of face and red marks that appeared. On 25Mar2021, patient went to urgent care and was diagnosed with shingles. Patient then reported that the tingling had disappeared, and just had some mild teeth pain on right side and mild ear pain on right side. Patient felt much improved and noted that the red marks were scabbing. Patient felt fine and noted just little bit of scabs and little irritation in ear and teeth. Patient went back to his doctor on 29Mar2021 and doctor said he was getting the right treatment. Doctor told him the reactions didn't seem like it was related to the vaccine but the timing was close. Patient reported his next schedule of vaccine was on 09Apr2021 and called to check if there was any concern. He reported that he would like to get the vaccine. The patient underwent lab tests and procedures which included HIV test: positive on an unspecified date. Patient went to urgent care and received valacyclovir (manufacturer unknown) 1 mg 3 tabs for 7 days (reported as first dose on 25Mar2021 and last dose tonight) as a result of shingles. The outcome of all events reported was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
10/20/21 low grade fever 99.1, fatigue, mild headache, arm pain and general feeling of not feeling well. 10/21/21 low grade fever 99.5, fatigue, lymph node swelling and pain in axillary to breast area of injection arm and general feeling of not feeling well.  No reaction other than fatigue with the first 2 doses.
Information has been received from a physician concerning a female who on an unknown date was vaccinated with a dose of GARDASIL. Subsequently the patient experienced hair loss. The outcome of the event was not reported. Additional information has been requested.
Information has been received from a physician concerning a 12-month-old female with no pre-existing allergies, birth defects, or medical conditions who on 25-MAR-2006 (also reported as 10-APR-2006) was vaccinated SC in the right leg with a first dose of MMR II (Lot # 649515/0937P). Concomitant therapy that day included a first dose of Varivax (Lot # 652518/1021R) administered SC in the left leg. On 11-APR-2006, the day after vaccination, the patient presented to the physician's office with bruising. A CBC showed low platelets. She was noted to have developed idiopathic thrombocytopenic purpura (ITP) and was hospitalized. The patient was given IGG intravenously. After administration of IGG, her platelets went from 5000 to 68000 to 130000. The patient was discharged on 14-APR-2006, and was noted to be followed by a hematologist weekly. The outcome was recovered on 14-APR-2006. There was no product quality complaint. Follow up information received from a physician indicated that on 10-APR-2006, the patient was noted to have multiple bruises on her extremities and back. Blood work was done and the platelet count was extremely low (5000). The patient was admitted to the hospital and received IV IGG under a hematologist's care. The platelet count improved. The patient was discharged to home after 2 days. Weekly platelet counts will be obtained. The reporter indicated that the event was considered to be an other important medical event. Additional information is expected.
Pt presented with symptoms of pain, one-sided redness, blister and excruciating pain. Pt admitted to the ER, diagnosed with shingles.
Shaking chills for over 12 hours then diminished then came back 2 hours later for another 5 hours. Began 9 hours after injection. Rash on both forearms within 4 hours. Headache and body aches same time as chills.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # reported as L003220 exp date 30-JUL-2016) (dose and route not reported). This is one of several reports received from the same source. Additional information has been requested.
Fever, chills, severe headache and fatigue. It was exhausting opening my eyes.   Even after two weeks I would try to convince myself to pull over  in my truck and take a nap!  I am still extremely tired.  My  Heart was pounding, throbbing in ?my ears?.  I could hear it so loudly . 2weeks of brain fog ? could not stay on task (due to dehydration?)  I still can?t drink enough water and Gatorade to satisfy my thirst. Extreme Weakness, Nausea , especially when I would try to eat .  Increased thirst/ urination .  My ankles and feet swelled .  My friend who is a pharmacist instructed me to take a Tylenol but I couldn?t even get out of bed to get one to take.  ? any movement made my head swim and I felt like I would throw up.  I slept most of that day and also the next day
Tachycardia, shortness of breath, lightheaded and dizziness with nausea.  Symptoms started 2 days post first vaccine.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 28-AUG-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
The first menstrual cycle after the Covid vaccine was abnormally early and very heavy and abnormal.    I have never had a heavy period and it has always regular.  I actually bled through my pants at school and had to shower and change my clothes 3 times through the night and in all the years I have had a period, this has never happened to me.
This spontaneous report was received from a healthcare worker regarding two patients of unknown age and gender. There was no information on patients pertinent medical history and drug reactions or allergies. The healthcare worker reported that on 13-MAY-2015, the two patients were vaccinated with improperly stored MMR II, .5 milliliter (ml), subcutaneous (product lot#, expiry date not reported). No adverse experiences reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Information has been received from a nurse practitioner through a pregnancy registry for GARDASIL, concerning a 20-year-old female, with prior history of pregnancy and delivery, who on 31-JUL-2008 received a dose of 0.5 ml GARDASIL (lot # 660557/0072X) via intramuscular route in her deltoid area. Concomitant medication included birth control pill YAZ. It was reported that the patient was pregnant now. She had urine pregnancy test; her last menstrual period was on 12-JUL-2008. Estimated delivery date was 18-APR-2009. The patient sought medical attention at the office. At the time of reporting, no adverse symptom was reported. Follow-up information has been received from a completed questionnaire. The patient had positive PPD skin test as concurrent condition and a history of 1 previous pregnancy with full term delivery. There was neither birth defect nor infant complications in the previous pregnancy. Ultrasounds for pregnancy were performed on 02-OCT-2008 and 11-DEC-2008 with results "12 inch /7 w" and 22" inch/ 17 w", respectively. The patient was on iron TID per day and prenatal vitamins once per day during her pregnancy. On 04-APR-2009, 39 weeks (reported as "2 weeks") from LMP, the patient delivered a normal female infant weighing 7 pounds 8 ounces, with 19.5 inch in length and Apgar score 9/9. The infant had sacral dimple. There were no complications, infections or illnesses during her pregnancy, labor/delivery. The infant had no complications or abnormalities. Upon internal review, sacral dimple was considered to be an event of congenital anomalies. Additional information is not expected.
well child exam 9SEP97 pt recv vax 22SEP97 seen w/petechiae bruises;
Didn't feel good; little bit of diarrhea; arm was very, very sore from injection; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel good), DIARRHOEA (little bit of diarrhea) and VACCINATION SITE PAIN (arm was very, very sore from injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to beef ) and Food allergy (Allergic to pork).    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced MALAISE (Didn't feel good), DIARRHOEA (little bit of diarrhea) and VACCINATION SITE PAIN (arm was very, very sore from injection). At the time of the report, MALAISE (Didn't feel good), DIARRHOEA (little bit of diarrhea) and VACCINATION SITE PAIN (arm was very, very sore from injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Body temperature: low (Low) low-grade temperature.         No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-384221 (Patient Link).
Moderna COVID-19 Vaccine EUA  1/21- arm dark red in color at injection site 1/21-1/23 nausea, diarrhea, headache, redness worsens, arm painful/hot/swollen 1/24-1/26 symptoms seem to have improved 1/26 night- nausea returns, loss of appetite 1/27 am- rash on arm which looks like wheels or bullseyes starting at injection site and spreading down to mid-forearm, benadryl taken, improved, returned again later, benadryl taken again with improvement... feels feverish, very pale, flushed cheeks, body aches, no temp 1/27-1/29- loss of appetite, intermittent chills/body aches, arm redness waxes and wanes, still warm to touch 1/30 night- 101 oral temp, night sweats 1/31- low grade temp in afternoon, arm improved in color, still warm to touch, virtual health visit with MD and in person immediate care visit
Pt. states that after receiving the 2nd dose of Moderna 05/14/2021, started experiencing symptoms 05/28/2021 of double vision, fever, and joint pain. Hospitalization 05/28/2021 = 3 days. Re-admitted 06/02/2021 = 5 days discharged 06/07/2021. Symptoms have subsided.
Client had his first Pfizer Covid 19 Vaccine on 3/15/2021 and second Covid 119 vaccine on 4/5/2021.  He reported to day that he had mild reactive symptoms when he received the 2nd vaccine but the symptoms resolved without intervention after 2-3 days.  He took his 1st Pfizer Covid 19 Vaccine Booster on 10/2/2021 and went in to pharmacy to get the recommended 2nd Pfizer Covid 19 Vaccine Booster about 2:00 PM on 4/9/2022.  After he was up and about on 4/10/2022 at about 10:00 AM, he developed acute fever and chills.  He reported that he stayed in bed most of the day on 4/10/2022.  By the time he awoke on 4/11/2022, the fever and chills had dissipated but the patient became aware of the onset of right sided chest pain  that has been constant since it started on 4/11 at 4/10 on 0-10 pain scale.  He stated that the right sided chest pain is intermittently exacerbated when he takes a deep breath in.  Since the onset of the chest pain, client has also been experiencing "profound fatigue" and intermittent episodes of faster heart rate of 90-110 that are not associated with any physical activity but that make him feel "odd."  The pain has been constant since onset but has waxed and waned in intensity.  4/10 is the lowest the pain has been but at times, it arbitrarily and gradually increases to 7/10 without other associated symptoms. At the time of this office encounter, this client has not taken prescription medication, OTC medication or any supplement/herb to treat his current symptoms.   Client presented to the clinic today because of these ongoing symptoms that he believes are the result of taking the Covid 19 Vaccine Booster # 2 on 4/9/2022.
Pt had her third GARDISIL 11/17/09. She called the next day to report that on 11/18 AM, she awoke with nausea, soon followed by vomiting. When she got up, she was "lightheaded." Later in the day she developed hives on arms and thighs. Stated that sx are resolving. Told her to take BENADRYL 50 mg now. If hives get worse or throat swells, has difficulty breathing call 911 or have roommate take her to ER.
This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events on three patients. This is the second of three reports. A patient of an unspecified age and gender received PREVNAR 13, )lot N97935, exp. date 01Dec2017, NDC number 0005-1971-01) on the right deltoid muscle at single dose on 12May2016 for immunization. Relevant medical history and concomitant medication were not specified. On an unknown date the patient experienced warm, red and swollen at administration site and they turned red like cellulitis. The outcome of the events was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016586404 same reporter, same events, different patients. US-PFIZER INC-2016586397 same reporter, same events, different patients.
loss of balance, edema of lips, discoloration of hands & feet, blotches et blisters of thighs, buttock; mouth black w/blisters in it;
Headache hour after vacation, then as day progressed, continued headache,  approx 4pm pounding headache, nausea, lightheaded, fatigue and just feeling bad. Next day dizziness,  fatigue, headache and body aches.  Symptoms continued with some shortness of breath. Nyquil taken at approx 5-6pm. 3rd day woke up had dizzy spell fell on the floor. Still having some fatigue lightheadedness and nausea.
always gets "hardness at injection site" on her left arm and it goes away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE INDURATION (non-serious), outcome "recovered", described as "always gets "hardness at injection site" on her left arm and it goes away".  Additional Information: Question: Reporter states she just received her Pfizer Covid-19 "second booster shot" last Tuesday 05Apr2022. Reporter states she never had any issues before with the vaccine and is calling to report a potential side effect. Reporter states she always gets "hardness at injection site" on her left arm and it goes away. Last night when she was about to sleep, she turned on her side then her heart starts raising and beating extremely rapidly that lasted a minute and a half. No chest pain and shortness of breath. Reporter states when she rolled over slowly it did dissipate. Reporter states she never had that prior to getting the booster shot. Reporter states she didn't know if it is a reaction or can be related to myocarditis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
RARE REACTION; LEARNING TO WALK AGAIN; This spontaneous report received from a consumer via a company representative concerned an 18 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced rare reaction, and learning to walk again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rare reaction and learning to walk again was not reported. This report was non-serious.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL vaccine. On 22-MAY-2009, the patient was vaccinated with the second dose of GARDASIL vaccine. After receiving the first dose, the patient experienced pain at the injection site and then was fine. After receiving the second dose, the patient experienced arm pain at the injection site which went up her arm and started to have pain in her head and then when she looked to that side of the head her vision was blurry. The patient called the physician and the physician told the patient "if the symptoms were still occurring or get worse she should call the office back". At the time of reporting, the patient had not recovered. Additional information has been requested. Additional information has been requested.
SUDDEN AND SEVERE HEADACHE, ACUTE MEMORY LOSS, SHORTNESS OF BREATH, FITIGUE, SLEEPINESS. ED ON 3/26/2021 1:03 P.M. AND HOSPITALIZATION FROM 3/26 THROUGH 3/28/2021. AMBULANCE TRASFER TO HOSPITAL ED AFTER PRESENTING TO PARAMEDICS WHILE ASLEEP AT AN INTERSECTIOIN SLUMPTEDOVER THE WHEEL OF HIS CAR. HE WOKE QUICKLYM WHEN THE PARAMEDICS KNOOCKEDN ON THE DRIVER'S SIDE WINDOW. HE REPORTED THAT HE HAD NO MEMORY OF THE INCIDENT, NOR DRIVING TO LOCATION FROM A NEIGHBORING AREA.
Patient's mother informed office staff on 1/16/13 that patient experienced redness, warmth, and pain at injection site, extending across his upper arm after injection. She reported that his symptoms have resolved.
Headache, coughWheeze, Syncope, Facial sensitivity, GI cramping Narrative:  Symptoms resolved by 1/5/21.
This spontaneous report was received from a registered nurse and refers to a 2 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 04-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 55 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Hives on both arms; Scratched the hives, broke the skin; Broke the skin, got it infected; Scratched the hives, broke the skin; This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2022, the patient received the 1st dose of Shingrix .5 ml. In September 2022, 24 hrs after receiving Shingrix, the patient experienced hives, broken skin, skin infection and scratch. On an unknown date, the outcome of the hives, broken skin, skin infection and scratch were unknown.   It was unknown if the reporter considered the hives, broken skin, skin infection and scratch to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment:  Patient reported that received Shingrix vaccine in left arm. Patient stated 24 hours later broke out in hives on both arms. Patient also mentioned she was scratching the hives and broke the skin and it got infected. Reporter consented to follow up.
Fatigue, fever, dizziness, hurting all over, blacking out (syncope).
Developed tachycardia, heat intolerance, posterior cervical lymphadenopathy, a pruritic rash on the upper back, and a tender swollen thyroid.
Pt presented to pharmacy on 9/25 w/redness at injection site for ZOSTAVAX. Today pt informed RPh of HX of shingles approximately 4 wks prior. Was not mentioned at time of inject. See note at continuation site.
I developed  a bloody nose after both vaccine injections.  The first vaccine I received was on 3/4/21 and had a bloody nose in my left nostril around 3-4 hours after the injection.  It seemed odd as I do not typically have bloody noses.  When I got  my second dose today I received another bloody nose roughly 30 minutes after the vaccine.   Both times the bloody nose happened after lightly blowing my nose.  Again, I very rarely suffer bloody noses.  I currently am not bleeding anywhere else and the nose bleeds stopped after about 10 minutes.
Approx 3/4 hrs after receiving shots developed hives all over body.  No sob, swelling / redness on or near injection site, afebrile, BENADRYL given.  Hives lasted 2 days.
pt recv vax 22JUL97 & on 25JUL97 pt devel an intermittent fever, sore throat, muscles aches & a rash @ inj site;
has not gotten second dose of SHINGRIX yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2nd case of shingles occurred on 23rd September 2021, which was ongoing, refer case US2021AMR202744). Previously administered products included Shingrix with an associated reaction of herpes zoster (received 1st dose on 13th February 2019, intramuscularly, and had first case of shingles on 29th April 2019, which was resolved after being treated. refer case US2021202219).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient reported that, due to shortage of Shingrix in 2019 and pharmacy forgot to call her back, she did not get the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up with healthcare professional. However, she did not have full mailing address, fax number, and email address to healthcare professional. The reporter consented to follow up. She did not provide her email address.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202744:same reporter, 2nd Shingles outbreak US-GLAXOSMITHKLINE-US2021202219:same reporter, 1st Shingles outbreak