chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via sales rep and described the occurrence of pain in a 68-year-old female patient who received SHINGRIX. Concurrent medical conditions included core sores (on chronic therapy of FAMVIR, had not taken FAMVIR one week prior to receiving SHINGRIX). On 27th March 2018, the patient received the 1st dose of SHINGRIX. On 28th March 2018, 1 days after receiving SHINGRIX, the patient experienced pain, erythema, rash and scapula pain. The patient was treated with Analgesic. On an unknown date, the outcome of the pain, erythema, rash and scapula pain were unknown. It was unknown if the reporter considered the pain, erythema, rash and scapula pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced increase redness and pain the next day after vaccination, continued to progress and spread to scapula and rash developed over breast area. The patient was under case of physician and taking analgesic for pain at the time of reporting. The reporter agreed to follow up from GlaxoSmithKline. This case has been linked with case US2018GSK085328 and US2018GSK085329, reported by the same reporter.
1) Skin rash over 80% of my body including, face and lips; started to change my voice sound and started to compromise my airways. 2) Uncontrollable shakes, but not sure if this was related to Covid-19 itself.  Was given steroids via injection into my blood stream, within minutes the shakes stopped and within 2 hours the rash was gone.
patient is now 5 weeks pregnant and was pregnant at time second dose ofGARDASIL 9 was administered; This spontaneous prospective pregnancy report was received from a nurse and refers to a 23-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in October 2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (lot # and expiration date were not reported)for human papillomavirus (HPV) vaccination.  At the time of the vaccination the patient was pregnant. The patient had ultrasound pregnancy performed and sought medical attention. The patient was 5 weeks pregnant at the time of the report. The last menstrual period (LMP) was calculated as 20-SEP-2019 and estimated date of delivery (EDD) was calculated as 26-JUN-2020. The pregnancy outcome was outcome pending.
Patient was given 2nd dose of series too early; administered 23 days after 1st dose.
Information has been received from a health professional concerning a 64 year old male who on 04-OCT-2007 was vaccinated with a 0.65 ml dose in the left arm of Zostavax (Oka/Merck).  Concomitant therapy included prednisone, BENADRYL, metoprolol, ezetimibe (+) simvastatin (MSD), PLAVIX, aspirin, folic acid, vitamin E, niacin, montelukast sodium (MSD), ranitidine, isosorbide, COMBIVENT and GAS-X.  It was reported that the patient developed a blistering rash after he received the vaccine, and on 19-OCT-2007 was seen by the physician for the rash.  It was reported that the patient was treated with prednisone (also listed as a concomitant medication by the reporter) and as of 29-OCT-2007 had recovered.  A product quality complaint was not reported.  Follow up information received from the reporting nurse.  The nurse reported that she thought the patient might have recovered.  Follow up information received from the physician indicated that on 06-OCT-2007, the patient noticed a blistering rash on his left leg and then it went up to his left arm.  The rash was not painful but was fairly large.  The rash was mainly around his left knee and his forearm.  His vaccination was in the left arm and he did experience pain in that area.  He ultimately developed a little bit of rash on his back, right forearm, but mostly along the left side of his body.  The reporter indicated that the patient had a bit of exposure to some weeds and the rash was initially felt to be contact dermatitis.  He was treated with topical steroids with absolutely no help.  On 15-OCT-2007, he was started on oral prednisone.  Diagnostic studies included a "Sed Rate", blood count, renal function, and liver function tests all reported as normal.  His oral steroid dose was tapered on 19-OCT-2007, and he finally cleared about 10 days later (29-OCT-2007).  Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a male patient who received SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site discoloration. On an unknown date, the outcome of the injection site swelling and injection site discoloration were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling and injection discoloration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The vaccination date was unknown. It was given at a pharmacy. The patient received SHINGRIX vaccine in upper arm but which arm was not specified. The physician reported that the patient experienced the symptoms shortly after receiving the 2nd dose and they were still present after 6 weeks. There was swelling with a brown undertone at the injection site. The healthcare professional told the representative that she had more information to provided in follow up but did not have the information with her at the reporting time.
arm was sore and radiating to my back and neck; radiating to her back and neck.; not able to move easily; headaches that got worse over time; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (arm was sore and radiating to my back and neck), PAIN (radiating to her back and neck.), GAIT DISTURBANCE (not able to move easily) and HEADACHE (headaches that got worse over time) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included MAGNESIUM and GALCANEZUMAB GNLM (EMGALITY [GALCANEZUMAB GNLM]) for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore and radiating to my back and neck), PAIN (radiating to her back and neck.), GAIT DISTURBANCE (not able to move easily) and HEADACHE (headaches that got worse over time). The patient was treated with RIZATRIPTAN at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore and radiating to my back and neck), PAIN (radiating to her back and neck.), GAIT DISTURBANCE (not able to move easily) and HEADACHE (headaches that got worse over time) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient also used physical therapy and massage therapy as treatment for the events.   This case was linked to MOD-2021-075055 (Patient Link).
"Janssen COVID-19 Vaccine EUA"  Joint pain, including shoulders, hips knees and ankles. Chills. Sweating during sleep. Low grade fever. General body aches.  Symptoms began approx 12 hours after dose was given and still persist approx 36 hours later. No doctor or hospital visit is required at this time.
This spontaneous report as received from a nurse refers to a 4 year old patient (gender unspecified). On 02-APR-2014 (yesterday), the patient received a dose of PROQUAD injection, dose and frequency was unspecified (lot number J006568, expiry date 30-NOV-2014) that might have been administered intravascular. Concomitant medication was unspecified. The patient was evaluated at unspecified emergency room for precautionary reasons. No adverse effect reported. No product quality complaint was involved. The outcome of received a dose of PROQUAD that might have been administered intravascular was unknown. No other information was available. Follow up information has been received from the nurse via questionnaire concerning the 5 year old male patient (previously reported as 4 year old) with no known drug reactions or allergies and no illness at time of vaccination who on 02-APR-2014 at approximately 15:15, was vaccinated with PROQUAD in the right upper arm and KINRIX (Lot # AL20B267CA) in the left deltoid intramuscularly. The nurse reported that on 02-APR-2014 at 15:45, the patient seemed extremely tired. The patient's mother was upset and took him to ER at 16:00. ER called poison control center where they told he maybe more likely to get one of the diseased in the next 3-4 weeks. The nurse stated that there were no other concerns except KINRIX site arm above elbow that was red and swollen for the next 5 days. There were no Lad diagnosis or studies performed. It was planned to getting titres before considering revaccination. On 02-APR-2014, the patient recovered from seemed extremely tired. Additional information is not expected.
7:40a- before receiving the vaccine, patient was observed high level of anxiety, asking for friend to be there for the support. When she saw a needle, she moved away and ran out of the room. She came back after a few minutes, still looked nervous but still consented to receive the vaccine.  7:49a- Onset of dizziness, light headed, increase BP = 152/103. She was closely monitored by RNs for ~ 40 mins, reported feeling better and denied any further symptoms. She was released from observation room leaving for home 8:35   - while waiting for elevator, she screamed while lying down on the floor stating she was not feeling well. A rapid response was called, suspecting seizure-like reaction. BP = 150/106, P=80, repeated BP =  154/88 8:43 - blood glucose = 64, gave her glucose gel 5g, then was transported by EMS to closest ER. Patient did loose conscious ness or have injury related to falling and being on the floor.
I had minor sleep issues before the vaccine but after my 2nd dose of the Pfizer vaccine, I have had severe insomnia. I am getting 1-4 hours of sleep a night for about the past month. The night of my vaccine, I felt wired and had an immense amount of energy. Since that day, I haven't been able to get any normal sleep.
This spontaneous report has been received from a nurse referring to a 13-month-old female patient with iodine allergy. The patient's medical history and concomitant therapies information was not provided. On 30-APR-2019, the patient was vaccinated with M-M-R II (rHA) (strength, dose and frequency were not reported), (lot# R030810, expiration date: 24-OCT-2020) intramuscularly as 12 month vaccines, with VARIVAX, VAQTA, PREVNAR 13, PEDVAXHIB and ATARAX (all strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The patient was seen in the office on 05-MAY-2019 for "blanchable, papular lesions on her body, that were measles like". The patient was seen again in the office on 08-MAY-2019 and 15-MAY-2019, because the rash had spread to the face. The patient was prescribed BENADRYL and ATARAX on unknown date. The outcome of the event was reported as "still has rash". The causality between the event and M-M-R II, VARIVAX and VAQTA, PREVNAR 13, PEDVAXHIB and ATARAX was not provided. The event was considered to be an event of medical significant by the reporter.
Nausea and vomitting, and severe headache for 3 days after receiving the 2nd dose of COVID-19 vaccine Frequent episodes of chest pain, shortness of breath, lightheadedness 6 weeks after receiving the 2nd dose of COVID-19 vaccine
pt recvd vax;awoke w/ swollen rt eyelid & numb swollen lt upper lip;called er x 2 for info;21nov,awoke w/lt swollen eyelid & soreness;saw MD;20nov rash around neck;at least 3 hive episodes;8:30am hives(rash)all over;dph taken,hives abated;
4 year old received H1N1 nasal mist at her pediatrician's office at 4 Pm on 12/31/2009.  Some of the vaccine squirted in her eye, the eye was not irrigated.  The child woke at 4:50 AM on 1/1/2010 with the affected eye red and swollen, it was not swollen shut.  The side of her face was also swollen.  Her upper lip was puffy and she complained of itching.  She had red, raised "bumps" on her chest and back. She did not have any shortness of breath or wheezing.  A children's dose of Benadryl was given, at dose recomended on label.  One hour later the swelling had decreased to her eye and side of face. Rash was no longer raised.  Mother denied child had any new clothes, foods, or soaps.  Four hours later the rash returned and lip became puffy again.  Mom contacted the child's pediatrician and he saw the child in his office.  She was diagnosed with hives and Benadryl and Zyrtec were prescribed.  24 hours later all symptoms had subsided.
The following day of vaccination, a bumpy, itchy rash was climbing up from my feet to my thighs. At the injection site, it was raised, swollen, sore, and hot to the touch.
Pain in right arm developing days after vaccine. Arthralgias in right shoulder, collarbone, MCP joints in hands bilaterally and right groin lasting for > 1 week and causing significant limitation in mobility.
pt recv vax 17JAN97 & it was reported that about 48hr later the inj site had become red (about 5 inches), warm & hard;
some aches; This is a spontaneous report from a contactable consumer. This female (patient) consumer reported that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she had some aches and stuff after the first dose on an unspecified date. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 as single dose for covid-19 immunisation and experienced the events headache, nausea, body aches, muscle aches and chills. The outcome of the event was reported as unknown.  Follow-up attempts completed. No further information expected.
COVID 19 Treatment-PAXLOVID; COVID 19 Treatment-PAXLOVID; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Lot number: GG7223) for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunisation, reaction(s): "no adverse event"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunisation, reaction(s): "She had horrible intense itching to the booster for 6 weeks". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment-PAXLOVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300356590 same patient, different drug/AE.;US-PFIZER INC-202300357092 Same patient/product, different dose/events;US-PFIZER INC-202300357093 Same patient/product, different dose/events;
Immediate swelling at site of injection, difficulty breathing after a few minutes. Gave intramuscular diphenhydramine, which seemed to help greatly the swelling and breathing difficulties.  Called 911, transported by paramedics for observation and evaluation.
Chest pain beginning about a week after injection, sharp stabbing pain and times and aches in the chest and back muscles at other times
2 days after receiving vaccine patient complained of light headed and dizzy. Also numbness of his legs. Went to ER for treatment per Dr.
FAINT; HYPOTENSION; DIAPHORETIC; This spontaneous report received from a health care professional concerned a 53 year old  female. This report was received from news/social media. 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: 207A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient was faint and experienced hypotension and was diaphoretic. The patient was released after observation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the faint, hypotension and diaphoretic was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210415566.; Sender's Comments: V0-20210442589- Covid-19 vaccine ad26.cov2.s-Faint. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) from program. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Apr2021 at the age of 58-years-old (Batch/Lot number was unknown) as single dose for COVID-19 immunization. Lot Number reported as PW0153 or EW0153, administered either at 12:45PM or 2:45PM (first dose). The patient's medical history and concomitant medications were not reported. The caller said her next COVID-19 Vaccine dose was on 15May2021, but she had got COVID-19 after her first COVID-19 Vaccine dose. The caller wanted to know about getting her second COVID-19 Vaccine since she tested positive for the COVID-19 Virus on 27Apr2021. She tested positive 3 days after the first dose which was given on 24Apr2021. She still has the whooping cough now. The caller also mentioned her sister also tested positive and couldn't get her first dose. It was explained after the first dose she had a whooping cough, chills, loss of appetite, and high temperature that would go up and down, and she felt weak. This lasted two weeks. It started 3 days after getting the vaccine and she is fine right. She still has the whooping cough but not much now and it is fading. She got sick Tuesday afternoon, on 27Apr2021 and was sick through today, other than the cough. She explains at first for the high temperature she did not take any Tylenol at all because she didn't know she could. She did take Advil pm but it didn't work, Expiry: Feb2022, Lot: AW9333, and no UPC is known. It was explained she thinks it didn't work because she didn't continue it, she would stop then start a few days later with another dose. She didn't take it continuously or regularly and feels if she had it would have worked. After another week, because the fever didn't go down with the Advil, she then took Tylenol and her fever went down. Treatment included: She gargled warm salt water and used steam, through her nose and mouth to help her chest with the cough; she cured herself. She would drink lots of liquids, her mouth was dry a lot of time. It was reported whooping cough from 27Apr2021 to ongoing, recovering; chills was from 27Apr2021 to 11May2021; loss of appetite from 27Apr2021 to 11May2021; high temperature from 27Apr2021 to 11May2021; weakness from 27Apr2021 to 11May2021. The outcome of event positive COVID-19 test with symptoms was unknown.   Information on the lot/batch number has been requested.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date the patient visited pharmacy for a flu shot and stated that at an unspecified time in the past, she had received ZOSTAVAX injection (dose, route, lot number and expiration date not provided), at an unspecified location and from an unspecified provider, and on an unspecified date, she experienced post-vaccination rash that resembled shingles. The outcome of post vaccination rash resembled shingles was not reported. The relatedness between post-vaccination rash resembled shingles and ZOSTAVAX was not reported. Additionally, it has been reported that therapy with ZOSTAVAX was not reintroduced. Additional information has been requested.
needle tip dislodged; some of the medication ran down the patient's arm, unknown how much of the dose the patient received; A spontaneous report was received from a nurse for a 60 year old white female patient who received Moderna's COVID-19 vaccine (mRNA-1273).   The patient's medical history was not provided. No concomitant product use was reported.  On 02 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. While the vaccine was being administered the needle tip dislodged and consequentlysome of the medication ran down the patient's arm. The exact dose received by the patient was not reported.  Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the events needle tip dislodged and some of the medication ran down the patient's arm, unknown how much of the dose the patient received, was considered as recovered.
2 minutes after the patient was injection, she explained that she felt lightheaded and dizzy and she passed out. once she regained consciousness she felt numb, could not feel her hands and feet and felt her entire body vibrating. i had her squeeze my hands and she was able to do so. we called 911 and upon ems arrival they monitored her blood pressure and blood sugar which were both within normal range. she was given water and orange juice and after 60 minutes felt good enough to go home with family member
C/o chest pain EMS took BP and first reading was 240/160, subsequent reading were in the same range.  O2 stas were 97% HR 88.  Continued to c/o of chest pain.  Placed on monitor and ambulance called.  Transported by 9:50 AM  Had similar elevation of BP with first Moderna dose and was transported to hospital then as well per patient.
Dry skin; swollen feet, hands and face; hives; peeling skin; itchiness; pressure on chest; sinus headaches; and bleeding skin