chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Varicella Zoster (Shingles) of left arm; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Jan2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included esomeprazole magnesium (NEXIUM) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration on 19Dec2020 at 08:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 24Mar2021 at 06:00, about 10 weeks after the second dose of vaccine, the patient experienced varicella zoster (shingles) of left arm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the event included treatment with course of VALTREX and NEURONTIN. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event varicella zoster (shingles) of left arm was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
DAUGHTER WOKE UP, I PICKED HER UP. I FELT THAT SHE WAS WARM AND WAS GETTING READY TO GIVE HER MEDICINE, THEN SHE  BEGAN HAVING A SEIZURE IT LASTED FOR 2 MINUTES. CHILDS LIPS TURNED BLUE, EYES SARTED ROLLING BACKWARDS AND BABY WAS MOANING, MUSCLES WERE VERY RIGID. CHILD STARTED DROOLING. MY DAUGHTER BEGAN TO STARE FOR ANOTHER MINUTE. AFTER THE EPISODE BABY WAS GROGGY AND CRANKY. I ADMINISTERED MOTRIN. BROUGHT DAUGHTER TO HOSPITAL. SHE WAS GIVEN TYLENOL TO BRING DOWN HER FEVER, WHICH WAS 101.9 RECTAL.  DOCTOR DIAGNOSED HER WITH A FEBRILE SEIZURE MOST LIKELY RELATED TO VACCINE.
ACUTE DVT OF LEFT FEMORAL VEIN 3/5/2021 CHF EXACERBATION, UNSPECIFIED ACUTE RESPIRATORY FAILURE 3/5/2021 CHF EXACERBATION, UNSPECIFIED HYPOXIA 3/5/2021 CHF EXACERBATION, UNSPECIFIED
2 cm erythema left thigh. Generalized papular exanthem, sparing palms and soles.
very bad body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (very bad body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. No concomitant medication was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (very bad body aches). At the time of the report, MYALGIA (very bad body aches) outcome was unknown. Not Provided   Treatment medication was not provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    This case was linked to US-MODERNATX, INC.-MOD-2021-092872, US-MODERNATX, INC.-MOD-2021-092524 (E2B Linked Report).
Patient was given the wrong tetanus. Patient was given a DTaP instead of a Td.
Red, swollen left arm with swelling extending to mid-forearm resulting in numbness and tingling in medial hand onset within 12 hours of vaccination
She came to the hospital with a chief complaint of progressive worsening shortness of breath over the last 1 week.  Patient reports that she was exposed to COVID-19 from son-in-law at home.  She reports progressively worsening shortness of breath and some chest pain.   She denies any fevers but did have some chills.   Has chronic cough   8/10/2021 tested positive
The patient noted that blood and a "clear liquid" was running down his arm.  He stated that it was 1/16th to 3/32nds inch wide and ran to the level of the elbow. (This occurred while the vaccinator was looking away and disposing of the syringe in the sharps container.)  It was wiped up and pressure was applied to the site without further problem.  Upon reaching home he thought about this and then wondered if he had received a complete dose. He then contacted the health department and I contacted him in follow up. In discussing this with the vaccinee and the vaccinator, NP, her immediate impression was that this was blood only but admits that perhaps a portion of vaccine could have been mixed in as well.  This was discussed with the vaccinee and I feel that greater than half of the vaccine was s\administered so no repeat dose will be given. He will return for his 2nd dose in 21-42 days.
HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY VACCINE SERIES.
The day following the vaccination, I had a fever, intense chills, and a mild headache. I have had an upset stomach since the second vaccination, with intermittent stomach pain.   Last night (04/22/2021, starting around 7:30 PM), I had intense lower abdominal pain, loose stool, vomiting, and an intense chill. The symptoms came on suddenly (over the period of a half hour). After vomiting, I was seized by sudden, intense, lower-back pain immediately followed by full-body tremors. The tremors started with my legs, then went to my hands and finally my arms. I have never had a problem with tremors or seizures before. The back pain and tremors fully subsided after 10 minutes.   I did not visit a doctor, since it is doubtful that they would definitively blame the Covid vaccine, and I would be stuck with a large hospital bill. However, the symptoms were too peculiar to be attributed to a random illness. I do believe they are a side effect from the second vaccine dose.  This morning I feel tired and am a pound lighter, but I am quickly recovering.
Red raised ring around injection site approx 2in circumference.  Appeared 11 days after injection.  Slightly itchy.
Significant pain at injection site and throughout upper arm (6/10) subjection numbness some distribution slight swelling at site.
Information has been received from a RN concerning a 24 yr old female who on 09May05 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot649644/1050P). Concomitant therapy that day included a vaginal cream (which she started the day of vaccination). On 12May05 the pt broke out in an itchy rash on the inner thigh. No injection site reaction was noted. The physician did not feel that the rash was related to the vaccine. Follow up information received from a nurse indicated that the pt received a second dose of varicella virus vaccine live on 13Jul05 with no adverse effects. A titer was drawn in July which showed the pt had immunity. No additional information is expected.
I had a series of symptoms that culminated with a 103.9 fever at around 3:00 a.m., the morning after my first vaccination.  Most symptoms were in the list of common side effects.  What seemed different was how extreme my symptoms were extreme shivering and very high fever.   The fever lasted several hours and seemed to go don rather quickly after shedding the layers I put on to manage the extreme shivering/chills, took two Advil, and used a cold compress on my head.
Difficulty swallowing.  Severe headache.  Rash on chest area and generalized itching.
difficult to raise right arm; muscle soreness; hamstring muscle pain on left thigh; soreness and tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (soreness and tenderness), LIMB DISCOMFORT (difficult to raise right arm), MYALGIA (muscle soreness) and MYALGIA (hamstring muscle pain on left thigh) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced TENDERNESS (soreness and tenderness). On an unknown date, the patient experienced LIMB DISCOMFORT (difficult to raise right arm), MYALGIA (muscle soreness) and MYALGIA (hamstring muscle pain on left thigh). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of UNK dosage form. At the time of the report, TENDERNESS (soreness and tenderness), LIMB DISCOMFORT (difficult to raise right arm), MYALGIA (muscle soreness) and MYALGIA (hamstring muscle pain on left thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also used a heating pad for treatment.
pt was seen by MD d/t swollen leg, rash @ inj site, on forehead & mouth, fever 104 & tenderness @ inj site;MD instructed mom to inc APAP dose & monitor swelling;
Received shots on Monday, Nov 5, 2007.  Became sick on Tuesday afternoon with fever, chills, and body aches.  Left work early on Tuesday, came to work on Wednesday and went home sick that morning. Returned to work on Thursday, better, but feeling a little sluggish.
Extreme pain injection site; Extreme pain injection site up to the neck; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration on right arm on 19Mar2021 at 18:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included Bipolar II, Lymphodema. Patient has known allergies to remeron, clonazepam, Sulfa and tape (adhesive tape allergy). Concomitant medications included calcium 600 plus vitamin D (MANUFACTURER UNKNOWN); taken for an unknown indication from an unknown start date. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 19Mar2021 at 19:00, the patient experienced extreme pain at injection site up to the neck. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events extreme pain at injection site up to the neck were not resolved at the time this this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Came into clinic 3 days post immunization to report that she developed  a fever of 101 on 12/1 accompanied by a large red bump on L deltoid at insertion site.  Severe achiness and flu like sxs.  Denies itching.  Had to rent a hotel room so could sit in a hot tub for relief.
No other AE reported; HBP calling to report a temperature excursion on PROQUAD, MMR II and VARIVAX / the vaccines were administered; This spontaneous report was received from an "HBP", referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies.  On 28-SEP-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of injection, route of administration were not reported; lot number S027465, expiration date: 02-MAR-2021 and lot number S0317056, which is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot number S0317056 does not match any Company product as confirmed by Lot Verification team, expiration date reported as 06-APR-2021) as prophylaxis (product storage error). No other adverse effect (AE) reported.  The vaccine underwent a temperature excursion of 5.7 degrees Fahrenheit (F) for 14 hours, as recorded by a data logger. There was no previous temperature excursion.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in February 2021 and the estimated date of delivery was on an unknown date. On 30-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 30-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       she just found out last week that she was pregnant, and no prenatal care has been established. She currently does not have a doctor. Her last menstrual period was in Feb 2021, but she was not sure the day.
02/21/2004: Increased redness developed.  Complained of itching, warm and some pain.  No systemic problems.  11x12cm area of erythema and warmth to area on left arm.  02/24/04: Mother states swelling down.  Doing much better now.
Nurse was giving injection per normal fashion. After she depressed the plunger and took the needle out of the patient arm part the immunization came out . It is unknown how  much. Nurse did note that after pulling the needle out it was  not tight to the syringe. Again unsure the amount of the 0.5ml dose the patient received. No adverse reaction just unclear the dose given and the next step. Should she be given another dose ? Looking for direction.
5/20/22 I started hearing crackling in my ear. Suddenly, I felt like my head was going to explode. It felt like I had firecrackers going off in my left ear. It hurt a lot. It finally subsided. Later that day, I went to urgent care. My blood pressure was very high. I was treated for a trigeminal neuralgia episode. I was given an anti-inflammatory shot. I went to a Neurologist who sent me to an Endodontist and checked my teeth and said nothing was going on with my teeth. I went to see my PCP and she said she thought it was a reaction to my vaccine three days earlier. This never happened again. In November, I started having issues with pain when you touched my skin. My scalp also began hurting when I would wash my hair. At the end of November, I went to the Dermatologist and was told I had an inflamed scalp, and my hair was falling out. I told him it also hurt to touch the inside of my ear. I felt like this was all related. I was treated for Lichen Planopilaris with doxycycline for two months and cortisone shampoo. Both auto immune diseases seem to have resolved. My hair is coming back in. It seemed very odd to me, that in 7 months I was diagnosed with two super rare immune auto diseases which have both resolved.
I couldn't get out of bed because I was too dizzy for about 4 hours; I had that dizziness reaction; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN5318), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced that patient couldn't get out of bed because patient was too dizzy for about 4 hours; patient had that dizziness reaction. It was reported that the patient was fine the day the patient took the first shot in the morning and was fine that day and during the night but the next morning when the patient got up, the patient couldn't get out of bed because the patient was too dizzy for about 4 hours and a medical person tell patient that they did not think that patient should take the second shot because the patient had that dizziness reaction the next day. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Nausea, Severe migraine, sensitivity to light, Chills, Low grade fever, Body aches, extreme fatigue, weakness from 2/2/21 at 4:30 am until approximately 8:30 am 2/3/21. 8:30 am to 3:30pm on 2/3/21 only symptoms that remained was mild headache, fatigue.
Large knot a injection for 2wks, then a raise red rash started spreading out from the injection site. Whole arm swelled up and rash circled my arm. I was told to use ice packs and Benadryl to counter act the allergic reaction and intense itching. Missed 4 days of work.
This spontaneous report was received from a pharmacist referring to a 75 year old female patient with unspecified respiratory issues and allergy to unspecified sulfa drug. On 25-JAN-2016 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # L025001, exp date: 06-OCT-2016), subcutaneously. Concomitant therapies included SPIRIVA, SEREVENT, HYDROMET, REMERON and PEPCID. On 27-JAN-2016, the patient developed a blister at the injection site. The pharmacist stated one portion of the blistered area appeared as though the skin had fallen and was red underneath, while the rest of the blistered skin was intact. The patient had visited pharmacist. No lab diagnostics studies were performed. The patient had not received any treatment and did not recover from the events. Additional information has been requested.
My breastfed son feed at 9pm. Woke up around 315a throwing up and a fever of 99.6. Tried to give ibuprofen for fever reduction but emesis occurred immediately afterwards. Provided cool compress to forehead and neck areas until he went to sleep.
Initial report received from a healthcare professional on 15 August 2013. A female patient, had received first dose of ADACEL vaccine, batch number: U4612AA (anatomical site of administration was not reported) intramuscularly on an unspecified date. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 06 January 2013 and the estimated date of delivery was 05 October 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as "NA" and concomitant medications were not reproted. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: none.
Patient presented to the ER  with chest pain, non radiating, heavy weight. Patient was found to have acute DVT.
Increased pain in left shoulder, low grade fever, arm hot to touch and red at site. Pt stated he noticed it on Tuesday night.
fever >100.5 body aches, joint pain general malaise, fatigue headache chills and sweat
5/11/06 at 9:06 Mother states child started shaking, went limp, sent to ER. Diagnosed with seizures possibly due to Dtap immunization.
shingles; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as the patient was reporter's mother. The age at vaccination was not reported. The patient received her shot and within weeks got shingles.
Information has been received from a consumer concerning her 21 year old daughter with grass allergy who on 02-NOV-2010 was vaccinated with intramuscularly with the first 0.5 ml dose of GARDASIL (Lot # reported as 0565Z, Exp date 12-SEP-2015). The consumer reported that after her daughter received the first dose, on 02-NOV-2010, she experienced a rash that originated at the base of her spine and progressed all over her body. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299815, 2018SA299809, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299805, 2018SA299794, 2018SA268354 and 2018SA299808 (cluster). This case involves 72 years old female patient (height: 63, weight: 185 lbs) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UJ024AC, expiration date: 29 Apr 2019, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, the patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pt has had 2 initial doses of Moderna Covid vaccine (given 1/15/21 and 2/18/21) and then received 3rd booster dose on 10/27/21. Since 11/9/21 she has been dealing with chronic idiopathic urticaria and dermatographism. No other clear triggers have been identified for urticaria, so this is being reported as a potential association.
Adminstred at Day after vaccination, 8//11/21 hot flashes and headache developed. This headache did not go away. On 8/15/2021, started having dizzyness spells that would come and go randomly, whether sitting or standing. Headache was worsening.  BP taken with an automatic cuff was 175/110. Thought it was an inaccurate reading. Repeated BP later with a different cuff. It was 168/ 93.  Made an appointment to see provider.  BP remained elevated in 160s-170s/ 80s- 110.  Borrowed Labetalol from a friend and began taking that to try to controll BP until Dr. Appointment.  Was taking 50mg BID. ON */20/21 felt worse. Headache worsened and more dizziness. Labetalol was not working well. Decided to go to ED at Hospital. BP upon admission was 192/93. The BP went as high as 243/117. I was treated with 4 antihypertensives to bring the BP down. I was sent home with a prescription for losartan 50 mg daily.  It was not controlling my BP. I saw the cardiologist and am now taking losartan 100 with hctz 12.5. This seems to be working. I am still having the headache.
10AM pt recv vax on 14OCT96 & exp chills & fever (feet hot) & muscle aches;these s/s subsided 16OCT96;16OCT noticed rt arm got hot to touch & devel deep red circle 3" & puffy;pt to call own MD to recv further instructions;arm still aches;
Having chest pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Having chest pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Having chest pain). At the time of the report, CHEST PAIN (Having chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported