chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild soreness at the injection site; I was really, really tired & fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild soreness at the injection site) and FATIGUE (I was really, really tired & fatigued) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rheumatic fever (as a kid).    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced VACCINATION SITE PAIN (Mild soreness at the injection site) and FATIGUE (I was really, really tired & fatigued). At the time of the report, VACCINATION SITE PAIN (Mild soreness at the injection site) and FATIGUE (I was really, really tired & fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided. Patient hip replacement surgery scheduled in October and doctors had recommended it. the patient experiencing mild soreness at the injection site and was really, really tired  and fatigued.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Upon follow-up source document contain future surgery details updated in Inarrative supplement.
experiencing sneezing; runny eyes; stuffy nose; This is a spontaneous report from a contactable consumer(patient) via Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sneezing, runny eyes, stuffy nose on 22Mar2021. She reported that the second vaccination should take place on 25Mar2021 and wondering whether she should still receive the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Devel bilateral hand numbness p/receiving 1st Recombivax; presently pt gets minimal hand parathesia @ "odd" times as then exercising; no present neurological deficent;
Around February I noticed no taste and then six weeks ago I started having laryngitis. I visited my doctor and she ordered a CT Scan and I have an appointment for those results on Friday. I have tested numerous times for COVID-19 and they have all been negative. I am unable to still taste anything. I have had no other symptoms other than loss of taste and now laryngitis.
Swelling covering majority of upper arm, severe pain, heat from injection site. Patient took BENADRYL and applied ice to site. Reaction resolved within 24 hours of treatment.
Fever (102 degrees) Uncontrollable chills Body aches Nausea Headache Loss of appetite  Extreme pain at injection site  Started at 9pm after injection. Lasted two days. Tylenol did not help elevate symptoms
Information concerning a 9 year old male pt who was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed meningitis and subsequently died. The cause of death was meningitis.
Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine was administered.  The tachycardia resolved without medical intervention within 2 minutes.  The remainder of the symptoms remained the rest of the day, along with profound fatigue and intermittent self limited tachycardia.  The headache was managed with Tylenol.  I slept most of the  day and through the night.  The following day, I had a headache, which was mild.  Fatigue remained.  I also noted intermittent tachycardia with mild exertion, self limited, less than 1 minute.  Mild soreness at injection site.
It started as a sore arm that has continued for about 3 weeks. Last weekend the pain spread to my shoulder and down to my fingertips. I was in excruciating pain and had to go to the emergency room. My arm is now in a sling and I am not able to lift my arm over my head. They indicated that the x-ray was normal and that I needed to see an orthopedist. My arm is more or less paralyzed. I was given a short term amount of oxycodone which has not help. I have also taken Tylenol and Ibuprofen which has only helped minimally. My primary care doctor had to submit the prescription on my behalf.
Patient reports feeling tingling, throat itchy, feeling flushed, feeling as if she could pass out. No full syncope noted.
Covid symptoms began on 4/14. - Sore Throat,Congestion, Cough, Rash Home tested positive on  4/17. - Prescribed Paxlovid by primary care doctor. Self-Isolated for 10 days. Home tested negative on day 10.
Shingrix probably reconstituted with regular sterile suspension; Shingrix probably reconstituted with regular sterile suspension; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 57LJ9, expiry date 14th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, they found one Shingrix antigen that it was probably reconstituted with regular sterile suspension which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered, because they found a Shingrix liquid suspension that did not match with any other vial. The reporter consented to follow up via email. Nurse needed time to look patient's information.  She said that, they would call patient to revaccinate.
the patient called on saturday after receiving the immunization on friday.  He said he was having some type of reaction, but he wasn't sure if it was just redness, or a rash.  I asked him to come in so I could look at it.  the patient appeared to have a mild rash near his elbow, but the area around where the immunization was given appeared normal.  He said it had been itchy, and apply hydrocortisone cream to it, helped.  I gave him some diphenhydramine and cetirizine, and told him that I would follow up with him on sunday.  when I spoke to him on sunday he said his arm had become painful, and his children said the rash appeared worse.  He is going to contact his physician on monday morning.
headaches; This case was reported by a other health professional via sales rep and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, immediately after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had headaches ever since he received Shingrix and the flu vaccine on the same day.  The reporter asked was in different injection sites.
Student developed reddened, itchy areas, appeared as hives on his shoulders, forearms and complained that his back was itchy. At 09:50AM, he received 25mg. of diphenhydramine. He went home with mother and was later taken to the E.R. with more hives on his forearms. He received an oral steroid and an antihistamine in the ER.
Roving mild paresthesias of body, was able to work, but was concerned.  This was her Moderna booster.   Neg covid test, blood wnl.  no medications were prescribed as did not want to interfere with her abx production and sx were mild.  Symptoms completely resolved by 12-1-2021
Information has been received from a certified medical assistant concerning a 15 year old female with no medical history and no drug allergies, who on 02-JUL-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 657737/0522U). Concomitant therapy included MENACTRA. In September 2007 the pant was vaccinated with a second dose of Gardasil (Lot# 658556/1060U). On 11-OCT-2007 the patient was vaccinated with a third dose of Gardasil (Lot# 658556/1060U). Subsequently, after dose three the patient experienced injection site pain that lasted about 24 hours. The patient was seen in the office. No laboratory diagnostics were performed. The patient recovered on 12-OCT-2007. No product quality complaint was involved. Additional information has been requested.
a little dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 10Mar2021 (Lot number: EN6200) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "a little dizziness".  Additional information: Other Products: No. Patient History: No. Investigation Assessment: No. Reporter and his wife took the booster dose of Pfizer COVID-19 vaccine and are experiencing adverse events. Pfizer COVID-19 vaccine: Reporter says his wife's first dose was 10Mar2021 of LOT: EN6200, and second dose was 01Apr2021 of EN6206. He says NDC/EXP was not provided for any of her doses. Reporter says they are both pretty fit, and his wife works out 4 days a week, and he lifts 4 times at least a week. He says they can both get on a trail and hike 15 miles and be fine, they are in the upper percentages of health for their age. He says after their first vaccine dose they both had a little dizziness that was not bad, they were fine. Concomitant Medications: Reporter says his wife takes no medications, she was very fit.  Follow-up attempts are completed. No further information is expected.
pt recvd vax & exp edema of the upper arm from the inject site to the elbow, redness & heat; pt was treated w/APAP & compresses;
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 08-AUG-2018, the patient was vaccinated with and expired dose of VARIVAX lot # M025864, expired on -MAY-2018, for prophylaxis (dosage schedule and route of administration were not reported). Concomitant therapies included MERCK STERILE DILUENT lot N021030 which was not expired. No adverse event were reported.
Death occurred 3 days after vaccine receipt; attributed to complications of her chronic advanced dementia with aspiration at age 87. No evidence of acute vaccine reaction.
A report was received from a health care professional on 5 November 2003 concerning a 36-year-old female vaccine who experienced a red, itchy area that was mildly painful on the same day as receiving Fluvirin on 4 November 2033.  On 4 November 2003 the vaccine experienced a red, itchy area that was mildly painful.  The vaccine had not recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending.
a rash on her right face, behind her ear and on her scalp; her scalp itching was very severe / itchy scalp / itchiness has spread to other areas; itchiness is a tingling sensation; itchiness has spread to other areas including / ears; This case was reported by a consumer via call center representative and described the occurrence of rash in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling (and chills, fatigue after receiving 1st dose in September 2020, for tolerance refer case US2021062019).   In November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced rash, itchy scalp, tingling sensation and ear pruritus. The patient was treated with cosmetics (Shampoo), selenium sulfide (Selenium Sulfide Lotion), salicylic acid, sulfur (Exoderm), valaciclovir (Valacyclovir), fluocinolone acetonide and acetic acid (Vinegar). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, itchy scalp, tingling sensation and ear pruritus were not recovered/not resolved.   It was unknown if the reporter considered the rash, itchy scalp, tingling sensation and ear pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 83 or 84 years. After the second dose, the patient experienced rash on her right face, behind her ear and on her scalp, her scalp itching was very severe.  Her HCP (health care provider) gave her shampoo, selenium sulfide lotion 2.5 percent, exoderm cream, valacyclovir and fluticasone acetonide scalp oil.  The rash was not improved and actually gotten worse and spread to her left neck.  No hospitalization required. The patient experienced a itchy scalp. She reported that this itchiness had spread to other areas including her right and left jawbone, her back, as well as her ears. She reported that the itchiness was a tingling sensation and was still present and not resolved.  The physician recommended various shampoos and lotions, which had no effect.  She reported that, she had used witch hazel and clear vinegar, which had helped take away some of the itchiness. No further information reported. She also reported speaking with someone from GSK in who recommended a biopsy.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062019:same reporter
SHORTNESS OF BREATH; NAUSEA; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: YYZ24Z, expiry: 24-JUL-2021) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-JUN-2021, the subject experienced shortness of breath. On 23-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and nausea. This report was non-serious.
Information has been received from a RN concerning an 11 year old male who on 23Aug96 at 10:25 was vaccinated with a first dose of Varicella virus vaccine live (lot 617265/0566D) (SC) in the left leg. On 17Apr04 the pt developed an itchy, raised rash, and headache. The pt recovered. Unspecified medical attention was sought. No product quality complaint involved. It was also noted that the pt's sibling had also developed symptoms following vaccination with varicella virus vaccine live (WAES0405USA00092). No further information is expected.
Large spreading lump that went down after three days, started the day after the vaccine, 8 days following the vaccine injection site has puffed up and is itchy and painful
Patient received first dose on 4/8/21 and received second dose today 5/27/21, seven weeks later. Second dose is past the recommended time frame.
I am losing large amounts of hair.  Not thinning, LOSING larger areas of hair.  The skin is very smooth, not one bit of hair left.  The spots are increasing.
pt recv vax 21AUG98 & 2 days p/vax exp severe pain dx w/fibromyalgia, irritable bowel synd, insomnia, chronic h/a & body aches;
Varicella - Information has been received from a consumer who is a healthcare professional.  She is a 39 year old female who was vaccinated on 31 Mar 1996 and 22 Apr 1996 with one dose of varicella virus vaccine live from a family practice office Unknown site.  The patient report that on 15 Jan 2000 she was exposed to a child with severe chicken pox who was covered with lesions and she performed strep test on child.  On 20 jan 2000 the patient developed chicken pox approxiamtely 30 lesions.  The patient reports that her 2 children who received varivax at the same time she did did not develop chicken pox.  The patient reports that she did not see her family MD but saw the pediatrician she works with who treated her with Acyclovir.
About once a week I feel as though someone is extracting air out of my lungs.  This is not the same as being out of breath. I am workout daily to include running and have never experienced the feeling of having air removed from my body.
Patient had a sore arm after both doses (Pfizer dose #1 1/18/22 and Pfizer dose#2 2/11/22) but after second dose developed fatigue 5 days later and then had fevers staring 2/24/22 (T 103 F), poor appetite and was admitted to the hospital Presented with fever and elevated creatinine Dx: Interstitial nephritis confirmed by biopsy.  Treatment with steroids. Pulse methylprednisolone for 3 days, daily prednisone 1mg/kg for 2 weeks, and then spaced to every other day for a week with worsened kidney function. Restarted steroids 1mg/kg for 4 weeks and then completing a steroid taper of 10 mg every week that then decreased to 5 mg for a week to end the taper.
2 weeks after receiving TYPHIM injection her left arm developed muscle spasms that continue - PCP evaluated as anxiety?
Initial information received on 25-Sep-2018 regarding an unsolicited non-serious case received from an other health professional (physician's assistant). This case is related to 2018SA269762, 2018SA274519, 2018SA274520, 2018SA274521, 2018SA274522, 2018SA274523, 2018SA274524, 2018SA274525 (same reporter). This case involves 69 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UI993AB), expiry date 18 Mar 2019 via intramuscular route that were not considered valid due to prolonged shipping and unknown temperatures on 18 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that Vaxserve delivered FLUZONE HD 0.5mL the week of 09 Aug 2018 and it took 3 days to deliver, was told by Vaxserve that doses were viable at that time and temp indicator in shipping container did not show a change in temp, then received call from Vaxserve on 25 Sep 2018 stating that doses were not viable from  hipping excursion, doses were given to nine patients. It was not reported whether the patient experienced any adverse event following the vaccination. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
5/17/16 at 2000, fever started and it was 102.3 mom gave TYLENOL. Next morning woke up fine. Day care called mom, at 1400 of 5/18/16. They said he had fever of about 102.3 again and that his hands were very cold and his lips looked bluish in color. Mom picked him up and fever was still 102 at 1445. Mom gave TYLENOL. 1545 temp 100.1, woke up at 1900 after an hour as he was crying but very hot. Took temp it was 103 axillary then he started shaking, his whole body, lasted 30 sec. Mom gave him a dose of MOTRIN and dad took him to the ER at hosp. The ER said to overlap TYLENOL and MOTRIN as needed for fever. Parents though he was having a seizure but ER per mom basically said he was just upset. Also at 1900 when he was shaking mom said his heart was beating really hard and fast. Today, 5/19/16 seems fine per mom.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 22-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported. There was no adverse effect reported. This is one of several reporter received form the same reporter. Additional information has been requested.
Tired/fatigue; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program  and Medical Information Team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on Monday (an unspecified date), 2nd dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was wondering why he was experiencing severe side effects, due to people telling him side effects happened 1 to 3 days after Pfizer COVID-19 vaccine. The patient felt only a bit tired and fatigue. The outcome of the event was unknown.  Information on the lot/batch number has been requested.