chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of sneezing in a female subject in her 30's who was vaccinated with FLUARIX (GlaxoSmithKline). On 11 October 2011 at 13:30 the subject received a dose of FLUARIX. On 12 October 2011, 1 day after vaccination with FLUARIX, the subject experienced sneezing. On 22 October 2011, 11 days after vaccination with FLUARIX, the subject developed chills, a sore throat, body pain, cough, nausea, vomiting, headache and eye pain. At the time of reporting, sneezing and body pain were improved and chills and sore throat were resolved. According to the reporter, all four of these events were probably related to vaccination with FLUARIX. The outcome and FLUARIX attribution of cough, nausea, vomiting, headache and eye pain were not known, although a note was made that these symptoms lasted several days. It was indicated that a coworker who did not receive the FLUARIX vaccination, but had been exposed to the subject had not gotten sick; therefore, the reporter believes the subject's symptoms were not a contagious illness, but rather a reaction to the vaccine. Two additional subjects experienced events following vaccination with FLUARIX. Linked cases are A0951445A and A0951453A. Follow-up information from the healthcare professional was received on 6 December 2011. On 11 October 2011, immediately after the subject received FLUARIX, she experienced mild runny nose and sneezing. On 27 October 2011 she experienced chills, sore throat, body pain, cough, nausea, vomiting, headache, eye pain, blurry vision, stomach upset and lack of sleep. On 28 October 2011, she additionally experienced "sweaty", dizziness and fatigue. On 29 October 2011, she continued to experience sore throat, headache, dizziness, upset stomach and fatigue. The healthcare professional provided an end date of 30 October 2011 for sneezing, chills, body pain, cough, nausea, vomiting, eye pain and blurry vision. An end date of 31 October 2011 was provided for events sweaty and lack of sleep. And an end date of 01 November 2011 was provided for sore throat, headache, dizziness, upset stomach and fatigue. On unspecified dates runny nose resolved. The healthcare professional indicated that the events may have been associated with suspected transmission of an infectious agent via a medicinal product (flu shot). The healthcare professional indicated that the events were serious but did not provide criteria for seriousness. The events "caused loss of work". No others who came in contact with the subject became ill. The healthcare professional considered the events were probably related to vaccination with FLUARIX.
an insulin-dependent diabetic pt was vaxed 21APR95 on 22APR pt was exp peculiar feelings in the arms & legs;24APR pt devel severe hypoglycemia;no further clinical details provided
Patient says dose was given too low - no direct observation of the effects by me (the pharmacist/administrator of the shot). Patient reports arm swelling, warmth, and redness of the area. Patient has taken ibuprofen, acetaminophen, and Benadryl to help with the swelling, but she says it does not help. Patient says she will go to the doctor's office.
I started having muscle pain, chills and headache on 01/14/2021 lasting for 24 hours.
redness; pain; swelling; discoloring of the injection site; skin with raised red bubbles that look shingles; itchy; developed a little area of itchy red raised blisters; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site discoloration, injection site rash, injection site itching and injection site blisters. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, injection site discoloration, injection site rash, injection site itching and injection site blisters were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, injection site discoloration, injection site rash, injection site itching and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The patient stated that the arm blew up and was red and swollen for day. The patient also developed a little area of itchy red raised blisters near the vaccination site. The patient asked could the reaction be shingles. The patient was not a healthcare professional. The patient had pain, redness and swelling and discoloring of the injection site for over 2 weeks. The patient also had a patch of skin with raised red bubbles that look like pictures of seen of shingles. The patch of skin was near injection site. The patient concern was could have developed Shingles from the vaccine. The reporter was not able to provide the answer and recommended to speak with healthcare provider regarding shingles.
7days after receiving vaccine hard itchy swelling appeared at injection site.   Next morning two inch round spot appeared. Like sunburn not rash.
sore arm/muscle; sore arm/muscle; This is a spontaneous report from a contactable consumer (patient). A male patient (Age 73; units: Unspecified) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution of injection, Lot Number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and the concomitant medications were not reported. On an unspecified date the patient experienced sore arm/muscle. The reporter reported that 3 and 1/2 weeks ago the patient took the first shot, everything went good and it felt like it was kicking in and it went well. The patient didn't have any allergy or reactions. The patient had a sore arm/muscle for a little while and then felt good. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Pt recvd MMR vax on 18JUL90; on 26JUL90 devel fever; Next day, t103 r, cranky, extremely irritable; PE revealed neck was stiff; On 28JUL90 devel pink, slightly raised rash on torso & neck;
Day of vaccine: Very sore at site an hour or so following injection Body aches, pains, fatigue a few hours after injection Sour stomach and mild headache that evening after dinner Body pain, aches, chills and mild fever during the night and into next morning Day 2: No appetite Worsening headache and fever (did not have thermometer) through the morning slept off and on uncomfortably all day Bad headache and fever by evening continued to bedtime Took one Tylenol and 5mg of Diazapam and went to bed at 7:30pm Woke at 9:30pm in pool of cold sweat, fever had broken Went back to sleep, slept restlessly Day 3: Feel weak, very mild headache, mild nausea, mild body aches. Able to shower and go to work.
Information has been received from a 14 year old female who was vaccinated with all three doses of Gardasil on unspecified dates. Subsequently the patient experienced nausea, dizziness and heart rate dropped into the 20s after receiving the first vaccination. No further information was available. The patient's outcome was not reported. Additional information has been requested.
pt recv vax 20MAR96 & 21MAR96 pt exp pain @ inj site;inflammation or tenderness was not noted;23MAY96 pt recovered;
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not provided. It was reported that since 17-JAN-2017, the patient have been administered doses of improperly stored ROTATEQ Oral liquid (orally, lot # reported as M039744, expiration date 26-APR-2018) for prophylaxis (strength and dose were unknown). On an unknown date, the vaccine was reported to a temperature excursion between 0 Celsius degrees and 2 celsius degrees for 48 hours. There was no previous temperature excursion. The call was made because if a digital data logger. No adverse effects reported. This is one of several reports from the source. Additional information has been requested. Sender's Comments: US-009507513-1701USA013818: US-009507513-1701USA013631: US-009507513-1701USA013820: US-009507513-1701USA013821.
and multiple golf ball-sized clots.; Extreme menstrual period; High pain, extremely heavy flow; High pain, extremely heavy flow; This is spontaneous report from a contactable consumer (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 07Apr2021 11:15 (Lot Number: ER8734) at the age of 35-year-old, as 2nd dose, single for covid-19 immunisation. Medical history included known allergies Latex and Penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccine included first dose of bnt162b2 (lot number: EN6206) on 17Mar2021 11:15, administered in right arm, for covid-19 immunisation. The patient's concomitant medications were not reported. The patient had extreme menstrual period (unlike her typical cycle) experienced about 18 days after the second shot. High pain, extremely heavy flow (more than an oz and hour sustained for almost two full days), and multiple golf ball-sized clots. Events occurred on 25Apr2021 07:30. No treatment was taken for adverse event (AE). Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered.  No follow-up attempts are possible; information about lot/batch number obtained.
Myalgia, NauseaVomiting, very foggy, hard time focusing, tired, headache, sore Narrative:
Pt states he developed hives all over his body after FLUZONE HD shot. He stated his skin felt like it was burning. He took a CLARITIN and it resolved.
Pt. was noted to have a bald circular area on scalp 3 days after vaccine given - diagnosed with alopecia by dermatologist.
12Feb98 pt recv 1 dose vax. 21Feb98 pt devel 3 pox. 1 under the arm,1 on back & 1 on trunk. 23Feb98 pt was covered w/over 100 lesions & exp itching & discomfort.
This spontaneous report as received from a physician via a company representative refers to a 64 year old patient (gender unknown). On an unknown date the patient was vaccinated with VARIVAX (Merck) (lot number and expiration date not reported), subcutaneous. There was no concomitant medication reported. It was reported that on an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) instead of the intended ZOSTAVAX. No adverse effect reported. Additional information has been requested.
"pressure" headache, fever of 100.3, calf and feet cramps, sore arm (injection site) . Slept most of day. Woke up to slight soreness in arm, no fever, muscles back to normal, "pressure headache" until noon, then okay.
Headache chills, 99 degree F temp, tired for 24 hours, soreness at injection site, body aches, mild nausea Narrative:  employee gave consent for information to be share with FDA and CDC, felt that event was not over yet, still experiencing some chills at time of interview, Jan 6, 2021, 10:30am.
Vaccines administered 4/4/18; Bell's Palsy of right side of face: symptoms started 4/6/18; seen in office 4/10/18, sent to ER; Lyme titers returned from 4/10: negative; 4/18/18 f/u in office: symptoms improving. if persistent facial weakness will send to neurology for f/u.
Patient is a 69 year old female who presents for ER f/u. On 8/1/13, she was given the PNEUMOVAX vaccine in the left deltoid in this office. Within an hour or two of having received the shot, she developed swelling and pain in the area of the injection as well as red streaking distal to the injection site. Symptoms started to relieve with BENADRYL. In ER, she was in no respiratory distress and was given one PO dose of KEFLEX and Rx for KEFLEX for 5 days for prophylaxis, thought there was no cellulitis present at the time. She was advised to continue BENADRYL and discharged home. Symptoms have entirely resolved since that time. She continues the BENADRYL three times daily, and doesn't think she needs anymore ibuprofen. She has received vaccines and flu shots in the past with no problems. Is unsure if she had ever received a PNEUMOVAX prior to 8/1/13. She shows me a picture on her phone of what her left arm looked like after the injection it is noticeable red and swollen around the entire upper arm.
had one episode of vomiting this morning; feel poorly; she developed a cough with some SOA when she breathes in; she developed a cough with some SOA when she breathes in; Stomach upset; Hands are red; fingers turn black before going back to original color; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021SGN04754.  An elderly female patient received bnt162b2 (BNT162B2), administration date 10Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; tucatinib (TUKYSA) (Batch/Lot number: unknown) for breast cancer female. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 14Sep2021, outcome "unknown", described as "feel poorly"; COUGH (non-serious), DYSPNOEA (non-serious) all with onset 14Sep2021, outcome "unknown" and all described as "she developed a cough with some SOA when she breathes in"; VOMITING (non-serious) with onset 21Sep2021, outcome "unknown", described as "had one episode of vomiting this morning"; ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as "Stomach upset"; ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "Hands are red"; SKIN DISCOLOURATION (non-serious) with onset 2021, outcome "unknown", described as "fingers turn black before going back to original color". The action taken for tucatinib was unknown. Therapeutic measures were taken as a result of abdominal discomfort.  Additional information: The patient got her COVID vaccine last Friday and yesterday (14Sep2021) she began to feel poorly, she developed a cough with some SOA when she breathes in. She also had one episode of vomiting this morning. The patient believed this was related to the Pfizer vaccine she received. Patient had some stomach upset at times that resolved with eating. Her hands were red and sometimes her fingers turn black before going back to original color. MD was aware. Missed 3 days of doses about 2 weeks ago due to shipping error.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received via litigation article regarding a case in litigation concerning a male who was vaccinated with RECOMBIVAX HB. Subsequently the patient experienced psoriatic arthritis. The outcome of psoriatic arthritis was not reported. Additional information has been requested.
Patient passed out for around 30 seconds.  This was about 20 minutes after the shot was administered.
Tenivac was administered subcutaneously instead of intramuscular with no A/E; Initial information was received on 14-Dec-2021 regarding an unsolicited valid  non-serious case from a pharmacist via physician (under Inquiry Number: 00897326).  This case involves a 53 years old female patient who was administered DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] subcutaneously instead of intramuscular with no adverse event (incorrect route of product administration).   The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On 13-Dec-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number: C5779AA and expiry date: 02-Mar-2024) via subcutaneous route in the right arm for prophylactic vaccination.  It was reported "She wants to know if there any additional steps that need to be taken. The Pharmacist reported that she does not have specific information on needle size used or where on the right arm the dose was injected and that she was calling on behalf of one of their ambulatory centers; and that pharmacovigilance (PVG) can follow up with her if need be."  It was a case of an actual medication error due to inappropriate route of vaccination (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Flu vaccine was given on 10/15/20, that night she complained of left arm pain into neck, took naproxen with improvement. 10/17/20 she had a droopy left eye, saw her opthalmologist on 10/19/20 and given steroid drops. She has f/u in 2 weeks. She has not seen much improvement with eye drops.
Lymph Nodes Swollen/swelling of his lymph nodes near his armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04May2021 19:48 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Verbatim: Asthma. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1: Covid vaccine, Anatomical Location: right arm), administration date: 13Apr2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06May2021, outcome "unknown", described as "Lymph Nodes Swollen/swelling of his lymph nodes near his armpit". Additional information: Other Conditions has been a life-long condition; but is well controlled. Patient is curious because it looks like he had a side effect on his lymph nodes near his armpit. Patient does not have his vaccination card available. He also does not have any other information containing the Lot Number for his vaccinations. Relevant Tests none. Vaccination Facility Type is Pharmacy. Adverse event does not require a visit to Emergency Room or Physician Office. The patient had not received prior vaccinations within 4 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse who had read reviews on an unspecified web site on the Internet that refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patients were vaccinated with unspecified doses of ZOSTAVAX (route of administration, anatomical location, lot number and expiration date were not reported). There were no concomitant medications provided. The registered nurse reported that many of the reviews from an unspecified web site, stated that the patients developed shingles about 2 years after receiving an unspecified dose of ZOSTAVAX. The outcome of herpes zoster was not reported. The reporter did not assess the relatedness of ZOSTAVAX. This is one of several cases from the same reporter. Additional information has been requested.
Heavy menstruation July 22-25. It was enough to bleed through a normal tampon in just a few hours. I have not had a period that heavy in years. I don't think I've had one that heavy since I started taking birth control in 2011.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 17-OCT-2012, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration was unknown) as recommended for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster with extensive complications. On or about 28-OCT-2013, the patient was treated by a physician for the onset of a blistering vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 01-NOV-2013, the patient was treated again for ongoing and worsening symptoms, particularly as they affected her face. The patient was then diagnosed with the condition of trigeminal neuralgia, secondary to shingles. On or about 22-OCT-2014, the patient sought treatment by another physician for worsening facial pain attributable to the shingles which caused her facial paralysis, pain in her eyes, and trouble chewing and eating. On or about 03-JUN-2015, the patient underwent additional treatment from her initial treating physician for new and worsening shingles outbreaks. The patient was also treated by yet another physician, a neurologist, on or about 06-JUN-2015, who affirmed the diagnosis of severe shingles. Subsequently, on or about 14-OCT-2015, the patient was treated by the neurologist for continued facial pain, which was diagnosed as chronic trigeminal neuralgia on the left side, secondary to herpes zoster infections. On or about 12-NOV-2015, the patient was treated by a physician in the emergency department for severe migraines. The patient was then diagnosed with additional herpes zoster infections with visual disturbance and chronic migraines caused by her trigeminal neuralgia. Throughout her extended treatment of these conditions, the patient has been prescribed acyclovir, gabapentin, carbamazepine (TEGRETOL), acetaminophen and hydrocodone (NORCO), and tramadol for management of her excruciating symptoms. As a direct and proximate result of the defect ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further and proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not recovered. Upon internal review, facial paralysis was considered medically significant. Additional information has been requested.
I was put on high blood pressure medication which dehydrated me and I am no longer on the medication because blood pressure is find now. The vaccine caused it to spike and I was given nitro glycerin and rushed ER for treatment and observation. I had bruising all over my body which started around 05/10/2021 and I'm still getting bruising in places where I should not have it.