chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; headache; pain at injection site; fatigue; body aches; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: EW0158) at the age of 34 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing). Concomitant medications (in two weeks) included: PROZAC; METFORMIN; NUVARING; SYNTHROID. Vaccination history included: Bnt162b2 (Dose 1, single, administered in left arm; Lot number EN6204), administration date: 12Mar2021, when the patient was 34 years old, for COVID-19 immunisation, reactions: "Fatigue extreme", "Feeling hot", "Pruritus facial", "Vaccination site pain", "Headache". The following information was reported: NAUSEA (non-serious) with onset 09Apr2021, outcome "not recovered" (also reported as resolved on 10Apr2021), described as "nausea"; HEADACHE (non-serious) with onset 09Apr2021, outcome "not recovered" (also reported as resolved on 10Apr2021), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "recovered" (10Apr2021), described as "pain at injection site"; FATIGUE (non-serious) with onset 09Apr2021, outcome "not recovered", described as "fatigue"; PAIN (non-serious) with onset 09Apr2021, outcome "recovered", described as "body aches". Therapeutic measures were taken as a result of nausea, headache, vaccination site pain, fatigue, pain.  Additional information: nausea, headache, pain at injection site (starting a few hours after injection and lasted about 24 hours) fatigue, body aches (starting a few hours after injection and lasting a few days). Patient had no COVID prior vaccination, and she was not tested for COVID post vaccination. The patient had no known allergies. Patient did not receive any other vaccine in four weeks. Facility type vaccine was reported as other.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021505850 same patient, different vaccine dose/event
patient's arm is swollen at the injection site. patient describes it as the shape and size of a hardboiled egg. it has been over 1 week and it doesn't appear to get any better
12 days ago the patient tested positive for the COVID-19 infection; The patient did not present any sever symptoms when he was diagnosed with COVID-19, only a "small cold".; This is a spontaneous report from a contactable consumer reported for a friend. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for an unspecified indication COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The reporter reported that patient received the COVID-19 vaccine 3 weeks ago and is scheduled for the second dose in two days. Twelve days ago, the patient tested positive for the covid-19 infection on an unspecified date with outcome of unknown. The patient did not present any severe symptoms when he was diagnosed with covid-19, only a "small cold" (onset date unspecified). The outcome of the events was unknown.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on unknown date.  The reporter inquired if a patient who receive the vaccine could be infected with COVID-19, could it make one test positive for the a COVID-19 test, what the recommended maximum time period that a patient could wait in between the first and second dose of the vaccine and if it vaccine should be taken annually.
PER MOM STATES WOKE THAT AM WITH SMALL KNOT ON LLE THAT KEPT GETTING BIGGER BY THAT AFTERNOON.
Initial unsolicited case received from a physician on 21 November 2014. An 11-year-old male patient received the following vaccines at 6:00 pm on 03 November 2014: a right deltoid injection of MENACTRA (lot number U4923BA) and a left deltoid injection of BOOSTRIX (lot number "4 (2) 424", other manufacturer). At 7:00 am the following morning, he awoke with severe muscle pain in the right leg, which was painful on palpation and prevented him from getting out of bed and walking. He was treated with ADVIL beginning on 04 November 2014 and symptoms improved; according to the reporter, the day after treatment (i.e. 05 November 2014) the patient was able to walk and only complained of pain on palpation. He was diagnosed with myositis. It was not reported if the patient was seen by a physician, or if the event had recovered. Documents held by sender: Initial report done in different language, translated on 28 November 2014.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium
PAIN IN LEFT ARM, SWELLING, REDNESS...SAYS SKIN PEELED OFF   PATIENT SAYS IT'S STILL SORE AFTER 10 MONTHS
Flucelvax not approved by FDA for patients under 18. Flucelvax was inadvertently administered to this 15 year old patient. NO ADVERSE EFFECTS. Just reporting.
Myalgia, Fever, arm pain, swelling in hands/feet, swollen glands, chills Narrative:
Caller reports that the person that drove with her also received 3rd dose and she was also very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Caller reports that the person that drove with her also received 3rd dose and she was also very sick) 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.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Caller reports that the person that drove with her also received 3rd dose and she was also very sick). At the time of the report, ILLNESS (Caller reports that the person that drove with her also received 3rd dose and she was also very sick) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up document received contains no new information
wrong vaccine (Moderna) was given to specific age group. Pfizer should of been administered according to patient's age.
I got the vaccine, and within a couple of days, I started having chills, fatigue, nausea, muscle and body aches, and headaches. It got continually worse, and I eventually developed a migraine, blurred vision, tingling, severe nose bleeds, weakness (like peripheral neuropathy). The symptoms all got worse and worse, and I eventually went to the neurologist. They did a CT venogram; the results were normal. The BP was elevated, and they noted I had a really high heart rate. My blood work had abnormalities on the CBC and metabolic panels. I was sent back to my PCP and he found abnormal results in my blood work, plus he found abnormalities in the test for thyroid stimulating hormone. I still had elevated BP. A PCR COVID test was done, and I tested negative. They also tested for antibodies to see if I was responding to the vaccine; no antibodies were detected. They said it was weird and that I probably had lingering vaccine side effects that would go away, and in case the COVID test was wrong, I was advised to self-isolate. They plan to conduct further thyroid tests and blood work in the future to see if there are any changes. I am still having all the symptoms, and on 7/13/2021, I developed symptoms that are consistent either kidney stones or kidney infection. I plan to see my doctor to have this looked into.
On 2/5/12, patient developed a fever of up to 102.7 & had two febrile seizures 4 hours apart. Patient was observed in the ED & discharged to home in his baseline neurologic condition, to use DIASTAT PRN if seizures recur.
I was vaccinated at 3:07 PM. I had no reaction immediately after the vaccine. After I got home, I began to feel mildly nauseous around 6 or 7 PM. Then, sometime between 7 and 8 PM, I had a bought of vomiting and diarrhea. I continued to experience vomiting and diarrhea periodically through the night, until about 2 AM. I threw up a total of 5 times. The following day I experienced a fever, aches, and fatigue. I?m not sure if this is a case of a stomach bug overlapping with side effects from the vaccine, or if the vomiting and diarrhea were also side effects of the vaccine.
I had a fever, chills, every muscle in my body ached. I couldn't sleep, head congestion and lost of taste. Not too much of a cough.
Pt experienced pain, malaise, extreme redness and heat, headache. Pt applied ice and took BENADRYL and it was slowly getting better.
Immediately after receiving the vaccine my heart started racing, and my vision started going black, like I was going to pass out. My arm hurt, and towards evening I felt exhausted. I went to bed early, but then woke up at 11:30 with severe body aches, severe arm pain, a fever, and nausea.  the next day I found a baseball sized lump in my right armpit that has been extremely painful to the point that I could barely move my arm. I also started having headaches. I am still suffering with headaches and occasional nausea and severe tiredness.
high fever 105 @ home & 102.5 in clinic p/giving APAP & inconsolable crying;
Menstrual cycles have been more inconsistent since the vaccine was administered. Pt was on period and spotting for about 50 days in total.  Pt went to a Drs office for a physical, a pap smear and HPV testing. Results came back normal. Ob/gyn prescribed birth control pill to regulate periods taken daily. Since beginning birth control, spotting was still consistent, every day. Pt was prescribed a different form of  hormonal birth control pill  which pt has not began yet.
she has felt unwell; back of thigh and lot of pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 04Mar2021 (Lot number: EN6201) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN9809, Expiry date: 30Jun2021), for Covid-19 immunization. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "she has felt unwell"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "back of thigh and lot of pain".  No follow-up attempts are possible. No further information is expected.
No Additional adverse effect reported.; PNEUMOVAX 23(syringe), that experienced a temperature excursion was administered.; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-JUN-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T034630 has been verified to be a valid lot number, expiration date 22-JUN-2022 (dose, route of administration, anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored above 9 degree Celsius (9.1 C) for 46 minutes.. There was no previous temperature excursions reported. The digital data logger was involved. No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T034630; expirationdate: 22-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
pt recvd vax 8DEC92 states that day pt stiffened & screamed for 45 mins @ a time; vomited 10 times would eventually fall asleep but when awakened stared next day was fussy; 3rd day was OK;
The first few hours after the shot, I was fine other than the typical soreness at the needle site.  However, by 11 p.m, I developed severe achiness/pain everywhere on my body - toes/fingers, legs, everywhere, as well as a very strong headache.   I didn't take my temperature, but also had severe chills.  This severity of symptoms lasted throughout the night.  Every 3 hours, I took 2 extra-strength Tylenol, so I reached my limit of meds for a 24-hour period within 10 hours.   The next morning, I still felt awful and stayed home from work.  Around 5:00 p.m, I felt like my pain had subsided from a 9.5 to a 5, and by 11:00 pm, at about a 3.  The next morning (today), I would say about 2.  By mid-afternoon, I am fine.
LEUKEMIA; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry was not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  It was reported that "my buddy got leukemia from the shot, unbelievable/one friend got leukemia". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leukemia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220245881.; Sender's Comments: V0: 20220245849-COVID-19 VACCINE AD26.COV2.S-Leukemia. 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. Therefore, this event is considered unassessable.
Pt. called complaining of a hard lump with soreness at the site of injection. Pt. given appt. and checked by Dr. on 6/1/17.
This case was reported by a consumer via call center representative and described the occurrence of erythropapular rash in a 73-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date unknown) for prophylaxis. The patient's past medical history included shingles (7 years ago had the live shingles). On 11th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, 1 day after receiving SHINGRIX, the patient experienced erythropapular rash, erythromacular rash and pruritus. On an unknown date, the patient experienced sleep decreased, discomfort, exhaustion and injection site pain. The patient was treated with prednisone and cetirizine hydrochloride (Zyrtec). SHINGRIX was discontinued. On an unknown date, the outcome of the erythropapular rash and injection site pain were recovered/resolved and the outcome of the erythromacular rash, pruritus and exhaustion were unknown and the outcome of the sleep decreased and discomfort were not recovered/not resolved. The reporter considered the erythropapular rash, erythromacular rash, pruritus, sleep decreased, discomfort, exhaustion and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient described the symptoms as red, itchy bumps everywhere on the body, red splotches on the back and both sides and the newest symptom includes red splotches under the lips. On same day on initial reporting, the reporter provider more details of the events. The reporter stated that the red itch spots were almost every part of her body except from the nose up. She stated that she had been visited to 3 doctors for treatment of events. She was given prednisone and a cream that did not help. Then she went to an allergist and he changed the cream to and told her to take Zyrtec and then last weekend the red spots were bad again so she went to a clinic. She said the ointment helps but it wears off. She said that the redness and itchiness started around her waist, stomach, back and shoulder. She said it was not painful just red and itchy. She said her symptoms were getting worse and that hardly anywhere on her body where she did not have the redness or itchy bumps. She wants to know what could be done to stop this reaction. She said she had not changed detergents, soaps or eaten any different foods. She said that one doctor and one pharmacist had advised her not to get the second shot in the SHINGRIX series. On an unknown date, less tha year after vaccination, the patient experienced sleep decreased, discomfort, exhaustion and injection site pain. The patient stated that, she had only been able to get 3 to 4 hours of sleep per night because she was not comfortable and her legs itch. The patient was wearing herself out (due to lack of sleep). The patient said, she had not much pain or no pain at the injection site and no redness at the injection site.
Extreme chills first 2 days and nights. Muscle pain, joint pain, stomach pain and nausea during the 24 hours after injection. Headaches, night sweats 3 nights. Arm red and itching below injection site. This lasted several days. Stuffy and burning nose. Day 4 back of neck started itching and lasted several days.
couldn't locate a dose anywhere; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in spring 2018).   On 23rd November 2019, the patient received the 2nd dose of Shingrix. On 23rd November 2019, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were received as follows: The patient could not locate dose anywhere until the date of vaccination for 2nd dose.  The reporter did not consented to follow up. Patient said she did not want a phone call nor a letter from the company.
22 y/o developed non virulent pustules 2 hrs to small pox vaccination rash developed around 9 days after inoculation
The COVID-19 vaccine administered through vaccine administrator,  between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
3 weeks After 2nd dose. - November 2021 - awaken in the middle of the night with extreme pain in my head.  I couldn?t move as I thought my head was going to explode.  Felt something move from the left side of my forehead to the right side of my forehead.  As the pain started to subside I was left with headache for days.  Headaches would come back periodically.  Second episode was in December, same extreme pain in my head waking me in the middle of the night but this time only on my right side.  Have had chronicle headaches off and on since.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies: shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of covid-19.  Clinical course: it was reported that event COVID 19 Treatment was treated with Paxlovid from 01Jul2022 to 06Jul2022.   Follow-up attempts are completed. No further information is expected.
This case was reported by a physician and described the occurrence of chronic fatigue in a teenager female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included asthma. On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site and batch number). At an unspecified time after vaccination with CERVARIX, the subject experienced chronic fatigue in the first year of high school until the third year of high school. Tests in the orthopedic surgery department showed no abnormalities. Although the subject regularly attended clinic for symptoms such as asthmatic attack during the period, the subject made no complaints of chronic fatigue. At the time of reporting, the event was resolved. The causal relationship to CERVARIX was unknown. Follow-up information received on 12 May 2014: On an unknown date, the subject had chronic fatigue until the third year of high school after receiving vaccinations (unknown number of vaccinations) in the first year of high school. No further information was available, therefore, the case was closed. Follow-up information received on 07 July 2014: A201404982 was identified as a duplicate of A201403509. A201404982 was voided and all future information shall be reported to A201403509. Concurrent medical conditions included asthma. Concurrent vaccination included CERVARIX; GlaxoSmithKline; intramuscular; left arm given on 29 January 2011 and 2 August 2011. On 4 March 2011, the subject received 2nd dose of CERVARIX (intramuscular, right deltoid). Less than one month after vaccination with CERVARIX, the subject experienced chronic fatigue, chronic pain, generalized pain, exertional dyspnea and malaise. On March 2011, around this month, the subject had chronic pain (generalised aching) and chronic fatigue after the vaccination. She experienced exertional dyspnoea while she was walking. She had malaise, and could not climb stairs. She could not attend classes because of fatigue. On 02 August 2011, the subject was vaccinated with the third dose of CERVARIX at clinic A. On an unknown date, the subject underwent detailed examination at the department of orthopedics in hospital B, which revealed no abnormalities. On 01 May 2014, as of this date, the symptoms persisted. The causal relationship to CERVARIX was not provided for chronic fatigue, chronic pain, generalised aching, dyspnoea exertional, malaise). On an unknown date, detailed examination at the department of orthopedics in hospital B revealed no abnormalities. At the time of reporting, the events were unresolved. Follow-up information received on 05 August 2014: On 04 August 2014, as of this date, the subject was referred to Hospital C in the spring, the outcome was unknown. Follow up information was received on 29 Sep 2014. On 25 April 2014, at the time of pain, the patient used BRUFEN (100) 2 tablets on an as needed basis. Poultices including LOXONIN poultice and MS poultice were applied to the site of pain.