chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: ER8729), on 01May2021 as dose 2, single (Lot number: EW0173) and on 13Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 42 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 24May2022 as dose 4 (booster), single (Lot number: 056M21A) and on 22Sep2022 as dose 5 (booster), single (Lot number: AS7163B) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative using at-home antigen tests on Day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient tested negative using at-home antigen tests on Day 7 and Day 8 of illness (1 day and 2 days after completing Paxlovid series). Sinus congestion, nasal drip and sore throat reemerged on Day 12 (6 days after completing Paxlovid series).  No follow-up attempts are possible. No further information is expected.
The day after vaccination pt. experienced dull ache @ injection site took ibuprofen w/relief. This dull ache lasted until the end of Dec. Dec 31, 2009 arm became very still pt. saw PCP. Pain increased. Had treatment w/massage therapy and cold laser. Jan 24 developed a red rash, fever and nausea L arm chest, back. Seen by PCP & orthopedic sx. R/o bone infection, frozen shoulder. Doesn't believe rash is shingles. Pt. currently being treated with predinisone. Orthopedic sx. Dr. feels she has a frozen shoulder due to H1N1 vaccine. Pt. to begin physical therapy.
4:38 pm Post vaccination reports feeling symptoms including: dry throat, dizzy, light headed Medical assessment w/vital assessment: BP 141/86 P 99 O2 sat 99% RA; 4:50pm rest w/ symptom resolve, BP 116/86 P90 Released from facility w / parent
Information has been received from a registered nurse concerning a 46 year old female who on 09-Jan-2006 was vaccinated intramuscularly in the right arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Later that same day on 09-Jan-2006, the patient developed redness, pain, swelling, and hardness to her right arm. On 10-Jan-2006, the patient contracted the office to report the symptoms and that she could not lift her right arm. The physician started the patient on therapy with prednisone 50 mg. The nurse confirmed that the patient received no other treatment. At the time of this report, the patient had not contacted the office again, and it was unknown if the patient had recovered. The patient's redness, pain, swelling and hardness of her right arm, and decreased mobility of right arm were considered to be disabling and other medical events (OMIC). Additional information has been requested.
Dizziness, Headache, Myalgia, Tachycardia,  CHILLS; FEVER; INJECTION SITE REACTION Narrative:
The Fluzone HD 65+ PF 2021-22 INJ 0.7 ML vaccine gradually sapped my strength to the degree that I had trouble just getting up off the toilet that night. It also gave me a migraine headache which lasted overnight and into the next day, chills (but no fever), and the experience of an actual flu infection especially the first night. It felt ?too strong?. I?m reporting the experience because I think seniors should be advised and specifically warned about muscle weakness, especially if they live alone, and recommended to have someone on call or standby or even with them, as a safeguard. I live with my son, so that was not an issue for me, even though the experience was frightening.
Got vaccine and 2-3 hours afterwards, was at home, and had a seizure which she has not had in a number of years.  She has a routine that she knows when she has a seizure coming on, she immediately went to the floor, pushed things away that she may hit.  When she felt like she could get to a safe place she grabbed her phone and got there, she was able to move enough to move into the bed, wrap in the covers and if it was a tonic clonic she would not be ideally harmed.  Then had immediate sleep for over 12 hours, took her medicine in the middle of the night when she awakened but suffered the next day due to missing her dose due to sleeping, which affected her thought processes the next day and also with the brain damage that she already has.  She did report to the epilepsy center and also to her PCP.  The evening she again had another seizure, felt the effects coming on again repeated the process that she did the day before.  She did have the 12 hour sleep after that one as well.   She has also had pain in her thighs, hamstrings, feverish feeling.   She is still suffering the effects from the seizure.
Serious chills at night of injection, causing me to wake up and take a hot bath; intense headache lasting from night around 6pm until about 4pm the next day, finally too 100mg Tylenol at 1pm the next day, which helped; aching in muscles throughout the night and morning of the next day, including injection site; cramping in extremities on night of injection (hot bath solved this).
This spontaneous report was received from a physician and a nurse, via a company representative, referring to a 2 year old male patient. The patient's concurrent conditions and medical history were not provided. The patient did not have any drug reactions/allergies. On unknown days in February 2015 and March 2015, the patient was vaccinated with PREVNAR13, administration route, lot, expiration date and dose unknown. On 09-APR-2015 the patient was vaccinated with a dose of PNEUMOVAX23, administration route and dose unknown (lot # K020215, expiration date was not reported). After receiving the dose of PNEUMOVAX23, on an unknown date in APRIL 2015, the patient experienced tenderness in his leg,  he also could not walk on his leg after he received the vaccine and the leg was also red. It was reported that no treatment was given for the event and no laboratory tests were performed. At the time of this report, the outcome of the events were reported as recovered on an unknown date in 2015. Additional information has been requested.
Information has been received from a 24 year old female consumer with PAXIL allergy and no pertinent medical history who on 06-MAR-2008 was vaccinated with the first dose of GARDASIL vaccine 0.5 mL IM. There was no concomitant therapy. The patient experienced a diminished sex drive soon after starting therapy. On 06-MAY-2008, the patient was vaccinated with the second dose of GARDASIL vaccine 0.5 mL IM. There was no concomitant medication. On 06-MAY-2008, the patient experienced diminished sex drive much more soon after starting therapy. The patient's diminished sex drive persisted. The patient did not seek medical attention. No further information is available.
Hpv infection; This spontaneous report has been received from a nurse, referring to a 30-year-old female patient. The patient had no medical history, no concomitant medication and no drug reaction/allergy  On an unknown dates, the patient was vaccinated with the Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb (GARDASIL) (lot# with expiration date unknown by reporter; strength, dose, frequency not reported) series intramuscularly for prophylaxis when she was 14 or 15 years old.  In November 2019 (reported as two months ago), the patient was diagnosed with human papillomavirus (HPV) infection. The patient had sought medical attention. On an unspecified date, the patient was treated with a colposcopy. The outcome of event was reported as not recovered. The causality assessment was not provided by the reporter.
Initial report received from a health care professional on 15 Oct 2010: This patient was vaccinated with FLUVIRIN 2010/2011 (batch number: 11162401) 0.5 ml dose, intramuscularly on 08 Sep 2010. The patient experienced upper respiratory tract infection; numbness and tingling in hand and feet; balance and gait problems; and incontinence on 24 Sep 2010. Spinal tap was performed and the patient was diagnosed with Guillain Barre syndrome on 08 Oct 2010. The patient was currently in hospital. The outcome was reported as condition unchanged.
Mother reports patient was extremely agitated and unlike himself for 2 weeks following vaccination.  She described as "near inconsolable" .  Cried out in pain frequently.
Initial ones within 6 hours: sore arm, fatigue, headache, nausea, fever (101.8), body aches - these worsened for 3 days.   Then on 1/17 or 1/18 I had chest pain, cough, shortness of breath, worsened fatigue, and mild fever persisted.   Then 1/23 I had a rheumatoid arthritis flare and genital herpes outbreak.   As of today, 1/28, I still have mild chest pain (gets better after 10 minutes of slow deep breathing and focused attention on my heart and lungs).  The third dose for me was a full dose of the vaccine because I have R.A. I did not know this would happen until they administered it. Now I worry about future boosters.
Became ridgid and had jerking muscular movements noted on 10/10/2019
Patient had syncope episode and loss consciousness. She hit her left cheek and forehead on the concrete floor. BP 110/68. Was taken to observation area to be monitored. She laid flat until dizziness subsided and could resume walking. BP 110/68. Husband came to pick her up. She walked without assistance. No other adverse reactions noted.
random episodes of dizziness about once per week; This is a spontaneous report from a non-contactable consumer (patient).  A 23-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 at single dose in arm left for COVID-19 immunisation. Medical history included allergy to pumpkin. Concomitant medications included generic oral contraceptives. The patient experienced random episodes of dizziness about once per week since 16Apr2021. The patient was not treated for the event. On 19Apr2021, 26Apr2021 and 03May2021, rapid sars-cov-2 test resulted negative. The patient did not recover from the event. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
moderna COVID-19 Vaccine EUA rash occured on Feb. 18th on neck sides of face forhead very red very itchy also about a couple of inches on the front of my chest directly under my neck I had a similar reaction after a shingtrex second dose shot which was given January 19th 2021ad a teledoc appt. on Feb. 19th was prescribed to take an antihistamine(claritan or zyrtex and use a cream, triamcinolone acetate for the rash and if needed a benedryl tabblet at bed time but only if necessary due to severe itching the cream gave enough relief in that regard so no benedryl was necessary  I also had a very light head ache and a bit of stiffness in my neck during this time also, although  I don't know if this is relevant to the vaccine I am a carrier of Kennedy disease and occasionally have vessiculations I have not seen any doctor about this but I hbit of that the day after my shotad a slight
9/24/21  5:30 mild headache and backpain, by 6 pm back pain was so bad i could not sit up or stand. 8pm throat started to get scratchy. 9/25/21  8am still had headache & severe back pain. upper left side of back was swollen. left arm felt like it was on fire where injection site was. legs and toes very swollen, mild chest pain and shortness of breath. 1pm throat was swollen and had a lot of trouble catching breath. 4pm went to hospital because had difficulty breathing. blood pressure was very high when i arrived at the hospital 158/111. they administered benadryl and prednisone and fluids. i had chest xray, ekg, covid test and a bunch of labs done.  by 9pm i was breathing better still in severe pain so i went home so i could take some tylenol because the hospital wouldnt give me anything for the pain.  9/26/21 mild headache, feet only were swollen, still had bad back pain and chest discomfort from time to time.  very exhausted and lethargic. 9/27/21 to present day  still having chest discomfort a few times daily.
A long time she fainted after a flu shot.; This case was reported by a consumer via licensee and described the occurrence of faint in a 52-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included post-traumatic stress disorder and sleep apnea. Concurrent medical conditions included epilepsy.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, a long time she was fainted after the flu shot. No further information was available.
No additional AE's were reported; Patient that received a dose of ROTATEQ after it expired. / The patient received their dose on 11-OCT-2022 and the dose expired on 5-OCT-2022.; This spontaneous report has been received from a medical assistant referring a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 11-OCT-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter, lot number 1742084 with expiration date 05-OCT-2022, administered orally for prophylaxis (strength and vaccination scheme were not provided) (expired product administered) No additional adverse events were reported.
6 days after getting the shot her arm was sore. The next day she noticed it was warm and all red where it was injected.
giving shot tomorrow for Plantar fasciitis; This spontaneous case was reported by a consumer and describes the occurrence of PLANTAR FASCIITIS (giving shot tomorrow for Plantar fasciitis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLANTAR FASCIITIS (giving shot tomorrow for Plantar fasciitis). At the time of the report, PLANTAR FASCIITIS (giving shot tomorrow for Plantar fasciitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that the next dose was not scheduled yet but they said within 3 weeks. Patient had an appointment with foot doctor because patient had arthritis. Doctor would be giving shot tomorrow for Plantar fasciitis and would be giving pain medicine. Patient wanted to know that If patient take shot, would that interfere.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Right deltoid arm sore on 09/06/2017 after Influenza vaccine. 09/07/2017 had fever/chills, night sweats, temperature 100F, severe lower/upper back pain radiating to the front of chest, abdominal pain, 10/10. Took 500mg Tylenol, for HA frontal area, wisdom teeth pain, sniffles, applied ice packs to body. Took Epsom salt bath. No nausea, vomiting, diarrhea. Will take today off work , emotionally distraught in tears, has I/A packet.
On March 8th, I started my period 11 days early. I have 94 cycles tracked on my tracking application and my cycle does not deviate from 27-29 days. I had cramps and pain the 9th.  the symptoms that started on 2/28 were normal: site of injection soreness, fatigue, some face flushing and flashes of hot and cold.
Noticed diarrhea, nausea, abdominal pain a few hours after getting flu vaccine; had some low grade fever since then and consistent stomach pain, nausea, diarrhea x 5 days.
Initial misuse report received from a healthcare professional on 22 November 2013. The cases were received on 21 March 2014. It was reported that pregnant female had received last year dose of FLUZONE vaccine. No adverse event was reported. List of documents held by sender: none.
Patient had a sore arm for the first few days and the pain hasn't subsided still. Patient hadn't recovered the full motion of the arm.
patient reported feeling dizzy and faint while waiting the 15 minutes. patient was observed and blood pressure was normal
fell asleep w/in 15 mins p/shot for 2-3 hrs woke up w/high pitched cry for 1/2 unable to eat fell back to sleep for 3 hrs woke up high pitched cry 1 1/2 hrs;
Patient presents to clinic with 5cmx5cm rash to back of neck. States that she feel sharp pain to back sometimes.
Light headed. Heart palpitations.  Faint. Headaches. Weakness. Dizzy.  Since vaccine. Been seen by urgent care and doctors. Wearing heart halter monitor. Symptoms have not gone away.  Insomnia worse. Started 12 hours after vaccine. All labs normal 5 days before and all labs normal now., but still having symptoms. Missing work.
IT WAS DISCOVERED AFTER THE DOSE WAS GIVEN THAT THE VACCINE WAS PAST THE DISCARD DATE OF 10 WEEKS AT REFRIGERATION TEMPERATURES.
Felt Numbness in left arm and leg (same side as vaccination given on) several minutes after the injection, lasted 2 days. Blurry Vision set in about 1 day after vaccination and lasted several weeks. Skin rash that itched and had scabbing and bleeding and has persisted for several months.
tested positive for covid on 8/5/21; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid on 8/5/21) 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 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced COVID-19 (tested positive for covid on 8/5/21). At the time of the report, COVID-19 (tested positive for covid on 8/5/21) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.
1/5/04 Developed chicken pox after being exposed at school. Approximately 2-3 dozen pox. No fever or other symptoms.
Fever, chills, light cough, heavy fatigue starting 03/26 AM. Continuing into AM. Took fever reducer/pain relivever.
The pt was seen in the Dr's office for left shoulder, neck and arm pain affecting th trapezius. She was prescribed Flexeril, Ultram, and Baclofen. On 10/24/2000 she was seen again for a rash that had developed at the injection site. It was noted that the Dr feels the pain in the shoulder and trapezius is related to the injection of the vaccine.
The 1st shot hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR151276   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that the first shot hurts but had no side effects reported with it. The reporter wanted to know, if it was that normal since the patient did not had those effects during the first dose. The follow-up could not be possible as no contact details were available. Additional supportive information: For tolerance of 2nd dose, refer case US2022AMR151276 which was reported by Same reporter.; Sender's Comments:  US-GSK-US2022AMR151276:Same reporter
Patient had nasal H1N1 vaccination in 12/09 and had acute onset of snoring afterwards. Had second nasal spray in 2/10 and had again acute onset of snoring afterwards. Both lasted for greater than a month.
States right eye started to swell, red and itchy on 9/25/23 around 1000am, went away on its own after a couple of hours.   Today when woke up face has swollen bumps all over (hives), cheeks, lips starting to swell.  Feels hot touch and just feels hot, slight itchiness.  No trouble swallowing no itchiness in throat.  Nothing on rest of body.  Injection site is swollen, sore.  Never had flu shot before, so concerned is reaction to that.  Pt advised to take antihistamine like Benadryl and be seen in clinic.  If choosing to try Benadryl first, aware to see care if throat feels tight or feels difficulty swallowing. Provided address and phone for clinic.
temperature excursion as accidentally left the refrigerator door open too long/3 separate excursions for the vaccine with Total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes with no reported adverse event; administration of IPOL post excursion with no reported adverse event; Initial information received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 4 years old male patient and reporter reported temperature excursion for IPV (VERO) [IPOL] as accidentally left the refrigerator door open too long/3 separate excursions for the vaccine with total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event and administration of vaccine post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.   Caller reported that opened IPV (VERO) [IPOL] Suspension for injection (lot V1A021M, expiry date- 27-FEB-2024) at a dose of 0.5mL once via intramuscular route in unknown administration site for Immunization was exposed to temperature excursion as accidentally left the refrigerator door open too long/3 separate excursions for the vaccine with total: low of 1.85c for 30 minutes and a high of 8.74c for 60 minutes with no reported adverse event (product storage error) (unknown latency) and On 12-JUN-2023 the patient had administration of vaccine post excursion with no reported adverse event (poor quality product administered) (latency- same day). Human error was involved.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 guidelines. 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.