chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to a female patient of unknown age. The patient had no pertinent medical history or drug reactions/allergies. There was no concomitant medications. On 29-APR-2016 the patient was vaccinated with M-M-R II (dose and lot# were not provided), subcutaneously. On an unspecified date in 2016 the patient experienced induration at the injection site. On 20-MAY-2016 the patient sought medical attention by coming into the office. There was no treatment given for the adverse event and no lab diagnostics studies performed. The outcome of injection site induration and the causality of the event were not reported. This is one of two reports received from the same source. Additional information has been requested.
By 5 pm - 1513 - lips swollen - severe itching has been to ER x 2. Saw Dr - today received "shot" - steroids to take by mouth and has BENADRYL.
"Moderna arm"; redness; warm injection site; tenderness and hardness on injection site; tenderness and hardness on injection site; itching on injection site; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION ("Moderna arm"), ERYTHEMA (redness), VACCINATION SITE WARMTH (warm injection site), TENDERNESS (tenderness and hardness on injection site) and VACCINATION SITE INDURATION (tenderness and hardness on injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included vitamins D and C, multivitamins with Ca+Mg and PROBIOTICS NOS for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION ("Moderna arm"), ERYTHEMA (redness),VACCINATION SITE WARMTH (warm injection site), TENDERNESS (tenderness and hardness on injection site) and VACCINATION SITE PRURITUS (itching on injection site). On an unknown date, the patient experienced VACCINATION SITE INDURATION (tenderness and hardness on injection site). On 16-Mar-2021, TYPE IV HYPERSENSITIVITY REACTION ("Moderna arm"), ERYTHEMA (redness), INJECTION SITE WARMTH (warm injection site), TENDERNESS (tenderness and hardness on injection site) and VACCINATION SITE PRURITUS (itching on injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
06/09/2021 around 10:30 or 11:00 PM severe chills, all day and the chills came and went through the next day. I called my doctor and he said it was just a reaction from the vaccine. On 06/09 and 06/10, I had a lot of severe chills. I did not feel fever, but I would wake up as though someone dumped water on me, with a lot of sweat. This occurred throughout the day. 06/11/2021 at 11:00 PM- My blood pressure was very high, and I took 2 Tylenol and my chills continued. 06/12/2021 in the afternoon, I went to the hospital, my blood pressure was very high, and my oxygen level was very low, and I was dehydrated. I was given IV fluids and was given Tylenol, and my severe chills continued at the hospital. I was given a prescription of Cefpodoxime Proxetil tablet 200 mg. They diagnosed me with a kidney infection, and I was very dehydrated. They discharged me on 06/13/2021 in the AM. 06/13/2021, my severe chills and sweats continued at home. I never had a fever. 06/14/2021, at 09:00 AM I went to the hospital again because the chills and sweats were unbearable. They gave me a C-19 test and the results were negative. They put me on IV fluids, and an IV of Cefpodoxime Proxetil 200 mg. They took a lot of blood work and urine test. 06/15/2021 in the morning, at the hospital they transferred me at hospital, and I stay at that hospital on 06/16 and 06/17. At hospital they continued to take a lot of blood work and gave me Morphine because I could not tolerate my headache. I was discharged on 06/17/2021. 06/18/2021 I went to hospital, and they checked my IUD contraceptive, and it was in perfect condition. There was no infection. I do not drink alcohol. I do not drink sodas. I do not smoke. These questions were asked of me at the hospitals. I have never had kidney infection problems prior to the vaccine. 01/02/2021- I went to see my doctor and he diagnosed me with a UTI and prescribed me with an antibiotic, Cyclobenzaprine 10 mg, for 15 days. I have not recovered from my AE, kidney problems. My hair is falling out. I now have a lot of anxiety; I can't exercise anymore because I feel fatigue. My back hurts as though I have a bruise on my back where my belt area is at. I have never tested positive for Covid-19.
Pt had seizure after 24 hours of vaccine administration, had hospital FN on 08/31/2005 doing fine no neurological underlying conditions.
5-8-21: Pt reported that there was a red lump that appeared around the site of injection the day following her first dose of the COVID 19 vaccine (4/21/21), but resolved thereafter. However, this morning the red lump has reappeared and is the size of a "golf ball." Per pt, there is no pain, just redness and the presence (yet again) of the lump.
Patient filled out an administration form and stated that this was her first COVID-19 vaccine. We talked through the options of Johnson and Johnson and Pfizer and she chose Johnson and Johnson. After her vaccination and while entering data into WIR, it showed that she received one dose of Moderna back in May. I asked her and she confirmed that she had the first dose but missed the second which is why she came in for Johnson and Johnson. I let her know that at this time, we do not have enough data to know how safe it is to mix vaccine so she should carefully monitor any side effects or adverse reactions that she experiences. I also let her know that going forward, she should always let the vaccinator know that she has had both Johnson and Johnson and one dose of Moderna.
Patient had injection site reaction next day "size of a coin and it doubled by the evening" Patient took ibuprofen and used ice and it was better after couple days. Patient's husband called and said his wife had a reaction to the vaccine next day "size of a coin and then it doubled by the evening" The Pharmacist on duty recommended to take ibuprofen and use some ice. So patient did and was better after couple days.
Pt started on 5/4/2021 with generalized erythema and swelling. This progressed for which he visited his PCP who recommended benadryl.  Condition worsened until irritation affected the inside of his mouth, causing him difficulty eating.  He wento to ER at Hospital on 5/13/2021 and was admitted for IV treatment (steoids??).  He was treated by an Internist and ID Specialist (unknown names) who explained that this was secondary to the Moderna vaccine.  He was discharged home on 5/16/2021 to continue on PO steoids.  He denies exposure to any other potential allergen after his vaccine was administered (no new medications, or allergy-prone foods).  Currently, patient is slowly improving.
sore arm, chills, headache, body aches, gas, upset stomach, tiredness   lasted from 3/2/21 thru 3/4/21
Psoriasis flare-up/breakouts on arms and scalp; Felt ill; Sun sensitivity/being in sun made worse; Pain in arm/arm sore; Swollen arm/arm swelled and puffy; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up/breakouts on arms and scalp), PERIPHERAL SWELLING (Swollen arm/arm swelled and puffy), MALAISE (Felt ill), PHOTOSENSITIVITY REACTION (Sun sensitivity/being in sun made worse) and PAIN IN EXTREMITY (Pain in arm/arm sore) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PERIPHERAL SWELLING (Swollen arm/arm swelled and puffy). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/breakouts on arms and scalp), MALAISE (Felt ill), PHOTOSENSITIVITY REACTION (Sun sensitivity/being in sun made worse) and PAIN IN EXTREMITY (Pain in arm/arm sore). At the time of the report, PSORIASIS (Psoriasis flare-up/breakouts on arms and scalp) had not resolved and PERIPHERAL SWELLING (Swollen arm/arm swelled and puffy), MALAISE (Felt ill), PHOTOSENSITIVITY REACTION (Sun sensitivity/being in sun made worse) and PAIN IN EXTREMITY (Pain in arm/arm sore) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported.  The reporter's causality for the event(s) of arm swelled and puffy, arm sore and felt ill with Skyrizi (Risankizumab) was no reasonable possibility. The reporter's causality for the event(s) of psoriasis flare up/breakouts on arms and scalp/being in sun made worse unknown onset with Skyrizi(Risankizumab) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-625124 (Patient Link).
menquadfi on 6/16/23 and then the same 2 vaccines administered 6/27/23 with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 11 years old male patient who received meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] on 6/16/23 and then the same vaccines on 6/27/23 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 diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Prophylactic vaccination (immunization).  On 27-Jun-2023, the patient again received 0.5 mL dose 1 of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (lot: u7616ab) (expiry date unknown) via intramuscular route in the right arm for immunization with no reported adverse event (inappropriate schedule of product administration) (same day latency). The patient had received Menquadfi vaccine 11 days prior at a different location.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event menquadfi on 6/16/23 and then the same 2 vaccines administered 6/27/23 with no reported adverse event.  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.; Sender's Comments:  US-SA-2023SA202758:01672015: related case for adacel
days of lack of energy, upset stomach, tiredness, headache, body aches.  Unable to go to school day after through 3rd day and counting after receiving vaccine
Within 5 min after receiving vaccines, child started sneezing continuously x 20 - c/o "funny feeling" in chest - extremities cool. Flushing. Upper lip slightly cyanotic. Called 911. BP 110/68 P 120 R-20. Epinephrine (1:1000) - 0.3 ml in RA; BENADRYL (50 mg/cc) - 30mg (0.6 ml) given in LA. Four minutes later: BP 124/78, P 160 R-16. EMS arrived & evaluated child. Parents chose to see own pediatrician instead of going to ED. EMS had family sign a release form. Dr called by RN & notified of above reaction and emergency meds given. BP 120/54 P 160.
Vaccines given at the Senior Center. Pt had latex allergy, given appropriate vaccine. Pt c/o burning while being vaccinated, then became diaphoretic & lightheaded BP 176/110. Pt taken to ER after a call to her PCP office.
Via Telehealth video was diagnosed with Shingles in upper right side of temple where hairline begins.    Also sent in picture of affected area.   Telehealth Dr. prescibed "Valacyclovir" and took first dose at about 1:30.   Dose is 1 every 8 hours for 7 days.   Will schedule follow up visit with primary.
Extreme muscle ache/pain, fever, chills, pain at injection site for 36 hours.  Took Tylenol beginning on 1/28/23 at 7:00 and every 4 hours after.  Also, I've had a cold sore each week (clear up, come back in a different spot) following this last injection.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 23-SEP-2013, the patient was vaccinated with GARDASIL (lot # J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008847, 1312USA008940, 1312USA008941, 1312USA008942, 1312USA008944, 1312USA008945 (same reporter link). Additional information has been requested.
The vaccine was administered to this patient while in Skilled Nursing Care at this facility for Lumbar Spinal Stenosis.  Following the injection the patient has experienced intermittent fever of unknown origin, severe skin pain to extremities, and paralysis to both upper and lower extremities.  The symptoms are being investigated and the patient remains hospitalized.
This case was reported by a healthcare professional and described the occurrence of arm numbness in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced arm numbness and neuropathy arms. At the time of reporting the outcome of the arm numbness and neuropathy arms were unspecified. A friend of the subject reported problems with numbness and neuropathy in their arms after receiving the TWINRIX series. He also said another friend of theirs (the subject) is experiencing the same thing. This is third of three cases reported; for the first case see A0977548A and for the second case see case A0977598A.
No unusual ADR notified at this time. It had to be half of the original dose for booster, but was given full dose that are usually given to the immunocompromised patient.
A 44 year old female subject experienced a possible allergy reaction on the same day in which she had received an injection of Menactra.  Recovery status was not provided.  According to the investigator, the event was related to the study vaccine.  Follow up information received on 03/29/2006.  The subject has a past medical history of a positive PPD skin test and H. Pylori.  She has no known drug allergies.  She presented to the emergency room one hour post vaccination at 17:39 with complaints of throat tightness and soreness, hard time swallowing, mild shortness of breath, burning and pressure in her eyes bilaterally, facial redness, body weakness and aches, palpitations and chills.  She appeared lethargic.  Vital signs were T-98.2, P-82, R-16 B/P 126/85.  Cardiac assessment and EKG were normal.  Neurological exam was normal and she was speaking full sentences and had no tongue swelling or drooling.  Physical exam showed slight erythema of the tympanic membranes.  She was given Benadryl 25 mg IV.  Her discharge diagnosis was reaction to immunization.  She was instructed to call someone to give her a ride home from the facility at 19:50 and when the nurse went to do her assessment at 21:10 the subject was gone.  The recovery status was not reported at the time of this report.
Cough, congestion, exhaustion and body aches. Lasted 5 weeks. Treated with prescription Tylenol with codeine and budesonide.
Got chills and had 100.6 fever. Headache and fatigue lasted until the morning of 3/31.
no adverse event; patient inadvertently received an expired dose of proquad; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not reported. The patient's and concomitant medication included sterile diluent ( MERCK STERILE DILUENT). On 01-MAY-2020, the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: rHA) (PROQUAD) lot # R026722, expiration date reported as 17-MAR-2020 for prophylaxis (strength, dose, frequency, route, were not reported) (expired product administered). The patient experienced no adverse event.The outcome of expired product administered and no adverse event was unknown.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2005USA000315:
Diagnosed with Bells Palsy 6 weeks after vaccine.  Facial paralysis on the left side of my face
The patient called the same evening she received the vaccine complaining of a headache and hives and an itching rash on her face abdomen and legs. The pharmacist on duty advised her to use BENADRYL for her reaction and call her primary care doctor if she continued to have itching or if her symptoms worsened. I spoke with her 2 days later and her rash had subsided.
Information has been received from a licensed practical nurse concerning a 70 year old female with no known allergies, rheumatoid arthritis and a history of hyperthyroidism and irritable bowel syndrome, who on 11-OCT-2007 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck) (Lot#657766/0620U). There was no concomitant medication. On 13-OCT-2007, the patient developed an injection site reaction that was a red, raised and warm area that was about 4 inches. The patient called the doctor's office. No further information was provided. There was no product quality complaint involved. Additional information has been requested. 03/26/2008 Follow-up information from the reporting licensed practical nurse indicated that a 70 year old female who on 11-OCT-2007 at 13:30 was vaccinated SC with a dose of ZOSTAVAX (Oka/Merck) (lot#657764/0620U) in the right upper arm. On 12-OCT-2007 (also reported as 13-OCT-2007) the patient developed a warm, red, raised area at the injection site. It was noted that the patient did not seek medical attention but reported the events by phone and did not receive treatment. On 15-OCT-2007 the patient was recovered. Additional information has been requested.
The same day of the vaccine a felt very thirsty, very tired for almost 3 consecutive days, still feeling kind of tired, headache, haven't had my period, friday after the vaccine I saw little bit and very light blood on my underwear for 3 days, lost appetite.
patient "jerked" and needle came out of patient arm while still administering; This spontaneous report had been received from a nurse reporting a 3 year-old female patient. The patient did not have medical history, drug reactions, allergies, concomitant medications or concurrent conditions to be reported.  On 15-MAR-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength and dose not reported) administered subcutaneously as "school shot" (immunisation). Lot number T7E48 was an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD); however expiration date was reported as 20-JUN-2020.  It was reported that on that day during the administration of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) the patient "jerked" and the needle came out of the patient's arm while the vaccine was still being administered (accidental underdose). The patient did not seek for medical attentions, did not received any treatment for the occurred and no lab studied were performed. The occurred was considered resolved. No product quality complaint (PQC) was reported.
swelling & erythema 3cm circumference from inject site rt thigh; warm to touch; pt afebriel states it doesn't hurt; mom noticed swelling 1 day p/inject, erythema 3 days p/inject;
Hot, sweating, clammy.  Feeling unwell!  Can't sleep for days!  Sinus and brain pressure pain!
painful right  deltoid, painful right armpit, neck pain, headache, extreme fatigue, shivering/chills, swollen lymph nodes neck right side behind clavicle, dizziness
11/02/2022, I had my seasonal flu vaccine. That night I had usual reactions, slightly feverish with chills.  The next morning, I got really sick and stayed sick. I was given several tests and was diagnosed with acute kidney injury, anemia, elevated liver enzymes, elevated pancreatic enzymes, and I also developed GERD along the way. I am undergoing tests for LGL Leukemia.
Post vaccine pt developed fever, aches, rash on chest, back, arms and hairline.
Initial unsolicited report received from consumer via social media in on 09 Jul 2016. This case is linked to 2016SA128403, 2016SA131479 and 2016SA131486 (same vaccine, same reporter). This case involves a patient (age and gender were not reported) who was vaccinated with dose of MENINGOCOCCAL VACCINE (batch number, expiry date, route, dose and site of administration: not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, two weeks after vaccination the patient died. It was unknown whether autopsy was performed and the cause of death was unknown. Documents held by sender: none. Sender's Comments: This case corresponds to a poorly documented and non-medically confirmed social media report. Patient presumably received meningococcal vaccine for which the manufacturer was unknown. Clinical details- such as patient's age, medical history, vaccination details, the name of the specific vaccine administered, clinical details surrounding the event, diagnostic work-up, cause of death and autopsy reports- are lacking to allow adequate medical assessment. Reported Cause(s) of Death: DEATH NOS.
Severe UTI leading to sepsis requiring hospitalization.  Most likely due to MS drug therapy administered 24 hours earlier.  Required 4 days in hospital with intravenous antibiotics.
The morning after I received my shingles shot my arm hurt terribly.  It was throbbing for two days.  I could not put any pressure on it.  My whole body was achy.  I was also running a slight fever.  I was not feeling like myself at work all day the day after I received the shot.  It felt like the day after I had the shot the  next day was in slow motion.  My eyes were very droopy and sleepy.  I wanted to sleep that day.  I had to take a nap after work.  That is not the norm for me.  They need to put more warnings on this shot because I have never had a reaction to any shot like this.  I also have a large rash on my arm where I received the shot.  It is hot on the site where I had the shot like fever as well.
From correspondence received on 12/03/01, it was reported that a 50 year old male patient received a Fluzone SV '01-'02 vaccination administered on 10/10/01 That same day the patient developed pain at the injection site. X-rays negative - pain unresolved.
(L) upper arm red and swollen blood shot out put ice on and TYLENOL with detailed instruction.
Chief Complaint Patient presents with ? Fatigue     C/o feeling like he was going to faint since yesterday. Is feeling very weak. C/o still coughing and spitting up some green phlegm.  Admitted to hospital
Received HPV vaccine in right arm on 10/23/18. Went to unknown pharmacy after and received Flu shot to left arm. Reported numbness to left upper arm and felt nauseous and numb to hands. Reported HA and eye pain as well. Seen at local ER at 13:52.