chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23. Lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that PNEUMOVAX 23 was stored improperly in the freezer below 5F for 12 hours on an unspecified date. The improperly stored PNEUMOVAX 23 was administered to an unspecified patient on an unspecified date. No adverse effect reported. Additional information has been requested.
Tremendous pain; My entire spine hurts; My skin feels bruised and badly sunburned at the same time; My skin feels bruised and badly sunburned at the same time; This is a spontaneous report from a Pfizer sponsored program via Regulatory Authority. A contactable consumer reported for a 52-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 08Apr2021 (at the age 52-year-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included fibromyalgia, myofascial pain syndrome from an unknown date. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2, 1st dose (at the age 52-year-old) for COVID-19 immunisation. The patient experienced tremendous pain, my entire spine hurts, my skin feels bruised and badly sunburned at the same time, my skin feels bruised and badly sunburned at the same time. Patient stated that "I received my 2nd dose of your vaccine 08Apr2021 and have been in tremendous pain ever since. I have had to see my Doctor, have had 2 courses of steroids and she put me on gabapentin. Nothing is helping. My entire spine hurts. My skin feels bruised and badly sunburned at the same time. There are days I have to stay in bed because of the pain. My Doctor confirmed it is side effects from the shot. Please help me feel better". Therapeutic measures were taken as a result of tremendous pain (pain), my entire spine hurts (spinal pain), my skin feels bruised and badly sunburned at the same time (contusion), my skin feels bruised and badly sunburned at the same time (sunburn). Outcome of the events was unknown.  Information about lot/batch number has been requested.
I received the second dose of the Moderna covid vaccine Thursday at 1420.  At 0315 Friday, I woke up with a sore throat, headache, chills, body aches and pain at the injection site. (right arm) I was unable to work Friday.
hives; itching; This case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Fluarix Quadrivalent with an associated reaction of anaphylactic reaction (had an anaphylactic reaction to Fluarix last year).   On an unknown date, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, less than a year after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were unknown.   It was unknown if the reporter considered the hives and pruritus to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flulaval the allergist performed skin test and had no reaction but under the skin test resulted in hives and itching. The reporter did not consent to follow up. This case linked with US2020228553, reported by same reporter.
Information has been received from a nurse practitioner (NP), via a company representative, concerning a 10 year old female patient, who on 28-OCT-2007 was vaccinated IM with the first dose (lot # invalid), and on 07-JAN-2008 was vaccinated IM with the second dose of GARDASIL (lot #658556/1060U). On 07-JAN-2008, after receiving the second dose, the patient experienced dizziness and lightheadedness when she went to get up, and fell down on the floor. She also experienced nausea and a possible fever (onset time not clearly specified). She was observed for 45 minutes and was then released to go home. On 09-JAN-2008, she returned to the office with continued complaints of nausea and a possible fever, though she did not have a fever at the visit. Diagnostic testing was performed, but the results showed nothing abnormal. The patient recovered, and "is now doing fine" (duration not specified). Additional information has been requested.
Nausea; Joint pain; muscle pain; She experienced vomiting; Feeling disoriented; She experienced diarrhea; Headache; She experienced left arm pain; She experienced light headedness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She experienced left arm pain), DIZZINESS (She experienced light headedness), DISORIENTATION (Feeling disoriented), DIARRHOEA (She experienced diarrhea) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESTRADIOL (ESTRACE), FLUTICASONE, FISH OIL, CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D), VITAMIN E NOS and GARLIC [ALLIUM SATIVUM] for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (She experienced left arm pain), DIZZINESS (She experienced light headedness) and HEADACHE (Headache). On 13-Mar-2021, the patient experienced DISORIENTATION (Feeling disoriented), DIARRHOEA (She experienced diarrhea), ARTHRALGIA (Joint pain), MYALGIA (muscle pain) and VOMITING (She experienced vomiting). On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (She experienced left arm pain), DIZZINESS (She experienced light headedness), DISORIENTATION (Feeling disoriented), HEADACHE (Headache), ARTHRALGIA (Joint pain), MYALGIA (muscle pain) and NAUSEA (Nausea) outcome was unknown and DIARRHOEA (She experienced diarrhea) and VOMITING (She experienced vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: follow up received on 23 Mar 2021 contain information:  Added new events and concomitant medication.
Day after vaccine left deltoid size of goose egg.  The following day spread out warm and red.
T/C from mother. Today noticed small (size of dime) pink area right under skin at immunization site. Left thigh. States area not red , swollen or hot , although left thigh had some redness a day or two earlier.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 17-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided. The date of refrigeration was on 07-May-2021.   This case was linked to MOD-2021-363749 (Patient Link).
mom stated on 9DEC92 that noticed hearing problem about 1 wk p/pt recvd MMR inject;  mom took no action until problem seemed worse in early DEC; pt taken to MD dx severe hearing loss in rt ear & of a type rarely seen in children;
Narrative: Patient reports 3 days of dizziness following COVID vaccine administration. He reports walking 8 miles that morning, which may have contributed to the dizziness. Reports that now dizziness has much improved.
Patient presented for a Moderna booster; previously had Janssen for his primary dose. After the 15 minute waiting period, patient felt fine and proceeded to cafe area to have some pizza. When done with his pizza he came to check with me to ask if a tight throat was a normal adverse reaction. About half way through eating his pizza (~20minutes post vaccine) patient said it became more difficult to swallow his food. Upon questioning, patient said he felt okay in the moment, maybe a little tight and no difficulty breathing. He has a nut and pet dander allergy, but nothing he would think would be in the pizza. We decided it'd be best for him to have a dose of liquid diphenhydramine 25mg (given about 40 minutes post vaccine) and wait for 15 minutes to make sure there was no anaphylaxis. Patient reported feeling better with less tightening after the wait period and no difficulty breathing or other signs of anaphylaxis. He was with a friend and was not going to be driving, so patient left pharmacy area.
Dizziness, Myalgia, Fever, Palpitations,  INSOMNIA, FATIGUE, SORE ARM
mid grade fever, headache, fatigue, mild discomfort at injection site. Fever began approximately 8 hours after injection. Headache persisted  for approximately 20 hours after injection. ITC Tylenol alleviated most symptoms
Per Alert, patient already recieved 2 Pfizer vaccines/doses. First dose on 12/23/20, second dose on 1/15/21 and on 8/04/21 she received a 3rd dose.
Rash on left arm, sore left armpit, fever of 103 F for 24 hours, full body aches and cold sweats for 24 hours. Patient experienced inflamation on either side of nose closest to innner corners of eyes that resembled blisters that persisted for about 72 hours. Treated symptoms with rest hydration and 400mg ibuprofen every 4 hours for 24 hours.  rash on arm persists (12/09/2018) ( about 20% of original rash) at day 5. Patient is expected to make a full recovery.
Headache, Myalgia, Fever, Diarrhea, FATIGUE Narrative:
Patient admitted on 8/10/2021 with acute respiratory failure secondary to COVID pneumonia.  She was COVID positive on 7/22/2021 following a family gathering.  She had been hospitalized for 3 days previously (8/4 - 8/7/2021) and seen in the ED on 8/8/2021.  This current admission, she was intubated and required high dose dexamethasone.  After 20 days, she was converted to comfort care and compassionate extubation was performed.   She passed away comfortably soon after this.
initial symptoms started about 10 hours after vaccination: fatigue, headache, joint pain.  24 hours after: continued strong headache, fever 101.2  for most of the day, severe joint pain, fatigue, achy.  Mostly gone by 48 hours.  Vaccination site and surrounding upper arm itchy beginning around 48 hours and still happening at 72 hours (when this report made).
Next day started bleeding for about 11 days.   The following month I skipped my period.  The 3rd month it did return.   Alarming that hormones could be adversely effected.
36 hrs p/vax devel cystitis (hx of drug induced hepatitis) nose & face swollen, reddened hives noted 5MAY93 evening on stomach, back & face scattered hx of ? sensitivity to white bread;
The 1st Moderna shot reaction occurred 24 hours after shot and lasted 6 hours - fever , nausea, very fatigued.  The night after I received the  Booster I got Nov. 8 2021, my head started pounding All night long - visualized formulas in my brain - feverish all night long, nauseaus.  The pounding made me think I was going to have a stroke.  I was fatigued but somehow got up to put cold water on head.   In morning was able to swallow a Tylenol and get down a bit more water.  That helped some.  Had friend come over.  Stayed in bed all day - put cold compresses on head, more Tylenol.  Slept well that night and felt better in morning.  Believe recent s-t stress in my life combined with  the booster  exacerbated reaction.  Think I am fine now?
Patient was administered a second dose of Moderna vaccine following PCP prescription authorization. She had received the first dose mistakenly and was finishing the series
Erythema and induration spanning the length of lateral left upper arm, with 4cm area of blistered skin at site of injection.  Left arm mid-humerus circumference 5.5cm greater than right arm.  Mildly tender.  First evaluated two days after immunizations.  The swelling hurts sometimes, mostly with movement of the arm.  Overall she feels well, denies fever/chills, no SOB or wheezing, no vomiting, normal activity and appetite.
Soreness, tenderness and hot at the injection site.  Feeling achy and very tired.  Went to sleep approx. 11:15 PM on 11/03/2010 and slept except for waking to go to the bathroom and to pick up my son from school (about 30 minutes) until 7:30 AM on 11/5/2010. I feel fine now, but we were very concerned for a while.
This case concerns a legal case. Initial report received from a non-healthcare professional on 04 December 2013. A patient of unspecified demographics, whose medical history and concomitant medications were not reported, had received a dose of TYPHIM, Influenza vaccine from other manufacturer and Hepatitis A+B vaccine from other manufacturer (route, dose number, batch number and anatomical site of vaccination of all vaccines was not reported) on an unspecified date. On an unspecified date, the patient had developed unspecified adverse reaction after receiving vaccines. The corrective treatments and laboratory investigations were not reported. The outcome of the event was not reported. List of documents held by the sender is none.
Got the vaccine, looked at the site to take the band-aide off and the whole area was a large red area, shocking to see.  When she woke up in the morning the red area had turned the diameter of a grapefruit, about 5".  She then woke up the next morning the injection site to the elbow was warm, round, itchy, tender and inflamed.   She did not see anything that described what was going on with her arm on the internet.  She did not take anything for the reaction, she put ice on it.  As it was the weekend felt there was nothing much else she could do.  She was afraid to take any Benadryl on it, so used warm compresses.  She went to the UC on 2/28/21, and checked in with her PCP today, 3/2/21 on a video call.  She informed her to report to us her reaction.   It is getting a lot better, still very noticeable, slightly itchy.
Tingling, numbness that goes in a band around head above the ears wrapping around the head.  Burning in both feet- from the ball of foot to toes- worse at night  Balance issues that started 3 days after vaccination and lasted 2 days.
Patient vaccinated 2/1/05. Presented 2/2/05 with swelling to right thigh area measuring 11cmx7.5cm. Area warm to touch. Patient had no trouble walking or moving leg; no temperature. Patient was instructed to use warm compresses to area and return to clinic for observation.
Patient reports twitching, numbness, and tingling on one side of face.  Symptoms started 1 day after vaccine and has continued for 5 days without resolution.
Narrative:  COVID infection following COVID vaccine series 08/12, Pfizer, dose #1 09/02, Pfizer, dose #2 12/20 SARS-COV-2 Variant Sequencing: pending 12/20 COVID swab, result: detected 12/20 pt cc: sore throat exposure: unknown 12/20 CXR impression: no acute cardiopulmonary disease. 01/04/22 CXR Impression: No acute cardiopulmonary process.
Red, swollen hot arm after Pneumovax injection- ecchymotic with pain- resolved on own after Vicodin Rx- pt with residual problem.
NURSE GAVE 1 ML HAVRIX INSTEAD OF 0.5 HAVRIX. REPORTED TO SUPERVISOR, NURSING DIRECTOR OF REGION,AND MEDICAL DIRECTOR. MANUFACTURER WHO SENT OUT EMAIL OF  STUDIES OF CHILDREN WHO HAD BEEN GIVEN SAME DOSAGE WITHOUT ANY EFFECTS. TELEPHONE CALL TO CLIENT. CALLED MOM  AND EXPLAINED WHAT HAD BEEN GIVEN. MOM RELATES THAT CHILD HAS NOT HAD ANY ADVERSE EFFECTS FROM THE VACCINE.  ALSO TELEPHONED HER X2 WITHOUT ANY ISSUES FROM VACCINE. DISCUSSSED WITH CLIENT REPORT AND ADVERSE EFFECTS OR ISSUES AND IF NEEDED PCP.
Information has been received from a physician concerning a 8-week-old male who was vaccinated PO with a 2mL first dose of Rotateq (lot number unavailable). Subsequently, 4 days post vaccination, the patient experienced blue watery stool, was dehydrated, and had an anal fissure. Subsequently, the patient recovered. It was noted that he was sent to the emergency room but was uncertain of how may hours the patient stayed there. No additional information was provided. There was no product quality complaint. Additional information has been requested.
onset of fever 8MAY94 up to 103; onset rash 10MAY94-diarrhea x 1 11MAY94; difficulty walking 8MAY94; 12MAY94 few small ant cervical nodes, few papules face, trunk, legs-fading;
swollen arm from shoulder down to elbow, extremely hot & tender; temp up to 103 treated w/APAP;
This report as received from a reporter refers to a female patient of age reported as 11 (units not provided) enrolled in a market research. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown exact date in 2016 the patient was vaccinated with the first dose of GARDASIL (dosage information, route of administration, indication, lot # and expiration date were not reported). It was reported that the child received multiple vaccines on that day. In May 2016 the patient experienced soreness on injection site. The outcome of the event was reported as recovered 3 days after injection. The reporter considered the event to be related to GARDASIL. Action taken with GARDASIL was reported as none. Additional information has been requested.
Several local reaction. Redness, pain, edema of left upper arm 21 cm x 17cm around vaccination sit. (10 days after vaccination). Treatment Ibuprofen 500mg TID, Allegra 60mg BID
Severe body aches, chills, headache, fever, joint pain, back pain, fatigue, brain fog, diarrhea, loss of appetite
Patient was inadvertently administered the second dose of the Pfizer COVID-19 vaccine at 14 days subsequent to the first dose in the series while residing at a Long-Term Care facility.  The patient's immunization paperwork was mistakenly combined with remaining residents/staff that had to postpone vaccination on the first  clinic (1/13/21) and received on the second clinic for 1st doses (1/27/21); the patient's dose should have been due on 2/3/21.  Nursing staff reported error to pharmacy after realization of the error and reported that patient was not experiencing any adverse effects.  The patient's primary physician was notified and recommended to monitor patient.  The pharmacy checked in on patient the following week and was informed that patient was feeling normal and still had not experienced any side effects.
2 weeks after injection deep acne (R) shoulder superior and posterior, migrated pain to (R) breast numbness, tingling 4th and 5th digits, arm fatigue prednisone treatment.
pt recvd vax & left entire shoulder was red, swollen, hard, site painful; babysitter noticed red line;
I contracted COVID-19 on 4/26/2022 with symptoms of sore throat, fatigue, diarrhea, myalgia, cough, and I was ill for 10 days. I was prescribed Paxlovid on 4/29/2022, and I have fully recovered with all symptoms resolved.
Constant vertigo to the point of almost fainting making it very difficult to partake in normal daily activities   Also excessive drowsiness and sleeping.
Starting 04/26/2022, I woke up feeling sick and the inside of my right nostril felt like "sand paper" was rubbed in the nostril. My sore throat was bad as well. I took an at home test but wasn't sure the result. My husband got sick and tested positive the next day. We both got sicker and, by Thursday, I developed a fever, post nasal drip, hypersalivation and a headache. I didn't feel good and didn't feel like eating. On Friday 04/29/2022, I did do the at home test correctly and it was positive. When I did get a fever, I took Tylenol. However, by Saturday the fever went higher (102.7) but went down with the Tylenol. The next day the fever went lower. On Monday, I woke up feeling a little better. Randomly, my abdomen turned red and, at this time, I had started coughing so I was concerned about having another hernia. I ended up in the hospital and they determined it was a yeast infection. So, I came home and now I am getting better from being sick. I have been taking Mucinex and my rescue inhaler to try to open myself up and get the mucous out of my chest. My rescue inhaler and my nasal spray really helps to loosen the congestion, and the Mucinex expectorant has helped to clear the chest congestion as well.
Inconsolable crying for greater than or equal to 3 hrs-starting one hr after injections. DTaP, IPV, HIB, Prevnar 7/3/02 by history  from parents.
Patient states that the site of injection is red, hard, swollen (oblong, about 2 inches in size). Patient has no pain or fever.
TOOK AN UNREFRIGERATED DOSE; This spontaneous case (PVX2019-1051, PVX2019-1052) was received form a pharmacist on 30-Apr-2019. It describes a 43-year-old male consumer who "took an unrefrigerated dose". The consumer was receiving oral Vivotif (one dose every other day; lot number: 3003253) for typhoid fever prophylaxis.  Case report: The consumer took an unrefrigerated dose of Vivotif on 29-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took an unrefrigerated dose" was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose" was considered as not applicable.
Sneezing, sore throat, coughing, fever, stuffy nose, dizziness.
3/26-rash on body, puffy eyes  3/27-Pt has hives all over her body. She called her md on Friday and they were closing.  She has been taking Benadryl. Getting worse.  Recommend f/u with md.  Urgent care or ed.  She had her shot on Monday and noticed it and it has gotten worse. Recommend that you go in and be seen as the sx are worsening.   3/28-caller stated rash has not improved after taking benadryl. recommended zyretec or claritin and to see her pcp for prescription meds if symptoms are not resolving. informed her to go to an ED if any swelling of the throat, difficulty breathing, etc. caller verbalized understanding.
Pt has presented today with a red, hot, swollen, painful arm. 2 inch circumference. 2nd Shingrix shot