chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain; sweat; could not walk; could not eat; chills; nausea; rash was itchy; rash on her back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), HYPERHIDROSIS (sweat), GAIT INABILITY (could not walk), FEEDING DISORDER (could not eat) and RASH PRURITIC (rash was itchy) in an 81-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.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced RASH PRURITIC (rash was itchy) and RASH (rash on her back). On an unknown date, the patient experienced PAIN (pain), HYPERHIDROSIS (sweat), GAIT INABILITY (could not walk), FEEDING DISORDER (could not eat), CHILLS (chills) and NAUSEA (nausea). On 20-Mar-2021, RASH PRURITIC (rash was itchy) and RASH (rash on her back) had resolved. On 04-Apr-2021, PAIN (pain), HYPERHIDROSIS (sweat), GAIT INABILITY (could not walk), FEEDING DISORDER (could not eat), CHILLS (chills) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient stated that the day after the  first shot that her body odor smells like a rotten egg. A week before she received the second shot she stated that she started to smell it in her bodily fluids. She stated that she still has that smell and she can taste it in certain foods. After second shot she stated that  her face broke out in  a severe hormonal acne. She went to a dermatologist and has been treating the acne with medication.
Patient age 7 years was given DTaP instead of Tdap. The Tdap box had an orange box warning stating "For 10 years of age and older". According to agency catch up schedule Tdap is to be given to children over 7 years of age. At the time of the clinic, the orange box on the Tdap was followed. 1/24/23: Contacted parent. Child is not having any adverse symptoms. An additional Tdap will be required before 7th grade entry.
Pt.'s mother states child began complaining of left upper arm soreness 2 hours after receiving PPV23 vaccine. Another two hours later, mother noted erythematous ring around left upper arm and shoulder. Child was given acetaminophen and ibuprofen before bed. Pt. unable to sleep from pain and discomfort, waking every hour. That morning, significant swelling had spread down to left anterior antecubital fossa, shoulder, neck and upper back. Avoiding use of left arm, leaving it hanging at his side. Mother denies fever, nausea or vomiting, stomach pain, or headache. Eating and drinking normally. Prescribed 50mg/kg/day cephalexin x 7 days and 250 mg ibuprofen every 6 hours for possible cellulitis.
patient was found down on the ground. he was slow to respond but eventually came around. he had a syncopal event or seizure.
Irregular heart beats; I could barely move; exhausted/didn't had any energy/tired; stressed out; Blood spots, just a small section of leg leading to the skin.; Headache; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 24May2021 (Lot Number: EW0168; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included Pre-diabetic. Concomitant medication(s) included ergocalciferol (VIT D); calcium (CALCIUM).  But she didn't take any when she was taking the vaccine shot like for like a week. The patient experienced headache on 25May2021, she had a headache for two and half weeks continuously then after that for another week later, she had often on and off for another week even then the next week it's still little bit of handle for at least like 5 minutes and hour then but couldn't better but it took her quite a while to get better. Irregular heart beats for 4 days from an unspecified date, her heart was jumping so much, it's kind of get out of her, she thought she was going to die. Because it was so much and she felt so exhausted. She didn't have any energy. She could barely move, this was her heart jumping so much and she was just feel so tired and so stressed out. She started getting some blood spot and leading to the skin, just a small section of her leg on an unspecified date. No treatment received for events. The outcome of events was unknown.
?COVID arm? swelling that has increased over the last 24 hours. Alternates between burning and itching. Very hard to the touch, bumpy rash. Began as quarter size around the injection site and is now taking up most of my upper arm. Rash extends onto my shoulder/back. Used Benadryl pills, cream,  and hydroxizine (prescription for anxiety, also used to treat hives) as well as  ibuprofen to help treat. Extremely exhausted. Chills a few times today (took ibuprofen). Slept nearly 14 hours.
pt recv vax 1997 & 21AUG97 pt exp a rash;MD felt pt exp was r/t vax;
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 27-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Patient was injected with a new, unfilled/empty syringe. Patient was then injected with a new filled syringe with the appropriate dosage of the Moderna first dose vaccine.   Patient was nervous, had blurry eyesight, and felt faint, vitals were checked by staff and by responding EMS. Patient felt better by the time EMS showed up after having some snacks. Patient has reported no adverse reaction other than initial blurriness and faintness as of 4/15/21
This spontaneous report as received from a physician concerning a 24 year old female patient with type 1 diabetes and no drug reactions/allergies. On 17-SEP-2013 the patient was vaccinated with the first dose of GARDASIL (lot # J006850; expiration date: 31-MAR-2016), 0.5 ml, subcutaneous. Concomitant therapies included insulin and ethinyl estradiol, MICROGESTIN and insulin. The physician reported that on 29-OCT-2013, the patient had an episode of confusion, at which time the patient's blood sugar was taken and determined to be 50 (units unknown). On an unspecified date after this episode of confusion, the patient developed severe muscle aching in her lower extremities and she became very weak. The patient was currently very fatigued when walking and was unable to get up fully. The patient went to see an unspecified neurologist on an unspecified date, who performed electromyogram studies, nerve conduction studies and unspecified blood studies, all of which returned normal results. The physician reported that the patient's leg pain had gotten a bit better to the point that is was not as uncomfortable as it was before. The outcome of confusion, patient unable to get up fully, severe muscle aching in her lower extremities and the patient's blood sugar abnormal were reported as recovering/resolving. At the time of the report, the patient continued having weakness, chest pain, arm pain, a positive Gower signs, and tiredness which made it difficult for her to work. Additional information has been requested.
This initial spontaneous case, was received on 21-Aug-2017 from a pharmacist and concerns a 63-year-old female patient. The patient's medical history was not reported. The patient was on unspecified concomitant medications. On 02-Feb-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, batch number: WT57908, expiry date: 30-JUN-2017, route of administration, anatomical location: not reported). It was reported that, the patient had been feeling sick since Feb-2017 (reported as, from 6 months to the time of this report). The treatment medications were not reported. At the time of report, the symptoms were ongoing and the patient had not recovered from the event. The reporter stated that, the patient was hospitalized but he believed that the patient was hospitalized for some unspecified reasons. Hence, the reporter assessed the case as non-serious.
In the middle of May, I noticed a patch of light red dots on my legs and arms - that were slightly raised. My doctor said it looked like hives. I already had eczema in the past, but the hives rash was new.
Patient received his 2nd dose of the COVID vaccine (pfizer) on 4/29/21. The next day he developed a fever of 103 F which lasted about 36 hours. He felt achy and generalize malaise and felt sweaty in the evening on 5/1.  Presented to ED on 5/2 with chest pain and shortness of breath. Patient given nitro x3, asa, and heparin gtt and transferred for ongoing management of NSTEMI.  Family history of CAD; grandfather and all 6 of his brothers died from heart attack
This spontaneous report as received from a physician via a representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, expiry, dose and route not reported). On an unknown date, the patient experienced rash across the face area. The patient sought medical attention via office visit. The outcome of rash across the face area was unknown. Additional information has been requested.
Was sick for a week and half after the 2nd covid shot.  Then after that still had a issue with fatigue which was getting worse overtime, as I tried to get back to my normal life (exercising between 30 mins to 3 hrs a day, hiking, walking , yard work, time with friends.) I went to the doctor June 24 and had labs done. The only thing the was low was my Iron. The doctor gave them a prescription for Iron, which I took till  Aug 18 when the doctor retest my iron, as I was still having fatigue problems and had stopped doing just about everything but lying around and sleep off and on. The lab showed the iron was better, so the doctor had me take over the counter iron till Nov 19, when doing another follow up as the problem is still there, but better and now the iron is normal and doctor changed me to a over the counter  multivitamin with iron. I still having problem with the fatigue and most day can do about 1-2 of activity before my body say that's it, time to rest, nap and be still.
Pt. received 2nd shot series for Boot Camp. Series consisted of IPV, YF, and Hep A/B #2. Pt had blanching, diffuse, mac/papular rash t/o his body. Vital Signs stable and no pain, itch, or burning. 3/31/08-records received for DOS 2/24-2/26/08-DX DC: Allergic reaction. Presented with erythematous rash on all areas of the body, both knees red and edematous. Mild swelling of hands.
Information has been received from a nurse concerning a 54 year old male school teacher with hypertension, cholesterolemia, hypothyroidism, penicillin allergy, iodine allergy, reactive airways disease and only back pain at time of vaccination and a history of feeling terrible while on therapy with SINGULAIR (WAES# 1012USA02628), bulging discs (2, 3, 4, 5), tetanus (given 2000), neck surgery, disc removal, bone graft (04-MAY-2007), and pneumonia (at age 17) who on 27-OCT-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot# not reported) in his left deltoid, after a routine follow-up visit. Concomitant vaccination included a dose of influenza virus vaccine (unspecified) administered on 08-OCT-2010. Concomitant therapy included SYNTHROID, aspirin, famotidine (MSD), lisinopril, PRAVACOL, cyclobenzaprine HCl (MSD), mometasone furoate (MSD), TESSALON, ALEVE, econazole, ALEVE, VIMOVO and TESSALON PERLES. On 28-OCT-2010 the patient developed fever and he called the physician's office on 29-OCT-2010 complaining of temperatures up to 103, aching, swelling at injection site between baseball and golfball size and chilling. The patient also complained of sweats. The physician examined the patient in the office; no hoarseness, rhinorrhea, shortness of breath or cough. Physical examination was within normal limits except for myalgias. The patient also presented redness at the injection site. The patient was treated with ALEVE, TYLENOL, MOTRIN and BENADRYL. No lab or diagnostic tests were performed. By 01-NOV-2010 the injection site was hard and painful. At the time of the report, the injection site was still swollen. Temperature was below 100, after treatment with KEFLEX. It was also reported that there was a reaction with KEFLEX (no further explained). At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
This spontaneous report was received from a pediatrician refers to a 1 month old female patient (also reported as 2 months) with milk protein allergy required a change in formula to Elecare which she was doing fine on, she had blood in her stools in the past with the protein allergy, which resolved, and successive hemoccult tests were all negative. On 27-JUL-2014 a stool had faint amount of blood and on 03-JUL-2014 and 10-JUL-2014 both stool samples were negative for blood, she also had Gastrooesophageal reflux disease (GERD). Her relevant past drug history was unknown. On 25-JUL-2014 the patient was vaccinated with ROTATEQ, oral, once, lot number: K001935, expiration date: 12-AUG-2015, (dosage was not reported) for vaccination. Concomitant therapies included ranitidine. On 26-JUL-2014 about 24 hours after receiving ROTATEQ, the patient did not want to eat as much formula and became fussy. On 27-JUL-2014 her mother noted mucous in her stools. On 28-JUL-2014, the mother spoke with the pediatrician about the events and on 29-JUL-2014 she was seen in the office and the mother brought in 2 of her stools samples, which did not have overwhelming amounts of mucous did not have some estringinessa to it. One of the stools samples, which had been collected last night on 28-JUL-2014 was negative for blood. The other spots sample, which had been collected that morning on 29-JUL-2014 was slightly positive for blood, but nothing like she had in the past. This pediatrician reports that the blood was seen microscopically and was not visible in the stool. On 29-JUL-2014 she had increased bowel sounds. As of 29-JUL-2014 at the time of the call, it was unknown if she will receive another ROTATEQ. She was still not eating as much formula, and the outcome of her fussiness, mucous blood and blood in her stools and increased bowel sound were unknown. Additional information has been requested.
COVID Arm. Red rash and itching appeared post vaccination on day 8 to 9.  Slight red circular area app. 2" in diameter, warm to the touch and itchy.
body aches; fever of 102; severe sinus pressure; a little nausea; joint pain; muscle pain; headaches; wheezing; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 51-year-old), as dose 2, single for COVID-19 immunisation. Medical history included ongoing asthma and ongoing lung disease. Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for lung disease (reported as Advair Discus 250). On an unspecified date, 14 hrs. after administration of vaccine, the patient experienced body aches, fever of 102, severe sinus pressure, and little nausea. It was reported that the patient was hurting and at one point of time he was wheezing so he had to take his rescue inhaler. The patient also experienced few aches and pains, joint pain, muscle pain and headaches. It was reported that, the patient knows that it was okay to take Tylenol after receiving the vaccine, but he would like to know if it was okay to take Motrin, Prednisone, Advair and nasal antihistamine that was prescribed by his allergist. The patient asked how soon after the shot he can take Advair. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit on an unspecified date. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tastebuds all over the surface of my tongue became enflamed early Saturday morning, two days after receiving a booster of the pfizer vaccine. When I say all over my tongue, I mean all over the surface, and probably roughly about 50-75 sporadically enflamed. They were significantly swollen throughout the day and slightly subsided on Sunday. Monday morning, while the tastebuds were still noticeably swollen when I was eating, rather than feeling their swelling (as it's hard not to be aware of this), my tongue felt like the entire surface had been burned. There was no effect on the taste of foods, while it was unpleasant to drink or eat, I DID NOT experience any adverse tastes.
SOB, Fatigue, weakness Narrative: F: Telephone call: Pt's wife called and said that patient is in the hospital- He went into hospital on 1/24/21. He had the Covid injection here at facility on 1/22/21@0945. He was feeling fine till approximately 1800 that night. His symptoms included the following: chills- fever of 102- he took Motrin 11PM on 1/22. On 1/23- @0200 fever was 99 on 1/23- he was fatigued feverish was back @ 101 degrees. He had no appetite all day. He was tired- weak- trouble breathing with SOB- Call was made to to this facility at 0230 but there was no answer. On 1/24/21- 0230AM patient could not breath and 911 was called. The EMT came- Sao2 was 65 %- couldn't walk- very short of breath. He was taken to hospital where he has been since. He was Dx with Pneu and placed on IV/ABT. Covid test was done and was negative at hospital. He has been on Oxygen since. His wife was very tearful. Family says that he may need O2 at home and a HHA.
Injection site pain (for 2 days following vaccine) muscle tension in neck and knot in uppers back/shoulders, tension headache (for 3 days following vaccination) - husband massaging knots, got a chiropractic adjustment. Neck is still tight on/off a week after vaccination
Information has been received from a physician concerning a female who on 25-MAR-2008 was vaccinated with the second dose of Gardasil (lot# not reported).  On 26-MAR-2008 the patient experienced a swollen face and was taken to the emergency room.  The date of the first dose was unknown and it was not specified whether or not this experience occurred with the first dose.  No additional information was provided.  Additional information has been requested.
Patient experienced swelling in the arms near the injection site, therefore they seeked medical attention, the doctor at the clinic claims it is an infection so he prescribed the patient antibiotics
non-itchy rash surrounding injection site, throbbing headache, fatigue, starting day 2
13MAY94 lt knee became edematous & painful; pt noted a bump w/pus-like discharge; applied heat; bump cont to swell until 17MAY94 then dec in size;
New onset atrial fibrillation, began at home after dinner. Patient presented to ER, was placed on diltiazem drip and admitted overnight. Converted to sinus rhythm at noon on 10/04/09. Diagnosis of lone atrial fibrillation, with unknown precipitators.
Narrative:  Patient reports fever 1 day after vaccination  Other Relevant Hx: Symptoms:   Fever Treatment:
Some vaccine squirted out the hole; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine and some squirted out of the hole [Incomplete dose administered].  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, after receiving the vaccine some squirted out of the hole. Treatment for the event was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event, some squirted out of her arm was considered resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of a female patient who experienced non-serious event of some squirted out of the hole (Incomplete dose administered)  for mRNA-1273 (lot # unknown, Exp date-unknown). There were no reported AEs associated with the event of some squirted out of out the hole
Tingling. About ten minutes after injection, tingling started in left arm, then proceeded to my spine, hips, and legs.  Intense Pain.  The tingling quickly turned into pain so intense I thought I would pass out.   Muscle numbness in hips and legs.  I was unable to move. After about 5 minutes, I was able to shuffle toward the back of the pharmacy where my partner saw me and came to my aid. He helped me up the stairs and out to the car where I waited until these side effects subsided. After about 15 minutes, I could walk on my own, and pain and numbness gradually improved. The entire episode lasted about 30 minutes.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diverticulitis" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: 100.6, notes: patient had 100.6 temperatures; SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: For three plus days with positive test for Covid 19 via home tests; Positive, notes: For three plus days with positive test for Covid 19 via home tests; Positive, notes: For three plus days with positive test for Covid 19 via home tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 02Jun2023 to 07Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300223658 same patient, different drug, different events;
T.C. 1-27-12 pt reports "fibromyalgia sx" x 1 wk in both arms - describes as muscle cramping. He took last oral Typhoid on 1-14-12. He has taken Ibuprofen with no relief. He has appt with PCP today at 4:30 pm.
Moderate joint pain in all joints. Took tylenol. Pain was constant the initial 48 hours after shot.  Then the joint pain rotated around my body and began to diminish in severely and frequency. Finally subsided approx 3/26/2021