chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left shoulder was swollen; Red and hot to the touch at the injection site; Arm is still swollen; Red and hot to the touch at the injection site; This is a spontaneous case, initially received from consumer via Company (reference number: SEQ19-06647) on 14-Nov-2019, concerning a 24-year-old, male patient.   The patient's relevant medical history was not reported.  The patient's concomitant medications were not provided.  On 12-Nov-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: P100110982 and expiration date: 03-Jun-2020] as prevention of seasonal influenza.   On the same day, after vaccination, the patient's left shoulder was swollen, red and hot to the touch at the injection site.   On an unspecified date in Nov-2019, the patient's arm was still swollen. It was reported that a 4 inch diameter was around injection site.  The patient did not recover from the events of swollen arm and swelling. The outcome for the events of vaccination site erythema and vaccination site warmth was not reported.  The case was assessed as non-serious. The reporter did not provide causality assessment to Afluria Quadrivalent.  Company Comment: The patient experienced swelling, vaccination site warmth, peripheral swelling and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: Company Comment: The patient experienced swelling, vaccination site warmth, peripheral swelling and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is possible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Day 10 post vax for smallpox, began having a headache. Described headache as halo type. She became progressively more ill and was not able to attend work due to extreme fatigue and constant headache.
I had body ache, headache, chills, cramps, loss of aplite, dizziness, trouble walking and diarrhea that lasted for 3 days. I was in bed all day.
Bad headaches, lo-grade fever and chills, body aches and pains.  I hadn't had any headaches for many years before this event.
On May 8, 2021 I experienced vaginal bleeding. I have been menopausal for 8 or more years. The bleeding was light, but lasted all that day. I went to my clinic to see my doctor on May 27, 2021. I had a PAP smear and ultrasound. All were negative. No explanation could be found to explain the vaginal bleeding except that may women have experienced vaginal bleeding after this vaccination.
Arm soreness approx 4 hours after shot, gradually to where I cant lift my left arm outwards or up without significant pain. Up all night on and off crying from pain in arm. Sweats from midnight on 8/8/2021 until current time of submisison including migrane (which I never get) on the front forhead temple to temple and back occipital region, severe enough to take 1000mg of Tylenol every 6 hours. Left arm has slight swelling where vaccine was administered, is hard to the touch and very warm. Nauseated feeling, along with no feel to eat any food since midnight on 8/8/2021. Drowsiness feeling, like blah....
Contracted COVID after being fully vaccinated.  No booster. Headache, congestion, fatigue, muscles aches.
Patient was given the 2nd Moderna vaccine 8 days before the recommended time between the 1st and 2nd dose.
Infant received vaccine and within 24 hrs had increased apneic, bradycardic and desaturation episodes. CBC and blood cultures obtained are normal, no growth on culture. Infant placed on NIPPV x 24 hrs then removed. Episodes required bag and mask ventilation. No episodes in prior 72 hrs.
Acute pancreatitis/I had the pancreatic attack; in pain, she was hurting; Nausea; she was swollen; barely eat; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 05Mar2021 (Lot Number: EN6203) as 1st dose, single dose for covid-19 immunisation. Medical history included blood pressure high. Concomitant medications included losartan 100 mg, once a day taken for blood pressure high; metoprolol 25 mg, once a day. The patient had a side effect of vaccine so after that first dose in March and had been in emergency room at that time she did not realize that acute pancreatitis was one of the side effect of the vaccine. She had the vaccine and she got fits when she had the pancreatic attack and she could not go and get the other one. She had the first one on 05Mar2021, second was on the 18May2021 (lot number ET7533). She was supposed to go back was on the 26th and she already had some problems that didn't stopped (not clarified), so she got the shot for pain so she could not take on 26th, then she ended up going to the emergency room on the 29th. She was giving Tylenol with codeine for pain and she was given 'Oma' something for nausea. She was told not to eat anything solid for 2 days. They did blood work and they did an MRI. Then she had blood work done by 3 or 4 times. They tell she had pancreatitis. They wanted to put her in hospital but didn't because with the COVID and the lack of space. So she was at home with the clear instructions. She was given IV before she left the emergency room and she was given clear instructions no solid food for 2 days and make sure had hydrated, anything was not solid, she did that week she appear to be doing better, she had consultation with a nutritionist, the doctor said he could not understand what was causing the pancreatitis because she did not have a gall bladder problem, she was not a heavy drinker. Primary doctor did not know, she did not have any of those what was causing the pancreatitis. she had pain, she was swollen, she has to be careful what she eat, she was in constant pain. She never had a problem with her pancreas until now. She never had trouble with her pancreas and in the end she probably would not have reason that to call the problem with her pancreas but its ongoing pain, she was in pain, she was hurting, she barely eat. The outcome of events was unknown.
1) Difficulty sleeping. 2) Pain in right knee, severely limiting mobility. 3) Feverish with chills and sweats. 4) Fatigue and malaise. 5) Incontinence.
Local skin reaction at injection site. Red hardened  area at injection site. Pt reports area is improving less redness, edema since onset
Temp of 101.2, large non tender lump in left side of neck.Tiered.
Information has been received from a pharmacist referring to a 65 year old female patient. The patient's concurrent condition included spots found during breast reduction surgery in November 2014. The patient had no drug allergies. On 05-AUG-2015 the patient was vaccinated with ZOSTAVAX (lot # K020187 with expiration date of 27-JAN-2016, 0.65 ml, subcutaneous). Concomitant therapies included FOSAMAX. On 07-AUG-2015, the patient had a rash above her upper lip. No lab diagnostics studies were performed. The dermatologist prescribed VALTREX for the rash above her lip. The patient applied triple antibiotic ointment. The outcome of rash was recovering No product quality complaint (PQC) involved. Additional information has been requested.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for an unknown indication.     Concurrent medical conditions included Hypertension.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced RASH (Rash). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash) had resolved.            Concomitant medication include antihypertensive drug. . Treatment include antihistamine and hydrocortisone cream.  Action taken with mRNA-123 is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-046350 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046350:2nd Dose
Patient began having symptoms of pain in upper R leg on 3/16/21. Presented to ER on 3/20/21 and was discharged on lovenox. Presented back on 3/21/21 after venous duplex - now being treated with Eliquis.
Within a few weeks to months after my second vaccine (left arm was injection site for both doses of Pfizer)  I developed heart palpitations, severe pain in my left arm that settled in my elbow requiring physical therapy,  severe middle trigger fingers which will now require surgery on my left hand (surgery date will be 2/21/22), and chronic fatigue with periods of brain fog. Brain fog was horrible in the few weeks after vaccination.
20-30 min generalized FC sz; maximum t101; observed overnight after sequelae; lP, lytes, glu, NH3, LFTs all neg; tox screen neg;
Vertigo and Vomiting that was so extreme I could not get out of bed. Lasted for about 5-6 hours. Afterwards had a dull headache that has persisted for 3 days.
Received Pfizer vaccines on 2/4/21 and 2/24/21. Tested positive for COVID-19 on 4/12/21. Patient was asymptomatic, was tested due to upcoming procedure at our facility.
The site of the injection became very painful, so patient cried when it was touched or his leg was moved. Patient developed a red rash starting near his hairline by his ears, the rash spread and enlarged across his body, in the groin area, on his stomach, on his arms, face and the nape of his neck. He also developed swollen hands, feet and eyelids. His temperature became elevated and he was very fussy.
Left hand got very weak and numb.  Slowly got better, but still do not have full feeling  or strength.  Cannot grip items.
Pt said that she developed a rash on her arm, and was painful for a few days. swelling has since been reduced as well as the pain.
Temperature excursion; A spontaneous report was received from a nurse concerning 100 patients who received Moderna's COVID-19 Vaccine (mRNA-1273) that was affected by a temperature excursion.    The patients' medical history was not provided. No relevant concomitant medications were reported.  On 06 Jan 2021, the patients received their first of two planned doses of mRNA-1273 (Lot number: 639K20A) intramuscularly for prophylaxis of COVID-19 infection.    On 29 Dec 2020, the refrigerator temperature reached 35.6 Fahrenheit for 4 minutes. 100 doses were administered after the temperature excursion. No adverse events were reported following the vaccinations. A visual inspection was completed at the time of excursion and there was no product complaint reported. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, temperature excursion, was considered resolved on 29 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # 639K20A with no associated AEs.
Child 5 years old usually walks at night time past 3-4 weeks 90 minutes. After going to sleep gets up, screams, panic sweats, eyes wide open and non responsive. When wakes up does not remember anything.  Starting to be very tired every morning since this has gone on so long.
Less than 24 hours following vaccine employee got a fine red rash on chest, neck, arms and trunk. Not raised, not itchy, - completely resolved within 24 hours.
low grade fever;fussiness x 2 days started w/in 48hr of vax;tx APAP;
Patient reported her tongue began tingling sensation on 1/30/21 @ 1:30AM.  Woke up 9 hours later with drooping left eye, facial weakness, unable to close left eye lid, eye running water,  left face drawn up with drooping left lip, drooling, difficulty pursing lips and  difficulty swallowing.
Red, swollen Rt deltoid; Went to E.R for evaluation. Routine lab tests done (CBC, CPK's and X rays) Dx with deep infection - cellulitis. Surgery was performed; IV abx started. 2nd surgery done 11-2-09 to close initial incisions.  11/12/09 Medical records received fro DOS 10/25/09.  Final DX: Deep infection, R upper extremity  S/P one day vaccines. Developed swelling over R arm and shoulder. SX increased. Spread to lower arm.  ER visit. Abcess/cellulitis. Necrotizing fasciitis.  I&D and fasciectomy. PICU. Upon d/c resolving erythema and edema.   Good motor sensation, pink muscle under wound. Stable.
Report sore arm with redness and mild swelling. Felt nauseous after getting shot. State "just don't feel good". Counseled to apply cool cloth to area and take Tylenol. If persist, see private PMD or go to ER.
Right-sided facial numbness and slight facial drooping right after receiving vaccine. Tingling and pins/needles sensation. Numbness has prolonged up til this day.  Received medical treatment from physician who mentioned bells palsy and prescribed  Prednisone 20mg take 3 tablets by mouth everyday for 7 days and Valacyclovir 1 gram 3x a day for 7 days.
Approximately  6 hours after receiving my second Pfizer Covid 19 vaccination I began feeling cold.  This continued to he point of having chills and almost shivering.  By 11:00 PM I felt like I was freezing.  I  took two generic Tylenol and went to bed.  I woke up the next morning, (about 9 hours of sleep) feeling fine.  However, a little over 48 hours later I got the same feeling of chills, but to a much lesser degree.  I took generic Tylenol again, and went to bed early.  It has now been a week and no other side effects have been noticed.
After 12 hours patient's entire body turned bright red. He was seen in the ER and given IV steroids.
Burning; itching; redness bilateral feet; had dose 1 and dose 2 on 03Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 09:30 (Lot number: FC3182) at the age of 47 years as dose 1, single and administered in arm left, administration date 03Sep2021 09:30 (Lot number: FC3183) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL. Past drug history included: None. The following information was reported: BURNING SENSATION (non-serious) with onset 05Sep2021 23:00, outcome "not recovered", described as "Burning"; PRURITUS (non-serious) with onset 05Sep2021 23:00, outcome "not recovered", described as "itching"; ERYTHEMA (non-serious) with onset 05Sep2021 23:00, outcome "not recovered", described as "redness bilateral feet"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 03Sep2021 09:30, outcome "unknown", described as "had dose 1 and dose 2 on 03Sep2021". Therapeutic measures were not taken as a result of burning sensation, pruritus, erythema.  Additional information: Patient had no known allergies. Patient did not had any vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, post vaccination.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: deleted event 'overdose' and updated the event from 'inappropriate schedule of vaccine administered' to 'inappropriate dose of vaccine administered'.
Local reaction silver dollar sz, severe Headache, vomiting , temp >101.1 , loss of appetite
I haven't felt myself since receiving the vaccine.  On June 13th I became very ill feeling and was having terrible abdominal pain.  I went to the hospital and they did a CT scan and my small intestine was inflamed and I was admitted to the hospital.  I was there for 5 days and received multiple bags of IV fluids, steroid blasts, stool tests, blood test and blew 6 IV's during the 5 day stay.  On July 5th I went back to the hospital because my right arm swelled up and I lost complete use of the arm and was in terrible pain.  They Xrayed it and said it was not broken and sent me home.  The next night the pain was worse, the arm became more swollen and I went back to the ER and they ran a CT scan with contrast.  Thought I had a blood clot in my arm at the hospital and sent me to facility to have the Doppler done on out patient status.  They said it wasn't blood clots but could not tell me what it was.  When I returned, I went to urgent care, and they treated me with antibiotics and pain pills for cellulitis.  The next day, the pain and swelling worsened and I went to Hospital and they ran another XRay and another CT Scan with contrast and they said it was gout and started me on treatments for that.  Its been two weeks and the arm is still very sore.  They sent me to a surgeon and he put me in a brace and is watching it but is talking about injections and surgery.  I am seeing a gastroenterology specialist, to see why I got sick with the terrible pain in June and then why my arm became very painful and inability to use the arm.  I am still struggling to type and do my job with this arm today.  I am going to have another CT scan and more blood work tomorrow to try to figure out a diagnosis as to what is going on.  My hips are hurting in the joints.  My shoulder has been hurting in the joints and I am not myself at all.   They are testing me for Cronhs disease but still no concrete answers to what is going on with my health.  I've never been on medications or been sick in my life.
A physician reported that a 14 month old male received his 2nd Prevnar on 9/12/00 and the next day, the child developed urticaria and angioedema. He was seen in a clinic and recovered. Angioedema is considered "Medically Important". Both the investigator and the medical monitor agree that the events are possibly related to vaccine administration. Follow up info received on 3/9/01 clarified that the pt did not experience angioedema as previously reported, he experienced urticaria only. Therefore, this report has been downgraded to "non-serious."
Patient called 4/9/09 AM to notify us approximately two hrs after vacc. She felt "weak and with headache"; this morning after 15 min run she c/o sweats, chills, weakness and nausea. Patient referred to PMD if sx persist. Vacc given 4/8/09 PM.
Client received Pfizer COVID-19 vaccine for 5-11 yr olds. Client is only 4 years old. Parent was informed at the time the error occurred.
Patient was given the dose of 0.25ml on 9/14/22. They returned and received a full dose of  0.5ml on 9/16/22.
pt recvd 1st dose of Hep B (recomb) on 4FEB92 & approx 30 hrs following vax pt exp some flushing of face that lasted approx 30 mins; pt did not devel a fever, rash, itching, angioedema nor SOB; pt recovered;
Patient received vaccine that morning, she was off her daily aspirin for an upcoming procedure, and she had transient vision loss over night that lasted 1 minute, suspicious for amarosis fugax.  She is getting a TIA work up including MRI, MRA / head neck.  The episode happened the night of the vaccine (overnight on 4/21 around 2-4 am) and again on the night of 4/22/21 around 2 am.  She had two episodes of complete vision loss R eye, that self resolved within 1 minute.
My son had 2 adverse reactions to the DTaP vaccination.  This form is regarding the reaction that he had when he was 4 months old.  He had his shot on December 23rd and his appetite immediately decreased.  Two days later, he began with vomiting and diarrhea.  His symptoms lasted for about 3 weeks and he was seen in the Emergency Room on 12/31/04.  They didn't believe me when I said it was a reaction to the shots and labeled it the "flu".  My son then had the EXACT same response to the shot when it was given to him again at 6 months of age.
itching, redness, swelling and hotness at the injection site that appeared exactly one week after injection lasting 2+ days.
Patient experienced swelling/pain in arm where injection occurred. Presented at hospital and received antibiotics.
Swelling to arm 1 day after shots, vomiting 2 days after shots.
Headache, Myalgia, Fever, Temp 101.9 Temp 99.9 1/6 @ 0600
Diarrhea (liquid) since day after vaccine, no other symptoms at this time.  Day 3 when called office, diarrhea is improving but still having them.
received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am.  Awoke at 12 midnight unable to herself out of bed, needed to wake husband for assistance due to employee being unable to use Right arm.   Developed headache, chills, sweats, joint pain Stated "it felt like I was hit by a bus"  felt like I got beat up.    Wednesday Headache was gone, R arm swollen, lymph nodes at axilla and R neck large as grapes, painful. No appetite, effort to move .Arm was swollen and reddened at injection site.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 69-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). On 7th April 2018, 10:35, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, itchy rash, impetigo, blister and scab. On an unknown date, the outcome of the erythema and impetigo were not recovered/not resolved and the outcome of the itchy rash, blister and scab were recovering/resolving. The reporter considered the erythema and itchy rash to be related to SHINGRIX. It was unknown if the reporter considered the impetigo, blister and scab to be related to SHINGRIX. Additional details were provided as follows: The patient developed a large redden areas on underside of abdomen and it almost looked like impetigo. It was about a foot long and 1/2 foot wide. The patient also developed a blistery scab like itchy rash on his head and several other parts of his body. The rash was improving and the reddened area was still visible as of past Friday of the date of reporting.
This spontaneous report as received from a other health professional refers to a 4 month old female patient with prophylaxis. On 17-AUG-2017 the patient was vaccinated with LIQUID PEDVAXHIB, .5 ml, intramuscular for prophylaxis. Other suspect therapies included PEDIARIX, PREVNAR 13 and ROTARIX.  On AUG-2017, 20 min after onset of therapy the patient experienced urticaria. The outcome of urticaria was reported as recovered/resolved.
24 hrs post vaccination of MENACTRA and BOOSTRIX - pt had red raised itchy area surrounding the site of each vaccine. Left arm (MENACTRA) was larger 8 x 9 cm. Right arm (BOOSTRIX) was 3x3 cm. Started Amoxicillin for possible cellulitis.
Injection site pain after four hours and lasted 24 hours, chills for about 15 hours, shivering for 8-10 hours, sweating for close to 10 hours, extreme body pain for over 30 hours, headache for longer than 30 hours, vomited twice, had diarrhea a few times, very jittery for about a day, vision issues, fast heart rate, dizziness still ongoing