chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her breasts doubled in size and became very tender; Her breasts doubled in size and became very tender; Sty in her eye; Gums became inflamed; Her lymph node in her left arm, the arm of the injection, began swelling, Her lymph node in her right arm began swelling; Headache; She related the experience to feeling hungover; She began feeling tired; Achy; This spontaneous case was reported by a nurse and describes the occurrence of HANGOVER (She related the experience to feeling hungover), BREAST ENLARGEMENT (Her breasts doubled in size and became very tender), BREAST TENDERNESS (Her breasts doubled in size and became very tender), HORDEOLUM (Sty in her eye) and NONINFECTIVE GINGIVITIS (Gums became inflamed) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced HANGOVER (She related the experience to feeling hungover), FATIGUE (She began feeling tired), PAIN (Achy) and HEADACHE (Headache). On 28-Jan-2021, the patient experienced BREAST ENLARGEMENT (Her breasts doubled in size and became very tender), BREAST TENDERNESS (Her breasts doubled in size and became very tender), HORDEOLUM (Sty in her eye), NONINFECTIVE GINGIVITIS (Gums became inflamed) and LYMPHADENOPATHY (Her lymph node in her left arm, the arm of the injection, began swelling, Her lymph node in her right arm began swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Jan-2021, HANGOVER (She related the experience to feeling hungover), FATIGUE (She began feeling tired), PAIN (Achy) and HEADACHE (Headache) had resolved. At the time of the report, BREAST ENLARGEMENT (Her breasts doubled in size and became very tender), BREAST TENDERNESS (Her breasts doubled in size and became very tender), HORDEOLUM (Sty in her eye), NONINFECTIVE GINGIVITIS (Gums became inflamed) and LYMPHADENOPATHY (Her lymph node in her left arm, the arm of the injection, began swelling, Her lymph node in her right arm began swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication provided; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
The patient was doing great.   After 30 min later, the pt started to have numbness on the face.  Felt like the face was completely numb.  Came back to clinic and numbness started to go away.  It would wax and wane.  It started to improve.   Now the patient is doing great.  Other vitals fine.  NO SOB,  No intervention done.  Pt released home.
I had had back surgery in August, recovering well, Day after vaccine began having pain at right SI joint which was surgical site, then progressed up my spine into my neck with complete spasm and pain unrelieved by any meds or therapy. Absolutely complete systemic inflammatory response after the vaccine.  This lasted for 2 weeks, saw my ortho in followup and prescribed Medrol dose pack.  Within 24hurs, pain started to subside and back to baseline discomfort by end of dosepack.
REDNESS/SWELLING AT AREA OF VACCINATION AND MODERATE TO SEVERE HEADACHE. TREATED WITH TYLENOL/MOTRIN AND ORAL BENADRYL.
Face and arm became itchy, a few hours later hives developed. Hives increased in frequency after soccer practice, hand and feet were swollen and hives on soles of her feet.
This spontaneous report as received from a physician refers to a 2 month old patient. On 19-AUG-2014 the patient ws vaccinated with a dose of PNEUMOVAX23 (0.5 ml, intramuscular, lot number was not reported) accidentally at the age of 2 months old instead of PREVNAR. No adverse effect reported. Additional information has been requested.
Rash & UrticariaPruritus Narrative:  Upper arm rash that encompassing entire area including vaccine site. Described as indurated, pruritic, warm and erythematous. Developed the day after vaccination and grew to largest size by day 5 prior to slowly subsiding. Took about 2 weeks to resolve completely. Employee took OTC antihistamine, which helped. Did not apply topical medication or lotion. No other symptoms reported including sloughing, hives, flushing, etc.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No information regarding their current conditions and medical history was provided by the reporter. On an unknown date since 30-DEC-2015, the patients were vaccinated with improperly stored GARDASIL (strength, dose, route and indication not reported) of lot # K011325 and expiry date: 08-APR-2017. Concomitant medications were not mentioned. The vaccine was stored at 58.5 degree Fahrenheit for a time frame of 24 hours which was outside of the recommended range (incorrect product storage) and administered to patients. There was no previous temperature excursion. No adverse effects have been reported. No additional information was provided. Product Quality complaint was not filed. Additional information has been requested. This is one of the five reports received from the same reporter.
Fever after imms 101.3 R day of, 100.5 R day after.
Narrative: Patient received first Pfizer COVID19 vaccine dose 4/10/21 and second dose 5/4/21. Presented to PCP appointment 5/10 and reported DIZZINESS, FATIGUE, HEADACHE, and LOSS OF APPETITE after second dose. No treatment documented.
I had fever; fatigue; nausea; my joints were killing me in my spine. I was so tired, I couldn't walk from chair to the kitchen - about 10 feet. I started getting dizziness; and my right arm and my neck especially right side were really sore and stiff and hard to move. Along with the fatigue,  it was hard for me to talk or make sense - I couldn't concentrate or remember anything. It took me a few minutes to answer a basic question. I didn't eat much for a few days with the nausea. Fatigued for at least a week. The dizziness accompanied that. The fatigue and dizziness didn't go away. I started developing headaches where whole head was pounding and throbbing. I continued with headaches, fatigue and dizziness for almost the entire three weeks and even then some afterward. Saw Dr a few times. He hadn't really give me anything at all of any of the symptoms - told me it was a cytokine reaction from the latest research he had heard. He said the aches, fatigue and the headaches and the joint pain -Tylenol was the only thing that would work. I started taking Tylenol after that. The headaches and fatigue interfered with a lot of my life for two or three weeks.  I missed work for three weeks.
This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCOLOURATION (rash spread to shoulder and spread to chest in between breasts a few days after second dose), PERIPHERAL SWELLING (arm swelling), RASH PRURITIC (Itchiness of rash), WOUND (use a special medication for cuts) and RASH (bad rash of arm down to elbow which started the evening of the day she got second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030AZ1A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swelling) and RASH (bad rash of arm down to elbow which started the evening of the day she got second dose). On 12-Mar-2021, the patient experienced BREAST DISCOLOURATION (rash spread to shoulder and spread to chest in between breasts a few days after second dose) and RASH PRURITIC (Itchiness of rash). On an unknown date, the patient experienced WOUND (use a special medication for cuts). At the time of the report, BREAST DISCOLOURATION (rash spread to shoulder and spread to chest in between breasts a few days after second dose), PERIPHERAL SWELLING (arm swelling) and RASH PRURITIC (Itchiness of rash) had not resolved and WOUND (use a special medication for cuts) and RASH (bad rash of arm down to elbow which started the evening of the day she got second dose) outcome was unknown.            Additional information: Says she has to go to hospital this upcoming Monday and will be getting anesthesia so the "doctor can look inside stomach". Says the symptoms went from arm swelling, to a bad rash of arm down to elbow which started the evening of the day she got second dose, which then spread to shoulder and the rash "spread to chest in between breasts". Feels itchy. Ongoing symptoms. "I use a special medication for cuts", cortisone.  Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant information not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-070263 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070263:1st dose
Jaw locked in the middle of night Also experiencing typical symptoms however sever- fever, joint pain. violent chills, body aches, dizziness
all the lymph nodes on the left side of my body swelled.  could raise left arm or turn neck to left for several days
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 02-NOV-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M034586; expiry date: 27-JUL-2018), which was reconstituted with properly stored sterile diluent (lot #M044953, expiry date: 27-FEB-2019). The vaccine was stored at a temperature of 15ºF to 46ºF for 132 Days. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA012320: US-009507513-1802USA012323: US-009507513-1802USA012326.
1:12pm: Patient received vaccine 1:25pm: Patient reports throbbing headache.  He has never experienced a migraine but thinks that is what he is feeling. Patient is asked to stay 30 minutes for observation. 1:40pm: Patient reports really tight chest and slightest improvement in headache.  He is given diphenhydramine 50mg PO and moved to a recliner and put in reclining position. BP 150/94, pulse 76-106bpm, pulse ox 96%.  No shortness of breath, no sore throat, no swelling of tongue. 2:05pm: Patient reports throbbing headache at 7 out of 10 on pain scale.  Chest tightness has improved, but getting drowsy (likely due to diphenhydramine).  BP 128/88, pulse 77bpm, Pulse Ox 97%.  Patient refuses Tylenol at this time. 2:24pm: Patient accepts Tylenol 650mg PO, BP 130/82, pulse 74, pulse ox 97%, no longer has chest tightness, but headache is throbbing and remains unchanged. Patient has light sensitivity and the lights were dimmed. 2:35pm: BP 120/80, pulse 75, pulse ox 95%, no chest tightness and headache is still throbbing and unchanged. 3:30pm: BP 122/84, pulse 75, pulse ox 97%.  Patient still has severe throbbing headache, but voices desire to go home and leaves facility.   Upon follow up on 1/19/2021, patient reports headache lasted 3 days.  Patient woke on 1/16/2021 with redness, swelling, heat, and itchiness at the injection site.  This resolved on 1/19/2021.
He got his vaccine, had extreme pain in his right arm.  He went back to the pharmacy and let her know that it hurt for several days and then went away, and he is still having the tenderness in the arm.  It was so painful that he could not sleep on it due to the pain.   He then had no problems up until 5/24/21 when he noticed some swelling on his ankle of his right leg.  He put it in cold water to see if the swelling would go down and it did not.  Then he didn't think about it again until it was stiff, swollen and wanted to turn to the right side and hard for him to drive and taking his anti-inflammatories.  It progressively got worse and around 5/25/21 the swelling was severe and doubled in size and getting worse and on 6/3/21 he could not get his pants off due to the swelling and he went to the Dr. The next day.  He had pain behind the knee, ankle, pain in the leg.  He went to the doctor, and they sent him to the ER for an US which showed DVT of the right leg.  He was informed that it was large and that it was in the thigh of his right leg and not returning blood to his heart.  He was put on Eliquis 5 mg twice a day and is doing well for him.  The swelling is a little better, the ankle is still swollen, and the leg is still swollen, the top of his foot is really bad, front of his leg and thigh.  The knee does not seem to be swollen, but the thigh is.   He has no problem with the left side.  He is to follow up with his doctor on Thursday.  He is on Hydrocodone as well for the pain as needed for his neck pain and lower back.
Having a stomach bug (feels like throwing up); Having a stomach bug (feels like throwing up); Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset May2021, outcome "unknown", HEADACHE (non-serious) with onset May2021, outcome "unknown" and all described as "Headache"; GASTROENTERITIS VIRAL (non-serious), outcome "unknown", described as "Having a stomach bug (feels like throwing up)".  Additional Information: A contactable consumer (patients mother) reported for her son that he had taken the first dose and got symptoms as stomach bug, he woke up and he was throwing up and then he doesn't have a fever he has got a bit headache. Reporter queried whether patient can take 2nd one dose or can he wait a day, so that he feels a little better and then he can take 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 12 month old male with no pertinent medical history and no drug reactions/allergies who on 02/14/2005 was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy included a dose of HIB conj-hepatitis B vaccine (MSD) administered in the same thigh and a dose of pneumococcal 4  (prevnar) administered in the other thigh.  On 02/16/2005, the patient experienced a red area with papules at the injection site.  He was seen on 02/28/2005 with a hard, red, swollen area with papules on it and a temperature of 100 degrees at home, 98.5 degrees in the office.  No treatment was required.  There were no lab diagnostic studies performed.  There was no product quality complaint.  Additional information has been requested.
lot of coughing; sneezing; runny nose; felt really tired; tingling on the lips; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling on the lips), COUGH (lot of coughing), SNEEZING (sneezing), RHINORRHOEA (runny nose) and FATIGUE (felt really tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Gastrointestinal discomfort.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling on the lips). On 06-Feb-2021, the patient experienced FATIGUE (felt really tired). On 08-Feb-2021, the patient experienced COUGH (lot of coughing), SNEEZING (sneezing) and RHINORRHOEA (runny nose). On 05-Feb-2021, PARAESTHESIA ORAL (tingling on the lips) had resolved. On 06-Feb-2021, FATIGUE (felt really tired) had resolved. At the time of the report, COUGH (lot of coughing), SNEEZING (sneezing) and RHINORRHOEA (runny nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recv vax; soreness & swelling at site which extended up into side of the neck & involved the lymph nodes; no SOB;
9 hours after vaccination, patient experienced ringing and sudden loss of hearing in right ear.  Sounds are garbled.  No treatment has been sought at this time.  Symptoms continue past 36 hours after onset of initial symptoms with no improvement.
Could not walk or stand June 19, 2010, diagnosed Guillain-Barre Syndrome. IVIG given as treatment had reaction almost died. Recurred Nov 4 IVIG given 21 days in rehab. This has changed my life & my marriage. I can't do any kind of work & don't feel like being a companion to my husband. This is a very bad sickness, I have been fighting it a long time. I had it 2 times & could have it again. I don't think I will ever be the same.
Client received Daptacel, Prevnar, and Rotateq on 12/04/06. Twin brother received same shots on the same day. They did not have any adverse symptoms after few days. On 12/19/06, mom fed them at 5am, went to bed, then found them dead at 9:00 am.  6/29/07 Received Autopsy Report which reveals COD as Undetermined & contributing condition as simultaneous death of twin brother & tracheitis & bronchitis.  Pathological Dx: I. Sudden unexpected infant death    A. Twin A infant male found unresponsive in crib on stomach    B. Vitreous electrolytes, abnormal, w/decreased Na & increased Cl, urea nitrogen, calcium, carbon dioxide    C. Brain, congestion and neuronal heterotopis, mild    D. Tracheitis & bronchitis, chronic, mild to mod sever. II. Ancillary studies, other, non-contributory III. Simultaneous death of twin brother IV.  Fractures, ribs, anterior & lateral, w/minimal hemorrhage.
Patient reported back to pharmacy today, 12/19/20 with redness from shoulder down to elbow of the left arm (injection arm) not just localized to the injection site. States sore, slightly swollen, and red in color. No streaks or other signs of infection present.
Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Medium, Error: Wrong Route (SC, IM, etc.), Additional Details: Swollen left Axillary lymph Nodes probably sequel to localized immune reaction. Injection was given a little too low on the arm.
Right upper arm muscle hard, painful. Enlarged lymph nodes under right arm and right side of neck. Upper right arm 1 cm larger than left arm. Decreased range of motion in right arm.
During his observation period, the patient complained of a "lump in his throat". I gave him 50 mg of Diphenhydramine and we observed him for 20 more minutes. The nurse on site will contact him 3 more times during the day to check on him. He says he feels fine.
This spontaneous report was received from a consumer who is the patient's mother, referring to a female patient of unknown age. No concurrent conditions were reported. On an unknown date in 2002, about eleven years ago, the patient was vaccinated with VARIVAX (Merck) for prevention of varicella. Dose, route and lot number were not reported. No co-suspect and concomitant therapies were reported. On an unknown date, years later to vaccination, the patient had titers drawn while she was pregnant. The reporter stated that "the titers showed that the vaccine did not take". At the time of this report the outcome was unknown. The causality was not reported. Additional information has been requested.
Arm is hot to touch; Arm is hard; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is hot to touch), VACCINATION SITE INDURATION (Arm is hard) and VACCINATION SITE RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Arm is hot to touch), VACCINATION SITE INDURATION (Arm is hard) and VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE WARMTH (Arm is hot to touch), VACCINATION SITE INDURATION (Arm is hard) and VACCINATION SITE RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication was not provided.  Treatment information was not provided.
Shot was painful.  I told the assistant I had never had a  shot that hurt that badly.  She didn't even acknowledge.  After waiting 15 minutes I left with some discomfort but figured my  arm will probably be sore for a few days.  A couple hours after getting the injection, I couldn't move my left arm without excruciating pain. I'm only assuming she gave me the shot to close to the shoulder joint.  It's now Tuesday, February 10, and it is improving with more mobility and not as painful.  But, still hurts.  Cannot sleep on my left side.  I'm concerned about getting the second dosage on February 27 and if this has caused any damage to the joint.  So far, I have not seen this side affect listed in  any Covid fact sheets.
My mother died in the hospital after being in the ICU for a week with severe breathing problems.  Her symptoms matched that of a Covid patient but she tested negative for Covid twice (once was the 24 hour test).
Fever; chills; arm ached; ached all over; felt faint; sick to my stomach; This is a spontaneous report from a contactable consumer or other non hcp (patient).     A 71-year-old (age at vaccination) non-pregnant (at the time of vaccination) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: unknown) via an unspecified route of administration, administered in left arm on 05Mar2021 at 11:30 as single dose for covid-19 immunization. Medical history included covid-19 in Jul2020 (prior vaccination), allergies with codeine and sulfur drugs. Concomitant medications included levothyroxine sodium (THYROXINE), omeprazole, estradiol (ESTROGEN), progesterone. The patient previously took codeine and experienced drug hypersensitivity. Patient not administered other vaccine in four weeks. Patient was not tested for Covid post vaccination. On 06Mar2021 at 04:00, after vaccination the patient experienced fever, chills, arm ached, ached all over, felt faint, sick to her stomach. The outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
redness on arm, fever, diarrhea the next day;freezing cold the next day, hives;MD prescribed ATB;
We received from a health care professional the following information on 21 NOV 2007: A female patient was vaccinated with Fluvirin, batch-no. and date unknown, into the rotator cuff.  Patient has lost some functions of the affected arm.  Seriousness criterion: medically significant.  Causality: unrelated.  The wrong vaccine administration is more likely responsible for the complaints.  Expectedness assessment according to SPC/US label: The reported symptoms are not expected after vaccination with Fluvirin.  No change in benefit-risk ratio.  No measure necessary.