chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An 81 y.o. female presented to the emergency department on 7/28/2021 for evaluation of generalized weakness, SOB, and cough that started approximately one week ago. Patient was admitted to hospital and started on oxygen, remdesivir, and steroids.  She received 5 days of remdesivir  and 12 days of steroids while in the hospital.  She was discharged on oxygen.
Heart shaped rash appeared 6" below injection site; excruciating lymph node pain; pain in tricep, under arm; hard lump at injection site; Swelling down to hand and fingers; 99.3 fever; pain in tricep, under arm; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 21Feb2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or concomitant medications. The patient reported she had allergies to medications, food or other products. Prior to vaccination the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (lot number unknown) on 31Jan2021 at 16:00 (at the age of 57-years-old) in the right arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 21Feb2021 at 22:00 the patient experienced a heart shaped rash six inches below the injection site 8 hours after the shot. 10 hours later the patient had excruciating lymph node pain and pain in the tricep, under arm and hard lump at injection site. She also experienced swelling down to hand and fingers and 99.3 fever. The events were reported as non-serious and didn't require hospitalization. No treatment was provided for the events. The clinical outcomes of heart shapes rash six inches below injection site, excruciating lymph node pain, pain in tricep under arm, hard lump at injection site, swelling down to hand and fingers, and 99.3 fever were reported as not recovered. It as also reported that since vaccination the patient had not been tested for COVID-19.
No additional AE reported.; an expired dose of MMR II was administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 11-OCT-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml injection, lot # S029454 was confirmed to be valid, expiration date 19-SEP-2021 (albumin status rHA) (route of administration and injection site were not provided) for prophylaxis. No additional adverse events were reported. There were no excursions reported.
Immediate rash & facial flushing after Pfizer -- passed in first 1-2 hours.  Chills and headaches passed in 36 hours.   Neurological symptoms occurred 2 hours after shot.  Numbness, tingling, paresthesias, stabbing pains, muscle cramping, muscle weakness and mobility issues that worsened over the course of 2-3  weeks following shot.  DX:  peripheral neuropathies; GBS syndrome.
Red and itchy rash; Rash under her elbow, breast, abdomen and scalp; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Red and itchy rash) and RASH (Rash under her elbow, breast, abdomen and scalp) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced RASH PRURITIC (Red and itchy rash) and RASH (Rash under her elbow, breast, abdomen and scalp). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Red and itchy rash) and RASH (Rash under her elbow, breast, abdomen and scalp) outcome was unknown.            No concomitant medications were provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Patient should have received the Pfizer Monovalent as her first Covid vaccine dose.  She was given the Bivalent.
tenderness/ tenderness that had radiated into her armpit; swelling; chills; fever; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received Shingrix. On 25th January 2020, 1 days after receiving Shingrix, the patient experienced chills and fever. On 26th January 2020, the patient experienced tenderness and swelling. On an unknown date, the outcome of the chills and fever were resolved with sequelae and the outcome of the tenderness and swelling were recovering/resolving.   It was unknown if the reporter considered the chills, fever, tenderness and swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and developed chills and a fever of 101 degrees F on 25th January 2019. She went to pharmacy and reported that she had tenderness that had radiated into her armpit and it was swollen. No other information was reported.
Patient reported to immunizing technician before administration of vaccine that he had a history of fainting post-vaccination due to anxiety and nerve about needles. Pt stated that previously he had fainted immediately post-vaccination. After discussing patient's medical history the supervising pharmacist advised pt to stay in vaccination seat for direct observation for 10-15min. After about 10 minutes post-vaccination in observation period the pt alerted immunizing tech, "oh, its happening." The tech brought a wet paper towel and placed it on the back of patient's neck and pt replied, "oh, that feels good", then patient's head immediately dropped and he went out of consciousness. Pharmacist witnessed event and rushed over to support patient from falling off chair. Pharmacist was rubbing and patting patients back and chest, yelling his name to arouse him. Pharmacist directed tech to call code white and alert store manager. In total, the patient was approximately in and out of consciousness about 20 seconds. Pt responded to stimulus and recovered without other effects or injury. Patient was fully responsive and aware of event went he became conscious again. We offered him a cold water bottle and encouraged him to remove mask if it helped him to breath better. Pt was able to communicate with pharmacist about the sensations he had leading to the event where he described first tingling in his feet, than dissociation from body, where he felt like he was having a dream but could hear someone yelling at him. EMS arrived at the scene and performed vital check. Based on patient abnormal hypertension at scene and higher BMI, EMS offered to transport patient to the ED for further tests and observation but patient declined. Patient was accompanied by his emergency contact, his father (who also witnessed the events unfold).
pt recv vax 20JUL95 & pt devel breakthrough chickenpox;the health care professional reported two other patients;they were assigned WAES 97021127 and WAES 97021129;
Patient presented in the ED on 5/14/20 at Hospital with a left sided stroke.  Was treated with alteplase.  Pt was then transferred to another Hospital
Information has been received from a licensed practical nurse concerning a male whose child was vaccinated with a dose of ROTATEQ (which dose in series was not known) on 10-JUN-2008 (WAES #0811USA02623).  Following the administration, the mother reported the next time she was in the clinic, that the child's father had severe diarrhea in the next couple of days following the dose. The outcome is unknown. The reporter stated it was unknown if this was due to ROTATEQ, however the reporter thought maybe it was shedding. No further information is available. This is one of several reports from the same reporter. 03/05/09 This is in follow-up to report(s) previously submitted on 10/13/2008; 12/3/2008. Follow-up information received from the nurse concerning the father also had severe diarrhea which lasted 48 hours. No further information is available. This is one of several reports from the same reporter.
Following first dose of Moderna vaccine, mild pain and paresthesia began in left arm/hand (ulnar nerve--pinky and elbow, under left armpit).   Very mild rash on abdomen and left arm (few vesicles; mild itch).  Following second vaccine on April 16 2021, shooting pain in left arm hand and profound pinky weakness developed in conjunction with viral reactivation of HSV1 in left eye.  Treated with valacyclovir 3 gm per day for 7 days plus topical ophthal valacyclovir.  Eye condition resolved (dendritic lesion healed and vision restored).  No change to left hand/paresthesia.  Left-handed; left hand approx 1/2 strength of right hand.  Positive wartenburg sign and positive
I started feeling a stinging on my vaccinated arm early in the morning.  When  I got up later noticed a patch of blotchy red on my arm near where the vaccination was given.  It has grown to about7 inches in length and 3 inches in width.   It is warm, but does not itch, and does not appear to be excessively swollen.  (does not appear to be like the hives I've had in the past, nor are their blisters) I had a similar breakout after a flu shot I had 2 years ago when it was given at the time of a hip replacement.  (It, however, had blisters similar to shingles).
Swelling under left armpit.   Small 1/30/2021, enlarged to 2? diameter today2/1/2021.   No pain,  but mild discomfiture when I lift arm, or press on it.
MUSCLE SORENESS; HEADACHE; FATIGUE; BODY ACHE; SORENESS IN ARM; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced soreness in arm. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 100 F. On 11-APR-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in arm, fever, headache, chills, body ache, fatigue and muscle soreness was not reported. This report was non-serious.
Same day after the 2nd shot, I started experiencing strong cramps in both my feet. I drank water and it resolved.  But next day my feet and hands started cramping pretty hard and for longer. Not sure what?s going on. Didn?t happen with first dose. Did not have these symptoms b4.  Now left foot so cramped I can barely walk. Haven?t seen a dr yet.
Case number PHEH2013US025842 is an initial spontaneous report received from a nurse on 13 Dec 2013: This report refers to a 17-year-old female patient. She was given only MenA powder component of MENVEO (batch number: A13058) mixed with sterile water instead of Men-CYW-135, intramuscularly on 27 Nov 2013. No adverse event was reported following this administration error.
My 17 year old daughter had her second Pfizer shot on Sunday, May 16 at 10AM. On Wednesday, May 19the she woke up and said that she had a terrible time in the middle of the night with a tight chest and she couldn't catch her breath. She wouldn't go to Urgent Care with me so I told her that we had to call the 24 hour nurse line (on the back of the insurance card). I called and she spoke with a nurse, then spoke with a doctor on the phone who told her to go the doctor if her symptoms got any worse.
Approximately 7 mins after the patient received his first dose of the Moderna Covid-19 vaccine, he reported that he wasn't feeling well. A nurse and a medical technician addressed his concerns and the patient was diaphoretic, lightheaded, pale, and vomiting. We immediately provided 1 adult dose of epinephrine, laid him down with his feet elevated, and contacted EMS. Once he was stable to walk we moved him into a private room to be further assessed by EMS. Vitals were taken every 5 mins until the patient was transported to a local hospital.
Jan 26 @ 4:30 pm  arm began being sore at site. Jan 26 @ 7:30 pm arm hurt to move, cold chills, headache that would not go away, body aches, fever. Fever ranged 100.1 - 102.3. Jan 27 same as above plus very tired. Jan 28 fever broke early am, but returned in afternoon. Headache continues, chills, fever, tired and feeling blah and drained. Jan 29 10:00 am. Headache continues, tired, body aches, no fever as of now (that may change).
all sorts of sick; Fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: fever) and sickness (Verbatim: all sorts of sick). The outcome of the fever was recovered/resolved (duration 3 days) and the outcome of the sickness was not reported.   It was unknown if the reporter considered the fever and sickness to be related to Shingles vaccine.     It was unknown if the company considered the fever and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she got a three day fever and was all sorts of sick.  The patient stated that when he/she called the number they gave him/her to report adverse reactions and all they wanted to know about was Covid. The follow-up could not be possible as no contact details were available.
Information has been received from a physician concerning a 40 year old female patient with no pertinent medical history or drug reactions who on 04-MAY-2010 was vaccinated with a standard dose of VARIVAX (Merck). Concomitant therapy included ADACEL. On 21-MAY-2010 (last Friday) the patient had rash on her neck, face, and abdomen. She had about dozen lesions. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered from this event. Additional information has been requested.
I believe it triggered PHN pain which I haven't had a reoccurrence of since being on Gabapentin 600 mgs. I increased it by 100 mg and took Acyclovir 400 mg bid and the pain subsided  after several days.
Brachial neuritis (neuralgic amyotrophy) began subtly with right Scapular pain on Saturday 2/27/2021 that progressed slightly over the next few days and then on Tuesday February  30 at around two in the morning they were severe eight Dash 9/10 throbbing aching and sharp pain in the right proximal arm scapula and shoulder. Cervical and arm imaging ruled out a structural problem or a cervical etiology.The distribution of focal distribution weakness over the next week confirmed the diagnosis of brachial neuritis.
pt recv vax & 45min p/vax pt began w/dry cough & became hoarse;devel tightness in chest & fever of 100;took APAP & then napped;woke up feeling better;
I broke out with a rash 3/12 on my arms, thighs, legs, sides, under my breasts, on my back. its red and itchy.
Pain in Left shoulder, radiating down arm toward elbow. Decreased range of motion in Left shoulder, decreased strength in Left shoulder, numbness in fingers.
Welts hives developing each night since after 1st Moderna. One visit to ER so far hives appear when waking
Significant pain, erythema, edema and warmth starting about one hour after co-administration of Pneumovax and dT in left upper arm.  Resolved to a bruise extending from elbow to site of injections after 48 hours of intermittent ice.  No evidence of cellulitis.
Individual was found to have received the janssen COVID-19 vaccine the previous month and then received the Pfizer vaccine. This was not known until after she received the different brand covid vaccine and her information was being input into database.
Occipital stroke presenting as headache and left vision deficit.  Full recovery achieved after hospitalization for 3 days.
dizziness/lightheadedness; increased BP; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (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: DIZZINESS (non-serious) with onset Feb2021, outcome "not recovered", described as "dizziness/lightheadedness "; BLOOD PRESSURE INCREASED (non-serious) with onset Feb2021, outcome "recovered", described as "increased BP". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
muscle spasm; Explosive diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Explosive diarrhea) and MUSCLE SPASMS (muscle spasm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (Explosive diarrhea). On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at a dose of 1 dosage form. On 20-Mar-2021, DIARRHOEA (Explosive diarrhea) had resolved. At the time of the report, MUSCLE SPASMS (muscle spasm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-080395 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080395:2nd dose event
rash which is like a cluster of mosquito bites; itchy; redness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash which is like a cluster of mosquito bites), PRURITUS (itchy) and ERYTHEMA (redness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced RASH (rash which is like a cluster of mosquito bites), PRURITUS (itchy) and ERYTHEMA (redness). At the time of the report, RASH (rash which is like a cluster of mosquito bites), PRURITUS (itchy) and ERYTHEMA (redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications of the patient included Calahist lotion. No concomitant medications were reported.
Swollen middle finger of right hand; in excruciating pain for 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen middle finger of right hand) and PAIN (in excruciating pain for 30 minutes) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen middle finger of right hand) and PAIN (in excruciating pain for 30 minutes). At the time of the report, PERIPHERAL SWELLING (Swollen middle finger of right hand) and PAIN (in excruciating pain for 30 minutes) outcome was unknown.            He was in excruciating pain for about 30 minutes and it was swollen twice in size.  He takes monthly medication for arthritis.  Treatment information was not provided.   This case was linked to MOD21-074521 (E2B Linked Report).; Sender's Comments:  MOD21-074521:
On Jan 1st developed small itchy resented area size of a penny. It further progressed over the next day or two to approximately 2 inch diameter reddened area not raised  itchy. It is still itchy at time but fading to just a reddened ring around the 2 inch area. Slight itching
Severe sore throat; Painful bumps all over my tongue; Transient lingual papillitis, maybe it is similar to COVID tongue; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 03Apr2021 at 11:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown. The patient had mild allergy to eggs and peanuts. The patient did not receive any medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received penicillin and experienced allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 05Apr2021 at 07:00, within 72 hours of getting the vaccine, the patient experienced severe sore throat, painful bumps all over tongue and transient lingual papillitis. The patient was not sure if it was directly related to the vaccine, but stated might be it was similar to "COVID tongue". Even after 5 days of vaccination the symptoms were ongoing. On 06Apr2021, the patient underwent SARS 2 Ag Point-Of-Care test (POCT) (nasal swab) and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe sore throat, painful bumps all over tongue and transient lingual papillitis was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Per mother, patient developed temperature of 103 and broke out in rash on face and shoulder which looked like hives in the evening of April 2, after receiving DTaP and HBV/HIB vaccines. He was acting like he had "swollen throat" and could not swallow well. Given Ibuprofen at 10PM, and 11Am the following day. Patient taken to ER at 3PM.
5-8 min after receiving CODEINE child's tongue started swelling, vomited, HR increase, lips edematous, SOB, unresponsive EPI PEN given IM, O2 started, paramedics called child, transported to hospital approx 20 mins later, child more responsive at this time, asking for mother.