chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GI issues (upset stomach); in the area where she received the vaccine it felt hot to the touch; in the area where she received the vaccine it felt itchy; in the area where she received the vaccine it felt swollen; in the area where she received the vaccine it felt red; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (GI issues (upset stomach)), VACCINATION SITE WARMTH (in the area where she received the vaccine it felt hot to the touch), VACCINATION SITE PRURITUS (in the area where she received the vaccine it felt itchy), VACCINATION SITE PAIN (a sore arm) and VACCINATION SITE SWELLING (in the area where she received the vaccine it felt swollen) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no specific medical history was reported.  Concomitant products included GABAPENTIN and CYCLOBENZAPRINE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (a sore arm). On 27-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (GI issues (upset stomach)), VACCINATION SITE WARMTH (in the area where she received the vaccine it felt hot to the touch), VACCINATION SITE PRURITUS (in the area where she received the vaccine it felt itchy), VACCINATION SITE SWELLING (in the area where she received the vaccine it felt swollen) and VACCINATION SITE ERYTHEMA (in the area where she received the vaccine it felt red). On 22-Jan-2021, VACCINATION SITE PAIN (a sore arm) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (GI issues (upset stomach)), VACCINATION SITE WARMTH (in the area where she received the vaccine it felt hot to the touch), VACCINATION SITE PRURITUS (in the area where she received the vaccine it felt itchy), VACCINATION SITE SWELLING (in the area where she received the vaccine it felt swollen) and VACCINATION SITE ERYTHEMA (in the area where she received the vaccine it felt red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
After receiving the vaccine I had soreness of the arm and it went away about a week later. Then a month later first thing in the morning my little finger on my left hand was number and purple. I went to a same day clinic and they determined Raynaud syndrome.
Woke up with fever, chills, headache and loud ringing in the right ear.  All symptoms and lethargic feeling went away by 9:30-10:00 pm on 02/12/2021 except the ringing in the ear.  The left ear started ringing approximately 8-9 days later . Ringing in both ears is still present today (02/24/2021).
Received Flumist 10/20/2006. 10/22/2006 developed headache and fever. 10/23/2006 developed nose bleed only symptomatic treatment needed but sent home from school and mom was quite upset.
Employee received FLUARIX QUADRIVALENT vaccine administration at approximately 12:32 PM. At approximately 3:45 PM she was sitting in the office talking with a coworker. She stated that she felt a sudden "hot flash", broke out into a profuse sweat and noticed that her hands were shaking. The coworker walked her downstairs to the clinic here at work where she was assessed. Most of the symptoms were gone within an hour but she still had a very slight tremor noted in her fingers. That evening at home, the employee stated that she experienced a bout of diarrhea around 6:30 PM (after she ate dinner). Today she feels very tired but was able to return to work on her usual schedule. It should be noted that this employee has never received a flu vaccination before. This was the first time.
This spontaneous report was received from a medical assistant and refers to a currently 3 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # K015464 with expiration date 09-JUL-2017 (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Swollen right supraclavicular lymph node(s); Soreness and sensitivity above right clavicle and right side of lower neck region.
Pt recvd vax & 3 days later exp itching & burning under skin;
High fever irritability. Fever got worse. Called doctor. Doctor said no worries. She got worse. Took her to walk in clinic. They said to see her doctor if it hasn?t improved as they saw no reasons why she was ill. Started having a cough and congestion Saturday the 20th. Had a rash all over her belly, back and privates the 21st.  Rash spread to face, neck, and legs on the 22nd. Called to request follow up appointment today. They will see her tomorrow.
rash; This is a spontaneous report from a contactable consumer reported patient (father). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9264), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunisation. The patient experienced rash on an unspecified date. The reporter asked what to do about it use an antihistamine. The outcome of the event was reported as unknown.  Follow-up attempts completed. No further information expected.
recurring dermatitis; condition aggravated; possible drug interaction; This case was reported by a consumer via call center representative and described the occurrence of dermatitis in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Medrol for an unknown indication.   Concurrent medical conditions included dermatitis.   On 23rd April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Medrol at an unknown dose and frequency. In April 2019, less than a week after receiving Shingrix, the patient experienced dermatitis, condition aggravated and drug interaction. On an unknown date, the outcome of the dermatitis and condition aggravated were recovering/resolving and the outcome of the drug interaction was unknown.   It was unknown if the reporter considered the dermatitis and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient reported that she got her first Shingrix shot on Tuesday of this week and her dermatitis was flaring up.  The patient does not know if it was related but asked about possibly taking a Medrol dose pack and if that would interfere with the vaccine, which led to possible drug interaction. She was referred to her physician for discussion. Call declined health care professional (HCP) information at this time but open to receive authorization form later, she was not sure if she will pursue the Medrol dose pack.
Information has been received from a pharmacist referring to a 65 year old female patient with allergy to Penicillin. The patient's concurrent conditions included hypertension and hypothyroidism. There was no medical history reported. On 20-AUG-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # L006381, expiry date 25-MAY-2016) (dosage and strength were not reported) subcutaneously in the right arm, the patient was also administered with a dose of PREVNAR 13, in the left arm on the same day. Concomitant therapies also included amlodipine, atorvastatin and  levothyroxine sodium. The patient presented to the pharmacist on 24-AUG-2015 with the reactions: "a red, swollen area the size of a quarter at the ZOSTAVAX injection site: which started on an unspecified date in August 2015. The patient also had a rash on the back of her neck, and a faint rash on her right cheek just below her eye (started on an unspecified date in August 2015). The patient was going to see her physician on 24-AUG-2015. ON an unspecified date in August 2015, the patient was prescribed 800 mg of Acyclovir by an unspecified physician for the treatment of the rash. At the time of the report, the outcome of the events was reported as not recovered. This is one of the two reports that received from the same reporter. Additional information has been requested.
Eye swelling, lips swelling since woke up from nap at daycare.  Recommended Bedandryl 1/2 tsp every 6 to 8 hours.  Hold next flu vaccine.
CHILLS; LOW GRADE FEVER OF 99.1; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced chills, and low grade fever of 99.1.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever of 99.1 and chills was not reported. This report was non-serious.
10-04-2010 Vaccine administered. 10-05-10 about 24 hours later noticed slight discomfort R deltoid. Also minimal itching across chest - no rash - itching subsided after short time. By evening on 10-5-10 increase pain in R. upper arm - unable to sleep - took NAPROXEN and IBUPROFEN - no relief. Can raise R. arm forward and backward but not away from body. No other symptoms - no visible redness @ site of injection.
second dose until 06Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received first dose of Shingrix series on 15th October 2018).   On 6th August 2022, the patient received the 2nd dose of Shingrix. On 6th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 14-Nov-2022. Reporter's Comment: The reporter stated patient did not get second dose until 6th August 2022.   The reporter did not have the lot number /expiration date information for either dose. Consented to follow up. Reporter gave permission for follow-up. Additional supportive Information: The patient did not get second dose until 6th August 2022, which led to drug dose administration interval too long.
The patient woke up at 0200 n 12/5/19 with swelling of he eyes, face, lips. She took 50 mg of benadryl at 0230.  I saw her in the office at 13:15 and by then there was less swelling, but pictures the mother took looked like angioedema. She did not have any trouble breathing, swelling of her tongue, pruritis, hives, or abdominal symptoms. She has taken 400 mg of ibuprofen on 12/4/19 around 9 pm due to pain in her arm. She has take ibuprofen numerous times without any adverse reactions. She did not have any other new medications, foods, or topical exposures. Since she was improving by the time I saw her and no further treatment was recommended at this time. I did advise to not do the second dose for her vaccine in 6 months and to be proceed with caution the next time she uses ibuprofen or any nsaids.
My son was given the DPT, Hib and Polio vaccinations. About 4-5 hours later  he was running around and playing happily and normally in the park. During this routine play, his entire body suddenly seized up and fell to the ground. He was unable to walk normally for the rest of the night. The cycle of trying to walk, crying and falling continued until the next morning.  I was advised by our pediatrician to give him Tylenol.
101 fever, chills, cramps in varius parts of feet & legs, headaches, severely tired with body aches started 12 hours after vaccine was given and lasted 36 hours
I itched bad and was tired. I contacted my doctor and she just told me to wait it out a bit because I have had this reaction before.
Patient's first COVID-19 dose was Moderna administered on 10/14/2021. Patient came in to pharmacy for his second COVID-19 dose on Sunday 11/14/2021. Pfizer COVID-19 vaccine administered at pharmacy on 11/14/2021 in error. Patient should have received Moderna COVID-19 vaccine instead on 11/14/2021 for his second dose.
A few weeks after his second Covid vaccine, my son felt as if he is not satiated when breathing. This symptom has not gone away. He has had many extensive tests with numerous specialists, and every result has been negative and normal.
I was bruised where the shot was given, plus to the left and below the shot I had swelling with bruising and pain. I also have a lot of pain and trouble raising my arm up and out. I get a flu shot every year and have never had any problems before. Now I have trouble getting things from a cupboard, refrigerator, driving, doing my hair and many other things, all of which cause excruciating pain. I went to the doctor 11-10-16 he gave me a prescription for methylprednisolone 4mg Dospak 21s. The pain was less, but still there and still couldn't raise my arm without the pain. When the medication ended, the next day the pain was from my shoulder to my neck and down to my elbow and my shoulder was the size of a half of a softball. I still cannot use my right arm without pain. I live alone and need my arm. I want to know what's going on and what can be done to help me. Please help. Do I have SIRVA?
Patient stated it feels tight to breath. She also pointed to her throat. Lung sounds clear, O2 sat 99%. Patient given 50mg of benedryl at the time. Symptoms did not get worse. After 30 minutes patient stated she can breath normal again.
This spontaneous report was received from a physician, concerning a patient of unknown age and gender. Neither medical history nor concurrent conditions were reported. On 10-JUL-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose (lot # and expiration date unspecified). No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
The morning after the 2nd Pfizer, her left eye was very puffy and her face was red and she had a bad headache. The headache persisted for 10 days.  The second morning she had pain in her teeth and gums and it hurt to brush and floss for 10 days.
left thigh was swollen and erythematous within approximately 8 hr of shots.  It was a large swelling involving whole thigh.  Hep A and Dtap was given that thigh
Upon waking this morning around 8am, I noticed a red blotch on left arm around the area of the injection.  This redness appeared today, March 5, 2021 which is 1 week after receiving the Moderna vaccine.  My left arm is also a bit achy but not sore to touch.
Redness at Menactra injection site 2 1/4" long x 1" wide. Induration at Menactra injection side approx. 1/2" diameter.
Patient came in on 11/2 with a raised red lump on her arm where she was given the PREVNAR injection. She said that it was much larger the day before but it had started to decrease in size. Patient had been taking ibuprofen and diphenhydramine to help relieve her symptoms. Patient was told to continue to monitor the red area on her arm and if it did not improve in the coming days to be seen by her doctor.
Woke the am after shots with temp of  101 Mom says "just doesn't feel good" Sites of injection look fine + no other sxs.
Raised bump near site of injection. Painful when touched. Not red. No rash. Recommended Benadryl, ice, or cool compress. To contact MD if gets worse and that we will follow up with patient.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 19-JUL-2013, the patient was inoculated (by an unspecified person) with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-APR-2016, she was treated (by an unspecified healthcare professional) at a community physicians group for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Extreme pain inn joint-knee & shin numbness in leg & arm, Sometimes have trouble walking in the morning.
MOTHER CALLED THE NEXT MORNING AND STATED PT WOKE UP VERY NAUSEATED, LASTED FOR SEVERAL HOURS.
acute optic neuritis; Diplopia in the left eye; Blurry vision; This is a literature report.  A 42-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for COVID-19 immunisation. The following information was reported: OPTIC NEURITIS (medically significant), outcome "recovering", described as "acute optic neuritis"; DIPLOPIA (non-serious), outcome "unknown", described as "Diplopia in the left eye"; VISION BLURRED (non-serious), outcome "recovering", described as "Blurry vision". The events "acute optic neuritis", "diplopia in the left eye" and "blurry vision" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: anti-aquaporin-4 antibody: negative; csf oligoclonal band: were absent; csf test: was significant for increased protein; investigation: revealed horizontal diplopia in the left eye, notes: cranial nerve 3; revealed horizontal diplopia in the left eye, notes: cranial nerve 4; revealed horizontal diplopia in the left eye, notes: cranial nerve 6; diffuse gray field vision in the left eye was, notes: noted; negative.; 5/5 bilaterally and reflexes 2+ bilaterally; magnetic resonance imaging: revealed left optic nerve enhancement; magnetic resonance imaging head: unremarkable; ophthalmological examination: revealed a positive relative afferent pupillary, notes: defect in the left eye with clear disc margins. Therapeutic measures were taken as a result of optic neuritis, diplopia, vision blurred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Caller's arms are weak; Caller's knees are swollen and caller can barely walk; Caller's knees are swollen and caller can barely walk; Second dose: Just started to get a rash; Caller states his rash is not a bumpy rash, it is a blotchy rash; Second dose: Was violently shivering and freezing to death; Second dose: Fevers; Second dose: Was violently shivering and freezing to death; Second dose: Overall miserable; Second dose: Went home early from work with body aches; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 53-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0162, Expiration date: not reported) via an unspecified route of administration, administered in left arm on 04May2021 at 09:15 (at the age of 53-years-old) as dose 2, single for covid-19 immunization. Medical history included atrial fibrillation, Verbatim: Afib, Blood pressure, Probably 3 years or so caller states he had Afib and Anti-inflammatory. Concomitant medication(s) included metoprolol tartrate (METOPROLOL TARTRATE) taken for blood pressure measurement; diclofenac (DICLOFENAC) taken for Anti-inflammatory. On 09May2021, patient experienced second dose: just started to get a rash; caller states his rash is not a bumpy rash, it is a blotchy rash, on 04May2021, second dose: went home early from work with body aches, on 06May2021, second dose: was violently shivering and freezing to death, on 05May2021, second dose: overall miserable, on 06May2021, second dose: fevers, on an unspecified date, caller's arms are weak, caller's knees are swollen and caller can barely walk. On 06May2021, patient underwent lab tests and procedures which included body temperature: 97.7 fahrenheit, 97.7 , body temperature: 103 fahrenheit, 103 (after 15 minutes from previous temperature) , body temperature: 101 fahrenheit. Therapeutic measures were taken as a result of second dose: was violently shivering and freezing to death, second dose: was violently shivering and freezing to death. Patient took Tylenol for was violently shivering and freezing to death and fevers. Dis not received prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations, patient received flu shot every year with no issue. The outcome of events second dose: just started to get a rash; caller states his rash is not a bumpy rash, it is a blotchy rash, Caller's arms are weak and Caller's knees are swollen and caller can barely walk were unknown, rest all events was not recovered.   No follow-up attempts are possible. No further information is expected.
I got the vaccine on Monday and at 7:30 pm the same say, I felt a bit of a tingling feeling on my upper cheek area on my left side. the feeling went away and then it came back on Tuesday in the evening, the same side and feeling. Then on Wednesday, the lightly tingly feeling is now both sides. My upper cheek areas are slightly swollen as well. I can still function, but I am concerned about this side effect to the vaccine as it wasn't documented. Or if it's an allergic reaction.
Extreme swelling at injection - skin red and swollen to elbow.  Fever for 2 days with rash on legs, arms, neck and stomach.  Loss of appetite and stomach cramping after eating or drinking, lasting 4 days.
Took first pill and almost exactly 8 hours later had sudden and horrific hives and had swelling of neck and face
started with a cough few hours after receiving vaccine and 1 wk later started with itchy rash on lower extremities that lasted 1 wk.
Right-sided eustachian tube itchiness, throat discomfort, rhinorrhea, and sneezing 6 hours post-vaccine. I took one allergy pill which mildly resolved symptoms.
Pt tested positive for COVID 4/6/21. Completed COVID vaccine series 1/25/21. Onset of symptoms 4/3/21.