chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 18 hours after vaccination. Initial Sx were arm aching, hard to lift and swelling. Then was a band of redness around arm approx. 5 inches below injection site. Pt. used calamine lotion and iced area. Appears to be resolving.
This is a spontaneous report from a contactable consumer. This consumer reported that her 56 years-old male son (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on 24Mar2021. Relevant history and concomitant drugs were unknown. The reporter stated that her 56 year old son received his first dose of the Pfizer BioNTech COVID-19 vaccine a day earlier than she received hers (which was on 25Mar2021) and while waiting after getting his vaccination, her son became "very, very dizzy." He told the nurse working at the vaccination site that the dizziness was getting worse and "getting very bad." He was asked how his breathing was and he told the nurse it was okay, but an ambulance was called for him anyways and he was sent to the hospital. Her son reported feeling better when he laid down but still reported feeling dizzy. At the hospital, her son was told that all the test came back okay. When her son got up to use the restroom with the assistance of the doctor, the doctor told him that he was dehydrated and gave him IV fluids. Caller stated that her son reported feeling "a lot better" after the IV fluids but "couldn't hardly walk" and had to have someone else drive him. Her son reported feeling "alright" the next day. Caller stated that she was reading in the information pamphlet on the Pfizer vaccine that a severe reaction could include dizziness. Caller was worried about her son getting his second dose and think she should speak with his physician before receiving his next dose, and would like to know if this was okay. She was concerned because she states that she had heard that people have gotten sick from the second dose of the vaccine. Outcome of the events was resolving. Information about the Lot/batch number has been requested.
Severe flu symptoms, called out of work. Lasted 24-36 hours. Did not seek medical help.  Slept for the most part of the day.
Rash that began several hours after vaccine was given IM . No recent new foods, medications, personal care products. Rash was generalized small macule rash with no blistering or drainage. No difficulty breathing or swallowing. DECADRON injection given. Told to go to ER with any SOB or difficulty breathing/swallowing. Instructed her that I would coordinate with Employee health future vaccines to hold patient in clinical setting and have epi available and pre-dose with antihistamine.
Her right arm / was red; Her right arm / was warm to the touch; Her right arm / was / swollen/swelling; Her right arm / was / a little bit itchy; Exposed to Covid-19  / test results / positive for Covid-19; Redness at the injection site; Swelling / at the injection site; Joint pain /  mild Covid-19 symptoms including joint pain; Body aches; Headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 3rd December 2020, refer linked case US2021072885).   On 19th March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 19th March 2021, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On 20th March 2021, the patient experienced joint pain, general body pain and headache. On 24th March 2021, the patient experienced covid-19. On 30th March 2021, the patient experienced erythema of extremities, skin warm, swelling arm and pruritus. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, joint pain, general body pain and headache were recovered/resolved and the outcome of the covid-19 was unknown and the outcome of the erythema of extremities, skin warm, swelling arm and pruritus were not recovered/not resolved.   The reporter considered the injection site erythema, injection site swelling, joint pain, general body pain and headache to be possibly related to Shingrix. It was unknown if the reporter considered the covid-19, erythema of extremities, skin warm, swelling arm and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient experienced injection site erythema, injection site swelling, joint pain, general body pain,headache, erythema of extremities, skin warm, swelling arm and pruritus. The outcome of the injection site erythema, injection site swelling, joint pain, general body pain and headache were resolved. The outcome of the erythema of extremities, skin warm, swelling arm and pruritus were not resolved. On 24th March 2021, the patient found out that she had been exposed to Covid 19 by a coworker.  On 26th March 2021, patient's test results showed that she was positive for Covid 19. The reporter consented to follow-up. This case had been linked with US2021072885, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021072885:Same reporter
an itchy, red, raised rash at the injection site; an itchy, red, raised rash at the injection site; an itchy, red, raised rash at the injection site; Headache; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (an itchy, red, raised rash at the injection site), VACCINATION SITE ERYTHEMA (an itchy, red, raised rash at the injection site), VACCINATION SITE RASH (an itchy, red, raised rash at the injection site) and HEADACHE (Headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (an itchy, red, raised rash at the injection site), VACCINATION SITE ERYTHEMA (an itchy, red, raised rash at the injection site), VACCINATION SITE RASH (an itchy, red, raised rash at the injection site) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PRURITUS (an itchy, red, raised rash at the injection site), VACCINATION SITE ERYTHEMA (an itchy, red, raised rash at the injection site), VACCINATION SITE RASH (an itchy, red, raised rash at the injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Rash - wheal - appears like a mix of hives and erythema multiforme - all over body.
This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A 37-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.The patient medical history and concomitant medications were not reported.The patient had patient reported she had chills, body aches and restlessness, she stated symptoms were similar to her covid-19 injections on an unspecified date. The outcome of the events were unknown. Information on lot/batch number has been requested.
Swelling from her elbow to the injection site that is getting bigger/swollen left arm; Redness from her elbow to the injection site that is getting bigger; Excruciating body pain; Also had Chills; Also had fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (Swelling from her elbow to the injection site that is getting bigger/swollen left arm), ERYTHEMA (Redness from her elbow to the injection site that is getting bigger), MYALGIA (Excruciating body pain), CHILLS (Also had Chills) and PYREXIA (Also had fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced PERIPHERAL SWELLING (Swelling from her elbow to the injection site that is getting bigger/swollen left arm), ERYTHEMA (Redness from her elbow to the injection site that is getting bigger), MYALGIA (Excruciating body pain), CHILLS (Also had Chills) and PYREXIA (Also had fever). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Fever, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling from her elbow to the injection site that is getting bigger/swollen left arm), ERYTHEMA (Redness from her elbow to the injection site that is getting bigger), MYALGIA (Excruciating body pain), CHILLS (Also had Chills) and PYREXIA (Also had fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.
THIS IS A REPORT FOR THE FIRST OF SIX IMMUNIZATIONS. IT STARTED WITH NUMBNESS ON THE OUT PORTION OF THE LEFT ARM THE SAME TIME AS THE SHOT WAS GIVEN.  PT. THOUGHT IT WOULD GO AWAY BUT IT DIDNT.  6 MONTHS PASSED AND NUMBNESS PERSISSTED.  AT THIS TIME THE NUMBNESS TRAVELED TO THE ELBOW.  IT SEEMS THAT NUMBNESS AND AREA OF COMPLICATION INCREASED WITH EACH SHOT.  TEMP. OF THE ARM (LEFT) THE VACCINE WAS GIVEN IN WAS NOTICIBABLY DIFFERENT FROM THE OTHRE ARM (RIGHT).
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) 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 CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
My fever was at 101; I felt achy; I had rash on my neck and body; It was a terrible headache; It was a terrible headache. I don't usually get migraines; I have burning skin all over; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number unknown) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had a side effect after the first dose of the vaccine. On an unspecified date, the patient had a fever for 5 days, and the fever was at 101. Patient felt achy and stuff after. Patient had rash on neck and body. Two nights after, patient couldn't see cause of the headache. It was a terrible headache. Patient didn't usually get migraines. Patient had burning skin all over and had been taking baths to calm it down. Event fever resolved while outcome of the other events was unknown.  Information on Lot/Batch number has been requested.
started noticing a developing bald spot that is bigger than the size of half a dollar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jul2021 (Lot number: EW0916, Expiration Date: Sep2021) at the age of 20 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IRON PILLS. Vaccination history included: Bnt162b2 (1st dose, Lot: EW0181, Expiry: Aug2021, 0.3mL by injection, Sticker also says: EUA062021.), administration date: 08Jul2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "no adverse effect". The following information was reported: ALOPECIA (non-serious) with onset Sep2021, outcome "not recovered", described as "started noticing a developing bald spot that is bigger than the size of half a dollar". The event "started noticing a developing bald spot that is bigger than the size of half a dollar" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia.  Additional information: States that since her daughter got the vaccine in late Jul2021, got her 2nd dose 29Jul2021, she had developed a bald spot the size of a half dollar that is growing. She had visited to the doctor and they have run all kinds of tests on her. States that the doctor tested her iron level 2 weeks ago when she had the appointment, and her levels were fine. The patient noticed the bald spot the end of Sep2021, but didn't show it to the mother until Dec2021. It started out really small and now it's really big; it's rapidly worsening. Went to the doctor's office 2 weeks ago for the bald spot, but they didn't even look at it; no treatment. She goes back to the doctor again on Monday. Patient had no prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). The patient had no adverse event following prior vaccinations. The patient had no family Medical History.  Follow-up attempts completed. No further information expected.
patient c/o tingling and numbness (slight) on L arm all the way to fingertips. No itching noted. No c/o pain  V/S 98% RA  70 HR 19 cmp 130/60 BP  @2:52pm v/s 97% RA 79 HR 19cmp 120/80  Patient stable symptoms improved left at 2:57pm
menopause symptoms worse; COVID-19; HOT FLASHES; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (HOT FLASHES), MENOPAUSAL SYMPTOMS (menopause symptoms worse) and COVID-19 (COVID-19) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. 04521A, 016/20A and 027/20P) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high and Drug allergy (Unspecified drug). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) for an unknown indication.   On 13-Jan-2021, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced HOT FLUSH (HOT FLASHES). On 24-May-2023, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MENOPAUSAL SYMPTOMS (menopause symptoms worse). At the time of the report, HOT FLUSH (HOT FLASHES) and MENOPAUSAL SYMPTOMS (menopause symptoms worse) had not resolved and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2023, SARS-CoV-2 test: (Positive) Nasal Swab.         Patient received first dose of Moderna vaccine at 03:00 PM. The patient received second dose of Moderna vaccine at 01:00 PM. Patient had hot flashes like patient never had before. Patient sweating so badly so patient makeup runs and hair was constantly feeling oily like patient took a 5-mile run. Patient got period back exactly one month after her second vaccine, Monthly periods lasted for 6 months, then tapered off. Patient menopause symptoms round 2 were significantly worse than menopause round 1. Prior to vaccination, patient not diagnosed with COVID-19.  Treatment medications were not reported.
HAVRIX, Extreme arm pain, loss of function/mobility, loss of consciousness, extreme fatigue, severe headache. (Reaction occurred in right arm).
pt waited her 15 minutes.   walked outside then returned to take son to the restroom.  said her heart started beating fast then she passed out in front of the pharmacy.  we were able to wake pt within a minute or 2.  Store manager called 911.  pt was dizzy but after20 to 30 minutes was able to leave the pharmacy with her husband.  pt did not need to go to the hospital
Had VZV and HPV vaccine in the right arm, VZV given SC in the right mid lateral arm, HPV given IM/RD on 12-13-2011.  Right arm started hurting after the vaccine, was a little red in the evening of the 13th.  Morning of the 14th started to swell at the VZV site. Was seen for an OV 12-15-2011 when mom indicated that the swelling at the VZV site was improved, but that the site itched and the redness had gotten larger.  The VZV site is hot to touch and painful. There is a 10 cm x 7.5 cm area of erythema, induration, tenderness to palpation at the VZV injection site.  She has full ROM right shoulder. The circumference of the right mid upper arm is 15 inches with the circumference of the left mid upper arm at 14 inches.  Diagnosed with cellulitis of the right upper arm.  Loratadine 10 mg,daily, and Keflex 500 mg, one TID x 10 days ordered 12-15-11.
Patient had/has severe arm/shoulder pain. Had flu shot 10/28/11 and now has to go to physical therapy on arm. Only has 50% use of her arm.
Less than24c hours after receiving dose 2:  I was feeling only tired with no other symptoms. I had slowly walked through my living room for abut 10 -12 steps and suddenly with no warning of any type I just passed out. I have never done this in 71 years. I ended up with a bruised knee (no apparent other damage to knee) and a bruised and cut chin, broken tooth, two chipped teeth and undetermined yet possible chin bone damage. I am having the tooth pulled completely this week, bone grafting and implant placed as it is tooth #12 toward front and needs support. The other two chipped teeth require bonding.  The chin bone still feels a little off and tender in one spot. Until the other tooth comes out I do not know if the bite is a problem which would indicate possible jaw damage also. My big concern is this "free" shot could cost me several thousand dollars before they are done! Is there any place to get help paying for the damage repairs?
14SEP98 pt c/o pain @ site of inj;15SEP98 pt c/o pain rt breast & rt shoulder;17SEP or 18SEP pt saw MD dx mastitis prescribed NSAID & ATB;22SEP98 saw another MD dx inflammation of vein under rt breast;24SEP-25SEP98 dec size of vein;pain
pt recv 20JAN97 & pt exp a h/a, dizziness & pain in the arm;
Injection site-left arm very swollen-twice as big as right arm.  Very high fever: 103.6 - 24 hours after pneumonia injection.
Soreness, redness, swelling and large hives, 13 x 9 cm and other evidence of hives in area of site of tetanus-diptheria injection.  Hives developed 5 days after shot.
Administered DTaP Vaccine that expired on 08/14/03.  No adverse effects.
This was an excursion, no side effects. Patient was given dose on 10/25/2021  from a vial that was mixed on 10/22/2021. This vial was sitting on the counter all weekend so was room temperature.
The patient  may have been given a partial dose of Moderna COVID- 19 Vaccine EUA.  The patient declined to return to the clinic and receive an additional follow up vaccine.
Patient presented to ED on 12/9/21 with generalized weakness, fatigue, cough, SOB and fever, found to be covid positive. patient is fully vaccinated, Patient was appropriately treated for covid and was dishcarged on 12/13/21.
Nausea, diarrhea, aches evening of vaccination and all of next day.
ED; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm in Aug2021 (Lot Number: FC3181) at the age of 40-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. COVID prior vaccination was none. COVID tested post vaccination was none. The patient didn't receive other vaccine in four weeks. In Aug2021, the patient experienced ED. No treatment was received. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 13-months-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # U014656 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 09-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number reported as U014656 confirmed as valid, expiration date reported and stablished as 07-MAY-2023) administered as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
Patients dementia symptoms got worse after getting vaccine. Patient became nonverbal, would not eat, and started having  falls. Patient was hospitalized and eventually went home with hospice.
3/10/2021 -- Pain in left arm (more than any other vaccine, biofreeze and 800mg ibuprofen at 5:30 pm 3/11/2021 -- pain in arm lessened but headache and body aches all over, 400mg ibuprofen at 9:30 am
Patient developed upper arm soreness and swelling  with heat beginning the day following the immunization.  The patient reported having a previous similar reaction after receiving PPSV23 from another provider.  The patient was advised to use home treatment consisting of cold compresses and over the counter NSAIDS.  It was also recommended she seek medical treatment if the symptoms worsen.  She will report the event to her allergist and her PCP.  The pharmacist recommended any future immunizations to be done in a clinic setting.
morning p/vax given inj site appeared hard, red, swollen, sore;redness & swelling extended down arm to forearm, to breast & underarm;seen by MD told may have infect given ATB;also had fever & chills 24hr p/vax;