chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost her balance; had the sensation of her head spinning around; Today she stopped feeling pain in her arm and was able to drive; when she was sitting she stopped feeling the malaise but when she stood up she felt the malaise again; 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 female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (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: BALANCE DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "lost her balance"; VERTIGO (non-serious) with onset Apr2021, outcome "unknown", described as "had the sensation of her head spinning around"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Today she stopped feeling pain in her arm and was able to drive"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "when she was sitting she stopped feeling the malaise but when she stood up she felt the malaise again".  Additional information: Patient received the first dose of the vaccine the day before yesterday (April 7th), during the night she woke up to go to the bathroom and lost her balance on two occasions (2 hours in between each event) she had to lean on a wall to avoid falling down, when she was sitting she stopped feeling the malaise but when she stood up she felt the malaise again, in the morning she had the sensation of her head spinning around. Today she stopped feeling pain in her arm and was able to drive. She wants to know if this is normal and if she should receive the second dose of the vaccine. Patient declined to get transferred to a HCF. During the call she mentioned that she went to sleep leaning her body against her shoulder where she received the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0140, expiration date unspecified), via an unspecified route of administration on 22Dec2020 at 13:30 at single dose at left arm for COVID-19 immunization. Medical history included hypertension and hypothyroidism. The patient had no known allergies and no allergies to medications, food or other products and patient was not pregnant. The patient's concomitant medications were not reported. On 22Dec2020 at 13:30, the patient experienced sore arm. There was no therapy received for the event. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient had other medications that was received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of event was recovered on an unspecified date.
This spontaneous report was received from a physician referring to a 13 years old patient of unknown gender. No information about the patient's medical history, concurrent conditions and conocmitant medications was reported. On 14-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fhrenheit degrees for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
INFLAMED LYMPH NODES; VACCINE SITE INFLAMMATION; MENSTRUAL CRAMPS; ASTHMA SYMPTOMS; EXCESSIVE PERIOD BLEEDING AND LONG PERIODS; SHORTNESS OF BREATH; FELT  LOOPY; BODY ACHES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and concurrent conditions included seasonal allergy. The patient experienced drug allergy when treated with cetirizine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: salbutamol.  On 08-APR-2021, the subject experienced shortness of breath. On 08-APR-2021, the subject experienced felt loopy. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced excessive period bleeding and long periods. On 09-APR-2021, the subject experienced menstrual cramps. On 09-APR-2021, the subject experienced asthma symptoms. On 10-APR-2021, the subject experienced inflamed lymph nodes. On 10-APR-2021, the subject experienced vaccine site inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt loopy on 08-APR-2021, was recovering from body aches, and had not recovered from fatigue, headache, shortness of breath, excessive period bleeding and long periods, asthma symptoms, vaccine site inflammation, inflamed lymph nodes, and menstrual cramps. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
1 minute after vaccination, pt felt dizzy, pale, diaphoretic. Also had bleeding and bruising at site. Vital signs stable. Given water and granola bar. Band-aid applied to site. Monitored x 30 minutes and released without further symptoms
3DEC97 fever of 102 x 2 days;rash began 4DEC97 macular, erythematous areas approx 1-2min in size of abd & back;
Injection site hot; Rash at the injection site; Injection site very itchy; Injection site red; Injection site a little swollen; Tenderness at the injection site; Injection site a little swollen; Injection site a little red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PAIN (Tenderness at the injection site), the first episode of VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE ERYTHEMA (Injection site a little red) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L25A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at the injection site), the first episode of VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE ERYTHEMA (Injection site a little red). On 28-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Injection site very itchy), VACCINATION SITE ERYTHEMA (Injection site red) and the second episode of VACCINATION SITE SWELLING (Injection site a little swollen). On 22-Jan-2021, VACCINATION SITE PAIN (Tenderness at the injection site) and VACCINATION SITE ERYTHEMA (Injection site a little red) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site hot), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Injection site very itchy), VACCINATION SITE ERYTHEMA (Injection site red) and the last episode of VACCINATION SITE SWELLING (Injection site a little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications not provided by the reporter. Treatment drug, administered, but she didn't want to provide this information.
Describes redness, swelling, itching at site of Shingles (Zostavax) inj. x 2 days size about 31/2 x 21/2 improved slowly over next 4-5 days.
Migraines (confirmed by doctor) started within 24 hours of Covid 3rd vaccine. Pain, sensitivity to light, sounds, flashes of light in periphery of vision, dizziness, nausea.
gotten dizzy seemed like she had vertigo; gotten dizzy seemed like she had vertigo; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Feb2021 (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), VERTIGO (non-serious) all with onset 20Feb2021, outcome "unknown" and all described as "gotten dizzy seemed like she had vertigo". Additional information: The patient was questioning whether to get 2nd dose or not. Went to website to look for help. Over 19 pages of people with same issues she has.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
15 total doses were administered/ the vials expired on 10OCT2021/ the vials had already expired when they received them; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (15 total doses were administered/ the vials expired on 10OCT2021/ the vials had already expired when they received them) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (15 total doses were administered/ the vials expired on 10OCT2021/ the vials had already expired when they received them). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (15 total doses were administered/ the vials expired on 10OCT2021/ the vials had already expired when they received them) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported. All the vials were from the same lot number, the lot number is 006C21A. No break in cold chain supply had occurred. The vials expired on 10 Oct 2021. Thirteen of those doses were first doses in the primary series and two were second doses in the primary series.  No booster doses were administered.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up received includes No New information. On 12-Nov-2021: Follow-up received include updated Number of patients , Details about vaccine expiration.
Slight swollen lips, hive like rash on legs, Nausea and vomiting: all went away with in 24 hours severe vertigo with this for 2 days, vertigo is still happening on 3rd day but has lessened did not seek medical attention: took benadryl 1st day only and it took care of the symptoms except vertigo Started Meclizine 25 mg over the counter on day2 and it makes vertigo tolerable but still persitant at this point
Skin on chest is itchy but NOT rashy. Usually at night during sleeping hours.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant 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 16Apr2021 at 15:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine headache. The patient previously took naproxen and experienced allergy to the medication. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included eletriptan (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 23Apr2021 the patient experienced that her skin on chest was itchy but not rashy, usually at night during sleeping hours. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event skin on chest was itchy but not rashy was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Prior to getting the COVID-19 vaccine I was taking off all of my medications two weeks prior to the vaccine, which are biologics for my autoimmune disorders by my Rheumatologist. I received the first dose of COVID-19 vaccine on 3/12/21 at 7:45am, by 12:30-1pm I started with 102 fevers, left arm was red, burning, swollen and felt like it was on fire. My 102 fevers lasted for 4-5 days along with severe fatigue, headaches that felt like my brain was on fire and severe increase in pain throughout my body. fevers, left arm was red, burning, swollen and felt like it was on fire. On 3/15/21 my symptoms were not getting better. I started to have right side weakness, right leg was dragging behind me, and unstable on my feet, pain intensity was severe throughout my body. By 3/16/2021 I was completely unstable on my feet, falling due to the weakness/bilateral leg swelling and unable to walk, stand, stand-up right, I needed help to get place to place. On 3/17/21 I went to Emergency room due to the extreme pain I was in. I was admitted to Hospital from 3/17/21 -  3/22/21 with extensive blood work, images, IV medications and consultations by specialist due to my symptoms and my autoimmune on medical leave from work from 3/17/21 until I follow up with my Rheumatologist on 4/21/2021. I was unable to return to work on 4/26/2021.   Discussion took placed about the second COVID-19 vaccine. Per my Rheumatologist, I would stay on all my medications except I would stop my Rasuvo 30mg one week prior to the next COVID-19 vaccine and continue on my high doses of Prednisone. On 4/9/2021 I received my second COVID-19 vaccine at 7:45am. Around 1pm, I started with 103 fevers for 3-4 days, fatigue, headaches, increased pain levels, started with lesions and skin started to peel on my tongue, unsteady on my fees, right arm/hand tremor. On 4/17 I was hospitalized with increased pain levels in bilateral legs, numbness in my feet. I am currently still dealing with side effects to the COVID-19 vaccine that I did not have prior to this Immunization.  Current doctors treating me since COVID-19 Vaccine: -Neurology: Numbness in bilateral feet and tremor in right arm/hand. Currently taking Primidone 50mg for my tremor -Pain Management: treating me to get my pain levels back to my baseline before the vaccine. Currently taking Lyrica 100mg for the pain. -Rheumatology: treating me for my autoimmune disorders and currently seeing me monthly for vaccine reactions.
Soreness; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness) and FATIGUE (Feeling tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025J20-2A) for COVID-19 vaccination. No Medical History information was reported.On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Soreness) and FATIGUE (Feeling tired). At the time of the report, MYALGIA (Soreness) and FATIGUE (Feeling tired) outcome was unknown. No concomitant medications was reported.No treatment drug details was reported. This case was linked to MOD-2021-389097, MOD-2021-389050 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 28Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Ms" (unspecified if ongoing); "epilepsy" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL, start date: 01Jan1994. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.The patient was treated with Anti viral Product Paxlovid, Treatment start date: 14May2022 and Treatment stop date: 18May2022,  indicated for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Shortly after receiving the vaccine, I began having extreme pain in my opposing arm whenever I did small actions that involved moving my shoulder. For example buckling my children in their car sears was torturous. I saw a neurologist who recommended that I see an orthopedist who diagnosed vaccine-induced bursitis. He put me on a course of Meloxicam and gave me some shoulder exercises.  After a month or so I felt fine.
A week after receiving my first dose of the vaccine, I was watching television and noticed that my left arm was itching. As I started to scratch, I noticed that I had a large bump or wheal over the spot where my vaccine had been administered. It was about an inch in length and width. I applied topical OTC cortisone cream as needed on it for the itching. Within a few days, the area subsided to normal.
Patient received 2 vaccines on 9.25.23.  Fluad in her left deltoid and Prevnar 20 in her right deltoid.  Patient stated that nothing was unusual with the way the vaccinations were given, she had no health issues and she was feeling great.  Later that night patient states that her right deltoid turned warm and red and this continued to get worse over the next 3 days.  After 3 days, the site of injection, the right deltoid, turned hard and swelled up to golf ball size.  Today, November 2nd, 2023,  patient states that the spot is extremely painful and she has radiating pain from it.  The pain is interfering with her ability to sleep at night.  She did speak with her provider, who looked at the spot, and the provider was not alarmed and stated to patient that it might just take some time for it to go away completely, that this just happens sometimes.   Patient states that she was already being seen for a different reason, that she did not go to her provider because of the injection site spot.
Patient had received in order IPV, DTaP, Hib and within this time span, approximately 3-4 mins., feet turned bright red and face red, blotchy skin "hives" per doctor. Prevnar was given. Approximately 1 min after, noting feet were red, we gave pt. children Benadryl PO immediately and observed pt in office for about 1 hr. Hives disappeared and no further problem.
This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age. It was reported that the patient was not pregnant. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose and route not provided). Shortly thereafter (unspecified date), the patient returned to the office with a birth mark discoloration on her lip. The patient decided to discontinue the rest of the GARDASIL series of doses. The patient's outcome was unknown. Additional information has been requested.
Herpes zoster started 8/27/05 rx'ed with acyclovir, vaccine failure.
Vomited once on 7/6/10. Fever and diarrhea on 7/7/10.
Arthus reaction (redness, swelling, wheezing, lymphadenitis, intermittent chest pain.
Patient made F/U apt for EVAL of increased redness around (R) thigh vaccine site. Vaccines administered 12-18-17- Mild redness per parent after shots that worsened overnight. No D/C or swelling observed on assessment. Limbs move without difficulty.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash, two and a half inches around the vaccination area.) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE, METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash, two and a half inches around the vaccination area.). At the time of the report, VACCINATION SITE RASH (Rash, two and a half inches around the vaccination area.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Patient did not treat the rash.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No specific follow-up information recorded.