chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Waves of metalic taste in my mouth on the second dose. On the first dose I had a VERY strong metallic mucus tasted for about 3 days and nausea. After the second dose all my muscles seized up and I had fever, chills, overnight sweats, I had waves of nausea and a terrible headache. I am still nauseous 2 weeks later. I am taking anti nausea meds and drinking ginger teas. Any injury I have ever had like broken bones or torn rotator cuffs have all started hurting so incredibly bad. I also had a COPD flare up.
red bumps on palm; redness on injection site; swelling at injection site; This spontaneous case was reported by a patient and describes the occurrence of RASH (red bumps on palm), VACCINATION SITE ERYTHEMA (redness on injection site) and VACCINATION SITE SWELLING (swelling at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (red bumps on palm), VACCINATION SITE ERYTHEMA (redness on injection site) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, RASH (red bumps on palm), VACCINATION SITE ERYTHEMA (redness on injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided. Treatment information not provided.
Adult dose (0.3ml)  administered , patient is 11 years and 7 months at time of administration.
12 Days after receiving Hepatitis A and Varicella she began limping. The exam was normal except for limping that is not bearing weight on the right leg. She slowly improving.
pt inadvertently recv vax 1/6/99;early February devel a sore throat & an inflamed uvula which persisted as of 3/17/99;
Report 2001010237-1 describes migratory joint discomfort in a 40 year old female who received Lyme disease vaccine recombinant OspA (Lymerix). Medical history included "many somatic complaints". Concurrent medications were not specified. The patient received two injections of Lymerix on unspecified dates. At some later time, she experienced migratory joint discomfort. As of 04/24/01, the joint discomfort had persisted for several months and was ongoing. The reporting physician considered the joint discomfort to be "probably not related" to Lymerix administration. The adverse event of migratory joint discomfort does not meet ICH serious criteria, but is being submitted as an expedited report by report by special FDA request per the June 28, 2000 letter. On 08/02/2001, additional info was received from a different physician within the initial reporter's group. The second physician did not confirm the occurrence of migratory joint discomfort. The second physician reproted that on 04/29/1999, the pt experienced chills, fever and myalgias. These events were of moderate intensity. No laboratory evaluations were performed. The chills, fever, and myalgias resovlved after an unspecified period of time. the second physician considered the chills, fever, and myalgias to be possibly related to LYMErix administration, and the immunization series was discontinued. The follow up states that the additional info was received from another physician within the same medical group. Medical history also included osteoarthritis. The pt had no known drug allergies. There were no concurrent medications. The initial reporter stated that the patient received one injection of LYMErix on 04/28/1999. On 08/02/2001, additional info was received from a different physician within the initial reporter's group. The second physician did not confirm the occurrence of migratory joint discomfort. The second physician reported that, on 04/29/1999, the pt experienced chills, fever and myalgias. These events were of moderate intensity. No laboratory evaluations were performed. The chills, fever, and myalgias resolved after an unspecified period  of time. The second physician considered the chills, fever, and myalgias to be possibly related to LYMErix administration, and te immunization series was discontinued.
Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003964 is a spontaneous case report initially received on 05-Oct-2022 from nurse via agency (reference number: USBAV22-1628) and concerns a patient of unknown demographics (ninth out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via agency (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
unable to abduct left arm due to deltoid area muscular pain; injection to the left deltoid area, a moderate pain developed while at rest/deltoid area muscular pain; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on arm left on 22Jan2020 20:30 at a single dose for immunization. The patient's medical history and  concomitant medications were not reported. On 22Jan2020 21:30, approximately 1 hour after the injection to the left deltoid area, a moderate pain developed while at rest. No redness or heat or swelling or bruising was noted. No systemic symptoms noted. On 23Jan2020 15:30, 19 hour after receiving the injection, the patient was unable to abduct left arm due to deltoid area muscular pain. However, no acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDS) were used. As of today, while arm is at rest, there is no pain. There is only pain with attempting to abduct left arm. Flexion and extension of the left arm is without any pain, but only mild deltoid muscle area pain upon internal and external rotation of the left arm. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
I began having chest pain on 1/23/2021. I had never experienced chest pain before. Chose to ignore it. Pain persisted and intensified with periods shortness of breath. I visited an urgent care on 1/25/2021 for chest pain. The doctors listened to my chest and decided that because of my age, I  probably had a sore muscle. No imaging or tests were performed. No one asked if I had been vaccinated recently (this was in January, so most average people were not). I got a COVID test at the urgent care because I worried it could?ve been that. The test came back negative. The chest pain went away, but have noticed ongoing periods of shortness of breath. I didn?t know myocarditis became a listed potential side effect of the vaccine until recently. I am certain my chest pain was caused by the vaccine. If I had known this was a since-known adverse effect of the vaccine I would?ve reported at the time, but because of how practitioners treated me in January, I thought I was overreacting.
Expired - 5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 10:41 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported.  Reporter stated that Moderna vaccine pulled from freezer 16 Dec 2021, BUD date of 15 Jan 2022 printed in red and taped to the top of the boxes. On 26 Jan 2022, staff brought it to attention that it was still in the fridge and expired and 5 doses had been given. On 31 Jan 2022, responded that revaccination was not required.  Patient denies any adverse effects.  No treatment information details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up information includes - IRD changed(25-feb-2022 to 24-Feb-2022).
Patient had his arm swell down to his elbow as well as redness and pain, wife treated him with Benadryl
couldn't get the second dose as it had an unexpected back to back surgery; Headache; so tired; Nauseated; body aches, hurt all over/sore; pretty sick/got sick; had no energies, had to go to bed; The patient thought it was sinusitis; it was red around, localized; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (pretty sick/got sick), ASTHENIA (had no energies, had to go to bed), SINUSITIS (The patient thought it was sinusitis), ERYTHEMA (it was red around, localized) and PRODUCT DOSE OMISSION ISSUE (couldn't get the second dose as it had an unexpected back to back surgery) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 04-Nov-2020, Cancer and Surgery (2 surgeries after first dose of vaccine).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced ILLNESS (pretty sick/got sick), ASTHENIA (had no energies, had to go to bed), SINUSITIS (The patient thought it was sinusitis), ERYTHEMA (it was red around, localized), HEADACHE (Headache), FATIGUE (so tired), NAUSEA (Nauseated) and MYALGIA (body aches, hurt all over/sore). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (couldn't get the second dose as it had an unexpected back to back surgery). At the time of the report, ILLNESS (pretty sick/got sick), ASTHENIA (had no energies, had to go to bed), SINUSITIS (The patient thought it was sinusitis), ERYTHEMA (it was red around, localized), PRODUCT DOSE OMISSION ISSUE (couldn't get the second dose as it had an unexpected back to back surgery), HEADACHE (Headache), FATIGUE (so tired), NAUSEA (Nauseated) and MYALGIA (body aches, hurt all over/sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
feeling nauseous; fever/high fever; chills; slight joint aching; headache; sick; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (Reporter's colleague) that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was none and concomitant medications were not reported. Patient had no known allergies. Patient did not receive vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested COVID-19 post vaccination. The patient previously received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration, as dose 1, single for COVID-19 immunization. It was reported that on 18Feb2021 03:00, the patient experienced feeling nauseous, high fever, chills, headache, slight joint aching and sick. Three other colleagues and my department out sick after second vaccine with same symptoms. Four of us all woke up between 2-3am with noticeable symptoms, including high fever and chills. We have all since recovered. The patient did not received any treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
(L) arm erythema, edema, warmth from shoulder below to elbow. Pt was applying ice packs, took one ibuprofen. Came to clinic today for eval order ice, elevation, ibuprofen 400 mg Q 6 hours x 3-4 days. BENADRYL 25 mg Q 6 hours x 2 days. 24 hours after vaccination.
The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information; The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT LABEL CONFUSION (The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LABEL CONFUSION (The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient had both the 1st shots, then 2 boosters.  Patient received the new Moderna Covid booster from local Pharmacy. They gave some confusing information. The paper mentioned that patient needed to get 2 shots of this. The paper said it was the booster for 12 plus.  Treatment information was not provided.   Reporter did not allow further contact
2/27 Moderna 1 2/27 overnight headache, nausea  2/28 injection site rash/itch/lump 3/1 injection site red/puffy/painful to touch 3/7 injection site rash/itch/lump 3/9 injections site rash/itch 3/14 injection site rash/itch 3/17 injection site rash/itch 3/22 all over itching (2nd time that week don't know what day the 1st was) 3/27 Moderna 2 3/28 Reflux and nausea, Injection site hot/red/itchy 3/29 injection site rash/itch 3/30 puffy/tingly cheeks and lips, all over itchy 9/? Now tongue and lips swell when eating home made pancakes and waffles 11/6  Moderna 3 booster shot 11/6 lips and tongue swell and hurt all night 11/7  all over/back/nose/mouth itchy, lips puffy, arm painful, lymph node (right side) under jaw hurts, lips tingly, talking and swallowing harder 11/10  Injection site red/warm/itcy/spreading lump/changing color, puffy lips 11/17  Arm rash/blisters and hand blisters 11/25 belvita biscuit - swollen tongue throat and lips and hurt 11/26  Dramamine - numb tongue? 12/3 Dramamine - lips/tongue/throat swelling and hurt 12/4 Rice crispy one test bite - lips/tongue/throat swelling and hurt
Had rotor cuff surgery...Mentioned that she had two shots prior to the surgery.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: ROTATOR CUFF REPAIR (medically significant) with onset 2022, outcome "recovered" (2022), described as "Had rotor cuff surgery...Mentioned that she had two shots prior to the surgery.". Therapeutic measures were taken as a result of rotator cuff repair. Clinical course: Patient had rotor cuff surgery (right side) last year, had it on unspecified date in 2022. Mentioned that she had two shots prior to the surgery. It was reported that these were all for the Pfizer shots. First Pfizer shot had no lot or expiry to provide. Second Pfizer shot had no lot or expiry to provide. Recovered completely in 2022. Treatment: Went to therapy.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300091588 same patient and product, different dose number and event;
had just a sore after the first dose; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for COVID-19 immunisation. Medical history included Prolapsed mitral valve and hypothyroidism, both from an unknown date, ongoing white blood cell count never came back to normal after cancer treatment. Concomitant medication included levothyroxine sodium taken for an unspecified indication, start and stop date were not reported. The patient had just a sore after the first dose of the vaccine, it was in and out for a day. The outcome of event was recovered.  No follow-up attempts are needed. No further information is expected.
Muscle twitches for the first 3 days, after a week two hours of feeling like I had the flu, tired.
pt recv vax 1AUG95 & pt exp mumps w/fever, rash & cervical adenopathy;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-FEB-2016 the patient was vaccinated with an improperly stored dose of VAQTA 50U/1ml (lot # L018498, expiration date 28-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 696 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, fatigue Narrative:
Patient reported feeling faint after receiving vaccine, so she laid down on the ground & put her knees up. A couple minutes later, she said she was about to faint then went unconscious. Immediately after going unconscious, she began having involuntary muscle contractions, mainly in her arms, neck & face & she was moaning & gasping for breath. Within 30-60 seconds, she was breathing noisily and clenching her teeth. After 3-4 minutes, the seizure/convulsive syncope ended & she woke up. She was checked out by EMS, who were called at the beginning of the incident & she refused to go to the hospital b/c she said this has happened to her most of her life, including when receiving any vaccine b/c her blood pressure dropping so low. She has been seen for this issue in the past.
After immunizations for Diphtheria/Tetanus, Polio IPV, Hepatitis A, Typhoid, developed rash that migrated around my body. Comes up fast, skin bubbles up-lasts about 10-15 minutes-very itchy and then stops- Comes up again in a different area
I woke up with a headache; fever; muscle pain; chills; My arm is really hurting and sore; fatigue and tiredness; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 01May2021 (age at the time of vaccination 24-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, on an unspecified date, for COVID-19 immunization. On an unspecified date May2021, the patient experienced I woke up with a headache, fever, muscle pain, chills, My arm is really hurting and sore, fatigue and tiredness. Patient was asking Can I take Tylenol or ibuprofen'. The outcome of the events was unknown.  Further probing was not done as Consumer hung up the call abruptly. Hence, Limited information was available over the call.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.