chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 days after receiving Bexsero #2, developed right shoulder pain and stiffness in the shoulder joint.  Not improved with ice, heat, and ibuprofen. In fact symptoms increased including at rest, sleeping, and with any movement or motion. 02/19/2018: first visit to PCP. Home care advised. 02/23/2018: second visit to PCP. Symptoms worsening; right shoulder stiffening and freezing up. Treatment with oral prednisone started. 02/28/2018: third visit to PCP. Gradual improvement but impossible to drive a car and difficult to change clothes. Continue prednisone taper; start naproxen twice daily; physical therapy evaluation and treatment.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 04-APR-2013, the patient was vaccinated with the first dose of (Merck) VARIVAX (lot number reported as 670180/0435AA) that had expired on 21-MAR-2013. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
My COVID-19 infection symptoms started on  03/12/2023 in the morning. I had cold like symptoms such as headaches, runny nose, sore throat, cough, and body aches. I went to the  urgent care on 03/16/2023 where they did rapid and PCR tests both were positive. Since my symptom were passed 5 days of time period they didn't prescribe me any medication. They advised me to take over the counter cold medications. I tested negative on 03/20/2023 using a home test.
Pain at the injection / Described it as tender and sensitive and hurt; Pain at the injection / Described it as tender and sensitive and hurt; hurt if someone brushed up against; felt like pure cement was in her arm.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 93JN5, expiry date 27th March 2022) for prophylaxis.   On 26th February 2020, the patient received the 1st dose of Shingrix. On 26th February 2020, 3 hrs after receiving Shingrix, the patient experienced injection site pain, sensitive skin, pain upon movement and feeling abnormal. On an unknown date, the outcome of the injection site pain, sensitive skin, pain upon movement and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the injection site pain, sensitive skin, pain upon movement and feeling abnormal to be related to Shingrix.  Additional details were reported as follows: The patient reported feeling pain at the injection site 3 hours after administration.  She described it as tender and sensitive and hurt if someone brushed up against her.   The patient said it felt like pure cement was in her arm.   It lasted 3 to 4 days before resolving.   The patient did Yoga the second day after receiving the vaccine.
Patient states a rash developed 10 days after her first dose of Moderna COVID vaccine. She said it was red with raised bumps around the injection site. This lasted ~3-4 days. It itched "a little bit" for about one day. She also stated that 15 days after her first dose she experienced a sore throat, body aches, nasal congestion, runny nose, coughing, and sneezing. This lasted ~two weeks. She said she had a COVID test at CVS, which was negative.
I Have injection site pain,  headeche,  muscle pain all body,   chills,   fever over 100.54
when he went to take the cotton ball off there was a 3/4" in by 3/8" of diluted blood; This is a spontaneous report from a contactable consumer via Medical information team. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown, Expiration date; unknown), via an unspecified route of administration on 20Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the vaccine yesterday and last night on 20Jan2021, when he went to take the cotton ball off, there was a 3/4" in by 3/8" of diluted blood. The consumer stated, "We are worried the medicine just come right back out." The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (19 Mar 2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jul2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 64 years, in right arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 19Feb2021 at 15:00 as dose 1, single (Lot number: 006M20A), in left arm, on 19Mar2021 as dose 2, single (Lot number: 003AZIA), in left arm and on 06Dec2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing), notes: Other medical history: no. Concomitant medication(s) included: CITALOPRAM; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment was yes. Patient received other medication in 2weeks. anti viral details as product: COVID 19 Treatment, brand: PAXLOVID, treatment start date: 01Sep2022, treatment stop date: 06Sep2022, indication: Treatment of COVID-19. No Known allergies. No Other medical history.
Missed period for 5 months.  I should?ve started April 1, but after my first dose (March 15, 2021), I didn?t have another period until August 13, 2021.   The first period was 2 days longer than normal, and twice as heavy.
fatigue, sore throat, HA, feeling hot and cold, light headedness/dizziness recommended she get covid tested due to sore throat being reported. stated she would check her local pharmacy
Swollen left arm extending to wrist, temperature, pain, called MD after 2 weeks ,was told to wait two more weeks, at present left arm has limitations and pain.
Dose received 3; My left under arm is swollen.  Looks like a baseball; This is a spontaneous report received from a contactable consumer, the patient.   A 32 year-old female patient (not pregnant) received the third (booster) dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN via an unspecified route of administration in the left arm on 24Nov2021 (Lot number: unknown) at the age of 32 years as a single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included:  COVID-19 vaccine (MANUFACTURER UNKNOWN) Dose 1 in 2021 and Dose 2 on 25May2021 for COVID-19 immunisation. The following information was reported: SWELLING (non-serious) with onset 24Nov2021, outcome "recovering", described as "My left under arm is swollen.  Looks like a baseball".  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu vaccine 11/9/12. 11/10 & 11/11 -> had nausea, dizziness & vomiting. 11/12/13 - presented to ER and was diagnosed with a kidney stone.
lost of taste; lost of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "lost of taste"; ANOSMIA (non-serious) with onset 2021, outcome "unknown", described as "lost of taste and smell".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Woke up next morning with tightness in throat and used rescue inhaler x 2. Face was swollen by the end of the day. The following day her face was so swollen when she woke up that her left eye was almost swollen shut. She had flushing, facial heat and a persistent headache. Today the swelling is down but not gone and the headache is still there.
No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 29-AUG-2022, the patient was vaccinated with improperly stored 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, for prophylaxis (strength, and route of administration were not provided) lot # w004504, expiration date: 16-JUN-2023 or lot# W002562 which has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) expiration date reported as 12-OCT-2023, the same as internal validation (product storage error). Administrated vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at 11.3 Celsius degrees for 34 minutes, no previous temperature excursion were reported.  There were no adverse events reported (no adverse events).
15 minutes post second dose of vaccine patient reported a rash on the left upper extremity surrounding the injection site. Patient was given 25 mg of Benadryl.
BLOOD CLOT IN ARM; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total was administered for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot in her arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220325124-COVID-19 VACCINE AD26.COV2.S- blood clot in arm. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Pt. states that after receiving the 1st dose of Phizer 01/21/2022, started experiencing symptoms that evening of passing out, "medicine" smell, and fatigue. No noted Primary visit/communications.
my injection site was sore; cough; nasal drainage; tested positive for Covid-19; severe tiredness; no appetite; vomiting; diarrhea; fever of 100.3°F; chills; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), FATIGUE (severe tiredness), DECREASED APPETITE (no appetite), VOMITING (vomiting) and DIARRHOEA (diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced FATIGUE (severe tiredness), DECREASED APPETITE (no appetite), VOMITING (vomiting), DIARRHOEA (diarrhea), PYREXIA (fever of 100.3°F), CHILLS (chills), PAIN (body aches) and HEADACHE (headache). On 11-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). On 03-Feb-2021, the patient experienced INJECTION SITE PAIN (my injection site was sore), COUGH (cough) and RHINORRHOEA (nasal drainage). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), FATIGUE (severe tiredness), DECREASED APPETITE (no appetite), VOMITING (vomiting), DIARRHOEA (diarrhea), PYREXIA (fever of 100.3°F), CHILLS (chills), PAIN (body aches), HEADACHE (headache), INJECTION SITE PAIN (my injection site was sore), COUGH (cough) and RHINORRHOEA (nasal drainage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included I took Tylenol for the headache   Reporter did not allow further contact
Patient requested Moderna bivalent. Pfizer bivalent was drawn up instead. Instead of Pfizer bivalent dose (0.3 ml), 0.5 ml was administered. Higher dose was administered to patient. Patient was observed for 30 minutes without any reaction. Patient was informed of the error,
Administered 2nd dose of COVID-19 vaccination on 06/28/2021. BUD for vaccination was 06/26/2021, vaccination given 2 days past BUD. Attempted to contact patient, unknown at this time if patient called back yesterday or today. Waiting to hear back from Moderna regarding efficacy of dose administered and next steps for follow-up with patient.
I broke out in an itchy red rash with tiny bumpy blisters all over my torso ? mainly upper back and chest. The rash has dried up but the itching and discomfort continue one week later
Swelling at the elbow joint, erythema, hot to touch, mild pain (cellulitis like in appearance). Pain with 7 hours of receiving shot.
Contact dermatitis to face from chemicals from cleaning; sore arm; hives; burning; This is a spontaneous report  from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Deltoid Right on 16Apr2021 08:30 (Batch/Lot Number: ER8731) at the age of 59-years-old as single dose for covid-19 immunization. Medical history included heart disease diagnosed in 2003 and She had a heart attack. Family medical history: high blood pressure and heart disease. Mother had Diabetes. The patient's concomitant medications were not reported. The patient previously got the 1st dose of BNT162B2 on 24Mar2021 Lot ER8727, it was also injected on right arm in the muscle for covid-19 immunization. She got the second shot on Friday (on 16Apr2021) and all had was sore arm. There were no side effects. On the second day on 17Apr2021, or actually the night, she was cleaning and got contact dermatitis on her face. She was not wearing gloves and touched her face. She got contact dermatitis to face from the chemical. She went to an Urgent Care and was prescribed Prednisone 10mg. She took 5 of them on Saturday, 4 on Sunday and 3 today. Now it was gone, so she was not going to finish out day 2 and day 1. Her doctor told her not to. No emergency Room (ER) or physician's office required. She would like to know if taking the Prednisone will effect the efficacy of the vaccine. It was not from the vaccine. It was from the chemical. She got hives and burning on an unknown date in Apr2021. The outcome of the event contact dermatitis to face was recovering, and the outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The event dermatitis contact is attributed to chemicals from cleaning product and assessed unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
Information has been received from a registered nurse concerning a patient who on 26-SEP-2008 were vaccinated with PNEUMOVAX (lot # 659487/1960U) 0.5 mL "interdermally" instead of PPD (manufacturer unspecified), (human error/no PQC involvement).  The nurse reported that the patient had not recovered.  No additional information was available.  This is one of several reports received from the same source.  Additional information is not expected.
I woke up at 5am with a tight chest and nausea, 14 hours after receiving the first dose of the Pfizer vaccine.  I decided to get up and try to puke. Within two steps to my bathroom I became dizzy and my eyesight become blurred. I fell to the ground on my hands and knees. My chest became tighter and it became harder to breath. I remember telling myself to say calm and focus on your breathing.  When I began to realize my breathing was not regulating I called for my husband. We almost called 911 but after a few minutes I finally was able to breath reguraly again. I threw up after i was able to breath again and than all 10 of my fingers were tingling for a few minutes. I had all the other listed side effects later that day fever, headache, tiredness, more nausea. It's now four days later and I'm still dealing with on and off chest pain and random nausea.
Student reported generalized skin rash to (B) UE, (B) LE and torso with c/o itcihng to sites. After MD evaluation, Rx. provided for ZYRTEC 10mg 1 PO Q Daily and BENADRYL 25mg 2 tabs P.O QHS.
patient reported severe nausea, vomitting and low blood pressure as was as debilitating pain
severe arthritis; arthralgia; This spontaneous report was received from a consumer and refers to a female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered subcutaneously for prophylaxis (strength, dose, lot #, expiry date, anatomical site injection and route of administration were not provided).  On an unknown date, the patient experienced severe arthritis, and arthralgia. At the time of reporting, the outcome of the events unknown.    The causal relationship between arthralgia, arthritis and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Several hours after vaccine started feeling unable to focus and slightly confused and my neck became very tight and I had difficulty turning my head. While sleeping I began to experience intense muscle spasms and sharp cramping pains My thighs and feet cramping so bad I could not get off bed. I laid and moaned every few minutes for hours. My lips hands and feet swollen and my neck looked like a bullfrog because my lymph nodes were swollen as well. I took antihistamine twice to help with the allergy reaction and increased my water intake.The cramping and pain has stopped now 2 days after vaccine  but I feel muscle fatigue as if I had been hiking a tall mountain and still have tightness in my neck and shoulder muscles.
On 05/30/2014 a medical asst gave a dose of TDAP instead of a DTAP 5th dose.
At 1 pm, patient claimed to have some throat tightness, about 10 mins after the vaccine. The patient was offered EpiPen, he accepted and was administered one dose. The patient never lost consciousness and was responsive at all times. The patient was offered 911 services but he refused. After 20 mins of the EpiPen administration, he said he was feeling better without any symptoms and left the facility. I gave the patient instructions on what to do in case of anaphylaxis and he confirmed understanding. I gave him a call at 3:30 pm. He was doing well at home with no complaints. I once again advised him on what to do incase of emergency.
COVID arm. 101.8 temp, chills, sick for about a day, loss of appetite.
I?m a neonatal nurse practitioner, I have a high pain threshold .  I had Covid in January 2021 I am a healthcare worker and did not seek medical treatment.  This was not a normal reaction to a vaccine. Extreme headache  Fever of 101° normal for me is 95.7- 97° Extreme joint pain, left hip still inflamed Sever chills, almost spasmodic, teeth chattering.  Rigors Extreme Weakness  Numb fingers and thumb on left hand Lymph node popped the size of a Cherry tomato
Dr reports wheezing in the 1st 24 hrs which improved also reddened 3 x 3 lower than injection site viewed 9/25/14 as well as warm to touch and generalized warmth.
BODY ACHE; EVERYTHING TASTED METALLIC FOR 48 HOURS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced body ache, everything tasted metallic for 48 hours, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, everything tasted metallic for 48 hours, chills, fever, and headache. This report was non-serious.
pt recvd vax; inject site (rt thigh) had 2.5-3 c knot & pt exhibited high pitched scream continually in the 24 hrs post inject;mom contacted MD immed;
COLD/MUCUS CONGESTION/COUGHING GREEN MUCUS/FEELING SICK/TIRED/NO ENERGY/SLUGGISH; MIGRAINE/SEVERE POUNDING HEADACHE; This spontaneous report received from a parent concerned a 24 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1A05031 expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced cold/mucus congestion/coughing green mucus/feeling sick/tired/no energy/sluggish. On 10-APR-2021, the subject experienced migraine/severe pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold/mucus congestion/coughing green mucus/feeling sick/tired/no energy/sluggish and migraine/severe pounding headache was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
p/vax site w/moderate amount of bleeding until 1";pressure applied to site;c/o swelling in lt leg;tx ice pack on leg;
I experienced tiredness after my vaccine. I have like my legs hurt, feel from my calf down, they feel like burning sensation, but they are not hot but they are cold and feel like pins and needles and my right arm also feels like that. I do not have any pain to my chest. I do not have high blood pressure or cholesterol. They have done lab work and all seems okay. I have a test scheduled for Friday 10/07/2022 of ultrasound of the lower extremities to see if there is a clot with my PCP. My pain to my legs is constant and for the past two weeks has bee present everyday and also through the night.  I know this is not normal. I still have the burning sensation to my legs today.