chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Short of breath; tightening of chest; felt heavy; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer reported that a 40-year non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number ER8729, Expiry date not reported) via Intramuscular route of administration, administered in left arm on 8Apr2021 at 10:00 (at age of 40-years-old) as dose 1, single for COVID-19 Immunisation. Patient medical history include Asthma. Patient concomitant medications were not reported. Allergies to medications, food, or other products were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient reported that about her adverse events on Pfizer COVID Vaccine which received on 08Apr2021. On same day of vaccination patient experienced short of breath, tightening of chest, and felt heavy approximately 13 hours after the vaccine shot. The symptoms last overnight and the shorting of breath has continued but more mild". The adverse event result in doctor or other healthcare professional office/clinic visit. Patient received treatment for the adverse event when scheduled with doctor on 13Apr2021.The Outcome of the events short of breath was recovering, tightening of chest, and felt heavy was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
04/11/21 @ 2300 - Sudden onset migraine w/o aura; N&V x1, treated with 7.5mg Zolmitriptan sublingual tabs. 04/13/21 @ 0600 - Sudden onset migraine w/o aura; no N&V, treated with 5mg Zolmitriptan sublingual tabs.
This spontaneous report as received from a physician via field representative refers to a 73 year old female patient. On 05-JUN-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # H017759, (exp. date 04-JUL-2014) 0.5 ml, (route reported as injection). On 07-JUN-2013, the patient returned to the office with extreme swelling, pain, tenderness at the injection site. The swelling was said to measure 4 and a quarter by 12 and a quarter inches in diameter and spread toward the elbow. On an unknown date in June 2013 the patient experienced limited arm mobility. The patient was treated with ROCEPHIN and other unspecified antibiotics for two days. The patient improved after antibiotics, but limited arm mobility continued for several days. The relatedness between events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same source (related MARRS # 1307USA001665). Additional information has been requested.
7/25/06 Vaccines given, no c/o fever or s/s of side effects. 7/26/06 No c/o fever.  No other s/s. 7/27/06 9:30 AM, sitter was giving infant bottle, reported head and left arm began shaking.  Infants eyes rolled back x few seconds.  Infant taken to MD.  MD checked infant and made no recommendations.  Mom states infant appeared sluggish/sleepy x 1 hour after the episode.
Severe stomach pain. Went to ER. Sent home with medicine.  More severe stomach pain. Diagnosed with a  stomach blockage. Had to have emergency surgery. Had to remove 7 or 8 inches o f small intestines.  Leakage from incision site.
FLUE LIKE SYMPTOMS; INJECTION SITE ARM PAIN; TIRED; This spontaneous report received from a consumer concerned a 66 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced flue like symptoms. On 05-MAR-2021, the subject experienced injection site arm pain. On 05-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flue like symptoms on 08-MAR-2021, and tired on 09-MAR-2021, and had not recovered from injection site arm pain. This report was non-serious.
Eruptions, red and scabbed on Rt and Lt deltoid started after first injection was given 3-21-07 Did not report until 3 rd inj.
pt recvd vax; numbness in arms; generalized aches, slurring of speech; recovered by 31may94;
Patient tested positive for COVID-19 after completing the full Moderna vaccine series, 53 days after 2nd dose.  Patient received 2nd dose of COVID vaccine on 2/12/2021.  Tested positive for COVID on 4/6/2021.  NOT hospitalized. Symptoms reported: Fatigue ; symptom onset date: 4/5/2021
Within a few days after first vaccine noticed red bumps on lower part of the back did fade some. After second vaccine the bumps spread up the back along the spine and to the back of the neck. No itching, no pain. Did see NP and was told it was a reaction to vaccine. Was prescribed a steroid cream unsure the name, reports it does seem to be helping.
Approx. 12 hours after vaccine fever, chills, headache, buddy aches, stomach cramps, fatigue. Fever and body aches improved within 36 hours. Headache and fatigue continue.
Severe chills, fever, nausea on evening of and day after vaccinations. Two days after vaccinations and continuing for 36 hours, left arm from shoulder to elbow was extremely inflamed, red and itchy.
Significant swelling, redness and itching at injection site?I took extra antihistamines and used ice and heat and it subsided in about a week
Headache, tiredness and nausea.  Next day and 2 days later still felt these symptoms.
Administered PREVNAR 4/28/15-to current 5/1/15. Pt has rash bilateral arms and torso and back. Red raised local reaction to injections site. Headache, cough and wheezing. Temp 99.3 orally.
Full-body hives; tightening of the throat, paleness, glassy eyes, itching.  Was given 25 mg of Benadryl every 6 hours, and was prescribed Prednisolone 1.5 tsp, twice daily for 5 days.
employee received the vaccine 12/31/2020. 15 minutes later she stated she felt very sleepy. Stated it was hard to keep her eyes open. She was observed for 30 minutes and sent home. Telephone calls to her during the day indicate she felt sleepy until late afternoon.  She stated she felt sleepy for the rest of the afternoon. She stated she woke next day feeling fine.
Profuse shaking and cold. Lasted 40 min. - took 20 min. to time down. Put on a winter coat, gloves, turned up the heat to 75*, and used a heating pad to warm up my hands.
pt had EMG for possible tendonitis in lt leg;a mild bilateral lower extremity sensory neuropathy noted;hosp; worsening knee & leg pain;possible Dx of myositis made;disch 8/29; 9/2 pain worsening;possible muscle biopsy/CPK recheck
Hearing loss; more than 36 days from1st vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-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 DEAFNESS (Hearing loss) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (more than 36 days from1st vaccination). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DEAFNESS (Hearing loss) and PRODUCT DOSE OMISSION ISSUE (more than 36 days from1st vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided  Company Comment: This is a product dose omission issue for mRNA 1273, with associated event of deafness. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Event seriousness was automatically upgraded by list and will be kept that way until further follow-up information is received.; Sender's Comments: This is a product dose omission issue for mRNA 1273, with associated event of deafness. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Event seriousness was automatically upgraded by list and will be kept that way until further followup information is received.
Developed rotavirus 2 days after receiving immunization. Vomiting, diarrhea - diagnosed in ER.
Rash on left arm, itchy, painful, burning.  -patient states that she took antihistamines(cetirizine) which were not helpful -
Narrative:  Patent was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there ADR that occurred between the observation period and the date of death. PMH Significant for multiple myeloma, cervical myelopathy, Hepatocellular carcinoma, hx of hepatitis c, ckd, anemia, hyperlipidemia, lung nodules, essential htn, hepatocellular carcinoma. Was under the care of palliative care and hospice. He decompensated in april and placed into hospice.
Vaccine was diluted with sterile water instead of sodium chloride, and administered to the patient.
There were no noted adverse signs or symptoms at the time of vaccination. Fiance of patient called Public Health on 4/12/21 to report the patient died in her sleep overnight on 4/7 or 4/8.  Autopsy not performed, body embalmed prior to Public Health's knowledge of client death.  Pfizer BioNTech COVID-19 Vaccine EUA
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. The concomitant therapies included sterile diluent. On 17-AUG-2017, the patient was vaccinated with a dose of expired ZOSTAVAX (lot # M041510, 0.65 ml, once, expiration date of 27-JUL-2017) subcutaneously for prophylaxis. No adverse effects were reported.
Approximately 10 to 12 days after 2nd vaccination, strong  joint pain began, first left arm, then abated after 3-4 days; next right wrist then abated after 3-4 days; next right arm abating after 3-4 days; next left wrist abating after 3-4 days. Made appointment with my doctor who said he found I had a high degree of inflammation. Referred me to a specialist who performed blood tests. She found abnormal results and concluded that I was experiencing rheumatiod arthritis. Currently taking methotrexate by injection and prednisone orally to relieve symptoms.
Patient came in to say to the technician that she wanted a High Dose Flu shot.  We processed vaccination.  I went into the flu shot room, verified her birthday and that she was getting  a high dose flu shot in her left arm.  I administered the vaccination.  A few minutes later she came up to me, confused.  She wanted to be sure that she was getting the High Dose Booster.  After asking many questions it was determined she really wanted her 3rd Covid Pfizer shot.  She did not present her covid vaccination card.  She already had gotten her High Dose Flu shot in August.  I looked her up and she did get her flu shot at her doctor's office.  I gave her her Pfizer covid shot in her right arm.  I called her physician to inform them of the situation.
Patient recieved a dose of Pfizer prior to it being authorized for the age group that the patient is in. 15 at the time of vaccination of first dose.   Second dose was held until 15 year old age category was allowe dto get the vaccine. Same dose and product were administered on 5/13/2021 when 12-15 year olds were allowed to get the vaccine.
Information has been received from a registered nurse concerning an 18 year old female patient who was vaccinated with a second dose of Gardasil. Subsequently, the patient became light headed and fainted. This experience lasted for approximately a minute or two. Unspecified medical attention was sought. At the time of this report, the patient recovered. It was reported that just prior to receiving the vaccination, a blood draw was performed and the patient was fine. It was also reported that the patient did not have this experience with the first dose of the vaccine. No product quality complaint was involved. Additional information has been requested.
A few weeks after my 2nd dose, on 5/22/21, early in the morning I began to feel immense lower back and side pain and pressure. Within 10 minutes or so, the pain and pressure began to spread to my stomach and then my heart/chest. I tried to lay down to rest, but felt worse. About 30 minutes later, the pain and pressure was concentrated in my heart/chest area and became intense.  The pressure was squeezing the center of my chest but also radiating to my shoulders, arms, and fingers. My arms and fingers went slightly numb. I was light-headed and dizzy. I had trouble catching my breath and breathing deeply. Leaning forward helped slightly. After about 1 hour and 15-30 minutes total (the severity of it for roughly 30 minutes), I was going to go to the Emergency Room but decided to try a hot shower first. Within 5 minutes in a hot shower, the pain/pressure began to slightly ease. After 10 minutes in the shower, I was feeling better enough that I didn't think I needed to go to the ER at that time. I was able to lay down and rest and breathe normally. I experienced some chest soreness and mild-moderate fatigue right after and sporadically since then. I don't know for sure if this was due to the vaccine, but this type of pain is not normal for me. I haven't seen a doctor for this yet, but plan to if the chest soreness continues. I did also experience other symptoms within 3 days of the vaccine's 2nd dose. The same night of the 2nd dose, I had soreness at vaccine site, slight muscle aches, chills, low-grade fever. The following day, I had low-grade fever, muscle aches, slight nausea, fatigue, and general discomfort. The third day, I experienced those same symptoms but more mild.
This case was reported by a nurse and described the occurrence of bradycardia in a 17-year-old female patient who received MENVEO. Concurrent medical conditions included multiple allergies. Concomitant products included DEPOMED. In June 2015, the patient received the 2nd dose of MENVEO. In December 2015, 183 days after receiving MENVEO, the patient experienced general body pain. In April 2016, the patient experienced bradycardia (serious criteria GSK medically significant) and fatigue. In June 2016, the patient experienced seizure (serious criteria GSK medically significant) and tremor. On an unknown date, the patient experienced difficulty breathing, breathing rate increased and weakness. The patient was treated with KEPPRA. MENVEO was discontinued (Dechallenge was unknown). Rechallenge with MENVEO was unknown. On an unknown date, the outcome of the bradycardia and fatigue were not recovered/not resolved and the outcome of the seizure and tremor were unchanged and the outcome of the difficulty breathing, breathing rate increased, weakness and general body pain were unknown. It was unknown if the reporter considered the bradycardia, seizure, difficulty breathing, breathing rate increased, weakness, general body pain, fatigue and tremor to be related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported. Nurse reported that her daughter received a booster dose of MENVEO as well as a booster shot of DEPOMED in early June 2015. A couple of weeks after that her daughter started noticing some changes. The reporter had a very healthy child and all of a sudden her daughter started experiencing some changes after that shot. Two weeks after receiving MENVEO, the patient experienced difficulty breathing, breathing more excessively, weakness. The reporter said that the patient was a competitive swimmer prior to receiving the shot. In September of 2015, the patient experienced shortness of breath. In December of 2015, approximately 6 months after vaccination, the patient experienced body aches. In April of 2016, approximately 10 months after vaccination, the patient experienced fatigue and bradycardia. In June of 2016, approximately 1 year after vaccination, the patient went in for a neurology consult because of tremors, and seizure like symptoms. The patient took KEPPRA 1200 mg to control the symptoms. Nurse was relating the events to MENVEO.
Episodes of racing heart, periodic feelings of chest pressure (worse when lying down) --occasional difficulty breathing or getting a full breath of air.   She says she has no idea how many times a day nor how long it lasts - it builds gradually until she notices it's been happening, then subsides gradually.
Swelling, heat & redness to left deltoid for 2 days. No visible symptoms on this date. Continue with residual soreness today per patient.
Patient stated she felt an electric shock like sensation with vaccination and developed pain immediately.    Pain got progressively worse over the week after the vaccine was given and patient could not move her arm much because of the pain.  She never developed swelling nor did she develop a rash.  Patient went to her primary care provider and was given steroids, ibuprofen,  and a sling for her arm. She was also told to use ice packs.  Patient initially was getting some improvement after starting steroids, but her pain level started to increase on day 3 of steroids so her primary care provider added ultram to her meds.
Information has been received from a physician concerning a 20 month old male patient who on 28-AUG-2008 was vaccinated with a first 0.2 ml oral dose of ROTATEQ, a second 0.2 ml oral dose of ROTATEQ on 27-OCT-2008 and a third 0.2 ml oral dose of ROTATEQ on 02-JAN-2009. It was reported that the patient developed rotavirus after all three doses of ROTATEQ. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Very sore arm in vicinity of injection site. General overall muscle aches. Chills/fever. Exhaustion.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin"; Dilaudid, reaction(s): "Known allergies: Dilaudid"; Doxycycline, reaction(s): "Known allergies: Doxycycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took other medication in two weeks. The patient took Antiviral drug Paxlovid from 25Jan2023 to 30Jan2023 for the treatment of COVID-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a medical assistant (also reported as a nurse) referring to an unspecified number of patients of unknown age and gender. Relevant medical history, drug reactions/allergies and concomitant medication for the patients involved were not reported. The medical assistant reported that on unspecified date, the patients were vaccinated with improperly stored doses of PROQUAD (rHa) lot # N019827 (expiration date: 09-JAN-2019) for prophylaxis (strength, route, dose or units were not provided). There was digital data logger involved. Temperature and time frame: 15 F to 46 F (15.5F) for 24 hours. Previous temperature excursion: 6 F to 14 F (7.1F) for 54 minutes. No adverse events were reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from the reporter referring to a currently 1 year old female patient on 20-FEB-2018. On 25-JAN-2018 (previously reported as an unknown date), the patient was vaccinated with PROQUAD (rHa) (lot # N019827, expiration date of 09-JAN-2019, strength, dose and frequency were not reported) intramuscularly for prophylaxis. The other suspect therapies included PENTACEL (lot# C5296AB, expiration date, strength, dose and frequency were not reported) (previous vaccinated doses was one) and pneumococcal 13v conj vaccine (CRM197) (lot# S43262, expiration date, strength, dose and frequency were not reported) (previous vaccinated doses was three) both intramuscularly for prophylaxis.
DYSPNEA, RAPID HEART RATE, WEAKNESS, CHEST PAIN.
I started feelin strong COVID Symptoms like when I was sick, head and neck pain, chills, joint and body pain, weakness, body heaviness lasted for 2 days.   A week after, I had minimal physical exercise with my upper body and had a very strong pain on my right thigh, like muscle pain but stronger with some burning sensation just in the upper part then it turn into a rheumatism like pain with no strength, next day the left thigh same thing, by Friday the pain in my thighs was less but went up to my hips and was a kind of pain and numbness and still difficulty to walk, by Saturday I got better, pain and legs weakness almost gone.   I have exercised years, and I know what is a muscle pain when returning to work out.  I don't even use my legs and this pain way different and stronger.   I had covid on December, started with symptom's on 12/15/2020
Youth developed sensation of shortness of breath and chest pain. He was admitted to a local hospital for observation overnight and diagnosed with musculo-skeletal pain post vaccination.  No other diagnoses or abnormal findings.
Pain through back across both arms and neck.; A headache that feels like my heads going to explode.; swell up like a balloon; Nauseated; Chills; fever; Pain on both my legs cannot walk; Pain through back across both arms and neck. Cannot lift my arms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the right arm on 20Jan2021 16:00 at single dose for covid-19 immunization.  Medical history included atrial fibrillation from an unknown date and unknown if ongoing , hypersensitivity (Known allergies: Yes) from an unknown date and unknown if ongoing, covid-19 (if covid prior vaccination: Yes) from an unknown date and unknown if ongoing. Concomitant medications included unspecified medications. The patient experienced pain through back across both arms and neck, the patient cannot lift their arms. The patient also experienced pain on both their legs cannot walk, a headache that feels like their heads going to explode, nauseated all the time, swell up like a balloon, chills and fever. It was reported that the events occurred on 21Jan2021. Therapeutic measures were taken as a result of pain through back across both arms and neck. The patient did not recover from the events.  Information on the lot/batch number has been requested.