chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nauseous; Throwing up; Severe stomach pains; This is a spontaneous report from a contactable consumer. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced nauseous, throwing up, severe stomach pains on 13Jan2021. The reporter described that the patient received the vaccine on 08Jan2021 and on 13Jan2021 he was nauseous, throwing up and had severe stomach pains. The reporter wondered if 5 days is too long to consider a side effect or not. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Swelling, redness on inner aspect of R arm. Redness had a streking effect to it.
(R) arm swollen with cellulitis from injection site to elbow 3+ swelling 2 + (R) to wrist.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-JUL-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX, lot # L002869, expiration date: 27-JAN-2017, (dose, route of administration and injection site were not reported). No adverse effects were reported. Additional information has been requested.
Headache, muscle aches, nausea, low grade fever (less than 100 degrees), chills; fatigue; pain, redness, and swelling at injection site. Stayed in bed all day. ALKA-SELTZER early, then ibuprofen later helped some with symptoms. Symptoms lasted morning to night the day after injection; next morning all were gone except the soreness at injection site. This was the 2nd SHINGRIX shot. Same symptoms the first time, but I think were more severe with round 2.
Pt arm was swollen from armpit to elbow and developed a large blister. Had low grade fever. Went to urgent care with fever and MD worried about necrotic tissue fever is now gone and pt swelling is down. Just has a red hard scaly area at the injection site. MD told me this may take a month to go away. Still has small red circle at injection site but much better.
Received shot May 2, 2021 at 12:30 pm by Monday mid morning I was experience dizziness anytime I would stand up turn, etc. as well as a feeling of being on a dose of medication that makes you feel sort of lucid and out of it. That's the best way I know how to describe it. My dizziness is still here, but not quite to the effect it was at first, but the way my head feels is the most troubling.
Noticed hard spot and soreness at injection site, progressed to large red warm lumpy  rash that was raised.  Sounds like ?covid arm? but 12 hrs later added a rash. It started as slight itching  with red spots appearing, some blistering, similar to chicken pox, that cover legs, feet, elbows hands, wrists and a few on my face. Torso is pretty clear.  They are painful if pressure applied but are only slightly itchy. Oral Antihistamines did nothing, antihistamine lotion did nothing.  Epson salt bath did nothing.  48 hrs later and I?m still covered in a rash. Slight change in appearance of dots from the onset.   More blisters still being added 24 hrs  after initial spots starting, 36 hours after arm initially was noticed. Arm rash is paler  and not as raised.
Pt developed a very large DVT in his left lower extremity. The symptoms started approximately 10 days after receiving his first Covid vaccine
Fever of 101F after 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever of 101F after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PYREXIA (Fever of 101F after 2nd dose). In 2021, PYREXIA (Fever of 101F after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101 (High) 101 Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  It was reported that  fever went away by itself in a day or two   This case was linked to MOD-2021-319548, MOD-2021-319555.
Sore throat; Ear pain; Discomfort in shoulder, neck and jaw; A spontaneous report was received from a healthcare professional who was a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore throat [Oropharyngeal pain], ear pain [Ear pain] and some discomfort in her shoulder, neck and jaw [arthralgia].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   The patient reported that after receiving the vaccine, she experienced a sore throat, ear pain and some discomfort in her shoulder, neck and jaw. Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were considered unknown.; Reporter's Comments: 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.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient vaccinated with ZOSTAVAX (route, dose and lot # were unknown) on an unknown age. No other co-suspects were reported. No concomitant medications were reported. The pharmacist noted that the patient had a one-inch-by-about-one-inch size redness around the injection site which was warm, swollen, and hard, but no blistering. The outcome of the event was unknown. The relatedness of event was unknown for ZOSTAVAX. This is one of several reports received from the same source. Additional information is not expected.
Pt developed rash on R/thigh.  Has 2 cm x 5 cm confluent erythematous area with 5 vesicles.  Rt thigh poss site (Recording - transposed??).  Afebrile, rash, itch.
I got my shot 2 / a sore arm; This case was reported by a consumer via (facebook) interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.   The patient stated that he/she had 2nd shot of vaccine ago and had sore arm. The information regarding consent to follow up was not reported.
Pt felt lightheaded about 5 minutes after receiving shot. his pupils were dilated and he momentarily lost consciousness. we called 911, but as we were doing so he asked us not to and said he would be fine, and that this has happened before. He remained on the floor for about 1/2 hour. We monitored his blood pressure. He sat up, but then felt queasy and vomited several times. He remained for 20 more minutes. He said he was feeling much better and he wanted to leave.
Localized redness, swelling of upper arm. Pt sought treatment Wed. sent home with Motrin. Told to apply ice PRN
Client had Hepatitis A vaccine during an outreach at the Shelter. Client denied any allergies or illness prior to the vaccine. This nurse reviewed the purpose of the vaccine, how the vaccine was delivered and the screened client for any previous reactions to Hepatitis A vaccine. Client allowed to view the Hepatitis A VIS prior to the vaccine. The Hepatitis A vaccine was given in client's left deltoid without a problem. Client reports the next day 3/1/2019 she (client) had " shortness of breath,chills, body aches, and headache". Client reports she felt "warm" but "did not have fever".
CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. 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 was not reported, administered on 25-MAR-2021 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 25-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
A pink patch nearby the injection site (not at injection site). Patient felt ill 1 day after the vaccination. BENADRYL.
Case number PHEH2015US019571, is an initial spontaneous report received from a health care professional (HCP) on 30 Sep 2015. This report refers to a 57 year old female patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. The HCP reported that the FLUCELVAX which was stored at room temperature for 24 hours was administered to employees. No adverse event was reported following the medication error (incorrect storage of drug).
Initial misuse report received from a healthcare professional on 01 October 2013. The 15 year old patient had received FLUZONE. Nurse reported that 0.25 ml vaccine was administered to patient instead of 0.5 ml. No adverse event was reported. List of documents held by sender: none.
We had to call 911 at 2:00am. He \woke up from sleep with Uvulitis and sore throat with swelling in his throat. He felt like his throat was closing. His wife gave him 2 Benedryl while waiting for the paramedics to arrive. They arrived quickly, within 10 minutes.  The medical team monitored him at home for about 30 minutes. During this time had high Blood Pressure. They offered to take him to the hospital but he declined. He wanted to monitor himself at home to see if it would resolve itself.  He spent the rest of the night in a recliner to help him breath, with his wife by his side.  He did not follow up with any medical professional.  He did NOT get the 2nd vaccination and will NOT.
Localized redness to injection site right upper arm with low grade fever up to 100.4.
I am in through menopause and have not had menstruation for 18 months. Within 72 hours of the vaccine I had light menstruation that lasted for 24 hours. I had slight cramping (not a usual menstruation symptom for me).  No changes to diet, stress levels, medications, nor dietary supplements were done prior to the vaccine.
Vaccine administer 11/02/09. Pt woke and noticed disseminated small papules from ankle to calves, pruritic.
ABNORMALLY HEAVY MENSTRUAL BLEEDING: Spotting day after booster followed by very heavy menstrual bleeding and uterine pain/cramping. I am menopausal and have not bled since June 2021 (six months), which was light flow. I do not get regular periods anymore.  At present I am using a super tampon every two hours - crime scene levels of blood, mild backache, fatigue.  My previous vaccines were Moderna. Had significant side effects - upper arms swelling and redness, brain fog, muscle aches, fatigue for at least five days. I travel frequently and had lots of Covid tests, all negative. Switched to Pfizer for booster for hopefully less downtime. Overall I feel better than after Moderna, but the bleeding is rather alarming but probably not dangerous.
Fever between 100.0 - 102.0 degrees F that lasted until 06/11/2014 AM; redness and severe swelling at injection site, vomited once on 06/10/2014 AM, lethargic on 06/10/2014 - 06/11/2014, became sick with a cough, runny nose, sneezing on 06/13/2014.
Would like to get the 3rd dose this month (May2021); May have received the 1st dose of Twinrix in Aug2019 / late 2nd dose in May 2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on August 2019).   In May 2020, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In May 2020, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details was reported as follows: The age at vaccination was not reported for 2nd dose.  The age at vaccination was not applicable for 3rd dose.  The HCP did not have the patient's 1st initial and stated the last initial. Patient received 2nd dose later than the recommended interval, which led to lengthening of vaccine schedule. No symptoms were reported. The patient reported that he would like to get the 3rd dose in this month on May 2021. Till the time of reporting, patient did not receive the 3rd dose, which led to incomplete course of vaccination. The reporter stated he had to look further into patient history as the patient did not receive Twinrix at his facility. The reporter did not consent to follow up.
Extreme fatigue, Body Rash that started on abdominal trunk and moved to legs and arms, Fever, Decreased appetite and Fussiness. The doctor that administered the vaccine did not have my son come in to be seen and said to keep the my son comfortable and that the patient may be contagious. Went to a 2nd  doctor who had the patient come to see her and she recommended certain supplements to take to help. This helped the patient to feel better in about 5-7 days.
COVID breakthrough. SOB and cough for one week(starting around 11/27/21). Per patient he started to feel poorly with fever and had diarrhea then he became increasingly swollen and SOB. He went to ED on 12/2/2021 and his COVID test came back positive
Received Flu shot on 10/29, on 10/30 pt noticed mild redness, swelling and itching over the site. 5cm mild erythematous area consistent with urticaria on left deltoid.
Fever/chills, elevated blood pressure (161/88) and elevated heart rate (105 bpm)
Could not get the second dose before 42 days, do I need to get the 2nd dose or do I repeat the; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Could not get the second dose before 42 days, do I need to get the 2nd dose or do I repeat the) and VACCINATION SITE PAIN (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) and PARACETAMOL (TYLENOL) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 11-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Could not get the second dose before 42 days, do I need to get the 2nd dose or do I repeat the) and VACCINATION SITE PAIN (sore arm). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Could not get the second dose before 42 days, do I need to get the 2nd dose or do I repeat the) and VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   patient did not want to call the vaccinating facility to reschedule as she is frustrated that the 2nd dose scheduling got messed up. And mentioned that her healthcare provider asked her to call the Moderna for recommendation. No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up contain no new information
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing and adverse drug event. The ADR did not occur at the time of administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient had appointment for diabetes on 4/7/21 where he complained of leg pain and was told to go to the ER for a possible blood clot. Patient did not go to ER. On 4/15/21, patient was mowing lawn and became short of breath and unresponsive. EMS was called and resuscitation attempts were unsuccessful after patient experience cardiac arrest.
Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli; DVT/PE; Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli; Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli; This is a spontaneous report from a contactable Physician. A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number unknown), via intramuscular route of administration on 22Mar2021 (at the age of 44-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number unknown), via intramuscular route of administration on 19Apr2021 as single dose for COVID-19 immunisation. Medical history included obesity s/p Gastric bypass, iron deficiency anemia, gastritis, depression, remote history of lung surgery for empyema/lobectomy. Patient is allergic to Lanzoprazole and Vantin. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her usual home medications (unspecified) within 2 weeks of vaccination. On 28May2021, the patient was presented to hospital after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli. The seriousness of all the events was reported as serious (hospitalization/Prolonged hospitalization). The reporting physician stated that it was unclear regarding the relatedness between second dose of vaccine and the events, but the patient does not have any other known history to provoke DVT/PE. The patient underwent lab tests and procedures which included SARS-CoV-2 Test: Negative (Nasal swab) on 28May2021. Since the vaccination, the patient tested for COVID-19. The device (unspecified) date was reported as 29May2021. The patient received anticoagulation as treatment for pulmonary embolism. The outcome of all the events was reported as unknown.  Information about batch no/lot no has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Pulmonary embolism, deep vein thrombosis, dyspnoea  and peripheral swelling cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
tested positive COVID; tested positive COVID; nasal congestion; loss of smell; This is a spontaneous report from a contactable physician (patient).  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730, Expiration Date Mar2021), via an unspecified route of administration in her right deltoid on 19Dec2020 at single dose for COVID-19 immunization.  Medical history included ongoing Crohn's disease from 2007/ diagnosed at 33 years old. There were no other concomitant drugs. The doctor who received the COVID vaccine stated that she must had been exposed to the virus prior to receiving the vaccine because she became symptomatic 48 hours after getting the vaccine. She noted that on Pfizer website recommended that a person not get the vaccine until 6 weeks after active infection but she of course did not know she had been exposed and when her second dose was due, she would not be 6 weeks after active infections. The vaccine was received on 19Dec2020 and she tested positive on 22Dec2020. The only symptoms she had experienced after testing positive are nasal congestion and loss of smell and they started on 21Dec2020 in the morning. She had had no worsening of her Crohn's disease. The only testing she had had done was the PCR testing for COVID. No treatments for the symptoms at this point. The outcome of the events tested positive COVID was not recovered, while for other events was unknown.; Sender's Comments: A causal role of BNT162B2 would seem unlikely based on the temporal gap between the vaccination therapy and the event onset.
Rash for 3 days, but does not hurt. A little hard. Told patient to put a cold pack for now, possibly contact doctor if rash worsens.
Fever over 100.6 started 4/15/21 @ 8:00am. Severe body aches, chills, weakness, nausea, tiredness, and inability to lower temperature. By 12:00pm on 4/15/21 fever had gone up to 102.6, continued alternating Tylenol and ibuprofen. Temperature would not go lower than 100.6. Fever, chills, body aches, nausea through the night. Morning of 4/16/21 fever of 101.9 continued with Tylenol/ ibuprofen regimen as well as staying hydrated. Continued through the day. As of now.... 5:00pm 4/16/21 temperature is 100.8 and all other symptoms still present. Body aches and chills have gotten worse.   Injection site on left arm is tender but getting better.