chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore upper left deltoid; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (sore upper left deltoid) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 027B21A and 040A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced MYALGIA (sore upper left deltoid). At the time of the report, MYALGIA (sore upper left deltoid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had only the same symptom of sore upper left deltoid for all the other moderna vaccines.    No treatment medications were reported.   This case was linked to MOD-2023-725757 (Patient Link).
Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy and gastro esophageal reflux disease (GERD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN), esomeprazole (NEXIUM) and fexofenadine hydrochloride (ALLEGRA) for unknown indication from an unknown date and unknown if ongoing. On 13Apr2021, the patient experienced diarrhea onset 4 days after shot, diarrhea 4 plus times a day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 72-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), second dose via an unspecified route of administration, administered in right arm on 25Feb2021 13:45 as SINGLE DOSE for covid-19 immunization. Patient was 72 years old at the time of vaccination. Medical history included chronic obstructive pulmonary disease, hypothyroidism and arthritis. Patient did not tested positive for Covid prior to vaccination. Patient had no known allergies. Patient did not receive any other vaccine in 4 weeks prior to vaccination. On 04Feb2021 at 8:30 patient received first dose of bnt162b2(lot number: EL3249) in right arm. Concomitant medications included BUDESONIDE, levothyroxine sodium (SYNTHROID), NABUMETONE, formoterol fumarate (PERFOROMIST), revefenacin (YUPELRI), all taken on unspecified date for unknown indication. On 26Feb2021 at 06:00 the patient experienced headache and fatigue. Outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Client developed fever, body aches, headache and experienced enlargement of the lymph nodes several hours after receiving MMR, TWINRIX and Tdap. Continues with neck aches, vision problems and cognitive difficulties, vertigo.
slight cramps; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2), (Formulation: Solution for injection, Batch/Lot Number was EN6205, Expiration Date: Jun2021) as dose 1, single via an unspecified route of administration on 05Mar2021 16:00 for covid-19 immunisation. Medical history included Acid reflux from an unknown date and unknown if ongoing. Concomitant medication(s) included denosumab (PROLIA) taken for an unspecified indication, start and stop date were not reported and patient stated that patient take Acid blockers. On 07Mar2021 the patient experienced diarrhoea and on an unknown date, the patient had slight cramps. The patient underwent lab tests and procedures on 26Feb2021 which included blood test: unknown result on, computerised tomogram: unknown result. Therapeutic measures were taken as patient stated that she did not know she still have slight cramps. The patient took lot of Imodium and lot Pepto-Bismol, so was not really sure. The outcome of event diarrhoea was unknown, and outcome of event slight cramps was not recovered.  No follow-up attempts are possible. No further information is expected.
Tongue swelling, throat tightening chest tightness/pressure, saliva watering, fogginess
reports immediate pain @ injection site which caused her to almost pass out, says did not happen w/ prev vaccines including prev HPV vaccine
Left arm hurts at side of injection when lifted above should level only.  Heart with palpation x2 wks but that has resolved. No bumps or bumps at side. No color changes. "Feels like something sticky there when I lift my arm."
Anaphylactic shock; A spontaneous report was received from a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock.    The patient's medical history was not provided.  Concomitant product use was not reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced a severe reaction to the vaccine that resulted in being transported to the emergency room and treated for anaphylactic shock. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, anaphylactic shock, was unknown.; Reporter's Comments: This case concerns a male patient of unknown age with unknown medical history subject, who experienced a serious unexpected event of anaphylactic shock. The event occurred on unspecified time after the first dose of mRNA-1273 vaccine. Treatment information was reported; however, patient was transported to emergency room.  Outcome of reported anaphylactic shock is unknown. The event was assessed as possibly related, however additional information has been requested.
Dose was administered at 10:16am. Pain at injection site as well as redness and swelling began around 5:00pm on the same day. Pain, redness, and swelling have continued for 24 more hours and has not yet gone away. The swelling is like a hard knot below the skin?s surface, but it protrudes a bit at the injection site.
Patient developed a rash and angioedema at some point later in the day after receiving  the vaccine.  Patient reported taking Benadryl routinely for several days after the development of symptoms.  This was self reported to hospital at time of scheduling the second dose.  It is believed patient had some follow up with PCP, possibly per phone or office visit.
Vomit; Feeling nauseated; When he received the booster shot they jabbed him quite bad that he had a bit of blood on the bandage they stuck on his arm.; Feeling very cold; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE, FEELING COLD, NAUSEA, and VOMITING in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939908) for COVID-19 vaccination.     No medical history was provided by the reporter. Concomitant products included MELOXICAM from 15-Oct-2021 to an unknown date for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced VACCINATION SITE HAEMORRHAGE and FEELING COLD. On 31-Oct-2021, the patient experienced NAUSEA. On 01-Nov-2021, the patient experienced VOMITING. At the time of the report, VACCINATION SITE HAEMORRHAGE, FEELING COLD, NAUSEA, and VOMITING outcome was unknown.            No treatment medications were reported.
Initial report received from a healthcare professional on 08 September 2014. A male patient, whose medical history and concomitant medication was not reported, had received a dose of FLUZONE HD (batch number, dose, dose in series, route of administration and site of administration was not reported) on 06 September 2014 at 12 p.m. On 06 September 2014 at 7 p.m., seven hours after vaccination, the patient presented coordination. Reporter stated the intent of her call was to find out FLUZONE HD could affect a person's coordination. Reporter was calling on behalf of a patient who contacted her regarding to obtain this information. Laboratory investigations and corrective treatment was not reported. At the time of this report the patient outcome was unknown. Documents held by sender: none.
At approximately 1445 EMT was notified by the mother of client, a 15yo male, that her son was feeling light headed. The client's mother stated that they were leaving the observation site after the client's 15 minute wait following a first dose Pfizer COVID vaccine (LOT EW0191, exp: 08/31/2021) when the client reported feeling light headed. The mother brought the client back to the observation area for evaluation. EMT  placed the client in the zero gravity chair and at 1450 took a first set of vitals with client seated: BP 122/48, HR 75, RR 20, skins normal color for ethnicity, dry and warm. Lead RN assessed client who explained that approximately 10 minutes after receiving the first dose Pfizer COVID vaccine (given at 1425) he felt light headed, like a "buzzed" feeling. He did not mention the feeling to his mother or the EMTs. When he stood up to leave he stated the feeling got stronger. Client stated his last oral intake was a sandwich he ate at 1230. Client denied any other symptoms such as chest pain, shortness of breath, nausea, tingling of face, mouth or throat swelling. Client's mother denied any pertinent medical history, stated client had ADHD and anxiety, denied any daily medication use and denied any allergies to foods/medications/environment. Client stated he gets the same feeling when he gets the flu vaccine. Client was given a juice box which he drank and a bottle of water which he sipped. At 1452 a second set of vitals were taken: BP 136/64, HR 70, RR 20, skins warm, dry and normal color for ethnicity. Client advised to stay in observation and to alert if symptoms worsen or persist. At 1300 a third set of vitals were taken: BP 118/52, HR 80, RR 24. Client's mother confirmed with EMT that these are normal vital ranges for client. At 1310 client stated he felt better and symptoms of dizziness and feeling lightheaded had resolved. Lead RN educated client's mother on ED protocols. Client left the observation site with his mother on his own accord and with a steady gait.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 19-JAN-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K006682 with expiration date of 17-DEC-2015; dosage and route unspecified) (incorrect product storaeg). No adverse symptoms were reporetd. This is one of several erports received from the same reporter. Additional information has been rquested.
Headache, body aches, extreme fatigue, and fever for 36 hours followed by a "roseola" type rash on 2nd day after shot with some lingering body aches as well.
A 24 year old woman received MassBiologics Td vaccine (Lot# A080A) in the left deltoid on 9/16/15 for wound prophylaxis.  The following day she reported she felt warm to the touch and developed itching, swelling, and pain at the injection site.  Two days after the immunization (9/18/15), she contacted her health care provider to report these symptoms along with expansion of the pruritus to her hand as well as hand stiffness.  Following the adverse event, she took ibuprofen 600mg orally.  The patient was offered an evaluation by her health care provider, but she declined. Sender's Comments: This adverse event is assessed as non-serious and labeled, as injection site reactions including pain, pruritus, and swelling are described in the product labeling, as is pyrexia (which may have caused the patient to feel "warm to the touch").  It is possible the reported hand stiffness was due to musculoskeletal stiffness (reaction described in the package insert) or was secondary to the swelling in the affected limb, but this is unable to be confirmed as the patient declined an evaluation by the provider on the day the symptoms were reported.  MassBiologics performed a follow up with the health care provider on two occasions as summarized below: Follow-up on 10/14/15:  The reporter informed that the patient did not visit the physician since the adverse event and that the clinic had not heard from the patient since she last called to report the event. The reporter also mentioned that the patient was scheduled for a visit on the 29th of October. Follow-up on 10/30/15:  The reporter informed that the patient had failed to keep her appointment at the physician's office. Patient's recovery status is unknown. All attempts to obtain additional information have been unsuccessful.
Received second Pfizer Covid 19 vaccine on 9/1/21. Spiked a fever to 103.7 on 9/2. On 9/4 began experiencing mid-sternal chest pain described as aching and intermittent. On 9/5 chest pain worsened and patient became diaphoretic. He was taken to an ED where his troponin was found to be elevated. He was given aspirin, toradol and decadron, then transferred to different hospital. 9/6: chest pain still present but improved.
Information has been received form an unknown reporter referring to unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, unknown number of patients were probably vaccinated with improperly stored doses of M-M-R II (lot# and expiration date not specified; dose, route, site of administration unknown) for prophylaxis. It was reported that M-M-R II lot # K014833 (expiration date 14-SEP-2016), K021151 (expiration date 02-NOV-2016), K024824 (expiration date 02-DEC-2016), L001336 (expiration date13-JAN-2017), L009213 (expiration date 17-MAR-2017), L012480 (expiration date 10-APR-2017) and L015279 (expiration date 30-APR-2017) underwent a temperature excursion in 2015. From May 2015 to December 2015, the minimal/maximal temperature was 33/46, 32/46, 32/ 47, 31/48, 32/47, 32/48, 32/48 and 31/56 (units not provided) respectively. The lot number L015279 (expiration date 30-APR-2017), L024266 (expiration date 01-JUL-2017), L026553 (expiration date 16-JUL-2017), L030162 (expiration date 11-AUG-2017), L036851 (expiration date 23-SEP-2017), L039551 (expiration date 07-OCT-2017), M008589 (expiration date 16-FEB-2018), M015931 (expiration date 30-MAR-2018) and M020073 (expiration date 19-APR-2018)  underwent a temperature excursion in 2016. In January to September, November and December of 2016, the minimal/maximal temperature was 31/49, 31/49, 30/ 86, 31/75, 30/49, 27/86, 29/86, 26/51, 28/54, 24/49 and 24/53 (units not provided) respectively. There was no M-M-R II lot number reported in 2017 temperature excursions. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007740: US-009507513-1705USA007741: US-009507513-1705USA004287: Original Case: 1705USA004287 US-009507513-1706USA001288: US-009507513-1706USA001287: US-009507513-1706USA001290: US-009507513-1706USA001291: US-009507513-1706USA001292.
Sore arm at injection site with small nodule present day after shot.  Lethargic, continued sore arm, and feverish.   Tylenol for pain and fever Still feeling tired and sore day 3. However, fever is only slightly elevated (99.1) Not enough to warrant medical intervention. Overall feeling as expected, however with 1st and 2nd shot only experienced soreness at the injection site.
Patient received vaccine that may have been stored outside of recommended temperature. No adverse reaction.  Will revaccinate in 4 weeks.
Shortness of breath on exertion; weakness; fatigue; chills; tingling sensation of extremities that continues on; This is a spontaneous report from a contactable healthcare professional, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection intramuscular on 21Dec2020 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included neuropathy. Concomitant medication included gabapentin. Past drug history included known allergies: TOPAMAX. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Dec2020, the patient experienced fatigue, chills, tingling sensation of extremities that continues on. Treatment for the events fatigue, chills, tingling sensation of extremities included ibuprofen (MOTRIN) and acetaminophen (TYLENOL) taken with minimal or short temporary relief. On 30Dec2020, the patient experienced shortness of breath on exertion and weakness and tried to go to Urgent care clinic for Covid test but no available test so the doctor prescribed ZITHROMAX in case it was Covid. On 30Dec2020, MRI, XRAY, LABS were taken and all came back negative and normal except having all these symptoms. On 02Jan2021, Covid test done and result was negative, tested for antibody and it was positive. The outcome of the event fatigue was unknown. The outcome of the events chills and tingling sensation of extremities was recovered in Jan2021. The outcome of the events shortness of breath on exertion and weakness was not recovered. The events fatigue, chills, tingling sensation of extremities that continues on, shortness of breath on exertion and weakness required a physician office visit.
59 Y/O female, BMI 34.75, with PMHx of Asthma, CAD, GERD, HTN, inflammatory arthritis, tendonitis, admitted with increasing SOB on 8/5/21 and hypoxic at 86% room air. Pt received Regeneron earlier in the day. Pt was started on IV Decadron, inhaled budesonide, remdesivir, and Olumiant, while continuing home medication of Brilinta and ASA. Chest x-ray shows bilateral atypical pneumonia. Pt was discharged home with oxygen on 8/10/21. Pt was then seen in ER several times before transitioning to hospice within 3 days of discharge.
i was perfectly healthy with no underlying medical conditions.  now here we are 11 months post vax.  i have musle spasm twitching ringing in my ear rashes that come and go a lump in my neck my teeth are loose and my hair is falling out.  my heart races skips beats i experience dizziness brain fog.  i have days where i could slep all day and night.  severe anxiety dry mouth
Right arm puffy from shoulder to mid arm, (upper) warm and red. Ne fever, drainage.  6-6-03 puffiness decreasing
Patient vaccinated for smallpox 8/3/04 due to impending deployment. Patient tested positive for HCG 8/12/04. No adverse consequence to date. Note: HCG on 5/11, 6/16/04.
Sore left arm, temperature of 100.4, red rash on upper left arm from injection site to crook of elbow.
PATIENT FULLY VACCINATED FOR COVID, RECEIVED SECOND SHOT IN MARCH, INFECTED WITH COVID IN JUNE.  COUGH, SORE THROAT, AND NASAL CONGESTION STARTED 6/17/21.  POSITIVE HOUSEHOLD CONTACT WITH COVID.  PATIENT HAD POSITIVE COVID TEST ON 6/21/21.
employee became light headed, dizzy and nauseous. 10-15 min after vaccine.  0956 vitals were taken and employee was asked to lay down on cot (vitals 143/83 p 90)  1003 employee began to have seizure like activity a rapid response was called at 1008. Employee refused to go to ED , husband notified.  1020 Benadryl was given per MD  continued monitoring until 1135 employee was recommended to go to ED by MD , she refused stated she was ok just tired.  Assisted to vehicle with husband at 1140
pt recv vax & exp a terrible influenza-like illness w/dizziness & blood pressure problems;@ the time of the report pt was still under the care of a cardiologist, but is unable to function w/nl activities;
Client report at this time not having a reaction but did have a runny nose, back pain. fatigue, and pain at the site on the day following the vaccination (01/24).  When asked about rash developing on both legs after vaccination (01/23) that was reported to COVID hotline, she denied having a rash at this time.    Per client she spoke with her PCP regarding reported symptoms and have resolved.
Pt came in with her mother and her mother's boyfriend. All three were on Our Covid Vaccine schedule. Someone put her on the schedule and she shouldn't have been. She should have received Pfizer someone else.
Patient skin had red blotches like hives all over arms and hands/arms swelled. Notified the DOT Medical Examiner and check patient. In 15 minute wait time, symptoms went away. Patient denied having difficulty breathing. Epi-pen was not administered. Patient advised to take Benadryl, seek emergency care if symptoms reappear or worsen, and if she has any breathing problems.
Given the wrong  vaccine, gave the Influenza was suppose to give PCV23. Notified provider and she spoke with the patient and informed her of possible side effects.
On February 4, he had problems coordinating words. Lack of strength in arms and hands. He felt sand in his eyes. No one thought it was a spill. There are no strength in the legs. Neurologist confirmed that it was something like that.
Patient had a fever for approximately 3 days at times over 103 that was difficult to keep in control by keeping cool cloths on him under a fan and alternating tylenol and motrin. He said his body hurt and that he didn't feel well. He experienced significant congestion and he told his dad that it was hard to breath. I am not sure if it was hard to breath bc of congestion or if he was having any respiratory issues. He was significantly congested for several days. Patient stayed home from school due to his symptoms for 3 days. Patient saw a doctor who thought he probably picked up a cold at the exact same time he received his first covid vaccine dose, as Patient's 3 year old brother started experiencing the same symptoms approximately 5 days after Patient received his covid vaccine. It is just strange that a cold would happen at the exact same time that a covid vaccine was received. It is possible that it was a cold, but it is also possible that Patient had pretty significant symptoms in response to the covid vaccine. I thpught it should be reported in case other people experience the same thing.