chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site has been slightly sore for almost a week; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable male consumer reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced injection site has been slightly sore for almost a week. It was reported that the received the first dose of Pfizer Covid-19 vaccine this morning and later today he had a dental procedure done. His dentist will prescribe an antibiotic. The patient wanted to know if he could take the medication after receiving the 1st dose. It was reported that the patient stated his injection site has been slightly sore for almost a week. It wasn't sore for the first couple days and has developed some soreness. The patient stated soreness isn't bad and does not want to talk about it. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Diarrhea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Constant pain in left shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2022, the patient received the 1st dose of Shingrix (intramuscular). On 20th October 2022, less than a day after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-Feb-2023 Reporter's Comments: The patient received a dose of Shingrix in her left arm and after the injection she developed pain in her left shoulder that had not gone away since then.  The patient stated the pain was constant, 5/10 and 7/10 at times.  The patient had been under medical attention, without relief. The reporter consented to follow up. As it was not clear from the narrative that 5/10 and 7/10 times was pain measurement scale result was provided or it was reporting for any other point therefore query was raised for the same and meanwhile this information was captured in narrative.
severe aching all over my body; Severe fatigue; severe headache; nausea; vomiting; fever up to 102 degrees F; This is a spontaneous report from a contactable nurse. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) via an unspecified route of administration in the left arm on 14Apr2021 at 09:45(at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, restless leg syndrome and allergic to sulfa drugs. Concomitant medications included insulin (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO), dulaglutide (TRULICITY), dapagliflozin propanediol monohydrate (FARXIGA) and losartan potassium (LOSA), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in the right arm on 24Mar2021 at 09:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient previously took liraglutide (VICTOZA) and amoxicillin, clavulanate potassium (AUGMENTIN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 14Apr2021 at 15:00, the patient experienced severe aching all over the body, severe fatigue, severe headache, nausea, vomiting and fever up to 102 degrees F. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received zofran, ibuprofen, bedrest, cold shower and fluids as treatment for the reported events.  The patient underwent lab tests which included body temperature and tested with a temperature up to 102 degrees F. The clinical outcome of the events severe aching all over body, severe fatigue, severe headache, nausea, vomiting and fever was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Arm within a few hrs of the vaccines turned red, hot & swollen.  Took 5 days for symptoms to resolve on their own.
Pt came to pharmacy with swelling and redness from injection site almost to elbow. She said it started after injection. She's been using hydrocortisone cream. I advised she go to doctor. Nurse practitioner saw her, gave DECADRON IM, ZANTAC PO and told her to continue hydrocortisone.
On 5-29-09-4AM started vomiting/diarrhea, 11:00AM Fever 100.7. By 7:00 PM fever 102.8. Continued to vomit, went to emergency room. Received IV fluids with ZOFRAN IV for vomiting. Blood work was normal. UA normal, CXR normal. After hydrated (3 hours) was discharged with oral PHENERGAN. 5-30-09 Temp 100.1; 6-1 Temp 99.6. 6-2 temp normal.
Heart palpitations that continued for the rest of the day. The next day was very tired. 72 hours later still have a tightness in chest with heart palpitations on and off during the day. They last about 15 minutes and ease up when I rest. I am notifying my doctor today.
HYPOTENSION 11/29/2022,  12/21/2022,  2/15/2023,  1/24/2023,  1/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
arm really hurts; freezing; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and feeling cold. On an unknown date, the outcome of the pain in arm and feeling cold were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and feeling cold to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. Post vaccination the patient's arm really hurted and he was freezing. The reporter inquired how long will the events would last.
Headache, Myalgia, CHILLS, SHIVERING Narrative: STAYED HOME FROM WORK
Redness between the toes, halfway through the toe affecting the bottom half only. Toes feel very warm.
I am like itchy all over in my the body; Rash; This is Spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer vaccine for COVID earlier on 29Dec2020 and few hours past, the patient got at around 3 O'clock and then at time of the report the patient was like itchy all over in the body and the patient had like rashes. The outcome of the events was unknown.  No follow-up attempts are possible. Information on lot/batch cannot be obtained.
RN administered Pfizer vaccination (2nd dose) approximately 11:06am to client via drive through.  While RN was logging passenger of same vehicle, approximately 11:08am, passenger yelled out for help.  RN  called for MEDIC.   11:08-11:14 Client became alert, AO x3 11:16 MEDIC arrived on scene
I have a painful knot in my armpit from a swollen lymph node. It is still ongoing.
Initial medication error report received on 03 December 2013 from nurse. A 3 year child patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (route, lot number and site of vaccination  was not reported) on an unknown date. Reporter stated that child received 0.25 ml FLUZONE to child. Patient did not have any adverse events. List of documents held by sender: none.
36 weeks pregnant was given the AREXVY vaccination; given AREXVY vaccine instead of ABRYSVO vaccine; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 28-SEP-2023, the patient received Arexvy. On 28-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: given AREXVY vaccine instead of ABRYSVO vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 36 weeks pregnant was given the AREXVY vaccination).  The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 36 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 29-SEP-2023 The patient states that she was 36 weeks pregnant and was given the Arexvy vaccine instead of Abrysvo vaccine which led to inappropriate age at vaccine administration. The patient who was pregnant received Arexvy vaccine, which led to vaccine exposure during pregnancy.
1 day fever, malaise, achiness, cough, congestion lasting 3 weeks. Z pak, chest x-ray.
This is a spontaneous report received from a contactable consumer (Patient). A 65-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9269 and Expiration date was not reported) via an unspecified route of administration, in right arm, on 05Feb2021 at 13:00 (at the age of 65-year-old), as a single dose for COVID-19 immunization. The patient's medical history included Pre diabetic, high BP (blood pressure) and thyroid.The patient previously took Advil (ibuprofen) and experienced allergies, aspirin (acetylsalicylic acid) and experienced allergies. Other medications in 2 weeks included thyroid medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 05Feb2021 at 6:00 PM, patient had experienced very bad upper stomach pain for 3 days with diarrhoea. No treatment was received. The outcome of the events was reported as recovering. Follow-up attempts completed. No further information expected.
Severe  headache 8/10 Extreme sleepiness~ slept approx 15 hrs without waking
This spontaneous report as received from a nurse who refers to multiple unspecified patients of unknown age and gender. The multiple patient's medical history and concurrent conditions were not reported. On an unspecified date in February 2016, multiple patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L019297 expiration date 19-AUG-2017, lot # L043214 expiration date 30-AUG-2017, lot # M003659 expiration date 20-SEP-2017, Lot # M005714 expiration date 03-OCT-2017. Dose, route and anatomical location were not provided. No other concomitant medications were reported. Excursion details: The vaccine was exposed to 9 degrees F for 9 hours, as well as to 0.3 degrees F for 837 hours and as to 30 degrees F for 542 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chills; Headaches; Pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches), INJECTION SITE PAIN (Pain in the injection site) and CHILLS (Chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (Headaches) and INJECTION SITE PAIN (Pain in the injection site). On 02-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, HEADACHE (Headaches), INJECTION SITE PAIN (Pain in the injection site) and CHILLS (Chills) outcome was unknown.
From initial information received on 10/18/04 from a healthcare facility regarding an adverse event occurring in the USA, it was reported that a 7 month old female patient received FLUZONE SV 2004-2005, lot number U1407AA, on 10/12/04. The route and site of administration were not reported. An unspecified amount of time later, the patient was seen by a surgeon at a hospital and was diagnosed with intussusception of the bowel. It is unknown if the patient was actually admitted, however, the reporter stated that she believed she was. No other details were provided. The reporter stated that she believes the patient recovered from this event.  Follow up on 11/12/04 states: "From additional information received on 11/04/04 from a health care professional, the vaccine was administered in the pt's left leg on 10/12/04 at 12:00 in the afternoon. Four days later on 10/16/04 at 3:00AM, the pt developed intussusception of the bowel. No other medical information was provided at this time."
still got COVID; still got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "still got COVID". Clinical course: It was a great time saver to get both vaccines at the same time. Patient was a bit skeptical because the last booster did not seem to help; patient still got COVID and was pretty ill. Patient did not know if she would choose to get any future boosters if they were available.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
loose the smell, she had pain all over her body and headaches; loose the smell, she had pain all over her body and headaches; loose the smell, she had pain all over her body and headaches; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced loose the smell, had pain all over her body and headaches on unspecified date in Mar2021.The reporter stated that, the patient was administered with the first dose of the vaccine on 24Mar2021 and he developed loose the smell, had pain all over her body and headaches after 5 days of vaccine administration. The reporter states the patient and the family were tested for COVId-19 the day the vaccine was administered, and the results were negative. The reporter stated that the symptoms have been lowering down in intensity since the administration of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021 tested for Covid-19 the day the vaccine was administered, and the results were negative. The outcome of the events was reported as recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021365219 same drug and event, different patient
About 2 months post vaccine, I started to experience some minor pain in the injection area and throughout my left arm. Initially, the paid was a 4 out of 10 on the worst day with some limited range of motion. Now, two months after the onset of pain, pain is progressively worse with a 10 out of 10 at its worst. There is limited range of motion with temporary periods of paralysis of the arm. There is also numbness and tingling in my left hand.
Pediatric patient was administered a Pfizer 12+ (Purple Cap) vaccine. We checked on the patient the following morning and father stated the patient was very lethargic; however, was able to go to school. He will report back to us if anything changes.
Pt was 17 at the time of both of her Moderna COV 19 Vaccination series. Pt was made aware of minimum age and vaccine research restrictions. Pt and guardian verbalized understanding and notified manager than computer system allowed her to create the appointment. No further questions were asked.
There was a splatter and she thought she may have gotten some product into her eye; Eye was red, after vaccine exposure in eye.; Occupational exposure: another Pharmacist was diluting the Covid vaccine vial and the syringe broke, and the Pharmacist got vaccine in her eye.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 30 year-old female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 16Sep2021, outcome "unknown", described as "There was a splatter and she thought she may have gotten some product into her eye"; OCULAR HYPERAEMIA (non-serious) with onset 16Sep2021, outcome "unknown", described as "Eye was red, after vaccine exposure in eye."; OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious) with onset 16Sep2021, outcome "unknown", described as "Occupational exposure: another Pharmacist was diluting the Covid vaccine vial and the syringe broke, and the Pharmacist got vaccine in her eye.".  Additional information: The Pharmacist while diluting vaccine was unsure what had happened or if the vaccine did splash into her eye.  She was having issues with the syringe and the pressure built up in the vial and the syringe busted, but not the vial. There was a splatter and she thought she may have gotten some product into her eye.  She immediately flushed her eye. She did speak to her OB and was advised that they did not see this as an emergency situation and further advised her to follow up if she experienced continued irritation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Date and time adverse event started: On Wednesday pain started, notably worsened on Thursday night into Friday, unable to clarify exactly the time. Adverse events experienced and are they still occurring now: Pain on left side mostly on moving, unable to describe the nature of the pain (ex unable to clarify if aching, sharp, etc), not in the arm, but generalized all over mostly on the left side, no numbness no tingling, pain comes and goes, not getting any better or worse, Acetaminophen helps. Acetaminophen to treat (Q 6 hours 500 mg x 2). I adv Acetaminophen is fine but don't exceed this amount. Can also alternate with other OTC pain relievers as needed. Also try a heating pad for the pain. Advise that if pain doesn't start to feel better in the next few days and resolve in a week, consider this may be unrelated. FU with HCP if pain worsens/persists.  Provided phone # for FU. I asked if ok to follow with her, but pt. declined us calling her. However she would like to call us back herself, and speak directly to me.  I adv to call back Friday after 7 PM in that case when I'm back. I'll put in a FU for Friday at 10:15 AM in case she doesn't reach out.  4/25-Pt calling back, pain is improved by about 50% since we last talked but persists. No fever. Had been recommended some acetaminophen but it doesn't work. Left leg "feels soft" and tries to put the leg up and it hurts. Didn't see her long time PCP in person, just gave him a call and is expecting a call back on Monday. Is "100% confident" that this issue isn't medical and is related to the shot.  Got the shot at hospital. Still doesn't have the CDC card unable to provide lot number. 93 lb wt.  Pain was very severe on the first half of the week starting on Monday. Should she still get the second shot? I adv the second shot wouldn't be contraindicated in this case, but adv to discuss this with her doctor more to discuss risks and benefits. Informed the patient that there are no existing case reports with this type of severe or persisting pain so would recommend an in person evaluation with either PCP, urgent care, ortho, etc.  Agreed with caller to discontinue the IBU and Acetaminophen if it doesn't work, can try some heat to try and help relief. She will reportedly call back this same time next week late sat night/Sunday with the CDC card.
Wednesday (4-28-21)on the evening of 2nd dose  I had trouble sleeping , muscle soreness at injection site, chills and sweating.  I had a headache but temperature was normal 97.7 F.   Thursday morning (4-29-21)   I had body aches and chills along with a headache, temperature still in normal range 97.7F.  During the day at work I felt very lethargic and headache continued.  Left work early and took 2 extra strength Tylenol and took a nap.  Woke up sweating  and continued to drink fluids.  During the night I woke up sweating and had body chills.  Friday April 30th all symptoms were gone and resumed my normal activities.
After 2nd injection: Extreme upper gastric pain, heavy chest pain , nausea, vomiting, Resulted in an ER visit. Troponen level slightly elevated -no other cardiac symptoms . Resulted in Cardac Cath procedure-  and endoscopy. Endoscopy revealed inflamed stomach mucosa.  After booster: Again extreme upper gastric pain and burning. nausea/vomiting. chest pain.  ER visit. result was pneumonia, cystitis and abnormal tests.
5 days after vaccines administered pt was found face-down in crib not breathing. Resuscitation not successful. No other signs of illness. Presumed SIDS vs suffocation.  3/9/09-autopsy report received-COD Sudden Infant Death Syndrome.
vaccine had a temperature excursion of 0.5 degrees high for 1 hour during storage at our location.