chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 62-year-old (non-pregnant) female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 62, via an unspecified route of administration, left arm, on Apr 6, 2021, at 15:00, single dose, for COVID-19 immunisation. Medical history included breast cancer in 2012 and penicillin allergy. The patient received other medications within two weeks of vaccination; names were unspecified. The patient previously took Codeine, Tylenol (acetaminophen); all from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr 2021, patient vomited the entire evening. On Apr 6, 2021, patient experienced a headache, aches and severe nausea. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of headache, aches, severe nausea and vomited the entire evening: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Sore arm starting day of vaccination, was given ibuprofen. One week after vaccination, severe conjunctivitis, fever 103, runny nose, cough. Sought treatment from Naturopath.
Fluid collection and discomfort of left axilla, no erythema, hematoma starting  approximately  1.5 days after injection and ongoing.  Also had low grade temp and dizziness that was self-limiting.
This spontaneous report was received from a certified medical assistant concerning a 18 month old patient. The patient's concurrent and historical conditions were not reported. On 14-MAR-2016, the patient was vaccinated with an expired dose of VAQTA (lot # K015827, exp.: 11-MAR-2016) (dose, frequency or anatomical location were not provided). Concomitant medications were not reported. No adverse effects reported. Additional information is not expected as no consent to contact HCP was informed.
No adverse event; improperly stored MMR II was administered on 8/14/2019; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 14-AUG-2019 (also reported as 16-AUG-2019), the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) injection, subcutaneously, lot # R027063 and expiration date 20-SEP-2020 (exact dose was not reported) for prophylaxis. The temperature was 70 F with a time frame of 4 days. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effects were reported. The outcome of product storage error was unknown.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA007229:
Patient was given her third COVID vaccine and received 0.5 mL (dose given to severely immunocompromised patients, as defined by CDC), instead of the standard 0.25 mL dose. No adverse reactions noted.
weeping "COVID" arm; arm feels very hot and sore; arm feels very hot and sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 19:00 (Lot number: EN6202) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dates for Pfizer Covid Vaccine: 01Feb2021, Lot number: EL9264, Dose 1, Single.), administration date: 01Feb2021, for COVID-19 immunization; encephalitis (10 years ago.), for Immunisation, reaction(s): "very painful experience"; Rabies (rabies and all of the other vaccines she had to get were fine.), for Immunisation. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 24Feb2021, outcome "recovered" (19Apr2021), described as "weeping "COVID" arm"; FEELING HOT (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 24Feb2021, outcome "not recovered" and all described as "arm feels very hot and sore".  Additional information: reporter stated no alcohol and marijuana was taken. Clinical course reported as COVID arm started right after the second dose, clarified as the day after on 24Feb2021. Her arm was weeping up until a few days ago. Caller clarifies it's not weeping anymore, it stopped about a week ago. Caller states she has recovered completely from the weeping. However, her arm still feels hot and sore.   No follow-up attempts are possible. No further information is expected.
Hives ( large red macular lesions, blanches with pressure, warm to touch, itchy ) Treated with Benadryl
t105.3 R @ PMD 15NOV96; advised Ibuprofen & APAP alternate q  4 hr;
Severe headache, muscle pain in the neck, shoulder,pain in the lymph nodes, severe chills. 2:30 p.m
sore arm, chills and exhaustion so bad came close to being nauseous.  All in first 24 hrs.   Was fine 24 hrs later
Pt received ADACEL vaccine in (L) deltoid on 3/29/13 presented to ER 3/31 with redness at site of injection 3 cm induration noted at PCP OV 4/1/13 swelling, warm - prescribed KEFLEX in ER.
This spontaneous report was received from a nurse via a field representative and refers to a 14 week old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was reported. On an unknown date, "after the patient turned 14 weeks of age", she/he was vaccinated with the first dose in vaccination series ROTATEQ oral liquid, 1 dose, orally (lot # and expiration date were not provided). No adverse effects were reported.
Information has been received concerning a female who was vaccinated with Hep-B and subsequently, the pt experienced arm hurting and arm feeling numb. The pt felt the arm hurting and feeling numb may be due to the severe arthritis. No further information is available.
not feeling good; nauseous; blood sugar is not very stable; This is a spontaneous report from a contactable consumer (parent).  A male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FA6780), via an unspecified route on 31Jul2021 as dose 2, single for covid-19 immunization. The patient medical history included Type-1 diabetic from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 2021 as dose 1, single for covid-19 immunization. On unspecified date, the patient experienced adverse reaction to medication for diabetics. Reporter stated, "patient father was calling about some questions regarding, and wanted to know any side effects of the Pfizer vaccine how long it last for? his kids all had their second dose on the same day, 3 of his kid. patients children 3 children had vaccination, second dose at the same time at same day. One kid had stomach ache and was really yucky for couple of days. Patients fathers other child had to continue to have headache since during the second shot migraine headaches since the second vaccine. patient father himself personally had his second shot. There was, last Saturday and he had headache so, like bad headache, may get headache all days. So, he took two Ibuprofen (Hence, captured as suspect) it's (headache) not going away so, he just wants to know. he wants to know, his son was Type-1 diabetic and it's not little managed and he had his first vaccination try to figure out to have his second and he didn't tried Ketone and BKA since he got his first vaccination, his first shot. He was not feeling good at all, he was been sick, he had no energy and he just feel yucky. So, how long last for how long before we are ok, just wanted to know about headache and stuff." Reporter stated, "He immediately, first of all like we sat there for 30 minutes after vaccination, because he had an adverse reaction to medication for diabetics (Further not clarified, hence Captured as unspecified Medication). So, we waited 30 minutes before they left there and got home, and it take 20 minutes of time. So, he has not feeling good nauseous didn't feel good, he lay down, he didn't take ketones because he is diabetic should have blood sugar his blood sugar is not very stable and he is not feeling good." The outcome of the events was unknown.
Extreme fatigue began on 3/3/21 (3 weeks post vaccine). Left sided facial drop and left sided weakness began on  3/6/21. 2 days later, symptoms were communicated to doctor and patient admitted to hospital, where CT scan and MRI confirmed right-sided stroke. No predisposing factors (no preceding HTN, non- smoker, normal carotid arteries, no congenital heart defects,  not on OCP, no history of blood clots or abnormal clotting factors.)
Very high fever (103 degrees F) (approx. 48 hours) mild hive like rash all over the body (3 days) loss of appetite; grumpy.
p/vax swollen red eyes w/excessive mucus, dark circles under eyes;h/a, nauseous, restless during noc, could not lie still or sit still, red (large spots @ started under arms & other various body parts;started under lt arm where shot given;
Tingling, stinging, itching, at and above site (injection given at 45 degree angle downward) she asked me to palpate a lump (which I could not discern) she said she felt she should "remove band aid, and vigorously scratch it". Phoned after 1 1/2 hrs to report a lump at injection site (no redness or discoloration at site).
I noticed an increased heart rate while relaxing in my recliner (over 100 for around 45 minutes). I looked at the health app on my phone and noticed that my resting heart rate had been trending around 10 bpm higher over the course of the past 7 weeks.  I have also had an increase in palpitations and can feel my heart beating nearly all the time. The increased rate started on 12/01/2021. I reported the increase to my cardiologist, who placed me on an event monitor for 3 weeks, had me try propranolol for a few days, and switched me to corlanor to lower my heart rate. I was also seen by an electrophysiologist who stated my heart rhythm is normal, just too fast.  I was also very itchy the night I received the vaccine. I took benadryl and went to bed and had no further itching.
This is a non-serious spontaneous case, initially received from a pharmacist on 10-Dec-2018, concerning a female patient of an unspecified age. The patient had no medical history and allergies. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal [route of administration: intramuscular, anatomical location: right arm, dose, batch number, expiry date, trade name and manufacturer: not reported] for an unknown indication. On an unspecified date, the patient was administered non-company suspect vaccine PNEUMOVAX 23 (route of administration: intramuscular, anatomical location: right arm, batch number: R018735 and expiry date: 06-Apr-2020, dose, trade name and manufacturer: not reported) for pneumonia. It was reported that, both suspect and co-suspect vaccines were given in the same arm. On an unspecified date after vaccination, the patient developed erythema in the right arm and swelling in elbow (reported as unspecified). On an unspecified date, the patient self-medicated with topical BENADRYL and topical cortisone cream (drug unspecified) but had no relief. On 03-Dec-2018, the patient returned to the pharmacy and the pharmacist advised the patient to take oral BENADRYL (unspecified dose). The outcome of the events was not recovered. Reporter's Comments: A female patient of an unspecified age experienced erythema in right arm and swelling of elbow on unspecified date after the administration of suspect vaccine INN Flu Vaccine Seasonal and non-company suspect vaccine vaccine PNEUMOVAX 23. It was reported that both the vaccines were given in the same arm. The company assessed the causality of the events erythema in right arm and swelling of elbows as unassessable due to lack of onset latency regarding the events. The company assessed the causality of the event drug administration error as not related due to accidental nature of the event.
This spontaneous report was received from a health care worker referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical histories were not provided. On an unspecified dates: in September 2015, and in December 2015, the patients were vaccinated with unspecified doses of improperly stored of GARDASIL 9, lot # L014415, expiration date 25-JUL-2017, lot # L016428, expiration date 30-JUL-2017 and lot # L016429, expiration date 09-AUG-2017, respectively, (routes, doses and anatomical sites of vaccination were not provided). It was reported that the temperature of excursion were the following: 53.6 for 392 hours, 58.5 F for 465 hours and 46.2 F for 15 hours, respectively. The outcome of excursion was not supported. Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
diarrhea; nausea; vomitting; redness; swollen bump; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swollen bump), NAUSEA (nausea) and VOMITING (vomitting) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swollen bump). On 01-Mar-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomitting). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swollen bump), NAUSEA (nausea) and VOMITING (vomitting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Fever; Chills; Nausea; A spontaneous report was received from a consumer concerning a female patient who experienced fever/: pyrexia, chills/: chills, and nausea/: nausea.   The patient's medical history and concomitant product use were not provided/unknown by the reporter.  On 29-Dec-2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after the patient received her first dose of vaccine she developed a fever of almost 103 degrees, chills, and nausea.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Information has been received from a healthcare worker (also reported as medical assistant) concerning a 35 year old male patient recently diagnosed as Human immunodeficiency virus (HIV) positive with no drug allergies who on 26-JAN-2011 was vaccinated IM with the first dose of PNEUMOVAX 23 (lot # 667916/1066Z, expiration date 03-MAR-2012) into the left deltoid. Concomitant therapy included ADDERALL (tablets). On approximately 26-JAN-2011 within 6 hours of receiving the vaccine the patient developed a fever (102 degrees F), redness, warmth and induration of 3-4 inches at the injection site and rash at the injection site. The patient had sought medical attention by office visit. Lab diagnostics studies were not performed. The symptoms subsided by 31-JAN-2011. Follow up information has been received from the healthcare worker who reported that the patient with HIV positive at time of vaccination on 26-JAN-2011 at approximately 2:00 PM was vaccinated with PNEUMOVAX 23. On 26-JAN-2011 approximately 4:00 PM approximately 2 hours after the vaccination the patient developed of pain, swelling, redness, warm to touch, fever persisted over the weekend. The patient's red area grew to approximately 4-5 inches diameter. The healthcare worker mentioned the patient's mother reported the patient's sister also has a similar reaction to PNEUMOVAX 23, which was reported in WAES # 1103USA01857. Additional information is not expected.
Patient has epilepsy but has not had a seizure in 6 weeks. Today, 5 days after his second dose of Pfizer vaccine he had 3 seizures. Pt. was taken to the local ER and after the nurse spoke with pt. neurologist, the doctors felt the seizures were caused by the 2nd dose. He has been pale, irritable and generally unwell looking. The neurologist felt that due to the immune response from the vaccine and the fact that pt. has been feeling crummy these past 5 days, that it lowered his seizure threshold.
Patient had a lot of bleeding on the day of immunization.  The bleeding did stop,  but patient said the pain is still after 9 days.  She said there were twitching  from injection site to her elbow and wrist.   There were bruising and muscle aches also.
COIVID-19 POSITIVE ON 06/15/2021, PULMONARY EMBOLISM 06/15/2021
01/20/21 @ 12:00 PM: Headache and body aches for less than 24 day. Went to bed. Symptoms are resolved. Feeling well.
She got the vaccine, and got a racing heart, tightness and heaviness in her chest immediately.  When she got to the nurse she relayed that to her.  Later she felt unwell, and that her heard in a vice.  She then went to the restroom and noticed swelling immediately under eye, and spread to the top of her checked and became dizzy around 1:00 AM that morning.  Her lymph does swell and had to see a doctor a week later.   Her doctor did an EKG, chest x-rays.  She could not rid of the tightness of chest that would not go away.   She gave her anti-inflammatory medicines and gave her a script for new inhaler, and is still having the tightness of the chest now.  This was not on and off and had to see a doctor.  She is taking her inhaler and taking Benadryl as she is now break and can't afford to go back if she has a problem.   She got really, really ill and had 10 of the possible effects and then got the severe side effects.  With the swelling, breathing difficulty and swelling of the face was advised not to get the 2nd vaccine.    She told the nurse at the vaccine site what she was experiencing and was informed by her that it was pre-vaccine anxiety and was dismissed.
Dr Diagnosed patient with Bells Palsey on the left side at 10:00am on Feb.10th,2021
pt recvd vax; 2 wks later p/ vax pt devel raised red bumps on the thorax at 2-3 different places; was found to have ringworm;
Patient had a 19cm long x 14cm across allergic reaction 3 days after receiving the vaccination.  Area was swollen, red, and hot to touch.  (Covid Arm).  Patient was prescribed a topical steroid cream to help with the itching.
Chills (1 day); Left Arm Swelling and redness from Shoulder to elbow.   Severe swelling and pain for 3 days;  Minor swelling and redness following that in decreasing severity for another 6 days.
Arm pain, muscle aches, headache, chills. Started with arm pain a 6 hours after shot. Developed rest of symptoms overnight.
On 02/14/2023, I had a cough and just felt an all over weakness and fatigue with chills. The next day, those symptoms got worse. I took my temperature, and it got as high as 102.6. I tested myself for COVID-19 and it was positive. I called my physician and got a telephone appointment for 02/16/2023. He prescribed Paxlovid which I began that day. I was symptomatic for five days. I isolated for five days. I felt pretty much better by the sixth day. I was completely symptom free by the seventh day. I continued to quarantine for another three or four days.
12 hour post-vaccination- shivering and body aches 20 hours post-vaccination- angioedema/tongue swelling
Fever (101.4 F), lethargy, and no appetite  elevate BP 133/113, P-129
Had to go to the Emergency room on 03/27/2021 for an event that is totally not Vaccine related.
Since this morning she has been very cranky and nauseous and she it has had been having abdominal pain and weakness but extreme amounts of fatigue and she thought she had a fever but every time I felt her head her head was really cold now she is sleeping and my son has the similar issue and my son has autism
Redness at injection site; Swelling at injection site; Prevented sleeping at night; Tingling in left hand; Excruciating pain throughout left arm; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2022, the patient received the 1st dose of Shingrix. In March 2022, less than a week after receiving Shingrix, the patient experienced pain in arm, difficulty sleeping and tingling of extremity. On an unknown date, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site swelling and pain in arm were recovered/resolved and the outcome of the difficulty sleeping was unknown and the outcome of the tingling of extremity was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, pain in arm, difficulty sleeping and tingling of extremity to be related to Shingrix.     Additional Information: GSK receipt date: 01-Apr-2022 Reporter's comment: The case was reported by physician for herself. The patient received a dose of Shingrix in left arm and experienced redness and swelling at the injection site, that had since resolved. The patient not keeping track of the redness and swelling, as they were expected side effects.  The patient experiencing excruciating pain throughout the entire left arm within a couple of days of receiving the dose and the pain in the left arm prevented them sleeping at night. This pain in left arm lasted approximately 1 week.  The patient reported experiencing tingling in the left hand approximately 6 or 7 days after the resolution of the excruciating pain in the left arm and approximately 2 weeks after receiving the dose.  The patient reported tingling in left hand was ongoing.  The patient reported wearing a brace at night in an attempt to resolve the tingling, to no avail. Did not consent to follow-up.