chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: Albuterol [Salbutamol]; Symbicort; Azelastine; Vitamin D [Colecalciferol]; Restasis; Voltaren [Diclofenac Diethylamine]; Flaxseed Oil [Linum Usitatissimum Oil]; Flonase [Fluticasone Propionate]; Synthroid; Metamucil [Plantago Ovata]; Miralax; Omeprazole; Probiotic [Bifidobacterium Lactis]; Crestor. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course included Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Reoccurrence of COVID symptoms; went from home test negative to home test positive. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Platelets dropped  to 35 on 4/22/21 from 357 when tested on 3/25/21
PT. received  antibiotic clindamycin on 10/15/16 from urgent care, and then went to provider for second opinion and received bactrim DS on 10/16.  pt reported improvement on 10/16/20
About 2 weeks following 2nd vaccination I began to experience dizziness when first laying in bed, getting out of bed or chair. I have never had this before and am otherwise quite healthy. I have tried Epley maneuver for Vertigo.  I still have the problem. Blood pressure was normal. I contacted my PCP after 2 weeks and he referred me to an ENT specialist. Internet sources say this happens to 18% of Covid vaccine recipients. So I question if the ENT Dr would be of any help, and can this go away soon on its own.
Vaccines given 07/21/2003: Mom called 07/22/2003 reactions size of quarter, red and hard.  No fever.  Came into office 07/23/2003 left palm size reaction  and then right 2-3 inches in size.  Swollen, red, child very fussy.
Severe vertigo; Light headedness; 5 rash central to injection site; Pain enough that when I roll over at night it wakes me; some equilibrium; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th January 2020, the patient received Shingles vaccine. On 11th January 2020, 5 days after receiving Shingles vaccine, the patient experienced vertigo and light headedness. In January 2020, the patient experienced injection site rash, pain and disorder equilibrium. On an unknown date, the outcome of the injection site rash, pain, disorder equilibrium and light headedness were unknown and the outcome of the vertigo was recovered/resolved.   It was unknown if the reporter considered the injection site rash, pain, disorder equilibrium, vertigo and light headedness to be related to Shingles vaccine.  Additional details were received as follows: The age at vaccination was not reported, but it could be 69 or 70 years. The patient stated that after vaccination had rash central to injection site, pain enough that when roll over at night it wakes me, and some equilibrium. The patient also had severe vertigo initially, but lasted for a few hours, with light headedness persisting throughout day. The patient do not want another vaccine for some time as patient was concerned about reactions. The patient asked whether vertigo related to vaccine.
charlie horse/stiff neck.; charlie horse/stiff neck.; This case was reported by a pharmacist via call center representative and described the occurrence of stiff neck in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received Shingrix. On 20th October 2020, 30 min after receiving Shingrix, the patient experienced stiff neck and charley horse. On an unknown date, the outcome of the stiff neck and charley horse were not recovered/not resolved.   It was unknown if the reporter considered the stiff neck and charley horse to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. A pharmacist reported that a female of unknown age received Shingrix 3 days ago from the day of reporting and about 30 minutes after the vaccination she experienced a charlie horse, stiff neck. The report was given via chat and the HCP did not provide additional information.
At approximately 5:30 PM patient started developing "scratchy" eyes and blurry vision. She felt like she could not take a deep breath. After a while she felt like her throat was closing up and she developed mucus in her eyes. She waited until her husband came home and he took her to the emergency room about 8:00 PM. She said her breathing was better by that time, but she had a "horrible" headache and was "freezing". She was given a breathing treatment at the emergency room. She was discharged with an inhaler and Benadryl. The next morning she still had a "horrible" headache, bloodshot eyes, and was chilling. Patient still has "scratchy" eyes today, but all other symptoms have subsided.
4 days p/shot was treated for severe ear infection was very sick; wouldn't eat, didn't want to be touched anywhere, t102, slept alot; devel rash, irritable;
Headache, Arthralgia, Fever, fatigue, sore arm Narrative:  Fever, chills, muscle aches, joint pain, fatigue, took some Aleve OTC and slept.
Expired Havrixadministered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 24th February 2023) for prophylaxis.   On 27th February 2023, the patient received Havrix. On 27th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 27-FEB-2023 Reporter's comment: The reporter did not consent to follow-up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Red splotch developed at injection site about 8 days after vaccination. Splotch is warm to the touch and slightly itchy at times. Doesn't appear to be getting worse at this time.  Pregnancy history: two prior miscarriages; current pregnancy has had no complications and is low risk, 31 weeks at time of vaccination, due date 6/1/21.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore injection site arm), vaccination site swelling (swollen injection site arm) and vaccination site erythema (red injection site arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026021A and 033B21A) for COVID-19 vaccination. No medical history reported. On May 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 21, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced vaccination site pain (sore injection site arm), vaccination site swelling (swollen injection site arm) and vaccination site erythema (red injection site arm). At the time of the report, vaccination site pain (sore injection site arm), vaccination site swelling (swollen injection site arm) and vaccination site erythema (red injection site arm) outcome: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information. Action taken with mRNA-1273 in response to the events: not applicable. This case linked to MOD-2021-220030 (patient link).
grandma reports t104 could only get temp down to 103 p/vax; took to MD  who gave prescription for med for fever;
received a Pfizer covid-19 booster dose on Thursday and Sunday she tested positive for Covid; received a Pfizer covid-19 booster dose on Thursday and Sunday she tested positive for Covid; She only has part of a heart that works; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 26May2022 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: CARDIAC DISORDER (non-serious) with onset May2022, outcome "unknown", described as "She only has part of a heart that works"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 29May2022, outcome "unknown" and all described as "received a Pfizer covid-19 booster dose on Thursday and Sunday she tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) Negative; (29May2022) Positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective, cardiac disorder. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: Caller received a Pfizer COVID-19 booster dose on Thursday and Sunday she tested positive for COVID. She tested negative on Saturday. She only has part of a heart that works, so her treating HCP prescribed her Paxlovid. She wants to know how she knows if it's safe for her to take. She has not started Paxlovid yet. Caller stated they just prescribed Paxlovid for her and didn't even check to see if it would interact with any of the other medications she was taking.
shoulder sore at injection site (frozen shoulder).  Also, developed a blister at injection site, scab slow to heal.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 25-JUN-2015, the patient was vaccinated with improperly stored doses of VARIVAX (Merck) (lot number, dose and route were unknown). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Starting 08/17/2021, I started getting severe headaches and it felt like my head was "going to explode". It was getting more intense to the point of becoming unbearable. I started getting some chest pain and I took TYLENOL which did not help. So, after the chest pain continued and the unbearable headache persisted, I went to the hospital in 09/2021. My blood pressure was extremely elevated (200/120) so they prescribed me clonidine and baby aspirin. They discharged me and told me to follow up with my PCP and see neurology for the headaches. I tested positive for COVID-19 on 02/03/2022. When I followed up with the neurologist, they did multiple tests for "thunderclap headaches" (MRI and MRA). I was diagnosed with "Reversible Cerebral Vasoconstriction syndrome which lasts for no more than 12 weeks" which I was passed that window and my symptoms were gone. I went to the clinic and they did a work up for my overnight headaches (checked for sleep apnea or other causes of headaches). They did a lumbar puncture (05/04/2022) and noticed my intracranial fluid pressure was elevated and they pulled 3 ccs of fluid to lower it to 21. Also, I was prescribed acetazolamide to take 3x daily or as needed. On 06/24/2022, the doctor said overnight hypertension and sleep apnea were excluded as the cause of the overnight headaches. The overnight headaches have gone into remission on acetazolamide despite opening pressure being 24. The doctor suspected I had a "mild case of secondary pseudotumor cerebri syndrome without papilledema and my pressure was elevated only at night". Also, the doctor suspected it was due to "baseline pre-disposition due to unilateral focal venous sinus stenosis tipped over the edge by probable arachnoid scarring from previous Lyme meningitis". She thought I would need acetazolamide for the rest of my life. I am still having headaches to this day but they are less frequent and less severe.
I developed shingles , left side of my face, days after the first dose of the vaccine.; This is a spontaneous report from contactable consumer (patient herself). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6208, Expiry date: Unknown) via an unspecified route of administration in left arm on 25Mar2021 at 15:30 (at the age of 55-year-old) as 1st dose, single for COVID-19 immunization. Patient did not have any other medical history or known allergies to medications, food, or other products. Other medications (concomitant) the patient received within 2 weeks of vaccination included levothyroxine sodium (Synthroid 100 mcg) and escitalopram oxalate (Lexapro 10mg) both taken for unspecified indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 31Mar2021, days after the first dose of the vaccine, patient developed shingles, left side of face. Reporter considered the event as non-serious. Therapeutic measures taken in response to the event included Valacyclovir. The outcome of the event was recovering.
I received a full 3rd dose of 100 mcg of Moderna. Approximately a month later, I started to get a flare up of my autoimmune disorder. The first symptoms was a large amount of hair loss. I had severe joint pain. I also had dry eyes, dry nose, and dry mouth which I took OTC meds to help relieve the symptoms. I went to a rheumatologist in February 2022, I had blood work. He had placed me on Hydroxychloroquine 200mg twice daily which I do not want to take due to side effects and being on these meds once before. These symptoms lasted about 4-5 months. I still have hair loss, joint discomfort, and dry mucus membranes. I am also using OTC products for hair loss.
Joint & Muscle ache and pain, Lethargy, Exhaustion, Breathing difficulty, Coughing, Irritability, Phlegm all continuing in varying degrees. Difficulty focusing (mentally) lasted a couple of weeks. Weakened immune system--experienced flu/cold like sickness for the first time in 15-20 years.  Overall not feeling well and continuing lack of energy.
FAINT SPOTS ON LEGS/BODY; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-OCT-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. Age at time of vaccination 65 years old. No concomitant medications were reported. On OCT-2021, the patient experienced faint spots on legs/body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient had not recovered from faint spots on legs/body. This report was non-serious.
Patient complained of exhaustion and malaise within 24 hours of receiving the dose.  This never resolved.  Three weeks later he complained of the same exhaustion and malaise.  Jaw pain was reported on 5/23/2021.  Patient found deceased 5/24/2021 at age of 53.
pt recv vax 5APR97 & exp a swollen lump on lt arm that lasted 4wk;pt did not mention this to anyone;
Injection site and deltoid area was reddened, very warm to touch and swollen. I became achey with "sore" muscles entire body. Muscle aching last 24 hrs. Redness and swelling in injection site arm lasted 2-3 days. I have all my vaccinations, including annual flu shots, but never had a reaction to any of those. There was no reaction to first shot of SHINGRIX on 4/04/18.
Report 2002001273-1 describes a 36-year-old female who failed to respond to a 3-injection series of hepatitis B vaccine recombinant (Engerix-B). Medical history, concurrent conditions and concurrent medications were not specified. The pt received injections of hepatitis B vaccine (Recombivax-HB, Merck) on 05/23/2000 (lot 1960J, expiry 02/04/2002), 06/28/2000 (lot 0488K, expiry 03/12/2002) and 01/03/2001 (lot 0488K, expiry 03/12/2001). Antibody titer against hepatitis B surface antigen (HBsAg) was measured on 03/01/2001 and was negative. The pt received her 1st injection of Engerix-B on 03/12/2001 (lot ENG3375A4, expiry 04/20/2003). Anti-HBsAg titer measured on 05/02/2001 was negative. She received her 2nd injection of Engerix-B on 05/24/2001 (lot ENG 3375A4, expiry 04/20/2003). Anti-HBsAg titer was negative on 08/29/2001. The pt received her 3rd injection of Engerix-B on 09/24/2001 (lot ENG3375A4, expiry 04/20/2003). Anti-HBsAg titer measured on 11/27/2001 was negative.
Itching all over the body; Aches and pain all over body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Aches and pain all over body) and PRURITUS (Itching all over the body) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (Aches and pain all over body). On 21-Jan-2021, the patient experienced PRURITUS (Itching all over the body). At the time of the report, PAIN (Aches and pain all over body) and PRURITUS (Itching all over the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Reporter's Comments: Based on the current available information which shows a  strong temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded.  Rash is consistent with the known safety profile of the mRNA-1273.
Swelling, erythema noted left deltoid 24 hours after injection. Increased temp 101.3 F.
Patient developed Gilliam Barre after administration of the second dose of Covid vaccine on 2/15/21; After multiple calls,  clinic was where patient received vaccine with LOT #EN6200 (expiration date unavailable in computer system per pharmacist); pt then went to a hospital and was diagnosed as above; treated in the ED for several days per notes at the hospital and was not put in a room due to bed shortages so was transferred to another hospital; patient subsequently developed an NSTEMI, seizures, and was intubated.
My daughter had a low grade fever (101.5' F) and a spotted rash that broke out first on her abdominal area, and later spread to her face and extremities - essentially, head to toe. The fever occurred first in the afternoon and as the day went on, more and more spots appeared. I took a picture and sent it to the Drs office at 9:30pm. By looking at the photo of the rash and asking me questions, he was able to pinpoint it's likely cause to her MMR vaccine administered 10 days prior.
Myalgia, Fever, NauseaVomiting, gassy, fatigue, swollen lymph node in left armpit Narrative: Fever 100.7, myalgia, nausea, gassy, fatigue, swollen lymph node in left armpit; alternating APAP/ibuprofen.
Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via unspecified route of administration in right arm on 30Mar2021 (at the age 0f 71-year-old) as single dose for COVID-19 immunisation. Medical history of the patient was reported as none. Concomitant medications were not reported. The patient previously received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER9206) via unspecified route of administration in left arm on 09Mar2021 as single dose for COVID-19 immunisation. It was reported that the patient had no known allergies to food, medications or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient had not tested for COVID-19. On 31Mar2021 at 15:00, the patient experienced injection site pain (vaccination site pain), tiredness, headache, muscle pain, chills, joint pain, fever and feeling unwell. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site pain, tiredness, headache, muscle pain, chills, joint pain, fever and feeling unwell was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
My wife still has pain where she took injection. it's been 1 months..pain reducess and increases. Sometime it get worse. Please advise. She had lot of pain when took the injection.
Extremely sore arm 4-5 hrs after the shot. By about 7 hrs muscle achiness, nech ache, tired. Woke at 2am with chills and a fever of about 100-101, hot/cold flashes. Took 2 advil, fell asleep about 2 hours later. Woke up very tired and achy still but fever gone.
Report 2002000378-1 describes arthritis in a 44 year old male who received Lyme disease vaccine recombinant OspA (LYMErix). The medical history included asthma, pneumonia, and epilepsy. The vaccinee had no known drug allergies. The vaccinee's occupation reportedly put him at risk for tick bites. There was no illness at the time of immunization. Concurrent medications were not known by the reporter. The vaccinee received his first injection of LYMErix (lot LY104A2) on 4/12/99. He had no adverse experience following receipt of this injection. He received his second injection of LYMErix (lot LY136B9) on 5/3/00. An unknown time post-immunization, he experienced extreme joint pain (NOS). The vaccinee reported that he was seen by an arthritis specialist, who made a diagnosis of arthritis (NOS). The vaccinee stated that this specialist recommended that he not receive the third injection of LYMErix. As of 1/8/02, the vaccinee stated that he remains in a lot of pain and is having difficulty just trying to move about. The most recent information, received 2/4/02, did not specify the treatment or outcome of the event. The adverse event arthritis does not meet ICH serious criteria, but is being submitted as an expedited report by special request per the June 28, 2000 letter.
Headache, joint pain, fever, dizziness, nausea, eye pain, abdominal pain, leg pain