chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid19 breakthrough.  1st Vaccine on 01/16/2021.  91 y/o with PMH HTN, HLD presented to ER with c/o acute SOB/AMS.  EMS states sat's wear in the 60's and then dropped to the 30's.  Pt hypoxic, placed on 15L NRB but ended up requiring intubation.  CTA-ground glass opacities Bilat.  Treated with IV ABX/IV steroids, Remdesivir and Lasix.
Left arm and leg falling asleep. Numbness in left leg; Tingling sensation in left leg into foot; This is a spontaneous report from a contactable nurse, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7534), via an unspecified route of administration on left arm on 23Mar2021 at 09:45 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient was allergic to lisinopril, ULTRAM, and ROBAXIN. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), LEXAPRO, NORVASC for unknown indications. 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 vaccine. On 23Mar2021 at 12:00, about 14 to 15 hours after injection, patient noticed that left arm and leg falling asleep. Patient still had numbness and tingling sensation in left leg into foot. The patient did not receive any treatment for the event. 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 numbness and tingling sensation in left leg was not recovered. No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a male patient of unknown age who was also a pharmacist and refers to himself, via a company representative. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Since an unknown date, the patient was vaccinated multiple unspecified times every 5 years with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) due to a diagnosis of asthma. There were no adverse effects reported.
I had fever, fatigue, SOB, light cough, and difficulty breathing. I had a sore throat and flu like symptoms. These lasted for about 10 days. I did a at home Covid-19 test, positive results. I went to my doctor after that. She did a physical exam and just asked about my symptoms.
Ongoing migraine headaches that are not relieved. Loss of peripheral vision in left eye. Constant ear ringing. Blood clot in right arm. Ongoing dizziness and vertigo. Possible intracranial hypertension. I am being tested next week. These symptoms have been ongoing and have not been relieved. I was given Eliquis for the blood clot, which I no longer take. I take Trokendi 100 mg daily which is being increased for the migraine. I am also suffering with chronic fatigue.
Patient stated that about 10 days after her vaccine she started getting hives all over. She now has chronic hives and oral trreatment was not working so she is taking xolair to treat the urticaria
Post COVID vaccine the patient had nose itching and history of post allergy shot (shot unknown). Benadryl 25 mg was given which resolved the symptoms. The patient was observed for 30 min and then went home.
Patient (11years and 5 months weighing 180 LB)  was administered the Pfizer-BioNTech Bivalent recommended for 12 years and above. Currently his mum says he's doing okay with no unsual effects and that he weighs 180LB
Patient got her High Dose Flu shot today and when the nurse dispensed the flu shot, it dripped on her arm and she may not have gotten the full dose with no reported adverse event; Patient got her High Dose Flu shot today and when the nurse dispensed the flu shot, it dripped on her arm with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 67 years old female patient who got her influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] high dose flu shot today and when the nurse dispensed the flu shot, it dripped on her arm and she may not have gotten the full dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2023, the patient received 0.7 ml (once) dose of suspect  influenza quadrival A-B high dose HV vaccine, (strength, formulation, dose, route, batch number and expiry date: unknown) via unknown route in the arm nos (not otherwise specified) for immunization when the nurse dispensed the flu shot, it dripped on her arm and she may not have gotten the full dose with no reported adverse event (incorrect dose administered) (accidental exposure to product) (latency: same day).  Action taken: not applicable.  Outcome :  Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
tested positive; tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8727), on 15Apr2021 as dose 2, single (Lot number: FP7533) and on 19Dec2021 as dose 3 (booster), single (Lot number: FJ8757), in left arm for covid-19 immunisation; paracetamol (TYLENOL), from 30Dec2022 (Batch/Lot number: unknown) to 04Jan2023. The patient's relevant medical history included: "Known allergies: iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) Positive; (06Jan2023) Negative, notes: I did a home test; (09Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 31Dec2022 to 05Jan2023, the patient received Paxlovid as treatment of COVID-19. The patient started Paxlovid the day tested positive. The patient started with the evening dose and took for 5 days as directed ending the morning of 05Jan2023. Patient did a home test on 06Jan2023, 5 days after day of onset, it was negative. When patient woke up 07Jan2023, patient was feeling stopped up which was completely new, more fatigued than previously and very out of it. This continued to get worse each day until patient decided to test again on 09Jan2023, it was positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness, headache, loss of appetite, weakness, dizziness, high fever X 24 hours.
Pt may have local reaction.  Tdap givin to pt rather than Dtap.
On 5/1/17 I received the ZOSTAVAX (Zoster) single dose Vaccine. In the afternoon on 5/2/17 a welt appeared at the injection site and was red and swelled with severe itching, NEOSPORIN was used to reduce itching. On 5/10/17 the welt and itching had subsided to a minimum. On 5/10/17 my throat became raw. I had a cough that had phlegm. On 5/12/17 my throat was better. Not so raw, but I still coughed and the cough woke me up during the night several times (at least six times) during the night for over a week. On 5/13/17 my tongue became irritated on the right side like a huge canker sore. This lasted several days along with the cough. On 5/15/17 the canker sore disappeared but the cough still lingered. On 5/17/17 in the evening I noticed that I felt a cold sore on my lip. My cough remains and have two cold sores on the right, lower lip area and a cough.
Pt did not report any symptoms but received 2 Prevnar vaccines that was not indicated.
symptoms of dizziness, slight "disorientation", shaky, nausea; notes very sensitive to meds. 1340 BP 158/100, pulse 99, p ox 99%. Able to drink water; no issues swallowing, able to breathe without issue. Still nausea, hot, shaky. Continued monitoring. Denies headache or vision changes. 1350 BP 136/100, pulse 99; complaints of heart racing, hot, comes and goes. No issues breathing. Wanting to go to bathroom; feels stable; accompanied by staff. 1400 BP 140/90, pulse 106. 1410 BP 138/90, pulse 95, p ox 99%. Feeling more herself; still some shakiness. Refused ED evaluation; feels comfortable going home. Brother accompanying; will drive.Aware if symptoms worsen/issues breathing, to seek medical attention; agreed.
The pt experienced a fever of 103 - 105, diffusely disseminated macular and papular rash noted on all extremities and trunk. Swollen and painful joints (ankles and wrists). Unable to weight bear or walk. Duration of 4-5 days.
Skin rash 3 days after getting influenza and varicella vaccines. Very itchy. Spread all over body. Wheal type. Better after taking BENADRYL.
swelling and pain at the injection sites; pain at the injection sites; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "swelling and pain at the injection sites"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "pain at the injection sites". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site pain.  Additional information: Physician reported patient started to experience swelling and pain at the injection sites days after patient received their 2nd dose of the Covid 19 Pfizer vaccine. The patient was injected approx. 10 months prior with Juvederm VOLUMA with Lidocaine and Juvederm VOLBELLA with Lidocaine and 11 months prior with Juvederm VOLUMA with Lidocaine and Juvederm VOLITE. Treated with Telfast and betacorten steroidal ointment. Symptoms resolved. This record captures events relating to the second injection with Juvederm VOLUMA with Lidocaine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt came in for his 2nd dose of Shingrix. He said he was delayed to get the second dose because he has partial loss of his left eye vision after a week received the shingrix. He still loss his vision now. He said he cant see anything below. He sees thing in front or upper are fine.
Quick-developing extreme arm and shoulder pain, extreme migraine through the night, sleeplessness, aching muscles that developed around 7PM, inability to lift arm with injection due to pain, migraine through the day following vaccine, continuing muscle and joint pain.
Pt reports pain and redness to injection site and several hours after administration. Reports on 9/24/2016 pain worsened. As of 9/25/16 when patient was seen in our clinic pain was improved but swelling and redness and worsened. Erythema noted to wrap around pt left upper arm and was warm to touch. Prednisone was ordered along with OTC Benadryl.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  09/02/2021 Is this your first or second dose- 2nd Date of symptom onset - ? 09/03/2021 Symptoms - ? fatigue, bodyache Last day of work and shift - ? 09/02/2021 Home remedies- none Any improvement- no Recommendation- Advised employee to take Tylenol/Ibuprofen per package instructions as needed for any pain. If symptoms continue, worsen, or new ones develop follow up with PCP. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employees satisfaction -Yes
became symptomatic with COVID symptoms on 7/20/2021. Tested (+) on 7/22/2021. Admitted to hospital due to shortness of breath and admitted with diagnosis of pneumonia Discharged two days later on room air and nebulizer
Itchy all over; first started on back, stomach, arms, leg,; today on face; I still woke up from sleep because of itch; rash is hard to see, there are little bumps; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy all over), PRURITUS (first started on back, stomach, arms, leg,), PRURITUS (today on face), IRREGULAR SLEEP WAKE RHYTHM DISORDER (I still woke up from sleep because of itch) and RASH (rash is hard to see, there are little bumps) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced PRURITUS (Itchy all over), PRURITUS (first started on back, stomach, arms, leg,), PRURITUS (today on face), IRREGULAR SLEEP WAKE RHYTHM DISORDER (I still woke up from sleep because of itch) and RASH (rash is hard to see, there are little bumps). The patient was treated with LIDOCAINE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy all over), PRURITUS (first started on back, stomach, arms, leg,), PRURITUS (today on face), IRREGULAR SLEEP WAKE RHYTHM DISORDER (I still woke up from sleep because of itch) and RASH (rash is hard to see, there are little bumps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
This spontaneous report as received from an approximately 28 year old male pathologists' assistant refers to himself. On unspecified date, the patient was vaccinated with two doses of M-M-R II (lot#, expire date, route, dose, strength and indication not reported) as a child. When two antibody titers were recently drawn the patient had low titer results for the measles, portion. On 13-JAN-2014 (today), the patient was vaccinated with one dose of M-M-R II injection (lot#, expire date, route, dose, strength and indication not reported) in the left arm. No adverse effects reported. It was unspecified if the patient seek medical attention. Additional information is not expected.
tiredness; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported last Thursday), the patient experienced tiredness. The outcome of the event was not recovered/not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
RASH OVER BOTH ARMS, INTENSE ITCHING. SCHOOL ADMINISTERED BENADRYL 25 MG PO. RECD PERMISSION FROM MOTHER. NO DIZZINESS, NO PROBLEMS BREATHING. FOLLOW UP CALL 6:00 PM, DOING WELL.
Patient brought in by EMS to ED on 12/6/22 for weakness and shortness of breath. To note, patient fell transferring to wheelchair the morning of 12/6. COVID PCR test done in the ED was positive, and he notably tested positive for COVID the day before. Ultimately, patient admitted to the hospital 12/6/22 - 12/8/22 for COVID-19 and generalized weakness attributed to COVID-19 infection, among other problems. Patient has received the COVID primary vaccine series and two boosters.
vaccine expired on 8/31/22,  vaccine administered on 9/1/22. Mother was contacted by provider, mother wants to think about revaccination before going ahead.
Sleep Paralysis with Lucid dreaming; when he sleeps he has difficulty breathing; fatigue; mild fever; Horrible but bearable sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP PARALYSIS (Sleep Paralysis with Lucid dreaming), DYSPNOEA (when he sleeps he has difficulty breathing), FATIGUE (fatigue), PYREXIA (mild fever) and MYALGIA (Horrible but bearable sore arm) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Sleep paralysis.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SLEEP PARALYSIS (Sleep Paralysis with Lucid dreaming), DYSPNOEA (when he sleeps he has difficulty breathing), FATIGUE (fatigue), PYREXIA (mild fever) and MYALGIA (Horrible but bearable sore arm). At the time of the report, SLEEP PARALYSIS (Sleep Paralysis with Lucid dreaming), DYSPNOEA (when he sleeps he has difficulty breathing), FATIGUE (fatigue), PYREXIA (mild fever) and MYALGIA (Horrible but bearable sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient says he has similar symptoms when he had Covid, its like he is having Covid again. Concomitant medication were not provided Treatment information was not provided   This case was linked to MOD-2021-297642 (Patient Link).
Shoulder pain and limited range of shoulder movement. Has been taking Ibuprofen 600 mg, twice daily and Gabapentin 100mg at bedtime. Advised to check with her doctors.
pain at injection site; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date refer case US2021AMR191209).   On 7th September 2021, the patient received the 2nd dose of Shingrix. On 7th September 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingrix vaccine about 4 hours before the time of reporting and experienced pain at injection site. The patient wanted to know if the patient can take Tylenol or Ibuprofen to relieve pain at injection site. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR191209:same patient, different dose
A report was received from a health professional on 11/20/2001, concerning an 18 year old female patient who experienced fever 38.5 C and pronounced asthenia, 3 days after receiving Fluvirin on 11/11/01. The patient recovered after treatment on 11/15/01. the reporter has assessed the relationship of the study medication to the event as possible.
Flu vaccine  given  8-9 am on 11/07/02 15 mins later- HA,Vertigo,nausea, ''cold sweats" + advancing edema of hand on arm , 15 mins after above vomiting,very unsteady on feet, Sent to hospital ER
right arm has psoriasis  on olecranon process and developed cellulitis over the psoriasis
He is not sleeping because he is constantly chocking and coughing every second.; having excess mucous/ He has fits where he is trying to cough up mucous/ having a mucous coughing spell/He is not sleeping because he is constantly chocking and coughing every second.; He is not sleeping because he is constantly chocking and coughing every second.; He is not sleeping because he is constantly chocking and coughing every second.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EM6208), via an unspecified route of administration, administered in Arm Right on 15Mar2021 11:00 (received at 59-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history and concomitant medications were not reported.  The patient just got his second Pfizer shot Monday 12Apr2021 10:45 am (lot number: EW0162) administered in Arm Right, and he got his first one on 15Mar2021. He wants to report what he thinks is a side effect. He does not know if it is related or not, but at the end of Mar2021/ beginning of Apr2021, he started having excess mucous. He has fits where he is trying to cough up mucous for 45 minutes. Ever since it started there has been a lot of mucous. He has been taking Benadryl and stuff like that. He headed to urgent care on 11Apr2021 but decided to go to the ER (emergency room) instead because he was having a mucous coughing spell. They checked for pneumonia, but it was negative. The chests x-ray was clear with no pneumonia. They are saying it is allergies, but he has never had a reaction like this with mucous.  He has been wearing his mask too. He knows the allergy season is supposed to be bad, but they said on the news the masks were actually helping with the allergies. That people were having less symptoms. They were contributing it to allergies, but he has never had them this way before. He wants to report because he is thinking maybe it was something from having the vaccine. He thinks the mucous first started the end of Mar2021 or the first day of Apr2021. He went to ER on 11Apr2021. He also went back and forth with the doctor. They gave him allergy medicine. The ER gave him codeine cough syrup and Allegra D. His GP has him on Sudafed now, Flonase, Allegra, and Benadryl. He has fits at night nothing seems to change. He is not sleeping because he is constantly choking and coughing every second. Last night, 13Apr2021, he finally fell asleep at 3 am and woke up at 9am. They do not want to give him prednisone yet. He would have to wait 2 weeks after his last shot for it. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
I was fatigued badly the two days following the shot. Then after about 10 days, I got cloudy vision.