chrisvoncsefalvay/vaers-outcomes huggingface dataset:
POTS; dizziness; headache; fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 23-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
severe pain comes in waves; tingles in her left arm/ tingling spreading It moved to her left shoulder, between neck,shoulder, down her left side to her waist. It's also in her left shoulder blade, moving down her left leg; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Oct-2021 and was forwarded to Moderna on 13-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingles in her left arm/ tingling spreading It moved to her left shoulder, between neck,shoulder, down her left side to her waist. It's also in her left shoulder blade, moving down her left leg) and PAIN (severe pain comes in waves) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PARAESTHESIA (tingles in her left arm/ tingling spreading It moved to her left shoulder, between neck,shoulder, down her left side to her waist. It's also in her left shoulder blade, moving down her left leg). On an unknown date, the patient experienced PAIN (severe pain comes in waves). The patient was treated with PREDNISONE at an unspecified dose and frequency and GABAPENTIN (NEURONTIN) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingles in her left arm/ tingling spreading It moved to her left shoulder, between neck,shoulder, down her left side to her waist. It's also in her left shoulder blade, moving down her left leg) had not resolved and PAIN (severe pain comes in waves) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that, after receiving her 1st dose she started getting tingles in her left arm within a minute of it being administered. The tingling became more intense.  Patient scheduled for an EMG and was going to see a neurologist.   This case was linked to MOD-2021-351199 (Patient Link).
Face and tongue swelling, three times to the emergency room during a three month period. Swelling occurring about every week or two. Had an allergy test done and find I'm now allergic to everything in the book, never allergic to anything prior.
Left upper extremity DVT in brachial vein. Left upper extremity SVT in basilic vein.  Started on xarelto, plan for 3 month course. Sepsis - no source
Severe prolonged dizziness to the point where a walk to the bathroom made me nauseated.  Moving my head at all made the world tumble around me.  Started gradually in late evening of the day of the shots, and progressed until I looked up Meniere's Disease and read that one of the medications for that is Valium.  I have a prescription for Valium 5, so I took one, and fell asleep, but after that was able to move around more.  By 4:00 am on the 20th, I was able to move around normally, but I had another, ver minor, dizzy spell in the afternoon of the 20th.  Dizziness seemed to last about 28 hours.
I administered FLUVIRIN to patient on 10/23/10 about 5 AM. On 10/24/10 at 3:30 AM she came in to see me. She showed me a red patch on her arm below the injection site and told me she had nausea and sweating (flu like symptoms).
received her #1 COVID 19 vaccine, Moderna, at 0903 this morning. At approximately 0913 patient reports having a strange "tingling" sensation and an overall feeling of weakness. She describes this as her arms feel "heavy". At approximately 0930 patient reported that she is having a "burning pain" in her chest. She is brought into a room and assessed by provider, Blood pressure on auto machine is 193/107, heart rate 86, and O2 sats are at 96-98% on room air. Patient is calm and is not reporting any other symptoms. She denies any SOB, difficulty swallowing, and is not itching any where. She states that she feels "tingling/burning" is moving up her arms and legs. Rechecked patients BP manually and reading os 192/112. Patient reports feeling "weak" and "heavy" in her arms and "tingling/burning" describing it as "a minor sunburn" in her arms only. The "burning/pain" in her chest has resolved and she feels like she is even breathing deeper now. Recheck of BP at 0945 shows manual reading 176/94, and auto reading 162/93. provider asks that she give another 5 to 10 minutes and recheck BP. Manual BP checked at 1000 and 158/72.  provider revisits patient and states that patient BP is coming down nicely and no other symptoms. She states that if next BP is still coming down, she is free to go home. Recheck of BP at 1015 152/78.
Localized reaction at injection site.  Arm swelled, red, hardened, warm to touch.  patient given OTC antihistamine
This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13 at single dose, for immunization. Medical history and concomitant medications were not reported. The patient experienced headache the day after vaccination, on an unspecified date. Event outcome was unknown. Information on the batch number has been requested.
3:00am-CN noted resident awake sitting up in bed verbally responsive, encouraged to lie down and sleep, resident complied. 4:00am- resident noted sleeping in bed, unlabored breathing, same sleeping position as of 3am. 5:15am- Charge nurse went into resident's room to give him his routine  breathing treatment. CN found resident in bed unresponsive, pupils fixed and dilated, facial swelling, drooping noted on left side of face. 911 called, resident transferred to hospital.
A week after the first shot which was on the left arm, I had a large red welt that looked like a giant bug bite.  It resolved itself in a few days and wasn't particularly worrisome or itchy.  After the second shot on the RIGHT arm, the next day I immediately experienced the typical systems they say happens with Moderna, some fevering, chills, sore arm, redness/swelling at injection site and a golf ball size lymph node under the right arm. Symptoms resolved with in a few days except lymph node did take about two weeks to mostly go down.  A week after the second shot, I expereinced some prickly like itching on my chest and neck more towards the same side as the injection site -on the right side of my body.   Nothing on the left.  Red splotches appeared.  This went on for a couple of days and wasn't resolving itself.  It sort of got better with cold compresses and mitigated with benadryl cream but the issue persisted.  I immediatley called a dermatologist and scheduled appointment.
Information was received from a physician concerning a 27 month old male who in the morning of 14-JUN-2007 was vaccinated with Pneumovax 23, 0.5 ml, IM (lot # 654974/0355F). There was no concomitant medication. At 14:30 in the afternoon, the patient was sent to the clinic due to a fever. Meanwhile, his body temperature was measured as 39.6 degrees, Celsius. Ten minutes later, the patient developed a convulsion. At the time of the report, it was unknown if the patient recovered from fever or convulsion. The reporter felt that the patient's fever and convulsion were related to therapy with Pneumovax 23. Upon internal review it was considered that convulsion an other important medical event.
Swelling in neck, left side, abive adams apple; jawbone tenderness, difficulty opening mouth
Tiredness; headache; muscle pain; chills; joint pain; fever; nausea; difficulty breathing; dizziness; weakness; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; EN6199) via an unspecified route of administration in the left arm on 12Mar2021 at 12:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergies to  generic codons. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) from an unknown date and for unknown 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. Since the vaccination, patient had not been tested for COVID-19. On 17Mar2021 at 12:00, 5 days after vaccination, the patient experienced tiredness, headache, muscle pain, chills, joint pain, fever, nausea, difficulty breathing/shortness of breath, dizziness and weakness. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit. The clinical outcome of the event tiredness, headache, muscle pain, chills, joint pain, fever, nausea, difficulty breathing/shortness of breath, dizziness and weakness were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Multiple red papular lesions distant from vaccination site - on abdomen, anterior neck, left upper arm.  Lesions are nonpruritic.  No vesicles or pustules.  No signs of anaphylaxis.  Patient looks and feels well otherwise.  No fever or chills.  No treatment provided.
This spontaneous case, initially received on 04-Nov-2016, was reported by a Non-Health Professional and concerns a 27-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA for influenza vaccination from 04-NOV-2016 to 04-NOV-2016. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT57008. No additional suspect drugs. Adverse event description: On 04-Nov-2016, the patient was administered AFLURIA but she did not receive the full dose of AFLURIA (outcome: unknown, special circumstances: underdose without adverse event). The needle was attached properly, but it did leak. As the patient was injected, it started leaking. The patient could not tell where the leak was from.
Got vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and  got diagnosed with Covid 19 on 26Jun2021; Got vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and got diagnosed with Covid 19 on 26Jun2021; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number was not reported) via an unspecified route of administration on Feb2021, dose number unknown, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that she got vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and she got diagnosed with Covid 19 on 26Jun2021. The reporter further mentioned that her whole family was vaccinated with the Covid 19 vaccine by Pfizer since Feb2021 and her parents were also diagnosed with Covid 19 on the same day. MD said them that they had the virus breakthrough and she mentioned that it seems to be happening to many people. On 26Jun2021, the patient underwent lab tests and procedures which included being diagnosed with Covid 19 (sars-cov-2 test was positive). The outcome of the event was unknown.  Follow up needed, further information about Lot/Batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021884586 Same reporter/drug/AE, different patient.;US-PFIZER INC-2021884585 Same reporter/drug/AE, different patient.
Within days of receiving vaccine, my joints all over my body were inflamed.  I was unable to walk for several days and my knee joint looked dislocated.  I woke up and was in severe pain.  Within days, many joints left me with little to no mobility.  I have been wearing a brace on my right wrist (dominant side, so unable to complete many daily tasks).  Joints most affected: right wrist, right knee, left and right knuckle joints, left and right thumb joints, left elbow joint.
Miscarriage - diagnosed during ultrasound, but baby appears to have stopped growing about 1 week after vaccine was given.  12/08/09 MR received for DOS 12/07/09. DX: Missed abortion not resolving spontaneously. Pt presented with no complaints. Pt did not have spontaneous abortion, so was referred to Gynecology services.  12/08/09 MR received for DOS 11/30/09. Pt was examined using ultrasound and heart beat was absent consistent with fetal demise. Pt with nausea, but did not have any bleeding or cramping. Assessment: missed abortion. Dr. discussed D&C with Pt, but Pt refused intervention. Pt was to follow up in 1 wk.  12/08/09 MR received for DOS 11/09/09.  Pt presented for first OB visit. Pt received H1N1 vaccine.
fever (tmax 102.1F); chills; Cold sweat; headache; I developed swelling and a mild rash at the injection site; I developed swelling and a mild rash at the injection site; along with axillary lymphadenopathy; I received a third dose of the COVID vaccine on 23Aug/2021 as I am immune compromised and qualify for the booster dose.; I received a third dose of the COVID vaccine on 23/Aug/2021 as I am immune compromised and qualify for the booster dose.; This is a spontaneous report from a contactable Other HCP (patient). A 25-years-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FO8448), via an unspecified route on 23Aug2021 (at the age of 25-years) as dose 3, single in the left arm for covid-19 immunisation. The patient medical history included lupus nephritis, asthma and known allergies to sulfa antibiotics, amoxicillin, hyroxycholoroquine. The patient concomitant medications included Mycophenolic Acid, Tacrolimus (oral), Pantoprazole from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982), via an unspecified route on 28Jan2021 (at the age of 24-years) as dose 1, single in the left arm and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267), via an unspecified route on 18Feb2021 (at the age of 24-years) as dose 2, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Aug2021, the patient received a third dose of the COVID vaccine on 23Aug2021 as I am immune compromised and qualify for the booster dose, 12 hours post-injection, patient experienced fever (tmax 102.1F), chills, cold sweats, and headache. These symptoms resolved around 28 hours post-injection, 36 hours post injection, she developed swelling and a mild rash at the injection site, along with axillary lymphadenopathy. Patient did not received treatment for events. The outcome of the events was fever (tmax 102.1F), chills, cold sweats, and headache, swelling and a mild rash at the injection site, along with axillary lymphadenopathy was recovering and other events was unknown.
PT had shortness of breath, tightness in chest, numbness in both legs. PT ate at 10 am ...we gave PT snack and water at 4pm. PT was cleared by EMS and NP after symptoms resolved.
100 degree fever, headache, abdominal pain, muscle aches, fatigue, diarrhea
It should be noted that this was a booster, but symptoms although the same as the 2nd shot, were worse and lasted longer than 2nd shot.  The arm reaction is new regarding the booster.  Arm itched well into the next week. Fever Headache Overall aches and pain Lethargic Neck and head pain 48 hours after shot injection site turned red circle, felt like bad bruise, itched
"baseball size lump under his armpit "; "baseball size lump under his armpit "/like a swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on 06Jan2021 at SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported. The patient received the Pfizer COVID vaccine on Sunday (06Jan2021), and the next day (07Jan2021), he woke up with a baseball size lump under his armpit. His doctor said it sounded like a swollen lymph node. He thought it was a side effect and wanted to find out if that was expected. Outcome of the events were unknown.   Information on lot/batch has been requested.
9AM 25SEP97 lt upper arm area of redness & warmth to touch 3" wide x 3 1/2";deep aching pain in upper arm-Limited ROM, diff lifting or moving arm;
Last night, eight days after I received the vaccine, I was getting ready for bed, I noticed that my left arm in the area of the injection was itching. I saw a large red oval around the injection site. There is some swelling. I took one antihistamine pill (diphenhydramine hydrochloride 25mg) and went to bed. I awoke at 8:30 AM. The redness and swelling remain, but not the itching. I have not sought medical assistance.
Patient received a dose of expired Menactra with no adverse event.; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- 00561594) and transmitted to Sanofi on 14-Apr-2021.  This case involves a patient with unknown demography who received an expired 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6585AA and expiry date: 11-Apr-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 13-Apr-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter wanted to know what side effects are associated with giving an expired Mentactra to a patient. The reporter also reported that she did not have any additional information available at her location at the time of the call, therefore the AE template was not completed.  At the time of reporting, the patient experienced no adverse event.  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 guidelines. 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.
Severe onset headache, that has lasted throughout the day and continues as patient reports this despite being on medication for 1 year for migraine headaches and not having any headaches for the last 6 months.
Varicella vaccine administered 4/15/04. Patient developed generalized vesicular rash and fever-103.9 4/25/04 Seen in ER. Dx-Viral Syndrome RIT Varicella Vaccine.
Boostrix given instead of Kinrix; Boostrix administered to 4 years-old; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 57GJ2, expiry date 29th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2023, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 24th February 2023, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comments: Office manager reported that a 4 years old patient, supposed to be receiving Kinrix as part of the 4th Dtap-IPV vaccination and received Boostrix by mistake. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The 4 years old patient received Boostrix instead of Kinrix by mistake, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Mom called 09/06/2005, 15 chicken pox spots over body, pox in mouth.
big red large oval on arm it looks like a red band; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (big red large oval on arm it looks like a red band) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced ERYTHEMA (big red large oval on arm it looks like a red band). At the time of the report, ERYTHEMA (big red large oval on arm it looks like a red band) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non significant follow up received on 30-Apr-2021 included Email id.
RECEIVED 1ST DOSE OF PFIZER COVID VACCINE ON 02/21/21. ON 02/27/21 WENT TO ICC F OR RT HIP PAIN AND KNEE PAIN AFTER FALL ON 02/27/21 AND HAD XRAYS.  ON 02/27/21 WENT TO ER AND HAD CT OF RT HIP WO CONTRAST DONE . DIAGNOSED WITH HIP PAIN (ACUTE,RIGHT) AND FALL (INITIAL ENCOUNTER). INSTRUCTED TO FOLLOW UP WITH PCP.
CDC Reports:2 yo child developed fever 104.3, pain, swelling & increased warmth @ inject site for 1 hr, c/o muscular pain in upper arm for 3 days & convulsion following DTP/OPV immun.