chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Paxlovid indication:Treatment of COVID-19; Paxlovid indication:Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster) , single (Lot number: FF2593) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Aug2021 as dose 2 , single (Lot number: 025A21A), in left arm. The patient's relevant medical history included: "Charcot Marie Tooth disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Darvon, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose 1 manufacture unknown), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14May2022, outcome "not recovered" and all described as "Paxlovid indication:Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti viral details product COVID 19 Treatment, brand Paxlovid, treatment start date 30Apr2022, treatment stop date 05May2022, indication Treatment of COVID-19. Covid positive April 30, Paxlovid regimen started April30 completed May 5, tested negative May 6 and continued to test negative through May 13. Symptomatic headache and cough May 14 and test positive. Urgent Care phone consult with nurse advised to treat manageable symptoms with over-the-counter meds, but go directly to ER if symptoms become severe
Information has been received from a health professional concerning a 10 year old male pt who was vaccinated on 06/13/1996 with a dose of varicella virus vaccine, live. Subsequently, on approximately 03/10/2004. the pt  developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that "there was not a single report of an adverse reaction following varicella vaccination". The reporter indicated that 49 other pt's developed breakthrough cases of chicken pox (WAERS  # 0405USA02615, 0405USA00572, 0405USA00573, 0405USA00574, 0405USA00575, 0405USA00576, 0405USA00577, 0405USA00578, 0405USA00579, 0405USA00580, 0405USA00581, 0405USA00582, 0405USA00583, 0405USA00584, 0405USA00585, 0405USA00586, 0405USA00587, 0405USA00588, 0405USA00589, 0405USA00590, 0405USA00591, 0405USA00592, 0405USA00593, 0405USA00594, 0405USA00595, 0405USA00596, 0405USA00597, 0405USA00598, 0405USA00599, 0405USA00600,  0405USA00601,  0405USA00602,  0405USA00603,  0405USA00604,  0405USA00605,  0405USA00606,  0405USA00607,  0405USA00608,  0405USA00609,  0405USA00610,  0405USA00611,  0405USA00612,  0405USA00613,  0405USA00614,  0405USA00615,  0405USA00616,  0405USA00617,  0405USA00618,  0405USA00619).
arm hurt; everything hurt; dizziness; Headache; fever; bone ache; wanted to vomit; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm hurt), MYALGIA (everything hurt), DIZZINESS (dizziness), HEADACHE (Headache) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt), MYALGIA (everything hurt), DIZZINESS (dizziness), HEADACHE (Headache), PYREXIA (fever), BONE PAIN (bone ache) and NAUSEA (wanted to vomit). At the time of the report, PAIN IN EXTREMITY (arm hurt), MYALGIA (everything hurt), DIZZINESS (dizziness), HEADACHE (Headache), PYREXIA (fever), BONE PAIN (bone ache) and NAUSEA (wanted to vomit) 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.   The patient  had symptoms like COVID (headache, fever, bone ache, dizziness, wanted to vomit, everything hurt) and it lasted only one day. The patient's arm  hurt for about a week.  No relevant concomitant medications were reported.  Treatment information was not provided.  Based on HA comment, all events ("Unknown" should be captured).
still dealing with pain on my forehead; This case was reported by a consumer via interactive digital media and described the occurrence of forehead headache in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received shot 8 years ago of reporting date) and Shingles vaccine with an associated reaction of headache (received 1st dose on unknown date, for tolerance refer case US2021AMR094078).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced forehead headache. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the forehead headache was not recovered/not resolved.   It was unknown if the reporter considered the forehead headache to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient got a shot 8 years ago and still came down with it. The patient's physician send him/her to get the new vaccine shot a series of 2 Shots. The patient received Shingles vaccine and experienced pain on forehead.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094078:same reporter
Intussusception was resolved by pneumatic enema. Symptoms started 1 day after vaccine with runny nose and cranky and flu like symptoms then stoppped eating on 12/2 vomiting and abdominal pain on 12/3 ER in 12/3 @ midnight.
Swelling, rash > within 2 days of immunization. Induration = 3 x 4 mm. Erythema = 3 x 3 mm.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number M77B4, expiry date unknown) for prophylaxis. On 4th August 2018, the patient received the 1st dose of SHINGRIX. On 4th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site warmth and injection site itching were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The health care professional did not have expiration date of SHINGRIX because her computer system automatically input it as 1 year from vaccination date. The health care professional reported that the patient received SHINGRIX and presented to the pharmacy on 10th August 2018, with worsening redness at the injection site. Redness was described as warm and itchy and being roughly 5cm in diameter.
Swelling and redness in left deltoid area. Treatment - local ice, OTC pain relief.
Metrorragia (Gyn bleeding) , moderate. Actually happened on both previous moderna COVID-19 vaccine received but I hadn?t correlated it and did not report then
shakiness/she had been real shaky; was getting a little bit of anxiety; 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 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25May2021 13:00 (Lot number: EZ0185, Expiration Date: 31Aug2021) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Panic attack" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TREMOR (non-serious) with onset May2021, outcome "unknown", described as "shakiness/she had been real shaky"; ANXIETY (non-serious) with onset May2021, outcome "unknown", described as "was getting a little bit of anxiety".  Additional information: She said she did not call her own facility because she thought the manufacturer of the COVID-19 Vaccine would have the information she was looking for. She stated she had anxiety, panic attacks, depression, and all that. She asked if the COVID-19 vaccine would make her have any that. Caller was advised she would be transferred to Pfizer Medical Information for further assistance with her question. Reported the face sheet she was given with the COVID-19 Vaccine did not say anything about the COVID-19 vaccine causing anxiety or anything like that, and she was wondering if the COVID-19 vaccine would bring it on because she had been real shaky and was getting a little bit of anxiety.  No follow-up attempts are possible. No further information is expected.
Pt developed  limited ROM, pain in shoulder. DX= sub acromial and subdeltoid bursal synovitis with mild fluid; no nerve damage. Treated with PO steroids, nonsteroidal anti-inflammatory drug (NSAID), cortisol injection.
This employee received both covid  vaccinations (Pfizer) 12/28/20, 1/18/21
Patient received 3 doses of SHINGRIX due to system limitations. First dose received 7/2018, second 12/2018 and third 10/20/21. Computer profile did not go back far enough to see July date. Patient had 101 degree fever the day after the vaccine
UTI infection; swollen lymph nodes,hard to touch; swollen at site of injection; Headache; Fatigue; Tenderness at site of injection; A spontaneous report was received from a consumer concerning a 54 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lymph nodes near neck are swollen and hard to touch, tenderness at site of injection, swollen at site of injection, Urinary tract infections, tiredness and headache.   The patient's medical history was not provided. Relevant concomitant medications were reported "hidden".   On 04-FEB-2021 approximately a week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number012M2 (or 7) 0A) in left arm for prophylaxis of COVID-19 infection.  On 11-FEB-2021 or 12-FEB-2021, the patient started feeling something on the left area near the neck lymph nodes swollen and hard to touch and headache. On that weekend patient experienced tenderness and swollen at injection site and tiredness.  Treatment for the event included two paracetamol for pain and OTC "Quora" for Urinary tract infections on 17-FEB-2021.   The outcome of the events, lymph nodes near neck are swollen and hard to touch, tenderness at site of injection, swollen at site of injection, Urinary tract infections, tiredness and headache, were unknown.; Reporter's Comments: Based on the information provided which includes a temporal association, and known safety profile  of the vaccine, a causal association between the reported events of lymphadenopathy, injection site tenderness and swelling, tiredness and headache  and the administration of the mRNA-1273 vaccine cannot be excluded. Urinary tract infections is assessed as unlikely related to vaccine use but due to an infection
Patient states that he had soreness near the injection site of the left arm later in the day that he received the immunization (12/31/19). He developed a fever in the evening that maxed at 102 F. He took Tylenol with relief of the fever. Patient states that over the next two days his left arm became increasingly sore with a large reddened and hot area in his left deltoid. He presented to Walk In Clinic on 1/3/2020. Physical exam showed a large erythemic and hot area measuring approximately 10 x 6 cm on the left tricep/deltoid area. It had a cellulitic appearance with no fluctuance or discharge. It was tender. He was diagnosed with cellulitis of the left upper extremity and injection site reaction, initial encounter. He was prescribed Keflex 500 mg capsules with directions take 1,000 mg by mouth every eight hours for 5 days. It was also recommended to apply warm compresses to the area.
On approximately 02/15/2023, I had nasal congestion, productive phlegm, no fever, headache. I got better in three to four days, but the symptoms returned 02/22/2023. On 03/03/2023, I went to a clinic. Sinusitis was the diagnosis. I was prescribed medications and the symptoms are gone, except for a slight cough.
Slight itching on upper extremities; Developed a few hives; This is a spontaneous report from a contactable healthcare professional. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 21May2021 at 10:45(at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, osteoarthritis and allergy to penicillin V. Patient previously took potassium (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), fluticasone propionate (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included amlodipine besilate (AMLODIPINE BESYLATE) 10mg 1 tablet daily from unknown start date and for unspecified indication. 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 vaccine. On 21May2021 at 10:45, the patient experienced slight itching on upper extremities and developed a few hives. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with one dose of oral BENADRYL. The clinical outcome of the event slight itching on upper extremities and developed a few hives were recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
her arm felt like it was on fire, body feels flushed, and felt like her throat was going to close up but it didn't; her arm felt like it was on fire, body feels flushed, and felt like her throat was going to close up but it didn't; her arm felt like it was on fire, body feels flushed, and felt like her throat was going to close up but it didn't; Injection site felt like it was on fire; Felt fine today and was fine 2-3 hours after the onset of the hot and fiery feeling; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E73246, expiry date not reported), via an unspecified route of administration on 06Jan2021 14:15 in the left arm at single dose for COVID-19 immunisation. Medical history included cardiac pacemaker insertion, high blood pressure for years. Concomitant medication included apixaban (ELIQUIS). The patient previously took flu shot (FLU VACCINE II) and never had a reaction to the flu shot, macrodantin and experienced drug hypersensitivity and hives. It was reported that about 15:15, injection site felt like it was on fire and then the whole arm felt like it was on fire. The patient got concerned. Her throat felt like it was going to close. Symptoms got less severe. She was fine yesterday and was fine that day. She called her doctor and was advised to put cold compresses on the arm and take Tylenol. She was ok. She read an article that stated if a person had a reaction to not have the second shot. She did not know if her reaction is severe. The second shot is due around 27Jan2021. She wanted to know what to do.  She felt fine on the day of report and was fine 2-3 hours after the onset of the hot and fiery feeling. It was scary and she didn't know what was happening. She also added that around 15:15, the injection arm felt like it was on fire. She felt flushed. Her throat felt like it would close up but never did. Everything resolved 2-3 hours after it started. Clinical outcome of the events was recovered on 06Jan2021.
patient mentioned on July 27 2019 that her arm still hurts sometimes and it took a while for the place of injection to heal
Pt received 2 doses of HPV9 vaccine 6/5/17 and 7/6/17. Went away for college in Aug 2017. Pt started symptoms of depression 2-3 months after 2nd dose of HPV9. He dropped out of college in April 2018, became suicidal in June. I saw him in June 2018, referred him to psychiatrist. He has no prior H/O mental problem/depression.
Moderate swelling, tenderness around injection site left deltoid. R/O cellulitis Tx: Keflex 150 mg PO TID x 10 days.
Pt reported that approximately 2 days after receiving dose, she experience periorbital swelling and hives. She reports that she consulted with her PCP and Dermatologist who diagnosed her with a post vaccination reaction and started oral prednisone and topical cream.  Pt reports that her symptoms are almost resolved.
Body aches all over from neck to legs; severe back pain; headaches; sore ribs; a little out of breath; a little chest pain; very tired; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: elo140), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history included COPD, emphysema, type 2 diabetic, arthritis in hands and knees from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced body aches all over from neck to legs, severe back pain, sore ribs, headaches, a little out of breath, a little chest pain and very tired on 22Dec2020 with outcome of unknown.
Oral shingles lesions; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 13th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th October 2019, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of Shingrix on the left deltoid. On 17Oct2019, the patient was seen by her dentist and was diagnosed with oral shingles (shingles in mouth). No treatment was prescribed at timeof reporting. The reporter was consented to follow up.
Parent stated pt had sz 2hrs p/immun; Was hospitalized  x 2 days for observation & awaiting results of EEG(neg) t100.8 r; Was found to have persistant otitis;
8-year-old female received Ipol 0.5 ml intramuscular in an unknown site on 16Aug2019 inadvertently that had expired on 23Jun2019; Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 8 years old female patient who had received 0.5 mL dose of an expired vaccine IPV (VERO) [IPOL] (N1F181M, expiry date: 23-Jun-2019) inadvertently via intramuscular route in an unknown site on 16-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.   It was a case of actual medication error due to expired vaccine used.  It was not reported if the patient experienced any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  Documents held by sender: none.
Broke out in hives starting 05/04/21 in the evening and lasting till 05/09/21 in the morning.
D DIMER POSITIVE; DIZZY; FEELS TERRIBLE; This spontaneous report received from a company representative via media post and concerned an adult female (age approximately 30).  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient reported dizzy and felt terrible. On an unspecified date, the patient went to urgent care and tested positive for D-Dimer (PT of Fibrin D dimer increased). The patient went to emergency room for full body ultrasound to look for clots.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, feels terrible and d dimer positive was not reported. This report was non-serious.
2 hours after vaccination- extreme tinnitus (both ears) 4 hours after vaccination (dizziness and fatigue)
The patient received Td on 04/07/04. The patient knew that she had received Td in the past but could not remember when. On the morning of 04/09/04 the patient's son called the doctor's office to report that his mother's arm was red and swollen and she had a temperature of 102F. the office asked the patient to come to the office. The patient was seen by a physician who diagnosed cellulitis and prescribed oral Keflex. The patient was told to "re-check" with the office. However, that evening the patient went to ER and was admitted for IV antibiotics. The cellulitis is resolving and physician thins that the patient is going to be fine as far as cellulitis is concerned. The patient is still hospitalized for other issues rather than reaction.
I had a rash which stared on my right front shoulder area. It was about 4cm in circumference. It was not pustular nor itchy or raised. Over the next months, it persisted and spread to my lower abdomen, upper arms, under breast, front of torso and towards the sides of my torso and groin. It was different sizes but all every similar. No drainage or itchiness. I tried some Clobetasol. I saw a dermatologist several times. I had a total of 5 biopsies. I was sent to clinic where they did another 2 biopsies, Malignancies were ruled out. The dermatologist suggested it was definitely from the vaccine. I had received a steroid cream which did not really help. Towards the end of May beginning of June it did eventually go away. The dermatologist did recommend the 3rd dose for me.