chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of Recombivax HB. Subsequently the patient experienced an adverse event. The physician would not provided any further details. There was no product quality complaint involved. No further information is available.
temperature excursion for PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications or concurrent conditions was provided.  On 08-JUL-2021, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot # T034630 was confirmed to be valid, expiration date 22-JUN-2022 (dose, route and site of administration were not reported), for prophylaxis. The administered dose was exposed to the temperature of 75 degrees Fahrenheit (F) for 960 hours. It was reported that the call was not because of a digital data logger and there was no previous temperature excursion.
Patient informed me on 03/30/2022 that her arm was still hurting from a Shingles vaccine I gave her in November 2022. I called her today, April 1, 2023 @ 8:50 a.m.,  to get more information, so I could fill out this form.  I asked her if it was still hurting. She said not as bad. I recommended Ice, Aleve, and Lidocaine gel. I verified which arm. She replied, it is the right arm that hurts. The Shingles vaccine was given into the left arm.  She claims it is the right arm that is sore.  Then she changed the date  to  September 10th, 2022. She received a TDAP and Flu vaccines. Both in the left arm.
This spontaneous report as received from a pharmacist via company representative refers to a 66 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous. Concomitant medications were not provided. The pharmacist stated that the patient had called on Sunday night (date unknown) to report swelling, soreness, tenderness, and redness around the injection after receiving ZOSTAVAX. As a treatment patient was advised to apply ice in the injection site area. Patient did not seek medical attention. Causality assessment was not provided. No further AE information was provided. Product quality complaint was not filed. Additional information has been requested.
I suffer from Meniere's disease and have had 2 episodes over the past 6 months.  Since the vaccine I've had several small episodes and two big episodes in the span of 2 weeks and ongoing.  A big episode will knock me out for hours even up to a day.  See symptoms below.  Small episodes: Dizziness-feel tipsy Nausea Headaches Vomiting   Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking.  Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly   This has affected my work. My doctor told me to report this to you.  I got the 1st vaccine shot on 04/05/21.  I suffer from Meniere's disease and have had 2 episodes over the past 6 months.  Since the vaccine I've had several small episodes and two big episodes n the span of 2 weeks and ongoing. .  A big episode will knock me out for hours even up to a day.  See symptoms below.  Small episodes: Dizziness Nausea Headaches Vomiting   Big episodes: (includes small) Full vertigo, feels like I'm drunk and have trouble walking.  Feels like room is spinning Migraines Pressure in my head makes me feel like a bobble head and wobbly    My second does is scheduled for 04/26/21, should I take it?
nurse gave the Dtap-IPV portion of the Pentacel vaccine only; Initial information received on 09-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient of an unknown demographics who received the dtap-ipv portion only, while received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number, expiry date, route and site of administration were unknown).  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapis were not provided.   It was a case of actual medication error due to inappropriate reconstitution technique.  It was unknown whether the patient had any 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 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.  Information on the batch number was requested  Documents held by sender: none.
administered on 07Jul2022, expiration date of 05Jul2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th July 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 7th July 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 18-Aug-2022 Reporter's Comments: A nurse reported a patient was administered Boostrix vaccine on 7th July 2022, which had an expiration date of 5th July 2022. At the time of reporting, the dose had not been repeated.  Reporter declined to provide patient information aside from gender. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Boostrix, which was already expired, which led to expired vaccine used.
2 days after 1st dose, developed pins and needles in both feet and both hands, with lightning like shocks occasionally. This has persisted, with hands getting a little better, but both feet hurt every day and worse at night- can't sleep. Pain is severe at times. Rubbing and soaking feet does not help. Pain continues day and night, worsening at times. OTC pain medicines do very little. Feels like razor cuts all over feet at times. This is not going away, after 4 months. I only sleep a few hours at a time, because I'm exhausted. Pain in hands occasionally returns for a few hours, on bad days.
Pt reports painful left upper arm after receiving vaccine. Next day took Aleve. Pain from upper arm to elbow, hurts when moves hand in circle. Much improved today. If not improved will contact MD next week.
Initial information received on 08-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 22 years old female patient who was vaccinated with MENACTRA (lot details, dose, route and site of administration were not reported) instead of MENINGOCOCCAL VACCINE B. The patient's past vaccination(s) included MENACTRA in 2008 and 2013. It was an actual medication error due to wrong vaccine administered and extra dose administered. It was reported that that she received a meningitis A,C,Y,W-135 vaccine in 2008, another in 2013, and again in 2017. One of them was supposed to be a meningitis B vaccine, but they gave her the same one again. It was unknown whether the patient had any adverse reactions. 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 Directive and Module VI of the 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. List of documents held by sender: none.
Patient given two vaccination shots, one shot each arm (Hep B and P20). The left arm (P20) seemed to irritate the front left lymph node located just inside the shoulder area and directly below the collar bone.  I first noticed a burning feeling on Friday midday.  No other issues observed. Still has the same feeling  but it seems to be diminishing in intensity. After my second covid-19 shot in the left arm, the same node developed a hard lump about the size of pea that lasted for 5-7 days.
Pain at touch on the arm of injection; Rash is warm; Dizziness; Rash on the arm of injection; Fatigue; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at touch on the arm of injection), FEELING HOT (Rash is warm), DIZZINESS (Dizziness), RASH (Rash on the arm of injection) and FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at touch on the arm of injection), FEELING HOT (Rash is warm), DIZZINESS (Dizziness), RASH (Rash on the arm of injection), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain at touch on the arm of injection), FEELING HOT (Rash is warm), DIZZINESS (Dizziness), RASH (Rash on the arm of injection), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
An 82 year old man have this Prevnar 20 vaccine even though already have both the PPSV 23 and Prevnar 13; An 82 year old man have this Prevnar 20 vaccine even though already have both the PPSV 23 and Prevnar 13; No adverse event; This spontaneous report was received from a consumer via Pfizer concerning a 82-year-old male patient. The patient's medical history, concurrent conditions, previous drugs reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (indication, dose, frequency, route, lot # and expiration date not reported) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) for prophylaxis (frequency, route, lot # and expiration date not reported). However, even though he had already received both vaccines, on an unspecified day, the reporter though that the Pharmacist said he was not supposed to get it but he got it because it was write it as the prescription and he was vaccinated with Pneumococcal 20-valent Conjugate Vaccine (PREVNAR 20) for prophylaxis (dose, frequency, route, lot # and expiration date not reported) Product prescribing issue, (Inappropriate schedule of product administration) (Extra dose administered). No adverse event was seen.
Localized swelling and erythema to upper right arm; Tx: Benadryl 50mg, Motrin 800mg;
My blood pressure was extremely elevated and I had to go to the ER and they held me for 6 hours. I was also very fatigued for about 3 weeks after the shot.
possible cellulitis vs immunization rxn to lt arm deltoid area;adm IV antibiotic;quickly improved, home in 24hr;
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), POLYMENORRHOEA (periods twice a month), PYREXIA (lot of temperature), HEADACHE (headache) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (lot of temperature), HEADACHE (headache), CHILLS (chills) and MYALGIA (body aches). On an unknown date, the patient experienced POLYMENORRHOEA (periods twice a month). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (lot of temperature), HEADACHE (headache), CHILLS (chills) and MYALGIA (body aches) had resolved and POLYMENORRHOEA (periods twice a month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-102397 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-MAY-2021 contains significant information- Outcome and new event added On 12-May-2021: Follow-up information received on 12-MAY-2021 contains non-significant information.
pt recvd vax in 1990 & devel GBS which resulted in pain, fatigue, neuropathies, muscle weakness, paralyzation, numbness, tingling in the extremities, balance disturbances, SOB, sense of coldness in extremities, paresthesias;
Shot arm very sore on day 2 after shot but also very sore on day 7 after shot. Red splotch about 4 inches in diameter around injection site. Red splotch is warm to the touch and a bit swollen. Also itchy on day 8 after  the shot.
03/06/2018 16:10 Temp 99.3 TYLENOL given 16:21. 03/06/2018 20:20 Temp 100.9 Afebrile after this. MOTRIN given 20:45. 03/07/2018 noted in doctor's rounds right upper arm pain and redness. 03/07/2018 11:42 dx with cellulitis and KEFLEX ordered. Received first dose 11:56. 03/08/2018 09:54 swelling, redness increased, firm tender areas warm to touch. Monitor. 03/09/2018 10:48 erythema receding / fading. Discharged routinely.
FEVER OF 101.2 DEGREES FAHRENHEIT; HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, the batch number was not reported and has been requested) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced fever of 101.2 degrees Fahrenheit, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 101.2 degrees Fahrenheit and headache was not reported. This report was non-serious.
Patient was given egg free vaccine. Had hives, trouble breathing was given 1 mg of EPI and symptoms resolved. Was advised to follow up in emergency room, but she declined.
Vertigo with first shot; body aches like the flu after the first dose; body aches like the flu after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo with first shot), INFLUENZA (body aches like the flu after the first dose) and MYALGIA (body aches like the flu after the first dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PROBIOTICS NOS, VITAMINS NOS and VITAMIN B NOS for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo with first shot), INFLUENZA (body aches like the flu after the first dose) and MYALGIA (body aches like the flu after the first dose). At the time of the report, VERTIGO (Vertigo with first shot), INFLUENZA (body aches like the flu after the first dose) and MYALGIA (body aches like the flu after the first dose) outcome was unknown. Not Provided      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.   Concomitant medications included Atrial fibrillation medications, Blood pressure medications, Thyroid medications, Reflux medications, Antidepressants, ADHD medications. No treatment information reported.   This case was linked to MOD-2021-116489 (Patient Link).
Extreme sensitivity in pads and tips of all fingers, followed by subdermal bumps and blisters. Blisters eventually (over 3-4 days) worked to surface and broke (water only). I reported effects to clinic then but was told it wasn't a symptom. Blisters eventually stopped appearing over 4 months period.
Patient fainted in parking lot 5 minutes after receiving the yellow fever vaccine. Subsequently was brought back into the clinic by her mother to rest and recover. Within 5 minutes, patient's arms and hands began to shake. During this time, patient was unresponsive to verbal commands however was awake. Patient recovered in 5 minutes after skaking.
Apr 8th: 10:30AM - Vaccination  -Mild Fatigue, Body Aches Apr 9th: Vaccine Symptoms -Fatigue, Body Ache, Mild Fever Apr 10th-12th: No Issues Apr 13: Urticaria all over body, started from morning Apr 14-15th: Full Body Urticaria, Acidity, Uncomfortable feeling, Feels like lump in throat Prednisone Medrol Dosepak 5mg/Triamcinolone Acetonide No symptoms during prednisone dosage, itchiness started to appear at 10mg/5mg dosage Apr 20th-23rd: Symptoms Recurred, now including small swelling in fingers and toes Apr 24th-29th: 2nd medrol dosepak prednisone, all symptoms subside. Itchniness appeared in 10mg/5mg dose Apr 30th: Hives Returned, Acidity, Lump in Throat
On 02/19/2001 the patient's mother called the office to tell them that her son had a mild case of chicken pox. It was reported that the child had less than 30 lesions and a low grade fever. Unspecified medical attention was sought. Follow up information has been received which states that the patient had "about 30 lesions, no fever, stuffy nose,  and itch". The patient was advised to use Aveeno anti itch. Additional information has been requested.
At around 1030 hours the patient felt: dizzy, lightheaded, nauseous, had blurry vision, tightness in her throat, and was hypotensive with a BP of 62/27 and HR of 45. At around 1035 hours the patient was given 0.3 mg of epinephrine and her BP was then 81/37 and a HR of 55. Medics arrived at 1040 hours and the patient was sent to a hospital.
Approx. 5 mins after vaccination in (L) arm, pt felt (R) hand weakness that lasted 1 hr, then resolved. Also experienced 5 mins of (L) hand weakness during episode. Now resolved with no lingering effects.
Intense Vertigo episodes lasting 5 seconds at a time After the FIRST Shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Intense Vertigo episodes lasting 5 seconds at a time After the FIRST Shot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant product use was not provided.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced VERTIGO (Intense Vertigo episodes lasting 5 seconds at a time After the FIRST Shot). On 06-Feb-2021, VERTIGO (Intense Vertigo episodes lasting 5 seconds at a time After the FIRST Shot) outcome was unknown.            This case was linked to MOD-2021-066581 (Patient Link).
21 adult patient received only the Fluzone Quadrivalent 1.0 ml dose, no adverse event; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 21 adult patients (age not reported) who were vaccinated with a 1.0 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number , Exp. Date, dose, route and site of administration not reported) on 22-Oct-2019.  The patient's medical history not reported and no patient received any other vaccine.  It was an actual medication error case due to overdose.  No adverse event reported at the time of reporting.  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 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.  Information on the batch number was requested.
INFLAMMATION OF ARMPIT GANGLIONS (INMEDIATELY AFTER THE SHOT). PAINFUL, COULD NOT LIFT MY ARMS. FEELING CONSTANLTY SICK (GOT THE FLU, INFECTED TONSILS WITHIN 2 MONTHS OF THE SHOT). Weak immune defenses. Ganglions in armpits and inguen are swollen still (stressed lymphatic system). No specific treatment. Trying to strengthen immune system.
This spontaneous report was received from a pharmacist referring to a 12 months old male patient. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2016, the patient was vaccinated with PROQUAD (injection, 5ml, lot #L046506, expiration date 15-MAY-2015, by subcutaneous route), PEDVAXHIB (injection), ENGERIX-B, PREVNAR and HAVRIX. There were no concomitant medications reported. The primary reporter stated that on 02-SEP-2016, the patient developed a rash on his face and chest. The pharmacist stated that a rapid strep test was performed on 02-SEP-2016, which the result was negative. The outcome of the event was not recovered and no product quality complain was involved. Additional information has been requested.
On 12-Mar-2023 I received a Tetanus vaccination of which I had after effects from. I had my temperature checked in the middle of the night with a 105 degree fever (which broke by morning). I was achy and sore all over and had extremely sensitive teeth. These symptoms only lasted one day. Then the following day I noticed a very sore and swollen lymph node above my left collar bone. The sore and swollen lymph node is still in that condition at the time of this report.