chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Peripheral neuropathy of feet and hands; flulike symptoms; Post Herpetic Neuralgia; pain in joints of toes; This case was reported by a physician via call center representative and described the occurrence of peripheral neuropathy in a elderly female patient who received Herpes zoster (Shingrix) (batch number M95T2, expiry date 20th July 2020) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (for tolerance of 1st dose, refer case US2019153184).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), influenza-like symptoms, post herpetic neuralgia and joint pain. On an unknown date, the outcome of the peripheral neuropathy, influenza-like symptoms, post herpetic neuralgia and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathy, influenza-like symptoms, post herpetic neuralgia and joint pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician called regarding adverse events experienced by his wife after receivng Shingrix.  The patient had peripheral neuropathy feet and hands, post herpatic neuralgia, flu like symptoms. The patient had also experienced pain in joints of toes. The symptoms were getting progressively a little worse. Peripheral neuropathy was severe. These symptoms had been persisting for almost 3 weeks now. The reporter consented to follow up. The batch number of Shingrix was reported as M9512, which was corrected to M95T2 as per sales data sheet.
Pt became lightheaded and pale. We had pt sit back down in a chair, gave pt some juice and monitored pt for 30 mins. Pt was released to his father once blood pressure was in normal rang and color returned to his face.
Patient is 13 years old, and he received Moderna approved for 18 years and older. The patient and parent came in today on 1/28/2023 to get the second dose of the vaccine. I realized then that he had received the first dose in error. I told the family I would fill out appropriate forms, and ask CDC the best course of action from here. The CDC recommended not to give another dose of Moderna approved for 18 years and older. The patient has not had any adverse effects to the vaccine, but I am reporting this because the wrong dosage/vaccine was given to him.
Headache & Chills  for 24 hours starting on 13 Jan 2021 @ 19:30. Sore Left upper arm for 3 days following the vaccination.
About a month after the vaccine late that night I developed increased leg pain.  My hip and knee joint is so inflammed it cause issues with sleeping and I was diagnosed with Versitis in my hip and sent me to physical theraphy
pt recv vax & devel an inj site rxn characterized by a golfball size area of redness, swelling & warmth;rxn was described as cellulitis;
03-04-2021:  12 hours temp 101.4    10hours temp 99.9  headache. body aches . relentless chills. mild nausea. no appetite .  Aleve  03-06-2021 Return to perfect normalcy. temp 97.8 (typical for my body)
pt had rxn to vax pt rt arm red, hot, itching & hard;pt recv vax 10MAR97 & pt called about rxn on 17MAR97 was told cold soaks & PDH & medrol dose pack;
PT reprots first siezures 8 days after shot, no siezures again. is on gabapentin now.
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure systolic: 220. On an unknown date, Tachycardia: greater than or equal to 150..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medication was provided by reporter.  No treatment medication was provided by reporter.  Reporter stated she has been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and has seen 88-90% success rate in resolving the symptoms of long-haul COVID.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 Patients received bivalent booster with 38 having improvement of symptoms and 50s or more. Patient was treated skin lesions, scary brain, body aches. No adverse reactions occurred.     This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
developed a bumpy red rash on the side of her face; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer-sponsored program reporting for herself (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: not reported, expiry: unknown) via an unspecified route of administration on 16Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2021 after 6 hours of vaccination, the patient developed a bumpy red rash on the side of her face. She asked how to prevent these side effects from the vaccine. The outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 04-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 vaccine had two temperature excursions; one of 24 hours and other one of 32 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius) and the highest recorded temperature was 48 F (8.888888889 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
The patient got two shots and went through COVID; The patient got two shots and went through COVID; This is a spontaneous report from a contactable consumer reporting for the doctor. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got two shots and went through COVID on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient reported on 1/26/07 that rash to chest started on 11/7/07. Rash spread to neck 11/7/07 - 11/12/07. On 11/12/07 patient was evaluated by her PMD. Information provided on 11/26/07.
Very tired; Nauseous; Slight cramp in left thigh or leg; Tiredness and feeling unwell; This is a spontaneous report from a contactable consumer.  A 85-years-old female patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration, administered in left arm on 29Jan2021 as single dose for prophylaxis, COVID-19 immunization. the patient does not received other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported but other relevant medical history including but not limited to these conditions: Diagnosed allergies, compromised immune status, Respiratory illness, Genetic Chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity from unknown. The concomitant medications were not reported. On 04Feb2021 08:00 patient experienced (at the age 0f 86-years-old time of onset reaction or event occurred) very tired (fatigue), nauseous (nausea), slight cramp in left thigh or leg (muscle spams) and tiredness and feeling unwell (malaise). Received call from consumer regarding the Pfizer COVID vaccine.  She was called on behalf of someone else. They received their first vaccination on 29Jan2021, and on page 3, she was reading the side effects.  Patient reports being very tired today.  She also felt nauseous and had a cramp in her leg that disappeared almost as quick as it came. The outcome of the events was recovering.  Information on the Lot/batch number has been requested.
Swelling and red rash around the injection site that did not occur until one week following the injection. It is itchy and raised
history of Pulmonary Ventricular Contractions (PVC's) that increased after the vaccine; mild numbness on the left side of their chin and lip that came and went for a few days/numbness subsided during the day but increased in the evening; painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,; patient was feeling uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (history of Pulmonary Ventricular Contractions (PVC's) that increased after the vaccine), HYPOAESTHESIA (mild numbness on the left side of their chin and lip that came and went for a few days/numbness subsided during the day but increased in the evening), FACIAL PAIN (painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,) and FEELING ABNORMAL (patient was feeling uncomfortable) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included Premature ventricular contractions.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPOAESTHESIA (mild numbness on the left side of their chin and lip that came and went for a few days/numbness subsided during the day but increased in the evening), FACIAL PAIN (painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,) and FEELING ABNORMAL (patient was feeling uncomfortable). On an unknown date, the patient experienced VENTRICULAR EXTRASYSTOLES (history of Pulmonary Ventricular Contractions (PVC's) that increased after the vaccine). On 19-Mar-2021, FACIAL PAIN (painful and uncomfortable numbness in the left side of their chin and lip that spread to their teeth,) had resolved. At the time of the report, VENTRICULAR EXTRASYSTOLES (history of Pulmonary Ventricular Contractions (PVC's) that increased after the vaccine) and HYPOAESTHESIA (mild numbness on the left side of their chin and lip that came and went for a few days/numbness subsided during the day but increased in the evening) had not resolved and FEELING ABNORMAL (patient was feeling uncomfortable) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.   The patient took ibuprofen and loratadine for treatment of symptoms which provided temporary relief.   This case was linked to MOD-2021-052734 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: F/U 1:  No new information was received.
Patient was given a supplemental dose .5 ml when they should have received a booster .25 ml.
2 days after the 2nd dose my asthma was triggered.  This flare up was the worst I have ever experienced.  My chest consistently feels tight and pressure.  Shortness of breath and chest pain.  Followed up with pulmonologist.  2 rounds of prednisone, started Clarinex and singulair again, started advair and spiriva.  Consistently needing to use nebulizer several times a day since that day.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies / reactions and concomitant medication were unknown. On 08-DEC-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (Lot number reported as M035148, expiration date 25-OCT-2017) dose, route and anatomical location were not provided for prophylaxis.        No adverse effects were reported. There was no previous excursion reported. The temperature time excursion was 17F for 48 hours and 8F for 120 hours. No data logger was reported. Additional information has been requested.
Post vax, had flu/cold-like symptoms for over a week with sneezing, coughing, headaches, low-grade fever, stuffy head, tired and just sore all over.
Information has been received from a physician concerning a patient who on 31-MAY-2007 was vaccinated with a dose of ZOSTAVAX. In approximately July 2007, the patient developed a rash. There was no other information provided. There was no product quality complaint in involved. Additional information has been requested.
Pt has reddening and swelling that wrapped around arm. Headache and hot to touch.
Fever of 102-103, malaise, body aches, runny nose, tiredness for 4 days
More than 2 days after DTAP, fever 102 T max followed by seizure (generalized) tonic clonic. Seizures: occurred (2x). (5 hours apart). Cough barking & seal like cough. Given ALBUTEROL & PULMICORT inhalation. (+) relief. Next day better. Painful. No history of AE's seizure in the past.
would like to know if an adult only got the .25 , does the patient need to do anything or come back in for another 0.25mL of the Bivalent vaccine?/It would be 0.25mL of the Moderna Bivalent 6 year and up; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (would like to know if an adult only got the .25 , does the patient need to do anything or come back in for another 0.25mL of the Bivalent vaccine?/It would be 0.25mL of the Moderna Bivalent 6 year and up) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (would like to know if an adult only got the .25 , does the patient need to do anything or come back in for another 0.25mL of the Bivalent vaccine?/It would be 0.25mL of the Moderna Bivalent 6 year and up) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (would like to know if an adult only got the .25 , does the patient need to do anything or come back in for another 0.25mL of the Bivalent vaccine?/It would be 0.25mL of the Moderna Bivalent 6 year and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (would like to know if an adult only got the .25 , does the patient need to do anything or come back in for another 0.25mL of the Bivalent vaccine?/It would be 0.25mL of the Moderna Bivalent 6 year and up).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
1st shot on 2-3-2021 at 2 PM, Bad diarrhea on 2-5-2021 at 1 AM, lasted about 2 hrs; 2nd shot on 3-3-2021,at 2 PM, bad diarrhea  started on 3-7-3032 at 1 AM, lasted about 2 hrs
Red, inflamed skin at the injection site, warm to the touch. Patient also states pain, itching at the injection site.
Mother specifies that after the PNEUMOVAX 23 vaccine was administered on the left arm there was swelling, she complained of pain, it was warm to touch, redness and fever. She was examined by doctor and was prescribed Cephalexin 250mg/oral/6ml/every 8 hours for 7 days.
Started to feel ill five hours after the shot--tired, migraine, fatigue. During the night, my lymphoids under my left arm and in my right side of my neck swelled--felt like a golf ball in both areas.  The migraine stayed constant for over a day.  I could barely walk the following morning after the shot.  Incredible pain in my hips, knees, arms, and left shoulder blade.   As the day went on, I started to experience coughing and some tightness in my chest.  I called my doctor in order to get an inhaler.  My asthma tends to become active when I am ill.  Once I used the inhaler and laid down, the pressure in my chest eased.  My joint and muscle pain and spasms didn't ease until the third day.
-Right thigh - 2 cm round erythema and tender. -Left thigh - 5 cm round erythema and tender. Getting smaller per Mom.
She became very nervous right after the shot. Seemed confused. Had trouble getting her thoughts together. She became very depressed, started her period (which she takes medication to stop her period, having a period is very unusual), she ran a fever, loose bowel movements. Ever since the shot she has been very depressed and confused. She was doing very well prior to the shot. She has a brain injury and had been sick for sometime due to an emotional breakdown. Had been on medication to help calm her and help her to not be confused anymore. She had been doing so well we were able to wean her off of the medication. Now she is back on it cause once she got the Gardasil shot she changed right away. has even told us the shot made her sick. She has special needs and for her to make a connection to the shot and her not feeling well, that says a lot.
Pt stated she "got sick" after receiving flu vaccine. had fever of 100 degrees F. No arm soreness. Client stayed home and rested. Symptoms resolved.
08/08/03 started with rash on neck and trunk - on Benadryl. On 8/11/03 a few new lesions on arm and legs - still on Benadryl, baking soda or corn starch baths.
1 day after receiving shingles shot multiple blisters (pea sized spots) formed on lower right leg, also, blotchiness at injection site and in the same area on the other arm.  Follow-up discussion with primary physician - wash only with soap and water, also recommended a lotion to temper itchiness.
Severe pain began in bicep almost 6 hours after receiving vaccines. Within an hour of onset, I was unable to even move a finger without it causing excruciating pain in my entire upper arm (like a red hot poker had been inserted with a thousand hot needles extending with movement). For the next 3 days I was unable to sleep and or move because of pain, despite the pain medications and muscle relaxants I take. Pain has very gradually subsided but a week after receiving vaccines, I still have considerable pain with movement and to touch, and I'm unable to lift or carry anything without added pain. There was never any swelling or redness, but I did have a fever between 101.1 and 102.3 for the first 3 days.
Patient presented to pharmacy the day after administration complaining of bruising, a hard knot under the skin, and previous excess bleeding at injection site.  I examined the injection site and observed some bruising and a lump under the skin.  I did not observe bleeding, redness, or other signs of infection.  Patient denied any sudden movement during administration which could have caused more than usual muscle injury. I advised the patient to watch for worsening symptoms and/or signs of infection such as increased swelling, redness, fever, or heat at injection site, and to call or come back to the pharmacy if this occurs. I also suggested and ice pack to reduce swelling and pain if she wished.
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 78-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported
My arm was very sore and aching at the injection site. Following my neck started hurting on the left side and it got very swollen and I kept waiting for it to get better and it kept getting worse. I went to see my doctor on March 3, 2021, we did thyroid test was normal, ultra sound found a tumor and did a biopsy and following the right side started hurting and all was normal. It was a inflammation. Went to see a ENT and suggested to get tumor removed and I didn't want to, I later started feeling very fatigue, and ran more thyroid test and it was hyperthyroidism and was sent to endocrinologist and was put on a heart monitor. Now I'm being monitored for 18 months to allow the thyroids run its course. My body is fighting a viral infection and I think its from the vaccine.
Pt recvd vax 19AUG92 & 2 days later devel hives; seen by MD treated w/DPH & w/in 3 days sx resolved;